OP0035 Upadacitinib as monotherapy: a phase 3 randomised controlled double-blind study in patients with active rheumatoid arthritis and inadequate response to methotrexate

Abstract

Background: Upadacitinib (UPA), an oral JAK inhibitor, showed efficacy in rheumatoid arthritis (RA) patients (pts) with an inadequate response to csDMARDs or bDMARDs on continuing stable csDMARD(s).1 2 Objectives: Safety and efficacy of switching to UPA 15 mg or 30 mg monotherapy vs continuing methotrexate (MTX) as a blinded study drug was evaluated in pts with inadequate response to MTX (MTX-IR). Methods: Pts with active RA (TJC >=6, SJC>=6, hsCRP >=3 mg/L) on stable MTX were enrolled and randomised 1:1:1 in a double-blind manner to once-daily (QD) UPA 15 mg or 30 mg monotherapy or to continue MTX (cMTX) at their prior stable dose. At BL, all pts discontinued prior MTX without washout and received PBO (for pts on UPA) or MTX at prior dose (cMTX) as blinded study drug. The primary endpoints at Week (Wk) 14 were the proportion of pts achieving ACR20, and the proportion achieving DAS28-CRP <0.001); at Wk 14, a significantly greater proportion of pts receiving UPA monotherapy (15 mg and 30 mg) vs cMTX achieved ACR20 (67.7% and 71.2% vs 41.2%), and DAS28-CRP <2.6 (28.1% and 40.5% vs 8.3%), DELTAHAQ-DI (-0.65 and-0.73 vs-0.32). DELTASF-36 PCS and DELTAMorning Stiffness data are also shown (table 1). The proportion of pts achieving CDAI