Dataset Information

Efficacy of alemtuzumab in relapsing-remitting MS patients who received additional courses after the initial two courses: Pooled analysis of the CARE-MS, extension, and TOPAZ studies.

ABSTRACT: Background: Alemtuzumab is given as two annual courses. Patients with continued disease activity may receive as-needed additional courses.

Objective: To evaluate efficacy and safety of additional alemtuzumab courses in the CARE-MS (Comparison of Alemtuzumab and Rebif^® Efficacy in Multiple Sclerosis) studies and their extensions.

Methods: Subgroups were based on the number of additional alemtuzumab courses received. Exclusion criteria: other disease-modifying therapy (DMT); <12-month follow-up after last alemtuzumab course.

Results: In the additional-courses groups, Courses 3 and 4 reduced annualized relapse rate (12?months before: 0.73 and 0.74, respectively; 12?months after: 0.07 and 0.08). For 36?months after Courses 3 and 4, 89% and 92% of patients were free of 6-month confirmed disability worsening, respectively, with 20% and 26% achieving 6-month confirmed disability improvement. Freedom from magnetic resonance imaging (MRI) disease activity increased after Courses 3 and 4 (12?months before: 43% and 53%, respectively; 12?months after: 73% and 74%). Safety was similar across groups; serious events occurred irrespective of the number of courses.

Conclusion: Additional alemtuzumab courses significantly improved outcomes, without increased safety risks, in CARE-MS patients with continued disease activity after Course 2. How this compares to outcomes if treatment is switched to another DMT instead remains unknown.

SUBMITTER: Comi G

PROVIDER: S-EPMC7720359 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Efficacy of alemtuzumab in relapsing-remitting MS patients who received additional courses after the initial two courses: Pooled analysis of the CARE-MS, extension, and TOPAZ studies.

Comi Giancarlo G Alroughani Raed R Boster Aaron L AL Bass Ann D AD Berkovich Regina R Fernández Óscar Ó Kim Ho Jin HJ Limmroth Volker V Lycke Jan J Macdonell Richard Al RA Sharrack Basil B Singer Barry A BA Vermersch Patrick P Wiendl Heinz H Ziemssen Tjalf T Jacobs Alan A Daizadeh Nadia N Rodriguez Claudio E CE Traboulsee Anthony A

Multiple sclerosis (Houndmills, Basingstoke, England) 20191125 14

<h4>Background</h4>Alemtuzumab is given as two annual courses. Patients with continued disease activity may receive as-needed additional courses.<h4>Objective</h4>To evaluate efficacy and safety of additional alemtuzumab courses in the CARE-MS (Comparison of Alemtuzumab and Rebif<sup>®</sup> Efficacy in Multiple Sclerosis) studies and their extensions.<h4>Methods</h4>Subgroups were based on the number of additional alemtuzumab courses received. Exclusion criteria: other disease-modifying therapy ...[more]

PMID: 31762387

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Project description:One of our new major finding among the genes that contributes to MS susceptibility is ICSBP1. The so called disease modifying therapies like interferon-beta (IFN-β), possibly acting on the peripheral T-cells, reduce the disease activity and the clinical progression, with a MRI-detectable effect in preventing lesion burden and cerebral atrophy development in RR-MS. It suggests a critical role of peripheral blood mononuclear cells (PBMCs) immune response and modulation in developing inflammation in the brain. We tested the hypothesis that the genetic effect of the susceptible allele ICSBP1 can impact the gene expression profile of molecules belonging to the interferon pathway. We therefore interrogated the PBMC for changes in gene expression profile. We correlate those changes with the minor allele frequency for ICSBP1, performing independent quantitative trait analysis for each treatment category. Expression Quantitative Trait Loci Association with a p value < 0.05 have been used in follow up analysis. The regression coefficient of the Quantitative trait association represents the degree of correlation between the gene expression for each interrogated target gene and the minor allele frequency of the SNP for our gene of interest. This coefficient has been used as input in the subsequent Gene Set Enrichment Analysis performed in a pre-ranked approach. The resulting GSEA-SNP method rests on the assumption that SNPs underlying a disease phenotype might affect genes constituting a signaling pathway or genes with a common regulation. Therefore, GSEA-SNP can facilitate the identification of pathways or of underlying biological mechanisms. We used microarrays to capture gene expression profile of untreated subjects and of subjects under disease modyfing treatment (Interferon Beta and Glatiramer Acetate), in order to correlate gene expression and genotype data and in order to identify sets of genes specifically regulated in the different treatment categories.

Dataset Information

Efficacy of alemtuzumab in relapsing-remitting MS patients who received additional courses after the initial two courses: Pooled analysis of the CARE-MS, extension, and TOPAZ studies.

Publications

Efficacy of alemtuzumab in relapsing-remitting MS patients who received additional courses after the initial two courses: Pooled analysis of the CARE-MS, extension, and TOPAZ studies.

Similar Datasets

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