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A Study to Learn About the Study Medicine (Called Tofacitinib) in People With Psoriatic Arthritis

An Investigation of Tofacitinib PsA Initiators in the CorEvitas SpA Registry

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05195814
Enrollment
141
Registered
2022-01-19
Start date
2021-11-15
Completion date
2023-10-31
Last updated
2025-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriatic Arthritis

Brief summary

The purpose of this study is to learn about the safety and effects of the study medicine for the potential treatment of Psoriatic Arthritis (PsA). Psoriatic Arthritis is a joint swelling disease that can also affect the skin, nails and eyes. The study medicine is called Tofacitinib. This study is seeking participants who: * Started taking tofacitinib alone or with other approved medicines (eg. methotrexate, leflunomide, sulfasalazine, apremilast) for PsA disease. We will only look at participants' who started tofacitinib after December 14, 2017. * Have a 6-month follow-up visit (with a 3-month window) This is an observational study. Participants receiving Tofacitinib will be included to assess how well tofacitinib works. We will look at participants' demographic information and therapy history. We will also monitor participants' disease progression before and 6 months after treatment. We will examine the experiences of people receiving the study medicine. This will help us determine if the study medicine is safe and effective.

Detailed description

Tofacitinib is an oral Janus kinase (JAK) inhibitor approved in 2017 by the US Food and Drug Administration (FDA) for the treatment of adult patients with active PsA who have had an inadequate response or intolerance to methotrexate or other disease modifying antirheumatic drugs (DMARDs). As of December 3, 2021, Tofacitinib is approved for use in patients who have had an inadequate response or intolerance to one or more TNF blockers. This is an observational retrospective cohort study that will be conducted using patients enrolled in the CorEvitas PsA/SpA Registry, initiating tofacitinib on or after December 14th, 2017. Patients receiving tofacitinib will be included to assess the effectiveness of tofacitinib overall and when stratified by key variables of interest. More specifically, the overall aim will be to describe baseline demographic, therapy history, and disease activity characteristics and assess change in disease activity measures six months after initiation of tofacitinib. There are two primary objectives for this study: 1. To describe the effectiveness of all tofacitinib initiators at 6 months in PsA patients 2. To describe the effectiveness of all tofacitinib initiators at 6 months stratified by monotherapy and combination therapy of PsA

Interventions

None listed

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* PsA patients in CorEvitas initiating tofacitinib monotherapy or in combination with oral small molecules (eg methotrexate, leflunomide, sulfasalazine, apremilast) after 14 December 2017 (market approval of tofacitinib in the US) with no prior use of tofacitinib. Only the patient's first initiation after December 14, 2017 will be included in the analysis * Have a 6 month follow-up visit (with ±3 month window)

