Psoriasis, Psoriasis Vulgaris
Conditions
Keywords
plaque psoriasis, vulgaris, topical treatment, skin diseases, papulosquamous, Tofacitinib, CP-690550, Xeljanz, psoriasis, moderate, severe, itch, nail psoriasis
Brief summary
The study is beng done to test if tofacitinib ointment is safe and effective for people with plaque psoriasis. Two dose strengths of tofacitinib ointment (20 mg/g and 10 mg/g) applied once or twice daily are being tested. The safety and effectiveness of tofacitinib ointment used for 12 weeks will be compared to the safety and effectiveness of placebo ointment (vehicle) used for 12 weeks.
Interventions
DRUGtofacitinib ointment 20 mg/g
tofacitinib ointment 20 mg/g BID (twice daily) for 12 weeks
DRUGtofacitinib ointment 10 mg/g
tofacitinib ointment 10 mg/g BID (twice daily) for 12 weeks
placebo ointment (vehicle) BID (twice daily) for 12 weeks
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have mild, moderate or severe plaque psoriasis (psoriasis vulgaris) for at least 6 months prior to Baseline * At Baseline, have plaque psoriasis covering 2% to 20% of total body surface area (BSA) on the trunk and limbs (excluding palms, soles, and nails) * If received certain treatments, should be off treatment for a minimum period of time (washout)
Exclusion criteria
* Currently have non-plaque forms of psoriasis or drug-induced psoriasis * Require treatment with or cannot stop medication(s) prohibited during the study * Have certain laboratory abnormalities at Baseline * Current or history of certain infections * Females who are pregnant, breastfeeding, or are of childbearing potential not using highly effective contraception
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (≥) 2 Grade/Point Improvement From Baseline at Week 12 | Baseline, Week 12 | Clinical signs of plaque psoriasis (erythema \[E\], induration \[I\], and scaling \[S\]) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. The PGA-C was a static assessment; i.e., without regard to a previous assessment. The PGA subscores are then summed and averaged after which the total average was rounded to the nearest whole number to determine the PGA-C score and category. A higher score indicated a higher level of severity. 0 is equal to (=) cleared except for any residual discoloration and 1=almost clear, majority of lesions had individual scores for E+I+S that when summed, averaged, and rounded equaled 1. |
| Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8 | Baseline, Week 8 | Clinical signs of plaque psoriasis (E, I, and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. The PGA-C was a static assessment; i.e., without regard to a previous assessment. The PGA subscores are then summed and averaged after which the total average was rounded to the nearest whole number to determine the PGA-C score and category. A higher score indicated a higher level of severity. 0 is equal to (=) cleared except for any residual discoloration and 1=almost clear, majority of lesions had individual scores for E+I+S that when summed, averaged, and rounded equaled 1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving a Gestalt Physician's Global Assessment (PGA-G) Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 12 | Baseline, Week 12 | Clinical signs of plaque psoriasis (E, I and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. After scoring each of the PGA subscores, a clinical evaluator of psoriasis performed an assessment of the overall severity of psoriasis and assigned a PGA-G score and category. 0=Clear, except for any residual discoloration (post-inflammatory hyperpigmentation and/or hypopigmentation) and 1=almost clear, the psoriasis is not entirely cleared and remaining plaques are light pink (not including post inflammatory hyperpigmentation), and/or have barely palpable elevation and/or have occasional fine scale. The PGA-G was a static assessment; i.e., without regard to a previous assessment. |
| Percentage of Participants Achieving a PGA-G Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8 | Baseline, Week 8 | Clinical signs of plaque psoriasis (E, I and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. After scoring each of the PGA subscores, a clinical evaluator of psoriasis performed an assessment of the overall severity of psoriasis and assigned a PGA-G score and category. 0=Clear, except for any residual discoloration (post-inflammatory hyperpigmentation and/or hypopigmentation) and 1=almost clear, the psoriasis is not entirely cleared and remaining plaques are light pink (not including post inflammatory hyperpigmentation), and/or have barely palpable elevation and/or have occasional fine scale. The PGA-G was a static assessment; i.e., without regard to a previous assessment. |
| Percent Change From Baseline to Week 12 in Psoriasis Area and Severity Index (PASI) | Baseline, Week 12 | Combined assessment of lesion severity and area affected into single score. Body was divided into 4 regions: head, arms, trunk, legs. For each region, percent (%) area of skin involved was estimated: 0=0% to 6=90-100%. Severity was estimated by clinical signs: erythema, induration, scaling; scale: 0=none to 4=maximum. Final PASI = sum of severity parameters for each region\*area score\*weight of region (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0=no disease to 72=maximal disease. The maximum PASI score was \<72 since the PASI assessment excluded scalp, palms, finger nails, soles, and toe nails. |
| Percent Change From Baseline to Week 8 in PASI | Baseline, Week 8 | Combined assessment of lesion severity and area affected into single score. Body was divided into 4 regions: head, arms, trunk, legs. For each region, percent area of skin involved was estimated: 0=0% to 6=90-100%. Severity was estimated by clinical signs: erythema, induration, scaling; scale: 0=none to 4=maximum. Final PASI = sum of severity parameters for each region\*area score\*weight of region (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0=no disease to 72=maximal disease. The maximum PASI score was \<72 since the PASI assessment excluded scalp, palms, finger nails, soles, and toe nails. |
