Ozoralizumab shows promising outcomes in Active RA patients Without Methotrexate Co-Therapy
JAPAN: Patients with active rheumatoid arthritis (RA) were successfully treated with subcutaneous ozoralizumab at doses of 30 and 80 mg without the addition of methotrexate (MTX), and the results persisted for 52 weeks. Research that was published in Modern Rheumatology showed that the medication had an acceptable tolerability profile over the course of 52 weeks.
RA is a typical autoimmune condition. Despite the fact that the development of tumor necrosis factor (TNF) inhibitors marked a significant advancement in the management of rheumatoid arthritis (RA), conventional anti-TNF antibodies are somewhat immunogenic and their use leads to the development of anti-drug antibodies (ADAs) and loss of efficacy (secondary failure). The trivalent, bispecific NANOBODY® substance ozoralizumab is structurally distinct from IgGs.
Since methotrexate's efficacy and tolerability are insufficient for all rheumatoid arthritis patients, the trial focused solely on ozoralizumab.
With active rheumatoid arthritis, the authors sought to evaluate the effectiveness and safety of a 52-week subcutaneous ozoralizumab treatment at 30 and 80 mg without methotrexate (MTX).
In the open-label, multicenter, phase 3 research (JapicCTI-184031), 140 patients were randomly assigned to receive ozoralizumab 30 mg (n = 94) or 80 mg (n = 46) subcutaneously every four weeks, without MTX, for 52 weeks. Patients who kept taking csDMARDs (conventional synthetic disease-modifying antirheumatic medications), such as MTX, for at least 8 weeks at the visit 4 weeks before starting ozoralizumab treatment, or patients who stopped taking csDMARDs due to safety concerns, were considered eligible. Improvements in the American College of Rheumatology 20/50/70 response rate (ACR20/50/70), Simplified Disease Activity Index (SDAI), and Health Assessment Questionnaire Disability Index (HAD-DI) were among the efficacy endpoints used to measure the treatment's success.
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