Exclusion criteria

* Patients taking tofacitinib in combination with any other bDMARD

Design outcomes

Primary

MeasureTime frameDescription
Change From Baseline to 6 Months in Tender Joint Count (68)Baseline, 6 months after tofacitinib initiation (anytime in between 3 to 9 months); data collected and evaluated for over 23.5 months in this retrospective observational studyTender joint count (TJC) 68 is a method of assessing joint inflammation. Number of tender joints was determined by examining 68 joints and identifying the joints that were painful under pressure or to passive motion. The joints examined included the temporomandibular (n = 2), sternoclavicular (n = 2), acromioclavicular (n = 2), shoulder (n = 2), elbow (n = 2), wrist (n = 2), metacarpophalageal (n = 10), interphalangeal of thumb (n = 2), distal interphalangeal (n = 8), proximal interphalangeal (n =8), hip (n = 2), knee (n = 2), ankle mortise (n = 2), ankle tarsus (n = 2), metatarsophalangeal (n = 10), interphalangeal of great toe (n = 2), and proximal/distal interphalangeal of the toes (n = 8). Change from baseline in TJC at 6 months after tofacitinib treatment initiation was reported in this outcome measure. Baseline was defined as the date of tofacitinib treatment initiation anytime in between 14 December 2017 to 31 August 2023.
Change From Baseline to 6 Months in Swollen Joint Count (66)Baseline, 6 months after tofacitinib initiation (anytime in between 3 to 9 months); data collected and evaluated for over 23.5 months in this retrospective observational studyJoint swelling was defined as soft tissue swelling that was detectable along the joint margins. Swollen Joint Count (SJC) was determined by examination of 66 joints and identifying when swelling was present. The joints examined included the temporomandibular (n = 2), sternoclavicular (n = 2), acromioclavicular (n = 2), shoulder (n = 2), elbow (n = 2), wrist (n = 2), metacarpophalangeal (n = 10), interphalangeal of thumb (n = 2), distal interphalangeal (n = 8), proximal interphalangeal (n = 8), knee (n = 2), ankle mortise (n = 2), ankle tarsus (n = 2), metatarsophalangeal (n = 10), interphalangeal of great toe (n = 2), and proximal/distal interphalangeal of the toes (n = 8). Change from baseline in SJC at 6 months after tofacitinib treatment initiation was reported in this outcome measure. Baseline was defined as the date of tofacitinib treatment initiation anytime in between 14 December 2017 to 31 August 2023.
Percentage of Participants Achieving Minimal Disease Activity at 6 Month Follow-up Visit6 month follow-up visit (anytime in between 3 to 9 months after tofacitinib initiation); data collected and evaluated over 23.5 months in this retrospective observational studyPsoriatic arthritis participant was defined as having minimal disease activity (MDA) when participant met at least 5 of following criteria: 1) tender joint count less than or equal to (\<=) 1; 2) swollen joint count \<= 1; 3) body surface area (BSA) \<=3%; 4) patient pain VAS on 100 mm scale \<= 15; where 0= 'no pain' and 100= 'pain as severe as can be imagined', higher scores indicated greater severity; 5) patient's global activity VAS on a 100 mm scale \<= 20, where 0= 'lowest level of disease activity' and 100= 'highest level of disease activity', higher scores indicated greater level of disease activity; Health Assessment Questionnaire-Disability Index (HAQ-DI) score \<=0.5, scale ranged from 0-3, where 0= 'normal or no difficulty' and 3= 'inability to perform', higher scores indicated more difficulty to perform; 6) tender entheseal point \<= 1 using Leed's index ranged from 0-6; where 0= 'non tender' and 6= '6 tender tendon insertions', higher scores indicated more tendon insertions.
Percentage of Participants With Percent Body Surface Area Score of 0% at 6 Month Follow-up Visit6 month follow-up visit (anytime in between 3 to 9 months after tofacitinib initiation); data collected and evaluated over 23.5 months in this retrospective observational studyFour body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint = 10 percent (%) for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region \* % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis. Percentage of participants with % BSA score of 0% at 6-month follow-up visit were reported in this outcome measure.
Percentage of Participants With Psoriatic Arthritis Disease Activity Score (PASDAS) Less Than (<) 3.2 at 6 Month Follow-up Visit6 month follow-up visit (anytime in between 3 to 9 months after tofacitinib initiation); data collected and evaluated over 23.5 months in this retrospective observational studyPASDAS: patient global psoriatic arthritis assessment (PAA),physician global PAA, each scored on 100mm VAS,0=no disease activity(DA), 100=maximum DA, higher scores=greater DA;TJC(0-68);SJC(0-66);Leed's Enthesitis Index score ranging from 0-6;where 0=non tender,6=6 tender tendon insertions,higher scores=more tender insertions; tender dactylitic digit score ranging from 0-3 where 0=no tenderness,3=participant withdrew digit, higher scores=more tenderness; physical component summary(PCS) of short form 12(SF-12) score ranging from 0-100;where 0-20=severe physical health(PH)limitations,21-40=significant PH issues,41-60=moderate physical health,61-80=good PH,81-100=excellent PH. PASDAS total score were transformed & ranged from 0-10 where score 1.9 or less=remission,1.9-3.2=low disease activity(LDA),3.2-5.4=moderate DA,5.4 and higher=high DA, with higher scores indicating more severe disease. Percentage of participants with PASDAS score \<3.2 (LDA) at 6-month follow-up visit were reported.
Percentage of Participants With Resolution of Enthesitis6 month follow-up visit (anytime in between 3 to 9 months after tofacitinib initiation); data collected and evaluated over 23.5 months in this retrospective observational studyEnthesis:site where joint capsules,ligaments,tendons attach to bone.Enthesitis is inflammation of entheses.This inflammation lead to severe pain,discomfort.Resolution of enthesitis determined by Spondyloarthritis Research Consortium of Canada(SPARCC)Enthesitis Index evaluates presence,severity of enthesitis at specific sites on body & includes:medial epicondyle,lateral epicondyle,supraspinatus insertion into greater tuberosity of humerus,greater trochanter,quadriceps insertion into superior border of patella,patellar ligament insertion into interior pole of patella/tibial tubercle,achilles tendon insertion into calcaneum,plantar fascia insertion into calcaneum.Each site is scored based on tenderness,ranged from 0-16.Higher scores=more severe enthesitis.Enthesitis was considered as resolved in those participants who had SPARCC \>0 at 6 month follow-up visit(anytime in between 3-9 months after tofacitinib initiation).Percentage of participants with resolution of enthesitis were reported.
Percentage of Participants With Resolution of Dactylitis6 month follow-up visit (anytime in between 3 to 9 months after tofacitinib initiation); data collected and evaluated over 23.5 months in this retrospective observational studyDactylitis is severe inflammation of the finger or toe tendons and joints, making them look like sausages. Resolution of dactylitis can be achieved by usage of NSAIDs, local steroid injections, biologic drugs and DMARDs. Resolution in dactylitis was considered when the following criteria were met: reduction in swelling: the affected digits showed a significant decrease in swelling; pain relief: there was a notable reduction or complete absence of pain in the affected area; improved functionality: the digits regained normal function and movement; absence of tenderness: the affected area no longer exhibited tenderness upon examination. Percentage of participants with resolution of dactylitis were reported in this outcome measure.
Percentage of Participants Achieving Score of Clear or Almost Clear According to Investigator Global Assessment (IGA) of Psoriasis (PsO)6 month follow-up visit (anytime in between 3 to 9 months after tofacitinib initiation); data collected and evaluated over 23.5 months in this retrospective observational studyThe Investigator's Global Assessment (IGA) is a tool used to assess the severity of psoriasis. It is a scale that typically ranges from 0 to 4, where 0 indicates clear skin (no signs of psoriasis), 1 indicates almost clear (minimal signs of psoriasis), 2 indicates mild psoriasis, 3 indicates moderate psoriasis and 4 indicates severe psoriasis, higher scores indicated greater severity of psoriasis and provides a subjective evaluation of the overall severity of psoriasis based on clinical signs such as erythema, induration, and scaling. Percentage of participants with score of Clear (score 0) or Almost Clear (score 1) according to IGA of PsO were reported in this outcome measure.
Change From Baseline at 6 Months Follow-up Visit in Disease Activity in Psoriatic Arthritis (DAPSA)Baseline, 6 months follow-up visit after tofacitinib initiation (anytime in between 3 to 9 months); data collected and evaluated for over 23.5 months in this retrospective observational studyDAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), CRP level (milligram per deciliter \[mg/dL\]), participant assessment of pain (0 to 10 cm VAS, 0= no pain, 10= worst possible pain, higher scores indicated more pain), and participant's global assessment of disease activity on arthritis (0 to 10 cm VAS, 0= excellent and 10= poor, higher scores indicated more disease activity). DAPSA score ranges from 0 to more than (\>) 28. Where 0-4 indicates remission, 5-14 indicates low disease activity, 15-28 indicates moderate disease activity and \>28 indicates high disease activity. A higher DAPSA score indicated more active disease activity.
