Psoriasis
Conditions
Keywords
chronic, severe, treatment, safety, CP-690,55, Plaque Psoriasis, Psoriasis Vulgaris, Xeljanz, Tofacitinib
Brief summary
The main objective of this study is to evaluate the long-term safety of CP-690,550 in patients being treated for moderate to severe chronic plaque psoriasis. This is an open label extension study available to patients who participated in one of the qualifying studies with CP-690,550 providing entry criteria is met.
Detailed description
The study terminated on 08MAR2016 as it met its objectives of characterizing long term safety and tolerability. The study did not terminate due to safety concerns.
Interventions
DRUGCP-690,550
5 mg oral BID
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have participated in qualifying study with CP-690,550 and are 18 years or older with diagnosis of plaque-type psoriasis (psoriasis vulgaris).
Exclusion criteria
* Non-plaque or drug induced forms of psoriasis; * Cannot discontinue current oral, injectable or topical therapy for psoriasis or cannot discontinue phototherapy (PUVA or UVB). * Any uncontrolled significant medical condition.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Malignancy Events | Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months) | Malignancy events included lymphoma, and demyelinating neurologic events. Biopsies collected for malignancy events were submitted to the central laboratory for pathologist over-read. |
| Number of Participants With Clinically Significant Change From Baseline in Physical Examination | Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months) | Physical examinations included: general appearance; skin, head, eyes, ears, nose and throat; heart; lungs; abdomen; lower extremities (for the presence of peripheral edema) and lymph nodes. Clinical significance of change from baseline values in physical examination was based on investigator's discretion. |
| Number of Participants With Vital Sign Abnormalities | Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months) | Criteria for abnormalities in vital signs included: Systolic blood pressure (SBP): less than (\<) 90 millimeter of mercury (mmHg) and maximum increase from baseline (IFB) of greater than or equal to (\>=) 30 mmHg; diastolic blood pressure (DBP): \<50 and greater than (\>) 120 mmHg and maximum IFB of \>=20 mmHg; heart rate: \<40 and \>120 beats per minute. |
| Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 1 | Baseline, Month 1 | — |
| Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 3 | Baseline, Month 3 | — |
| Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 6 | Baseline, Month 6 | — |
| Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 12 | Baseline, Month 12 | — |
| Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 24 | Baseline, Month 24 | — |
| Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 36 | Baseline, Month 36 | — |
| Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 48 | Baseline, Month 48 | — |
| Change From Baseline in Heart Rate at Month 1 | Baseline, Month 1 | — |
| Change From Baseline in Heart Rate at Month 3 | Baseline, Month 3 | — |
| Change From Baseline in Heart Rate at Month 6 | Baseline, Month 6 | — |
| Change From Baseline in Heart Rate at Month 12 | Baseline, Month 12 | — |
| Change From Baseline in Heart Rate at Month 24 | Baseline, Month 24 | — |
| Change From Baseline in Heart Rate at Month 36 | Baseline, Month 36 | — |
| Change From Baseline in Heart Rate at Month 48 | Baseline, Month 48 | — |
| Number of Participants With Electrocardiogram (ECG) Abnormalities | Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months) | Criteria for ECG abnormality: PR interval \>=300 milliseconds (msec); QT interval \>=500 msec; QTcB (Bazett's Correction) and QTcF (Fridericia's Correction) 450 to \<480 msec, 480 to \<500 msec and \>=500 msec. |
| Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 | Baseline, Month 6 | — |
| Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 12 | Baseline, Month 12 | — |
| Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 24 | Baseline, Month 24 | — |
| Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 36 | Baseline, Month 36 | — |
| Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 48 | Baseline, Month 48 | — |
| Number of Participants With Adjudicated Cardiovascular Events | Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months) | Adjudicated cardiovascular events were assessed by adjudication committee as independent reviewers based on event documentation including: hospital discharge summaries, operative reports, clinic notes, ECGs, diagnostic enzymes, results of other diagnostic tests, autopsy reports and death certificate information; as applicable. |
| Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 3 | Baseline, Month 3 | — |
| Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 6 | Baseline, Month 6 | — |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 4 weeks after last dose (up to 67 months) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events. |
| Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 12 | Baseline, Month 12 | — |
| Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 24 | Baseline, Month 24 | — |
| Number of Adverse Events (AEs) by Severity | Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months) | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified according to the severity in 3 categories: a) mild: AEs did not interfere with participant's usual function; b) moderate: AEs interfered to some extent with participant's usual function; c) severe: AEs interfered significantly with participant's usual function. |
| Number of Participants With Laboratory Abnormalities | Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months) | Abnormality criteria: hematology (hemoglobin, hematocrit, red blood cell \<0.8\*lower limit of normal \[LLN\]; reticulocyte\<0.5\*LLN,\>1.5\*ULN; platelets\<0.5\*LLN,\>1.75\* upper limit of normal \[ULN\]; WBC\<0.6\*LLN, \>1.5\*ULN; lymphocytes, neutrophils, basophils, eosinophils, monocytes\<0.8\*LLN; \>1.2\*ULN; coagulation (prothrombin \[PT\], PT ratio\>1.1\*ULN) liver function (bilirubin\>1.5\*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma GT\>0.3\*ULN, protein, albumin\<0.8\*LLN; \>1.2\*ULN, globulin\<0.5\*LLN; \>1.5\*ULN); renal function (blood urea nitrogen, creatinine\>1.3\*ULN); electrolytes(sodium\<0.95\* LLN; \>1.05\* ULN, potassium, chloride, calcium, bicarbonate\<0.9\*LLN; \>1.1\*ULN), chemistry (glucose\<0.6\*LLN; \>1.5\* ULN), urinalysis (pH \<4.5;\>8, glucose, ketones, protein, blood, urobilinogen, nitrite, bilirubin, leukocyte esterase\>=1; RBC, WBC\>=20); lipids (cholesterol \[C\], LDL-C \>1.3\*ULN, HDL-C\<0.8\*LLN, triglycerides\>1.3\* ULN), hormones(T4, T3, T4, TSH\<0.8\* LLN; \>1.2\* ULN). |
| Change From Baseline in Hemoglobin Level at Month 1 | Baseline, Month 1 | — |
| Change From Baseline in Hemoglobin Level at Month 3 | Baseline, Month 3 | — |
| Change From Baseline in Hemoglobin Level at Month 6 | Baseline, Month 6 | — |
| Change From Baseline in Hemoglobin Level at Month 12 | Baseline, Month 12 | — |
| Change From Baseline in Hemoglobin Level at Month 24 | Baseline, Month 24 | — |
| Change From Baseline in Hemoglobin Level at Month 36 | Baseline, Month 36 | — |
| Change From Baseline in Hemoglobin Level at Month 48 | Baseline, Month 48 | — |
| Change From Baseline in Lymphocyte and Neutrophil Count at Month 1 | Baseline, Month 1 | — |
| Change From Baseline in Lymphocyte and Neutrophil Count at Month 3 | Baseline, Month 3 | — |
| Change From Baseline in Lymphocyte and Neutrophil Count at Month 6 | Baseline, Month 6 | — |
| Change From Baseline in Lymphocyte and Neutrophil Count at Month 12 | Baseline, Month 12 | — |
| Change From Baseline in Lymphocyte and Neutrophil Count at Month 24 | Baseline, Month 24 | — |
| Change From Baseline in Lymphocyte and Neutrophil Count at Month 36 | Baseline, Month 36 | — |
| Change From Baseline in Lymphocyte and Neutrophil Count at Month 48 | Baseline, Month 48 | — |
| Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 1 | Baseline, Month 1 | — |
| Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 3 | Baseline, Month 3 | — |
| Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 36 | Baseline, Month 36 | — |
| Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 48 | Baseline, Month 48 | — |
| Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 6 | Baseline, Month 6 | — |
| Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 12 | Baseline, Month 12 | — |
| Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 24 | Baseline, Month 24 | — |
| Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 36 | Baseline, Month 36 | — |
| Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 48 | Baseline, Month 48 | — |
| Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 1 | Baseline, Month 1 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Greater Than or Equal to (>=) 75 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Baseline, Month 1, 3, 6, 12, 24, 36, 48 | PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck \[h\], upper limbs \[u\], trunk \[t\] and lower limbs \[l\]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of participants with \>=75 percent (%) reduction from baseline in PASI scores were reported. |
| Psoriasis Area and Severity Index (PASI) Scores | Baseline, Month 1, 3, 6, 12, 24, 36, 48 | PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck \[h\], upper limbs \[u\], trunk \[t\] and lower limbs \[l\]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. |
| Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 | Baseline, Month 1, 3, 6, 12, 24, 36, 48 | PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck \[h\], upper limbs \[u\], trunk \[t\] and lower limbs \[l\]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. |
| Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Baseline, Month 1, 3, 6, 12, 24, 36, 48 | PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Erythema was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. |
| Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Baseline, Month 1, 3, 6, 12, 24, 36, 48 | PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Induration was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. |
| Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Baseline, Month 1, 3, 6, 12, 24, 36, 48 | PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Scaling was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. |
| Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Baseline, Month 1, 3, 6, 12, 24, 36, 48 | PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Erythema was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. |
| Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Baseline, Month 1, 3, 6, 12, 24, 36, 48 | PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Induration was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. |
| Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Baseline, Month 1, 3, 6, 12, 24, 36, 48 | PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Scaling was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. |
| Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Baseline, Month 1, 3, 6, 12, 24, 36, 48 | PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck \[h\], upper limbs \[u\], trunk \[t\] and lower limbs \[l\]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of participants with \>=50% reduction from baseline in PASI scores were reported. |
| Percentage of Participants Achieving Greater Than or Equal to (>=) 90 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Baseline, Month 1, 3, 6, 12, 24, 36, 48 | PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck \[h\], upper limbs \[u\], trunk \[t\] and lower limbs \[l\]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of participants with \>=90% reduction from baseline in PASI scores were reported. |
| Percentage of Participants Achieving Greater Than or Equal to (>=) 125 Percent Increase From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Baseline, Month 1, 3, 6, 12, 24, 36, 48 | PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck \[h\], upper limbs \[u\], trunk \[t\] and lower limbs \[l\]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of participants with \>=125% increase from baseline in PASI scores were reported. |
| Itch Severity Item (ISI) Scores | Baseline, Month 1, 3, 6, 12, 24, 36, 48 | ISI assessed severity of itching due to psoriasis. ISI was a single item, horizontal numeric rating scale. Participants were asked to rate their 'severity of itching' due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms '0=no itching' and '10=worst possible itching' at the ends. Higher scores indicated greater severity of itching. |
| Change From Baseline in Itch Severity Item (ISI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 | Baseline, Month 1, 3, 6, 12, 24, 36, 48 | ISI assessed severity of itching due to psoriasis. ISI was a single item, horizontal numeric rating scale. Participants were asked to rate their 'severity of itching' due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms '0=no itching' and '10=worst possible itching' at the ends. Higher scores indicated greater severity of itching. |
| Dermatology Life Quality Index (DLQI) Scores | Baseline, Month 1, 6, 12, 24, 36, 48 | The DLQI was a validated, self-administered, 10-item quality-of-life questionnaire that consisted of 10 items that assessed the impact of skin disease on quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). Each question was scored on a scale of 0=not at all/not relevant to 3=very much. Response from all of the 10 questions were added to derive the DLQI total scores. Total DLQI scores ranges from 0=not at all to 30=very much, with higher scores indicating greater impairment in quality of life. |
| Change From Baseline in Dermatology Life Quality Index (DLQI) Scores at Month 1, 6, 12, 24, 36 and 48 | Baseline, Month 1, 6, 12, 24, 36, 48 | The DLQI was a validated, self-administered, 10-item quality-of-life questionnaire that consisted of 10 items that assessed the impact of skin disease on quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). Each question was scored on a scale of 0=not at all/not relevant to 3=very much. Response from all of the 10 questions were added to derive the DLQI total scores. Total DLQI scores ranges from 0=not at all to 30=very much, with higher scores indicating greater impairment in quality of life. |
| 36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Physical Component Summary Scores | Baseline, Month 6, 12, 24, 36, 48 | The SF-36 questionnaire, version 2, acute was a 36-item generic health status measure. SF-36 evaluated 8 health-related aspects of an individual: physical functioning, role-physical, bodily pain, social functioning, mental health, role emotional, vitality, and general health. The score range for each of the 8 health aspects ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition. Two summary scale scores were computed from the 8 health aspect scores: physical component summary score and mental component summary score. Score range for both summary scales ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition. |
| 36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Mental Component Summary Scores | Baseline, Month 6, 12, 24, 36, 48 | The SF-36 questionnaire, version 2 was a 36-item generic health status measure. SF-36 evaluated 8 health-related aspects of an individual: physical functioning, role-physical, bodily pain, social functioning, mental health, role emotional, vitality, and general health. The score range for each of the 8 health aspects ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition. Two summary scale scores were computed from the 8 health aspect scores: the Physical Component Summary and the Mental Component Summary. Score range for both summary scale ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition. |
| Number of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear | Baseline, Month 1, 3, 6, 12, 24, 36, 48 | The PtGA evaluated the overall skin disease of participants at that point in time on a single-item. Participants provided their response on a 5-point scale ranges from: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe. Higher score indicated greater severity of disease. Participants who provided their response as clear (score of 0) or almost clear (score of 1) in PtGA at each specified visit were reported in this outcome measure. |
| Euro Quality of Life- 5-Dimensions (EQ-5D)-Utility Scores | Baseline, Month 6, 12, 24, 36, 48 | EQ-5D: participant rated 5-dimension (mobility, self-care, usual activities, pain and discomfort, and anxiety and depression) questionnaire to assess health-related quality of life in terms of a single utility score. Each dimension was assessed on a 3-point scale (1=no problems, 2=some problems, 3=extreme problems, where higher scores=worse health condition). The responses from the 5 dimensions were used to calculate a single utility index value. Scoring formula developed by EuroQol Group assigned a utility value for each dimension in the profile. Score was transformed and results in a total score range -0.594 to 1.000; higher score indicated a better health state. |
| Euro Quality of Life-5-Dimensions (EQ-5D)-Visual Analogue Scale Scores (VAS) | Baseline, Month 6, 12, 24, 36, 48 | EQ-5D VAS was a participant rated questionnaire to assess health-related quality of life in terms of a single index value. It was a visual analogue scale that ranged from 0 (minimum) to 100 (maximum), with higher scores indicating a better health condition. |
| Number of Participants Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) | Baseline, Month 1, 3, 6, 12, 24, 36, 48 | Ps-HCRU was a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. In the first section, it assessed direct costs associated with healthcare resource use which included participant's interactions with healthcare providers such as general practitioners, dermatologists, cardiologists, gastroenterologists, psychiatrists, surgeons and nurses. When taking the evening dose of tofacitinib, participants were asked to answer the Ps-HCRU questionnaire only if they had an interaction with a healthcare provider or their work was impacted by psoriasis on that specified day. In this outcome measure, number of participants who answered Ps-HCRU at any specified visits were reported. |
| Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' | Month 1, 3, 6, 12, 24, 36, 48 | The PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema (E), induration (I), and scaling (S) across all psoriatic lesions in participants. The severity rating scores (Erythema: 0= no evidence of erythema to 4= dark, deep red; Induration: 0= no evidence of plaque elevation to 4= marked plaque elevation, hard/sharp borders; Scaling: 0= no evidence of scaling to 4= thick, coarse scale predominates) were summed (E + I + S = total) and the average (total/3) was taken. The total average was rounded to the nearest whole number score to determine the PGA. The 5-point scale for PGA was: 0= clear; 1= almost clear; 2= mild; 3= moderate; 4= severe, where higher score indicated more severity of psoriasis. Percentage of participants with response of 'clear' (score of '0') and 'almost clear' (score of '1') were reported. |
Countries
Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Japan, Mexico, Netherlands, Poland, Puerto Rico, Russia, Serbia, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Ukraine, United Kingdom, United States
Participant flow
Pre-assignment details
A total of 2881 participants were enrolled in this study, however 2867 participants received treatment.
