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Anaptys Announces New Positive Phase 2b Trial Results for Rosnilimab in Rheumatoid Arthritis at ACR Late-Breaking Oral Presentation
New data reinforce rosnilimab’s efficacy profile in rheumatoid arthritis (RA) with deepening of clinical responses, including CDAI remission, from Week 12 to
About this update from Anaptysbio, Inc.
[{"type":"text","content":"New data reinforce rosnilimab’s efficacy profile in rheumatoid arthritis (RA) with deepening of clinical responses, including CDAI remission, from Week 12 to Week 28 regardless of prior advanced therapy, including JAKsNew data confirm durable clinical benefit across multiple higher-order response measures, including CDAI LDA and DAS28 LDA, after Week 28 for at least three months off drugUpdated safety data through Week 38 demonstrate rosnilimab was well-tolerated with no treatment-related serious adverse events and no malignancies in rosnilimab-treated patients SAN DIEGO, Oct. 29, 2025 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, today announced late-breaking data from the robust, global 424-patient Phase 2b trial of rosnilimab, a selective and potent pathogenic T cell depleter, in rheumatoid arthritis (RA) at the American College of Rheumatology (ACR) Convergence 2025 in Chicago. New study results showed that positive Week 12 data across multiple higher-order response measures continue to deepen into Week 28 regardless of prior treatment. These results were then durable for at least three months off drug. Additionally, rosnilimab was well-tolerated with no treatment-related serious adverse events and no malignancies in rosnilimab-treated patients through end-of-trial follow-up (Week 38). Paul Emery, M.D., professor of rheumatology at the University of Leeds and Leeds Biomedical Research Centre, U.K., presented data that show: As previously reported, at Week 12, statistically significant and clinically meaningful efficacy was achieved on the primary endpoint DAS28-CRP, as well as for ACR20, for all doses, including monthly doses (Q4W);At Week 28, CDAI LDA, CDAI remission and ACR50/70 rates continued to improve independent of prior treatments, including anti-TNFα, anti-IL6R or JAK inhibitors;Similar effects were seen for patients previously treated with at least two prior biologic or targeted synthetic disease-modifying antirheumatic drug classes (b/tsDMARDs), particularly at the mid (400mg Q4W) and high (600mg Q2W) doses;Week 28 responses across multiple clinically meaningful measures, including CDAI LDA, mean CDAI, mean DAS28-CRP and ACR50/70, were durable off drug through at least three months after the last rosnilimab dos...