Psoriatic Arthritis
Conditions
Brief summary
This is a Multinational Study of Tofacitinib in Patients Treated for Psoriatic Arthritis in order to evaluate the effectiveness of treatment with tofacitinib on disease activity, remission, and Quality of Life, in a real-world setting over a 12-month observation period
Interventions
None listed
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study: 1. Patients aged ≥ 18 years 2. Moderate to severe PsA disease activity diagnosed 3. Patients for whom the physician's decision has been made to initiate treatment with tofacitinib, in usual clinical practice conditions and in compliance with the local label 4. Patients are treatment naïve to tofacitinib on the date of providing informed consent 5. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study 6. Patients on DMARDs must have not had a treatment change in the past 3 months
Exclusion criteria
Patients meeting any of the following criteria will not be included in the study: 1. Contraindications according to the Xeljanz® (tofacitinib) Prescribing Information 2. Receipt of any investigational drug within 3 months before study inclusion 3. Patient is pregnant or breastfeeding 4. Recent herpes zoster infection (within past 6 months) or history of severe disseminated herpes zoster infection 5. Active treatment for a malignancy 6. Concomitant treatment with a biological disease-modifying antirheumatic drugs (bDMARD)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved Low Disease Activity (LDA) Based on Psoriatic Arthritis Disease Activity Score (PASDAS) at Month 6 | At Month 6 | PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global psoriatic arthritis assessment (PAA), physician global PAA, each scored on 100 mm visual analog scale (VAS), 0=no disease activity (DA), 100=maximum DA; tender joint count (TJC) (0-68); swollen joint count (SJC) (0-66); Leed's Enthesitis index (LEI) score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; physical component summary (PCS) of short form 36 (SF-36) score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and C-reactive protein (CRP) in milligram per liter (mg/L). PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease. LDA was defined as PASDAS score less than or equal to (\<=) 3.2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved Minimum Disease Activity (MDA) at Months 3, 6 and 12 | At Month 3, Month 6 and Month 12 | A participant was classified as MDA achieved if they met 5 of 7 criteria: (i) (TJC66) \<=1, (ii) (SJC68)\<=1, (iii) psoriasis area and severity index (PASI) score \<=1 (PASI=combined assessment of lesion severity and area affected into single score; range=0 \[no disease\] to 72 \[maximal disease\], higher scores=more disease. or body surface area (BSA) \<=3%,(iv) patient pain assessment (VAS, 0-100) \<=15; where 0='no pain' and 100='pain as severe as can be imagined', higher scores=more pain, (v) patient global assessment (VAS, 0-100) \<=20, where 0='lowest level of disease activity' and 100= 'highest level of disease activity, higher scores=more disease activity, (vi) health assessment questionnaire-disability index (HAQ- DI) \<=0.5; scale ranged=0-3, where 0='normal or no difficulty' and 3='inability to perform', higher scores=more difficulty, (vii) tender enthesial points \<=1 using Leed's index range=0=non tender to 6=more enthesitis burden, higher scores=more burden. |
| Percentage of Participants Who Achieved Remission Based on PASDAS at Months 3, 6 and 12 | At Month 3, Month 6 and Month 12 | PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease. Remission was defined as PASDAS score less than or equal to (\<=) 1.9. |
| Percentage of Participants Who Achieved Remission Based on Disease Activity in Psoriatic Arthritis (DAPSA) Score at Months 3, 6 and 12 | At Month 3, Month 6 and Month 12 | DAPSA was composite disease activity measure and was calculated as: SJC66 + TJC68 + patient global assessment VAS (0 to 10 cm VAS, 0= excellent and 10= poor, higher scores indicated more disease activity) + patient pain assessment (0 to 10 cm VAS, 0= no pain, 10= worst possible pain, higher scores indicated more pain) + CRP (mg/dL). DAPSA score ranged from 0 to 164, higher scores indicated more disease activity. Remission was defined as DAPSA score =\<4.0. |
| Change From Baseline in Psoriatic Arthritis Impact of Disease 12 Questions (PsAID12) Score at Months 3, 6 and 12 | Baseline (measurement at enrollment), at Month 3, Month 6 and Month 12 | PsAID12: questionnaire used for evaluating how much PsA impacted quality of life (QoL) and comprised of following domains: Pain, Fatigue, Skin problems, Work and/or leisure activities, Function, Discomfort, Sleep disturbance, Coping, Anxiety, Embarrassment, Social life and Depression. Each one of domain was based on a 0-10 numerical rating scale (NRS) and with different weight. PsAID12= (PsAID12.Q1 \[pain\] NRS value\*3) +(PsAID12.Q2\[fatigue\] NRS value\*2) +(PsAID12.Q3 \[skin\] NRS value\*2) +(PsAID12.Q4\[Work and/or leisure activities\] NRS value\*2) +(PsAID12.Q5\[function\] NRS value\*2) +(PsAID12.Q6\[discomfort\]NRS value\*2) +(PsAID12.Q7\[sleep\] NRS value\*2) +(PsAID12.Q8 \[coping\]NRS value\*1) +(PsAID12.Q9\[anxiety\] NRS value\*1) +(PsAID12.Q10\[embarrassment\] NRS value\*1) +(PsAID12.Q11\[social life\] NRS value\*1) +(PsAID12.Q12\[depression\] NRS value\*1). Total is divided by 20 for final score. Range of final PsAID score is 0-10 (higher numbers indicate worse status). |
| Change From Baseline in Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC-EI) Score at Months 3, 6 and 12 | Baseline (measurement at enrollment), at Month 3, Month 6 and Month 12 | The SPARCC-EI evaluated 16 enthesial sites: greater trochanter (Right/Left \[R/L\]), quadriceps tendon insertion into the patella (R/L), patellar ligament insertion into the patella and tibial tuberosity (R/L), achilles tendon insertion (R/L), plantar fascia insertion (R/L), medial epicondyles (R/L), lateral epicondyles (R/L) and supraspinatus insertion (R/L) for the presence or absence of tenderness. Tenderness at each site was quantified as: 0 = non-tender and 1 = tender. The maximum score of the SPARCC-EI was 16. SPARCC-EI score range: 0 (no enthesitis) to 16 (enthesitis is present at all assessed sites), higher scores indicated more presence of enthesitis. |
| Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12 | At Month 3, Month 6 and Month 12 | BMI = Weight (kilograms \[kg\]) / Height (meter square \[m\]\^2). LDA was defined as PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease. In this outcome measure, participants with PASDAS scores are reported according to BMI categories of 18.5 - \<25 kg/m\^2, 25 - \<30 kg/m\^2, \>= 30 kg/m\^2 and missing. |
| Number of Participants Who Achieved LDA According to Treatment Line at Months 3, 6 and 12 | At Month 3, Month 6 and Month 12 | Participants who achieved LDA according to treatment line were reported in this outcome measure. Treatment line included: tofacitinib monotherapy, combination therapy with MTX, and combination therapy with other csDMARDs. LDA was defined as PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease. |
| Number of Participants Who Achieved LDA According to Duration of Current Episode Symptoms of at Least 6 Weeks Prior to Enrollment at Months 3, 6 and 12 | At Month 3, Month 6 and Month 12 | Duration of current episode of symptoms prior to enrollment were presented as: \< 6, \>=6 weeks. LDA was defined as PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease. |
| Number of Participants Who Achieved LDA According to Erythrocyte Sedimentation Rate (ESR) Results at Months 3, 6 and 12 | At Month 3, Month 6 and Month 12 | ESR result=abnormal if test result was above normal range. ESR normal range:0-50 years(male \<15 mm/h, female \<20 mm/h), 51-85 years(\<20 mm/h males and \<30 mm/h females),older than 85 years(\<30 mm/h males and \<42 mm/h females). Number of participants who achieved LDA according to ESR results(normal and abnormal) were reported. LDA=PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of following:participant global PAA,physician global PAA,each scored on 100 mm VAS,0=no DA, 100=maximum DA; TJC(0-68); SJC(0-66); LEI score=0-6;0=non tender,6=more enthesitis burden; tender dactylitis digit score=0-3,0=no tenderness,3=participant withdrew digit; PCS of SF-36 score=0-100; 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged=0(no disease)to 10(severe disease);higher scores=more severe disease. |
| Number of Participants Who Achieved LDA According to C-reactive Protein (CRP) Results at Months 3, 6 and 12 | At Month 3, Month 6 and Month 12 | For CRP, result was considered abnormal if t the test result was above the normal range (0.3 to 10 mg/L). LDA was defined as PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease. |
| Percentage of Participants Who Achieved LDA Based on PASDAS at Months 3 and 12 | At Month 3 and Month 12 | PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease. LDA was defined as PASDAS score less than or equal to (\<=) 3.2. |
| Number of Participants Who Achieved LDA According to Presence of Unequivocal Radiological Erosion at Months 3, 6 and 12 | At Month 3, Month 6 and Month 12 | Unequivocal radiological erosion: 'present',if Sharp-Van der Heijde modified score (S-VH MS)for erosion \>0;'absent',if S-VH MS for erosion score=0. S-VH MS sum of erosion,JSN scores(range 0-528). Higher score=more severe disease. If a component score is missing, S-VH MS is missing. LDA=PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of following: participant global PAA,physician global PAA,each scored on 100 mm VAS,0=no DA,100=maximum DA; TJC(0-68); SJC(0-66); LEI score range=0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score range=0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score range=0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0(no disease)to 10(severe disease); higher scores=more severe disease. |
| Number of Participants Who Achieved LDA According to Presence of Unequivocal Bony Decalcification Localized to the Joints of the Hands and Wrists at Months 3, 6 and 12 | At Month 3, Month 6 and Month 12 | Unequivocal Bony decalcification was reported as present or absent at enrollment. LDA was defined as PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease. |
| Number of Participants Who Achieved LDA According to Presence of Symmetric Arthritis at Months 3, 6 and 12 | At Month 3, Month 6 and Month 12 | Arthritis at enrollment was identified when a participant reported swelling and/or tenderness/pain in any joint. Number of participants who achieved LDA according to presence (Yes/No) of symmetric arthritis was reported. LDA was defined as PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease. |
| Number of Participants Who Achieved LDA According to Arthritis of the Hand Joints at Months 3, 6 and 12 | At Month 3, Month 6 and Month 12 | Hand joints included metacarpal phalangeal joints(MCP), finger proximal interphalangeal and finger distal interphalangeal joints. Number of participants who achieved LDA according to presence(Yes/No) of arthritis of any of hand joints was reported. LDA=PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of following: participant global PAA,physician global PAA, each scored on 100 mm VAS,0=no DA,100=maximum DA;TJC(0-68); SJC(0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease. |
| Number of Participants Who Achieved LDA According to Arthritis of Only 1 Medium-Large Joint at Months 3, 6 and 12 | At Month 3, Month 6 and Month 12 | Medium joints=temporomandibular, sternoclavicular, acromioclavicular, finger proximal interphalangeal, finger distal interphalangeal and tarsus/midfoot(feet) joints. Large joints=glenohumeral, elbows, hips, knees and ankles joint. Number of participants who achieved LDA according to presence (Yes/No) of arthritis of only 1 medium-large joint was reported. LDA=PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA incorporated assessment of: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA;TJC(0-68);SJC(0-66); LEI score ranging from 0-6;0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3;0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100;0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS score (0-10) uses a weighted formula; higher scores=more severe disease. |