| Percentage of Participants Achieving at Least a 75% Reduction in PASI Response (PASI75), Relative to Baseline at Week 12 | Baseline, Week 12 | Combined assessment of lesion severity and area affected into single score. Body was divided into 4 regions: head, arms, trunk, legs. For each region, percent area of skin involved was estimated: 0=0% to 6=90-100%. Severity was estimated by clinical signs: erythema, induration, scaling; scale: 0=none to 4=maximum. Final PASI = sum of severity parameters for each region\*area score\*weight of region (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0=no disease to 72=maximal disease. The maximum PASI score was \<72 since the PASI assessment excluded scalp, palms, finger nails, soles, and toe nails. |
| Percentage of Participants Achieving PASI75, Relative to Baseline at Week 8 | Baseline, Week 8 | Combined assessment of lesion severity and area affected into single score. Body was divided into 4 regions: head, arms, trunk, legs. For each region, percent area of skin involved was estimated: 0=0% to 6=90-100%. Severity was estimated by clinical signs: erythema, induration, scaling; scale: 0=none to 4=maximum. Final PASI = sum of severity parameters for each region\*area score\*weight of region (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0=no disease to 72=maximal disease. The maximum PASI score was \<72 since the PASI assessment excluded scalp, palms, finger nails, soles, and toe nails. |
| Percent Change From Baseline to Week 12 in Body Surface Area (BSA) Affected With Psoriasis | Baseline, Week 12 | Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. BSA (%)=the sum of the BSAs of the 4 body regions. BSA assessment excluded head and neck, palms, finger nails, soles and toe nails. |
| Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 12 | Week 12 | Clinical signs of plaque psoriasis (E, I, and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. The PGA-C was a static assessment; i.e., without regard to a previous assessment. The PGA subscores are then summed and averaged after which the total average was rounded to the nearest whole number to determine the PGA-C score and category. A higher score indicated a higher level of severity. 0 is equal to (=) cleared except for any residual discoloration and 1=almost clear, majority of lesions had individual scores for E+I+S that when summed, averaged, and rounded equaled 1. |
| Change From Baseline to Week 12 in Clinic-Based Itch Severity Item (ISI) Scores | Baseline, Week 12 | The severity of itch (pruritus) due to psoriasis was assessed using the ISI. Participants were asked to assess their worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms no itching (0) and worst possible itching (10) at the ends. Participants completed the ISI assessments at the clinic (i.e., clinic-based). |
| Change From Baseline to Week 8 in Clinic-Based ISI Scores | Baseline, Week 8 | The severity of itch (pruritus) due to psoriasis was assessed using the ISI. Participants were asked to assess their worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms no itching (0) and worst possible itching (10) at the ends. Participants completed the ISI assessments at the clinic (i.e., clinic-based). |
| Change From Baseline to Week 12 in the Dermatology Life Quality Index (DLQI) Total Score | Baseline, Week 12 | DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire assesses participant health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. |
| Change From Baseline to Week 8 in the DLQI Total Score | Baseline, Week 8 | DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire assesses participant health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. |
| Percentage of Participants Achieving a Patient's Global Assessment (PtGA) Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 12 for Participants With a PtGA Score ≥2 at Baseline | Baseline, Week 12 | The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe). |
| Percentage of Participants Achieving a PtGA Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8 for Participants With a PtGA Score ≥2 at Baseline | Baseline, Week 8 | The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe). |
| Percent Change From Baseline to Week 8 in BSA Affected With Psoriasis | Baseline, Week 8 | Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. BSA (%)=the sum of the BSAs of the 4 body regions. BSA assessment excluded head and neck, palms, finger nails, soles and toe nails. |
| Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 8 | Week 8 | Clinical signs of plaque psoriasis (E, I, and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. The PGA-C was a static assessment; i.e., without regard to a previous assessment. The PGA subscores are then summed and averaged after which the total average was rounded to the nearest whole number to determine the PGA-C score and category. A higher score indicated a higher level of severity. 0 is equal to (=) cleared except for any residual discoloration and 1=almost clear, majority of lesions had individual scores for E+I+S that when summed, averaged, and rounded equaled 1. |
Countries
Canada, Denmark, Poland, United States
Participant flow
Recruitment details
Participants with mild (PGA-C score of 2), moderate (PGA-C score of 3), or severe (PGA-C score of 4) chronic plaque psoriasis were recruited for this study. The primary analysis population for this study included only the participants with mild and moderate disease.
