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Efficacy of tofacitinib in patients with rheumatoid arthritis stratified by background methotrexate dose group

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Fleischmann R1, Mease PJ2, Schwartzman S3, Hwang LJ4, Soma K5, Connell CA5, Takiya L6, Bananis E7. Clin Rheumatol. 2017 Jan;36(1):15-24. doi: 10.1007/s10067-016-3436-1. Epub 2016 Oct 12.

Abstract

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1 Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX, USA.

2 Swedish Medical Center and University of Washington School of Medicine, Seattle, WA, USA.

3 Hospital for Special Surgery, New York, NY, USA.

4 Pfizer Inc, New York, NY, USA.

5 Pfizer Inc, Groton, CT, USA.

6 Pfizer Inc, Collegeville, PA, USA.

7 Pfizer Inc, Collegeville, PA, USA. stratis.bananis@pfizer.com.

Abstract

Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). This post hoc analysis investigated the effect of methotrexate (MTX) dose on the efficacy of tofacitinib in patients with RA. ORAL Scan (NCT00847613) was a 2-year, randomized, Phase 3 trial evaluating tofacitinib in MTX-inadequate responder (IR) patients with RA. Patients received tofacitinib 5 or 10 mg twice daily (BID), or placebo, with low (≤12.5 mg/week), moderate (>12.5 to <17.5 mg/week), or high (≥17.5 mg/week) stable background MTX. Efficacy endpoints (at months 3 and 6) included American College of Rheumatology (ACR) 20/50/70 response rates, and mean change from baseline in Clinical Disease Activity Index (CDAI), Disease Activity Score in 28 joints (DAS28)-4(erythrocyte sedimentation rate [ESR]), Health Assessment Questionnaire-Disability Index (HAQ-DI), and modified Total Sharp score. 797 patients were treated with tofacitinib 5 mg BID (N = 321), tofacitinib 10 mg BID (N = 316), or placebo (N = 160); 242, 333, and 222 patients received low, moderate, and high MTX doses, respectively. At months 3 and 6, ACR20/50/70 response rates were greater for both tofacitinib doses vs placebo across all MTX doses. At month 3, mean changes from baseline in CDAI and HAQ-DI were significantly greater for both tofacitinib doses vs placebo, irrespective of MTX category; improvements were maintained at month 6. Both tofacitinib doses demonstrated improvements in DAS28-4(ESR), and less structural progression vs placebo, across MTX doses at month 6. Tofacitinib plus MTX showed greater clinical and radiographic efficacy than placebo in MTX-IR patients with RA, regardless of MTX dose.