| Number of Participants Who Achieved LDA According to Arthritis of 2-10 Medium-Large Joints and/or 1-3 Small Joints at Months 3, 6 and 12 | At Month 3, Month 6 and Month 12 | Medium joints=temporomandibular, sternoclavicular, acromioclavicular, finger proximal interphalangeal (IP), finger distal interphalangeal, tarsus/midfoot (feet). Large joints=glenohumeral, elbows, hips, knees, ankles. Small joints=MCP, proximal IP, second through fifth metatarsal phalangeal (MTP), thumb IP, wrists. Number of participants who achieved LDA according to presence (Yes/No) arthritis of 2-10 medium-large joints and/or 1-3 small joints was reported. LDA=PASDAS score =\<3.2. PASDAS is a composite PsA activity score including: participant /physician global (VAS 0-100; 0=no DA, 100=maximum DA), TJC (0-68), SJC (0-66), LEI (0-6; 0=non tender, 6=more enthesitis burden), tender dactylitis digit score (0-3; 0=no tenderness, 3=participant withdrew digit), SF-36 PCS (0-100; 0=severe physical health limitations, 100=excellent physical health),CRP in mg/L. PASDAS score (0-10) uses a weighted formula; higher scores=more severe disease. |
| Number of Participants Who Achieved LDA According to Arthritis of 4-10 Small Joints With or Without Involvement of Large Joints at Months 3, 6 and 12 | At Month 3, Month 6 and Month 12 | Large joints=glenohumeral, elbows, hips, knees and ankles joint. Small joints=MCP, proximal IP, second through fifth MTP, thumb IP, wrists. Number of participants who achieved LDA according to presence (Yes/No) of arthritis of 4-10 small joints with or without involvement of large joints was reported. LDA=PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA incorporated assessment of: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA;TJC(0-68); SJC(0-66); LEI score range=0-6; 0=non tender, 6=more enthesitis burden; tender dactylitis digit score range=0-3; 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores=more severe disease. |
| Number of Participants Who Achieved LDA According to Arthritis of >10 Joints (With at Least One Small Joint) at Months 3, 6 and 12 | At Month 3, Month 6 and Month 12 | Small joints=MCP, proximal IP, second through fifth MTP, thumb IP, wrists. Number of participants who achieved LDA according to presence (Yes/No) of arthritis of \>10 joints (with at least one small joint) was reported in this outcome measure. LDA=PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA incorporated assessment of: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC(0-68); SJC(0-66); LEI score ranging from 0-6; 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3; 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores=more severe disease. |
| Change From Baseline in Quality of Life (QoL) Based on Short Form 36 (SF-36) Score at Months 3, 6 and 12 | Baseline (measurement at enrollment), Month 3, Month 6 and Month 12 | The SF-36 is a participant administered scale assessing general quality of life. It consists of self-administered 36-item questionnaire that measured 8 health domains: physical function, role-physical, bodily pain, general health, vitality, social function, role-emotional, and mental health. These 8 domains are also summarized as physical and mental component scores. The score for each domain and component score is the mean of the individual question scores, which are scaled from 0 (minimum) to 100 (maximum), where high scores in each dimension and high overall scores indicate a better quality of life. |
| Change From Baseline in QoL Based on Health Assessment Questionnaire - Disability Index (HAQ-DI41) at Months 3, 6 and 12 | Baseline (measurement at enrollment), Month 3, Month 6 and Month 12 | The HAQ-DI41 assessed the degree of difficulty a participant had experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. For each question in the questionnaire, the level of difficulty was scored from 0 to 3 with 0 =no difficulty, 1 = some difficulty, 2 = much difficulty, and 3 = unable to do. The disability index was computed by adding the scores for each of the components and dividing by the number of components with an available score. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities. |
| Number of Participants Who Achieved LDA According to Presence of Rheumatoid Nodules at Months 3, 6 and 12 | At Month 3, Month 6 and Month 12 | Number of participants who achieved LDA according to presence (present/absent) of rheumatoid nodules is presented in this outcome measure. LDA was defined as PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease. |
Countries
Belgium, Denmark, Finland, France, Israel, Netherlands, Spain, Sweden
Participant flow
Recruitment details
Participants diagnosed with psoriatic arthritis (PsA) and treated with tofacitinib in routine clinical practice were included in this prospective study.
Pre-assignment details
A total of 116 participants from rheumatologists and/or PsA specialist centres across 8 countries (Belgium, Denmark, Finland, France, Israel, Netherlands, Spain, and Sweden) signed the informed consent.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Participants diagnosed with PsA and treated with tofacitinib in routine clinical practice were included. No study drug was administered as part of this study. Participants were followed for up to 12 months. | 113 |
| Total | 113 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not receive treatment | 3 |
| Overall Study | Drug withdrawn | 44 |
| Overall Study | Eligibility criteria not met | 4 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Other | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | All Participants | — |
|---|---|---|
| Age, Continuous | 49.8 Years STANDARD_DEVIATION 10.47 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 63 Participants | — |
| Sex: Female, Male Male | 50 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 113 |
| other Total, other adverse events | 50 / 113 |
| serious Total, serious adverse events | 7 / 113 |
Outcome results
Primary
Percentage of Participants Who Achieved Low Disease Activity (LDA) Based on Psoriatic Arthritis Disease Activity Score (PASDAS) at Month 6
PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global psoriatic arthritis assessment (PAA), physician global PAA, each scored on 100 mm visual analog scale (VAS), 0=no disease activity (DA), 100=maximum DA; tender joint count (TJC) (0-68); swollen joint count (SJC) (0-66); Leed's Enthesitis index (LEI) score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; physical component summary (PCS) of short form 36 (SF-36) score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and C-reactive protein (CRP) in milligram per liter (mg/L). PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease. LDA was defined as PASDAS score less than or equal to (\<=) 3.2.
Time frame: At Month 6
Population: Full analysis set (FAS) included all enrolled participants who received at least one dose (including partial dose) of study medication. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Percentage of Participants Who Achieved Low Disease Activity (LDA) Based on Psoriatic Arthritis Disease Activity Score (PASDAS) at Month 6 | Overall | 43.1 Percentage of participants |
| All Participants | Percentage of Participants Who Achieved Low Disease Activity (LDA) Based on Psoriatic Arthritis Disease Activity Score (PASDAS) at Month 6 | Tofacitinib monotherapy | 46.9 Percentage of participants |
| All Participants | Percentage of Participants Who Achieved Low Disease Activity (LDA) Based on Psoriatic Arthritis Disease Activity Score (PASDAS) at Month 6 | Combined tofacitinib and methotrexate (MTX) therapy | 33.4 Percentage of participants |
| All Participants | Percentage of Participants Who Achieved Low Disease Activity (LDA) Based on Psoriatic Arthritis Disease Activity Score (PASDAS) at Month 6 | Combined tofacitinib and other conventional synthetic disease-modifying antirheumatic drug (csDMARD) | 4.0 Percentage of participants |
Secondary
Change From Baseline in Psoriatic Arthritis Impact of Disease 12 Questions (PsAID12) Score at Months 3, 6 and 12
PsAID12: questionnaire used for evaluating how much PsA impacted quality of life (QoL) and comprised of following domains: Pain, Fatigue, Skin problems, Work and/or leisure activities, Function, Discomfort, Sleep disturbance, Coping, Anxiety, Embarrassment, Social life and Depression. Each one of domain was based on a 0-10 numerical rating scale (NRS) and with different weight. PsAID12= (PsAID12.Q1 \[pain\] NRS value\*3) +(PsAID12.Q2\[fatigue\] NRS value\*2) +(PsAID12.Q3 \[skin\] NRS value\*2) +(PsAID12.Q4\[Work and/or leisure activities\] NRS value\*2) +(PsAID12.Q5\[function\] NRS value\*2) +(PsAID12.Q6\[discomfort\]NRS value\*2) +(PsAID12.Q7\[sleep\] NRS value\*2) +(PsAID12.Q8 \[coping\]NRS value\*1) +(PsAID12.Q9\[anxiety\] NRS value\*1) +(PsAID12.Q10\[embarrassment\] NRS value\*1) +(PsAID12.Q11\[social life\] NRS value\*1) +(PsAID12.Q12\[depression\] NRS value\*1). Total is divided by 20 for final score. Range of final PsAID score is 0-10 (higher numbers indicate worse status).
Time frame: Baseline (measurement at enrollment), at Month 3, Month 6 and Month 12
Population: The FAS included all enrolled participants who received at least one dose (including partial dose) of study medication. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified rows.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| All Participants | Change From Baseline in Psoriatic Arthritis Impact of Disease 12 Questions (PsAID12) Score at Months 3, 6 and 12 | Overall-Month 3 | -1.3 Units on a scale |
| All Participants | Change From Baseline in Psoriatic Arthritis Impact of Disease 12 Questions (PsAID12) Score at Months 3, 6 and 12 | Tofacitinib monotherapy-Month 3 | -1.4 Units on a scale |
| All Participants | Change From Baseline in Psoriatic Arthritis Impact of Disease 12 Questions (PsAID12) Score at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy-Month 3 | -1.0 Units on a scale |
| All Participants | Change From Baseline in Psoriatic Arthritis Impact of Disease 12 Questions (PsAID12) Score at Months 3, 6 and 12 | Combined tofacitinib and other csDMARD-Month 3 | NA Units on a scale |
| All Participants | Change From Baseline in Psoriatic Arthritis Impact of Disease 12 Questions (PsAID12) Score at Months 3, 6 and 12 | Overall-Month 6 | -1.3 Units on a scale |
| All Participants | Change From Baseline in Psoriatic Arthritis Impact of Disease 12 Questions (PsAID12) Score at Months 3, 6 and 12 | Tofacitinib monotherapy-Month 6 | -1.5 Units on a scale |
| All Participants | Change From Baseline in Psoriatic Arthritis Impact of Disease 12 Questions (PsAID12) Score at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy-Month 6 | -0.9 Units on a scale |
| All Participants | Change From Baseline in Psoriatic Arthritis Impact of Disease 12 Questions (PsAID12) Score at Months 3, 6 and 12 | Combined tofacitinib and other csDMARD-Month 6 | NA Units on a scale |
| All Participants | Change From Baseline in Psoriatic Arthritis Impact of Disease 12 Questions (PsAID12) Score at Months 3, 6 and 12 | Overall-Month 12 | -1.1 Units on a scale |
| All Participants | Change From Baseline in Psoriatic Arthritis Impact of Disease 12 Questions (PsAID12) Score at Months 3, 6 and 12 | Tofacitinib monotherapy-Month 12 | -1.3 Units on a scale |
| All Participants | Change From Baseline in Psoriatic Arthritis Impact of Disease 12 Questions (PsAID12) Score at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy-Month 12 | -0.7 Units on a scale |
| All Participants | Change From Baseline in Psoriatic Arthritis Impact of Disease 12 Questions (PsAID12) Score at Months 3, 6 and 12 | Combined tofacitinib and other csDMARD-Month 12 | NA Units on a scale |
Secondary
Change From Baseline in QoL Based on Health Assessment Questionnaire - Disability Index (HAQ-DI41) at Months 3, 6 and 12
The HAQ-DI41 assessed the degree of difficulty a participant had experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. For each question in the questionnaire, the level of difficulty was scored from 0 to 3 with 0 =no difficulty, 1 = some difficulty, 2 = much difficulty, and 3 = unable to do. The disability index was computed by adding the scores for each of the components and dividing by the number of components with an available score. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities.
