N/A N=116

Effectiveness of Treatment With Tofacitinib in Patients With Psoriatic Arthritis in Routine Clinical Practice

Psoriatic Arthritis

Bottom Line

View on ClinicalTrials.gov: NCT04517669 ↗

Enrolled (actual)

116

Serious AEs

6.2%

Results posted

Oct 2025

Primary outcome: Primary: Percentage of Participants Who Achieved Low Disease Activity (LDA) Based on Psoriatic Arthritis Disease Activity Score (PASDAS) at Month 6 — 43.1; 46.9; 33.4; 4.0 Percentage of participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Jul 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants Who Achieved Low Disease Activity (LDA) Based on Psoriatic Arthritis Disease Activity Score (PASDAS) at Month 6	43.1; 46.9; 33.4; 4.0	—
SECONDARY Percentage of Participants Who Achieved LDA Based on PASDAS at Months 3 and 12	23.5; 21.1; 33.3; 0; 46.2; 47.4	—
SECONDARY Percentage of Participants Who Achieved Minimum Disease Activity (MDA) at Months 3, 6 and 12	17.6; 16.7; 21.7; 0; 42.3; 42.0	—
SECONDARY Percentage of Participants Who Achieved Remission Based on PASDAS at Months 3, 6 and 12	12.1; 14.3; 7.1; 0; 15.7; 20.0	—
SECONDARY Percentage of Participants Who Achieved Remission Based on Disease Activity in Psoriatic Arthritis (DAPSA) Score at Months 3, 6 and 12	11.3; 11.6; 11.1; 0; 28.9; 36.4	—
SECONDARY Change From Baseline in Psoriatic Arthritis Impact of Disease 12 Questions (PsAID12) Score at Months 3, 6 and 12	-1.3; -1.4; -1.0; NA; -1.3; -1.5	—
SECONDARY Change From Baseline in Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC-EI) Score at Months 3, 6 and 12	0.1; 0.1; 0.2; NA; -0.8; -0.4	—
SECONDARY Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12	2; 6; 3; 1; 8; 8	—
SECONDARY Number of Participants Who Achieved LDA According to Treatment Line at Months 3, 6 and 12	8; 4; 0; 15; 5; 9	—
SECONDARY Number of Participants Who Achieved LDA According to Duration of Current Episode Symptoms of at Least 6 Weeks Prior to Enrollment at Months 3, 6 and 12	4; 6; 2; 11; 8; 1	—
SECONDARY Number of Participants Who Achieved LDA According to Erythrocyte Sedimentation Rate (ESR) Results at Months 3, 6 and 12	2; 8; 2; 4; 10; 6	—
SECONDARY Number of Participants Who Achieved LDA According to C-reactive Protein (CRP) Results at Months 3, 6 and 12	7; 5; 8; 12; 4; 8	—
SECONDARY Number of Participants Who Achieved LDA According to Presence of Rheumatoid Nodules at Months 3, 6 and 12	12; 0; 20; 0; 12; 0	—
SECONDARY Number of Participants Who Achieved LDA According to Presence of Unequivocal Radiological Erosion at Months 3, 6 and 12	1; 1; 10; 1; 2; 17	—
SECONDARY Number of Participants Who Achieved LDA According to Presence of Unequivocal Bony Decalcification Localized to the Joints of the Hands and Wrists at Months 3, 6 and 12	1; 7; 4; 3; 12; 5	—
SECONDARY Number of Participants Who Achieved LDA According to Presence of Symmetric Arthritis at Months 3, 6 and 12	12; 0; 20; 0; 12; 8	—
SECONDARY Number of Participants Who Achieved LDA According to Arthritis of the Hand Joints at Months 3, 6 and 12	4; 8; 6; 14; 1; 11	—
SECONDARY Number of Participants Who Achieved LDA According to Arthritis of Only 1 Medium-Large Joint at Months 3, 6 and 12	10; 2; 17; 3; 11; 1	—
SECONDARY Number of Participants Who Achieved LDA According to Arthritis of 2-10 Medium-Large Joints and/or 1-3 Small Joints at Months 3, 6 and 12	0; 12; 1; 19; 1; 11	—
SECONDARY Number of Participants Who Achieved LDA According to Arthritis of 4-10 Small Joints With or Without Involvement of Large Joints at Months 3, 6 and 12	8; 4; 12; 8; 6; 6	—
SECONDARY Number of Participants Who Achieved LDA According to Arthritis of >10 Joints (With at Least One Small Joint) at Months 3, 6 and 12	10; 2; 16; 4; 10; 2	—
SECONDARY Change From Baseline in Quality of Life (QoL) Based on Short Form 36 (SF-36) Score at Months 3, 6 and 12	4.8; 2.4; 5.0; 2.5; 3.6; 1.5	—
SECONDARY Change From Baseline in QoL Based on Health Assessment Questionnaire - Disability Index (HAQ-DI41) at Months 3, 6 and 12	-0.1; -0.1; -0.0; NA; -0.1; -0.1	—

Summary

This is a Multinational Study of Tofacitinib in Patients Treated for Psoriatic Arthritis in order to evaluate the effectiveness of treatment with tofacitinib on disease activity, remission, and Quality of Life, in a real-world setting over a 12-month observation period

Eligibility Criteria

Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

Patients aged ≥ 18 years
Moderate to severe PsA disease activity diagnosed
Patients for whom the physician's decision has been made to initiate treatment with tofacitinib, in usual clinical practice conditions and in compliance with the local label
Patients are treatment naïve to tofacitinib on the date of providing informed consent
Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study
Patients on DMARDs must have not had a treatment change in the past 3 months

Exclusion Criteria: Patients meeting any of the following criteria will not be included in the study:

Contraindications according to the Xeljanz® (tofacitinib) Prescribing Information
Receipt of any investigational drug within 3 months before study inclusion
Patient is pregnant or breastfeeding
Recent herpes zoster infection (within past 6 months) or history of severe disseminated herpes zoster infection
Active treatment for a malignancy
Concomitant treatment with a biological disease-modifying antirheumatic drugs (bDMARD)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04517669). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.