Participants by arm
| Arm | Count |
|---|---|
| Tofacitinib 10 mg Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months). | 2,281 |
| Tofacitinib 5 mg or 10 mg Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator's discretion. | 586 |
| Total | 2,867 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 300 | 78 |
| Overall Study | Death | 17 | 5 |
| Overall Study | Insufficient Clinical Response | 423 | 29 |
| Overall Study | Lost to Follow-up | 125 | 23 |
| Overall Study | Medication Error | 1 | 0 |
| Overall Study | Ongoing | 13 | 4 |
| Overall Study | Other Unspecified | 170 | 34 |
| Overall Study | Protocol Violation | 43 | 12 |
| Overall Study | Study Terminated by Sponsor | 978 | 349 |
| Overall Study | Withdrawal by Subject | 199 | 50 |
| Overall Study | Withdrawn Due to Pregnancy | 12 | 2 |
Baseline characteristics
| Characteristic | Tofacitinib 10 mg | Tofacitinib 5 mg or 10 mg | Total |
|---|---|---|---|
| Age, Continuous | 45.3 years STANDARD_DEVIATION 12.5 | 47.0 years STANDARD_DEVIATION 13 | 45.6 years STANDARD_DEVIATION 12.6 |
| Sex: Female, Male Female | 640 Participants | 203 Participants | 843 Participants |
| Sex: Female, Male Male | 1641 Participants | 383 Participants | 2024 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1,415 / 2,281 | 394 / 586 |
| serious Total, serious adverse events | 304 / 2,281 | 88 / 586 |
Outcome results
Primary
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 1
Time frame: Baseline, Month 1
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 1 | Baseline: AST (n =2278, 586) | 24.02 international unit per liter (IU/L) | Standard Deviation 12.22 |
| Tofacitinib 10 mg | Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 1 | Baseline: ALT (n =2278, 586) | 28.47 international unit per liter (IU/L) | Standard Deviation 17.29 |
| Tofacitinib 10 mg | Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 1 | Change at Month 1: AST (n =2198, 564) | 3.48 international unit per liter (IU/L) | Standard Deviation 15.39 |
| Tofacitinib 10 mg | Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 1 | Change at Month 1: ALT (n =2199, 564) | 4.07 international unit per liter (IU/L) | Standard Deviation 19.04 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 1 | Change at Month 1: ALT (n =2199, 564) | 4.84 international unit per liter (IU/L) | Standard Deviation 17.5 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 1 | Baseline: AST (n =2278, 586) | 24.66 international unit per liter (IU/L) | Standard Deviation 10.36 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 1 | Change at Month 1: AST (n =2198, 564) | 4.07 international unit per liter (IU/L) | Standard Deviation 12.01 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 1 | Baseline: ALT (n =2278, 586) | 28.17 international unit per liter (IU/L) | Standard Deviation 16.56 |
Primary
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 12
Time frame: Baseline, Month 12
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 12 | AST (n =1772, 531) | 4.88 IU/L | Standard Deviation 16.63 |
| Tofacitinib 10 mg | Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 12 | ALT (n =1774, 532) | 6.68 IU/L | Standard Deviation 23.12 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 12 | AST (n =1772, 531) | 7.29 IU/L | Standard Deviation 22.7 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 12 | ALT (n =1774, 532) | 8.91 IU/L | Standard Deviation 25.21 |
Primary
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 24
Time frame: Baseline, Month 24
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 24 | AST (n =1397, 450) | 4.10 IU/L | Standard Deviation 14.64 |
| Tofacitinib 10 mg | Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 24 | ALT (n =1398, 450) | 5.31 IU/L | Standard Deviation 19.37 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 24 | AST (n =1397, 450) | 6.77 IU/L | Standard Deviation 15.74 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 24 | ALT (n =1398, 450) | 7.56 IU/L | Standard Deviation 18.93 |
Primary
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 3
Time frame: Baseline, Month 3
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 3 | AST (n =2200, 573) | 4.09 IU/L | Standard Deviation 17.75 |
| Tofacitinib 10 mg | Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 3 | ALT (n =2201, 573) | 4.86 IU/L | Standard Deviation 18.52 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 3 | AST (n =2200, 573) | 5.65 IU/L | Standard Deviation 16.37 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 3 | ALT (n =2201, 573) | 6.86 IU/L | Standard Deviation 20.8 |
Primary
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 36
Time frame: Baseline, Month 36
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 36 | AST | 5.38 IU/L | Standard Deviation 20.68 |
| Tofacitinib 10 mg | Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 36 | ALT | 5.46 IU/L | Standard Deviation 20.61 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 36 | AST | 5.32 IU/L | Standard Deviation 15.65 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 36 | ALT | 6.56 IU/L | Standard Deviation 22.43 |
Primary
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 48
Time frame: Baseline, Month 48
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 48 | AST (n =416, 127) | 4.49 IU/L | Standard Deviation 14.05 |
| Tofacitinib 10 mg | Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 48 | ALT (n =417, 127) | 4.92 IU/L | Standard Deviation 27.11 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 48 | AST (n =416, 127) | 8.40 IU/L | Standard Deviation 26.41 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 48 | ALT (n =417, 127) | 6.92 IU/L | Standard Deviation 20.98 |
Primary
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 6
Time frame: Baseline, Month 6
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 6 | AST (n =2052, 564) | 4.50 IU/L | Standard Deviation 15.6 |
| Tofacitinib 10 mg | Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 6 | ALT (n =2054, 564) | 5.98 IU/L | Standard Deviation 19 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 6 | AST (n =2052, 564) | 5.07 IU/L | Standard Deviation 14.9 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 6 | ALT (n =2054, 564) | 6.15 IU/L | Standard Deviation 18.4 |
Primary
Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 1
Time frame: Baseline, Month 1
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 1 | Baseline: TC (n =2277, 586) | 192.11 milligram per deciliter (mg/dL) | Standard Deviation 38.1 |
| Tofacitinib 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 1 | Change at Month 1: Creatinine (n =2204, 563) | 0.03 milligram per deciliter (mg/dL) | Standard Deviation 0.1 |
| Tofacitinib 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 1 | Change at Month 1: LDL-C (n =2125, 546) | 11.49 milligram per deciliter (mg/dL) | Standard Deviation 28.77 |
| Tofacitinib 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 1 | Change at Month 1: HDL-C (n =2203, 562) | 8.19 milligram per deciliter (mg/dL) | Standard Deviation 9.89 |
| Tofacitinib 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 1 | Change at Month 1: TC (n =2203, 562) | 21.12 milligram per deciliter (mg/dL) | Standard Deviation 34.08 |
| Tofacitinib 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 1 | Baseline: Creatinine (n =2278, 586) | 0.90 milligram per deciliter (mg/dL) | Standard Deviation 0.17 |
| Tofacitinib 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 1 | Baseline: LDL-C (n =2253, 585) | 114.14 milligram per deciliter (mg/dL) | Standard Deviation 32.53 |
| Tofacitinib 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 1 | Baseline: HDL-C (n =2277, 586) | 49.05 milligram per deciliter (mg/dL) | Standard Deviation 13.93 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 1 | Baseline: HDL-C (n =2277, 586) | 51.87 milligram per deciliter (mg/dL) | Standard Deviation 17.33 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 1 | Baseline: TC (n =2277, 586) | 194.96 milligram per deciliter (mg/dL) | Standard Deviation 39.79 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 1 | Change at Month 1: TC (n =2203, 562) | 22.65 milligram per deciliter (mg/dL) | Standard Deviation 34.36 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 1 | Change at Month 1: Creatinine (n =2204, 563) | 0.02 milligram per deciliter (mg/dL) | Standard Deviation 0.1 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 1 | Baseline: LDL-C (n =2253, 585) | 115.00 milligram per deciliter (mg/dL) | Standard Deviation 35.03 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 1 | Change at Month 1: LDL-C (n =2125, 546) | 11.55 milligram per deciliter (mg/dL) | Standard Deviation 29.55 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 1 | Baseline: Creatinine (n =2278, 586) | 0.88 milligram per deciliter (mg/dL) | Standard Deviation 0.16 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 1 | Change at Month 1: HDL-C (n =2203, 562) | 8.63 milligram per deciliter (mg/dL) | Standard Deviation 10.5 |
Primary
Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 12
Time frame: Baseline, Month 12
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 12 | Creatinine (n =1777, 533) | 0.04 mg/dL | Standard Deviation 0.12 |
| Tofacitinib 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 12 | LDL-C (n =1728, 521) | 11.31 mg/dL | Standard Deviation 31.45 |
| Tofacitinib 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 12 | HDL-C (n =1776, 531) | 8.13 mg/dL | Standard Deviation 10.48 |
| Tofacitinib 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 12 | TC (n =1776, 531) | 21.20 mg/dL | Standard Deviation 39.15 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 12 | TC (n =1776, 531) | 16.97 mg/dL | Standard Deviation 37.84 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 12 | Creatinine (n =1777, 533) | 0.04 mg/dL | Standard Deviation 0.12 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 12 | HDL-C (n =1776, 531) | 6.88 mg/dL | Standard Deviation 11.15 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 12 | LDL-C (n =1728, 521) | 9.65 mg/dL | Standard Deviation 32.87 |
Primary
Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 24
Time frame: Baseline, Month 24
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 24 | Creatinine (n =1398, 450) | 0.05 mg/dL | Standard Deviation 0.11 |
| Tofacitinib 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 24 | LDL-C (n =1353, 435) | 11.35 mg/dL | Standard Deviation 35.33 |
| Tofacitinib 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 24 | HDL-C (n =1397, 450) | 9.02 mg/dL | Standard Deviation 11.62 |
| Tofacitinib 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 24 | TC (n =1398, 450) | 21.74 mg/dL | Standard Deviation 41.05 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 24 | TC (n =1398, 450) | 19.22 mg/dL | Standard Deviation 39.69 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 24 | Creatinine (n =1398, 450) | 0.04 mg/dL | Standard Deviation 0.11 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 24 | HDL-C (n =1397, 450) | 7.55 mg/dL | Standard Deviation 11.94 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 24 | LDL-C (n =1353, 435) | 10.13 mg/dL | Standard Deviation 35.67 |
Primary
Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 3
Time frame: Baseline, Month 3
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 3 | Creatinine (n =2211, 573) | 0.04 mg/dL | Standard Deviation 0.21 |
| Tofacitinib 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 3 | LDL-C (n =2130, 559) | 11.97 mg/dL | Standard Deviation 29.77 |
| Tofacitinib 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 3 | HDL-C (n =2204, 573) | 7.69 mg/dL | Standard Deviation 10.23 |
| Tofacitinib 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 3 | TC (n =2203, 573) | 21.52 mg/dL | Standard Deviation 35.63 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 3 | TC (n =2203, 573) | 21.06 mg/dL | Standard Deviation 38.34 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 3 | Creatinine (n =2211, 573) | 0.03 mg/dL | Standard Deviation 0.1 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 3 | HDL-C (n =2204, 573) | 7.96 mg/dL | Standard Deviation 10.33 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 3 | LDL-C (n =2130, 559) | 10.44 mg/dL | Standard Deviation 32.72 |
Primary
Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 36
Time frame: Baseline, Month 36
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 36 | Creatinine (n =1122, 384) | 0.05 mg/dL | Standard Deviation 0.12 |
| Tofacitinib 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 36 | LDL-C (n =1085, 375) | 10.11 mg/dL | Standard Deviation 35.83 |
| Tofacitinib 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 36 | HDL-C (n =1119, 384) | 8.80 mg/dL | Standard Deviation 11.59 |
| Tofacitinib 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 36 | TC (n =1119, 384) | 20.20 mg/dL | Standard Deviation 41.28 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 36 | TC (n =1119, 384) | 15.55 mg/dL | Standard Deviation 43.59 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 36 | Creatinine (n =1122, 384) | 0.04 mg/dL | Standard Deviation 0.15 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 36 | HDL-C (n =1119, 384) | 6.39 mg/dL | Standard Deviation 11.91 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 36 | LDL-C (n =1085, 375) | 7.25 mg/dL | Standard Deviation 37.41 |
Primary
Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 48
Time frame: Baseline, Month 48
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 48 | Creatinine (n =417, 127) | 0.04 mg/dL | Standard Deviation 0.12 |
| Tofacitinib 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 48 | LDL-C (n =402, 123) | 12.98 mg/dL | Standard Deviation 36.89 |
| Tofacitinib 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 48 | HDL-C (n =417, 127) | 8.62 mg/dL | Standard Deviation 11.36 |
| Tofacitinib 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 48 | TC (n =417, 127) | 24.99 mg/dL | Standard Deviation 43.35 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 48 | TC (n =417, 127) | 16.36 mg/dL | Standard Deviation 40.99 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 48 | Creatinine (n =417, 127) | 0.04 mg/dL | Standard Deviation 0.11 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 48 | HDL-C (n =417, 127) | 8.19 mg/dL | Standard Deviation 12.72 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 48 | LDL-C (n =402, 123) | 6.61 mg/dL | Standard Deviation 34.66 |
Primary
Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 6
Time frame: Baseline, Month 6
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 6 | Creatinine (n =2057, 564) | 0.03 mg/dL | Standard Deviation 0.11 |
| Tofacitinib 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 6 | LDL-C (n =1983, 553) | 11.44 mg/dL | Standard Deviation 30.1 |
| Tofacitinib 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 6 | HDL-C (n =2056, 564) | 7.68 mg/dL | Standard Deviation 10.33 |
| Tofacitinib 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 6 | TC (n =2057, 564) | 20.91 mg/dL | Standard Deviation 35.94 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 6 | TC (n =2057, 564) | 19.17 mg/dL | Standard Deviation 39.06 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 6 | Creatinine (n =2057, 564) | 0.03 mg/dL | Standard Deviation 0.1 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 6 | HDL-C (n =2056, 564) | 8.19 mg/dL | Standard Deviation 11.6 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 6 | LDL-C (n =1983, 553) | 8.74 mg/dL | Standard Deviation 33.22 |
Primary
Change From Baseline in Heart Rate at Month 1
Time frame: Baseline, Month 1
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Heart Rate at Month 1 | Baseline (n =2277, 586) | 71.81 beats per minute | Standard Deviation 9.67 |
| Tofacitinib 10 mg | Change From Baseline in Heart Rate at Month 1 | Change at Month 1 (n =2210, 563) | -0.82 beats per minute | Standard Deviation 9.16 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Heart Rate at Month 1 | Baseline (n =2277, 586) | 71.46 beats per minute | Standard Deviation 9.93 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Heart Rate at Month 1 | Change at Month 1 (n =2210, 563) | -1.23 beats per minute | Standard Deviation 9.03 |
Primary
Change From Baseline in Heart Rate at Month 12
Time frame: Baseline, Month 12
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Heart Rate at Month 12 | -1.13 beats per minute | Standard Deviation 9.66 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Heart Rate at Month 12 | -1.14 beats per minute | Standard Deviation 9.07 |
Primary
Change From Baseline in Heart Rate at Month 24
Time frame: Baseline, Month 24
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Heart Rate at Month 24 | -1.07 beats per minute | Standard Deviation 9.91 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Heart Rate at Month 24 | -0.94 beats per minute | Standard Deviation 8.89 |
Primary
Change From Baseline in Heart Rate at Month 3
Time frame: Baseline, Month 3
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Heart Rate at Month 3 | -0.57 beats per minute | Standard Deviation 9.35 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Heart Rate at Month 3 | -0.32 beats per minute | Standard Deviation 9.19 |
Primary
Change From Baseline in Heart Rate at Month 36
Time frame: Baseline, Month 36
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Heart Rate at Month 36 | -1.38 beats per minute | Standard Deviation 9.81 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Heart Rate at Month 36 | -1.00 beats per minute | Standard Deviation 9.26 |
Primary
Change From Baseline in Heart Rate at Month 48
Time frame: Baseline, Month 48
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Heart Rate at Month 48 | -0.91 beats per minute | Standard Deviation 10.64 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Heart Rate at Month 48 | -0.64 beats per minute | Standard Deviation 10.64 |
Primary
Change From Baseline in Heart Rate at Month 6
Time frame: Baseline, Month 6
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Heart Rate at Month 6 | -0.73 beats per minute | Standard Deviation 9.65 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Heart Rate at Month 6 | -1.05 beats per minute | Standard Deviation 9.18 |
Primary
Change From Baseline in Hemoglobin Level at Month 1
Time frame: Baseline, Month 1
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies participants evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Hemoglobin Level at Month 1 | Baseline (n =2277, 586) | 14.64 gram per deciliter (g/dL) | Standard Deviation 1.27 |
| Tofacitinib 10 mg | Change From Baseline in Hemoglobin Level at Month 1 | Change at Month 1 (n =2201, 563) | -0.24 gram per deciliter (g/dL) | Standard Deviation 0.83 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Hemoglobin Level at Month 1 | Baseline (n =2277, 586) | 14.64 gram per deciliter (g/dL) | Standard Deviation 1.24 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Hemoglobin Level at Month 1 | Change at Month 1 (n =2201, 563) | -0.32 gram per deciliter (g/dL) | Standard Deviation 0.86 |
Primary
Change From Baseline in Hemoglobin Level at Month 12
Time frame: Baseline, Month 12
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Hemoglobin Level at Month 12 | -0.34 g/dL | Standard Deviation 0.93 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Hemoglobin Level at Month 12 | -0.30 g/dL | Standard Deviation 0.9 |
Primary
Change From Baseline in Hemoglobin Level at Month 24
Time frame: Baseline, Month 24
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Hemoglobin Level at Month 24 | -0.30 g/dL | Standard Deviation 0.96 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Hemoglobin Level at Month 24 | -0.29 g/dL | Standard Deviation 0.89 |
Primary
Change From Baseline in Hemoglobin Level at Month 3
Time frame: Baseline, Month 3
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Hemoglobin Level at Month 3 | -0.27 g/dL | Standard Deviation 0.85 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Hemoglobin Level at Month 3 | -0.39 g/dL | Standard Deviation 0.83 |
Primary
Change From Baseline in Hemoglobin Level at Month 36
Time frame: Baseline, Month 36
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Hemoglobin Level at Month 36 | -0.32 g/dL | Standard Deviation 0.93 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Hemoglobin Level at Month 36 | -0.37 g/dL | Standard Deviation 0.88 |
Primary
Change From Baseline in Hemoglobin Level at Month 48
Time frame: Baseline, Month 48
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Hemoglobin Level at Month 48 | -0.35 g/dL | Standard Deviation 0.97 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Hemoglobin Level at Month 48 | -0.43 g/dL | Standard Deviation 0.94 |
Primary
Change From Baseline in Hemoglobin Level at Month 6
Time frame: Baseline, Month 6
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Hemoglobin Level at Month 6 | -0.27 g/dL | Standard Deviation 0.88 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Hemoglobin Level at Month 6 | -0.30 g/dL | Standard Deviation 0.87 |
Primary
Change From Baseline in Lymphocyte and Neutrophil Count at Month 1
Time frame: Baseline, Month 1
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Lymphocyte and Neutrophil Count at Month 1 | Baseline: Neutrophil Count (n =2275, 586) | 4.74 1000 cells/mm^3 | Standard Deviation 1.68 |
| Tofacitinib 10 mg | Change From Baseline in Lymphocyte and Neutrophil Count at Month 1 | Change at Month 1: Lymphocyte Count (n =2182, 559) | 0.07 1000 cells/mm^3 | Standard Deviation 0.52 |
