Evaluating the feasibility of a real world pharmacovigilance study (OPTIMISE:MS).
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
Author Information
Ruth Dobson: Preventive Neurology Unit, Wolfson Institute of Population Health, Queen Mary University of London, London, UK; Department of Neurology, Royal London Hospital, Barts Health NHS Trust, London, UK. Electronic address: ruth.dobson@qmul.ac.uk.
Matthew Craner: Department of Neurology, John Radcliffe Hospital NHS Trust, Oxford, UK; Department of Neurology, Frimley Park Health Foundation NHS Trust, Frimley, UK.
Ed Waddingham: Department of Brain Sciences, Imperial College London and UK Dementia Research Institute, Imperial College London, London, UK.
Aleisha Miller: Department of Brain Sciences, Imperial College London and UK Dementia Research Institute, Imperial College London, London, UK.
Jayant Pindoria: Department of Brain Sciences, Imperial College London and UK Dementia Research Institute, Imperial College London, London, UK.
Ana Cavey: Department of Neurology, John Radcliffe Hospital NHS Trust, Oxford, UK.
Camilla Blain: Department of Neurology, St Georges Hospital NHS Trust, London, UK.
Gabriele De Luca: Department of Neurology, John Radcliffe Hospital NHS Trust, Oxford, UK.
Nikos Evangelou: Nottingham University Hospitals NHS Trust, Nottingham, UK.
Helen Ford: Centre for Neurosciences, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
Paul Gallagher: Queen Elizabeth University Hospital, Glasgow, UK.
Katila George: Preventive Neurology Unit, Wolfson Institute of Population Health, Queen Mary University of London, London, UK.
Ruth Geraldes Ramos Dias: Department of Neurology, John Radcliffe Hospital NHS Trust, Oxford, UK.
Paula Harman: Department of Neurology, Southend Hospital, Westcliff-on-Sea, UK.
Jeremy Hobart: Plymouth University Peninsula Schools of Medicine and Dentistry, Plymouth, UK; Department of Neurology, University Hospitals Plymouth NHS Trust, Plymouth, UK.
Tanya King: Plymouth University Peninsula Schools of Medicine and Dentistry, Plymouth, UK; Department of Neurology, University Hospitals Plymouth NHS Trust, Plymouth, UK.
Ruth Linighan: Department of Neurology, John Radcliffe Hospital NHS Trust, Oxford, UK.
Niall MacDougall: Neurology Department, Hairmyres Hospital, East Kilbride, UK; Neurology Department, Institute of Neurological Sciences, Glasgow, UK.
Monica Marta: Department of Neurology, Royal London Hospital, Barts Health NHS Trust, London, UK; Department of Neurology, Southend Hospital, Westcliff-on-Sea, UK.
Stephanie Mitchell: Department of Neurology, Greater Manchester Neurosciences Centre, Salford Royal NHS Foundation Trust, Salford, UK.
Richard Nicholas: Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK.
David Rog: Department of Neurology, Greater Manchester Neurosciences Centre, Salford Royal NHS Foundation Trust, Salford, UK.
Antonio Scalfari: Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK.
Neil Scolding: Department of Neurology, Southmead Hospital NHS Trust, Bristol, UK; Department of Neurosciences, University of Bristol, Bristol, UK.
Stewart Webb: Queen Elizabeth University Hospital, Glasgow, UK.
Sarah White: Department of Neurology, St Georges Hospital NHS Trust, London, UK.
Judith Wilton: Department of Neurology, Frimley Park Health Foundation NHS Trust, Frimley, UK.
Carolyn Young: The Walton Centre, Liverpool, UK.
Paul M Matthews: Department of Brain Sciences, Imperial College London and UK Dementia Research Institute, Imperial College London, London, UK.
BACKGROUND: Clinical trial populations do not fully reflect routine practice. The power of routinely collected data to inform clinical practice is increasingly recognised. METHODS: 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. RESULTS: 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, p<0.01 vs no DMT). Unadjusted Poisson regression demonstrated increased incident adverse events in people taking natalizumab (IRR 5.28, 95%CI 1.41-19.74, p<0.05), ocrelizumab (IRR 3.24, 95%CI 1.22-8.62, p<0.05), and GA biosimilar (Brabio) (IRR 4.89, 95%CI 1.31-18.21, p<0.05) vs no DMT. CONCLUSIONS: 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.
