Objective: To assess the efficacy and safety through a 52-week treatment with subcutaneous ozoralizumab at 30 or 80 mg in patients with active rheumatoid arthritis despite methotrexate therapy.
Methods: This multicentre, randomized, placebo-controlled, double-blind, parallel-group confirmatory trial included a 24-week double-blind treatment period followed by a 28-week open-label treatment period. The double-blind treatment period randomized 381 (2:2:1) patients to placebo and ozoralizumab at 30 or 80 mg, and patients receiving placebo were re-randomized (1:1) to ozoralizumab at 30 or 80 mg in the open-label period.
Results: The ozoralizumab groups showed good clinical improvement, with high American College of Rheumatology response rates at 52 weeks, as well as good improvements in other endpoints, which were observed from Day 3 and maintained through Week 52. Furthermore, the ozoralizumab groups showed a high remission rate in clinical and functional remission at Week 52. Serious adverse events occurred in a total of 23 patients in the ozoralizumab groups, without differences in incidence between doses.
Conclusions: Ozoralizumab demonstrated significant therapeutic effects and efficacy, which was maintained for 52 weeks. The safety profile was consistent with the evaluated results in interim analysis at Week 24, and ozoralizumab was well-tolerated up to Week 52.
Keywords: Methotrexate; VHH antibody; ozoralizumab; rheumatoid arthritis; tumour necrosis factor-alpha inhibitor.
© Japan College of Rheumatology 2022. Published by Oxford University Press.