Trial Outcomes & Findings for Effectiveness of Treatment With Tofacitinib in Patients With Psoriatic Arthritis in Routine Clinical Practice (NCT NCT04517669)
NCT ID: NCT04517669
Last Updated: 2025-10-14
Results Overview
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.
COMPLETED
116 participants
At Month 6
2025-10-14
Participant Flow
Participants diagnosed with psoriatic arthritis (PsA) and treated with tofacitinib in routine clinical practice were included in this prospective study.
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
116
|
|
Overall Study
Safety (Started Tofacitinib Irrespective of Eligibility Criteria)
|
113
|
|
Overall Study
Full Analysis Set
|
109
|
|
Overall Study
COMPLETED
|
59
|
|
Overall Study
NOT COMPLETED
|
57
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Drug withdrawn
|
44
|
|
Overall Study
Other
|
1
|
|
Overall Study
Eligibility criteria not met
|
4
|
|
Overall Study
Did not receive treatment
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Participants
n=113 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.
|
|---|---|
|
Age, Continuous
|
49.8 Years
STANDARD_DEVIATION 10.47 • n=113 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=113 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=113 Participants
|
PRIMARY outcome
Timeframe: At Month 6Population: 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.
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.
Outcome measures
| Measure |
All Participants
n=72 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.
|
|---|---|
|
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
Interval 29.9 to 56.3
|
|
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
Interval 31.4 to 62.4
|
|
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
Interval 9.4 to 57.5
|
|
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
Upper limit and lower limit of 95% confidence interval (CI) could not be calculated due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: At Month 3 and Month 12Population: 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.
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.
Outcome measures
| Measure |
All Participants
n=51 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.
|
|---|---|
|
Percentage of Participants Who Achieved LDA Based on PASDAS at Months 3 and 12
Overall-Month 3
|
23.5 Percentage of participants
Interval 13.9 to 36.9
|
|
Percentage of Participants Who Achieved LDA Based on PASDAS at Months 3 and 12
Tofacitinib monotherapy-Month 3
|
21.1 Percentage of participants
Interval 10.8 to 36.6
|
|
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
Interval 13.6 to 61.2
|
|
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
Interval 0.0 to 82.9
|
|
Percentage of Participants Who Achieved LDA Based on PASDAS at Months 3 and 12
Overall-Month 12
|
46.2 Percentage of participants
Interval 28.7 to 64.5
|
|
Percentage of Participants Who Achieved LDA Based on PASDAS at Months 3 and 12
Tofacitinib monotherapy-Month 12
|
47.4 Percentage of participants
Interval 27.3 to 68.3
|
|
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
Interval 15.8 to 75.0
|
SECONDARY outcome
Timeframe: At Month 3, Month 6 and Month 12Population: 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.
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.
Outcome measures
| Measure |
All Participants
n=91 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.
|
|---|---|
|
Percentage of Participants Who Achieved Minimum Disease Activity (MDA) at Months 3, 6 and 12
Overall-Month 3
|
17.6 Percentage of participants
Interval 11.0 to 26.8
|
|
Percentage of Participants Who Achieved Minimum Disease Activity (MDA) at Months 3, 6 and 12
Tofacitinib monotherapy-Month 3
|
16.7 Percentage of participants
Interval 9.4 to 27.6
|
|
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
Interval 9.2 to 42.3
|
|
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
Interval 0.0 to 71.1
|
|
Percentage of Participants Who Achieved Minimum Disease Activity (MDA) at Months 3, 6 and 12
Overall-Month 6
|
42.3 Percentage of participants
Interval 31.4 to 53.9
|
|
Percentage of Participants Who Achieved Minimum Disease Activity (MDA) at Months 3, 6 and 12
Tofacitinib monotherapy-Month 6
|
42.0 Percentage of participants
Interval 29.4 to 55.8
|
|
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
Interval 25.8 to 65.8
|
|
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
Interval 0.0 to 82.9
|
|
Percentage of Participants Who Achieved Minimum Disease Activity (MDA) at Months 3, 6 and 12
Overall-Month 12
|
43.9 Percentage of participants
Interval 31.8 to 56.7
|
|
Percentage of Participants Who Achieved Minimum Disease Activity (MDA) at Months 3, 6 and 12
Tofacitinib monotherapy-Month 12
|
45.0 Percentage of participants
Interval 30.7 to 60.2
|
|
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
Interval 23.1 to 66.8
|
|
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
Interval 0.0 to 82.9
|
SECONDARY outcome
Timeframe: At Month 3, Month 6 and Month 12Population: 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.
