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诺华制药(NVS.US)CD20靶向疗法维持高效长达7年 可供患者自我注射
贝塔投资智库· 2025-09-26 04:04
Core Viewpoint - Novartis has announced positive data regarding its monoclonal antibody Kesimpta for treating relapsing multiple sclerosis (RMS), demonstrating long-lasting efficacy and safety in patients [1][2]. Group 1: Efficacy of Kesimpta - In a 3b phase study (ARTIOS), patients with RMS who switched to Kesimpta after inadequate response to other treatments showed a significantly low annualized relapse rate (ARR) of only 0.06 at 96 weeks [1]. - Over 90% of participants in the study exhibited no evidence of disease activity (NEDA-3) as assessed by MRI, indicating nearly complete suppression of disease activity [1][2]. - In the ALITHIOS study, more than 90% of treatment-naive RMS patients achieved NEDA-3 after 7 years of continuous Kesimpta treatment, further confirming its durable efficacy [2]. Group 2: Safety Profile - The transition to Kesimpta did not reveal any new safety concerns, regardless of the last disease-modifying therapy (DMT) the patients received [1][2]. - The overall population and treatment-naive patients demonstrated good safety characteristics throughout the studies, with no new safety issues reported [2]. Group 3: Product Information - Kesimpta is a fully humanized monoclonal antibody targeting CD20, which works by depleting B cells from circulation [2]. - It received FDA approval in 2020 for treating relapsing adult multiple sclerosis patients and is notable for being the first B-cell targeted therapy that allows patients to self-administer monthly injections at home using an auto-injector [2].