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Abstract Number: 613

Effect of Tofacitinib on Efficacy and Patient-Reported Outcomes in Psoriasis Patients with Baseline Psoriatic Arthritis: A Pooled Analysis of 2 Phase 3 Studies

Hervé Bachelez1, Christopher EM Griffiths2, Kim Papp3, Stephen Hall4, Joseph F Merola5, Steven R Feldman6, Majed Khraishi7, Anna Tallman8, Huaming Tan9 and Ming-Ann Hsu9, 1Sorbonne Paris Cité Université Paris Diderot, AP-HP Hôpital St. Louis, Paris, France, 2Dermatology Centre, University of Manchester, Manchester, United Kingdom, 3Probity Medical Research and K. Papp Clinical Research Inc, Waterloo, ON, Canada, 4Emeritus Research, Melbourne, Australia, 5Harvard Medical School, Boston, MA, 6School of Medicine, Wake Forest University, Winston-Salem, NC, 7Memorial University of Newfoundland, St. John's, NF, Canada, 8Pfizer Inc, New York, NY, 9Pfizer 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). Up to 42% of patients (pts) with psoriasis also have PsA. We examined tofacitinib efficacy and patient-reported outcomes (PROs) in pts with psoriasis and concomitant PsA.

Methods: Data were pooled from identical 52-week, randomized, controlled studies: OPT Pivotal 1 (NCT01276639) and OPT Pivotal 2 (NCT01309737). Both studies enrolled pts with moderate to severe psoriasis. This analysis included only those with a medical history of PsA at baseline (prior diagnosis by a rheumatologist). Pts were randomized 2:2:1 to receive tofacitinib 5 or 10 mg twice daily (BID), or placebo (PBO). Pts receiving PBO advanced to tofacitinib at Week 16. The co-primary efficacy endpoints at Week 16 were the proportion of pts achieving a 75% improvement in the Psoriasis Area and Severity Index score (PASI75) and the proportion of pts achieving Physician’s Global Assessment (PGA) of “clear” or “almost clear”. Secondary endpoints included the proportion of pts achieving Patient’s Global Assessment (PtGA) of “clear” or “almost clear” and changes from baseline in Joint Pain Assessment (ΔJPA), Nail Psoriasis Severity Index (ΔNAPSI), and Short Form-36 Health Survey (ΔSF-36) physical component summary (PCS) score, mental component summary (MCS) score, and 8 domain scores.

Results: The analysis included 430 psoriasis pts with PsA at baseline; 172, 168, and 90 pts received tofacitinib 5 mg BID, tofacitinib 10 mg BID, and PBO, respectively. At Week 16 a greater proportion of pts achieved PASI75, PGA, and PtGA responses with tofacitinib 5 and 10 mg BID vs PBO (all p<0.0001 vs PBO; Table). Improvements were observed with tofacitinib 5 and 10 mg BID vs PBO in ΔJPA and ΔNAPSI (all p<0.0001 vs PBO; Table). Tofacitinib 5 mg BID significantly improved SF-36 PCS (p≤0.05) and 5 of 8 domain scores (physical functioning, role limitations: physical, bodily pain, vitality, social functioning [all p≤0.05]). Tofacitinib 10 mg BID significantly improved SF-36 PCS (p<0.001), MCS (p<0.001), and all 8 domain scores (all p≤0.05). A dose-response was observed across all endpoints following tofacitinib treatment (Table).

Conclusion: Tofacitinib significantly improved clinical endpoints and PROs vs PBO at Week 16 in pts who had concomitant psoriasis and PsA. Details of safety endpoints in pts with psoriasis and PsA in the OPT Pivotal studies will be included in the final presentation.


