THU0193 EFFICACY OF TOFACITINIB MONOTHERAPY, TOFACITINIB WITH METHOTREXATE AND ADALIMUMAB WITH METHOTREXATE IN PATIENTS WITH EARLY (≤2 YEARS) VS ESTABLISHED (>2 YEARS) RHEUMATOID ARTHRITIS: A POST HOC ANALYSIS OF DATA FROM ORAL STRATEGY

Abstract

Background: Tofacitinib is an oral JAK inhibitor for the treatment of RA. Greater improvements in efficacy outcomes have been reported with tofacitinib 5 mg BID ± csDMARDs in patients (pts) with early vs established RA.1,2 Objectives: This post hoc analysis of ORAL Strategy data evaluated the efficacy and safety of tofacitinib monotherapy, tofacitinib + methotrexate (MTX) and adalimumab (ADA) + MTX, stratified by baseline (BL) RA duration. Methods: ORAL Strategy (NCT02187055) was a P3b/4, 1-yr, double–blind, triple-dummy, active comparator-controlled study. MTX inadequate-responder pts were randomised 1:1:1 to receive tofacitinib 5 mg BID (tofa mono), tofacitinib 5 mg BID + MTX (tofa+MTX), or ADA SC 40 mg Q2W + MTX (ADA+MTX); MTX was dosed at 15–25 mg/wk except in cases of intolerance/toxicity. In this analysis, pts were stratified by BL RA duration as having early (≤2 yrs) or established (>2 yrs) RA. Efficacy outcomes (Months [M]3, 6 and 12): ACR20/50/70; change from BL (Δ) in DAS28–4(ESR), SDAI and CDAI; and rates of DAS28-4(ESR)-, SDAI- and CDAI–defined LDA (≤3.2, ≤11 and ≤10, respectively) and remission ( Results: 241 pts had early RA (tofa mono: N=80; tofa+MTX: N=83; ADA+MTX: N=78; mean RA duration: 1.0–1.1 yrs); 905 pts had established RA (tofa mono: N=304; tofa+MTX: N=293; ADA+MTX: N=308; mean RA duration: 9.4–10.4 yrs). BL demographics and disease characteristics were generally comparable for early vs established RA pts, with some expected differences (the latter were slightly older, and a greater proportion had received prior bDMARDs); RF+ and anti-CCP+ rates were higher for established RA pts (Table). ACR50 and ΔDAS28-4(ESR) were generally similar for tofa mono and tofa+MTX up to M12 in early RA but significantly greater with tofa+MTX in established RA (p Conclusion: Efficacy was similar for tofa mono and tofa+MTX in early RA, and significantly higher with tofa+MTX in established RA. ADA+MTX was numerically but not always significantly more effective than tofacitinib in early RA. AE rates were generally similar regardless of BL RA duration. These findings, especially in established RA, are consistent with the conclusion of the primary analysis.3 Limitations to this post hoc analysis include low numbers of early RA pts.