Participants by arm
| Arm | Count |
|---|---|
| Mild/Moderate: Tofacitinib 20 mg/g BID Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks. | 71 |
| Mild/Moderate: Tofacitinib 10 mg/g BID Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks. | 70 |
| Mild/Moderate: Placebo (Vehicle) BID Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks. | 71 |
| Mild/Moderate: Tofacitinib 20 mg/g QD Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks. | 70 |
| Mild/Moderate: Tofacitinib 10 mg/g QD Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks. | 74 |
| Mild/Moderate: Placebo (Vehicle) QD Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks. | 74 |
| Severe: Tofacitinib 20 mg/g BID Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks. | 7 |
| Severe: Tofacitinib 10 mg/g BID Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks. | 7 |
| Severe: Placebo (Vehicle) BID Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), BID for 12 weeks. | 7 |
| Severe: Tofacitinib 20 mg/g QD Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks. | 7 |
| Severe: Tofacitinib 10 mg/g QD Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment 10 mg/g, QD for 12 weeks. | 6 |
| Severe: Placebo (Vehicle) QD Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), QD for 12 weeks. | 7 |
| Total | 471 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 4 | 6 | 3 | 7 | 0 | 1 | 1 | 1 | 0 | 2 |
| Overall Study | Death | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Lack of Efficacy | 5 | 8 | 7 | 6 | 9 | 8 | 1 | 1 | 2 | 2 | 2 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 4 | 2 | 0 | 3 | 0 | 0 | 0 | 1 | 0 | 1 |
| Overall Study | Non-compliance with study treatment | 2 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Other | 2 | 3 | 2 | 2 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 1 | 1 | 2 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 6 | 3 | 3 | 3 | 3 | 5 | 0 | 0 | 0 | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Mild/Moderate: Tofacitinib 20 mg/g BID | Mild/Moderate: Tofacitinib 10 mg/g BID | Mild/Moderate: Placebo (Vehicle) BID | Mild/Moderate: Tofacitinib 20 mg/g QD | Mild/Moderate: Tofacitinib 10 mg/g QD | Mild/Moderate: Placebo (Vehicle) QD | Severe: Tofacitinib 20 mg/g BID | Severe: Tofacitinib 10 mg/g BID | Severe: Placebo (Vehicle) BID | Severe: Tofacitinib 20 mg/g QD | Severe: Tofacitinib 10 mg/g QD | Severe: Placebo (Vehicle) QD | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized 18-44 years | 30 Participants | 23 Participants | 25 Participants | 21 Participants | 30 Participants | 25 Participants | 2 Participants | 0 Participants | 1 Participants | 3 Participants | 3 Participants | 2 Participants | 165 Participants |
| Age, Customized < 18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 45-64 years | 28 Participants | 34 Participants | 34 Participants | 38 Participants | 35 Participants | 39 Participants | 4 Participants | 6 Participants | 4 Participants | 2 Participants | 2 Participants | 2 Participants | 228 Participants |
| Age, Customized >= 65 years | 13 Participants | 13 Participants | 12 Participants | 11 Participants | 9 Participants | 10 Participants | 1 Participants | 1 Participants | 2 Participants | 2 Participants | 1 Participants | 3 Participants | 78 Participants |
| Sex: Female, Male Female | 28 Participants | 23 Participants | 30 Participants | 33 Participants | 24 Participants | 32 Participants | 1 Participants | 3 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 176 Participants |
| Sex: Female, Male Male | 43 Participants | 47 Participants | 41 Participants | 37 Participants | 50 Participants | 42 Participants | 6 Participants | 4 Participants | 6 Participants | 6 Participants | 6 Participants | 7 Participants | 295 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 30 / 71 | 29 / 70 | 27 / 71 | 34 / 70 | 28 / 74 | 40 / 74 | 2 / 7 | 4 / 7 | 4 / 7 | 3 / 7 | 2 / 6 | 2 / 7 |
| serious Total, serious adverse events | 0 / 71 | 5 / 70 | 2 / 71 | 0 / 70 | 2 / 74 | 1 / 74 | 0 / 7 | 0 / 7 | 0 / 7 | 0 / 7 | 0 / 6 | 1 / 7 |
Outcome results
Primary
Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8
Clinical signs of plaque psoriasis (E, I, and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. The PGA-C was a static assessment; i.e., without regard to a previous assessment. The PGA subscores are then summed and averaged after which the total average was rounded to the nearest whole number to determine the PGA-C score and category. A higher score indicated a higher level of severity. 0 is equal to (=) cleared except for any residual discoloration and 1=almost clear, majority of lesions had individual scores for E+I+S that when summed, averaged, and rounded equaled 1.
Time frame: Baseline, Week 8
Population: FASm. A participant with a missing value was considered a non-responder.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mild/Moderate: Tofacitinib 20 mg/g BID | Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8 | 22.5 Percentage of Participants |
| Mild/Moderate: Tofacitinib 10 mg/g BID | Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8 | 10.0 Percentage of Participants |
| Mild/Moderate: Placebo (Vehicle) BID | Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8 | 11.3 Percentage of Participants |
| Mild/Moderate: Tofacitinib 20 mg/g QD | Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8 | 18.6 Percentage of Participants |
| Mild/Moderate: Tofacitinib 10 mg/g QD | Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8 | 14.9 Percentage of Participants |
| Mild/Moderate: Placebo (Vehicle) QD | Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8 | 8.1 Percentage of Participants |
p-value: 0.07180% CI: [3.1, 18.5]Cochran-Mantel-Haenszel
p-value: 0.817580% CI: [-7.9, 5.5]Cochran-Mantel-Haenszel
p-value: 0.051380% CI: [3.8, 18.2]Cochran-Mantel-Haenszel
p-value: 0.202180% CI: [0, 13.4]Cochran-Mantel-Haenszel
Primary
Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (≥) 2 Grade/Point Improvement From Baseline at Week 12
Clinical signs of plaque psoriasis (erythema \[E\], induration \[I\], and scaling \[S\]) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. The PGA-C was a static assessment; i.e., without regard to a previous assessment. The PGA subscores are then summed and averaged after which the total average was rounded to the nearest whole number to determine the PGA-C score and category. A higher score indicated a higher level of severity. 0 is equal to (=) cleared except for any residual discoloration and 1=almost clear, majority of lesions had individual scores for E+I+S that when summed, averaged, and rounded equaled 1.
