Evaluating the feasibility of a real world pharmacovigilance study (OPTIMISE:MS)

• DOI: 10.1016/j.msard.2022.103894
• Publication Date: 2022-05-20T17:10:23Z
• Authors: 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 Ram...; 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
• Keywords: Natalizumab; Clinical Practice; Glatiramer acetate; Ocrelizumab

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 a prospective, pragmatic observational study, conducted across 13 UK MS centres. Data were at the time visits. first participant was recruited on 24th May 2019; extracted 11th November 2021.2112 participants included (median age 44.0 years; 1570 (72%) female; 1981 (94%) relapsing-remitting MS). 639 (30%) untreated entry, 205 (10%) taking interferon beta/copaxone, 1004 (47%) second/third generation DMT line and 264 (13%) had escalated from platform DMT. 342 events reported, which 108 infections. There an increased risk adverse in people (RR 3.45, 95%CI 1.57-7.60, p<0.01 vs no DMT). Unadjusted Poisson regression demonstrated incident natalizumab (IRR 5.28, 1.41-19.74, p<0.05), ocrelizumab 3.24, 1.22-8.62, GA biosimilar (Brabio) 4.89, 1.31-18.21, p<0.05) DMT.Routinely healthcare can be used evaluate safety with MS. These highlight potential studies guide understanding risks benefits associated