Efficacy and safety of anti-TNF multivalent NANOBODY (R) compound 'ozoralizumab' without methotrexate co-administration in patients with active rheumatoid arthritis: A 52-week result of phase III, randomised, open-label trial (NATSUZORA trial)

Objectives The aim is to assess the efficacy and safety of a 52-week subcutaneous ozoralizumab treatment at 30 and 80 mg without methotrexate (MTX) in active rheumatoid arthritis. Methods This randomised, open-label, multicentre phase III trial randomly allocated 140 patients in 2:1 ratio as subcutaneous ozoralizumab at 30 or 80 mg every 4 weeks for 52 weeks without MTX. Results Both groups administered ozoralizumab at 30 and 80 mg showed good clinical improvement. The American College of Rheumatology response rates were high at Week 24 and maintained through 52 weeks. The ozoralizumab groups also showed good improvement in other end points, and improvements observed from Week 1 were maintained through 52 weeks. Improvements in many efficacy assessments were similar between doses. No deaths were reported, and serious adverse events occurred in a total of 20 patients in the ozoralizumab groups. Increased antidrug antibodies were observed in approximately 40% of patients in the ozoralizumab groups, and 27.7% of the patients in the 30 mg group were neutralising antibody-positive. Conclusions Ozoralizumab, at 30 and 80 mg, demonstrated significant therapeutic effects without MTX, and the efficacy was maintained for 52 weeks with active rheumatoid arthritis. Ozoralizumab showed an acceptable tolerability profile over 52 weeks.