Key clinical point: Obefazimod (ABX464 ) at a dose of 50 mg showed promising efficacy and was safe and well-tolerated in patients with moderate-to-severely active rheumatoid arthritis (RA).
Major finding: A dose of 50 mg ABX464 vs. placebo was associated with numerically more severe adverse events (14.3% vs. 5%) but with no malignancies, opportunistic infections, or deaths, and a significant reduction in the Disease Activity Score 28-C reactive protein (−1.41 vs. −0.60; P = .043) and Clinical Disease Activity Index Score (−15.8 vs. −6.9; P = .020) at week 12.
Study details: This was a phase 2 trial including 60 patients with moderate-to-severely active RA and inadequate response to methotrexate or anti-tumor necrosis factor alpha therapy who were randomly assigned to ABX464 or placebo in combination with methotrexate for 12 weeks.
Disclosures: The study was supported by Abivax. C Daien reported receiving consulting fees, punctual links, or research grants from Abivax and other sources. Ten authors reported being current/former employees or investigators contracted by Abivax.
Source: Daien C et al. Safety and efficacy of the miR-124 upregulator ABX464 (obefazimod, 50 and 100 mg per day) in patients with active rheumatoid arthritis and inadequate response to methotrexate and/or anti-TNFα therapy: A placebo-controlled phase II study. Ann Rheum Dis. 2022 (May 31). Doi: 10.1136/annrheumdis-2022-222228