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Abstract Number: 596

Effect of Tofacitinib on Patient-Reported Outcomes in Patients with Active Psoriatic Arthritis: Results from 2 Phase 3 Studies

Vibeke Strand1, Kurt de Vlam2, Jose A Covarrubias-Cobos3, Philip J Mease4, Dafna D Gladman5, Thijs Hendrikx6, Elizabeth Kudlacz7, Daniela Graham7, Joseph Wu7, Joseph C Cappelleri7 and Ming-Ann Hsu7, 1Stanford University, Palo Alto, CA, 2UZ Leuven, Leuven, Belgium, 3Unidad Reumatologica Las Americas S.C.P, Yucatán, Mexico, 4Swedish Medical Center and University of Washington, Seattle, WA, 5Department of Medicine, University of Toronto, Toronto Western Hospital, Toronto, ON, Canada, 6Pfizer Inc, Collegeville, PA, 7Pfizer Inc, Groton, CT

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: Psoriatic arthritis, tofacitinib and treatment

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Session Information

Date: Sunday, November 5, 2017

Title: Spondyloarthropathies and Psoriatic Arthritis – Clinical Aspects and Treatment Poster I

Session Type: ACR Poster Session A

Session Time: 9:00AM-11:00AM

Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor under investigation for the treatment of psoriatic arthritis (PsA). Safety and efficacy were investigated in 2 Phase 3 randomized controlled trials (RCTs: OPAL Broaden [12 months; NCT01877668]; OPAL Beyond [6 months; NCT01882439]). This analysis evaluated patient-reported outcomes (PROs) in patients with active PsA in OPAL Broaden (N=422), with inadequate responses (IR) to ≥1 conventional synthetic DMARD, naïve to tumor necrosis factor inhibitors (TNFi); and in OPAL Beyond (N=394), IR to ≥1 TNFi.

Methods: Patients were randomized to tofacitinib 5 or 10 mg twice daily (BID) or placebo (PBO) advanced to either tofacitinib 5 or 10 mg BID at Month 3, and, in OPAL Broaden, to adalimumab 40 mg subcutaneously every 2 weeks. Based on a longitudinal model, least squares mean (LSM) changes from baseline were reported for the following: Patient Global Assessment of Disease Activity Visual Analog Scale (PtGA VAS), Pain VAS, Short Form-36 Health Survey Version 2 (SF-36v2), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Dermatology Life Quality Index (DLQI), and Ankylosing Spondylitis Quality of Life (ASQOL). Findings were reported using nominal p values without adjustments for multiple comparisons.

Results: Improvements in PtGA and Pain were observed as early as Week 2 (first assessment), and exceeded PBO at Month 3 with both tofacitinib doses in both RCTs (p≤0.05 vs PBO) (Table). At Month 3, SF-36v2 Physical Component Summary (PCS), physical functioning (PF), bodily pain (BP), and vitality (VT) domains, and FACIT-F scores, exceeded PBO with both doses (p≤0.05) in both trials; improvements in PCS, PF, BP, and FACIT-F exceeded minimum clinically important differences (MCID). DLQI and ASQOL scores at Month 3 exceeded PBO with both doses in both RCTs (p≤0.05), and social functioning (SF) domain with both doses in OPAL Beyond and 5 mg BID in OPAL Broaden (p≤0.05). PRO improvements reported in OPAL Broaden with tofacitinib were similar to adalimumab. The percentages of patients receiving both tofacitinib doses reporting changes ≥MCID at Month 3 in SF-36v2 PCS, PF, and BP domains were statistically significant in both RCTs, as were general health (GH) and mental health (MH) domains with 10 mg BID and FACIT-F with both doses in OPAL Broaden, and SF domains with both doses in OPAL Beyond and role physical (RP) with 10 mg BID.

Conclusion: Patients with active PsA receiving tofacitinib reported statistically greater and clinically meaningful improvements in PROs compared with PBO at Month 3 in both RCTs.


Disclosure: V. Strand, AbbVie, Amgen, Bristol-Myers Squibb, Corrona, Eli Lilly, Janssen, Novartis, Pfizer Inc, UCB, 5; K. de Vlam, Eli Lilly, Pfizer Inc, 5,Galapagos, 9; J. A. Covarrubias-Cobos, Bristol-Myers Squibb, Eli Lilly, Janssen, Pfizer Inc, 2; P. J. Mease, AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Novartis, Pfizer Inc, Sun Pharmaceutical, UCB, 2,AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Novartis, Pfizer Inc, Sun Pharmaceutical, UCB, 5,AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Genentech, Janssen, Novartis, Pfizer Inc, UCB, 8; D. D. Gladman, AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Novartis, Pfizer Inc, UCB, 2,AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Novartis, Pfizer Inc, UCB, 5; T. Hendrikx, Pfizer Inc, 1,Pfizer Inc, 3; E. Kudlacz, Pfizer Inc, 1,Pfizer Inc, 3; D. Graham, Pfizer Inc, 1,Pfizer Inc, 3; J. Wu, Pfizer Inc, 1,Pfizer Inc, 3; J. C. Cappelleri, Pfizer Inc, 1,Pfizer Inc, 3; M. A. Hsu, Pfizer Inc, 1,Pfizer Inc, 3.

To cite this abstract in AMA style:

Strand V, de Vlam K, Covarrubias-Cobos JA, Mease PJ, Gladman DD, Hendrikx T, Kudlacz E, Graham D, Wu J, Cappelleri JC, Hsu MA. Effect of Tofacitinib on Patient-Reported Outcomes in Patients with Active Psoriatic Arthritis: Results from 2 Phase 3 Studies [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/effect-of-tofacitinib-on-patient-reported-outcomes-in-patients-with-active-psoriatic-arthritis-results-from-2-phase-3-studies/. Accessed .
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