| Tofacitinib 10 mg | Change From Baseline in Lymphocyte and Neutrophil Count at Month 1 | Change at Month 1: Neutrophil Count (n =2182, 559) | -0.37 1000 cells/mm^3 | Standard Deviation 1.65 |
| Tofacitinib 10 mg | Change From Baseline in Lymphocyte and Neutrophil Count at Month 1 | Baseline: Lymphocyte Count (n =2275, 586) | 1.76 1000 cells/mm^3 | Standard Deviation 0.57 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Lymphocyte and Neutrophil Count at Month 1 | Baseline: Lymphocyte Count (n =2275, 586) | 1.80 1000 cells/mm^3 | Standard Deviation 0.56 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Lymphocyte and Neutrophil Count at Month 1 | Baseline: Neutrophil Count (n =2275, 586) | 4.55 1000 cells/mm^3 | Standard Deviation 1.7 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Lymphocyte and Neutrophil Count at Month 1 | Change at Month 1: Neutrophil Count (n =2182, 559) | -0.48 1000 cells/mm^3 | Standard Deviation 1.58 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Lymphocyte and Neutrophil Count at Month 1 | Change at Month 1: Lymphocyte Count (n =2182, 559) | 0.11 1000 cells/mm^3 | Standard Deviation 0.56 |
Primary
Change From Baseline in Lymphocyte and Neutrophil Count at Month 12
Time frame: Baseline, Month 12
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Lymphocyte and Neutrophil Count at Month 12 | Lymphocyte Count | -0.21 1000 cells/mm^3 | Standard Deviation 0.52 |
| Tofacitinib 10 mg | Change From Baseline in Lymphocyte and Neutrophil Count at Month 12 | Neutrophil Count | -0.23 1000 cells/mm^3 | Standard Deviation 1.61 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Lymphocyte and Neutrophil Count at Month 12 | Lymphocyte Count | -0.16 1000 cells/mm^3 | Standard Deviation 0.48 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Lymphocyte and Neutrophil Count at Month 12 | Neutrophil Count | -0.18 1000 cells/mm^3 | Standard Deviation 1.58 |
Primary
Change From Baseline in Lymphocyte and Neutrophil Count at Month 24
Time frame: Baseline, Month 24
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Lymphocyte and Neutrophil Count at Month 24 | Lymphocyte Count | -0.28 1000 cells/mm^3 | Standard Deviation 0.52 |
| Tofacitinib 10 mg | Change From Baseline in Lymphocyte and Neutrophil Count at Month 24 | Neutrophil Count | -0.19 1000 cells/mm^3 | Standard Deviation 1.69 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Lymphocyte and Neutrophil Count at Month 24 | Lymphocyte Count | -0.18 1000 cells/mm^3 | Standard Deviation 0.54 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Lymphocyte and Neutrophil Count at Month 24 | Neutrophil Count | -0.02 1000 cells/mm^3 | Standard Deviation 1.59 |
Primary
Change From Baseline in Lymphocyte and Neutrophil Count at Month 3
Time frame: Baseline, Month 3
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Lymphocyte and Neutrophil Count at Month 3 | Neutrophil Count | -0.28 1000 cells/mm^3 | Standard Deviation 1.63 |
| Tofacitinib 10 mg | Change From Baseline in Lymphocyte and Neutrophil Count at Month 3 | Lymphocyte count | -0.00 1000 cells/mm^3 | Standard Deviation 0.52 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Lymphocyte and Neutrophil Count at Month 3 | Lymphocyte count | 0.02 1000 cells/mm^3 | Standard Deviation 0.52 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Lymphocyte and Neutrophil Count at Month 3 | Neutrophil Count | -0.28 1000 cells/mm^3 | Standard Deviation 1.6 |
Primary
Change From Baseline in Lymphocyte and Neutrophil Count at Month 36
Time frame: Baseline, Month 36
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Lymphocyte and Neutrophil Count at Month 36 | Neutrophil Count | -0.26 1000 cells/mm^3 | Standard Deviation 1.61 |
| Tofacitinib 10 mg | Change From Baseline in Lymphocyte and Neutrophil Count at Month 36 | Lymphocyte Count | -0.35 1000 cells/mm^3 | Standard Deviation 0.55 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Lymphocyte and Neutrophil Count at Month 36 | Lymphocyte Count | -0.24 1000 cells/mm^3 | Standard Deviation 0.51 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Lymphocyte and Neutrophil Count at Month 36 | Neutrophil Count | -0.11 1000 cells/mm^3 | Standard Deviation 1.68 |
Primary
Change From Baseline in Lymphocyte and Neutrophil Count at Month 48
Time frame: Baseline, Month 48
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Lymphocyte and Neutrophil Count at Month 48 | Lymphocyte Count | -0.42 1000 cells/mm^3 | Standard Deviation 0.52 |
| Tofacitinib 10 mg | Change From Baseline in Lymphocyte and Neutrophil Count at Month 48 | Neutrophil Count | -0.28 1000 cells/mm^3 | Standard Deviation 1.7 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Lymphocyte and Neutrophil Count at Month 48 | Lymphocyte Count | -0.27 1000 cells/mm^3 | Standard Deviation 0.46 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Lymphocyte and Neutrophil Count at Month 48 | Neutrophil Count | -0.07 1000 cells/mm^3 | Standard Deviation 1.49 |
Primary
Change From Baseline in Lymphocyte and Neutrophil Count at Month 6
Time frame: Baseline, Month 6
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Lymphocyte and Neutrophil Count at Month 6 | Lymphocyte Count | -0.11 1000 cells/mm^3 | Standard Deviation 0.51 |
| Tofacitinib 10 mg | Change From Baseline in Lymphocyte and Neutrophil Count at Month 6 | Neutrophil Count | -0.25 1000 cells/mm^3 | Standard Deviation 1.61 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Lymphocyte and Neutrophil Count at Month 6 | Lymphocyte Count | -0.05 1000 cells/mm^3 | Standard Deviation 0.51 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Lymphocyte and Neutrophil Count at Month 6 | Neutrophil Count | -0.22 1000 cells/mm^3 | Standard Deviation 1.64 |
Primary
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 12
Time frame: Baseline, Month 12
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 12 | QRS Complex (n =1726, 516) | 1.89 msec | Standard Deviation 7.93 |
| Tofacitinib 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 12 | PR Interval (n =1717, 515) | 2.80 msec | Standard Deviation 14.32 |
| Tofacitinib 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 12 | QT Interval (n =1726, 516) | 2.49 msec | Standard Deviation 23.26 |
| Tofacitinib 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 12 | QTcB Interval (n =1726, 516) | -1.04 msec | Standard Deviation 20.63 |
| Tofacitinib 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 12 | QTcF Interval (n =1726, 516) | 0.16 msec | Standard Deviation 16.71 |
| Tofacitinib 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 12 | RR Interval (n =1727, 516) | 15.94 msec | Standard Deviation 130.6 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 12 | QTcF Interval (n =1726, 516) | 0.23 msec | Standard Deviation 17.2 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 12 | QRS Complex (n =1726, 516) | 2.11 msec | Standard Deviation 7.53 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 12 | QTcB Interval (n =1726, 516) | -1.09 msec | Standard Deviation 20.83 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 12 | PR Interval (n =1717, 515) | 3.21 msec | Standard Deviation 14.31 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 12 | RR Interval (n =1727, 516) | 17.55 msec | Standard Deviation 128.16 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 12 | QT Interval (n =1726, 516) | 2.69 msec | Standard Deviation 23 |
Primary
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 24
Time frame: Baseline, Month 24
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 24 | QRS Complex (n =1352, 432) | 2.00 msec | Standard Deviation 8.55 |
| Tofacitinib 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 24 | PR Interval (n =1346, 432) | 3.49 msec | Standard Deviation 14.55 |
| Tofacitinib 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 24 | QT Interval (n =1352, 432) | 3.93 msec | Standard Deviation 24.93 |
| Tofacitinib 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 24 | QTcB Interval (n =1352, 431) | 0.15 msec | Standard Deviation 20.77 |
| Tofacitinib 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 24 | QTcF Interval (n =1352, 431) | 1.47 msec | Standard Deviation 16.86 |
| Tofacitinib 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 24 | RR Interval (n =1352, 432) | 17.70 msec | Standard Deviation 139.47 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 24 | QTcF Interval (n =1352, 431) | 1.25 msec | Standard Deviation 17.72 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 24 | QRS Complex (n =1352, 432) | 2.42 msec | Standard Deviation 9.13 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 24 | QTcB Interval (n =1352, 431) | 0.78 msec | Standard Deviation 21.06 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 24 | PR Interval (n =1346, 432) | 3.81 msec | Standard Deviation 14.67 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 24 | RR Interval (n =1352, 432) | 8.66 msec | Standard Deviation 135.06 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 24 | QT Interval (n =1352, 432) | 2.28 msec | Standard Deviation 24.8 |
Primary
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 36
Time frame: Baseline, Month 36
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 36 | QRS Complex (n =845, 283) | 1.75 msec | Standard Deviation 8.47 |
| Tofacitinib 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 36 | PR Interval (n =840, 282) | 4.18 msec | Standard Deviation 14.5 |
| Tofacitinib 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 36 | QT Interval (n =844, 283) | 4.31 msec | Standard Deviation 24.93 |
| Tofacitinib 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 36 | QTcB Interval (n =844, 283) | 0.44 msec | Standard Deviation 21.29 |
| Tofacitinib 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 36 | QTcF Interval (n =844, 283) | 1.79 msec | Standard Deviation 17.57 |
| Tofacitinib 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 36 | RR Interval (n =845, 283) | 18.24 msec | Standard Deviation 136.44 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 36 | QTcF Interval (n =844, 283) | 0.84 msec | Standard Deviation 17.63 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 36 | QRS Complex (n =845, 283) | 1.85 msec | Standard Deviation 10.37 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 36 | QTcB Interval (n =844, 283) | -0.01 msec | Standard Deviation 22.21 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 36 | PR Interval (n =840, 282) | 3.25 msec | Standard Deviation 15.5 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 36 | RR Interval (n =845, 283) | 15.14 msec | Standard Deviation 131.42 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 36 | QT Interval (n =844, 283) | 2.52 msec | Standard Deviation 22.63 |
Primary
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 48
Time frame: Baseline, Month 48
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 48 | PR Interval (n =126, 55) | 6.26 msec | Standard Deviation 12.58 |
| Tofacitinib 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 48 | QTcB Interval (n =125, 55) | 3.42 msec | Standard Deviation 20.11 |
| Tofacitinib 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 48 | QRS Complex (n =126, 55) | 2.37 msec | Standard Deviation 10.17 |
| Tofacitinib 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 48 | QTcF Interval (n =125, 55) | 4.55 msec | Standard Deviation 15.84 |
| Tofacitinib 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 48 | QT Interval (n =126, 55) | 6.43 msec | Standard Deviation 24.05 |
| Tofacitinib 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 48 | RR Interval (n =126, 55) | 15.69 msec | Standard Deviation 143.06 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 48 | QT Interval (n =126, 55) | 1.69 msec | Standard Deviation 23.43 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 48 | QRS Complex (n =126, 55) | 1.31 msec | Standard Deviation 5.37 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 48 | PR Interval (n =126, 55) | 1.98 msec | Standard Deviation 13.2 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 48 | RR Interval (n =126, 55) | 20.78 msec | Standard Deviation 119.61 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 48 | QTcB Interval (n =125, 55) | -2.00 msec | Standard Deviation 22.64 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 48 | QTcF Interval (n =125, 55) | -0.87 msec | Standard Deviation 19.38 |
Primary
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6
Time frame: Baseline, Month 6
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 | Baseline: QRS Complex (n =2264, 583) | 92.88 milliseconds (msec) | Standard Deviation 9.12 |
| Tofacitinib 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 | Baseline: PR Interval (n =2258, 583) | 162.32 milliseconds (msec) | Standard Deviation 21.32 |
| Tofacitinib 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 | Baseline: QT Interval (n =2264, 583) | 392.39 milliseconds (msec) | Standard Deviation 29.12 |
| Tofacitinib 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 | Baseline: QTcB Interval (n =2264, 583) | 415.70 milliseconds (msec) | Standard Deviation 23.83 |
| Tofacitinib 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 | Baseline: QTcF Interval (n =2264, 583) | 407.48 milliseconds (msec) | Standard Deviation 20.74 |
| Tofacitinib 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 | Baseline: RR Interval (n =2264, 583) | 901.27 milliseconds (msec) | Standard Deviation 145.58 |
| Tofacitinib 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 | Change at Month 6: QRS Complex (n =1995, 550) | 1.51 milliseconds (msec) | Standard Deviation 8.28 |
| Tofacitinib 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 | Change at Month 6: PR Interval (n =1986, 549) | 2.46 milliseconds (msec) | Standard Deviation 13.79 |
| Tofacitinib 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 | Change at Month 6: QT Interval (n =1995, 550) | 2.25 milliseconds (msec) | Standard Deviation 24.49 |
| Tofacitinib 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 | Change at Month 6: QTcB Interval (n =1995, 550) | -0.84 milliseconds (msec) | Standard Deviation 20.49 |
| Tofacitinib 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 | Change at Month 6: QTcF Interval (n =1995, 550) | 0.23 milliseconds (msec) | Standard Deviation 17.14 |
| Tofacitinib 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 | Change at Month 6: RR Interval (n =1995, 550) | 14.35 milliseconds (msec) | Standard Deviation 130.91 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 | Change at Month 6: QTcF Interval (n =1995, 550) | -0.03 milliseconds (msec) | Standard Deviation 17.68 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 | Baseline: QRS Complex (n =2264, 583) | 92.31 milliseconds (msec) | Standard Deviation 9.75 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 | Change at Month 6: QRS Complex (n =1995, 550) | 2.01 milliseconds (msec) | Standard Deviation 7.5 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 | Baseline: PR Interval (n =2258, 583) | 158.91 milliseconds (msec) | Standard Deviation 20.62 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 | Change at Month 6: QTcB Interval (n =1995, 550) | -1.38 milliseconds (msec) | Standard Deviation 20.31 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 | Baseline: QT Interval (n =2264, 583) | 395.75 milliseconds (msec) | Standard Deviation 29.7 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 | Change at Month 6: PR Interval (n =1986, 549) | 2.76 milliseconds (msec) | Standard Deviation 14.81 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 | Baseline: QTcB Interval (n =2264, 583) | 416.91 milliseconds (msec) | Standard Deviation 23.04 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 | Change at Month 6: RR Interval (n =1995, 550) | 18.77 milliseconds (msec) | Standard Deviation 123.49 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 | Baseline: QTcF Interval (n =2264, 583) | 409.42 milliseconds (msec) | Standard Deviation 20.11 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 | Change at Month 6: QT Interval (n =1995, 550) | 2.52 milliseconds (msec) | Standard Deviation 24.39 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 | Baseline: RR Interval (n =2264, 583) | 911.59 milliseconds (msec) | Standard Deviation 150.35 |
Primary
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 1
Time frame: Baseline, Month 1
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 1 | Baseline: Systolic BP (n =2277, 586) | 126.07 millimeter of mercury (mmHg) | Standard Deviation 14.03 |
| Tofacitinib 10 mg | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 1 | Baseline: Diastolic BP (n =2277, 586) | 79.64 millimeter of mercury (mmHg) | Standard Deviation 9.42 |
| Tofacitinib 10 mg | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 1 | Change at Month 1: Systolic BP (n =2210, 564) | -0.43 millimeter of mercury (mmHg) | Standard Deviation 11.83 |
| Tofacitinib 10 mg | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 1 | Change at Month 1: Diastolic BP (n =2210, 564) | -0.03 millimeter of mercury (mmHg) | Standard Deviation 8.42 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 1 | Change at Month 1: Diastolic BP (n =2210, 564) | 0.22 millimeter of mercury (mmHg) | Standard Deviation 8.45 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 1 | Baseline: Systolic BP (n =2277, 586) | 126.24 millimeter of mercury (mmHg) | Standard Deviation 14.12 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 1 | Change at Month 1: Systolic BP (n =2210, 564) | -1.31 millimeter of mercury (mmHg) | Standard Deviation 11.55 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 1 | Baseline: Diastolic BP (n =2277, 586) | 78.88 millimeter of mercury (mmHg) | Standard Deviation 9.27 |
Primary
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 12
Time frame: Baseline, Month 12
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 12 | Systolic BP | 0.42 mmHg | Standard Deviation 11.97 |
| Tofacitinib 10 mg | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 12 | Diastolic BP | 0.23 mmHg | Standard Deviation 8.89 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 12 | Systolic BP | -0.20 mmHg | Standard Deviation 12.51 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 12 | Diastolic BP | 0.10 mmHg | Standard Deviation 9.1 |
Primary
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 24
Time frame: Baseline, Month 24
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 24 | Systolic BP | 0.84 mmHg | Standard Deviation 13 |
| Tofacitinib 10 mg | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 24 | Diastolic BP | 0.36 mmHg | Standard Deviation 9.45 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 24 | Systolic BP | -0.07 mmHg | Standard Deviation 13.02 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 24 | Diastolic BP | 0.35 mmHg | Standard Deviation 8.85 |
Primary
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 3
Time frame: Baseline, Month 3
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 3 | Systolic BP | -0.16 mmHg | Standard Deviation 11.97 |
| Tofacitinib 10 mg | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 3 | Diastolic BP | -0.26 mmHg | Standard Deviation 8.56 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 3 | Systolic BP | -0.95 mmHg | Standard Deviation 11.85 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 3 | Diastolic BP | 0.05 mmHg | Standard Deviation 8.52 |
Primary
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 36
Time frame: Baseline, Month 36
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 36 | Systolic BP | 0.52 mmHg | Standard Deviation 13.15 |
| Tofacitinib 10 mg | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 36 | Diastolic BP | 0.33 mmHg | Standard Deviation 9.33 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 36 | Systolic BP | 0.10 mmHg | Standard Deviation 13.92 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 36 | Diastolic BP | -0.06 mmHg | Standard Deviation 9.24 |
Primary
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 48
Time frame: Baseline, Month 48
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 48 | Systolic BP | 2.35 mmHg | Standard Deviation 13.45 |
| Tofacitinib 10 mg | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 48 | Diastolic BP | 0.97 mmHg | Standard Deviation 9.52 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 48 | Systolic BP | 1.13 mmHg | Standard Deviation 15.18 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 48 | Diastolic BP | 0.87 mmHg | Standard Deviation 9.8 |
Primary
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 6
Time frame: Baseline, Month 6
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 6 | Systolic BP | 0.22 mmHg | Standard Deviation 12.18 |
| Tofacitinib 10 mg | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 6 | Diastolic BP | -0.05 mmHg | Standard Deviation 8.87 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 6 | Systolic BP | -0.15 mmHg | Standard Deviation 12.48 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 6 | Diastolic BP | 0.55 mmHg | Standard Deviation 8.74 |
Primary
Number of Adverse Events (AEs) by Severity
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified according to the severity in 3 categories: a) mild: AEs did not interfere with participant's usual function; b) moderate: AEs interfered to some extent with participant's usual function; c) severe: AEs interfered significantly with participant's usual function.