Time frame: Baseline (measurement at enrollment), Month 3, Month 6 and Month 12
Population: The FAS included all enrolled participants who received at least one dose (including partial dose) of study medication. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified rows.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| All Participants | Change From Baseline in QoL Based on Health Assessment Questionnaire - Disability Index (HAQ-DI41) at Months 3, 6 and 12 | Combined tofacitinib and other csDMARD-Month 3 | NA Units on a scale |
| All Participants | Change From Baseline in QoL Based on Health Assessment Questionnaire - Disability Index (HAQ-DI41) at Months 3, 6 and 12 | Overall-Month 3 | -0.1 Units on a scale |
| All Participants | Change From Baseline in QoL Based on Health Assessment Questionnaire - Disability Index (HAQ-DI41) at Months 3, 6 and 12 | Tofacitinib monotherapy-Month 3 | -0.1 Units on a scale |
| All Participants | Change From Baseline in QoL Based on Health Assessment Questionnaire - Disability Index (HAQ-DI41) at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy-Month 3 | -0.0 Units on a scale |
| All Participants | Change From Baseline in QoL Based on Health Assessment Questionnaire - Disability Index (HAQ-DI41) at Months 3, 6 and 12 | Overall-Month 6 | -0.1 Units on a scale |
| All Participants | Change From Baseline in QoL Based on Health Assessment Questionnaire - Disability Index (HAQ-DI41) at Months 3, 6 and 12 | Tofacitinib monotherapy-Month 6 | -0.1 Units on a scale |
| All Participants | Change From Baseline in QoL Based on Health Assessment Questionnaire - Disability Index (HAQ-DI41) at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy-Month 6 | 0.0 Units on a scale |
| All Participants | Change From Baseline in QoL Based on Health Assessment Questionnaire - Disability Index (HAQ-DI41) at Months 3, 6 and 12 | Combined tofacitinib and other csDMARD-Month 6 | NA Units on a scale |
| All Participants | Change From Baseline in QoL Based on Health Assessment Questionnaire - Disability Index (HAQ-DI41) at Months 3, 6 and 12 | Overall-Month 12 | -0.2 Units on a scale |
| All Participants | Change From Baseline in QoL Based on Health Assessment Questionnaire - Disability Index (HAQ-DI41) at Months 3, 6 and 12 | Tofacitinib monotherapy-Month 12 | -0.2 Units on a scale |
| All Participants | Change From Baseline in QoL Based on Health Assessment Questionnaire - Disability Index (HAQ-DI41) at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy-Month 12 | -0.2 Units on a scale |
| All Participants | Change From Baseline in QoL Based on Health Assessment Questionnaire - Disability Index (HAQ-DI41) at Months 3, 6 and 12 | Combined tofacitinib and other csDMARD-Month 12 | NA Units on a scale |
Secondary
Change From Baseline in Quality of Life (QoL) Based on Short Form 36 (SF-36) Score at Months 3, 6 and 12
The SF-36 is a participant administered scale assessing general quality of life. It consists of self-administered 36-item questionnaire that measured 8 health domains: physical function, role-physical, bodily pain, general health, vitality, social function, role-emotional, and mental health. These 8 domains are also summarized as physical and mental component scores. The score for each domain and component score is the mean of the individual question scores, which are scaled from 0 (minimum) to 100 (maximum), where high scores in each dimension and high overall scores indicate a better quality of life.
Time frame: Baseline (measurement at enrollment), Month 3, Month 6 and Month 12
Population: The FAS included all enrolled participants who received at least one dose (including partial dose) of study medication. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified rows.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| All Participants | Change From Baseline in Quality of Life (QoL) Based on Short Form 36 (SF-36) Score at Months 3, 6 and 12 | Overall: Physical health component summary score-Month 3 | 4.8 Units on a scale |
| All Participants | Change From Baseline in Quality of Life (QoL) Based on Short Form 36 (SF-36) Score at Months 3, 6 and 12 | Overall: Mental health component summary score-Month 3 | 2.4 Units on a scale |
| All Participants | Change From Baseline in Quality of Life (QoL) Based on Short Form 36 (SF-36) Score at Months 3, 6 and 12 | Tofacitinib monotherapy: Physical health component summary score-Month 3 | 5.0 Units on a scale |
| All Participants | Change From Baseline in Quality of Life (QoL) Based on Short Form 36 (SF-36) Score at Months 3, 6 and 12 | Tofacitinib monotherapy: Mental health component summary score-Month 3 | 2.5 Units on a scale |
| All Participants | Change From Baseline in Quality of Life (QoL) Based on Short Form 36 (SF-36) Score at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Physical health component summary score-Month 3 | 3.6 Units on a scale |
| All Participants | Change From Baseline in Quality of Life (QoL) Based on Short Form 36 (SF-36) Score at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Mental health component summary score-Month 3 | 1.5 Units on a scale |
| All Participants | Change From Baseline in Quality of Life (QoL) Based on Short Form 36 (SF-36) Score at Months 3, 6 and 12 | Combined tofacitinib and other csDMARD: Physical health component summary score-Month 3 | NA Units on a scale |
| All Participants | Change From Baseline in Quality of Life (QoL) Based on Short Form 36 (SF-36) Score at Months 3, 6 and 12 | Combined tofacitinib and other csDMARD: Mental health component summary score-Month 3 | NA Units on a scale |
| All Participants | Change From Baseline in Quality of Life (QoL) Based on Short Form 36 (SF-36) Score at Months 3, 6 and 12 | Overall: Physical health component summary score-Month 6 | 5.5 Units on a scale |
| All Participants | Change From Baseline in Quality of Life (QoL) Based on Short Form 36 (SF-36) Score at Months 3, 6 and 12 | Overall: Mental health component summary score-Month 6 | 2.6 Units on a scale |
| All Participants | Change From Baseline in Quality of Life (QoL) Based on Short Form 36 (SF-36) Score at Months 3, 6 and 12 | Tofacitinib monotherapy: Physical health component summary score-Month 6 | 6.2 Units on a scale |
| All Participants | Change From Baseline in Quality of Life (QoL) Based on Short Form 36 (SF-36) Score at Months 3, 6 and 12 | Tofacitinib monotherapy: Mental health component summary score-Month 6 | 2.9 Units on a scale |
| All Participants | Change From Baseline in Quality of Life (QoL) Based on Short Form 36 (SF-36) Score at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Physical health component summary score-Month 6 | 3.2 Units on a scale |
| All Participants | Change From Baseline in Quality of Life (QoL) Based on Short Form 36 (SF-36) Score at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Mental health component summary score-Month 6 | 0.9 Units on a scale |
| All Participants | Change From Baseline in Quality of Life (QoL) Based on Short Form 36 (SF-36) Score at Months 3, 6 and 12 | Combined tofacitinib and other csDMARD: Physical health component summary score-Month 6 | NA Units on a scale |
| All Participants | Change From Baseline in Quality of Life (QoL) Based on Short Form 36 (SF-36) Score at Months 3, 6 and 12 | Combined tofacitinib and other csDMARD: Mental health component summary score-Month 6 | NA Units on a scale |
| All Participants | Change From Baseline in Quality of Life (QoL) Based on Short Form 36 (SF-36) Score at Months 3, 6 and 12 | Overall: Physical health component summary score-Month 12 | 5.5 Units on a scale |
| All Participants | Change From Baseline in Quality of Life (QoL) Based on Short Form 36 (SF-36) Score at Months 3, 6 and 12 | Overall: Mental health component summary score-Month 12 | 3.0 Units on a scale |
| All Participants | Change From Baseline in Quality of Life (QoL) Based on Short Form 36 (SF-36) Score at Months 3, 6 and 12 | Tofacitinib monotherapy: Physical health component summary score-Month 12 | 6.8 Units on a scale |
| All Participants | Change From Baseline in Quality of Life (QoL) Based on Short Form 36 (SF-36) Score at Months 3, 6 and 12 | Tofacitinib monotherapy: Mental health component summary score-Month 12 | 4.5 Units on a scale |
| All Participants | Change From Baseline in Quality of Life (QoL) Based on Short Form 36 (SF-36) Score at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Physical health component summary score-Month 12 | 3.8 Units on a scale |
| All Participants | Change From Baseline in Quality of Life (QoL) Based on Short Form 36 (SF-36) Score at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Mental health component summary score-Month 12 | -1.8 Units on a scale |
| All Participants | Change From Baseline in Quality of Life (QoL) Based on Short Form 36 (SF-36) Score at Months 3, 6 and 12 | Combined tofacitinib and other csDMARD: Physical health component summary score-Month 12 | NA Units on a scale |
| All Participants | Change From Baseline in Quality of Life (QoL) Based on Short Form 36 (SF-36) Score at Months 3, 6 and 12 | Combined tofacitinib and other csDMARD: Mental health component summary score-Month 12 | NA Units on a scale |
Secondary
Change From Baseline in Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC-EI) Score at Months 3, 6 and 12
The SPARCC-EI evaluated 16 enthesial sites: greater trochanter (Right/Left \[R/L\]), quadriceps tendon insertion into the patella (R/L), patellar ligament insertion into the patella and tibial tuberosity (R/L), achilles tendon insertion (R/L), plantar fascia insertion (R/L), medial epicondyles (R/L), lateral epicondyles (R/L) and supraspinatus insertion (R/L) for the presence or absence of tenderness. Tenderness at each site was quantified as: 0 = non-tender and 1 = tender. The maximum score of the SPARCC-EI was 16. SPARCC-EI score range: 0 (no enthesitis) to 16 (enthesitis is present at all assessed sites), higher scores indicated more presence of enthesitis.
Time frame: Baseline (measurement at enrollment), at Month 3, Month 6 and Month 12
Population: The FAS included all enrolled participants who received at least one dose (including partial dose) of study medication. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified rows.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| All Participants | Change From Baseline in Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC-EI) Score at Months 3, 6 and 12 | Overall-Month 3 | 0.1 Units on a scale |
| All Participants | Change From Baseline in Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC-EI) Score at Months 3, 6 and 12 | Tofacitinib monotherapy-Month 3 | 0.1 Units on a scale |
| All Participants | Change From Baseline in Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC-EI) Score at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy-Month 3 | 0.2 Units on a scale |
| All Participants | Change From Baseline in Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC-EI) Score at Months 3, 6 and 12 | Combined tofacitinib and other csDMARD-Month 3 | NA Units on a scale |
| All Participants | Change From Baseline in Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC-EI) Score at Months 3, 6 and 12 | Overall-Month 6 | -0.8 Units on a scale |
| All Participants | Change From Baseline in Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC-EI) Score at Months 3, 6 and 12 | Tofacitinib monotherapy-Month 6 | -0.4 Units on a scale |
| All Participants | Change From Baseline in Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC-EI) Score at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy-Month 6 | -1.8 Units on a scale |
| All Participants | Change From Baseline in Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC-EI) Score at Months 3, 6 and 12 | Overall-Month 12 | -0.3 Units on a scale |
| All Participants | Change From Baseline in Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC-EI) Score at Months 3, 6 and 12 | Tofacitinib monotherapy-Month 12 | 0.0 Units on a scale |
| All Participants | Change From Baseline in Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC-EI) Score at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy-Month 12 | -0.9 Units on a scale |
Secondary
Number of Participants Who Achieved LDA According to Arthritis of >10 Joints (With at Least One Small Joint) at Months 3, 6 and 12
Small joints=MCP, proximal IP, second through fifth MTP, thumb IP, wrists. Number of participants who achieved LDA according to presence (Yes/No) of arthritis of \>10 joints (with at least one small joint) was reported in this outcome measure. LDA=PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA incorporated assessment of: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC(0-68); SJC(0-66); LEI score ranging from 0-6; 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3; 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores=more severe disease.
