Comparative effectiveness of natalizumab

Background

For treatment of relapsing-remitting multiple sclerosis (RRMS), a broad range of disease-modifying therapies (DMT) is available. However, few comparative effectiveness studies between different drugs have been performed.

Objectives

This study aimed to compare the efficacy and treatment continuation of natalizumab and ocrelizumab in a real-world cohort of patients with relapsing-remitting multiple sclerosis (RRMS) from two German university hospitals.

Methods

We performed a retrospective analysis of RRMS patients who initiated treatment with natalizumab or ocrelizumab between January 2016 and April 2019 at the German university hospitals of Mainz and Düsseldorf. Bayesian propensity score matching was conducted to correct for differences in baseline characteristics. Our primary outcome was no evidence of disease activity [NEDA-3: no relapses, no confirmed disability progression, and no magnetic resonance imaging (MRI) activity] and its subcomponents. Secondary outcomes included measurement of neurofilament light chain (NfL) in serum, analysis of premature discontinuation, and evidence of rebound activity in patients switching from natalizumab to ocrelizumab.

Results

We identified 63 patients starting treatment with natalizumab and 76 patients starting with ocrelizumab. Binary logistic regression showed that treatment with natalizumab or a higher number of relapses in the previous year were independently associated with a higher risk for relapses. Patients receiving natalizumab had a higher probability of premature discontinuation of therapy (

Discussion

This study provides class IV evidence that treatment of RRMS patients with ocrelizumab and natalizumab show comparable effectiveness in combined endpoints, while ocrelizumab might be more effective in preventing the occurrence of relapses.

Informations de copyright

© The Author(s), 2022.

Déclaration de conflit d'intérêts

The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: K.P. reports no disclosures. L.R. received travel reimbursements from Merck Serono and Sanofi Genzyme, research support from Diamed, Merck Serono, and Novartis. Her research is funded by the Interdisciplinary Center for Clinical Studies (IZKF) Muenster. F.S. reports no disclosures. M.M. reports no disclosures. M.K. received honoraria for lecturing and travel expenses for attending meetings from Biogen, Merck Serono, and Novartis. Her research is funded by the German Multiple Sclerosis Society (DMSG) and Novartis. S.G.M. received honoraria for lecturing and travel expenses for attending meetings from Almirall, Amicus Therapeutics Germany, Bayer Health Care, Biogen, Celgene, Diamed, Genzyme, MedDay Pharmaceuticals, Merck Serono, Novartis, Novo Nordisk, ONO Pharma, Roche, Sanofi-Aventis, Chugai Pharma, QuintilesIMS, and Teva. His research is funded by the German Ministry for Education and Research (BMBF), Deutsche Forschungsgemeinschaft (DFG), Else Kröner Fresenius Foundation, German Academic Exchange Service, Hertie Foundation, Interdisciplinary Center for Clinical Studies (IZKF) Muenster, German Foundation Neurology, and by Almirall, Amicus Therapeutics Germany, Biogen, Diamed, Fresenius Medical Care, Genzyme, Merck Serono, Novartis, ONO Pharma, Roche, and Teva. F.Z. has recently received research grants and consultation funds from Biogen, Ministry of Education and Research (BMBF), Bristol Myers Squibb, Celgene, German Research Foundation (DFG), Janssen, Max Planck Society (MPG), Merck Serono, Novartis, Progressive MS Alliance (PMSA), Roche, Sanofi Genzyme, and Sandoz. S.B. has received honoria and compensation for travel from Biogen Idec, Bristol Myers Squibb, Merck Serono, Novartis, Sanofi Genzyme, Roche, and Teva.