Key clinical point: The addition of methotrexate or maintenance of ongoing methotrexate did not significantly enhance the efficacy of ustekinumab in patients with active psoriatic arthritis (PsA), suggesting ustekinumab as an effective therapy for PsA independent of methotrexate.
Major finding: Ustekinumab monotherapy demonstrated non-inferiority over ustekinumab+methotrexate with a comparable Disease Activity Score in 28 joints (DAS28) at week 24 (mean 2.9 vs 3.1; Mann-Whitney estimator 0.5426) and at week 52 (mean 2.8 vs 3.1; Mann-Whitney estimator 0.5461). Overall, serious adverse events occurred in 9% of patients in both treatment groups, but no deaths were reported.
Study details: Findings are from MUST, a phase 3b trial including 173 ustekinumab-naive patients with active PsA who were randomly assigned to receive ustekinumab+methotrexate or ustekinumab+placebo.
Disclosures: This study was supported by Janssen Cilag. Several authors reported receiving grants, contracts, travel support, or honoraria or fees for serving as speakers, consultants, or advisory board members for various sources.
Source: Koehm M et al. Methotrexate plus ustekinumab versus ustekinumab monotherapy in patients with active psoriatic arthritis (MUST): A randomised, multicentre, placebo-controlled, phase 3b, non-inferiority trial. Lancet Rheumatol. 2023;5(1):E14-E23 (Jan 1). Doi: 10.1016/S2665-9913(22)00329-0