Time frame: Baseline, Week 12
Population: The mild/moderate full analysis set (FASm) included all participants in the FAS with a baseline PGA-C disease severity of mild (2) or moderate (3). A participant with a missing value was considered a non-responder.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mild/Moderate: Tofacitinib 20 mg/g BID | Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (≥) 2 Grade/Point Improvement From Baseline at Week 12 | 21.1 Percentage of Participants |
| Mild/Moderate: Tofacitinib 10 mg/g BID | Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (≥) 2 Grade/Point Improvement From Baseline at Week 12 | 12.9 Percentage of Participants |
| Mild/Moderate: Placebo (Vehicle) BID | Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (≥) 2 Grade/Point Improvement From Baseline at Week 12 | 16.9 Percentage of Participants |
| Mild/Moderate: Tofacitinib 20 mg/g QD | Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (≥) 2 Grade/Point Improvement From Baseline at Week 12 | 20.0 Percentage of Participants |
| Mild/Moderate: Tofacitinib 10 mg/g QD | Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (≥) 2 Grade/Point Improvement From Baseline at Week 12 | 21.6 Percentage of Participants |
| Mild/Moderate: Placebo (Vehicle) QD | Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (≥) 2 Grade/Point Improvement From Baseline at Week 12 | 17.6 Percentage of Participants |
p-value: 0.542580% CI: [-4.3, 12]Cochran-Mantel-Haenszel
p-value: 0.497680% CI: [-11.5, 3.5]Cochran-Mantel-Haenszel
p-value: 0.603980% CI: [-4.9, 11.5]Cochran-Mantel-Haenszel
p-value: 0.527980% CI: [-4.1, 12.1]Cochran-Mantel-Haenszel
Secondary
Change From Baseline to Week 12 in Clinic-Based Itch Severity Item (ISI) Scores
The severity of itch (pruritus) due to psoriasis was assessed using the ISI. Participants were asked to assess their worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms no itching (0) and worst possible itching (10) at the ends. Participants completed the ISI assessments at the clinic (i.e., clinic-based).
Time frame: Baseline, Week 12
Population: FASm. Only observed data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mild/Moderate: Tofacitinib 20 mg/g BID | Change From Baseline to Week 12 in Clinic-Based Itch Severity Item (ISI) Scores | -2.88 Score on a Scale | Standard Deviation 3.14 |
| Mild/Moderate: Tofacitinib 10 mg/g BID | Change From Baseline to Week 12 in Clinic-Based Itch Severity Item (ISI) Scores | -2.89 Score on a Scale | Standard Deviation 3.32 |
| Mild/Moderate: Placebo (Vehicle) BID | Change From Baseline to Week 12 in Clinic-Based Itch Severity Item (ISI) Scores | -1.73 Score on a Scale | Standard Deviation 2.46 |
| Mild/Moderate: Tofacitinib 20 mg/g QD | Change From Baseline to Week 12 in Clinic-Based Itch Severity Item (ISI) Scores | -2.38 Score on a Scale | Standard Deviation 3.182 |
| Mild/Moderate: Tofacitinib 10 mg/g QD | Change From Baseline to Week 12 in Clinic-Based Itch Severity Item (ISI) Scores | -1.94 Score on a Scale | Standard Deviation 3.151 |
| Mild/Moderate: Placebo (Vehicle) QD | Change From Baseline to Week 12 in Clinic-Based Itch Severity Item (ISI) Scores | -1.50 Score on a Scale | Standard Deviation 2.961 |
Secondary
Change From Baseline to Week 12 in the Dermatology Life Quality Index (DLQI) Total Score
DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire assesses participant health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.
Time frame: Baseline, Week 12
Population: FASm. Only observed data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mild/Moderate: Tofacitinib 20 mg/g BID | Change From Baseline to Week 12 in the Dermatology Life Quality Index (DLQI) Total Score | -4.6 Score on a Scale | Standard Deviation 5.55 |
| Mild/Moderate: Tofacitinib 10 mg/g BID | Change From Baseline to Week 12 in the Dermatology Life Quality Index (DLQI) Total Score | -3.2 Score on a Scale | Standard Deviation 5.32 |
| Mild/Moderate: Placebo (Vehicle) BID | Change From Baseline to Week 12 in the Dermatology Life Quality Index (DLQI) Total Score | -2.6 Score on a Scale | Standard Deviation 5.45 |
| Mild/Moderate: Tofacitinib 20 mg/g QD | Change From Baseline to Week 12 in the Dermatology Life Quality Index (DLQI) Total Score | -5.6 Score on a Scale | Standard Deviation 7.04 |
| Mild/Moderate: Tofacitinib 10 mg/g QD | Change From Baseline to Week 12 in the Dermatology Life Quality Index (DLQI) Total Score | -3.3 Score on a Scale | Standard Deviation 5.97 |
| Mild/Moderate: Placebo (Vehicle) QD | Change From Baseline to Week 12 in the Dermatology Life Quality Index (DLQI) Total Score | -2.3 Score on a Scale | Standard Deviation 6.34 |
Secondary
Change From Baseline to Week 8 in Clinic-Based ISI Scores
The severity of itch (pruritus) due to psoriasis was assessed using the ISI. Participants were asked to assess their worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms no itching (0) and worst possible itching (10) at the ends. Participants completed the ISI assessments at the clinic (i.e., clinic-based).
Time frame: Baseline, Week 8
Population: FASm. Only observed data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mild/Moderate: Tofacitinib 20 mg/g BID | Change From Baseline to Week 8 in Clinic-Based ISI Scores | -3.07 Score on a Scale | Standard Deviation 2.971 |
| Mild/Moderate: Tofacitinib 10 mg/g BID | Change From Baseline to Week 8 in Clinic-Based ISI Scores | -2.38 Score on a Scale | Standard Deviation 2.984 |
| Mild/Moderate: Placebo (Vehicle) BID | Change From Baseline to Week 8 in Clinic-Based ISI Scores | -1.45 Score on a Scale | Standard Deviation 2.847 |
| Mild/Moderate: Tofacitinib 20 mg/g QD | Change From Baseline to Week 8 in Clinic-Based ISI Scores | -2.49 Score on a Scale | Standard Deviation 2.769 |
| Mild/Moderate: Tofacitinib 10 mg/g QD | Change From Baseline to Week 8 in Clinic-Based ISI Scores | -1.91 Score on a Scale | Standard Deviation 3.166 |
| Mild/Moderate: Placebo (Vehicle) QD | Change From Baseline to Week 8 in Clinic-Based ISI Scores | -1.34 Score on a Scale | Standard Deviation 3.285 |
Secondary
Change From Baseline to Week 8 in the DLQI Total Score
DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire assesses participant health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.