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.
Outcome measures
| Measure |
All Participants
n=66 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.
|
|---|---|
|
Percentage of Participants Who Achieved Remission Based on PASDAS at Months 3, 6 and 12
Overall-Month 3
|
12.1 Percentage of participants
Interval 6.0 to 22.4
|
|
Percentage of Participants Who Achieved Remission Based on PASDAS at Months 3, 6 and 12
Tofacitinib monotherapy-Month 3
|
14.3 Percentage of participants
Interval 6.8 to 27.0
|
|
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
Interval 0.0 to 33.5
|
|
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
Interval 0.0 to 62.0
|
|
Percentage of Participants Who Achieved Remission Based on PASDAS at Months 3, 6 and 12
Overall-Month 6
|
15.7 Percentage of participants
Interval 7.9 to 28.3
|
|
Percentage of Participants Who Achieved Remission Based on PASDAS at Months 3, 6 and 12
Tofacitinib monotherapy-Month 6
|
20.0 Percentage of participants
Interval 9.7 to 36.2
|
|
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
Interval 0.0 to 31.8
|
|
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
Interval 0.0 to 82.9
|
|
Percentage of Participants Who Achieved Remission Based on PASDAS at Months 3, 6 and 12
Overall-Month 12
|
21.6 Percentage of participants
Interval 11.1 to 37.4
|
|
Percentage of Participants Who Achieved Remission Based on PASDAS at Months 3, 6 and 12
Tofacitinib monotherapy-Month 12
|
25.9 Percentage of participants
Interval 12.9 to 44.9
|
|
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
Interval 0.0 to 45.7
|
|
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
Interval 0.0 to 82.9
|
SECONDARY outcome
Timeframe: At Month 3, Month 6 and Month 12Population: 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.
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.
Outcome measures
| Measure |
All Participants
n=53 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.
|
|---|---|
|
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
Interval 4.9 to 22.9
|
|
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
Interval 4.6 to 24.9
|
|
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
Interval 0.0 to 45.7
|
|
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
Interval 0.0 to 82.9
|
|
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
Interval 17.6 to 43.5
|
|
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
Interval 22.1 to 53.4
|
|
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
Interval 0.0 to 37.5
|
|
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
Interval 23.7 to 56.2
|
|
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
Interval 28.3 to 67.6
|
|
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
Interval 4.6 to 52.1
|
SECONDARY outcome
Timeframe: Baseline (measurement at enrollment), at Month 3, Month 6 and Month 12Population: 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.
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).
Outcome measures
| Measure |
All Participants
n=89 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.
|
|---|---|
|
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
Interval -1.91 to 0.08
|
|
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
Least squares mean and 95% CI limits could not be calculated due to insufficient number of participants with events.
|
|
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
Interval -1.61 to -0.56
|
|
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
Interval -1.94 to -0.64
|
|
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
Interval -1.69 to 0.25
|
|
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
Least squares mean and 95% CI limits could not be calculated due to insufficient number of participants with events.
|
|
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
Interval -1.69 to -0.84
|
|
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
Interval -1.91 to -0.86
|
|
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
Interval -1.84 to -0.15
|
|
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
Least squares mean and 95% CI limits could not be calculated due to insufficient number of participants with events.
|
|
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
Interval -1.79 to -0.8
|
|
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
Interval -2.06 to -0.87
|
SECONDARY outcome
Timeframe: Baseline (measurement at enrollment), at Month 3, Month 6 and Month 12Population: 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.
