1. Alemtuzumab treatment for multiple sclerosis in Austria: An observational long‐term outcome study.
- Author
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Moser, Tobias, Foettinger, Fabian, Hitzl, Wolfgang, Novotna, Bianka, Berger, Thomas, Bsteh, Gabriel, Di Pauli, Franziska, Hegen, Harald, Kornek, Barbara, Langenscheidt, Dieter, and Sellner, Johann
- Subjects
MULTIPLE sclerosis ,ALEMTUZUMAB ,MONOCLONAL antibodies ,DISEASE progression ,CONFIDENCE intervals - Abstract
Background/Objective: Observational real‐world study to analyze the clinical effects of alemtuzumab (ALEM) and subsequent disease‐modifying therapy (DMT) usage in multiple sclerosis (MS). Methods: Data retrieved from the Austrian MS treatment registry (AMSTR) included baseline (BL) characteristics (at ALEM start), annualized relapse rate (ARR), 6‐month confirmed progression independent of relapse activity (PIRA; ≥ 0.5‐point Expanded Disability Status Scale (EDSS) score increase), 6‐month confirmed disability improvement (CDI; ≥ 0.5‐point EDSS decrease), and safety outcomes until initiation of a subsequent DMT. The EDSS was re‐baselined at 30 days from ALEM start (BL EDSS). Results: Eighty‐seven ALEM‐treated patients (median age: 32 years, 72% female, 14% treatment‐naïve) were followed for a median of 55 (interquartile range 31–68) months. We found significant reductions in the ARR from 1.16 before ALEM to 0.15 throughout Years 1–9 (p < 0.001). Subsequent DMTs were initiated in 19 patients (22%, 74% anti‐CD20 monoclonal antibodies). At Year 5 (n = 53), more patients achieved CDI (58%, 95% confidence interval (CI) 45%–71%) than had experienced PIRA (14%, CI 7.5%–24%), and 58% remained relapse‐free. Shorter MS duration (p < 0.001, hazard ratio (HR) 0.86 (CI 0.80–0.93)) and no previous high‐efficacy treatment (p < 0.001, HR 5.16 (CI 2.66–10.0)) were the best predictors of CDI, while PIRA was associated with a higher number of previous DMTs (p = 0.04, HR 3.06, CI 1.05–8.89). We found no new safety signals. Interpretation: ALEM had long‐lasting beneficial effects on the ARR and disability improvement, especially when initiated early in the course of the disease. Only a subset of patients received subsequent DMTs. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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