Time frame: Baseline, Week 8
Population: FASm. Only observed data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mild/Moderate: Tofacitinib 20 mg/g BID | Change From Baseline to Week 8 in the DLQI Total Score | -4.6 Score on a Scale | Standard Deviation 5.16 |
| Mild/Moderate: Tofacitinib 10 mg/g BID | Change From Baseline to Week 8 in the DLQI Total Score | -2.6 Score on a Scale | Standard Deviation 4.98 |
| Mild/Moderate: Placebo (Vehicle) BID | Change From Baseline to Week 8 in the DLQI Total Score | -2.8 Score on a Scale | Standard Deviation 4.01 |
| Mild/Moderate: Tofacitinib 20 mg/g QD | Change From Baseline to Week 8 in the DLQI Total Score | -5.0 Score on a Scale | Standard Deviation 5.85 |
| Mild/Moderate: Tofacitinib 10 mg/g QD | Change From Baseline to Week 8 in the DLQI Total Score | -2.7 Score on a Scale | Standard Deviation 4.79 |
| Mild/Moderate: Placebo (Vehicle) QD | Change From Baseline to Week 8 in the DLQI Total Score | -2.2 Score on a Scale | Standard Deviation 5.63 |
Secondary
Percentage of Participants Achieving a Gestalt Physician's Global Assessment (PGA-G) Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 12
Clinical signs of plaque psoriasis (E, I and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. After scoring each of the PGA subscores, a clinical evaluator of psoriasis performed an assessment of the overall severity of psoriasis and assigned a PGA-G score and category. 0=Clear, except for any residual discoloration (post-inflammatory hyperpigmentation and/or hypopigmentation) and 1=almost clear, the psoriasis is not entirely cleared and remaining plaques are light pink (not including post inflammatory hyperpigmentation), and/or have barely palpable elevation and/or have occasional fine scale. The PGA-G was a static assessment; i.e., without regard to a previous assessment.
Time frame: Baseline, Week 12
Population: FASm. A participant with a missing value was considered a non-responder.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mild/Moderate: Tofacitinib 20 mg/g BID | Percentage of Participants Achieving a Gestalt Physician's Global Assessment (PGA-G) Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 12 | 18.3 Percentage of Participants |
| Mild/Moderate: Tofacitinib 10 mg/g BID | Percentage of Participants Achieving a Gestalt Physician's Global Assessment (PGA-G) Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 12 | 11.4 Percentage of Participants |
| Mild/Moderate: Placebo (Vehicle) BID | Percentage of Participants Achieving a Gestalt Physician's Global Assessment (PGA-G) Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 12 | 14.1 Percentage of Participants |
| Mild/Moderate: Tofacitinib 20 mg/g QD | Percentage of Participants Achieving a Gestalt Physician's Global Assessment (PGA-G) Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 12 | 15.7 Percentage of Participants |
| Mild/Moderate: Tofacitinib 10 mg/g QD | Percentage of Participants Achieving a Gestalt Physician's Global Assessment (PGA-G) Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 12 | 18.9 Percentage of Participants |
| Mild/Moderate: Placebo (Vehicle) QD | Percentage of Participants Achieving a Gestalt Physician's Global Assessment (PGA-G) Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 12 | 12.2 Percentage of Participants |
Secondary
Percentage of Participants Achieving a Patient's Global Assessment (PtGA) Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 12 for Participants With a PtGA Score ≥2 at Baseline
The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe).
Time frame: Baseline, Week 12
Population: FASm. Only observed data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mild/Moderate: Tofacitinib 20 mg/g BID | Percentage of Participants Achieving a Patient's Global Assessment (PtGA) Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 12 for Participants With a PtGA Score ≥2 at Baseline | 8.8 Percentage of Participants |
| Mild/Moderate: Tofacitinib 10 mg/g BID | Percentage of Participants Achieving a Patient's Global Assessment (PtGA) Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 12 for Participants With a PtGA Score ≥2 at Baseline | 17.5 Percentage of Participants |
| Mild/Moderate: Placebo (Vehicle) BID | Percentage of Participants Achieving a Patient's Global Assessment (PtGA) Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 12 for Participants With a PtGA Score ≥2 at Baseline | 7.3 Percentage of Participants |
| Mild/Moderate: Tofacitinib 20 mg/g QD | Percentage of Participants Achieving a Patient's Global Assessment (PtGA) Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 12 for Participants With a PtGA Score ≥2 at Baseline | 13.2 Percentage of Participants |
| Mild/Moderate: Tofacitinib 10 mg/g QD | Percentage of Participants Achieving a Patient's Global Assessment (PtGA) Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 12 for Participants With a PtGA Score ≥2 at Baseline | 14.5 Percentage of Participants |
| Mild/Moderate: Placebo (Vehicle) QD | Percentage of Participants Achieving a Patient's Global Assessment (PtGA) Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 12 for Participants With a PtGA Score ≥2 at Baseline | 7.7 Percentage of Participants |
Secondary
Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 12
Clinical signs of plaque psoriasis (E, I, and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. The PGA-C was a static assessment; i.e., without regard to a previous assessment. The PGA subscores are then summed and averaged after which the total average was rounded to the nearest whole number to determine the PGA-C score and category. A higher score indicated a higher level of severity. 0 is equal to (=) cleared except for any residual discoloration and 1=almost clear, majority of lesions had individual scores for E+I+S that when summed, averaged, and rounded equaled 1.