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.
Outcome measures
| Measure |
All Participants
n=57 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.
|
|---|---|
|
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
Interval -0.67 to 0.85
|
|
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
Interval -0.8 to 0.95
|
|
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
Interval -1.87 to 2.18
|
|
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
Least squares mean and 95% CI limits could not be calculated due to insufficient number of participants with events.
|
|
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
Interval -1.47 to -0.21
|
|
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
Interval -1.17 to 0.28
|
|
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
Interval -3.2 to -0.39
|
|
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
Interval -0.95 to 0.44
|
|
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
Interval -0.81 to 0.82
|
|
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
Interval -2.42 to 0.71
|
SECONDARY outcome
Timeframe: At Month 3, Month 6 and Month 12Population: 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.
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.
Outcome measures
| Measure |
All Participants
n=51 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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12
Overall: Missing-Month 3
|
1 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
|
|
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
|
|
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
|
|
Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12
Overall: Missing-Month 6
|
2 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
|
|
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
|
|
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
|
|
Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12
Overall: Missing-Month 12
|
1 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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: At Month 3, Month 6 and Month 12Population: 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.
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.
Outcome measures
| Measure |
All Participants
n=51 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.
|
|---|---|
|
Number of Participants Who Achieved LDA According to Treatment Line at Months 3, 6 and 12
Overall: Tofacitinib as monotherapy-Month 3
|
8 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
|
|
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
|
|
Number of Participants Who Achieved LDA According to Treatment Line at Months 3, 6 and 12
Overall: Tofacitinib as monotherapy-Month 6
|
15 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
|
|
Number of Participants Who Achieved LDA According to Treatment Line at Months 3, 6 and 12
Overall: Tofacitinib as monotherapy-Month 12
|
9 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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: At Month 3, Month 6 and Month 12Population: 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.
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.
Outcome measures
| Measure |
All Participants
n=51 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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: At Month 3, Month 6 and Month 12Population: 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.
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.
Outcome measures
| Measure |
All Participants
n=51 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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: At Month 3, Month 6 and Month 12Population: 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.
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.
Outcome measures
| Measure |
All Participants
n=51 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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: At Month 3, Month 6 and Month 12Population: 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.
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.
Outcome measures
| Measure |
All Participants
n=51 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.
|
|---|---|
|
Number of Participants Who Achieved LDA According to Presence of Rheumatoid Nodules at Months 3, 6 and 12
Overall: Absent-Month 3
|
12 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
|
|
Number of Participants Who Achieved LDA According to Presence of Rheumatoid Nodules at Months 3, 6 and 12
Overall: Absent-Month 6
|
20 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
|
|
Number of Participants Who Achieved LDA According to Presence of Rheumatoid Nodules at Months 3, 6 and 12
Overall: Absent-Month 12
|
12 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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: At Month 3, Month 6 and Month 12Population: 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.
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.
Outcome measures
| Measure |
All Participants
n=51 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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: At Month 3, Month 6 and Month 12Population: 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.
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.
Outcome measures
| Measure |
All Participants
n=51 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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: At Month 3, Month 6 and Month 12Population: 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.
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.
Outcome measures
| Measure |
All Participants
n=51 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.
|
|---|---|
|
Number of Participants Who Achieved LDA According to Presence of Symmetric Arthritis at Months 3, 6 and 12
Overall: No-Month 3
|
12 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
|
|
Number of Participants Who Achieved LDA According to Presence of Symmetric Arthritis at Months 3, 6 and 12
Overall: No-Month 6
|
20 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
|
|
Number of Participants Who Achieved LDA According to Presence of Symmetric Arthritis at Months 3, 6 and 12
Overall: No-Month 12
|
12 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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: At Month 3, Month 6 and Month 12Population: 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.