Time frame: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Population: Safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 10 mg | Number of Adverse Events (AEs) by Severity | Mild | 5354 adverse events |
| Tofacitinib 10 mg | Number of Adverse Events (AEs) by Severity | Moderate | 3268 adverse events |
| Tofacitinib 10 mg | Number of Adverse Events (AEs) by Severity | Severe | 410 adverse events |
| Tofacitinib 5 mg or 10 mg | Number of Adverse Events (AEs) by Severity | Mild | 1749 adverse events |
| Tofacitinib 5 mg or 10 mg | Number of Adverse Events (AEs) by Severity | Moderate | 766 adverse events |
| Tofacitinib 5 mg or 10 mg | Number of Adverse Events (AEs) by Severity | Severe | 136 adverse events |
Primary
Number of Participants With Adjudicated Cardiovascular Events
Adjudicated cardiovascular events were assessed by adjudication committee as independent reviewers based on event documentation including: hospital discharge summaries, operative reports, clinic notes, ECGs, diagnostic enzymes, results of other diagnostic tests, autopsy reports and death certificate information; as applicable.
Time frame: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Population: Safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib 10 mg | Number of Participants With Adjudicated Cardiovascular Events | 32 participants |
| Tofacitinib 5 mg or 10 mg | Number of Participants With Adjudicated Cardiovascular Events | 13 participants |
Primary
Number of Participants With Clinically Significant Change From Baseline in Physical Examination
Physical examinations included: general appearance; skin, head, eyes, ears, nose and throat; heart; lungs; abdomen; lower extremities (for the presence of peripheral edema) and lymph nodes. Clinical significance of change from baseline values in physical examination was based on investigator's discretion.
Time frame: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib 10 mg | Number of Participants With Clinically Significant Change From Baseline in Physical Examination | 683 participants |
| Tofacitinib 5 mg or 10 mg | Number of Participants With Clinically Significant Change From Baseline in Physical Examination | 191 participants |
Primary
Number of Participants With Electrocardiogram (ECG) Abnormalities
Criteria for ECG abnormality: PR interval \>=300 milliseconds (msec); QT interval \>=500 msec; QTcB (Bazett's Correction) and QTcF (Fridericia's Correction) 450 to \<480 msec, 480 to \<500 msec and \>=500 msec.
Time frame: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Population: Safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib 10 mg | Number of Participants With Electrocardiogram (ECG) Abnormalities | 7 participants |
| Tofacitinib 5 mg or 10 mg | Number of Participants With Electrocardiogram (ECG) Abnormalities | 2 participants |
Primary
Number of Participants With Laboratory Abnormalities
Abnormality criteria: hematology (hemoglobin, hematocrit, red blood cell \<0.8\*lower limit of normal \[LLN\]; reticulocyte\<0.5\*LLN,\>1.5\*ULN; platelets\<0.5\*LLN,\>1.75\* upper limit of normal \[ULN\]; WBC\<0.6\*LLN, \>1.5\*ULN; lymphocytes, neutrophils, basophils, eosinophils, monocytes\<0.8\*LLN; \>1.2\*ULN; coagulation (prothrombin \[PT\], PT ratio\>1.1\*ULN) liver function (bilirubin\>1.5\*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma GT\>0.3\*ULN, protein, albumin\<0.8\*LLN; \>1.2\*ULN, globulin\<0.5\*LLN; \>1.5\*ULN); renal function (blood urea nitrogen, creatinine\>1.3\*ULN); electrolytes(sodium\<0.95\* LLN; \>1.05\* ULN, potassium, chloride, calcium, bicarbonate\<0.9\*LLN; \>1.1\*ULN), chemistry (glucose\<0.6\*LLN; \>1.5\* ULN), urinalysis (pH \<4.5;\>8, glucose, ketones, protein, blood, urobilinogen, nitrite, bilirubin, leukocyte esterase\>=1; RBC, WBC\>=20); lipids (cholesterol \[C\], LDL-C \>1.3\*ULN, HDL-C\<0.8\*LLN, triglycerides\>1.3\* ULN), hormones(T4, T3, T4, TSH\<0.8\* LLN; \>1.2\* ULN).
Time frame: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib 10 mg | Number of Participants With Laboratory Abnormalities | 2203 participants |
| Tofacitinib 5 mg or 10 mg | Number of Participants With Laboratory Abnormalities | 565 participants |
Primary
Number of Participants With Malignancy Events
Malignancy events included lymphoma, and demyelinating neurologic events. Biopsies collected for malignancy events were submitted to the central laboratory for pathologist over-read.
Time frame: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Population: Safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib 10 mg | Number of Participants With Malignancy Events | 87 participants |
| Tofacitinib 5 mg or 10 mg | Number of Participants With Malignancy Events | 26 participants |
Primary
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 4 weeks after last dose (up to 67 months) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.
Time frame: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Population: Safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 10 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 1876 participants |
| Tofacitinib 10 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 304 participants |
| Tofacitinib 5 mg or 10 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 490 participants |
| Tofacitinib 5 mg or 10 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 88 participants |
Primary
Number of Participants With Vital Sign Abnormalities
Criteria for abnormalities in vital signs included: Systolic blood pressure (SBP): less than (\<) 90 millimeter of mercury (mmHg) and maximum increase from baseline (IFB) of greater than or equal to (\>=) 30 mmHg; diastolic blood pressure (DBP): \<50 and greater than (\>) 120 mmHg and maximum IFB of \>=20 mmHg; heart rate: \<40 and \>120 beats per minute.
Time frame: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 10 mg | Number of Participants With Vital Sign Abnormalities | DBP (n =2271, 577) | 12 participants |
| Tofacitinib 10 mg | Number of Participants With Vital Sign Abnormalities | Maximum IFB in SBP (n =2267, 577) | 187 participants |
| Tofacitinib 10 mg | Number of Participants With Vital Sign Abnormalities | Heart Rate (n =2271, 577) | 3 participants |
| Tofacitinib 10 mg | Number of Participants With Vital Sign Abnormalities | Maximum IFB in DBP (n =2267, 577) | 221 participants |
| Tofacitinib 10 mg | Number of Participants With Vital Sign Abnormalities | SBP (n =2271, 577) | 12 participants |
| Tofacitinib 5 mg or 10 mg | Number of Participants With Vital Sign Abnormalities | Maximum IFB in DBP (n =2267, 577) | 74 participants |
| Tofacitinib 5 mg or 10 mg | Number of Participants With Vital Sign Abnormalities | SBP (n =2271, 577) | 6 participants |
| Tofacitinib 5 mg or 10 mg | Number of Participants With Vital Sign Abnormalities | DBP (n =2271, 577) | 1 participants |
| Tofacitinib 5 mg or 10 mg | Number of Participants With Vital Sign Abnormalities | Heart Rate (n =2271, 577) | 1 participants |
| Tofacitinib 5 mg or 10 mg | Number of Participants With Vital Sign Abnormalities | Maximum IFB in SBP (n =2267, 577) | 65 participants |
Secondary
36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Mental Component Summary Scores
The SF-36 questionnaire, version 2 was a 36-item generic health status measure. SF-36 evaluated 8 health-related aspects of an individual: physical functioning, role-physical, bodily pain, social functioning, mental health, role emotional, vitality, and general health. The score range for each of the 8 health aspects ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition. Two summary scale scores were computed from the 8 health aspect scores: the Physical Component Summary and the Mental Component Summary. Score range for both summary scale ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition.
Time frame: Baseline, Month 6, 12, 24, 36, 48
Population: FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | 36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Mental Component Summary Scores | Baseline (n =2233, 580) | 43.51 units on a scale | Standard Deviation 11.98 |
| Tofacitinib 10 mg | 36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Mental Component Summary Scores | Month 6 (n =2025, 557) | 48.86 units on a scale | Standard Deviation 10.02 |
| Tofacitinib 10 mg | 36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Mental Component Summary Scores | Month 12 (n =1750, 524) | 49.10 units on a scale | Standard Deviation 9.89 |
| Tofacitinib 10 mg | 36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Mental Component Summary Scores | Month 24 (n =1362, 442) | 49.22 units on a scale | Standard Deviation 9.82 |
| Tofacitinib 10 mg | 36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Mental Component Summary Scores | Month 36 (n =857, 286) | 49.21 units on a scale | Standard Deviation 9.95 |
| Tofacitinib 10 mg | 36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Mental Component Summary Scores | Month 48 (n =124, 56) | 50.14 units on a scale | Standard Deviation 8.96 |
| Tofacitinib 5 mg or 10 mg | 36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Mental Component Summary Scores | Month 36 (n =857, 286) | 50.17 units on a scale | Standard Deviation 8.2 |
| Tofacitinib 5 mg or 10 mg | 36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Mental Component Summary Scores | Baseline (n =2233, 580) | 43.96 units on a scale | Standard Deviation 11.23 |
| Tofacitinib 5 mg or 10 mg | 36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Mental Component Summary Scores | Month 24 (n =1362, 442) | 49.66 units on a scale | Standard Deviation 9.54 |
| Tofacitinib 5 mg or 10 mg | 36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Mental Component Summary Scores | Month 6 (n =2025, 557) | 50.03 units on a scale | Standard Deviation 9.14 |
| Tofacitinib 5 mg or 10 mg | 36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Mental Component Summary Scores | Month 48 (n =124, 56) | 49.60 units on a scale | Standard Deviation 8.24 |
| Tofacitinib 5 mg or 10 mg | 36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Mental Component Summary Scores | Month 12 (n =1750, 524) | 49.78 units on a scale | Standard Deviation 9.28 |
Secondary
36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Physical Component Summary Scores
The SF-36 questionnaire, version 2, acute was a 36-item generic health status measure. SF-36 evaluated 8 health-related aspects of an individual: physical functioning, role-physical, bodily pain, social functioning, mental health, role emotional, vitality, and general health. The score range for each of the 8 health aspects ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition. Two summary scale scores were computed from the 8 health aspect scores: physical component summary score and mental component summary score. Score range for both summary scales ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition.
Time frame: Baseline, Month 6, 12, 24, 36, 48
Population: FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | 36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Physical Component Summary Scores | Baseline (n =2233, 580) | 47.31 units on a scale | Standard Deviation 9.38 |
| Tofacitinib 10 mg | 36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Physical Component Summary Scores | Month 6 (n =2025, 557) | 51.78 units on a scale | Standard Deviation 8.24 |
| Tofacitinib 10 mg | 36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Physical Component Summary Scores | Month 12 (n =1750, 524) | 51.96 units on a scale | Standard Deviation 8.13 |
| Tofacitinib 10 mg | 36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Physical Component Summary Scores | Month 24 (n =1362, 442) | 51.91 units on a scale | Standard Deviation 7.8 |
| Tofacitinib 10 mg | 36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Physical Component Summary Scores | Month 36 (n =857, 286) | 52.01 units on a scale | Standard Deviation 8.08 |
| Tofacitinib 10 mg | 36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Physical Component Summary Scores | Month 48 (n =124, 56) | 52.93 units on a scale | Standard Deviation 6.79 |
| Tofacitinib 5 mg or 10 mg | 36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Physical Component Summary Scores | Month 36 (n =857, 286) | 53.05 units on a scale | Standard Deviation 7.28 |
| Tofacitinib 5 mg or 10 mg | 36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Physical Component Summary Scores | Baseline (n =2233, 580) | 48.94 units on a scale | Standard Deviation 9.12 |
| Tofacitinib 5 mg or 10 mg | 36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Physical Component Summary Scores | Month 24 (n =1362, 442) | 53.15 units on a scale | Standard Deviation 7.32 |
| Tofacitinib 5 mg or 10 mg | 36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Physical Component Summary Scores | Month 6 (n =2025, 557) | 53.51 units on a scale | Standard Deviation 7.3 |
| Tofacitinib 5 mg or 10 mg | 36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Physical Component Summary Scores | Month 48 (n =124, 56) | 52.36 units on a scale | Standard Deviation 8.39 |
| Tofacitinib 5 mg or 10 mg | 36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Physical Component Summary Scores | Month 12 (n =1750, 524) | 53.58 units on a scale | Standard Deviation 7.19 |
Secondary
Change From Baseline in Dermatology Life Quality Index (DLQI) Scores at Month 1, 6, 12, 24, 36 and 48
The DLQI was a validated, self-administered, 10-item quality-of-life questionnaire that consisted of 10 items that assessed the impact of skin disease on quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). Each question was scored on a scale of 0=not at all/not relevant to 3=very much. Response from all of the 10 questions were added to derive the DLQI total scores. Total DLQI scores ranges from 0=not at all to 30=very much, with higher scores indicating greater impairment in quality of life.
Time frame: Baseline, Month 1, 6, 12, 24, 36, 48
Population: FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Dermatology Life Quality Index (DLQI) Scores at Month 1, 6, 12, 24, 36 and 48 | Month 1 (n =2163, 556) | -8.61 units on a scale | Standard Deviation 7 |
| Tofacitinib 10 mg | Change From Baseline in Dermatology Life Quality Index (DLQI) Scores at Month 1, 6, 12, 24, 36 and 48 | Month 6 (n =2005, 554) | -9.14 units on a scale | Standard Deviation 7.06 |
| Tofacitinib 10 mg | Change From Baseline in Dermatology Life Quality Index (DLQI) Scores at Month 1, 6, 12, 24, 36 and 48 | Month 12 (n =1730, 525) | -9.23 units on a scale | Standard Deviation 6.91 |
| Tofacitinib 10 mg | Change From Baseline in Dermatology Life Quality Index (DLQI) Scores at Month 1, 6, 12, 24, 36 and 48 | Month 24 (n =1345, 438) | -9.08 units on a scale | Standard Deviation 6.82 |
| Tofacitinib 10 mg | Change From Baseline in Dermatology Life Quality Index (DLQI) Scores at Month 1, 6, 12, 24, 36 and 48 | Month 36 (n =1083, 369) | -9.47 units on a scale | Standard Deviation 6.8 |
| Tofacitinib 10 mg | Change From Baseline in Dermatology Life Quality Index (DLQI) Scores at Month 1, 6, 12, 24, 36 and 48 | Month 48 (n =404, 122) | -8.99 units on a scale | Standard Deviation 6.74 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Dermatology Life Quality Index (DLQI) Scores at Month 1, 6, 12, 24, 36 and 48 | Month 36 (n =1083, 369) | -8.46 units on a scale | Standard Deviation 6.14 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Dermatology Life Quality Index (DLQI) Scores at Month 1, 6, 12, 24, 36 and 48 | Month 1 (n =2163, 556) | -8.75 units on a scale | Standard Deviation 6.56 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Dermatology Life Quality Index (DLQI) Scores at Month 1, 6, 12, 24, 36 and 48 | Month 24 (n =1345, 438) | -8.47 units on a scale | Standard Deviation 6.43 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Dermatology Life Quality Index (DLQI) Scores at Month 1, 6, 12, 24, 36 and 48 | Month 6 (n =2005, 554) | -9.22 units on a scale | Standard Deviation 6.92 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Dermatology Life Quality Index (DLQI) Scores at Month 1, 6, 12, 24, 36 and 48 | Month 48 (n =404, 122) | -7.78 units on a scale | Standard Deviation 6.1 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Dermatology Life Quality Index (DLQI) Scores at Month 1, 6, 12, 24, 36 and 48 | Month 12 (n =1730, 525) | -9.02 units on a scale | Standard Deviation 6.68 |
Secondary
Change From Baseline in Itch Severity Item (ISI) Scores at Month 1, 3, 6, 12, 24, 36 and 48
ISI assessed severity of itching due to psoriasis. ISI was a single item, horizontal numeric rating scale. Participants were asked to rate their 'severity of itching' due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms '0=no itching' and '10=worst possible itching' at the ends. Higher scores indicated greater severity of itching.
Time frame: Baseline, Month 1, 3, 6, 12, 24, 36, 48
Population: FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Itch Severity Item (ISI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 | Month 6 (n =1958, 543) | -3.91 units on a scale | Standard Deviation 3.2 |
| Tofacitinib 10 mg | Change From Baseline in Itch Severity Item (ISI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 | Month 24 (n =1340, 435) | -3.80 units on a scale | Standard Deviation 3.14 |
| Tofacitinib 10 mg | Change From Baseline in Itch Severity Item (ISI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 | Month 3 (n =2103, 554) | -3.94 units on a scale | Standard Deviation 3.18 |
| Tofacitinib 10 mg | Change From Baseline in Itch Severity Item (ISI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 | Month 36 (n =1078, 372) | -3.95 units on a scale | Standard Deviation 3.18 |
| Tofacitinib 10 mg | Change From Baseline in Itch Severity Item (ISI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 | Month 12 (n =1693, 514) | -3.90 units on a scale | Standard Deviation 3.17 |
| Tofacitinib 10 mg | Change From Baseline in Itch Severity Item (ISI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 | Month 48 (n =411, 126) | -4.03 units on a scale | Standard Deviation 3.19 |
| Tofacitinib 10 mg | Change From Baseline in Itch Severity Item (ISI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 | Month 1 (n =2107, 544) | -3.88 units on a scale | Standard Deviation 3.06 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Itch Severity Item (ISI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 | Month 48 (n =411, 126) | -3.78 units on a scale | Standard Deviation 3.25 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Itch Severity Item (ISI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 | Month 1 (n =2107, 544) | -4.26 units on a scale | Standard Deviation 3.07 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Itch Severity Item (ISI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 | Month 3 (n =2103, 554) | -4.44 units on a scale | Standard Deviation 3.06 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Itch Severity Item (ISI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 | Month 6 (n =1958, 543) | -4.36 units on a scale | Standard Deviation 3.14 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Itch Severity Item (ISI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 | Month 12 (n =1693, 514) | -4.01 units on a scale | Standard Deviation 3.3 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Itch Severity Item (ISI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 | Month 24 (n =1340, 435) | -4.11 units on a scale | Standard Deviation 3.17 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Itch Severity Item (ISI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 | Month 36 (n =1078, 372) | -3.84 units on a scale | Standard Deviation 3.06 |
Secondary
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48
PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Erythema was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.
