Key clinical point: Methotrexate+leflunomide therapy was superior to methotrexate monotherapy at improving disease activity in patients with psoriatic arthritis (PsA); however methotrexate+leflunomide therapy was less well tolerated than methotrexate monotherapy.
Major finding: At week 16, PsA disease activity score improved significantly in the methotrexate+leflunomide vs. methotrexate monotherapy group (3.1 vs. 3.7; P = .025). Incidence of mild adverse events, such as nausea/vomiting (44% vs. 28%) and altered bowel habits (26% vs. 8%), was higher with methotrexate+leflunomide vs. methotrexate+placebo.
Study details: Findings are from the phase 3 COMPLETE-PsA trial including 78 patients with active PsA who were randomly assigned to receive 2 tablets/day of 10 mg leflunomide or placebo once/day, both with 25 mg/week methotrexate.
Disclosures: This study was supported by the Regional Junior Researcher Grant from the Sint Maartenskliniek, Nijmegen, and the Radboudumc, Nijmegen, The Netherlands. The authors declared serving as speakers or consultants or receiving payments, honoraria, consulting and speaker fees, and support for attending meetings from several sources.
Source: Mulder MLM et al. Comparing methotrexate monotherapy with methotrexate plus leflunomide combination therapy in psoriatic arthritis (COMPLETE-PsA): a double-blind, placebo-controlled, randomised, trial. Lancet Rheumatol. 2022 (Feb 28). Doi: 10.1016/S2665-9913(22)00028-5