Change From Baseline at 6 Months Follow-up Visit in Psoriatic Arthritis Disease Activity (PASDAS) ScoreBaseline, 6 months follow-up visit after tofacitinib initiation (anytime in between 3 to 9 months); data collected and evaluated for over 23.5 months in this retrospective observational studyPASDAS is composite PsA disease activity score that included: patient global psoriatic arthritis assessment, physician global psoriatic arthritis assessment, each scored on 100 mm VAS scale where 0= no disease activity, 100= maximum disease activity, higher scores indicated greater disease activity; TJC (0-68); SJC (0-66); Leed's Enthesitis Index score ranging from 0-6; where 0=non tender, 6=6 tender tendon insertions, higher scores indicated more tender insertions; tender dactylitic digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit, higher scores indicated more tenderness; PCS of SF-12 score ranging from 0-100; where 0-20=severe physical health limitations, 21-40=significant physical health issues, 41-60=moderate physical health, 61-80=good physical health and 81-100=excellent physical health. PASDAS total score were transformed and ranged from 0 to 10, with higher scores indicating more severe disease.
Change From Baseline at 6 Month Follow-up Visit in Patient's Global Assessment of Pain Score (VAS)Baseline, 6 months follow-up visit after tofacitinib initiation (anytime in between 3 to 9 months); data collected and evaluated for over 23.5 months in this retrospective observational studyParticipants self-reported assessment of the severity of their arthritis pain using a 100 mm VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain, where higher scores indicated greater severity of pain.
Change From Baseline at 6 Month Follow-up Visit in Patient's Global Assessment of Fatigue Score (VAS)Baseline, 6 months follow-up visit after tofacitinib initiation (anytime in between 3 to 9 months); data collected and evaluated for over 23.5 months in this retrospective observational studyParticipants self-reported assessment of the severity of their arthritis fatigue using a 100 mm VAS by placing a mark on the scale between 0 (no fatigue) and 100 (most severe fatigue), which corresponded to the magnitude of their fatigue, where higher scores indicated greater severity of fatigue.
Change From Baseline at 6 Month Follow-up Visit in Investigator Global Assessment (IGA) of PsOBaseline, 6 months follow-up visit after tofacitinib initiation (anytime in between 3 to 9 months); data collected and evaluated for over 23.5 months in this retrospective observational studyThe IGA is a tool used to assess the severity of psoriasis. It is a scale that typically ranges from 0 (clear) to 4 (severe) higher scores indicated greater severity of psoriasis and provides a subjective evaluation of the overall severity of psoriasis based on clinical signs such as erythema, induration, and scaling.
Change From Baseline at 6 Month Follow-up Visit in Percentage Body Surface Area (BSA)Baseline, 6 months follow-up visit after tofacitinib initiation (anytime in between 3 to 9 months); data collected and evaluated for over 23.5 months in this retrospective observational studyFour body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of a body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint = 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region \* % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis.
Change From Baseline at 6 Month Follow-up Visit in Health Assessment Questionnaire-Disability Index (HAQ-DI) ScoreBaseline, 6 months follow-up visit after tofacitinib initiation (anytime in between 3 to 9 months); data collected and evaluated for over 23.5 months in this retrospective observational studyHAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing or grooming; arising; eating; walking; reach; grip; hygiene; and other activities. There were total of 30 items distributed in these 8 domains. Each item was scored on a 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. 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.
Change From Baseline at 6 Month Follow-up Visit in Percentage Work Time MissedBaseline, 6 months follow-up visit after tofacitinib initiation (anytime in between 3 to 9 months); data collected and evaluated for over 23.5 months in this retrospective observational studyThe Work Productivity and Activity Impairment (WPAI) assessed work productivity and impairment. It is a 6-item questionnaire used to assess degree to which psoriasis affected work productivity and regular activities over the past 7 days. Questions were as follows: question 1=currently employed; question 2=hours missed due to health problems; question 3=hours missed due to other reasons; question 4=hours actually worked; question 5=degree problem affected productivity while working (VAS 0-100 scale, with higher numbers indicating less productivity); question 6=degree problem affected regular activities (VAS 0-100 scale, with higher numbers indicating greater impairment of regular activities). Percent work time missed due to health problem was calculated as: question 2/ (question 2+question 4) and score ranged from 0-100% where higher numbers indicate greater impairment and less productivity. Change from baseline in percentage work time missed at 6 month follow-up visit was reported.
Change From Baseline at 6 Month Follow-up Visit in Percentage Impairment While WorkingBaseline, 6 months follow-up visit after tofacitinib initiation (anytime in between 3 to 9 months); data collected and evaluated for over 23.5 months in this retrospective observational studyThe WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which psoriasis affected work productivity and regular activities over the past 7 days. The questions are as follows: question 1 = currently employed; question 2 = hours missed due to health problems; question 3 = hours missed due to other reasons; question 4 = hours actually worked; question 5 = degree health affected productivity while working (0-10 scale, with higher numbers indicating less productivity); question 6 = degree health affected regular activities (0-10 scale, with higher numbers indicating greater impairment of regular activities). Percent impairment while working due to problem was calculated as: question 5/10 and score ranged from 0-100% where higher numbers indicate greater impairment and less productivity. Change from baseline in percentage impairment while working at 6 month follow-up visit was reported.
Change From Baseline at 6 Month Follow-up Visit in Percentage Overall Work ImpairmentBaseline, 6 months follow-up visit after tofacitinib initiation (anytime in between 3 to 9 months); data collected and evaluated for over 23.5 months in this retrospective observational studyThe WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which psoriasis affected work productivity and regular activities over the past 7 days. The questions are as follows: question 1 = currently employed; question 2 = hours missed due to health problems; question 3 = hours missed due to other reasons; question 4 = hours actually worked; question 5 = degree health affected productivity while working (0-10 scale, with higher numbers indicating less productivity); question 6 = degree health affected regular activities (0-10 scale, with higher numbers indicating greater impairment of regular activities). Percent overall work impairment due to problem was calculated as: question 2/ (question 2+question 4) + \[(1- question 2/ (question 2+question 4) \* (Q5/10)\] and score ranged from 0-100% where higher numbers indicate greater impairment. Change from baseline in percentage overall work impairment at 6 month follow-up visit was reported.
Change From Baseline at 6 Month Follow-up Visit in Percentage Activity ImpairmentBaseline, 6 months follow-up visit after tofacitinib initiation (anytime in between 3 to 9 months); data collected and evaluated for over 23.5 months in this retrospective observational studyThe WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which psoriasis affected work productivity and regular activities over the past 7 days. The questions are as follows: question 1 = currently employed; question 2 = hours missed due to health problems; question 3 = hours missed due to other reasons; question 4 = hours actually worked; question 5 = degree health affected productivity while working (0-10 scale, with higher numbers indicating less productivity); question 6 = degree health affected regular activities (0-10 scale, with higher numbers indicating greater impairment of regular activities). Percent activity impairment due to problem was calculated as: question 6/10 and score ranged from 0-100% where higher numbers indicate greater impairment. Change from baseline in percentage activity impairment at 6 month follow-up visit was reported.