Time frame: At Month 3, Month 6 and Month 12
Population: The FAS included all enrolled participants who received at least one dose (including partial dose) of study medication. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified rows. All participants in Overall Number of Participants Analyzed contributed data to the table but may not have data evaluable for every row.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of >10 Joints (With at Least One Small Joint) at Months 3, 6 and 12 | Overall: No-Month 3 | 10 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of >10 Joints (With at Least One Small Joint) at Months 3, 6 and 12 | Overall: Yes-Month 3 | 2 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of >10 Joints (With at Least One Small Joint) at Months 3, 6 and 12 | Overall: No-Month 6 | 16 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of >10 Joints (With at Least One Small Joint) at Months 3, 6 and 12 | Overall: Yes-Month 6 | 4 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of >10 Joints (With at Least One Small Joint) at Months 3, 6 and 12 | Overall: No-Month 12 | 10 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of >10 Joints (With at Least One Small Joint) at Months 3, 6 and 12 | Overall: Yes-Month 12 | 2 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of >10 Joints (With at Least One Small Joint) at Months 3, 6 and 12 | Tofacitinib monotherapy: No-Month 3 | 6 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of >10 Joints (With at Least One Small Joint) at Months 3, 6 and 12 | Tofacitinib monotherapy: Yes-Month 3 | 2 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of >10 Joints (With at Least One Small Joint) at Months 3, 6 and 12 | Tofacitinib monotherapy: No-Month 6 | 11 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of >10 Joints (With at Least One Small Joint) at Months 3, 6 and 12 | Tofacitinib monotherapy: Yes-Month 6 | 4 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of >10 Joints (With at Least One Small Joint) at Months 3, 6 and 12 | Tofacitinib monotherapy: No-Month 12 | 7 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of >10 Joints (With at Least One Small Joint) at Months 3, 6 and 12 | Tofacitinib monotherapy: Yes-Month 12 | 2 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of >10 Joints (With at Least One Small Joint) at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: No-Month 3 | 4 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of >10 Joints (With at Least One Small Joint) at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Yes-Month 3 | 0 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of >10 Joints (With at Least One Small Joint) at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: No-Month 6 | 5 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of >10 Joints (With at Least One Small Joint) at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Yes-Month 6 | 0 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of >10 Joints (With at Least One Small Joint) at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: No-Month 12 | 3 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of >10 Joints (With at Least One Small Joint) at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Yes-Month 12 | 0 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of >10 Joints (With at Least One Small Joint) at Months 3, 6 and 12 | Combined tofacitinib and other csDMARD: No-Month 3 | 0 Participants |
Secondary
Number of Participants Who Achieved LDA According to Arthritis of 2-10 Medium-Large Joints and/or 1-3 Small Joints at Months 3, 6 and 12
Medium joints=temporomandibular, sternoclavicular, acromioclavicular, finger proximal interphalangeal (IP), finger distal interphalangeal, tarsus/midfoot (feet). Large joints=glenohumeral, elbows, hips, knees, ankles. Small joints=MCP, proximal IP, second through fifth metatarsal phalangeal (MTP), thumb IP, wrists. Number of participants who achieved LDA according to presence (Yes/No) arthritis of 2-10 medium-large joints and/or 1-3 small joints was reported. LDA=PASDAS score =\<3.2. PASDAS is a composite PsA activity score including: participant /physician global (VAS 0-100; 0=no DA, 100=maximum DA), TJC (0-68), SJC (0-66), LEI (0-6; 0=non tender, 6=more enthesitis burden), tender dactylitis digit score (0-3; 0=no tenderness, 3=participant withdrew digit), SF-36 PCS (0-100; 0=severe physical health limitations, 100=excellent physical health),CRP in mg/L. PASDAS score (0-10) uses a weighted formula; higher scores=more severe disease.
Time frame: At Month 3, Month 6 and Month 12
Population: The FAS included all enrolled participants who received at least one dose (including partial dose) of study medication. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified rows. All participants in Overall Number of Participants Analyzed contributed data to the table but may not have data evaluable for every row.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of 2-10 Medium-Large Joints and/or 1-3 Small Joints at Months 3, 6 and 12 | Overall: No-Month 3 | 0 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of 2-10 Medium-Large Joints and/or 1-3 Small Joints at Months 3, 6 and 12 | Overall: Yes-Month 3 | 12 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of 2-10 Medium-Large Joints and/or 1-3 Small Joints at Months 3, 6 and 12 | Overall: No-Month 6 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of 2-10 Medium-Large Joints and/or 1-3 Small Joints at Months 3, 6 and 12 | Overall: Yes-Month 6 | 19 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of 2-10 Medium-Large Joints and/or 1-3 Small Joints at Months 3, 6 and 12 | Overall: No-Month 12 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of 2-10 Medium-Large Joints and/or 1-3 Small Joints at Months 3, 6 and 12 | Overall: Yes-Month 12 | 11 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of 2-10 Medium-Large Joints and/or 1-3 Small Joints at Months 3, 6 and 12 | Tofacitinib monotherapy: No-Month 3 | 0 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of 2-10 Medium-Large Joints and/or 1-3 Small Joints at Months 3, 6 and 12 | Tofacitinib monotherapy: Yes-Month 3 | 8 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of 2-10 Medium-Large Joints and/or 1-3 Small Joints at Months 3, 6 and 12 | Tofacitinib monotherapy: No-Month 6 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of 2-10 Medium-Large Joints and/or 1-3 Small Joints at Months 3, 6 and 12 | Tofacitinib monotherapy: Yes-Month 6 | 14 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of 2-10 Medium-Large Joints and/or 1-3 Small Joints at Months 3, 6 and 12 | Tofacitinib monotherapy: No-Month 12 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of 2-10 Medium-Large Joints and/or 1-3 Small Joints at Months 3, 6 and 12 | Tofacitinib monotherapy: Yes-Month 12 | 8 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of 2-10 Medium-Large Joints and/or 1-3 Small Joints at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Yes-Month 3 | 4 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of 2-10 Medium-Large Joints and/or 1-3 Small Joints at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Yes-Month 6 | 5 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of 2-10 Medium-Large Joints and/or 1-3 Small Joints at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Yes-Month 12 | 3 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of 2-10 Medium-Large Joints and/or 1-3 Small Joints at Months 3, 6 and 12 | Combined tofacitinib and other csDMARD: Yes-Month 3 | 0 Participants |
Secondary
Number of Participants Who Achieved LDA According to Arthritis of 4-10 Small Joints With or Without Involvement of Large Joints at Months 3, 6 and 12
Large joints=glenohumeral, elbows, hips, knees and ankles joint. Small joints=MCP, proximal IP, second through fifth MTP, thumb IP, wrists. Number of participants who achieved LDA according to presence (Yes/No) of arthritis of 4-10 small joints with or without involvement of large joints was reported. LDA=PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA incorporated assessment of: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA;TJC(0-68); SJC(0-66); LEI score range=0-6; 0=non tender, 6=more enthesitis burden; tender dactylitis digit score range=0-3; 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores=more severe disease.
Time frame: At Month 3, Month 6 and Month 12
Population: The FAS included all enrolled participants who received at least one dose (including partial dose) of study medication. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified rows. All participants in Overall Number of Participants Analyzed contributed data to the table but may not have data evaluable for every row.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of 4-10 Small Joints With or Without Involvement of Large Joints at Months 3, 6 and 12 | Overall: No-Month 3 | 8 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of 4-10 Small Joints With or Without Involvement of Large Joints at Months 3, 6 and 12 | Overall: Yes-Month 3 | 4 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of 4-10 Small Joints With or Without Involvement of Large Joints at Months 3, 6 and 12 | Overall: No-Month 6 | 12 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of 4-10 Small Joints With or Without Involvement of Large Joints at Months 3, 6 and 12 | Overall: Yes-Month 6 | 8 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of 4-10 Small Joints With or Without Involvement of Large Joints at Months 3, 6 and 12 | Overall: No-Month 12 | 6 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of 4-10 Small Joints With or Without Involvement of Large Joints at Months 3, 6 and 12 | Overall: Yes-Month 12 | 6 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of 4-10 Small Joints With or Without Involvement of Large Joints at Months 3, 6 and 12 | Tofacitinib monotherapy: No-Month 3 | 4 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of 4-10 Small Joints With or Without Involvement of Large Joints at Months 3, 6 and 12 | Tofacitinib monotherapy: Yes-Month 3 | 4 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of 4-10 Small Joints With or Without Involvement of Large Joints at Months 3, 6 and 12 | Tofacitinib monotherapy: No-Month 6 | 8 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of 4-10 Small Joints With or Without Involvement of Large Joints at Months 3, 6 and 12 | Tofacitinib monotherapy: Yes-Month 6 | 7 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of 4-10 Small Joints With or Without Involvement of Large Joints at Months 3, 6 and 12 | Tofacitinib monotherapy: No-Month 12 | 4 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of 4-10 Small Joints With or Without Involvement of Large Joints at Months 3, 6 and 12 | Tofacitinib monotherapy: Yes-Month 12 | 5 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of 4-10 Small Joints With or Without Involvement of Large Joints at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: No-Month 3 | 4 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of 4-10 Small Joints With or Without Involvement of Large Joints at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Yes-Month 3 | 0 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of 4-10 Small Joints With or Without Involvement of Large Joints at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: No-Month 6 | 4 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of 4-10 Small Joints With or Without Involvement of Large Joints at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Yes-Month 6 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of 4-10 Small Joints With or Without Involvement of Large Joints at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: No-Month 12 | 2 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of 4-10 Small Joints With or Without Involvement of Large Joints at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Yes-Month 12 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of 4-10 Small Joints With or Without Involvement of Large Joints at Months 3, 6 and 12 | Combined tofacitinib and other csDMARD: No-Month 3 | 0 Participants |
Secondary
Number of Participants Who Achieved LDA According to Arthritis of Only 1 Medium-Large Joint at Months 3, 6 and 12
Medium joints=temporomandibular, sternoclavicular, acromioclavicular, finger proximal interphalangeal, finger distal interphalangeal and tarsus/midfoot(feet) joints. Large joints=glenohumeral, elbows, hips, knees and ankles joint. Number of participants who achieved LDA according to presence (Yes/No) of arthritis of only 1 medium-large joint was reported. LDA=PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA incorporated assessment of: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA;TJC(0-68);SJC(0-66); LEI score ranging from 0-6;0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3;0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100;0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS score (0-10) uses a weighted formula; higher scores=more severe disease.
