Kramer John, Linker Ralf, Paling David, Czaplinski Adam, Hoffmann Olaf, Yong V Wee, Barker Noreen, Ross Amy Perrin, Lucassen Elisabeth, Gufran Mohammad, Hu Xixi, Zielman Ronald, Seifer Gustavo, Vermersch Patrick
Vanderbilt MS Center, Nashville, TN, USA.
Klinik und Poliklinik für Neurologie, Universitätsklinikum Regensburg, Regensburg, Germany.
Mult Scler J Exp Transl Clin. 2023 Oct 10;9(4):20552173231203816. doi: 10.1177/20552173231203816. eCollection 2023 Oct-Dec.
Ofatumumab is approved for treating relapsing multiple sclerosis (RMS). Examining tolerability will enable understanding of its risk-benefit profile.
Report the tolerability profile of ofatumumab in RMS during treatment of up to 4 years and the effect of pre-medication.
Cumulative data from the overall safety population included patients taking continuous ofatumumab or being newly switched from teriflunomide. Injection-related reactions (IRRs) by incidence and severity, and post-marketing surveillance data, with an exposure of 18,530 patient-years, were analyzed.
Systemic IRRs affected 24.7% of patients (487/1969) in the overall safety population; most (99.2% [483/487]) were mild (333/487) to moderate (150/487) in Common Terminology Criteria for Adverse Events severity; most systemic IRRs occurred after first injection. Local-site IRRs affected 11.8% (233/1969) and most (99.6% [232/233]) were mild/moderate. Incidence and severity of systemic and localized IRRs were similar between continuous and newly switched patients across repeated injections. Systemic IRR incidence and severity were not substantially affected by steroidal or non-steroidal pre-medication. Post-marketing surveillance identified no new tolerability issues.
Ofatumumab is well tolerated, displays a consistent safety profile during continuous use or after switching from teriflunomide and does not require pre-medication. This enables home management of RMS with a high-efficacy treatment.
奥法妥木单抗已被批准用于治疗复发型多发性硬化症（RMS）。研究其耐受性将有助于了解其风险效益概况。
报告奥法妥木单抗在治疗长达4年的RMS患者中的耐受性概况以及预处理的效果。
汇总总体安全人群的数据，包括持续使用奥法妥木单抗或刚从特立氟胺转换过来的患者。分析了注射相关反应（IRR）的发生率和严重程度，以及上市后监测数据，暴露时间为18,530患者年。
在总体安全人群中，24.7%（487/1969）的患者出现全身性IRR；根据不良事件通用术语标准，大多数（99.2%[483/487]）为轻度（333/487）至中度（150/487）；大多数全身性IRR发生在首次注射后。局部IRR影响了11.8%（233/1969）的患者，大多数（99.6%[232/233]）为轻度/中度。在重复注射的连续用药患者和新转换患者中，全身性和局部IRR的发生率和严重程度相似。全身性IRR的发生率和严重程度并未受到甾体或非甾体预处理的实质性影响。上市后监测未发现新的耐受性问题。
奥法妥木单抗耐受性良好，在持续使用或从特立氟胺转换后显示出一致的安全性，且无需预处理。这使得RMS患者能够在家中接受高效治疗。