Countries

United States

Participant flow

Recruitment details

This study included data from CorEvitas Psoriatic Arthritis/ Spondyloarthritis (PsA/SpA) registry.

Pre-assignment details

A total of 141 PsA participants who initiated tofacitinib monotherapy or in combination with oral small molecules (OSM) (example: methotrexate, leflunomide, sulfasalazine, apremilast) on or after 14-Dec-2017 to 31-August-2023, with no prior use of tofacitinib were included in this study. Data was evaluated over 23.5 months in this retrospective observational study.

Participants by arm

ArmCount
Tofacitinib Monotherapy
All participants with a diagnosis of PsA/SpA who received tofacitinib monotherapy with no other (pre-existing or new) disease modifying antirheumatic drug (DMARD) prescriptions on or after 14 December 2017 and had a 6-month follow-up visit were included in this retrospective observational study.
66
Tofacitinib + OSM Combination Therapy
All participants with a diagnosis of PsA/SpA who received tofacitinib with a concomitant (pre-existing or new) prescription of at least one OSM (methotrexate, leflunomide, sulfasalazine, apremilast) on or after 14 December 2017 and had a 6-month follow-up visit were included in this retrospective observational study.
75
Total141

Baseline characteristics

CharacteristicTotalTofacitinib + OSM Combination TherapyTofacitinib Monotherapy
Age at onset of psoriatic arthritis (PsA)43.3 Years
STANDARD_DEVIATION 13.3
44.2 Years
STANDARD_DEVIATION 14.2
42.1 Years
STANDARD_DEVIATION 12.3
Age, Continuous56.7 Years
STANDARD_DEVIATION 11.3
57.5 Years
STANDARD_DEVIATION 10.7
55.9 Years
STANDARD_DEVIATION 11.8
Body mass index32.6 kilogram/ metered square (^2)
STANDARD_DEVIATION 8.8
33.9 kilogram/ metered square (^2)
STANDARD_DEVIATION 10.3
31.2 kilogram/ metered square (^2)
STANDARD_DEVIATION 6.6
Comorbidity history
Anxiety
12 Participants5 Participants7 Participants
Comorbidity history
Cardiovascular disease
17 Participants6 Participants11 Participants
Comorbidity history
Depression
29 Participants12 Participants17 Participants
Comorbidity history
Diabetes
23 Participants12 Participants11 Participants
Comorbidity history
Fibromyalgia
24 Participants12 Participants12 Participants
Comorbidity history
Hypertension
50 Participants31 Participants19 Participants
Comorbidity history
Inflammatory bowel disease
4 Participants3 Participants1 Participants
Comorbidity history
Malignancy
11 Participants6 Participants5 Participants
Comorbidity history
Metabolic syndrome
75 Participants40 Participants35 Participants
Comorbidity history
Non-Melanoma Skin Cancer
5 Participants1 Participants4 Participants
Comorbidity history
Osteoporosis
3 Participants1 Participants2 Participants
Comorbidity history
Psoriatic nail dystrophy
12 Participants6 Participants6 Participants
Comorbidity history
Uveitis
2 Participants1 Participants1 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
7 Participants3 Participants4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
134 Participants72 Participants62 Participants
Insurance type
Medicare, Medicaid, or having no insurance
38 Participants19 Participants19 Participants
Insurance type
Private/commercial insurance
103 Participants56 Participants47 Participants
Prednisone use
Dose greater than (>) 10 mg
1 Participants1 Participants0 Participants
Prednisone use
Dose less than or equal to (<=) 10 milligrams (mg)
6 Participants5 Participants1 Participants
Prednisone use
No use
134 Participants69 Participants65 Participants
Prior biologic use
Prior non-TNF use
0
78 Participants44 Participants34 Participants
Prior biologic use
Prior non-TNF use
1
40 Participants24 Participants16 Participants
Prior biologic use
Prior non-TNF use
2 or more
23 Participants7 Participants16 Participants
Prior biologic use
Prior Tumor necrosis factor (TNF) use
0
44 Participants27 Participants17 Participants
Prior biologic use
Prior Tumor necrosis factor (TNF) use
1
45 Participants24 Participants21 Participants
Prior biologic use
Prior Tumor necrosis factor (TNF) use
2 or more
52 Participants24 Participants28 Participants
Prior small molecule use
0
25 Participants6 Participants19 Participants
Prior small molecule use
1
64 Participants39 Participants25 Participants
Prior small molecule use
2 or more
52 Participants30 Participants22 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
8 Participants6 Participants2 Participants
Race (NIH/OMB)
White
133 Participants69 Participants64 Participants
Sex: Female, Male
Female
86 Participants45 Participants41 Participants
Sex: Female, Male
Male
55 Participants30 Participants25 Participants
Smoking status
Current smoker
18 Participants12 Participants6 Participants
Smoking status
Former smoker
37 Participants16 Participants21 Participants
Smoking status
Never smoked
86 Participants47 Participants39 Participants
Time since onset of psoriasis (PsO)18.2 Years
STANDARD_DEVIATION 16
19.5 Years
STANDARD_DEVIATION 16.6
16.7 Years
STANDARD_DEVIATION 15.6
Time since PsA diagnosis8.7 Years
STANDARD_DEVIATION 8.9
8.4 Years
STANDARD_DEVIATION 8.9
9.1 Years
STANDARD_DEVIATION 8.9
Work status
Work full time
68 Participants36 Participants32 Participants
Work status
Working part-time or not working
73 Participants39 Participants34 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 0
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

Primary

Change From Baseline at 6 Month Follow-up Visit in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score

HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing or grooming; arising; eating; walking; reach; grip; hygiene; and other activities. There were total of 30 items distributed in these 8 domains. Each item was scored on a 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities.

Time frame: Baseline, 6 months follow-up visit after tofacitinib initiation (anytime in between 3 to 9 months); data collected and evaluated for over 23.5 months in this retrospective observational study

Population: Analysis population included all eligible participants whose data were included and observed in this study. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
All ParticipantsChange From Baseline at 6 Month Follow-up Visit in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score-0.1 Units on a scaleStandard Deviation 0.5
Tofacitinib MonotherapyChange From Baseline at 6 Month Follow-up Visit in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score-0.1 Units on a scaleStandard Deviation 0.4
Tofacitinib + OSM Combination TherapyChange From Baseline at 6 Month Follow-up Visit in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score0.0 Units on a scaleStandard Deviation 0.5
Primary

Change From Baseline at 6 Month Follow-up Visit in Investigator Global Assessment (IGA) of PsO

The IGA is a tool used to assess the severity of psoriasis. It is a scale that typically ranges from 0 (clear) to 4 (severe) higher scores indicated greater severity of psoriasis and provides a subjective evaluation of the overall severity of psoriasis based on clinical signs such as erythema, induration, and scaling.

