Key clinical point: Ozoralizumab at a dose of 30 or 80 mg significantly improved clinical outcomes compared to placebo and was well tolerated with no new safety signals in patients with active rheumatoid arthritis (RA) and an inadequate response to methotrexate therapy.
Major finding: A significantly higher proportion of patients receiving 30/80 mg ozoralizumab vs placebo achieved ≥ 20% improvement in American College of Rheumatology criteria (79.6%/75.3% vs 37.3%; P < .001) at 16 weeks and had structural damage nonprogression (73.0%/73.4% vs 56.0%; P < .01) at 24 weeks. No new adverse events were reported.
Study details: The data come from the phase 2/3 OHZORA trial including 381 patients with active RA and an inadequate response to methotrexate who were randomly assigned to receive ozoralizumab (30 or 80 mg) or placebo in combination with methotrexate for 24 weeks.
Disclosures: This trial was sponsored by Taisho Pharmaceutical Co., Ltd. Three authors reported being employees of Taisho Pharmaceutical. Several authors reported receiving grants, consulting fees, or speaking fees from various sources.
Source: Takeuchi T et al. Phase II/III results of the anti-TNF multivalent NANOBODY® compound ‘ozoralizumab’ in patient with rheumatoid arthritis (OHZORA trial). Arthritis Rheumatol. 2022 Jun 21. doi: 10.1002/art.42273 .