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.
Outcome measures
| Measure |
All Participants
n=51 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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: At Month 3, Month 6 and Month 12Population: 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.
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.
Outcome measures
| Measure |
All Participants
n=51 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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: At Month 3, Month 6 and Month 12Population: 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.
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.
Outcome measures
| Measure |
All Participants
n=51 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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: At Month 3, Month 6 and Month 12Population: 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.
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.
Outcome measures
| Measure |
All Participants
n=51 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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: At Month 3, Month 6 and Month 12Population: 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.
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.
Outcome measures
| Measure |
All Participants
n=51 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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: Baseline (measurement at enrollment), Month 3, Month 6 and Month 12Population: 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.
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.
Outcome measures
| Measure |
All Participants
n=87 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.
|
|---|---|
|
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
Interval 0.05 to 5.2
|
|
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
Interval 0.67 to 6.44
|
|
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
Interval -1.44 to 4.51
|
|
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
Interval 3.94 to 8.51
|
|
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
Least squares mean and 95% CI limits could not be calculated due to insufficient number of participants with events.
|
|
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
Interval 3.0 to 6.56
|
|
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
Interval 0.31 to 4.52
|
|
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
Interval 2.78 to 7.2
|
|
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
Interval -0.23 to 5.26
|
|
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
Least squares mean and 95% CI limits could not be calculated due to insufficient number of participants with events.
|
|
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
Interval 3.53 to 7.4
|
|
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
Interval -0.41 to 6.2
|
|
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
Interval -0.48 to 6.92
|
|
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
Interval -3.22 to 5.01
|
|
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
Least squares mean and 95% CI limits could not be calculated due to insufficient number of participants with events.
|
|
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
Least squares mean and 95% CI limits could not be calculated due to insufficient number of participants with events.
|
|
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
Interval 3.33 to 7.69
|
|
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
Interval 0.11 to 5.83
|
|
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
Interval 4.06 to 9.45
|
|
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
Interval 1.04 to 8.03
|
|
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
Interval 0.6 to 6.97
|
|
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
Interval -6.33 to 2.74
|
|
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
Least squares mean and 95% CI limits could not be calculated due to insufficient number of participants with events.
|
|
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
Least squares mean and 95% CI limits could not be calculated due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Baseline (measurement at enrollment), Month 3, Month 6 and Month 12Population: 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.
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.
Outcome measures
| Measure |
All Participants
n=88 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.
|
|---|---|
|
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
Interval -0.21 to -0.01
|
|
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
Interval -0.24 to 0.0
|
|
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
Interval -0.23 to 0.14
|
|
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
Least squares mean and 95% CI limits could not be calculated due to insufficient number of participants with events.
|
|
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
Interval -0.23 to 0.0
|
|
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
Interval -0.29 to 0.01
|
|
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
Interval -0.2 to 0.2
|
|
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
Least squares mean and 95% CI limits could not be calculated due to insufficient number of participants with events.
|
|
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
Interval -0.32 to -0.02
|
|
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
Interval -0.39 to 0.0
|
|
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
Interval -0.39 to 0.07
|
|
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
Least squares mean and 95% CI limits could not be calculated due to insufficient number of participants with events.
|
Adverse Events
All Participants
Serious adverse events
| Measure |
All Participants
n=113 participants at risk
All participants with a diagnosis of PsA who received tofacitinib up to 12 months of follow-up were included in this retrospective observational study.
|
|---|---|
|
Infections and infestations
Pyelonephritis
|
0.88%
1/113 • From Baseline (enrollment) until Month 12
Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. SAF included all participants who received at least one dose (including partial dose) of study medication independently of inclusion/exclusion criteria.