Time frame: Baseline, Month 1, 3, 6, 12, 24, 36, 48
Population: FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 1: Trunk (n =2195, 561) | -1.65 units on a scale | Standard Deviation 1.22 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 12: Head/Neck (n =1776, 531) | -1.56 units on a scale | Standard Deviation 1.19 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 3: Trunk (n =2201, 572) | -1.77 units on a scale | Standard Deviation 1.24 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 1: Upper Limbs (n =2195, 561) | -1.53 units on a scale | Standard Deviation 1.12 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 6: Trunk (n =2049, 563) | -1.81 units on a scale | Standard Deviation 1.24 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 3: Upper Limbs (n =2201, 572) | -1.59 units on a scale | Standard Deviation 1.15 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 12: Trunk (n =1776, 531) | -1.86 units on a scale | Standard Deviation 1.24 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 1: Head/Neck (n =2195, 561) | -1.43 units on a scale | Standard Deviation 1.15 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 24: Trunk (n =1394, 449) | -1.88 units on a scale | Standard Deviation 1.25 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 6: Upper Limbs (n =2049, 563) | -1.62 units on a scale | Standard Deviation 1.15 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 36: Trunk (n =1119, 384) | -1.99 units on a scale | Standard Deviation 1.26 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 24: Head/Neck (n =1394, 449) | -1.62 units on a scale | Standard Deviation 1.19 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 48: Trunk (n =422, 126) | -1.82 units on a scale | Standard Deviation 1.22 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 12: Upper Limbs (n =1776, 531) | -1.67 units on a scale | Standard Deviation 1.15 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 1: Lower Limbs (n =2195, 561) | -1.72 units on a scale | Standard Deviation 1.19 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 6: Head/Neck (n =2049, 563) | -1.52 units on a scale | Standard Deviation 1.2 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 3: Lower Limbs (n =2201, 572) | -1.87 units on a scale | Standard Deviation 1.21 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 24: Upper Limbs (n =1394, 449) | -1.70 units on a scale | Standard Deviation 1.18 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 6: Lower Limbs (n =2049, 563) | -1.90 units on a scale | Standard Deviation 1.22 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 36: Head/Neck (n =1119, 384) | -1.72 units on a scale | Standard Deviation 1.18 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 12: Lower Limbs (n =1776, 531) | -1.94 units on a scale | Standard Deviation 1.23 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 36: Upper Limbs (n =1119, 384) | -1.78 units on a scale | Standard Deviation 1.17 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 24: Lower Limbs (n =1394, 449) | -1.95 units on a scale | Standard Deviation 1.25 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 3: Head/Neck (n =2201, 572) | -1.50 units on a scale | Standard Deviation 1.18 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 36: Lower Limbs (n =1119, 384) | -2.04 units on a scale | Standard Deviation 1.23 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 48: Upper Limbs (n =422, 126) | -1.62 units on a scale | Standard Deviation 1.16 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 48: Lower Limbs (n =422, 126) | -1.87 units on a scale | Standard Deviation 1.2 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 48: Head/Neck (n =422, 126) | -1.55 units on a scale | Standard Deviation 1.19 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 48: Lower Limbs (n =422, 126) | -2.17 units on a scale | Standard Deviation 1.21 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 1: Head/Neck (n =2195, 561) | -1.66 units on a scale | Standard Deviation 1.2 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 3: Head/Neck (n =2201, 572) | -1.80 units on a scale | Standard Deviation 1.18 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 6: Head/Neck (n =2049, 563) | -1.72 units on a scale | Standard Deviation 1.21 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 12: Head/Neck (n =1776, 531) | -1.64 units on a scale | Standard Deviation 1.22 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 24: Head/Neck (n =1394, 449) | -1.67 units on a scale | Standard Deviation 1.23 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 36: Head/Neck (n =1119, 384) | -1.67 units on a scale | Standard Deviation 1.2 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 48: Head/Neck (n =422, 126) | -1.70 units on a scale | Standard Deviation 1.13 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 3: Upper Limbs (n =2201, 572) | -2.12 units on a scale | Standard Deviation 1.14 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 6: Upper Limbs (n =2049, 563) | -2.09 units on a scale | Standard Deviation 1.13 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 12: Upper Limbs (n =1776, 531) | -1.94 units on a scale | Standard Deviation 1.21 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 24: Upper Limbs (n =1394, 449) | -2.05 units on a scale | Standard Deviation 1.19 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 36: Upper Limbs (n =1119, 384) | -2.00 units on a scale | Standard Deviation 1.18 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 48: Upper Limbs (n =422, 126) | -1.90 units on a scale | Standard Deviation 1.22 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 1: Trunk (n =2195, 561) | -2.12 units on a scale | Standard Deviation 1.26 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 3: Trunk (n =2201, 572) | -2.33 units on a scale | Standard Deviation 1.17 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 6: Trunk (n =2049, 563) | -2.32 units on a scale | Standard Deviation 1.19 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 12: Trunk (n =1776, 531) | -2.21 units on a scale | Standard Deviation 1.25 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 24: Trunk (n =1394, 449) | -2.22 units on a scale | Standard Deviation 1.26 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 36: Trunk (n =1119, 384) | -2.18 units on a scale | Standard Deviation 1.3 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 48: Trunk (n =422, 126) | -2.08 units on a scale | Standard Deviation 1.17 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 1: Lower Limbs (n =2195, 561) | -2.16 units on a scale | Standard Deviation 1.26 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 3: Lower Limbs (n =2201, 572) | -2.36 units on a scale | Standard Deviation 1.21 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 6: Lower Limbs (n =2049, 563) | -2.42 units on a scale | Standard Deviation 1.18 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 12: Lower Limbs (n =1776, 531) | -2.24 units on a scale | Standard Deviation 1.33 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 24: Lower Limbs (n =1394, 449) | -2.32 units on a scale | Standard Deviation 1.24 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 36: Lower Limbs (n =1119, 384) | -2.28 units on a scale | Standard Deviation 1.3 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | Month 1: Upper Limbs (n =2195, 561) | -1.98 units on a scale | Standard Deviation 1.18 |
Secondary
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48
PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Induration was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.
Time frame: Baseline, Month 1, 3, 6, 12, 24, 36, 48
Population: FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 1: Trunk (n =2195, 561) | -1.55 units on a scale | Standard Deviation 1.19 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 24: Head/Neck (n =1394, 449) | -1.48 units on a scale | Standard Deviation 1.17 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 3: Trunk (n =2201, 572) | -1.65 units on a scale | Standard Deviation 1.22 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 3: Upper Limbs (n =2201, 572) | -1.47 units on a scale | Standard Deviation 1.17 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 6: Trunk (n =2049, 563) | -1.70 units on a scale | Standard Deviation 1.19 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 3: Head/Neck (n =2201, 572) | -1.37 units on a scale | Standard Deviation 1.17 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 12: Trunk (n =1776, 531) | -1.71 units on a scale | Standard Deviation 1.2 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 6: Upper Limbs (n =2049, 563) | -1.49 units on a scale | Standard Deviation 1.15 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 24: Trunk (n =1394, 449) | -1.76 units on a scale | Standard Deviation 1.19 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 36: Head/Neck (n =1119, 384) | -1.55 units on a scale | Standard Deviation 1.17 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 36: Trunk (n =1119, 384) | -1.85 units on a scale | Standard Deviation 1.2 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 12: Upper Limbs (n =1776, 531) | -1.54 units on a scale | Standard Deviation 1.14 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 48: Trunk (n =422, 126) | -1.68 units on a scale | Standard Deviation 1.17 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 12: Head/Neck (n =1776, 531) | -1.44 units on a scale | Standard Deviation 1.18 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 1: Lower Limbs (n =2195, 561) | -1.63 units on a scale | Standard Deviation 1.22 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 24: Upper Limbs (n =1394, 449) | -1.57 units on a scale | Standard Deviation 1.18 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 3: Lower Limbs (n =2201, 572) | -1.75 units on a scale | Standard Deviation 1.22 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 48: Head/Neck (n =422, 126) | -1.35 units on a scale | Standard Deviation 1.17 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 6: Lower Limbs (n =2049, 563) | -1.78 units on a scale | Standard Deviation 1.23 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 36: Upper Limbs (n =1119, 384) | -1.65 units on a scale | Standard Deviation 1.17 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 12: Lower Limbs (n =1776, 531) | -1.82 units on a scale | Standard Deviation 1.2 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 6: Head/Neck (n =2049, 563) | -1.40 units on a scale | Standard Deviation 1.16 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 24: Lower Limbs (n =1394, 449) | -1.85 units on a scale | Standard Deviation 1.22 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 48: Upper Limbs (n =422, 126) | -1.53 units on a scale | Standard Deviation 1.14 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 36: Lower Limbs (n =1119, 384) | -1.93 units on a scale | Standard Deviation 1.21 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 1: Upper Limbs (n =2195, 561) | -1.43 units on a scale | Standard Deviation 1.14 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 48: Lower Limbs (n =422, 126) | -1.77 units on a scale | Standard Deviation 1.18 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 1: Head/Neck (n =2195, 561) | -1.32 units on a scale | Standard Deviation 1.13 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 48: Lower Limbs (n =422, 126) | -2.07 units on a scale | Standard Deviation 1.24 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 1: Head/Neck (n =2195, 561) | -1.53 units on a scale | Standard Deviation 1.15 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 3: Head/Neck (n =2201, 572) | -1.63 units on a scale | Standard Deviation 1.14 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 6: Head/Neck (n =2049, 563) | -1.57 units on a scale | Standard Deviation 1.18 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 12: Head/Neck (n =1776, 531) | -1.49 units on a scale | Standard Deviation 1.18 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 24: Head/Neck (n =1394, 449) | -1.51 units on a scale | Standard Deviation 1.21 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 36: Head/Neck (n =1119, 384) | -1.51 units on a scale | Standard Deviation 1.15 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 48: Head/Neck (n =422, 126) | -1.41 units on a scale | Standard Deviation 1.1 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 1: Upper Limbs (n =2195, 561) | -1.85 units on a scale | Standard Deviation 1.22 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 3: Upper Limbs (n =2201, 572) | -1.97 units on a scale | Standard Deviation 1.16 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 6: Upper Limbs (n =2049, 563) | -1.94 units on a scale | Standard Deviation 1.19 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 12: Upper Limbs (n =1776, 531) | -1.82 units on a scale | Standard Deviation 1.27 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 24: Upper Limbs (n =1394, 449) | -1.97 units on a scale | Standard Deviation 1.19 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 36: Upper Limbs (n =1119, 384) | -1.92 units on a scale | Standard Deviation 1.18 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 48: Upper Limbs (n =422, 126) | -1.83 units on a scale | Standard Deviation 1.14 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 1: Trunk (n =2195, 561) | -2.01 units on a scale | Standard Deviation 1.26 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 3: Trunk (n =2201, 572) | -2.17 units on a scale | Standard Deviation 1.18 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 6: Trunk (n =2049, 563) | -2.18 units on a scale | Standard Deviation 1.2 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 12: Trunk (n =1776, 531) | -2.10 units on a scale | Standard Deviation 1.24 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 24: Trunk (n =1394, 449) | -2.13 units on a scale | Standard Deviation 1.2 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 36: Trunk (n =1119, 384) | -2.09 units on a scale | Standard Deviation 1.23 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 48: Trunk (n =422, 126) | -1.87 units on a scale | Standard Deviation 1.2 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 1: Lower Limbs (n =2195, 561) | -2.09 units on a scale | Standard Deviation 1.31 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 3: Lower Limbs (n =2201, 572) | -2.26 units on a scale | Standard Deviation 1.24 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 6: Lower Limbs (n =2049, 563) | -2.30 units on a scale | Standard Deviation 1.23 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 12: Lower Limbs (n =1776, 531) | -2.17 units on a scale | Standard Deviation 1.33 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 24: Lower Limbs (n =1394, 449) | -2.28 units on a scale | Standard Deviation 1.24 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | Month 36: Lower Limbs (n =1119, 384) | -2.22 units on a scale | Standard Deviation 1.29 |
Secondary
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48
PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Scaling was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.
Time frame: Baseline, Month 1, 3, 6, 12, 24, 36, 48
Population: FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 1: Trunk (n =2195, 561) | -1.58 units on a scale | Standard Deviation 1.2 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 24: Head/Neck (n =1394, 449) | -1.63 units on a scale | Standard Deviation 1.24 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 3: Trunk (n =2201, 572) | -1.67 units on a scale | Standard Deviation 1.22 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 3: Upper Limbs (n =2201, 572) | -1.47 units on a scale | Standard Deviation 1.2 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 6: Trunk (n =2049, 563) | -1.70 units on a scale | Standard Deviation 1.19 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 3: Head/Neck (n =2201, 572) | -1.51 units on a scale | Standard Deviation 1.24 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 12: Trunk (n =1776, 531) | -1.72 units on a scale | Standard Deviation 1.21 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 6: Upper Limbs (n =2049, 563) | -1.49 units on a scale | Standard Deviation 1.21 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 24: Trunk (n =1394, 449) | -1.77 units on a scale | Standard Deviation 1.2 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 36: Head/Neck (n =1119, 384) | -1.68 units on a scale | Standard Deviation 1.22 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 36: Trunk (n =1119, 384) | -1.84 units on a scale | Standard Deviation 1.2 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 12: Upper Limbs (n =1776, 531) | -1.52 units on a scale | Standard Deviation 1.21 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 48: Trunk (n =422, 126) | -1.62 units on a scale | Standard Deviation 1.19 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 12: Head/Neck (n =1776, 531) | -1.56 units on a scale | Standard Deviation 1.25 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 1: Lower Limbs (n =2195, 561) | -1.67 units on a scale | Standard Deviation 1.24 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 24: Upper Limbs (n =1394, 449) | -1.56 units on a scale | Standard Deviation 1.22 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 3: Lower Limbs (n =2201, 572) | -1.77 units on a scale | Standard Deviation 1.26 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 48: Head/Neck (n =422, 126) | -1.53 units on a scale | Standard Deviation 1.24 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 6: Lower Limbs (n =2049, 563) | -1.79 units on a scale | Standard Deviation 1.27 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 36: Upper Limbs (n =1119, 384) | -1.65 units on a scale | Standard Deviation 1.19 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 12: Lower Limbs (n =1776, 531) | -1.83 units on a scale | Standard Deviation 1.26 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 6: Head/Neck (n =2049, 563) | -1.52 units on a scale | Standard Deviation 1.24 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 24: Lower Limbs (n =1394, 449) | -1.86 units on a scale | Standard Deviation 1.27 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 48: Upper Limbs (n =422, 126) | -1.45 units on a scale | Standard Deviation 1.19 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 36: Lower Limbs (n =1119, 384) | -1.97 units on a scale | Standard Deviation 1.23 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 1: Upper Limbs (n =2195, 561) | -1.44 units on a scale | Standard Deviation 1.18 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 48: Lower Limbs (n =422, 126) | -1.77 units on a scale | Standard Deviation 1.29 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 1: Head/Neck (n =2195, 561) | -1.46 units on a scale | Standard Deviation 1.19 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 48: Lower Limbs (n =422, 126) | -2.11 units on a scale | Standard Deviation 1.23 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 1: Head/Neck (n =2195, 561) | -1.69 units on a scale | Standard Deviation 1.2 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 3: Head/Neck (n =2201, 572) | -1.78 units on a scale | Standard Deviation 1.19 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 6: Head/Neck (n =2049, 563) | -1.70 units on a scale | Standard Deviation 1.22 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 12: Head/Neck (n =1776, 531) | -1.61 units on a scale | Standard Deviation 1.24 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 24: Head/Neck (n =1394, 449) | -1.63 units on a scale | Standard Deviation 1.27 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 36: Head/Neck (n =1119, 384) | -1.64 units on a scale | Standard Deviation 1.22 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 48: Head/Neck (n =422, 126) | -1.58 units on a scale | Standard Deviation 1.17 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 1: Upper Limbs (n =2195, 561) | -1.84 units on a scale | Standard Deviation 1.24 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 3: Upper Limbs (n =2201, 572) | -1.97 units on a scale | Standard Deviation 1.18 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 6: Upper Limbs (n =2049, 563) | -1.94 units on a scale | Standard Deviation 1.26 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 12: Upper Limbs (n =1776, 531) | -1.82 units on a scale | Standard Deviation 1.3 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 24: Upper Limbs (n =1394, 449) | -1.96 units on a scale | Standard Deviation 1.22 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 36: Upper Limbs (n =1119, 384) | -1.93 units on a scale | Standard Deviation 1.15 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 48: Upper Limbs (n =422, 126) | -1.78 units on a scale | Standard Deviation 1.22 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 1: Trunk (n =2195, 561) | -1.98 units on a scale | Standard Deviation 1.24 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 3: Trunk (n =2201, 572) | -2.14 units on a scale | Standard Deviation 1.14 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 6: Trunk (n =2049, 563) | -2.14 units on a scale | Standard Deviation 1.22 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 12: Trunk (n =1776, 531) | -2.08 units on a scale | Standard Deviation 1.23 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 24: Trunk (n =1394, 449) | -2.11 units on a scale | Standard Deviation 1.19 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 36: Trunk (n =1119, 384) | -2.06 units on a scale | Standard Deviation 1.23 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 48: Trunk (n =422, 126) | -1.80 units on a scale | Standard Deviation 1.18 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 1: Lower Limbs (n =2195, 561) | -2.09 units on a scale | Standard Deviation 1.3 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 3: Lower Limbs (n =2201, 572) | -2.30 units on a scale | Standard Deviation 1.23 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 6: Lower Limbs (n =2049, 563) | -2.30 units on a scale | Standard Deviation 1.25 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 12: Lower Limbs (n =1776, 531) | -2.15 units on a scale | Standard Deviation 1.36 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 24: Lower Limbs (n =1394, 449) | -2.25 units on a scale | Standard Deviation 1.24 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | Month 36: Lower Limbs (n =1119, 384) | -2.21 units on a scale | Standard Deviation 1.26 |
Secondary
Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Month 1, 3, 6, 12, 24, 36 and 48
PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck \[h\], upper limbs \[u\], trunk \[t\] and lower limbs \[l\]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4.