Time frame: At Month 3, Month 6 and Month 12
Population: The FAS included all enrolled participants who received at least one dose (including partial dose) of study medication. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified rows. All participants in Overall Number of Participants Analyzed contributed data to the table but may not have data evaluable for every row.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of Only 1 Medium-Large Joint at Months 3, 6 and 12 | Overall: No-Month 3 | 10 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of Only 1 Medium-Large Joint at Months 3, 6 and 12 | Overall: Yes-Month 3 | 2 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of Only 1 Medium-Large Joint at Months 3, 6 and 12 | Overall: No-Month 6 | 17 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of Only 1 Medium-Large Joint at Months 3, 6 and 12 | Overall: Yes-Month 6 | 3 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of Only 1 Medium-Large Joint at Months 3, 6 and 12 | Overall: No-Month 12 | 11 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of Only 1 Medium-Large Joint at Months 3, 6 and 12 | Overall: Yes-Month 12 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of Only 1 Medium-Large Joint at Months 3, 6 and 12 | Tofacitinib monotherapy: No-Month 3 | 7 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of Only 1 Medium-Large Joint at Months 3, 6 and 12 | Tofacitinib monotherapy: Yes-Month 3 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of Only 1 Medium-Large Joint at Months 3, 6 and 12 | Tofacitinib monotherapy: No-Month 6 | 14 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of Only 1 Medium-Large Joint at Months 3, 6 and 12 | Tofacitinib monotherapy: Yes-Month 6 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of Only 1 Medium-Large Joint at Months 3, 6 and 12 | Tofacitinib monotherapy: No-Month 12 | 9 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of Only 1 Medium-Large Joint at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: No-Month 3 | 3 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of Only 1 Medium-Large Joint at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Yes-Month 3 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of Only 1 Medium-Large Joint at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: No-Month 6 | 3 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of Only 1 Medium-Large Joint at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Yes-Month 6 | 2 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of Only 1 Medium-Large Joint at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: No-Month 12 | 2 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of Only 1 Medium-Large Joint at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Yes-Month 12 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of Only 1 Medium-Large Joint at Months 3, 6 and 12 | Combined tofacitinib and other csDMARD: No-Month 3 | 0 Participants |
Secondary
Number of Participants Who Achieved LDA According to Arthritis of the Hand Joints at Months 3, 6 and 12
Hand joints included metacarpal phalangeal joints(MCP), finger proximal interphalangeal and finger distal interphalangeal joints. Number of participants who achieved LDA according to presence(Yes/No) of arthritis of any of hand joints was reported. LDA=PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of following: participant global PAA,physician global PAA, each scored on 100 mm VAS,0=no DA,100=maximum DA;TJC(0-68); SJC(0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease.
Time frame: At Month 3, Month 6 and Month 12
Population: The FAS included all enrolled participants who received at least one dose (including partial dose) of study medication. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified rows. All participants in Overall Number of Participants Analyzed contributed data to the table but may not have data evaluable for every row.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of the Hand Joints at Months 3, 6 and 12 | Overall: No-Month 3 | 4 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of the Hand Joints at Months 3, 6 and 12 | Overall: Yes-Month 3 | 8 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of the Hand Joints at Months 3, 6 and 12 | Overall: No-Month 6 | 6 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of the Hand Joints at Months 3, 6 and 12 | Overall: Yes-Month 6 | 14 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of the Hand Joints at Months 3, 6 and 12 | Overall: No-Month 12 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of the Hand Joints at Months 3, 6 and 12 | Overall: Yes-Month 12 | 11 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of the Hand Joints at Months 3, 6 and 12 | Tofacitinib monotherapy: No-Month 3 | 2 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of the Hand Joints at Months 3, 6 and 12 | Tofacitinib monotherapy: Yes-Month 3 | 6 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of the Hand Joints at Months 3, 6 and 12 | Tofacitinib monotherapy: No-Month 6 | 4 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of the Hand Joints at Months 3, 6 and 12 | Tofacitinib monotherapy: Yes-Month 6 | 11 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of the Hand Joints at Months 3, 6 and 12 | Tofacitinib monotherapy: No-Month 12 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of the Hand Joints at Months 3, 6 and 12 | Tofacitinib monotherapy: Yes-Month 12 | 8 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of the Hand Joints at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: No-Month 3 | 2 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of the Hand Joints at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Yes-Month 3 | 2 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of the Hand Joints at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: No-Month 6 | 2 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of the Hand Joints at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Yes-Month 6 | 3 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of the Hand Joints at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: No-Month 12 | 0 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of the Hand Joints at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Yes-Month 12 | 3 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Arthritis of the Hand Joints at Months 3, 6 and 12 | Combined tofacitinib and other csDMARD: Yes-Month 3 | 0 Participants |
Secondary
Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12
BMI = Weight (kilograms \[kg\]) / Height (meter square \[m\]\^2). LDA was defined as PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease. In this outcome measure, participants with PASDAS scores are reported according to BMI categories of 18.5 - \<25 kg/m\^2, 25 - \<30 kg/m\^2, \>= 30 kg/m\^2 and missing.
Time frame: At Month 3, Month 6 and Month 12
Population: The FAS included all enrolled participants who received at least one dose (including partial dose) of study medication. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified rows. All participants in Overall Number of Participants Analyzed contributed data to the table but may not have data evaluable for every row.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12 | Overall: Missing-Month 3 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12 | Overall: 18.5 - <25 kg/m^2-Month 3 | 2 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12 | Overall: 25 - <30 kg/m^2-Month 3 | 6 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12 | Overall: >= 30 kg/m^2-Month 3 | 3 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12 | Overall: 18.5 - <25 kg/m^2-Month 6 | 8 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12 | Overall: 25 - <30 kg/m^2-Month 6 | 8 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12 | Overall: >= 30 kg/m^2-Month 6 | 2 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12 | Overall: Missing-Month 6 | 2 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12 | Overall: 18.5 - <25 kg/m^2-Month 12 | 5 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12 | Overall: 25 - <30 kg/m^2-Month 12 | 4 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12 | Overall: >= 30 kg/m^2-Month 12 | 2 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12 | Overall: Missing-Month 12 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12 | Tofacitinib monotherapy: 18.5 - <25 kg/m^2-Month 3 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12 | Tofacitinib monotherapy: 25 - <30 kg/m^2-Month 3 | 5 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12 | Tofacitinib monotherapy: >= 30 kg/m^2-Month 3 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12 | Tofacitinib monotherapy: Missing-Month 3 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12 | Tofacitinib monotherapy: 18.5 - <25 kg/m^2-Month 6 | 4 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12 | Tofacitinib monotherapy: 25 - <30 kg/m^2-Month 6 | 8 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12 | Tofacitinib monotherapy: >= 30 kg/m^2-Month 6 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12 | Tofacitinib monotherapy: Missing-Month 6 | 2 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12 | Tofacitinib monotherapy: 18.5 - <25 kg/m^2-Month 12 | 3 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12 | Tofacitinib monotherapy: 25 - <30 kg/m^2-Month 12 | 4 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12 | Tofacitinib monotherapy: >= 30 kg/m^2-Month 12 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12 | Tofacitinib monotherapy: Missing-Month 12 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: 18.5 - <25 kg/m^2-Month 3 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: 25 - <30 kg/m^2-Month 3 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: >= 30 kg/m^2-Month 3 | 2 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Missing-Month 3 | 0 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: 18.5 - <25 kg/m^2-Month 6 | 4 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: 25 - <30 kg/m^2-Month 6 | 0 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: >= 30 kg/m^2-Month 6 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Missing-Month 6 | 0 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: 18.5 - <25 kg/m^2-Month 12 | 2 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: >= 30 kg/m^2-Month 12 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12 | Combined tofacitinib and other csDMARD: >= 30 kg/m^2-Month 3 | 0 Participants |
Secondary
Number of Participants Who Achieved LDA According to C-reactive Protein (CRP) Results at Months 3, 6 and 12
For CRP, result was considered abnormal if t the test result was above the normal range (0.3 to 10 mg/L). LDA was defined as PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease.
Time frame: At Month 3, Month 6 and Month 12
Population: The FAS included all enrolled participants who received at least one dose (including partial dose) of study medication. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified rows. All participants in Overall Number of Participants Analyzed contributed data to the table but may not have data evaluable for every row.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants Who Achieved LDA According to C-reactive Protein (CRP) Results at Months 3, 6 and 12 | Overall: Abnormal-Month 3 | 7 Participants |
| All Participants | Number of Participants Who Achieved LDA According to C-reactive Protein (CRP) Results at Months 3, 6 and 12 | Overall: Normal-Month 3 | 5 Participants |
| All Participants | Number of Participants Who Achieved LDA According to C-reactive Protein (CRP) Results at Months 3, 6 and 12 | Overall: Abnormal-Month 6 | 8 Participants |
| All Participants | Number of Participants Who Achieved LDA According to C-reactive Protein (CRP) Results at Months 3, 6 and 12 | Overall: Normal-Month 6 | 12 Participants |
| All Participants | Number of Participants Who Achieved LDA According to C-reactive Protein (CRP) Results at Months 3, 6 and 12 | Overall: Abnormal-Month 12 | 4 Participants |
| All Participants | Number of Participants Who Achieved LDA According to C-reactive Protein (CRP) Results at Months 3, 6 and 12 | Overall: Normal-Month 12 | 8 Participants |
| All Participants | Number of Participants Who Achieved LDA According to C-reactive Protein (CRP) Results at Months 3, 6 and 12 | Tofacitinib monotherapy: Abnormal-Month 3 | 4 Participants |
| All Participants | Number of Participants Who Achieved LDA According to C-reactive Protein (CRP) Results at Months 3, 6 and 12 | Tofacitinib monotherapy: Normal-Month 3 | 4 Participants |
| All Participants | Number of Participants Who Achieved LDA According to C-reactive Protein (CRP) Results at Months 3, 6 and 12 | Tofacitinib monotherapy: Abnormal-Month 6 | 5 Participants |
| All Participants | Number of Participants Who Achieved LDA According to C-reactive Protein (CRP) Results at Months 3, 6 and 12 | Tofacitinib monotherapy: Normal-Month 6 | 10 Participants |
| All Participants | Number of Participants Who Achieved LDA According to C-reactive Protein (CRP) Results at Months 3, 6 and 12 | Tofacitinib monotherapy: Abnormal-Month 12 | 2 Participants |
| All Participants | Number of Participants Who Achieved LDA According to C-reactive Protein (CRP) Results at Months 3, 6 and 12 | Tofacitinib monotherapy: Normal-Month 12 | 7 Participants |
| All Participants | Number of Participants Who Achieved LDA According to C-reactive Protein (CRP) Results at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Abnormal-Month 3 | 3 Participants |
| All Participants | Number of Participants Who Achieved LDA According to C-reactive Protein (CRP) Results at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Normal-Month 3 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to C-reactive Protein (CRP) Results at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Abnormal-Month 6 | 3 Participants |
| All Participants | Number of Participants Who Achieved LDA According to C-reactive Protein (CRP) Results at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Normal-Month 6 | 2 Participants |
| All Participants | Number of Participants Who Achieved LDA According to C-reactive Protein (CRP) Results at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Abnormal-Month 12 | 2 Participants |
| All Participants | Number of Participants Who Achieved LDA According to C-reactive Protein (CRP) Results at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Normal-Month 12 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to C-reactive Protein (CRP) Results at Months 3, 6 and 12 | Combined tofacitinib and other csDMARD: Normal-Month 3 | 0 Participants |
Secondary
Number of Participants Who Achieved LDA According to Duration of Current Episode Symptoms of at Least 6 Weeks Prior to Enrollment at Months 3, 6 and 12
Duration of current episode of symptoms prior to enrollment were presented as: \< 6, \>=6 weeks. LDA was defined as PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease.
