OPTIMISE-MS: real-world safety of disease-modifying therapies for multiple sclerosis

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Background Accurately assessing the safety of disease-modifying therapies (DMT) is important to ensure that patients and clinicians make fully-informed treatment decisions. Clinical trial data are restricted to narrow populations and may be less applicable to groups such as pregnant women, older people, and people from diverse ethnic backgrounds. Methods OPTIMISE-MS is a multi-centre, pragmatic, longitudinal real-world observational pharmacovigi- lance study recruiting from 15 UK sites. Data were extracted in January 2023. Results 2575 participants with complete baseline data were included (74% female, 79.7% White, 79.1% UK born, 92.9% relapsing-remitting MS, median age at diagnosis 34.6, median age at recruitment 44.5), with median follow-up of 2.1 years. At recruitment, 340 participants (13.1%) were taking a first generation DMT (Interferon/Glatiramer) and 1437 (55.5%) a second generation therapy (Natalizumab: 29.3%; Dimethyl Fumarate: 26.4%; Ocrelizumab: 16.1%; Fingolimod: 12.3%; Cladribine 5.9%; Alemtuzumab 4.9%; Teriflunomide: 4.6%). During prospective follow-up, 1227 clinical events were reported, including 609 MS relapses (11.7/100 per- son-years), 133 COVID infections (2.6/100 person-years), 180 opportunistic infections (3.5/100 person-years), 7 deaths (0.1/100 person-years), 11 cases of Herpes Zoster (0.2/100 person-years), and 3 cases of basal cell carcinoma (0.06/100 person-years). No PML cases were reported during follow-up. Conclusions OPTIMISE-MS will continue to collect real-world data on the safety of MS DMTs. These data will provide insight into the predictors of treatment-related adverse events, and help to inform clinical decision-making.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.