Time frame: Baseline, Month 1, 3, 6, 12, 24, 36, 48
Population: FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 | Month 12 (n =1776, 531) | -17.01 units on a scale | Standard Deviation 9.33 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 | Month 3 (n =2201, 572) | -16.18 units on a scale | Standard Deviation 9.73 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 | Month 24 (n =1394, 449) | -17.25 units on a scale | Standard Deviation 9.35 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 | Month 48 (n =422, 126) | -16.16 units on a scale | Standard Deviation 8.61 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 | Month 36 (n =1119, 384) | -17.44 units on a scale | Standard Deviation 9.23 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 | Month 6 (n =2049, 563) | -16.56 units on a scale | Standard Deviation 9.54 |
| Tofacitinib 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 | Month 1 (n =2195, 561) | -15.26 units on a scale | Standard Deviation 9.96 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 | Month 48 (n =422, 126) | -15.47 units on a scale | Standard Deviation 9.04 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 | Month 3 (n =2201, 572) | -16.99 units on a scale | Standard Deviation 9.27 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 | Month 6 (n =2049, 563) | -17.03 units on a scale | Standard Deviation 9.16 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 | Month 12 (n =1776, 531) | -16.45 units on a scale | Standard Deviation 9.04 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 | Month 24 (n =1394, 449) | -16.67 units on a scale | Standard Deviation 8.7 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 | Month 36 (n =1119, 384) | -16.49 units on a scale | Standard Deviation 8.81 |
| Tofacitinib 5 mg or 10 mg | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 | Month 1 (n =2195, 561) | -16.00 units on a scale | Standard Deviation 9.57 |
Secondary
Dermatology Life Quality Index (DLQI) Scores
The DLQI was a validated, self-administered, 10-item quality-of-life questionnaire that consisted of 10 items that assessed the impact of skin disease on quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). Each question was scored on a scale of 0=not at all/not relevant to 3=very much. Response from all of the 10 questions were added to derive the DLQI total scores. Total DLQI scores ranges from 0=not at all to 30=very much, with higher scores indicating greater impairment in quality of life.
Time frame: Baseline, Month 1, 6, 12, 24, 36, 48
Population: FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Dermatology Life Quality Index (DLQI) Scores | Month 6 (n =2028, 557) | 3.68 units on a scale | Standard Deviation 5 |
| Tofacitinib 10 mg | Dermatology Life Quality Index (DLQI) Scores | Month 24 (n =1361, 441) | 3.49 units on a scale | Standard Deviation 4.71 |
| Tofacitinib 10 mg | Dermatology Life Quality Index (DLQI) Scores | Month 1 (n =2189, 559) | 4.11 units on a scale | Standard Deviation 5.23 |
| Tofacitinib 10 mg | Dermatology Life Quality Index (DLQI) Scores | Month 36 (n =1093, 372) | 2.97 units on a scale | Standard Deviation 4.05 |
| Tofacitinib 10 mg | Dermatology Life Quality Index (DLQI) Scores | Month 12 (n =1751, 528) | 3.44 units on a scale | Standard Deviation 4.65 |
| Tofacitinib 10 mg | Dermatology Life Quality Index (DLQI) Scores | Month 48 (n =407, 124) | 3.20 units on a scale | Standard Deviation 4.39 |
| Tofacitinib 10 mg | Dermatology Life Quality Index (DLQI) Scores | Baseline (n =2243, 582) | 12.73 units on a scale | Standard Deviation 7.12 |
| Tofacitinib 5 mg or 10 mg | Dermatology Life Quality Index (DLQI) Scores | Month 48 (n =407, 124) | 1.81 units on a scale | Standard Deviation 2.98 |
| Tofacitinib 5 mg or 10 mg | Dermatology Life Quality Index (DLQI) Scores | Baseline (n =2243, 582) | 10.95 units on a scale | Standard Deviation 6.61 |
| Tofacitinib 5 mg or 10 mg | Dermatology Life Quality Index (DLQI) Scores | Month 1 (n =2189, 559) | 2.14 units on a scale | Standard Deviation 3.43 |
| Tofacitinib 5 mg or 10 mg | Dermatology Life Quality Index (DLQI) Scores | Month 6 (n =2028, 557) | 1.67 units on a scale | Standard Deviation 3.33 |
| Tofacitinib 5 mg or 10 mg | Dermatology Life Quality Index (DLQI) Scores | Month 12 (n =1751, 528) | 1.71 units on a scale | Standard Deviation 2.92 |
| Tofacitinib 5 mg or 10 mg | Dermatology Life Quality Index (DLQI) Scores | Month 24 (n =1361, 441) | 1.94 units on a scale | Standard Deviation 3.29 |
| Tofacitinib 5 mg or 10 mg | Dermatology Life Quality Index (DLQI) Scores | Month 36 (n =1093, 372) | 1.98 units on a scale | Standard Deviation 3.35 |
Secondary
Euro Quality of Life- 5-Dimensions (EQ-5D)-Utility Scores
EQ-5D: participant rated 5-dimension (mobility, self-care, usual activities, pain and discomfort, and anxiety and depression) questionnaire to assess health-related quality of life in terms of a single utility score. Each dimension was assessed on a 3-point scale (1=no problems, 2=some problems, 3=extreme problems, where higher scores=worse health condition). The responses from the 5 dimensions were used to calculate a single utility index value. Scoring formula developed by EuroQol Group assigned a utility value for each dimension in the profile. Score was transformed and results in a total score range -0.594 to 1.000; higher score indicated a better health state.
Time frame: Baseline, Month 6, 12, 24, 36, 48
Population: FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Euro Quality of Life- 5-Dimensions (EQ-5D)-Utility Scores | Baseline (n =2242, 581) | 0.77 units on a scale | Standard Deviation 0.19 |
| Tofacitinib 10 mg | Euro Quality of Life- 5-Dimensions (EQ-5D)-Utility Scores | Month 6 (n =2021, 559) | 0.87 units on a scale | Standard Deviation 0.15 |
| Tofacitinib 10 mg | Euro Quality of Life- 5-Dimensions (EQ-5D)-Utility Scores | Month 12 (n =1750, 523) | 0.88 units on a scale | Standard Deviation 0.15 |
| Tofacitinib 10 mg | Euro Quality of Life- 5-Dimensions (EQ-5D)-Utility Scores | Month 24 (n =1364, 443) | 0.88 units on a scale | Standard Deviation 0.14 |
| Tofacitinib 10 mg | Euro Quality of Life- 5-Dimensions (EQ-5D)-Utility Scores | Month 36 (n =857, 284) | 0.88 units on a scale | Standard Deviation 0.14 |
| Tofacitinib 10 mg | Euro Quality of Life- 5-Dimensions (EQ-5D)-Utility Scores | Month 48 (n =124, 56) | 0.90 units on a scale | Standard Deviation 0.13 |
| Tofacitinib 5 mg or 10 mg | Euro Quality of Life- 5-Dimensions (EQ-5D)-Utility Scores | Month 36 (n =857, 284) | 0.91 units on a scale | Standard Deviation 0.12 |
| Tofacitinib 5 mg or 10 mg | Euro Quality of Life- 5-Dimensions (EQ-5D)-Utility Scores | Baseline (n =2242, 581) | 0.80 units on a scale | Standard Deviation 0.17 |
| Tofacitinib 5 mg or 10 mg | Euro Quality of Life- 5-Dimensions (EQ-5D)-Utility Scores | Month 24 (n =1364, 443) | 0.90 units on a scale | Standard Deviation 0.14 |
| Tofacitinib 5 mg or 10 mg | Euro Quality of Life- 5-Dimensions (EQ-5D)-Utility Scores | Month 6 (n =2021, 559) | 0.91 units on a scale | Standard Deviation 0.13 |
| Tofacitinib 5 mg or 10 mg | Euro Quality of Life- 5-Dimensions (EQ-5D)-Utility Scores | Month 48 (n =124, 56) | 0.89 units on a scale | Standard Deviation 0.12 |
| Tofacitinib 5 mg or 10 mg | Euro Quality of Life- 5-Dimensions (EQ-5D)-Utility Scores | Month 12 (n =1750, 523) | 0.91 units on a scale | Standard Deviation 0.13 |
Secondary
Euro Quality of Life-5-Dimensions (EQ-5D)-Visual Analogue Scale Scores (VAS)
EQ-5D VAS was a participant rated questionnaire to assess health-related quality of life in terms of a single index value. It was a visual analogue scale that ranged from 0 (minimum) to 100 (maximum), with higher scores indicating a better health condition.
Time frame: Baseline, Month 6, 12, 24, 36, 48
Population: FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Euro Quality of Life-5-Dimensions (EQ-5D)-Visual Analogue Scale Scores (VAS) | Baseline (n =2224, 570) | 66.39 units on a scale | Standard Deviation 23.2 |
| Tofacitinib 10 mg | Euro Quality of Life-5-Dimensions (EQ-5D)-Visual Analogue Scale Scores (VAS) | Month 6 (n =2026, 559) | 78.28 units on a scale | Standard Deviation 17.11 |
| Tofacitinib 10 mg | Euro Quality of Life-5-Dimensions (EQ-5D)-Visual Analogue Scale Scores (VAS) | Month 12 (n =1749, 525) | 78.91 units on a scale | Standard Deviation 16.95 |
| Tofacitinib 10 mg | Euro Quality of Life-5-Dimensions (EQ-5D)-Visual Analogue Scale Scores (VAS) | Month 24 (n =1365, 443) | 79.80 units on a scale | Standard Deviation 16.98 |
| Tofacitinib 10 mg | Euro Quality of Life-5-Dimensions (EQ-5D)-Visual Analogue Scale Scores (VAS) | Month 36 (n =856, 286) | 79.43 units on a scale | Standard Deviation 17.01 |
| Tofacitinib 10 mg | Euro Quality of Life-5-Dimensions (EQ-5D)-Visual Analogue Scale Scores (VAS) | Month 48 (n =124, 56) | 82.14 units on a scale | Standard Deviation 14.07 |
| Tofacitinib 5 mg or 10 mg | Euro Quality of Life-5-Dimensions (EQ-5D)-Visual Analogue Scale Scores (VAS) | Month 36 (n =856, 286) | 84.62 units on a scale | Standard Deviation 14.28 |
| Tofacitinib 5 mg or 10 mg | Euro Quality of Life-5-Dimensions (EQ-5D)-Visual Analogue Scale Scores (VAS) | Baseline (n =2224, 570) | 68.21 units on a scale | Standard Deviation 22.91 |
| Tofacitinib 5 mg or 10 mg | Euro Quality of Life-5-Dimensions (EQ-5D)-Visual Analogue Scale Scores (VAS) | Month 24 (n =1365, 443) | 83.47 units on a scale | Standard Deviation 15.55 |
| Tofacitinib 5 mg or 10 mg | Euro Quality of Life-5-Dimensions (EQ-5D)-Visual Analogue Scale Scores (VAS) | Month 6 (n =2026, 559) | 83.95 units on a scale | Standard Deviation 16.18 |
| Tofacitinib 5 mg or 10 mg | Euro Quality of Life-5-Dimensions (EQ-5D)-Visual Analogue Scale Scores (VAS) | Month 48 (n =124, 56) | 84.50 units on a scale | Standard Deviation 16.87 |
| Tofacitinib 5 mg or 10 mg | Euro Quality of Life-5-Dimensions (EQ-5D)-Visual Analogue Scale Scores (VAS) | Month 12 (n =1749, 525) | 83.80 units on a scale | Standard Deviation 14.85 |
Secondary
Itch Severity Item (ISI) Scores
ISI assessed severity of itching due to psoriasis. ISI was a single item, horizontal numeric rating scale. Participants were asked to rate their 'severity of itching' due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms '0=no itching' and '10=worst possible itching' at the ends. Higher scores indicated greater severity of itching.
Time frame: Baseline, Month 1, 3, 6, 12, 24, 36, 48
Population: FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Itch Severity Item (ISI) Scores | Baseline (n =2172, 566) | 5.76 units on a scale | Standard Deviation 2.91 |
| Tofacitinib 10 mg | Itch Severity Item (ISI) Scores | Month 1 (n =2196, 561) | 1.88 units on a scale | Standard Deviation 2.26 |
| Tofacitinib 10 mg | Itch Severity Item (ISI) Scores | Month 3 (n =2197, 572) | 1.83 units on a scale | Standard Deviation 2.32 |
| Tofacitinib 10 mg | Itch Severity Item (ISI) Scores | Month 6 (n =2047, 560) | 1.87 units on a scale | Standard Deviation 2.33 |
| Tofacitinib 10 mg | Itch Severity Item (ISI) Scores | Month 12 (n =1774, 530) | 1.79 units on a scale | Standard Deviation 2.21 |
| Tofacitinib 10 mg | Itch Severity Item (ISI) Scores | Month 24 (n =1394, 449) | 1.83 units on a scale | Standard Deviation 2.23 |
| Tofacitinib 10 mg | Itch Severity Item (ISI) Scores | Month 36 (n =1117, 383) | 1.69 units on a scale | Standard Deviation 2.12 |
| Tofacitinib 10 mg | Itch Severity Item (ISI) Scores | Month 48 (n =417, 127) | 1.92 units on a scale | Standard Deviation 2.3 |
| Tofacitinib 5 mg or 10 mg | Itch Severity Item (ISI) Scores | Month 48 (n =417, 127) | 1.24 units on a scale | Standard Deviation 1.74 |
| Tofacitinib 5 mg or 10 mg | Itch Severity Item (ISI) Scores | Baseline (n =2172, 566) | 5.17 units on a scale | Standard Deviation 3 |
| Tofacitinib 5 mg or 10 mg | Itch Severity Item (ISI) Scores | Month 12 (n =1774, 530) | 1.08 units on a scale | Standard Deviation 1.67 |
| Tofacitinib 5 mg or 10 mg | Itch Severity Item (ISI) Scores | Month 1 (n =2196, 561) | 0.92 units on a scale | Standard Deviation 1.53 |
| Tofacitinib 5 mg or 10 mg | Itch Severity Item (ISI) Scores | Month 36 (n =1117, 383) | 1.21 units on a scale | Standard Deviation 1.72 |
| Tofacitinib 5 mg or 10 mg | Itch Severity Item (ISI) Scores | Month 3 (n =2197, 572) | 0.72 units on a scale | Standard Deviation 1.39 |
| Tofacitinib 5 mg or 10 mg | Itch Severity Item (ISI) Scores | Month 24 (n =1394, 449) | 1.01 units on a scale | Standard Deviation 1.54 |
| Tofacitinib 5 mg or 10 mg | Itch Severity Item (ISI) Scores | Month 6 (n =2047, 560) | 0.82 units on a scale | Standard Deviation 1.51 |
Secondary
Number of Participants Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU)
Ps-HCRU was a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. In the first section, it assessed direct costs associated with healthcare resource use which included participant's interactions with healthcare providers such as general practitioners, dermatologists, cardiologists, gastroenterologists, psychiatrists, surgeons and nurses. When taking the evening dose of tofacitinib, participants were asked to answer the Ps-HCRU questionnaire only if they had an interaction with a healthcare provider or their work was impacted by psoriasis on that specified day. In this outcome measure, number of participants who answered Ps-HCRU at any specified visits were reported.
Time frame: Baseline, Month 1, 3, 6, 12, 24, 36, 48
Population: Safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 10 mg | Number of Participants Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) | Baseline | 156 participants |
| Tofacitinib 10 mg | Number of Participants Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) | Month 1 | 153 participants |
| Tofacitinib 10 mg | Number of Participants Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) | Month 3 | 204 participants |
| Tofacitinib 10 mg | Number of Participants Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) | Month 6 | 288 participants |
| Tofacitinib 10 mg | Number of Participants Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) | Month 12 | 234 participants |
| Tofacitinib 10 mg | Number of Participants Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) | Month 24 | 171 participants |
| Tofacitinib 10 mg | Number of Participants Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) | Month 36 | 114 participants |
| Tofacitinib 10 mg | Number of Participants Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) | Month 48 | 22 participants |
| Tofacitinib 5 mg or 10 mg | Number of Participants Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) | Month 48 | 11 participants |
| Tofacitinib 5 mg or 10 mg | Number of Participants Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) | Baseline | 44 participants |
| Tofacitinib 5 mg or 10 mg | Number of Participants Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) | Month 12 | 71 participants |
| Tofacitinib 5 mg or 10 mg | Number of Participants Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) | Month 1 | 30 participants |
| Tofacitinib 5 mg or 10 mg | Number of Participants Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) | Month 36 | 30 participants |
| Tofacitinib 5 mg or 10 mg | Number of Participants Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) | Month 3 | 55 participants |
| Tofacitinib 5 mg or 10 mg | Number of Participants Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) | Month 24 | 50 participants |
| Tofacitinib 5 mg or 10 mg | Number of Participants Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) | Month 6 | 71 participants |
Secondary
Number of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear
The PtGA evaluated the overall skin disease of participants at that point in time on a single-item. Participants provided their response on a 5-point scale ranges from: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe. Higher score indicated greater severity of disease. Participants who provided their response as clear (score of 0) or almost clear (score of 1) in PtGA at each specified visit were reported in this outcome measure.
