| Autor: |
Ruth Dobson, Matthew Craner, Ed Waddingham, Aleisha Miller, Jayant Pindoria, Ana Cavey, Camilla Blain, Gabriele De Luca, Nikos Evangelou, Helen Ford, Paul Gallagher, Katila George, Ruth Geraldes Ramos Dias, Paula Harman, Jeremy Hobart, Tanya King, Ruth Linighan, Niall MacDougall, Monica Marta, Stephanie Mitchell, Richard Nicholas, David Rog, Antonio Scalfari, Neil Scolding, Stewart Webb, Sarah White, Judith Wilton, Carolyn Young, Paul M Matthews |
| Rok vydání: |
2022 |
| Předmět: |
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| Zdroj: |
Multiple sclerosis and related disorders. 63 |
| ISSN: |
2211-0356 |
| Popis: |
Clinical trial populations do not fully reflect routine practice. The power of routinely collected data to inform clinical practice is increasingly recognised.The OPTIMISE:MS pharmacovigilance study is a prospective, pragmatic observational study, conducted across 13 UK MS centres. Data were collected at the time of routine clinical visits. The first participant was recruited on 24th May 2019; data were extracted on 11th November 2021.2112 participants were included (median age 44.0 years; 1570 (72%) female; 1981 (94%) relapsing-remitting MS). 639 (30%) were untreated at study entry, 205 (10%) taking interferon beta/copaxone, 1004 (47%) second/third generation DMT first line and 264 (13%) had escalated from a platform DMT. 342 clinical events were reported, of which 108 infections. There was an increased risk of adverse events in people taking second/third generation DMT (RR 3.45, 95%CI 1.57-7.60, p0.01 vs no DMT). Unadjusted Poisson regression demonstrated increased incident adverse events in people taking natalizumab (IRR 5.28, 95%CI 1.41-19.74, p0.05), ocrelizumab (IRR 3.24, 95%CI 1.22-8.62, p0.05), and GA biosimilar (Brabio) (IRR 4.89, 95%CI 1.31-18.21, p0.05) vs no DMT.Routinely collected healthcare data can be used to evaluate DMT safety in people with MS. These data highlight the potential of pragmatic studies to guide understanding of risks and benefits associated with DMT. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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