Time frame: Baseline, 6 months follow-up visit after tofacitinib initiation (anytime in between 3 to 9 months); data collected and evaluated for over 23.5 months in this retrospective observational study

Population: Analysis population included all eligible participants whose data were included and observed in this study. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
All ParticipantsChange From Baseline at 6 Month Follow-up Visit in Investigator Global Assessment (IGA) of PsO-0.3 Units on a scaleStandard Deviation 1.1
Tofacitinib MonotherapyChange From Baseline at 6 Month Follow-up Visit in Investigator Global Assessment (IGA) of PsO-0.3 Units on a scaleStandard Deviation 1.1
Tofacitinib + OSM Combination TherapyChange From Baseline at 6 Month Follow-up Visit in Investigator Global Assessment (IGA) of PsO-0.2 Units on a scaleStandard Deviation 1.1
Primary

Change From Baseline at 6 Month Follow-up Visit in Patient's Global Assessment of Fatigue Score (VAS)

Participants self-reported assessment of the severity of their arthritis fatigue using a 100 mm VAS by placing a mark on the scale between 0 (no fatigue) and 100 (most severe fatigue), which corresponded to the magnitude of their fatigue, where higher scores indicated greater severity of fatigue.

Time frame: Baseline, 6 months follow-up visit after tofacitinib initiation (anytime in between 3 to 9 months); data collected and evaluated for over 23.5 months in this retrospective observational study

Population: Analysis population included all eligible participants whose data were included and observed in this study.

ArmMeasureValue (MEAN)Dispersion
All ParticipantsChange From Baseline at 6 Month Follow-up Visit in Patient's Global Assessment of Fatigue Score (VAS)-5.9 Units on a scaleStandard Deviation 24.8
Tofacitinib MonotherapyChange From Baseline at 6 Month Follow-up Visit in Patient's Global Assessment of Fatigue Score (VAS)-10.8 Units on a scaleStandard Deviation 25.6
Tofacitinib + OSM Combination TherapyChange From Baseline at 6 Month Follow-up Visit in Patient's Global Assessment of Fatigue Score (VAS)-1.6 Units on a scaleStandard Deviation 23.5
Primary

Change From Baseline at 6 Month Follow-up Visit in Patient's Global Assessment of Pain Score (VAS)

Participants self-reported assessment of the severity of their arthritis pain using a 100 mm VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain, where higher scores indicated greater severity of pain.

Time frame: Baseline, 6 months follow-up visit after tofacitinib initiation (anytime in between 3 to 9 months); data collected and evaluated for over 23.5 months in this retrospective observational study

Population: Analysis population included all eligible participants whose data were included and observed in this study.

ArmMeasureValue (MEAN)Dispersion
All ParticipantsChange From Baseline at 6 Month Follow-up Visit in Patient's Global Assessment of Pain Score (VAS)-8.9 Units on a scaleStandard Deviation 27.2
Tofacitinib MonotherapyChange From Baseline at 6 Month Follow-up Visit in Patient's Global Assessment of Pain Score (VAS)-13.7 Units on a scaleStandard Deviation 30
Tofacitinib + OSM Combination TherapyChange From Baseline at 6 Month Follow-up Visit in Patient's Global Assessment of Pain Score (VAS)-4.7 Units on a scaleStandard Deviation 23.8
Primary

Change From Baseline at 6 Month Follow-up Visit in Percentage Activity Impairment

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which psoriasis affected work productivity and regular activities over the past 7 days. The questions are as follows: question 1 = currently employed; question 2 = hours missed due to health problems; question 3 = hours missed due to other reasons; question 4 = hours actually worked; question 5 = degree health affected productivity while working (0-10 scale, with higher numbers indicating less productivity); question 6 = degree health affected regular activities (0-10 scale, with higher numbers indicating greater impairment of regular activities). Percent activity impairment due to problem was calculated as: question 6/10 and score ranged from 0-100% where higher numbers indicate greater impairment. Change from baseline in percentage activity impairment at 6 month follow-up visit was reported.

Time frame: Baseline, 6 months follow-up visit after tofacitinib initiation (anytime in between 3 to 9 months); data collected and evaluated for over 23.5 months in this retrospective observational study

Population: Analysis population included all eligible participants whose data were included and observed in this study. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
All ParticipantsChange From Baseline at 6 Month Follow-up Visit in Percentage Activity Impairment-12.1 Percentage activity impairmentStandard Deviation 25.8
Tofacitinib MonotherapyChange From Baseline at 6 Month Follow-up Visit in Percentage Activity Impairment-21.8 Percentage activity impairmentStandard Deviation 28.9
Tofacitinib + OSM Combination TherapyChange From Baseline at 6 Month Follow-up Visit in Percentage Activity Impairment-2.9 Percentage activity impairmentStandard Deviation 18.7
Primary

Change From Baseline at 6 Month Follow-up Visit in Percentage Body Surface Area (BSA)

Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of a body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint = 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region \* % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis.

Time frame: Baseline, 6 months follow-up visit after tofacitinib initiation (anytime in between 3 to 9 months); data collected and evaluated for over 23.5 months in this retrospective observational study

Population: Analysis population included all eligible participants whose data were included and observed in this study. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
All ParticipantsChange From Baseline at 6 Month Follow-up Visit in Percentage Body Surface Area (BSA)-0.7 Percentage BSAStandard Deviation 8.6
Tofacitinib MonotherapyChange From Baseline at 6 Month Follow-up Visit in Percentage Body Surface Area (BSA)-1.7 Percentage BSAStandard Deviation 8.7
Tofacitinib + OSM Combination TherapyChange From Baseline at 6 Month Follow-up Visit in Percentage Body Surface Area (BSA)0.2 Percentage BSAStandard Deviation 8.6
Primary

Change From Baseline at 6 Month Follow-up Visit in Percentage Impairment While Working

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which psoriasis affected work productivity and regular activities over the past 7 days. The questions are as follows: question 1 = currently employed; question 2 = hours missed due to health problems; question 3 = hours missed due to other reasons; question 4 = hours actually worked; question 5 = degree health affected productivity while working (0-10 scale, with higher numbers indicating less productivity); question 6 = degree health affected regular activities (0-10 scale, with higher numbers indicating greater impairment of regular activities). Percent impairment while working due to problem was calculated as: question 5/10 and score ranged from 0-100% where higher numbers indicate greater impairment and less productivity. Change from baseline in percentage impairment while working at 6 month follow-up visit was reported.