Time frame: Baseline, Month 1, 3, 6, 12, 24, 36, 48
Population: FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 10 mg | Number of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear | Baseline: Clear (n =2244, 583) | 1 participants |
| Tofacitinib 10 mg | Number of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear | Baseline: Almost Clear (n =2244, 583) | 25 participants |
| Tofacitinib 10 mg | Number of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear | Month 1: Clear (n =2192, 561) | 211 participants |
| Tofacitinib 10 mg | Number of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear | Month 1: Almost Clear (n =2192, 561) | 703 participants |
| Tofacitinib 10 mg | Number of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear | Month 3: Clear (n =2177, 568) | 248 participants |
| Tofacitinib 10 mg | Number of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear | Month 3: Almost Clear (n =2177, 568) | 762 participants |
| Tofacitinib 10 mg | Number of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear | Month 6: Clear (n =2030, 562) | 247 participants |
| Tofacitinib 10 mg | Number of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear | Month 6: Almost Clear (n =2030, 562) | 748 participants |
| Tofacitinib 10 mg | Number of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear | Month 12: Clear (n =1758, 530) | 209 participants |
| Tofacitinib 10 mg | Number of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear | Month 12: Almost Clear (n =1758, 530) | 662 participants |
| Tofacitinib 10 mg | Number of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear | Month 24: Clear (n =1380, 449) | 171 participants |
| Tofacitinib 10 mg | Number of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear | Month 24: Almost Clear (n =1380, 449) | 502 participants |
| Tofacitinib 10 mg | Number of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear | Month 36: Clear (n =1112, 377) | 162 participants |
| Tofacitinib 10 mg | Number of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear | Month 36: Almost Clear (n =1112, 377) | 418 participants |
| Tofacitinib 10 mg | Number of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear | Month 48: Clear (n =410, 125) | 40 participants |
| Tofacitinib 10 mg | Number of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear | Month 48: Almost Clear (n =410, 125) | 151 participants |
| Tofacitinib 5 mg or 10 mg | Number of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear | Month 48: Almost Clear (n =410, 125) | 60 participants |
| Tofacitinib 5 mg or 10 mg | Number of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear | Baseline: Clear (n =2244, 583) | 3 participants |
| Tofacitinib 5 mg or 10 mg | Number of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear | Month 12: Clear (n =1758, 530) | 151 participants |
| Tofacitinib 5 mg or 10 mg | Number of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear | Baseline: Almost Clear (n =2244, 583) | 16 participants |
| Tofacitinib 5 mg or 10 mg | Number of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear | Month 36: Clear (n =1112, 377) | 75 participants |
| Tofacitinib 5 mg or 10 mg | Number of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear | Month 1: Clear (n =2192, 561) | 127 participants |
| Tofacitinib 5 mg or 10 mg | Number of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear | Month 12: Almost Clear (n =1758, 530) | 236 participants |
| Tofacitinib 5 mg or 10 mg | Number of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear | Month 1: Almost Clear (n =2192, 561) | 246 participants |
| Tofacitinib 5 mg or 10 mg | Number of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear | Month 48: Clear (n =410, 125) | 25 participants |
| Tofacitinib 5 mg or 10 mg | Number of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear | Month 3: Clear (n =2177, 568) | 174 participants |
| Tofacitinib 5 mg or 10 mg | Number of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear | Month 24: Clear (n =1380, 449) | 111 participants |
| Tofacitinib 5 mg or 10 mg | Number of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear | Month 3: Almost Clear (n =2177, 568) | 254 participants |
| Tofacitinib 5 mg or 10 mg | Number of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear | Month 36: Almost Clear (n =1112, 377) | 183 participants |
| Tofacitinib 5 mg or 10 mg | Number of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear | Month 6: Clear (n =2030, 562) | 176 participants |
| Tofacitinib 5 mg or 10 mg | Number of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear | Month 24: Almost Clear (n =1380, 449) | 202 participants |
| Tofacitinib 5 mg or 10 mg | Number of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear | Month 6: Almost Clear (n =2030, 562) | 265 participants |
Secondary
Percentage of Participants Achieving Greater Than or Equal to (>=) 125 Percent Increase From Baseline in Psoriasis Area and Severity Index (PASI) Scores
PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck \[h\], upper limbs \[u\], trunk \[t\] and lower limbs \[l\]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of participants with \>=125% increase from baseline in PASI scores were reported.
Time frame: Baseline, Month 1, 3, 6, 12, 24, 36, 48
Population: FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 125 Percent Increase From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 6 (n =2048, 557) | 1.27 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 125 Percent Increase From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 24 (n =1393, 445) | 0.93 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 125 Percent Increase From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 3 (n =2200, 566) | 1.18 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 125 Percent Increase From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 36 (n =1118, 380) | 0.54 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 125 Percent Increase From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 12 (n =1775, 525) | 0.90 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 125 Percent Increase From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 48 (n =422, 124) | 0.71 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 125 Percent Increase From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 1 (n =2194, 555) | 0.96 percentage of participants |
| Tofacitinib 5 mg or 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 125 Percent Increase From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 48 (n =422, 124) | 0.00 percentage of participants |
| Tofacitinib 5 mg or 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 125 Percent Increase From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 1 (n =2194, 555) | 1.08 percentage of participants |
| Tofacitinib 5 mg or 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 125 Percent Increase From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 3 (n =2200, 566) | 0.71 percentage of participants |
| Tofacitinib 5 mg or 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 125 Percent Increase From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 6 (n =2048, 557) | 0.90 percentage of participants |
| Tofacitinib 5 mg or 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 125 Percent Increase From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 12 (n =1775, 525) | 1.33 percentage of participants |
| Tofacitinib 5 mg or 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 125 Percent Increase From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 24 (n =1393, 445) | 0.90 percentage of participants |
| Tofacitinib 5 mg or 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 125 Percent Increase From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 36 (n =1118, 380) | 1.32 percentage of participants |
Secondary
Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores
PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck \[h\], upper limbs \[u\], trunk \[t\] and lower limbs \[l\]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of participants with \>=50% reduction from baseline in PASI scores were reported.
Time frame: Baseline, Month 1, 3, 6, 12, 24, 36, 48
Population: FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 6 (n =2048, 557) | 85.64 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 24 (n =1393, 445) | 88.87 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 3 (n =2200, 566) | 81.59 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 36 (n =1118, 380) | 90.97 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 12 (n =1775, 525) | 87.66 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 48 (n =422, 124) | 88.86 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 1 (n =2194, 555) | 76.53 percentage of participants |
| Tofacitinib 5 mg or 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 48 (n =422, 124) | 97.58 percentage of participants |
| Tofacitinib 5 mg or 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 1 (n =2194, 555) | 86.67 percentage of participants |
| Tofacitinib 5 mg or 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 3 (n =2200, 566) | 95.05 percentage of participants |
| Tofacitinib 5 mg or 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 6 (n =2048, 557) | 93.90 percentage of participants |
| Tofacitinib 5 mg or 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 12 (n =1775, 525) | 93.14 percentage of participants |
| Tofacitinib 5 mg or 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 24 (n =1393, 445) | 94.61 percentage of participants |
| Tofacitinib 5 mg or 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 36 (n =1118, 380) | 92.63 percentage of participants |
Secondary
Percentage of Participants Achieving Greater Than or Equal to (>=) 75 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores
PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck \[h\], upper limbs \[u\], trunk \[t\] and lower limbs \[l\]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of participants with \>=75 percent (%) reduction from baseline in PASI scores were reported.
Time frame: Baseline, Month 1, 3, 6, 12, 24, 36, 48
Population: FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 75 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 6 (n =2048, 557) | 61.67 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 75 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 24 (n =1393, 445) | 67.26 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 75 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 3 (n =2200, 566) | 58.45 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 75 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 36 (n =1118, 380) | 70.75 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 75 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 12 (n =1775, 525) | 65.24 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 75 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 48 (n =422, 124) | 64.93 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 75 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 1 (n =2194, 555) | 51.96 percentage of participants |
| Tofacitinib 5 mg or 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 75 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 48 (n =422, 124) | 83.06 percentage of participants |
| Tofacitinib 5 mg or 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 75 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 1 (n =2194, 555) | 71.89 percentage of participants |
| Tofacitinib 5 mg or 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 75 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 3 (n =2200, 566) | 84.45 percentage of participants |
| Tofacitinib 5 mg or 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 75 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 6 (n =2048, 557) | 86.00 percentage of participants |
| Tofacitinib 5 mg or 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 75 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 12 (n =1775, 525) | 80.76 percentage of participants |
| Tofacitinib 5 mg or 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 75 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 24 (n =1393, 445) | 84.94 percentage of participants |
| Tofacitinib 5 mg or 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 75 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 36 (n =1118, 380) | 83.95 percentage of participants |
Secondary
Percentage of Participants Achieving Greater Than or Equal to (>=) 90 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores
PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck \[h\], upper limbs \[u\], trunk \[t\] and lower limbs \[l\]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of participants with \>=90% reduction from baseline in PASI scores were reported.
Time frame: Baseline, Month 1, 3, 6, 12, 24, 36, 48
Population: FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 90 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 6 (n =2048, 557) | 35.21 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 90 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 24 (n =1393, 445) | 38.33 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 90 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 3 (n =2200, 566) | 33.73 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 90 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 36 (n =1118, 380) | 43.02 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 90 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 12 (n =1775, 525) | 35.94 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 90 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 48 (n =422, 124) | 34.36 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 90 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 1 (n =2194, 555) | 29.99 percentage of participants |
| Tofacitinib 5 mg or 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 90 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 48 (n =422, 124) | 58.06 percentage of participants |
| Tofacitinib 5 mg or 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 90 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 1 (n =2194, 555) | 56.04 percentage of participants |
| Tofacitinib 5 mg or 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 90 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 3 (n =2200, 566) | 65.37 percentage of participants |
| Tofacitinib 5 mg or 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 90 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 6 (n =2048, 557) | 65.89 percentage of participants |
| Tofacitinib 5 mg or 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 90 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 12 (n =1775, 525) | 61.71 percentage of participants |
| Tofacitinib 5 mg or 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 90 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 24 (n =1393, 445) | 62.02 percentage of participants |
| Tofacitinib 5 mg or 10 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 90 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | Month 36 (n =1118, 380) | 60.53 percentage of participants |
Secondary
Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear'
The PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema (E), induration (I), and scaling (S) across all psoriatic lesions in participants. The severity rating scores (Erythema: 0= no evidence of erythema to 4= dark, deep red; Induration: 0= no evidence of plaque elevation to 4= marked plaque elevation, hard/sharp borders; Scaling: 0= no evidence of scaling to 4= thick, coarse scale predominates) were summed (E + I + S = total) and the average (total/3) was taken. The total average was rounded to the nearest whole number score to determine the PGA. The 5-point scale for PGA was: 0= clear; 1= almost clear; 2= mild; 3= moderate; 4= severe, where higher score indicated more severity of psoriasis. Percentage of participants with response of 'clear' (score of '0') and 'almost clear' (score of '1') were reported.
Time frame: Month 1, 3, 6, 12, 24, 36, 48
Population: Full analysis set (FAS) included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies participants evaluable for this outcome measure and 'n' signifies participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 10 mg | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' | Month 3 (n =2200, 571) | 54.86 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' | Month 24 (n =1397, 448) | 54.62 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' | Month 12 (n =1776, 532) | 54.79 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' | Month 36 (n =1123, 385) | 57.35 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' | Month 6 (n =2052, 564) | 54.97 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' | Month 48 (n =422, 126) | 48.58 percentage of participants |
| Tofacitinib 10 mg | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' | Month 1 (n =2196, 563) | 50.36 percentage of participants |
| Tofacitinib 5 mg or 10 mg | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' | Month 48 (n =422, 126) | 77.78 percentage of participants |
| Tofacitinib 5 mg or 10 mg | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' | Month 3 (n =2200, 571) | 85.29 percentage of participants |
| Tofacitinib 5 mg or 10 mg | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' | Month 6 (n =2052, 564) | 82.09 percentage of participants |
| Tofacitinib 5 mg or 10 mg | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' | Month 12 (n =1776, 532) | 75.19 percentage of participants |
| Tofacitinib 5 mg or 10 mg | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' | Month 24 (n =1397, 448) | 79.46 percentage of participants |
| Tofacitinib 5 mg or 10 mg | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' | Month 36 (n =1123, 385) | 76.36 percentage of participants |
| Tofacitinib 5 mg or 10 mg | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' | Month 1 (n =2196, 563) | 77.80 percentage of participants |
Secondary
Psoriasis Area and Severity Index (PASI) Component Scores: Erythema
PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Erythema was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.
Time frame: Baseline, Month 1, 3, 6, 12, 24, 36, 48
Population: FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 36: Trunk (n =1121, 384) | 0.86 units on a scale | Standard Deviation 1.06 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 6: Trunk (n =2051, 563) | 1.03 units on a scale | Standard Deviation 1.09 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 12: Lower Limbs (n =1779, 531) | 1.17 units on a scale | Standard Deviation 1.1 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Baseline: Head/Neck (n =2266, 585) | 2.26 units on a scale | Standard Deviation 0.99 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 1: Head/Neck (n =2198, 561) | 0.82 units on a scale | Standard Deviation 0.96 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 3: Head/Neck (n =2205, 572) | 0.76 units on a scale | Standard Deviation 0.95 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 6: Head/Neck (n =2051, 563) | 0.75 units on a scale | Standard Deviation 0.95 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 12: Head/Neck (n =1779, 531) | 0.70 units on a scale | Standard Deviation 0.92 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 24: Head/Neck (n =1397, 449) | 0.66 units on a scale | Standard Deviation 0.93 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 36: Head/Neck (n =1121, 384) | 0.57 units on a scale | Standard Deviation 0.88 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 48: Head/Neck (n =422, 126) | 0.70 units on a scale | Standard Deviation 0.93 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Baseline: Upper Limbs (n =2266, 585) | 2.82 units on a scale | Standard Deviation 0.74 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 1: Upper Limbs (n =2198, 561) | 1.29 units on a scale | Standard Deviation 0.98 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 3: Upper Limbs (n =2205, 572) | 1.23 units on a scale | Standard Deviation 1 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 6: Upper Limbs (n =2051, 563) | 1.20 units on a scale | Standard Deviation 1.01 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 12: Upper Limbs (n =1779, 531) | 1.16 units on a scale | Standard Deviation 1.01 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 24: Upper Limbs (n =1397, 449) | 1.13 units on a scale | Standard Deviation 1.03 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 36: Upper Limbs (n =1121, 384) | 1.06 units on a scale | Standard Deviation 1.01 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 48: Upper Limbs (n =422, 126) | 1.18 units on a scale | Standard Deviation 1.03 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Baseline: Trunk (n =2266, 585) | 2.83 units on a scale | Standard Deviation 0.83 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 1: Trunk (n =2198, 561) | 1.18 units on a scale | Standard Deviation 1.11 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 3: Trunk (n =2205, 572) | 1.06 units on a scale | Standard Deviation 1.09 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 12: Trunk (n =1779, 531) | 0.99 units on a scale | Standard Deviation 1.08 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 24: Trunk (n =1397, 449) | 0.96 units on a scale | Standard Deviation 1.08 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 48: Trunk (n =422, 126) | 1.00 units on a scale | Standard Deviation 1.1 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Baseline: Lower Limbs (n =2266, 585) | 3.10 units on a scale | Standard Deviation 0.7 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 1: Lower Limbs (n =2198, 561) | 1.37 units on a scale | Standard Deviation 1.09 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 3: Lower Limbs (n =2205, 572) | 1.24 units on a scale | Standard Deviation 1.08 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 6: Lower Limbs (n =2051, 563) | 1.20 units on a scale | Standard Deviation 1.11 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 24: Lower Limbs (n =1397, 449) | 1.15 units on a scale | Standard Deviation 1.11 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 36: Lower Limbs (n =1121, 384) | 1.07 units on a scale | Standard Deviation 1.11 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 48: Lower Limbs (n =422, 126) | 1.20 units on a scale | Standard Deviation 1.11 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 36: Trunk (n =1121, 384) | 0.53 units on a scale | Standard Deviation 0.9 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 3: Trunk (n =2205, 572) | 0.41 units on a scale | Standard Deviation 0.73 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 24: Upper Limbs (n =1397, 449) | 0.61 units on a scale | Standard Deviation 0.85 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Baseline: Lower Limbs (n =2266, 585) | 2.94 units on a scale | Standard Deviation 0.89 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 1: Lower Limbs (n =2198, 561) | 0.79 units on a scale | Standard Deviation 0.95 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 6: Lower Limbs (n =2051, 563) | 0.52 units on a scale | Standard Deviation 0.81 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 36: Upper Limbs (n =1121, 384) | 0.68 units on a scale | Standard Deviation 0.86 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Baseline: Head/Neck (n =2266, 585) | 2.13 units on a scale | Standard Deviation 1.08 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 48: Trunk (n =422, 126) | 0.50 units on a scale | Standard Deviation 0.86 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 1: Head/Neck (n =2198, 561) | 0.47 units on a scale | Standard Deviation 0.81 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 48: Upper Limbs (n =422, 126) | 0.58 units on a scale | Standard Deviation 0.84 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 3: Head/Neck (n =2205, 572) | 0.34 units on a scale | Standard Deviation 0.65 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 12: Lower Limbs (n =1779, 531) | 0.69 units on a scale | Standard Deviation 0.98 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 6: Head/Neck (n =2051, 563) | 0.42 units on a scale | Standard Deviation 0.75 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 36: Lower Limbs (n =1121, 384) | 0.67 units on a scale | Standard Deviation 0.96 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 12: Head/Neck (n =1779, 531) | 0.49 units on a scale | Standard Deviation 0.82 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 1: Trunk (n =2198, 561) | 0.62 units on a scale | Standard Deviation 0.92 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 24: Head/Neck (n =1397, 449) | 0.47 units on a scale | Standard Deviation 0.75 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 24: Lower Limbs (n =1397, 449) | 0.59 units on a scale | Standard Deviation 0.9 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 36: Head/Neck (n =1121, 384) | 0.48 units on a scale | Standard Deviation 0.79 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 6: Trunk (n =2051, 563) | 0.41 units on a scale | Standard Deviation 0.79 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 48: Head/Neck (n =422, 126) | 0.34 units on a scale | Standard Deviation 0.69 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 3: Lower Limbs (n =2205, 572) | 0.58 units on a scale | Standard Deviation 0.84 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Baseline: Upper Limbs (n =2266, 585) | 2.68 units on a scale | Standard Deviation 0.86 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 12: Trunk (n =1779, 531) | 0.51 units on a scale | Standard Deviation 0.89 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 1: Upper Limbs (n =2198, 561) | 0.71 units on a scale | Standard Deviation 0.86 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 48: Lower Limbs (n =422, 126) | 0.61 units on a scale | Standard Deviation 0.91 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 3: Upper Limbs (n =2205, 572) | 0.57 units on a scale | Standard Deviation 0.79 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 24: Trunk (n =1397, 449) | 0.49 units on a scale | Standard Deviation 0.84 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 6: Upper Limbs (n =2051, 563) | 0.58 units on a scale | Standard Deviation 0.83 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Baseline: Trunk (n =2266, 585) | 2.73 units on a scale | Standard Deviation 0.94 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | Month 12: Upper Limbs (n =1779, 531) | 0.74 units on a scale | Standard Deviation 0.95 |
Secondary
Psoriasis Area and Severity Index (PASI) Component Scores: Induration
PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Induration was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.
