Effect of the extended dosing interval of anti-TNF-α NANOBODY® compound ozoralizumab in patients with low disease activity rheumatoid arthritis

Abstract

ABSTRACT Objectives This article aims to evaluate the effect of the extended dosing interval on the efficacy and safety of ozoralizumab in patients with rheumatoid arthritis (RA). Methods In a long-term extension study (HOSHIZORA trial) for patients who had completed a phase II/III study with methotrexate or a phase III study without methotrexate, the dosing interval of ozoralizumab was allowed to extend from every 4 weeks (Q4W) to every 8 weeks (Q8W), at the physician’s discretion, for patients who had maintained a 28-joint disease activity score based on erythrocyte sedimentation rate (DAS28-ESR) <3.2 at the last two time points. The continuation rate, efficacy, and safety were examined in patients who had completed 24 weeks after the change in the dosing interval by the data cut-off point. Results Of the 32 patients who maintained DAS28-ESR <3.2 and changed the interval from Q4W to Q8W, 28 (87.5%) remained on Q8W for 24 weeks. At Week 24, the percentages of patients who remained on Q8W and achieved DAS28-ESR <2.6 and <3.2 were 71.9% and 84.4%, respectively. No safety concerns were observed for 24 weeks in the Q8W group. Conclusions In patients with RA and maintained DAS28-ESR <3.2 with ozoralizumab, efficacy was sustained and well tolerated after the dosing interval was extended from Q4W to Q8W.