Safety experience with continued exposure to ofatumumab in patients with relapsing forms of multiple sclerosis for up to 3.5 years
| Autor: | Stephen L Hauser, Anne H Cross, Kevin Winthrop, Heinz Wiendl, Jacqueline Nicholas, Sven G Meuth, Paul S Giacomini, Francesco Saccà, Linda Mancione, Ronald Zielman, Morten Bagger, Ayan Das Gupta, Dieter A Häring, Valentine Jehl, Bernd C Kieseier, Ratnakar Pingili, Dee Stoneman, Wendy Su, Roman Willi, Ludwig Kappos |
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| Rok vydání: | 2022 |
| Předmět: |
safety
Neurology & Neurosurgery Multiple Sclerosis Clinical Trials and Supportive Activities Clinical Sciences Neurosciences Ofatumumab monoclonal Evaluation of treatments and therapeutic interventions relapsing multiple sclerosis Relapsing-Remitting Antibodies Monoclonal Humanized Antibodies Rare Diseases Infectious Diseases Multiple Sclerosis Relapsing-Remitting Neurology Clinical Research 6.1 Pharmaceuticals Humans Patient Safety Neurology (clinical) Humanized |
| Zdroj: | Multiple sclerosis (Houndmills, Basingstoke, England), vol 28, iss 10 |
| ISSN: | 1477-0970 1352-4585 |
| DOI: | 10.1177/13524585221079731 |
| Popis: | Background: Ofatumumab is approved for the treatment of relapsing multiple sclerosis (RMS). Ongoing safety reporting is crucial to understand its long-term benefit–risk profile. Objective: Report the safety and tolerability of ofatumumab in RMS after extended treatment up to 3.5 years. Methods: Patients 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. Results: The 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. Conclusion: In 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. |
| Databáze: | OpenAIRE |
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