Time frame: Baseline, Month 1, 3, 6, 12, 24, 36, 48
Population: FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 48: Head/Neck (n =422, 126) | 0.60 units on a scale | Standard Deviation 0.85 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Baseline: Head/Neck (n =2266, 585) | 1.97 units on a scale | Standard Deviation 1.01 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 1: Head/Neck (n =2198, 561) | 0.65 units on a scale | Standard Deviation 0.85 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 3: Head/Neck (n =2205, 572) | 0.60 units on a scale | Standard Deviation 0.84 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 6: Head/Neck (n =2051, 563) | 0.59 units on a scale | Standard Deviation 0.86 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 12: Head/Neck (n =1779, 531) | 0.55 units on a scale | Standard Deviation 0.81 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 24: Head/Neck (n =1397, 449) | 0.53 units on a scale | Standard Deviation 0.82 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 36: Head/Neck (n =1121, 384) | 0.46 units on a scale | Standard Deviation 0.77 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Baseline: Upper Limbs (n =2266, 585) | 2.64 units on a scale | Standard Deviation 0.77 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 1: Upper Limbs (n =2198, 561) | 1.21 units on a scale | Standard Deviation 0.99 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 3: Upper Limbs (n =2205, 572) | 1.17 units on a scale | Standard Deviation 1.01 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 6: Upper Limbs (n =2051, 563) | 1.15 units on a scale | Standard Deviation 1.02 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 12: Upper Limbs (n =1779, 531) | 1.11 units on a scale | Standard Deviation 1.01 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 24: Upper Limbs (n =1397, 449) | 1.08 units on a scale | Standard Deviation 1.02 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 36: Upper Limbs (n =1121, 384) | 1.00 units on a scale | Standard Deviation 1.01 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 48: Upper Limbs (n =422, 126) | 1.09 units on a scale | Standard Deviation 1 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Baseline: Trunk (n =2266, 585) | 2.57 units on a scale | Standard Deviation 0.86 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 1: Trunk (n =2198, 561) | 1.02 units on a scale | Standard Deviation 1.04 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 3: Trunk (n =2205, 572) | 0.91 units on a scale | Standard Deviation 1.02 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 6: Trunk (n =2051, 563) | 0.88 units on a scale | Standard Deviation 1 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 12: Trunk (n =1779, 531) | 0.87 units on a scale | Standard Deviation 1 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 24: Trunk (n =1397, 449) | 0.82 units on a scale | Standard Deviation 0.98 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 36: Trunk (n =1121, 384) | 0.75 units on a scale | Standard Deviation 0.97 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 48: Trunk (n =422, 126) | 0.91 units on a scale | Standard Deviation 1.05 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Baseline: Lower Limbs (n =2266, 585) | 2.85 units on a scale | Standard Deviation 0.76 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 1: Lower Limbs (n =2198, 561) | 1.22 units on a scale | Standard Deviation 1.04 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 3: Lower Limbs (n =2205, 572) | 1.10 units on a scale | Standard Deviation 1.04 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 6: Lower Limbs (n =2051, 563) | 1.08 units on a scale | Standard Deviation 1.06 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 12: Lower Limbs (n =1779, 531) | 1.05 units on a scale | Standard Deviation 1.03 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 24: Lower Limbs (n =1397, 449) | 1.02 units on a scale | Standard Deviation 1.03 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 36: Lower Limbs (n =1121, 384) | 0.95 units on a scale | Standard Deviation 1.03 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 48: Lower Limbs (n =422, 126) | 1.07 units on a scale | Standard Deviation 1.04 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 48: Lower Limbs (n =422, 126) | 0.48 units on a scale | Standard Deviation 0.79 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 48: Upper Limbs (n =422, 126) | 0.50 units on a scale | Standard Deviation 0.75 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Baseline: Trunk (n =2266, 585) | 2.51 units on a scale | Standard Deviation 1.01 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Baseline: Head/Neck (n =2266, 585) | 1.88 units on a scale | Standard Deviation 1.1 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Baseline: Lower Limbs (n =2266, 585) | 2.77 units on a scale | Standard Deviation 0.96 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 1: Head/Neck (n =2198, 561) | 0.35 units on a scale | Standard Deviation 0.73 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 1: Trunk (n =2198, 561) | 0.52 units on a scale | Standard Deviation 0.86 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 3: Head/Neck (n =2205, 572) | 0.26 units on a scale | Standard Deviation 0.56 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 12: Lower Limbs (n =1779, 531) | 0.61 units on a scale | Standard Deviation 0.94 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 6: Head/Neck (n =2051, 563) | 0.31 units on a scale | Standard Deviation 0.67 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 3: Trunk (n =2205, 572) | 0.34 units on a scale | Standard Deviation 0.68 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 12: Head/Neck (n =1779, 531) | 0.38 units on a scale | Standard Deviation 0.71 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 1: Lower Limbs (n =2198, 561) | 0.68 units on a scale | Standard Deviation 0.95 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 24: Head/Neck (n =1397, 449) | 0.37 units on a scale | Standard Deviation 0.68 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 6: Trunk (n =2051, 563) | 0.34 units on a scale | Standard Deviation 0.71 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 36: Head/Neck (n =1121, 384) | 0.37 units on a scale | Standard Deviation 0.68 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 12: Upper Limbs (n =1779, 531) | 0.69 units on a scale | Standard Deviation 0.95 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 48: Head/Neck (n =422, 126) | 0.26 units on a scale | Standard Deviation 0.6 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 36: Lower Limbs (n =1121, 384) | 0.57 units on a scale | Standard Deviation 0.87 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Baseline: Upper Limbs (n =2266, 585) | 2.50 units on a scale | Standard Deviation 0.93 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 12: Trunk (n =1779, 531) | 0.42 units on a scale | Standard Deviation 0.77 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 1: Upper Limbs (n =2198, 561) | 0.66 units on a scale | Standard Deviation 0.88 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 3: Lower Limbs (n =2205, 572) | 0.51 units on a scale | Standard Deviation 0.84 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 3: Upper Limbs (n =2205, 572) | 0.53 units on a scale | Standard Deviation 0.81 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 24: Trunk (n =1397, 449) | 0.39 units on a scale | Standard Deviation 0.73 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 6: Upper Limbs (n =2051, 563) | 0.55 units on a scale | Standard Deviation 0.85 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 24: Lower Limbs (n =1397, 449) | 0.49 units on a scale | Standard Deviation 0.83 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 36: Trunk (n =1121, 384) | 0.43 units on a scale | Standard Deviation 0.79 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 24: Upper Limbs (n =1397, 449) | 0.53 units on a scale | Standard Deviation 0.84 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 6: Lower Limbs (n =2051, 563) | 0.47 units on a scale | Standard Deviation 0.82 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 36: Upper Limbs (n =1121, 384) | 0.60 units on a scale | Standard Deviation 0.82 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | Month 48: Trunk (n =422, 126) | 0.44 units on a scale | Standard Deviation 0.8 |
Secondary
Psoriasis Area and Severity Index (PASI) Component Scores: Scaling
PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Scaling was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.
Time frame: Baseline, Month 1, 3, 6, 12, 24, 36, 48
Population: FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Baseline: Trunk (n =2266, 585) | 2.55 units on a scale | Standard Deviation 0.89 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 48: Head/Neck (n =422, 126) | 0.65 units on a scale | Standard Deviation 0.93 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 1: Trunk (n =2198, 561) | 0.97 units on a scale | Standard Deviation 1.02 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Baseline: Head/Neck (n =2266, 585) | 2.22 units on a scale | Standard Deviation 1.08 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 3: Trunk (n =2205, 572) | 0.87 units on a scale | Standard Deviation 1 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Baseline: Upper Limbs (n =2266, 585) | 2.65 units on a scale | Standard Deviation 0.82 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 6: Trunk (n =2051, 563) | 0.85 units on a scale | Standard Deviation 0.99 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 6: Head/Neck (n =2051, 563) | 0.71 units on a scale | Standard Deviation 0.97 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 12: Trunk (n =1779, 531) | 0.83 units on a scale | Standard Deviation 0.97 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 3: Upper Limbs (n =2205, 572) | 1.18 units on a scale | Standard Deviation 1.04 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 24: Trunk (n =1397, 449) | 0.78 units on a scale | Standard Deviation 0.95 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 12: Head/Neck (n =1779, 531) | 0.67 units on a scale | Standard Deviation 0.92 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 36: Trunk (n =1121, 384) | 0.71 units on a scale | Standard Deviation 0.93 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 1: Head/Neck (n =2198, 561) | 0.75 units on a scale | Standard Deviation 0.95 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 48: Trunk (n =422, 126) | 0.86 units on a scale | Standard Deviation 0.99 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 12: Upper Limbs (n =1779, 531) | 1.12 units on a scale | Standard Deviation 1.03 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Baseline: Lower Limbs (n =2266, 585) | 2.89 units on a scale | Standard Deviation 0.81 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 24: Head/Neck (n =1397, 449) | 0.60 units on a scale | Standard Deviation 0.88 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 1: Lower Limbs (n =2198, 561) | 1.23 units on a scale | Standard Deviation 1.08 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 24: Upper Limbs (n =1397, 449) | 1.08 units on a scale | Standard Deviation 1.03 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 3: Lower Limbs (n =2205, 572) | 1.12 units on a scale | Standard Deviation 1.08 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 6: Upper Limbs (n =2051, 563) | 1.16 units on a scale | Standard Deviation 1.05 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 6: Lower Limbs (n =2051, 563) | 1.11 units on a scale | Standard Deviation 1.1 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 36: Upper Limbs (n =1121, 384) | 1.01 units on a scale | Standard Deviation 1.02 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 12: Lower Limbs (n =1779, 531) | 1.07 units on a scale | Standard Deviation 1.07 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 36: Head/Neck (n =1121, 384) | 0.55 units on a scale | Standard Deviation 0.88 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 24: Lower Limbs (n =1397, 449) | 1.04 units on a scale | Standard Deviation 1.06 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 48: Upper Limbs (n =422, 126) | 1.13 units on a scale | Standard Deviation 1.09 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 36: Lower Limbs (n =1121, 384) | 0.94 units on a scale | Standard Deviation 1.03 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 3: Head/Neck (n =2205, 572) | 0.71 units on a scale | Standard Deviation 0.95 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 48: Lower Limbs (n =422, 126) | 1.09 units on a scale | Standard Deviation 1.09 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 1: Upper Limbs (n =2198, 561) | 1.22 units on a scale | Standard Deviation 1.01 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 48: Lower Limbs (n =422, 126) | 0.48 units on a scale | Standard Deviation 0.76 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Baseline: Head/Neck (n =2266, 585) | 2.10 units on a scale | Standard Deviation 1.11 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 1: Head/Neck (n =2198, 561) | 0.42 units on a scale | Standard Deviation 0.79 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 3: Head/Neck (n =2205, 572) | 0.32 units on a scale | Standard Deviation 0.66 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 6: Head/Neck (n =2051, 563) | 0.40 units on a scale | Standard Deviation 0.77 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 12: Head/Neck (n =1779, 531) | 0.48 units on a scale | Standard Deviation 0.84 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 24: Head/Neck (n =1397, 449) | 0.45 units on a scale | Standard Deviation 0.77 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 36: Head/Neck (n =1121, 384) | 0.47 units on a scale | Standard Deviation 0.79 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 48: Head/Neck (n =422, 126) | 0.34 units on a scale | Standard Deviation 0.72 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Baseline: Upper Limbs (n =2266, 585) | 2.52 units on a scale | Standard Deviation 0.96 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 1: Upper Limbs (n =2198, 561) | 0.69 units on a scale | Standard Deviation 0.89 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 3: Upper Limbs (n =2205, 572) | 0.55 units on a scale | Standard Deviation 0.8 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 6: Upper Limbs (n =2051, 563) | 0.58 units on a scale | Standard Deviation 0.87 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 12: Upper Limbs (n =1779, 531) | 0.72 units on a scale | Standard Deviation 0.97 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 24: Upper Limbs (n =1397, 449) | 0.58 units on a scale | Standard Deviation 0.84 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 36: Upper Limbs (n =1121, 384) | 0.62 units on a scale | Standard Deviation 0.83 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 48: Upper Limbs (n =422, 126) | 0.53 units on a scale | Standard Deviation 0.79 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Baseline: Trunk (n =2266, 585) | 2.47 units on a scale | Standard Deviation 1 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 1: Trunk (n =2198, 561) | 0.50 units on a scale | Standard Deviation 0.83 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 3: Trunk (n =2205, 572) | 0.33 units on a scale | Standard Deviation 0.64 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 6: Trunk (n =2051, 563) | 0.33 units on a scale | Standard Deviation 0.7 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 12: Trunk (n =1779, 531) | 0.40 units on a scale | Standard Deviation 0.76 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 24: Trunk (n =1397, 449) | 0.39 units on a scale | Standard Deviation 0.72 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 36: Trunk (n =1121, 384) | 0.42 units on a scale | Standard Deviation 0.77 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 48: Trunk (n =422, 126) | 0.40 units on a scale | Standard Deviation 0.78 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Baseline: Lower Limbs (n =2266, 585) | 2.79 units on a scale | Standard Deviation 1 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 1: Lower Limbs (n =2198, 561) | 0.70 units on a scale | Standard Deviation 0.93 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 3: Lower Limbs (n =2205, 572) | 0.48 units on a scale | Standard Deviation 0.78 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 6: Lower Limbs (n =2051, 563) | 0.48 units on a scale | Standard Deviation 0.83 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 12: Lower Limbs (n =1779, 531) | 0.64 units on a scale | Standard Deviation 0.98 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 24: Lower Limbs (n =1397, 449) | 0.53 units on a scale | Standard Deviation 0.84 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | Month 36: Lower Limbs (n =1121, 384) | 0.60 units on a scale | Standard Deviation 0.9 |
Secondary
Psoriasis Area and Severity Index (PASI) Scores
PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck \[h\], upper limbs \[u\], trunk \[t\] and lower limbs \[l\]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4.
Time frame: Baseline, Month 1, 3, 6, 12, 24, 36, 48
Population: FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Scores | Month 3 (n =2205, 572) | 5.64 units on a scale | Standard Deviation 6.33 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Scores | Baseline (n =2266, 585) | 21.85 units on a scale | Standard Deviation 9.48 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Scores | Month 1 (n =2198, 561) | 6.60 units on a scale | Standard Deviation 7.14 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Scores | Month 6 (n =2051, 563) | 5.31 units on a scale | Standard Deviation 6.31 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Scores | Month 12 (n =1779, 531) | 4.72 units on a scale | Standard Deviation 5.29 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Scores | Month 24 (n =1397, 449) | 4.41 units on a scale | Standard Deviation 5.08 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Scores | Month 36 (n =1121, 384) | 3.91 units on a scale | Standard Deviation 4.66 |
| Tofacitinib 10 mg | Psoriasis Area and Severity Index (PASI) Scores | Month 48 (n =422, 126) | 4.75 units on a scale | Standard Deviation 5.37 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Scores | Month 48 (n =422, 126) | 1.85 units on a scale | Standard Deviation 2.31 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Scores | Month 12 (n =1779, 531) | 2.38 units on a scale | Standard Deviation 3.57 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Scores | Baseline (n =2266, 585) | 19.05 units on a scale | Standard Deviation 8.89 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Scores | Month 36 (n =1121, 384) | 2.19 units on a scale | Standard Deviation 3.23 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Scores | Month 1 (n =2198, 561) | 3.09 units on a scale | Standard Deviation 4.81 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Scores | Month 3 (n =2205, 572) | 1.95 units on a scale | Standard Deviation 3.25 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Scores | Month 24 (n =1397, 449) | 1.90 units on a scale | Standard Deviation 2.65 |
| Tofacitinib 5 mg or 10 mg | Psoriasis Area and Severity Index (PASI) Scores | Month 6 (n =2051, 563) | 1.90 units on a scale | Standard Deviation 3.25 |