Time frame: Baseline, 6 months follow-up visit after tofacitinib initiation (anytime in between 3 to 9 months); data collected and evaluated for over 23.5 months in this retrospective observational study

Population: Analysis population included all eligible participants whose data were included and observed in this study. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
All ParticipantsChange From Baseline at 6 Month Follow-up Visit in Percentage Impairment While Working-6.3 Percentage impairmentStandard Deviation 21.7
Tofacitinib MonotherapyChange From Baseline at 6 Month Follow-up Visit in Percentage Impairment While Working-12.7 Percentage impairmentStandard Deviation 23.3
Tofacitinib + OSM Combination TherapyChange From Baseline at 6 Month Follow-up Visit in Percentage Impairment While Working0.1 Percentage impairmentStandard Deviation 18.3
Primary

Change From Baseline at 6 Month Follow-up Visit in Percentage Overall Work Impairment

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which psoriasis affected work productivity and regular activities over the past 7 days. The questions are as follows: question 1 = currently employed; question 2 = hours missed due to health problems; question 3 = hours missed due to other reasons; question 4 = hours actually worked; question 5 = degree health affected productivity while working (0-10 scale, with higher numbers indicating less productivity); question 6 = degree health affected regular activities (0-10 scale, with higher numbers indicating greater impairment of regular activities). Percent overall work impairment due to problem was calculated as: question 2/ (question 2+question 4) + \[(1- question 2/ (question 2+question 4) \* (Q5/10)\] and score ranged from 0-100% where higher numbers indicate greater impairment. Change from baseline in percentage overall work impairment at 6 month follow-up visit was reported.

Time frame: Baseline, 6 months follow-up visit after tofacitinib initiation (anytime in between 3 to 9 months); data collected and evaluated for over 23.5 months in this retrospective observational study

Population: Analysis population included all eligible participants whose data were included and observed in this study. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
All ParticipantsChange From Baseline at 6 Month Follow-up Visit in Percentage Overall Work Impairment-6.0 Percentage work impairmentStandard Deviation 22.9
Tofacitinib MonotherapyChange From Baseline at 6 Month Follow-up Visit in Percentage Overall Work Impairment-13.0 Percentage work impairmentStandard Deviation 20.7
Tofacitinib + OSM Combination TherapyChange From Baseline at 6 Month Follow-up Visit in Percentage Overall Work Impairment1.4 Percentage work impairmentStandard Deviation 23.1
Primary

Change From Baseline at 6 Month Follow-up Visit in Percentage Work Time Missed

The Work Productivity and Activity Impairment (WPAI) assessed work productivity and impairment. It is a 6-item questionnaire used to assess degree to which psoriasis affected work productivity and regular activities over the past 7 days. Questions were as follows: question 1=currently employed; question 2=hours missed due to health problems; question 3=hours missed due to other reasons; question 4=hours actually worked; question 5=degree problem affected productivity while working (VAS 0-100 scale, with higher numbers indicating less productivity); question 6=degree problem affected regular activities (VAS 0-100 scale, with higher numbers indicating greater impairment of regular activities). Percent work time missed due to health problem was calculated as: question 2/ (question 2+question 4) and score ranged from 0-100% where higher numbers indicate greater impairment and less productivity. Change from baseline in percentage work time missed at 6 month follow-up visit was reported.

Time frame: Baseline, 6 months follow-up visit after tofacitinib initiation (anytime in between 3 to 9 months); data collected and evaluated for over 23.5 months in this retrospective observational study

Population: Analysis population included all eligible participants whose data were included and observed in this study. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
All ParticipantsChange From Baseline at 6 Month Follow-up Visit in Percentage Work Time Missed-1.9 Percentage work time missedStandard Deviation 15.9
Tofacitinib MonotherapyChange From Baseline at 6 Month Follow-up Visit in Percentage Work Time Missed-6.1 Percentage work time missedStandard Deviation 17.3
Tofacitinib + OSM Combination TherapyChange From Baseline at 6 Month Follow-up Visit in Percentage Work Time Missed2.5 Percentage work time missedStandard Deviation 13.1
Primary

Change From Baseline at 6 Months Follow-up Visit in Disease Activity in Psoriatic Arthritis (DAPSA)

DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), CRP level (milligram per deciliter \[mg/dL\]), participant assessment of pain (0 to 10 cm VAS, 0= no pain, 10= worst possible pain, higher scores indicated more pain), and participant's global assessment of disease activity on arthritis (0 to 10 cm VAS, 0= excellent and 10= poor, higher scores indicated more disease activity). DAPSA score ranges from 0 to more than (\>) 28. Where 0-4 indicates remission, 5-14 indicates low disease activity, 15-28 indicates moderate disease activity and \>28 indicates high disease activity. A higher DAPSA score indicated more active disease activity.

Time frame: Baseline, 6 months follow-up visit after tofacitinib initiation (anytime in between 3 to 9 months); data collected and evaluated for over 23.5 months in this retrospective observational study

Population: Analysis population included all eligible participants whose data were included and observed in this study. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
All ParticipantsChange From Baseline at 6 Months Follow-up Visit in Disease Activity in Psoriatic Arthritis (DAPSA)-7.2 Units on a scaleStandard Deviation 15.6
Tofacitinib MonotherapyChange From Baseline at 6 Months Follow-up Visit in Disease Activity in Psoriatic Arthritis (DAPSA)-10.7 Units on a scaleStandard Deviation 19.3
Tofacitinib + OSM Combination TherapyChange From Baseline at 6 Months Follow-up Visit in Disease Activity in Psoriatic Arthritis (DAPSA)-4.9 Units on a scaleStandard Deviation 12.4
Primary

Change From Baseline at 6 Months Follow-up Visit in Psoriatic Arthritis Disease Activity (PASDAS) Score

PASDAS is composite PsA disease activity score that included: patient global psoriatic arthritis assessment, physician global psoriatic arthritis assessment, each scored on 100 mm VAS scale where 0= no disease activity, 100= maximum disease activity, higher scores indicated greater disease activity; TJC (0-68); SJC (0-66); Leed's Enthesitis Index score ranging from 0-6; where 0=non tender, 6=6 tender tendon insertions, higher scores indicated more tender insertions; tender dactylitic digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit, higher scores indicated more tenderness; PCS of SF-12 score ranging from 0-100; where 0-20=severe physical health limitations, 21-40=significant physical health issues, 41-60=moderate physical health, 61-80=good physical health and 81-100=excellent physical health. PASDAS total score were transformed and ranged from 0 to 10, with higher scores indicating more severe disease.