Time frame: Week 12
Population: FASm. A participant with a missing value was considered a non-responder.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mild/Moderate: Tofacitinib 20 mg/g BID | Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 12 | 33.8 Percentage of Participants |
| Mild/Moderate: Tofacitinib 10 mg/g BID | Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 12 | 25.7 Percentage of Participants |
| Mild/Moderate: Placebo (Vehicle) BID | Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 12 | 23.9 Percentage of Participants |
| Mild/Moderate: Tofacitinib 20 mg/g QD | Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 12 | 27.1 Percentage of Participants |
| Mild/Moderate: Tofacitinib 10 mg/g QD | Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 12 | 29.7 Percentage of Participants |
| Mild/Moderate: Placebo (Vehicle) QD | Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 12 | 23.0 Percentage of Participants |
Secondary
Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 8
Clinical signs of plaque psoriasis (E, I, and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. The PGA-C was a static assessment; i.e., without regard to a previous assessment. The PGA subscores are then summed and averaged after which the total average was rounded to the nearest whole number to determine the PGA-C score and category. A higher score indicated a higher level of severity. 0 is equal to (=) cleared except for any residual discoloration and 1=almost clear, majority of lesions had individual scores for E+I+S that when summed, averaged, and rounded equaled 1.
Time frame: Week 8
Population: FASm. A participant with a missing value was considered a non-responder.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mild/Moderate: Tofacitinib 20 mg/g BID | Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 8 | 36.6 Percentage of Participants |
| Mild/Moderate: Tofacitinib 10 mg/g BID | Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 8 | 20.0 Percentage of Participants |
| Mild/Moderate: Placebo (Vehicle) BID | Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 8 | 22.5 Percentage of Participants |
| Mild/Moderate: Tofacitinib 20 mg/g QD | Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 8 | 32.9 Percentage of Participants |
| Mild/Moderate: Tofacitinib 10 mg/g QD | Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 8 | 21.6 Percentage of Participants |
| Mild/Moderate: Placebo (Vehicle) QD | Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 8 | 12.2 Percentage of Participants |
Secondary
Percentage of Participants Achieving a PGA-G Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8
Clinical signs of plaque psoriasis (E, I and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. After scoring each of the PGA subscores, a clinical evaluator of psoriasis performed an assessment of the overall severity of psoriasis and assigned a PGA-G score and category. 0=Clear, except for any residual discoloration (post-inflammatory hyperpigmentation and/or hypopigmentation) and 1=almost clear, the psoriasis is not entirely cleared and remaining plaques are light pink (not including post inflammatory hyperpigmentation), and/or have barely palpable elevation and/or have occasional fine scale. The PGA-G was a static assessment; i.e., without regard to a previous assessment.
Time frame: Baseline, Week 8
Population: FASm. A participant with a missing value was considered a non-responder.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mild/Moderate: Tofacitinib 20 mg/g BID | Percentage of Participants Achieving a PGA-G Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8 | 21.1 Percentage of Participants |
| Mild/Moderate: Tofacitinib 10 mg/g BID | Percentage of Participants Achieving a PGA-G Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8 | 7.1 Percentage of Participants |
| Mild/Moderate: Placebo (Vehicle) BID | Percentage of Participants Achieving a PGA-G Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8 | 11.3 Percentage of Participants |
| Mild/Moderate: Tofacitinib 20 mg/g QD | Percentage of Participants Achieving a PGA-G Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8 | 15.7 Percentage of Participants |
| Mild/Moderate: Tofacitinib 10 mg/g QD | Percentage of Participants Achieving a PGA-G Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8 | 9.5 Percentage of Participants |
| Mild/Moderate: Placebo (Vehicle) QD | Percentage of Participants Achieving a PGA-G Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8 | 4.1 Percentage of Participants |
Secondary
Percentage of Participants Achieving a PtGA Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8 for Participants With a PtGA Score ≥2 at Baseline
The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe).
Time frame: Baseline, Week 8
Population: FASm. Only observed data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mild/Moderate: Tofacitinib 20 mg/g BID | Percentage of Participants Achieving a PtGA Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8 for Participants With a PtGA Score ≥2 at Baseline | 5.0 Percentage of Participants |
| Mild/Moderate: Tofacitinib 10 mg/g BID | Percentage of Participants Achieving a PtGA Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8 for Participants With a PtGA Score ≥2 at Baseline | 6.3 Percentage of Participants |
| Mild/Moderate: Placebo (Vehicle) BID | Percentage of Participants Achieving a PtGA Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8 for Participants With a PtGA Score ≥2 at Baseline | 10.9 Percentage of Participants |
| Mild/Moderate: Tofacitinib 20 mg/g QD | Percentage of Participants Achieving a PtGA Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8 for Participants With a PtGA Score ≥2 at Baseline | 10.0 Percentage of Participants |
| Mild/Moderate: Tofacitinib 10 mg/g QD | Percentage of Participants Achieving a PtGA Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8 for Participants With a PtGA Score ≥2 at Baseline | 6.0 Percentage of Participants |
| Mild/Moderate: Placebo (Vehicle) QD | Percentage of Participants Achieving a PtGA Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8 for Participants With a PtGA Score ≥2 at Baseline | 1.7 Percentage of Participants |
Secondary
Percentage of Participants Achieving at Least a 75% Reduction in PASI Response (PASI75), Relative to Baseline at Week 12
Combined assessment of lesion severity and area affected into single score. Body was divided into 4 regions: head, arms, trunk, legs. For each region, percent area of skin involved was estimated: 0=0% to 6=90-100%. Severity was estimated by clinical signs: erythema, induration, scaling; scale: 0=none to 4=maximum. Final PASI = sum of severity parameters for each region\*area score\*weight of region (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0=no disease to 72=maximal disease. The maximum PASI score was \<72 since the PASI assessment excluded scalp, palms, finger nails, soles, and toe nails.
