AB0921 Impact of baseline demographics, disease activity and concomitant medication on american college of rheumatology 20 response rate and health assessment questionnaire-disability index score with tofacitinib in active psoriatic arthritis: a pooled subgroup analysis of 2 phase 3 studies

Background Tofacitinib is an oral Janus kinase inhibitor for the treatment of psoriatic arthritis (PsA). In a pooled analysis of data from 2 Phase 3 trials in patients (pts) with active PsA, tofacitinib 5 and 10 mg twice daily (BID) significantly improved American College of Rheumatology (ACR) 20 response rates vs placebo (PBO) (50.0, 53.0 vs 28.0%, respectively; p Objectives To compare the efficacy of tofacitinib 5 and 10 mg BID vs PBO in predefined pt subgroups based on differences in BL demographics, disease activity and concomitant medication. Methods This was an analysis of pooled efficacy data from 2 Phase 3, randomised, double-blind, PBO-controlled studies (OPAL Broaden [12 months; NCT01877668] and OPAL Beyond [6 months; NCT01882439]) in pts with active PsA (defined as ≥3 swollen and ≥3 tender joints). Pts in OPAL Broaden were tumour necrosis factor inhibitor (TNFi)-naive with an inadequate response (IR) to ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD). Pts in OPAL Beyond had an IR to ≥1 TNFi. Pts were randomised to receive tofacitinib 5 or 10 mg BID, subcutaneous adalimumab 40 mg every 2 weeks (OPAL Broaden; data not included) or PBO. Pts continued to receive a stable dose of a single csDMARD. ACR20 response rates and LSM change from BL in HAQ-DI at Month 3 (primary endpoint data) were evaluated by subgroup category (demographic and disease characteristics at BL or at screening). Analyses were based on the full analysis set (table 1). Results In total, 238, 236 and 236 pts received tofacitinib 5 mg BID, 10 mg BID, or PBO, respectively. Across all subgroups analysed, tofacitinib 5 and 10 mg BID were generally associated with greater improvements at Month 3 in ACR20 and change from BL in HAQ-DI score than PBO (table 1). In pts classified as current smokers, slightly lower ACR20 response rates and similar changes from BL in HAQ-DI score to corresponding PBO at Month 3 were observed relative to never- or ex-smokers; however, the sample size was small. Statistical methods: ACR20 response was defined as achieving a≥20% improvement in ACR criteria components Missing ACR20 response was considered a non-response to treatment LSMs were calculated based on a mixed model for repeated measures without imputation for missing values ACR, American College of Rheumatology; BID, twice daily; BMI, body mass index; BSA, body surface area; CRP, C-reactive protein; csDMARD, conventional synthetic disease-modifying antirheumatic drug; DSS, Dactylitis Severity Score; HAQ-DI, Health Assessment Questionnaire-Disability Index; LEI, Leeds Enthesitis Index; LSM, least squares mean; MTX, methotrexate; N, number of patients in full analysis set (randomised and received ≥1 treatment dose); n, number of responders; N1, number of patients in the full analysis set by category of subgroup and treatment; N2, number of patients included in the repeated measures model by category of subgroup and treatment; NC, analysis not conducted; PASDAS, Psoriatic Arthritis Disease Activity Score; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis; pts, patients; ROW, rest of world (Brazil, Mexico and Taiwan); SPARCC, Spondyloarthritis Research Consortium of Canada (enthesitis index) Conclusions In this analysis of pooled data from 2 Phase 3 studies in pts with active PsA, tofacitinib 5 and 10 mg BID consistently improved efficacy at Month 3 compared with PBO across all predefined subgroups evaluated, with the exception of current smoking; however, as this was not a pre-specified analysis and some subgroups (including smoking status) were small, interpretation should be made with caution. Reference [1] Nash P, et al. Arthritis Rheumatol2017;69(suppl 10):619. Acknowledgements Study sponsored by Pfizer Inc. Medical writing support was provided by K Nicholson of CMC and funded by Pfizer Inc. Disclosure of Interest F. Behrens Grant/research support from: AbbVie, Chugai, Novartis, Pfizer Inc, Prophylix, Roche, Consultant for: AbbVie, Biotest, BMS, Celgene, Chugai, Eli Lilly, Genzyme, Janssen, MSD, Novartis, Pfizer Inc, Roche, UCB, Speakers bureau: AbbVie, Biotest, BMS, Celgene, Chugai, Eli Lilly, Genzyme, Janssen, MSD, Novartis, Pfizer Inc, Roche, UCB, J. Gomez-Reino Grant/research support from: AbbVie, MSD, Pfizer Inc and Roche, Consultant for: Pfizer Inc, Speakers bureau: AbbVie, Biogen, Bristol-Myers Squibb, Janssen, MSD, Pfizer Inc and Roche, P. Nash Grant/research support from: AbbVie, BMS, Eli Lilly, Janssen, Novartis, Pfizer Inc, Roche, Sanofi, UCB, Consultant for: AbbVie, BMS, Eli Lilly, Janssen, Novartis, Pfizer Inc, Roche, Sanofi, UCB, Speakers bureau: AbbVie, BMS, Eli Lilly, Janssen, Novartis, Pfizer Inc, Roche, Sanofi, UCB, D. Gladman Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Novartis, Pfizer Inc, UCB, Consultant for: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Novartis, Pfizer Inc, UCB, O. FitzGerald Grant/research support from: AbbVie, BMS, Novartis, Pfizer Inc, Consultant for: Amgen, Celgene, Eli Lilly, Janssen, C. Ritchlin Grant/research support from: AbbVie, Amgen and UCB, Consultant for: AbbVie, Amgen, Celgene, Janssen, Novartis, Pfizer Inc, Sun and UCB, E. Kudlacz Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, J. Wu Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, C. Wang Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, A. Romero Shareholder of: Pfizer Inc, Employee of: Pfizer Inc