Time frame: Baseline, 6 months follow-up visit after tofacitinib initiation (anytime in between 3 to 9 months); data collected and evaluated for over 23.5 months in this retrospective observational study

Population: Analysis population included all eligible participants whose data were included and observed in this study. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
All ParticipantsChange From Baseline at 6 Months Follow-up Visit in Psoriatic Arthritis Disease Activity (PASDAS) Score-1.1 Units on a scaleStandard Deviation 1.5
Tofacitinib MonotherapyChange From Baseline at 6 Months Follow-up Visit in Psoriatic Arthritis Disease Activity (PASDAS) Score-1.3 Units on a scaleStandard Deviation 1.5
Tofacitinib + OSM Combination TherapyChange From Baseline at 6 Months Follow-up Visit in Psoriatic Arthritis Disease Activity (PASDAS) Score-1.0 Units on a scaleStandard Deviation 1.6
Primary

Change From Baseline to 6 Months in Swollen Joint Count (66)

Joint swelling was defined as soft tissue swelling that was detectable along the joint margins. Swollen Joint Count (SJC) was determined by examination of 66 joints and identifying when swelling was present. The joints examined included the temporomandibular (n = 2), sternoclavicular (n = 2), acromioclavicular (n = 2), shoulder (n = 2), elbow (n = 2), wrist (n = 2), metacarpophalangeal (n = 10), interphalangeal of thumb (n = 2), distal interphalangeal (n = 8), proximal interphalangeal (n = 8), knee (n = 2), ankle mortise (n = 2), ankle tarsus (n = 2), metatarsophalangeal (n = 10), interphalangeal of great toe (n = 2), and proximal/distal interphalangeal of the toes (n = 8). Change from baseline in SJC at 6 months after tofacitinib treatment initiation was reported in this outcome measure. Baseline was defined as the date of tofacitinib treatment initiation anytime in between 14 December 2017 to 31 August 2023.

Time frame: Baseline, 6 months after tofacitinib initiation (anytime in between 3 to 9 months); data collected and evaluated for over 23.5 months in this retrospective observational study

Population: Analysis population included all eligible participants whose data were included and observed in this study. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
All ParticipantsChange From Baseline to 6 Months in Swollen Joint Count (66)-1.6 Swollen jointsStandard Deviation 4.7
Tofacitinib MonotherapyChange From Baseline to 6 Months in Swollen Joint Count (66)-2.2 Swollen jointsStandard Deviation 5.4
Tofacitinib + OSM Combination TherapyChange From Baseline to 6 Months in Swollen Joint Count (66)-1.1 Swollen jointsStandard Deviation 4
Primary

Change From Baseline to 6 Months in Tender Joint Count (68)

Tender joint count (TJC) 68 is a method of assessing joint inflammation. Number of tender joints was determined by examining 68 joints and identifying the joints that were painful under pressure or to passive motion. The joints examined included the temporomandibular (n = 2), sternoclavicular (n = 2), acromioclavicular (n = 2), shoulder (n = 2), elbow (n = 2), wrist (n = 2), metacarpophalageal (n = 10), interphalangeal of thumb (n = 2), distal interphalangeal (n = 8), proximal interphalangeal (n =8), hip (n = 2), knee (n = 2), ankle mortise (n = 2), ankle tarsus (n = 2), metatarsophalangeal (n = 10), interphalangeal of great toe (n = 2), and proximal/distal interphalangeal of the toes (n = 8). Change from baseline in TJC at 6 months after tofacitinib treatment initiation was reported in this outcome measure. Baseline was defined as the date of tofacitinib treatment initiation anytime in between 14 December 2017 to 31 August 2023.

Time frame: Baseline, 6 months after tofacitinib initiation (anytime in between 3 to 9 months); data collected and evaluated for over 23.5 months in this retrospective observational study

Population: Analysis population included all eligible participants whose data were included and observed in this study. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
All ParticipantsChange From Baseline to 6 Months in Tender Joint Count (68)-2.5 Tender jointsStandard Deviation 9.6
Tofacitinib MonotherapyChange From Baseline to 6 Months in Tender Joint Count (68)-3.2 Tender jointsStandard Deviation 10.6
Tofacitinib + OSM Combination TherapyChange From Baseline to 6 Months in Tender Joint Count (68)-2.0 Tender jointsStandard Deviation 8.8
Primary

Percentage of Participants Achieving Minimal Disease Activity at 6 Month Follow-up Visit

Psoriatic arthritis participant was defined as having minimal disease activity (MDA) when participant met at least 5 of following criteria: 1) tender joint count less than or equal to (\<=) 1; 2) swollen joint count \<= 1; 3) body surface area (BSA) \<=3%; 4) patient pain VAS on 100 mm scale \<= 15; where 0= 'no pain' and 100= 'pain as severe as can be imagined', higher scores indicated greater severity; 5) patient's global activity VAS on a 100 mm scale \<= 20, where 0= 'lowest level of disease activity' and 100= 'highest level of disease activity', higher scores indicated greater level of disease activity; Health Assessment Questionnaire-Disability Index (HAQ-DI) score \<=0.5, scale ranged from 0-3, where 0= 'normal or no difficulty' and 3= 'inability to perform', higher scores indicated more difficulty to perform; 6) tender entheseal point \<= 1 using Leed's index ranged from 0-6; where 0= 'non tender' and 6= '6 tender tendon insertions', higher scores indicated more tendon insertions.

Time frame: 6 month follow-up visit (anytime in between 3 to 9 months after tofacitinib initiation); data collected and evaluated over 23.5 months in this retrospective observational study

Population: Analysis population included all eligible participants whose data were included and observed in this study.

ArmMeasureValue (NUMBER)
All ParticipantsPercentage of Participants Achieving Minimal Disease Activity at 6 Month Follow-up Visit17.8 Percentage of participants
Tofacitinib MonotherapyPercentage of Participants Achieving Minimal Disease Activity at 6 Month Follow-up Visit15.0 Percentage of participants
Tofacitinib + OSM Combination TherapyPercentage of Participants Achieving Minimal Disease Activity at 6 Month Follow-up Visit20.7 Percentage of participants
Primary

Percentage of Participants Achieving Score of Clear or Almost Clear According to Investigator Global Assessment (IGA) of Psoriasis (PsO)

The Investigator's Global Assessment (IGA) is a tool used to assess the severity of psoriasis. It is a scale that typically ranges from 0 to 4, where 0 indicates clear skin (no signs of psoriasis), 1 indicates almost clear (minimal signs of psoriasis), 2 indicates mild psoriasis, 3 indicates moderate psoriasis and 4 indicates severe psoriasis, higher scores indicated greater severity of psoriasis and provides a subjective evaluation of the overall severity of psoriasis based on clinical signs such as erythema, induration, and scaling. Percentage of participants with score of Clear (score 0) or Almost Clear (score 1) according to IGA of PsO were reported in this outcome measure.

Time frame: 6 month follow-up visit (anytime in between 3 to 9 months after tofacitinib initiation); data collected and evaluated over 23.5 months in this retrospective observational study

Population: Analysis population included all eligible participants whose data were included and observed in this study.