Time frame: Baseline, Week 12
Population: FASm. A participant with a missing value was considered a non-responder.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mild/Moderate: Tofacitinib 20 mg/g BID | Percentage of Participants Achieving at Least a 75% Reduction in PASI Response (PASI75), Relative to Baseline at Week 12 | 16.9 Percentage of Participants |
| Mild/Moderate: Tofacitinib 10 mg/g BID | Percentage of Participants Achieving at Least a 75% Reduction in PASI Response (PASI75), Relative to Baseline at Week 12 | 12.9 Percentage of Participants |
| Mild/Moderate: Placebo (Vehicle) BID | Percentage of Participants Achieving at Least a 75% Reduction in PASI Response (PASI75), Relative to Baseline at Week 12 | 12.7 Percentage of Participants |
| Mild/Moderate: Tofacitinib 20 mg/g QD | Percentage of Participants Achieving at Least a 75% Reduction in PASI Response (PASI75), Relative to Baseline at Week 12 | 15.7 Percentage of Participants |
| Mild/Moderate: Tofacitinib 10 mg/g QD | Percentage of Participants Achieving at Least a 75% Reduction in PASI Response (PASI75), Relative to Baseline at Week 12 | 10.8 Percentage of Participants |
| Mild/Moderate: Placebo (Vehicle) QD | Percentage of Participants Achieving at Least a 75% Reduction in PASI Response (PASI75), Relative to Baseline at Week 12 | 6.8 Percentage of Participants |
Secondary
Percentage of Participants Achieving PASI75, Relative to Baseline at Week 8
Combined assessment of lesion severity and area affected into single score. Body was divided into 4 regions: head, arms, trunk, legs. For each region, percent area of skin involved was estimated: 0=0% to 6=90-100%. Severity was estimated by clinical signs: erythema, induration, scaling; scale: 0=none to 4=maximum. Final PASI = sum of severity parameters for each region\*area score\*weight of region (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0=no disease to 72=maximal disease. The maximum PASI score was \<72 since the PASI assessment excluded scalp, palms, finger nails, soles, and toe nails.
Time frame: Baseline, Week 8
Population: FASm. A participant with a missing value was considered a non-responder.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mild/Moderate: Tofacitinib 20 mg/g BID | Percentage of Participants Achieving PASI75, Relative to Baseline at Week 8 | 14.1 Percentage of Participants |
| Mild/Moderate: Tofacitinib 10 mg/g BID | Percentage of Participants Achieving PASI75, Relative to Baseline at Week 8 | 8.6 Percentage of Participants |
| Mild/Moderate: Placebo (Vehicle) BID | Percentage of Participants Achieving PASI75, Relative to Baseline at Week 8 | 7.0 Percentage of Participants |
| Mild/Moderate: Tofacitinib 20 mg/g QD | Percentage of Participants Achieving PASI75, Relative to Baseline at Week 8 | 15.7 Percentage of Participants |
| Mild/Moderate: Tofacitinib 10 mg/g QD | Percentage of Participants Achieving PASI75, Relative to Baseline at Week 8 | 6.8 Percentage of Participants |
| Mild/Moderate: Placebo (Vehicle) QD | Percentage of Participants Achieving PASI75, Relative to Baseline at Week 8 | 6.8 Percentage of Participants |
Secondary
Percent Change From Baseline to Week 12 in Body Surface Area (BSA) Affected With Psoriasis
Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. BSA (%)=the sum of the BSAs of the 4 body regions. BSA assessment excluded head and neck, palms, finger nails, soles and toe nails.
Time frame: Baseline, Week 12
Population: FASm. Only observed data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mild/Moderate: Tofacitinib 20 mg/g BID | Percent Change From Baseline to Week 12 in Body Surface Area (BSA) Affected With Psoriasis | -32.8 Percent Change from Baseline | Standard Deviation 40.92 |
| Mild/Moderate: Tofacitinib 10 mg/g BID | Percent Change From Baseline to Week 12 in Body Surface Area (BSA) Affected With Psoriasis | -27.5 Percent Change from Baseline | Standard Deviation 36.4 |
| Mild/Moderate: Placebo (Vehicle) BID | Percent Change From Baseline to Week 12 in Body Surface Area (BSA) Affected With Psoriasis | -27.7 Percent Change from Baseline | Standard Deviation 43.43 |
| Mild/Moderate: Tofacitinib 20 mg/g QD | Percent Change From Baseline to Week 12 in Body Surface Area (BSA) Affected With Psoriasis | -24.6 Percent Change from Baseline | Standard Deviation 36.29 |
| Mild/Moderate: Tofacitinib 10 mg/g QD | Percent Change From Baseline to Week 12 in Body Surface Area (BSA) Affected With Psoriasis | -15.6 Percent Change from Baseline | Standard Deviation 36.63 |
| Mild/Moderate: Placebo (Vehicle) QD | Percent Change From Baseline to Week 12 in Body Surface Area (BSA) Affected With Psoriasis | -11.2 Percent Change from Baseline | Standard Deviation 56.38 |
Secondary
Percent Change From Baseline to Week 12 in Psoriasis Area and Severity Index (PASI)
Combined assessment of lesion severity and area affected into single score. Body was divided into 4 regions: head, arms, trunk, legs. For each region, percent (%) area of skin involved was estimated: 0=0% to 6=90-100%. Severity was estimated by clinical signs: erythema, induration, scaling; scale: 0=none to 4=maximum. Final PASI = sum of severity parameters for each region\*area score\*weight of region (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0=no disease to 72=maximal disease. The maximum PASI score was \<72 since the PASI assessment excluded scalp, palms, finger nails, soles, and toe nails.