Time frame: At Month 3, Month 6 and Month 12
Population: The FAS included all enrolled participants who received at least one dose (including partial dose) of study medication. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified rows. All participants in Overall Number of Participants Analyzed contributed data to the table but may not have data evaluable for every row.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants Who Achieved LDA According to Duration of Current Episode Symptoms of at Least 6 Weeks Prior to Enrollment at Months 3, 6 and 12 | Overall: < 6 weeks-Month 3 | 4 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Duration of Current Episode Symptoms of at Least 6 Weeks Prior to Enrollment at Months 3, 6 and 12 | Overall: >= 6 weeks-Month 3 | 6 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Duration of Current Episode Symptoms of at Least 6 Weeks Prior to Enrollment at Months 3, 6 and 12 | Overall: Missing-Month 3 | 2 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Duration of Current Episode Symptoms of at Least 6 Weeks Prior to Enrollment at Months 3, 6 and 12 | Overall: < 6 weeks-Month 6 | 11 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Duration of Current Episode Symptoms of at Least 6 Weeks Prior to Enrollment at Months 3, 6 and 12 | Overall: >= 6 weeks-Month 6 | 8 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Duration of Current Episode Symptoms of at Least 6 Weeks Prior to Enrollment at Months 3, 6 and 12 | Overall: Missing-Month 6 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Duration of Current Episode Symptoms of at Least 6 Weeks Prior to Enrollment at Months 3, 6 and 12 | Overall: < 6 weeks-Month 12 | 4 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Duration of Current Episode Symptoms of at Least 6 Weeks Prior to Enrollment at Months 3, 6 and 12 | Overall: >= 6 weeks-Month 12 | 8 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Duration of Current Episode Symptoms of at Least 6 Weeks Prior to Enrollment at Months 3, 6 and 12 | Tofacitinib monotherapy: < 6 weeks-Month 3 | 3 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Duration of Current Episode Symptoms of at Least 6 Weeks Prior to Enrollment at Months 3, 6 and 12 | Tofacitinib monotherapy: >= 6 weeks-Month 3 | 3 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Duration of Current Episode Symptoms of at Least 6 Weeks Prior to Enrollment at Months 3, 6 and 12 | Tofacitinib monotherapy: Missing-Month 3 | 2 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Duration of Current Episode Symptoms of at Least 6 Weeks Prior to Enrollment at Months 3, 6 and 12 | Tofacitinib monotherapy: < 6 weeks-Month 6 | 7 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Duration of Current Episode Symptoms of at Least 6 Weeks Prior to Enrollment at Months 3, 6 and 12 | Tofacitinib monotherapy: >= 6 weeks-Month 6 | 7 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Duration of Current Episode Symptoms of at Least 6 Weeks Prior to Enrollment at Months 3, 6 and 12 | Tofacitinib monotherapy: Missing-Month 6 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Duration of Current Episode Symptoms of at Least 6 Weeks Prior to Enrollment at Months 3, 6 and 12 | Tofacitinib monotherapy: < 6 weeks-Month 12 | 2 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Duration of Current Episode Symptoms of at Least 6 Weeks Prior to Enrollment at Months 3, 6 and 12 | Tofacitinib monotherapy: >= 6 weeks-Month 12 | 7 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Duration of Current Episode Symptoms of at Least 6 Weeks Prior to Enrollment at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: < 6 weeks-Month 3 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Duration of Current Episode Symptoms of at Least 6 Weeks Prior to Enrollment at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: >= 6 weeks-Month 3 | 3 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Duration of Current Episode Symptoms of at Least 6 Weeks Prior to Enrollment at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: < 6 weeks-Month 6 | 4 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Duration of Current Episode Symptoms of at Least 6 Weeks Prior to Enrollment at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: >= 6 weeks-Month 6 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Duration of Current Episode Symptoms of at Least 6 Weeks Prior to Enrollment at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: < 6 weeks-Month 12 | 2 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Duration of Current Episode Symptoms of at Least 6 Weeks Prior to Enrollment at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: >= 6 weeks-Month 12 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Duration of Current Episode Symptoms of at Least 6 Weeks Prior to Enrollment at Months 3, 6 and 12 | Combined tofacitinib and other csDMARD: >= 6 weeks-Month 3 | 0 Participants |
Secondary
Number of Participants Who Achieved LDA According to Erythrocyte Sedimentation Rate (ESR) Results at Months 3, 6 and 12
ESR result=abnormal if test result was above normal range. ESR normal range:0-50 years(male \<15 mm/h, female \<20 mm/h), 51-85 years(\<20 mm/h males and \<30 mm/h females),older than 85 years(\<30 mm/h males and \<42 mm/h females). Number of participants who achieved LDA according to ESR results(normal and abnormal) were reported. LDA=PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of following:participant global PAA,physician global PAA,each scored on 100 mm VAS,0=no DA, 100=maximum DA; TJC(0-68); SJC(0-66); LEI score=0-6;0=non tender,6=more enthesitis burden; tender dactylitis digit score=0-3,0=no tenderness,3=participant withdrew digit; PCS of SF-36 score=0-100; 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged=0(no disease)to 10(severe disease);higher scores=more severe disease.
Time frame: At Month 3, Month 6 and Month 12
Population: The FAS included all enrolled participants who received at least one dose (including partial dose) of study medication. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified rows. All participants in Overall Number of Participants Analyzed contributed data to the table but may not have data evaluable for every row.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants Who Achieved LDA According to Erythrocyte Sedimentation Rate (ESR) Results at Months 3, 6 and 12 | Overall: Abnormal-Month 6 | 4 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Erythrocyte Sedimentation Rate (ESR) Results at Months 3, 6 and 12 | Overall: Normal-Month 6 | 10 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Erythrocyte Sedimentation Rate (ESR) Results at Months 3, 6 and 12 | Overall: Missing-Month 6 | 6 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Erythrocyte Sedimentation Rate (ESR) Results at Months 3, 6 and 12 | Overall: Abnormal-Month 12 | 3 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Erythrocyte Sedimentation Rate (ESR) Results at Months 3, 6 and 12 | Overall: Normal-Month 12 | 7 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Erythrocyte Sedimentation Rate (ESR) Results at Months 3, 6 and 12 | Overall: Missing-Month 12 | 2 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Erythrocyte Sedimentation Rate (ESR) Results at Months 3, 6 and 12 | Tofacitinib monotherapy: Abnormal-Month 3 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Erythrocyte Sedimentation Rate (ESR) Results at Months 3, 6 and 12 | Tofacitinib monotherapy: Normal-Month 3 | 6 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Erythrocyte Sedimentation Rate (ESR) Results at Months 3, 6 and 12 | Tofacitinib monotherapy: Missing-Month 3 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Erythrocyte Sedimentation Rate (ESR) Results at Months 3, 6 and 12 | Tofacitinib monotherapy: Abnormal-Month 6 | 2 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Erythrocyte Sedimentation Rate (ESR) Results at Months 3, 6 and 12 | Tofacitinib monotherapy: Normal-Month 6 | 8 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Erythrocyte Sedimentation Rate (ESR) Results at Months 3, 6 and 12 | Tofacitinib monotherapy: Missing-Month 6 | 5 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Erythrocyte Sedimentation Rate (ESR) Results at Months 3, 6 and 12 | Tofacitinib monotherapy: Abnormal-Month 12 | 2 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Erythrocyte Sedimentation Rate (ESR) Results at Months 3, 6 and 12 | Tofacitinib monotherapy: Normal-Month 12 | 5 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Erythrocyte Sedimentation Rate (ESR) Results at Months 3, 6 and 12 | Tofacitinib monotherapy: Missing-Month 12 | 2 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Erythrocyte Sedimentation Rate (ESR) Results at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Abnormal-Month 3 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Erythrocyte Sedimentation Rate (ESR) Results at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Normal-Month 3 | 2 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Erythrocyte Sedimentation Rate (ESR) Results at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Missing-Month 3 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Erythrocyte Sedimentation Rate (ESR) Results at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Abnormal-Month 6 | 2 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Erythrocyte Sedimentation Rate (ESR) Results at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Normal-Month 6 | 2 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Erythrocyte Sedimentation Rate (ESR) Results at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Missing-Month 6 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Erythrocyte Sedimentation Rate (ESR) Results at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Abnormal-Month 12 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Erythrocyte Sedimentation Rate (ESR) Results at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Normal-Month 12 | 2 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Erythrocyte Sedimentation Rate (ESR) Results at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Missing-Month 12 | 0 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Erythrocyte Sedimentation Rate (ESR) Results at Months 3, 6 and 12 | Combined tofacitinib and other csDMARD: Normal-Month 3 | 0 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Erythrocyte Sedimentation Rate (ESR) Results at Months 3, 6 and 12 | Overall: Abnormal-Month 3 | 2 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Erythrocyte Sedimentation Rate (ESR) Results at Months 3, 6 and 12 | Overall: Normal-Month 3 | 8 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Erythrocyte Sedimentation Rate (ESR) Results at Months 3, 6 and 12 | Overall: Missing-Month 3 | 2 Participants |
Secondary
Number of Participants Who Achieved LDA According to Presence of Rheumatoid Nodules at Months 3, 6 and 12
Number of participants who achieved LDA according to presence (present/absent) of rheumatoid nodules is presented in this outcome measure. LDA was defined as PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease.
Time frame: At Month 3, Month 6 and Month 12
Population: The FAS included all enrolled participants who received at least one dose (including partial dose) of study medication. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified rows. All participants in Overall Number of Participants Analyzed contributed data to the table but may not have data evaluable for every row.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants Who Achieved LDA According to Presence of Rheumatoid Nodules at Months 3, 6 and 12 | Overall: Absent-Month 3 | 12 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Rheumatoid Nodules at Months 3, 6 and 12 | Overall: Missing-Month 3 | 0 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Rheumatoid Nodules at Months 3, 6 and 12 | Overall: Absent-Month 6 | 20 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Rheumatoid Nodules at Months 3, 6 and 12 | Overall: Missing-Month 6 | 0 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Rheumatoid Nodules at Months 3, 6 and 12 | Overall: Absent-Month 12 | 12 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Rheumatoid Nodules at Months 3, 6 and 12 | Overall: Missing-Month 12 | 0 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Rheumatoid Nodules at Months 3, 6 and 12 | Tofacitinib monotherapy: Absent-Month 3 | 8 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Rheumatoid Nodules at Months 3, 6 and 12 | Tofacitinib monotherapy: Missing-Month 3 | 0 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Rheumatoid Nodules at Months 3, 6 and 12 | Tofacitinib monotherapy: Absent-Month 6 | 15 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Rheumatoid Nodules at Months 3, 6 and 12 | Tofacitinib monotherapy: Missing-Month 6 | 0 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Rheumatoid Nodules at Months 3, 6 and 12 | Tofacitinib monotherapy: Absent-Month 12 | 9 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Rheumatoid Nodules at Months 3, 6 and 12 | Tofacitinib monotherapy: Missing-Month 12 | 0 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Rheumatoid Nodules at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Absent-Month 3 | 4 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Rheumatoid Nodules at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Absent-Month 6 | 5 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Rheumatoid Nodules at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Absent-Month 12 | 3 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Rheumatoid Nodules at Months 3, 6 and 12 | Combined tofacitinib and other csDMARD: Absent-Month 3 | 0 Participants |
Secondary
Number of Participants Who Achieved LDA According to Presence of Symmetric Arthritis at Months 3, 6 and 12
Arthritis at enrollment was identified when a participant reported swelling and/or tenderness/pain in any joint. Number of participants who achieved LDA according to presence (Yes/No) of symmetric arthritis was reported. LDA was defined as PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease.
Time frame: At Month 3, Month 6 and Month 12
Population: The FAS included all enrolled participants who received at least one dose (including partial dose) of study medication. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified rows. All participants in Overall Number of Participants Analyzed contributed data to the table but may not have data evaluable for every row.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants Who Achieved LDA According to Presence of Symmetric Arthritis at Months 3, 6 and 12 | Overall: No-Month 3 | 12 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Symmetric Arthritis at Months 3, 6 and 12 | Overall: Yes-Month 3 | 0 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Symmetric Arthritis at Months 3, 6 and 12 | Overall: No-Month 6 | 20 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Symmetric Arthritis at Months 3, 6 and 12 | Overall: Yes-Month 6 | 0 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Symmetric Arthritis at Months 3, 6 and 12 | Overall: No-Month 12 | 12 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Symmetric Arthritis at Months 3, 6 and 12 | Tofacitinib monotherapy: No-Month 3 | 8 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Symmetric Arthritis at Months 3, 6 and 12 | Tofacitinib monotherapy: Yes-Month 3 | 0 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Symmetric Arthritis at Months 3, 6 and 12 | Tofacitinib monotherapy: No-Month 6 | 15 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Symmetric Arthritis at Months 3, 6 and 12 | Tofacitinib monotherapy: Yes-Month 6 | 0 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Symmetric Arthritis at Months 3, 6 and 12 | Tofacitinib monotherapy: No-Month 12 | 9 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Symmetric Arthritis at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: No-Month 3 | 4 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Symmetric Arthritis at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Yes-Month 3 | 0 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Symmetric Arthritis at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: No-Month 6 | 5 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Symmetric Arthritis at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: No-Month 12 | 3 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Symmetric Arthritis at Months 3, 6 and 12 | Combined tofacitinib and other csDMARD: No-Month 3 | 0 Participants |
Secondary
Number of Participants Who Achieved LDA According to Presence of Unequivocal Bony Decalcification Localized to the Joints of the Hands and Wrists at Months 3, 6 and 12
Unequivocal Bony decalcification was reported as present or absent at enrollment. LDA was defined as PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease.
Time frame: At Month 3, Month 6 and Month 12
Population: The FAS included all enrolled participants who received at least one dose (including partial dose) of study medication. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified rows. All participants in Overall Number of Participants Analyzed contributed data to the table but may not have data evaluable for every row.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Bony Decalcification Localized to the Joints of the Hands and Wrists at Months 3, 6 and 12 | Overall: Present-Month 3 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Bony Decalcification Localized to the Joints of the Hands and Wrists at Months 3, 6 and 12 | Overall: Absent-Month 3 | 7 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Bony Decalcification Localized to the Joints of the Hands and Wrists at Months 3, 6 and 12 | Overall: Missing-Month 3 | 4 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Bony Decalcification Localized to the Joints of the Hands and Wrists at Months 3, 6 and 12 | Overall: Present-Month 6 | 3 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Bony Decalcification Localized to the Joints of the Hands and Wrists at Months 3, 6 and 12 | Overall: Absent-Month 6 | 12 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Bony Decalcification Localized to the Joints of the Hands and Wrists at Months 3, 6 and 12 | Overall: Missing-Month 6 | 5 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Bony Decalcification Localized to the Joints of the Hands and Wrists at Months 3, 6 and 12 | Overall: Present-Month 12 | 2 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Bony Decalcification Localized to the Joints of the Hands and Wrists at Months 3, 6 and 12 | Overall: Absent-Month 12 | 7 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Bony Decalcification Localized to the Joints of the Hands and Wrists at Months 3, 6 and 12 | Overall: Missing-Month 12 | 3 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Bony Decalcification Localized to the Joints of the Hands and Wrists at Months 3, 6 and 12 | Tofacitinib monotherapy: Present-Month 3 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Bony Decalcification Localized to the Joints of the Hands and Wrists at Months 3, 6 and 12 | Tofacitinib monotherapy: Absent-Month 3 | 6 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Bony Decalcification Localized to the Joints of the Hands and Wrists at Months 3, 6 and 12 | Tofacitinib monotherapy: Missing-Month 3 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Bony Decalcification Localized to the Joints of the Hands and Wrists at Months 3, 6 and 12 | Tofacitinib monotherapy: Present-Month 6 | 2 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Bony Decalcification Localized to the Joints of the Hands and Wrists at Months 3, 6 and 12 | Tofacitinib monotherapy: Absent-Month 6 | 11 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Bony Decalcification Localized to the Joints of the Hands and Wrists at Months 3, 6 and 12 | Tofacitinib monotherapy: Missing-Month 6 | 2 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Bony Decalcification Localized to the Joints of the Hands and Wrists at Months 3, 6 and 12 | Tofacitinib monotherapy: Present-Month 12 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Bony Decalcification Localized to the Joints of the Hands and Wrists at Months 3, 6 and 12 | Tofacitinib monotherapy: Absent-Month 12 | 6 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Bony Decalcification Localized to the Joints of the Hands and Wrists at Months 3, 6 and 12 | Tofacitinib monotherapy: Missing-Month 12 | 2 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Bony Decalcification Localized to the Joints of the Hands and Wrists at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Present-Month 3 | 0 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Bony Decalcification Localized to the Joints of the Hands and Wrists at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Absent-Month 3 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Bony Decalcification Localized to the Joints of the Hands and Wrists at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Missing-Month 3 | 3 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Bony Decalcification Localized to the Joints of the Hands and Wrists at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Present-Month 6 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Bony Decalcification Localized to the Joints of the Hands and Wrists at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Absent-Month 6 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Bony Decalcification Localized to the Joints of the Hands and Wrists at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Missing-Month 6 | 3 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Bony Decalcification Localized to the Joints of the Hands and Wrists at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Present-Month 12 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Bony Decalcification Localized to the Joints of the Hands and Wrists at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Absent-Month 12 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Bony Decalcification Localized to the Joints of the Hands and Wrists at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Missing-Month 12 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Bony Decalcification Localized to the Joints of the Hands and Wrists at Months 3, 6 and 12 | Combined tofacitinib and other csDMARD: Absent-Month 3 | 0 Participants |
Secondary
Number of Participants Who Achieved LDA According to Presence of Unequivocal Radiological Erosion at Months 3, 6 and 12
Unequivocal radiological erosion: 'present',if Sharp-Van der Heijde modified score (S-VH MS)for erosion \>0;'absent',if S-VH MS for erosion score=0. S-VH MS sum of erosion,JSN scores(range 0-528). Higher score=more severe disease. If a component score is missing, S-VH MS is missing. LDA=PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of following: participant global PAA,physician global PAA,each scored on 100 mm VAS,0=no DA,100=maximum DA; TJC(0-68); SJC(0-66); LEI score range=0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score range=0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score range=0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0(no disease)to 10(severe disease); higher scores=more severe disease.
Time frame: At Month 3, Month 6 and Month 12
Population: The FAS included all enrolled participants who received at least one dose (including partial dose) of study medication. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified rows. All participants in Overall Number of Participants Analyzed contributed data to the table but may not have data evaluable for every row.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Radiological Erosion at Months 3, 6 and 12 | Overall: Present-Month 3 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Radiological Erosion at Months 3, 6 and 12 | Overall: Absent-Month 3 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Radiological Erosion at Months 3, 6 and 12 | Overall: Missing-Month 3 | 10 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Radiological Erosion at Months 3, 6 and 12 | Overall: Present-Month 6 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Radiological Erosion at Months 3, 6 and 12 | Overall: Absent-Month 6 | 2 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Radiological Erosion at Months 3, 6 and 12 | Overall: Missing-Month 6 | 17 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Radiological Erosion at Months 3, 6 and 12 | Overall: Present-Month 12 | 0 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Radiological Erosion at Months 3, 6 and 12 | Overall: Absent-Month 12 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Radiological Erosion at Months 3, 6 and 12 | Overall: Missing-Month 12 | 11 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Radiological Erosion at Months 3, 6 and 12 | Tofacitinib monotherapy: Present-Month 3 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Radiological Erosion at Months 3, 6 and 12 | Tofacitinib monotherapy: Absent-Month 3 | 0 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Radiological Erosion at Months 3, 6 and 12 | Tofacitinib monotherapy: Missing-Month 3 | 7 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Radiological Erosion at Months 3, 6 and 12 | Tofacitinib monotherapy: Present-Month 6 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Radiological Erosion at Months 3, 6 and 12 | Tofacitinib monotherapy: Absent-Month 6 | 2 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Radiological Erosion at Months 3, 6 and 12 | Tofacitinib monotherapy: Missing-Month 6 | 12 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Radiological Erosion at Months 3, 6 and 12 | Tofacitinib monotherapy: Present-Month 12 | 0 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Radiological Erosion at Months 3, 6 and 12 | Tofacitinib monotherapy: Absent-Month 12 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Radiological Erosion at Months 3, 6 and 12 | Tofacitinib monotherapy: Missing-Month 12 | 8 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Radiological Erosion at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Absent-Month 3 | 1 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Radiological Erosion at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Missing-Month 3 | 3 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Radiological Erosion at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Absent-Month 6 | 0 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Radiological Erosion at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Missing-Month 6 | 5 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Radiological Erosion at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Missing-Month 12 | 3 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Presence of Unequivocal Radiological Erosion at Months 3, 6 and 12 | Combined tofacitinib and other csDMARD: Missing-Month 3 | 0 Participants |
Secondary
Number of Participants Who Achieved LDA According to Treatment Line at Months 3, 6 and 12
Participants who achieved LDA according to treatment line were reported in this outcome measure. Treatment line included: tofacitinib monotherapy, combination therapy with MTX, and combination therapy with other csDMARDs. LDA was defined as PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease.
Time frame: At Month 3, Month 6 and Month 12
Population: The FAS included all enrolled participants who received at least one dose (including partial dose) of study medication. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified rows. All participants in Overall Number of Participants Analyzed contributed data to the table but may not have data evaluable for every row.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants Who Achieved LDA According to Treatment Line at Months 3, 6 and 12 | Tofacitinib monotherapy: Tofacitinib as monotherapy-Month 6 | 15 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Treatment Line at Months 3, 6 and 12 | Overall: Tofacitinib as monotherapy-Month 3 | 8 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Treatment Line at Months 3, 6 and 12 | Overall: Combination therapy with MTX-Month 3 | 4 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Treatment Line at Months 3, 6 and 12 | Overall: Combination with other csDMARD-Month 3 | 0 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Treatment Line at Months 3, 6 and 12 | Overall: Tofacitinib as monotherapy-Month 6 | 15 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Treatment Line at Months 3, 6 and 12 | Overall: Combination therapy with MTX-Month 6 | 5 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Treatment Line at Months 3, 6 and 12 | Overall: Tofacitinib as monotherapy-Month 12 | 9 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Treatment Line at Months 3, 6 and 12 | Overall: Combination therapy with MTX-Month 12 | 3 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Treatment Line at Months 3, 6 and 12 | Tofacitinib monotherapy: Tofacitinib as monotherapy-Month 3 | 8 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Treatment Line at Months 3, 6 and 12 | Tofacitinib monotherapy: Tofacitinib as monotherapy-Month 12 | 9 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Treatment Line at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Combination therapy with MTX-Month 3 | 4 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Treatment Line at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Combination therapy with MTX-Month 6 | 5 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Treatment Line at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy: Combination therapy with MTX-Month 12 | 3 Participants |
| All Participants | Number of Participants Who Achieved LDA According to Treatment Line at Months 3, 6 and 12 | Combined tofacitinib and other csDMARD: Combination with other csDMARD-Month 3 | 0 Participants |
Secondary
Percentage of Participants Who Achieved LDA Based on PASDAS at Months 3 and 12
PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease. LDA was defined as PASDAS score less than or equal to (\<=) 3.2.
Time frame: At Month 3 and Month 12
Population: The FAS included all enrolled participants who received at least one dose (including partial dose) of study medication. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Percentage of Participants Who Achieved LDA Based on PASDAS at Months 3 and 12 | Overall-Month 3 | 23.5 Percentage of participants |
| All Participants | Percentage of Participants Who Achieved LDA Based on PASDAS at Months 3 and 12 | Tofacitinib monotherapy-Month 3 | 21.1 Percentage of participants |
| All Participants | Percentage of Participants Who Achieved LDA Based on PASDAS at Months 3 and 12 | Combined tofacitinib and MTX therapy-Month 3 | 33.3 Percentage of participants |
| All Participants | Percentage of Participants Who Achieved LDA Based on PASDAS at Months 3 and 12 | Combined tofacitinib and other csDMARD-Month 3 | 0 Percentage of participants |
| All Participants | Percentage of Participants Who Achieved LDA Based on PASDAS at Months 3 and 12 | Overall-Month 12 | 46.2 Percentage of participants |
| All Participants | Percentage of Participants Who Achieved LDA Based on PASDAS at Months 3 and 12 | Tofacitinib monotherapy-Month 12 | 47.4 Percentage of participants |
| All Participants | Percentage of Participants Who Achieved LDA Based on PASDAS at Months 3 and 12 | Combined tofacitinib and MTX therapy-Month 12 | 42.9 Percentage of participants |
Secondary
Percentage of Participants Who Achieved Minimum Disease Activity (MDA) at Months 3, 6 and 12
A participant was classified as MDA achieved if they met 5 of 7 criteria: (i) (TJC66) \<=1, (ii) (SJC68)\<=1, (iii) psoriasis area and severity index (PASI) score \<=1 (PASI=combined assessment of lesion severity and area affected into single score; range=0 \[no disease\] to 72 \[maximal disease\], higher scores=more disease. or body surface area (BSA) \<=3%,(iv) patient pain assessment (VAS, 0-100) \<=15; where 0='no pain' and 100='pain as severe as can be imagined', higher scores=more pain, (v) patient global assessment (VAS, 0-100) \<=20, where 0='lowest level of disease activity' and 100= 'highest level of disease activity, higher scores=more disease activity, (vi) health assessment questionnaire-disability index (HAQ- DI) \<=0.5; scale ranged=0-3, where 0='normal or no difficulty' and 3='inability to perform', higher scores=more difficulty, (vii) tender enthesial points \<=1 using Leed's index range=0=non tender to 6=more enthesitis burden, higher scores=more burden.
Time frame: At Month 3, Month 6 and Month 12
Population: The FAS included all enrolled participants who received at least one dose (including partial dose) of study medication. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Percentage of Participants Who Achieved Minimum Disease Activity (MDA) at Months 3, 6 and 12 | Overall-Month 3 | 17.6 Percentage of participants |
| All Participants | Percentage of Participants Who Achieved Minimum Disease Activity (MDA) at Months 3, 6 and 12 | Tofacitinib monotherapy-Month 3 | 16.7 Percentage of participants |
| All Participants | Percentage of Participants Who Achieved Minimum Disease Activity (MDA) at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy-Month 3 | 21.7 Percentage of participants |
| All Participants | Percentage of Participants Who Achieved Minimum Disease Activity (MDA) at Months 3, 6 and 12 | Combined tofacitinib and other csDMARD-Month 3 | 0 Percentage of participants |
| All Participants | Percentage of Participants Who Achieved Minimum Disease Activity (MDA) at Months 3, 6 and 12 | Overall-Month 6 | 42.3 Percentage of participants |
| All Participants | Percentage of Participants Who Achieved Minimum Disease Activity (MDA) at Months 3, 6 and 12 | Tofacitinib monotherapy-Month 6 | 42.0 Percentage of participants |
| All Participants | Percentage of Participants Who Achieved Minimum Disease Activity (MDA) at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy-Month 6 | 45.0 Percentage of participants |
| All Participants | Percentage of Participants Who Achieved Minimum Disease Activity (MDA) at Months 3, 6 and 12 | Combined tofacitinib and other csDMARD-Month 6 | 0 Percentage of participants |
| All Participants | Percentage of Participants Who Achieved Minimum Disease Activity (MDA) at Months 3, 6 and 12 | Overall-Month 12 | 43.9 Percentage of participants |
| All Participants | Percentage of Participants Who Achieved Minimum Disease Activity (MDA) at Months 3, 6 and 12 | Tofacitinib monotherapy-Month 12 | 45.0 Percentage of participants |
| All Participants | Percentage of Participants Who Achieved Minimum Disease Activity (MDA) at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy-Month 12 | 43.8 Percentage of participants |
| All Participants | Percentage of Participants Who Achieved Minimum Disease Activity (MDA) at Months 3, 6 and 12 | Combined tofacitinib and other csDMARD-Month 12 | 0 Percentage of participants |
Secondary
Percentage of Participants Who Achieved Remission Based on Disease Activity in Psoriatic Arthritis (DAPSA) Score at Months 3, 6 and 12
DAPSA was composite disease activity measure and was calculated as: SJC66 + TJC68 + patient global assessment VAS (0 to 10 cm VAS, 0= excellent and 10= poor, higher scores indicated more disease activity) + patient pain assessment (0 to 10 cm VAS, 0= no pain, 10= worst possible pain, higher scores indicated more pain) + CRP (mg/dL). DAPSA score ranged from 0 to 164, higher scores indicated more disease activity. Remission was defined as DAPSA score =\<4.0.
Time frame: At Month 3, Month 6 and Month 12
Population: The FAS included all enrolled participants who received at least one dose (including partial dose) of study medication. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Percentage of Participants Who Achieved Remission Based on Disease Activity in Psoriatic Arthritis (DAPSA) Score at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy-Month 6 | 8.3 Percentage of participants |
| All Participants | Percentage of Participants Who Achieved Remission Based on Disease Activity in Psoriatic Arthritis (DAPSA) Score at Months 3, 6 and 12 | Overall-Month 3 | 11.3 Percentage of participants |
| All Participants | Percentage of Participants Who Achieved Remission Based on Disease Activity in Psoriatic Arthritis (DAPSA) Score at Months 3, 6 and 12 | Tofacitinib monotherapy-Month 3 | 11.6 Percentage of participants |
| All Participants | Percentage of Participants Who Achieved Remission Based on Disease Activity in Psoriatic Arthritis (DAPSA) Score at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy-Month 3 | 11.1 Percentage of participants |
| All Participants | Percentage of Participants Who Achieved Remission Based on Disease Activity in Psoriatic Arthritis (DAPSA) Score at Months 3, 6 and 12 | Combined tofacitinib and other csDMARD-Month 3 | 0 Percentage of participants |
| All Participants | Percentage of Participants Who Achieved Remission Based on Disease Activity in Psoriatic Arthritis (DAPSA) Score at Months 3, 6 and 12 | Overall-Month 6 | 28.9 Percentage of participants |
| All Participants | Percentage of Participants Who Achieved Remission Based on Disease Activity in Psoriatic Arthritis (DAPSA) Score at Months 3, 6 and 12 | Tofacitinib monotherapy-Month 6 | 36.4 Percentage of participants |
| All Participants | Percentage of Participants Who Achieved Remission Based on Disease Activity in Psoriatic Arthritis (DAPSA) Score at Months 3, 6 and 12 | Overall-Month 12 | 38.7 Percentage of participants |
| All Participants | Percentage of Participants Who Achieved Remission Based on Disease Activity in Psoriatic Arthritis (DAPSA) Score at Months 3, 6 and 12 | Tofacitinib monotherapy-Month 12 | 47.6 Percentage of participants |
| All Participants | Percentage of Participants Who Achieved Remission Based on Disease Activity in Psoriatic Arthritis (DAPSA) Score at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy-Month 12 | 20.0 Percentage of participants |
Secondary
Percentage of Participants Who Achieved Remission Based on PASDAS at Months 3, 6 and 12
PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease. Remission was defined as PASDAS score less than or equal to (\<=) 1.9.
Time frame: At Month 3, Month 6 and Month 12
Population: The FAS included all enrolled participants who received at least one dose (including partial dose) of study medication. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Percentage of Participants Who Achieved Remission Based on PASDAS at Months 3, 6 and 12 | Overall-Month 3 | 12.1 Percentage of participants |
| All Participants | Percentage of Participants Who Achieved Remission Based on PASDAS at Months 3, 6 and 12 | Tofacitinib monotherapy-Month 3 | 14.3 Percentage of participants |
| All Participants | Percentage of Participants Who Achieved Remission Based on PASDAS at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy-Month 3 | 7.1 Percentage of participants |
| All Participants | Percentage of Participants Who Achieved Remission Based on PASDAS at Months 3, 6 and 12 | Combined tofacitinib and other csDMARD-Month 3 | 0 Percentage of participants |
| All Participants | Percentage of Participants Who Achieved Remission Based on PASDAS at Months 3, 6 and 12 | Overall-Month 6 | 15.7 Percentage of participants |
| All Participants | Percentage of Participants Who Achieved Remission Based on PASDAS at Months 3, 6 and 12 | Tofacitinib monotherapy-Month 6 | 20.0 Percentage of participants |
| All Participants | Percentage of Participants Who Achieved Remission Based on PASDAS at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy-Month 6 | 6.7 Percentage of participants |
| All Participants | Percentage of Participants Who Achieved Remission Based on PASDAS at Months 3, 6 and 12 | Combined tofacitinib and other csDMARD-Month 6 | 0 Percentage of participants |
| All Participants | Percentage of Participants Who Achieved Remission Based on PASDAS at Months 3, 6 and 12 | Overall-Month 12 | 21.6 Percentage of participants |
| All Participants | Percentage of Participants Who Achieved Remission Based on PASDAS at Months 3, 6 and 12 | Tofacitinib monotherapy-Month 12 | 25.9 Percentage of participants |
| All Participants | Percentage of Participants Who Achieved Remission Based on PASDAS at Months 3, 6 and 12 | Combined tofacitinib and MTX therapy-Month 12 | 11.1 Percentage of participants |
| All Participants | Percentage of Participants Who Achieved Remission Based on PASDAS at Months 3, 6 and 12 | Combined tofacitinib and other csDMARD-Month 12 | 0 Percentage of participants |