ArmMeasureValue (NUMBER)
All ParticipantsPercentage of Participants Achieving Score of Clear or Almost Clear According to Investigator Global Assessment (IGA) of Psoriasis (PsO)27.8 Percentage of participants
Tofacitinib MonotherapyPercentage of Participants Achieving Score of Clear or Almost Clear According to Investigator Global Assessment (IGA) of Psoriasis (PsO)28.6 Percentage of participants
Tofacitinib + OSM Combination TherapyPercentage of Participants Achieving Score of Clear or Almost Clear According to Investigator Global Assessment (IGA) of Psoriasis (PsO)26.9 Percentage of participants
Primary

Percentage of Participants With Percent Body Surface Area Score of 0% at 6 Month Follow-up Visit

Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint = 10 percent (%) for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region \* % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis. Percentage of participants with % BSA score of 0% at 6-month follow-up visit were reported in this outcome measure.

Time frame: 6 month follow-up visit (anytime in between 3 to 9 months after tofacitinib initiation); data collected and evaluated over 23.5 months in this retrospective observational study

Population: Analysis population included all eligible participants whose data were included and observed in this study.

ArmMeasureValue (NUMBER)
All ParticipantsPercentage of Participants With Percent Body Surface Area Score of 0% at 6 Month Follow-up Visit24.7 Percentage of participants
Tofacitinib MonotherapyPercentage of Participants With Percent Body Surface Area Score of 0% at 6 Month Follow-up Visit27.1 Percentage of participants
Tofacitinib + OSM Combination TherapyPercentage of Participants With Percent Body Surface Area Score of 0% at 6 Month Follow-up Visit22.0 Percentage of participants
Primary

Percentage of Participants With Psoriatic Arthritis Disease Activity Score (PASDAS) Less Than (<) 3.2 at 6 Month Follow-up Visit

PASDAS: patient global psoriatic arthritis assessment (PAA),physician global PAA, each scored on 100mm VAS,0=no disease activity(DA), 100=maximum DA, higher scores=greater DA;TJC(0-68);SJC(0-66);Leed's Enthesitis Index score ranging from 0-6;where 0=non tender,6=6 tender tendon insertions,higher scores=more tender insertions; tender dactylitic digit score ranging from 0-3 where 0=no tenderness,3=participant withdrew digit, higher scores=more tenderness; physical component summary(PCS) of short form 12(SF-12) score ranging from 0-100;where 0-20=severe physical health(PH)limitations,21-40=significant PH issues,41-60=moderate physical health,61-80=good PH,81-100=excellent PH. PASDAS total score were transformed & ranged from 0-10 where score 1.9 or less=remission,1.9-3.2=low disease activity(LDA),3.2-5.4=moderate DA,5.4 and higher=high DA, with higher scores indicating more severe disease. Percentage of participants with PASDAS score \<3.2 (LDA) at 6-month follow-up visit were reported.

Time frame: 6 month follow-up visit (anytime in between 3 to 9 months after tofacitinib initiation); data collected and evaluated over 23.5 months in this retrospective observational study

Population: Analysis population included all eligible participants whose data were included and observed in this study.

ArmMeasureValue (NUMBER)
All ParticipantsPercentage of Participants With Psoriatic Arthritis Disease Activity Score (PASDAS) Less Than (<) 3.2 at 6 Month Follow-up Visit21.8 Percentage of participants
Tofacitinib MonotherapyPercentage of Participants With Psoriatic Arthritis Disease Activity Score (PASDAS) Less Than (<) 3.2 at 6 Month Follow-up Visit21.1 Percentage of participants
Tofacitinib + OSM Combination TherapyPercentage of Participants With Psoriatic Arthritis Disease Activity Score (PASDAS) Less Than (<) 3.2 at 6 Month Follow-up Visit22.5 Percentage of participants
Primary

Percentage of Participants With Resolution of Dactylitis

Dactylitis is severe inflammation of the finger or toe tendons and joints, making them look like sausages. Resolution of dactylitis can be achieved by usage of NSAIDs, local steroid injections, biologic drugs and DMARDs. Resolution in dactylitis was considered when the following criteria were met: reduction in swelling: the affected digits showed a significant decrease in swelling; pain relief: there was a notable reduction or complete absence of pain in the affected area; improved functionality: the digits regained normal function and movement; absence of tenderness: the affected area no longer exhibited tenderness upon examination. Percentage of participants with resolution of dactylitis were reported in this outcome measure.

Time frame: 6 month follow-up visit (anytime in between 3 to 9 months after tofacitinib initiation); data collected and evaluated over 23.5 months in this retrospective observational study

Population: Analysis population included all eligible participants whose data were included and observed in this study.

ArmMeasureValue (NUMBER)
All ParticipantsPercentage of Participants With Resolution of Dactylitis27.8 Percentage of participants
Tofacitinib MonotherapyPercentage of Participants With Resolution of Dactylitis28.6 Percentage of participants
Tofacitinib + OSM Combination TherapyPercentage of Participants With Resolution of Dactylitis27.3 Percentage of participants
Primary

Percentage of Participants With Resolution of Enthesitis

Enthesis:site where joint capsules,ligaments,tendons attach to bone.Enthesitis is inflammation of entheses.This inflammation lead to severe pain,discomfort.Resolution of enthesitis determined by Spondyloarthritis Research Consortium of Canada(SPARCC)Enthesitis Index evaluates presence,severity of enthesitis at specific sites on body & includes:medial epicondyle,lateral epicondyle,supraspinatus insertion into greater tuberosity of humerus,greater trochanter,quadriceps insertion into superior border of patella,patellar ligament insertion into interior pole of patella/tibial tubercle,achilles tendon insertion into calcaneum,plantar fascia insertion into calcaneum.Each site is scored based on tenderness,ranged from 0-16.Higher scores=more severe enthesitis.Enthesitis was considered as resolved in those participants who had SPARCC \>0 at 6 month follow-up visit(anytime in between 3-9 months after tofacitinib initiation).Percentage of participants with resolution of enthesitis were reported.

Time frame: 6 month follow-up visit (anytime in between 3 to 9 months after tofacitinib initiation); data collected and evaluated over 23.5 months in this retrospective observational study

Population: Analysis population included all eligible participants whose data were included and observed in this study.

ArmMeasureValue (NUMBER)
All ParticipantsPercentage of Participants With Resolution of Enthesitis35.2 Percentage of participants
Tofacitinib MonotherapyPercentage of Participants With Resolution of Enthesitis33.3 Percentage of participants
Tofacitinib + OSM Combination TherapyPercentage of Participants With Resolution of Enthesitis36.7 Percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026