Relapses During High-Dose Biotin Treatment in Progressive Multiple Sclerosis: a Case-Crossover and Propensity Score-Adju
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ORIGINAL ARTICLE
Relapses During High-Dose Biotin Treatment in Progressive Multiple Sclerosis: a Case-Crossover and Propensity Score-Adjusted Prospective Cohort Pierre Branger 1 Gilles Defer 1
&
Jean-Jacques Parienti 2 & Nathalie Derache 1 & Nizam Kassis 3 & Rana Assouad 4 & Elisabeth Maillart 4 &
# The American Society for Experimental NeuroTherapeutics, Inc. 2020
Abstract High-dose biotin (HDB) is a therapy used in non-active progressive multiple sclerosis (PMS). Some reports have suggested that HDB treatment may be associated with an increased risk of relapse. We evaluate the relationship between exposure to HDB for treating PMS and the risk of relapse. We screened for PMS patients prospectively registered in a French regional cohort being part of the OFSEP national registry. In a case-crossover design among patients who received HDB, we first compared number of relapses before and after initiation of HDB. Second, time to the first clinical relapse was compared between patients who received HDB (biotin group) and a control group using a Cox survival analysis after a propensity score (PS) matching (1:1) and inverse probability of treatment weighting (IPTW) method. In the 42 PMS patients who received HDB, the number of relapses was statistically and clinically significant higher after biotin initiation than before biotin initiation (incident rate ratio [IRR] 7.4, 95% confidence interval [CI] 3.5– 15.9, p < 0.0001). With the PS matching method, the risk of relapse was significantly higher in the biotin group compared to the control group (hazard ratio [HR] 4.3, 95% CI 1.4–13.3, p = 0.01). The IPTW method with 440 control patients revealed consistent results (HR 5.1, 95% CI 2.3–11.3, p < 0.0001). In our non-randomized study, HDB treatment for PMS was associated with an increased risk of relapse. The follow-up of PMS patients initiating HDB should include careful assessment of clinical and radiological activity to monitor the potential pro-inflammatory effect of biotin. Key Words Multiple sclerosis . relapses . biotin . progressive . propensity score
Abbreviations HDB High-dose biotin MS Multiple sclerosis Electronic supplementary material The online version of this article (https://doi.org/10.1007/s13311-020-00880-z) contains supplementary material, which is available to authorized users. * Pierre Branger [email protected] 1
Department of Neurology, CHU de Caen, F-14000 Caen, France
2
Department of Clinical Research and Biostatistics, CHU de Caen, F-14000 Caen, France
3
Department of Neurology, CHP du Cotentin, F-50102 Cherbourg-en-Cotentin, France
4
Department of Neurology, GH Pitié-Salpêtrière, F-75013 Paris VI, France
PMS ARR PS IPWT
Progressive multiple sclerosis Annualized relapse rate Propensity score Inverse probability of treatment weighting
Introduction Progressive multiple sclerosis (PMS) can be categorized as active or non-active depending inflammatory activity [1]. New therapies have recently demonstrated some efficacy in PMS. Ocrelizumab was associated with lower rates of clinical an
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