Time frame: Baseline, Week 12
Population: FASm. Only observed data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mild/Moderate: Tofacitinib 20 mg/g BID | Percent Change From Baseline to Week 12 in Psoriasis Area and Severity Index (PASI) | -36.6 Percent Change from Baseline | Standard Deviation 40.88 |
| Mild/Moderate: Tofacitinib 10 mg/g BID | Percent Change From Baseline to Week 12 in Psoriasis Area and Severity Index (PASI) | -35.7 Percent Change from Baseline | Standard Deviation 43.78 |
| Mild/Moderate: Placebo (Vehicle) BID | Percent Change From Baseline to Week 12 in Psoriasis Area and Severity Index (PASI) | -32.0 Percent Change from Baseline | Standard Deviation 49.47 |
| Mild/Moderate: Tofacitinib 20 mg/g QD | Percent Change From Baseline to Week 12 in Psoriasis Area and Severity Index (PASI) | -38.6 Percent Change from Baseline | Standard Deviation 36.37 |
| Mild/Moderate: Tofacitinib 10 mg/g QD | Percent Change From Baseline to Week 12 in Psoriasis Area and Severity Index (PASI) | -31.4 Percent Change from Baseline | Standard Deviation 42.36 |
| Mild/Moderate: Placebo (Vehicle) QD | Percent Change From Baseline to Week 12 in Psoriasis Area and Severity Index (PASI) | -30.0 Percent Change from Baseline | Standard Deviation 38.68 |
Secondary
Percent Change From Baseline to Week 8 in BSA Affected With Psoriasis
Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. BSA (%)=the sum of the BSAs of the 4 body regions. BSA assessment excluded head and neck, palms, finger nails, soles and toe nails.
Time frame: Baseline, Week 8
Population: FASm. Only observed data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mild/Moderate: Tofacitinib 20 mg/g BID | Percent Change From Baseline to Week 8 in BSA Affected With Psoriasis | -25.4 Percent Change from Baseline | Standard Deviation 44.75 |
| Mild/Moderate: Tofacitinib 10 mg/g BID | Percent Change From Baseline to Week 8 in BSA Affected With Psoriasis | -22.5 Percent Change from Baseline | Standard Deviation 35.87 |
| Mild/Moderate: Placebo (Vehicle) BID | Percent Change From Baseline to Week 8 in BSA Affected With Psoriasis | -20.5 Percent Change from Baseline | Standard Deviation 34.9 |
| Mild/Moderate: Tofacitinib 20 mg/g QD | Percent Change From Baseline to Week 8 in BSA Affected With Psoriasis | -17.8 Percent Change from Baseline | Standard Deviation 28.59 |
| Mild/Moderate: Tofacitinib 10 mg/g QD | Percent Change From Baseline to Week 8 in BSA Affected With Psoriasis | -9.0 Percent Change from Baseline | Standard Deviation 30.08 |
| Mild/Moderate: Placebo (Vehicle) QD | Percent Change From Baseline to Week 8 in BSA Affected With Psoriasis | -11.7 Percent Change from Baseline | Standard Deviation 38.29 |
Secondary
Percent Change From Baseline to Week 8 in PASI
Combined assessment of lesion severity and area affected into single score. Body was divided into 4 regions: head, arms, trunk, legs. For each region, percent area of skin involved was estimated: 0=0% to 6=90-100%. Severity was estimated by clinical signs: erythema, induration, scaling; scale: 0=none to 4=maximum. Final PASI = sum of severity parameters for each region\*area score\*weight of region (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0=no disease to 72=maximal disease. The maximum PASI score was \<72 since the PASI assessment excluded scalp, palms, finger nails, soles, and toe nails.
Time frame: Baseline, Week 8
Population: FASm. Only observed data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mild/Moderate: Tofacitinib 20 mg/g BID | Percent Change From Baseline to Week 8 in PASI | -36.7 Percent Change from Baseline | Standard Deviation 36.01 |
| Mild/Moderate: Tofacitinib 10 mg/g BID | Percent Change From Baseline to Week 8 in PASI | -29.1 Percent Change from Baseline | Standard Deviation 40.86 |
| Mild/Moderate: Placebo (Vehicle) BID | Percent Change From Baseline to Week 8 in PASI | -28.8 Percent Change from Baseline | Standard Deviation 37.06 |
| Mild/Moderate: Tofacitinib 20 mg/g QD | Percent Change From Baseline to Week 8 in PASI | -36.5 Percent Change from Baseline | Standard Deviation 33.87 |
| Mild/Moderate: Tofacitinib 10 mg/g QD | Percent Change From Baseline to Week 8 in PASI | -29.0 Percent Change from Baseline | Standard Deviation 29.47 |
| Mild/Moderate: Placebo (Vehicle) QD | Percent Change From Baseline to Week 8 in PASI | -27.1 Percent Change from Baseline | Standard Deviation 32.93 |