THU0258 Oral Start: Effects of the Oral JAK Inhibitor Tofacitinib Monotherapy Versus Methotrexate on Patient-Reported Outcomes in the Phase 3 Oral Start Trial of Active Rheumatoid Arthritis

Background Tofacitinib is a novel, oral Janus kinase (JAK) inhibitor for the treatment of rheumatoid arthritis (RA). Objectives To compare the effects of tofacitinib 5 mg and 10 mg twice daily (BID) monotherapy versus methotrexate (MTX) on patient-reported outcomes in a 12-month interim analysis of a randomised, double-blind, parallel group Phase 3 study (NCT01039688).1 Methods MTX-naïve patients with RA (≥6 tender/swollen joints; erythrocyte sedimentation rate [ESR] >28 mm/hr and/or C-reactive protein [CRP) >7mg/L]) were randomised 2:2:1 to tofacitinib 5 mg BID, 10 mg BID, or MTX titrated from 10 mg/week to 20 mg/week. PROs were secondary endpoints, including mean changes from baseline in: patient-reported pain (Visual Analogue Scale; VAS), Patient Global Assessment (PtGA) of disease activity (VAS), physical function (Health Assessment Questionnaire-Disability Index; HAQ-DI), health-related quality of life (HR-QoL) (Short Form 36 version 2, acute; SF-36), and fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue; FACIT-F). Analyses used a linear mixed-effect model, with baseline values as covariates, on all patients who received ≥1 study drug dose (full analysis set) and had both a baseline and ≥1 post-baseline value. Least squares mean changes from baseline at Month 12 are presented; non-responder imputation for minimum clinically important differences (MCID) of PROs. Results At the 12-month cut-off (24 May 2012), 769 patients who received treatment were ongoing; 307 with tofacitinib 5 mg BID, 328 with tofacitinib 10 mg BID, 134 with MTX. Tofacitinib treatment resulted in statistically significant improvements versus MTX in all PROs except SF-36 mental component score for the 5 mg BID dose (Table 1). Changes in values for all PROs were numerically greater in patients receiving tofacitinib 10 mg BID than those receiving 5 mg BID. A significantly greater proportion of pts achieved at least MCID with tofacitinib 10 mg BID vs MTX for all PROs (FACIT-F data not available) (Table 1). Conclusions In this Phase 3 study, MTX-naive patients receiving tofacitinib monotherapy generally reported significant improvements in PROs compared with MTX over 12 months’ treatment. References Lee EB, et al. Arthritis Rheum 2012; 64(S10): S1049 Disclosure of Interest V. Strand Consultant for: Pfizer Inc., R. Fleischmann Grant/research support from: Pfizer Inc., Consultant for: Pfizer Inc., R. Alten Grant/research support from: Pfizer Inc., Speakers bureau: Pfizer In