|
|
Infections and infestations
Subcutaneous abscess
|
0.88%
1/113 • From Baseline (enrollment) until Month 12
Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. SAF included all participants who received at least one dose (including partial dose) of study medication independently of inclusion/exclusion criteria.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.88%
1/113 • From Baseline (enrollment) until Month 12
Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. SAF included all participants who received at least one dose (including partial dose) of study medication independently of inclusion/exclusion criteria.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell leukaemia
|
0.88%
1/113 • From Baseline (enrollment) until Month 12
Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. SAF included all participants who received at least one dose (including partial dose) of study medication independently of inclusion/exclusion criteria.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.88%
1/113 • From Baseline (enrollment) until Month 12
Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. SAF included all participants who received at least one dose (including partial dose) of study medication independently of inclusion/exclusion criteria.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.88%
1/113 • From Baseline (enrollment) until Month 12
Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. SAF included all participants who received at least one dose (including partial dose) of study medication independently of inclusion/exclusion criteria.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.88%
1/113 • From Baseline (enrollment) until Month 12
Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. SAF included all participants who received at least one dose (including partial dose) of study medication independently of inclusion/exclusion criteria.
|
|
Vascular disorders
Deep vein thrombosis
|
0.88%
1/113 • From Baseline (enrollment) until Month 12
Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. SAF included all participants who received at least one dose (including partial dose) of study medication independently of inclusion/exclusion criteria.
|
Other adverse events
| Measure |
All Participants
n=113 participants at risk
All participants with a diagnosis of PsA who received tofacitinib up to 12 months of follow-up were included in this retrospective observational study.
|
|---|---|
|
General disorders
Drug ineffective
|
18.6%
21/113 • From Baseline (enrollment) until Month 12
Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. SAF included all participants who received at least one dose (including partial dose) of study medication independently of inclusion/exclusion criteria.
|
|
Infections and infestations
COVID-19
|
8.8%
10/113 • From Baseline (enrollment) until Month 12
Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. SAF included all participants who received at least one dose (including partial dose) of study medication independently of inclusion/exclusion criteria.
|
|
Infections and infestations
Influenza
|
2.7%
3/113 • From Baseline (enrollment) until Month 12
Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. SAF included all participants who received at least one dose (including partial dose) of study medication independently of inclusion/exclusion criteria.
|
|
Infections and infestations
Nasopharyngitis
|
2.7%
3/113 • From Baseline (enrollment) until Month 12
Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. SAF included all participants who received at least one dose (including partial dose) of study medication independently of inclusion/exclusion criteria.
|
|
Infections and infestations
Urinary tract infection
|
2.7%
3/113 • From Baseline (enrollment) until Month 12
Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. SAF included all participants who received at least one dose (including partial dose) of study medication independently of inclusion/exclusion criteria.
|
|
Gastrointestinal disorders
Nausea
|
4.4%
5/113 • From Baseline (enrollment) until Month 12
Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. SAF included all participants who received at least one dose (including partial dose) of study medication independently of inclusion/exclusion criteria.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.5%
4/113 • From Baseline (enrollment) until Month 12
Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. SAF included all participants who received at least one dose (including partial dose) of study medication independently of inclusion/exclusion criteria.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.7%
3/113 • From Baseline (enrollment) until Month 12
Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. SAF included all participants who received at least one dose (including partial dose) of study medication independently of inclusion/exclusion criteria.
|
|
Nervous system disorders
Headache
|
7.1%
8/113 • From Baseline (enrollment) until Month 12
Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. SAF included all participants who received at least one dose (including partial dose) of study medication independently of inclusion/exclusion criteria.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.5%
4/113 • From Baseline (enrollment) until Month 12
Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. SAF included all participants who received at least one dose (including partial dose) of study medication independently of inclusion/exclusion criteria.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
3.5%
4/113 • From Baseline (enrollment) until Month 12
Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. SAF included all participants who received at least one dose (including partial dose) of study medication independently of inclusion/exclusion criteria.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER