학술논문
Safety experience with continued exposure to ofatumumab in patients with relapsing forms of multiple sclerosis for up to 3.5 years
Document Type
article
Author
Hauser, Stephen L; Cross, Anne H; Winthrop, Kevin; Wiendl, Heinz; Nicholas, Jacqueline; Meuth, Sven G; Giacomini, Paul S; Saccà, Francesco; Mancione, Linda; Zielman, Ronald; Bagger, Morten; Gupta, Ayan Das; Häring, Dieter A; Jehl, Valentine; Kieseier, Bernd C; Pingili, Ratnakar; Stoneman, Dee; Su, Wendy; Willi, Roman; Kappos, Ludwig
Source
Multiple Sclerosis Journal. 28(10)
Subject
Language
Abstract
BackgroundOfatumumab is approved for the treatment of relapsing multiple sclerosis (RMS). Ongoing safety reporting is crucial to understand its long-term benefit-risk profile.ObjectiveReport the safety and tolerability of ofatumumab in RMS after extended treatment up to 3.5 years.MethodsPatients completing ASCLEPIOS I/II (phase 3), APLIOS, or APOLITOS (phase 2) trials could enter ALITHIOS, a phase 3b, open-label, long-term safety study. We analyzed cumulative data of continuous ofatumumab treatment and of patients newly switched from teriflunomide.ResultsThe safety population had 1969 patients: 1292 continuously treated with ofatumumab (median time-at-risk 35.5 months, 3253 patient-years) and 677 newly switched (median time-at-risk 18.3 months, 986 patient-years). A total of 1650 patients (83.8%) had ⩾1 adverse events and 191 (9.7%) had ⩾1 serious adverse events. No opportunistic infections or progressive multifocal leukoencephalopathy events were identified; the risk of malignancies was low. Mean serum immunoglobulin (Ig) G levels remained stable. Mean IgM levels decreased but remained above the lower limit of normal in most. Serious infection incidence was low; decreased Ig levels were not associated with serious infections.ConclusionIn patients with up to 3.5 years' exposure, ofatumumab was well tolerated, with no new safety risks identified. These findings, with its established effectiveness, support a favorable benefit-risk profile of ofatumumab in RMS.