The following article is part of conference coverage from the 8th Joint American Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) MSVirtual2020 event. Neurology Advisor‘s staff will be reporting breaking news associated with research conducted by leading experts in neurology. .
Natalizumab was more effective than fingolimod or BRACETD (interferon beta, glatiramer acetate, dimethyl fumarate, or teriflunomide) in reducing relapses in patients with rapidly evolving severe (RES) relapsing-remitting multiple sclerosis (RRMS), according to study results presented at the 8th Joint American Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) MSVirtual2020 event, held September 11-13, 2020.
Study researchers sought to compare the clinical effectiveness of natalizumab, fingolimod, and BRACETd in patients with RES RRMS. To do so, they conducted an analysis of patient data taken from the online international MSBase registry. Specifically, the investigators identified adult patients with RRMS who reported ≥2 relapses in the past 12 months and had available baseline Expanded Disability Status Scale scores. Patients were either treatment naïve or had switched from BRACETD to natalizumab, fingolimod, or another BRACETD.
Propensity score matching 1:1:1 resulted in 721 triplets of patients with RRMS who had a mean follow up of about 3 years. Investigators compared groups in terms of their annualized relapse rates (ARRs). Additional outcomes, assessed using Cox marginal regression models, included time to first relapse, 6-month confirmed disability worsening (CDW), and 6-month confirmed disability improvement (CDI).
Between 23.3% and 23.9% of patients in each group were treatment naïve. The ARR was significantly lower with natalizumab (ARR, 0.18; 95% CI, 0.17–0.20) compared with fingolimod (ARR, 0.29; 95% CI, 0.26–0.31) and BRACETD (ARR, 0.39; 95% CI, 0.37–0.42; P <.001 for all comparisons). The rate ratio for natalizumab vs BRACETD was 0.46 (95% CI, 0.42–0.53) and 0.72 (95% CI, 0.65–0.80) for fingolimod vs BRACETD.
The risk of first relapse was significantly lower with natalizumab compared with fingolimod (hazard ratio [HR], 0.63; 95% CI, 0.53–0.74) or BRACETD (HR, 0.41; 95% CI, 0.36–0.48; P <.001 for both). Additionally, the risk of first relapse was lower with fingolimod vs BRACETD (HR, 0.66; 95% CI, 0.57–0.76; P <.001).
There were no differences between the groups regarding CDW. A 6-month CDI was significantly more likely with natalizumab compared with fingolimod (HR, 1.25; 95% CI, 1.01–1.55; P =.047) or BRACETD (HR, 1.46; 95% CI, 1.16–1.85; P =.002). No difference was found between fingolimod and BRACETD for CDI (HR, 1.17; 95% CI, 0.91–1.50; P =.209).
Disclosure: This clinical trial was supported by Biogen. Please see the original reference for a full list of authors’ disclosures.
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Spelman T, Acosta C, Hyde R, et al. Comparative effectiveness of natalizumab, fingolimod, and first-line therapies for rapidly evolving severe relapsing-remitting multiple sclerosis. Presented at: 8th Joint American Committee for Treatment and Research in Multiple Sclerosis and European Committee for Treatment and Research in Multiple Sclerosis MSVirtual2020 event; September 11-13, 2020. Abstract P0859.