Disclosure: H. Bachelez, Pfizer Inc, 2,AbbVie, Amgen, Boehringer Ingelheim, Baxalta, Celgene, Eli Lilly, Janssen, Leo Pharma, Novartis, Pfizer Inc, Sun Pharmaceuticals, UCB, 5,AbbVie, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen, Leo Pharma, Novartis, Pfizer Inc, Sun Pharmaceuticals, 8; C. E. Griffiths, AbbVie, Celgene, Eli Lilly, GSK, Janssen, Leo Pharma, Pfizer Inc, Novartis, Sandoz, 2,AbbVie, Almirall, Celgene, Eli Lilly, GSK, Janssen, Leo Pharma, Novartis, Pfizer Inc, Sun Pharmaceuticals, UCB, 5,AbbVie, Almirall, Celgene, Eli Lilly, GSK, Janssen, Leo Pharma, Novartis, Pfizer Inc, Sun Pharmaceuticals, UCB, 8; K. Papp, AbbVie, Akros, Allergen, Amgen, Anacor, Astellas, Baxalta, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Dermira, Dow Pharma, Eli Lilly, Galderma, Genentech, GSK, Janssen, Kyowa Hakko Kirin, Leo Pharma, MedImmune, Merck MSD, Merck-Serono, Mylan, 2,Novartis, Pfizer Inc, Regeneron, Roche, Sanofi-Aventis/Genzyme, Stiefel, Takeda, UCB, Valeant, 2,AbbVie, Akros, Amgen, Astellas, AstraZeneca, Baxalta, Baxter, Boehringer Ingelheim, Bristol-Myers Squibb, Can-Fite, Celgene, Dermira, Devonian, Dow Pharma, Eli Lilly, Galderma, Genentech, Janssen, Kyowa Hakko Kirin, Leo Pharma, Meiji Seika Pharma, 5,Merck MSD, Merck-Serono, Mitsubishi Pharma, Mylan, Novartis, Pfizer Inc, Regeneron, Roche, Sanofi-Aventis/Genzyme, Takeda, UCB, Valeant, 5,AbbVie, Amgen, Astellas, Celgene, Devonian, Eli Lilly, Galderma, Janssen, Kyowa Hakko Kirin, Leo Pharma, Merck MSD, Novartis, Pfizer Inc, Valeant, 8,Akros, Anacor, Kyowa Hakko Kirin, 9,AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen, Kyowa Hakko Kirin, Merck MSD, Merck-Serono, Novartis, Pfizer Inc, Regeneron, Sanofi-Aventis/Genzyme, Valeant, 9,AbbVie, Amgen, Astellas, Baxter, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Dow Pharma, Eli Lilly, Galderma, Janssen, Merck MSD, Novartis, Pfizer Inc, Regeneron, Sanofi-Aventis/Genzyme, UCB, Valeant, 9; S. Hall, AbbVie, Celgene, Eli Lilly, Janssen, Novartis, Pfizer Inc, Roche, UCB, 5; J. F. Merola, AbbVie, Amgen, Biogen Idec, Eli Lilly, Janssen, Kiniksa, Momenta, Mallinckrodt, Novartis, Pfizer Inc, Sumumed, UCB, 5,AbbVie, 8,Biogen Idec, Novartis, Pfizer Inc, 9; S. R. Feldman, Eli Lilly, Janssen, Novartis, Pfizer Inc, 2,AbbVie, Celgene, Eli Lilly, Janssen, Novartis, Leo Pharma, Pfizer Inc, 5,AbbVie, Eli Lilly, Celgene, Janssen, Novartis, 8; M. Khraishi, Pfizer Inc, 5; A. Tallman, Pfizer Inc, 1,Pfizer Inc, 3; H. Tan, Pfizer Inc, 1,Pfizer Inc, 3; M. A. Hsu, Pfizer Inc, 1,Pfizer Inc, 3.

To cite this abstract in AMA style:

Bachelez H, Griffiths CE, Papp K, Hall S, Merola JF, Feldman SR, Khraishi M, Tallman A, Tan H, Hsu MA. Effect of Tofacitinib on Efficacy and Patient-Reported Outcomes in Psoriasis Patients with Baseline Psoriatic Arthritis: A Pooled Analysis of 2 Phase 3 Studies [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/effect-of-tofacitinib-on-efficacy-and-patient-reported-outcomes-in-psoriasis-patients-with-baseline-psoriatic-arthritis-a-pooled-analysis-of-2-phase-3-studies/. Accessed .
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