TY - JOUR
T1 - Alemtuzumab treatment for multiple sclerosis in Austria
T2 - An observational long-term outcome study
AU - Moser, Tobias
AU - Foettinger, Fabian
AU - Hitzl, Wolfgang
AU - Novotna, Bianka
AU - Berger, Thomas
AU - Bsteh, Gabriel
AU - Di Pauli, Franziska
AU - Hegen, Harald
AU - Kornek, Barbara
AU - Langenscheidt, Dieter
AU - Sellner, Johann
N1 - Moser, Foettinger, Sellner: Department of Neurology, Christian Doppler Medical Center, Paracelsus Medical University, Salzburg, Austria; Hitzl: Department of Ophthalmology and Optometry, Paracelsus Medical University/Salzburger Landeskliniken (SALK), Salzburg, Austria, Research Program Experimental Ophthalmology and Glaucoma Research, Paracelsus Medical University, Salzburg, Austria, Department of Research and Innovation, Team Biostatistics and Publication of Clinical Trials, Paracelsus Medical University, Salzburg, Austria
PY - 2024/6
Y1 - 2024/6
N2 - 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-na & iuml;ve) 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.
AB - 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-na & iuml;ve) 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.
U2 - 10.1002/acn3.52056
DO - 10.1002/acn3.52056
M3 - Original Article (Journal)
C2 - 38715245
SN - 2328-9503
VL - 11
SP - 1442
EP - 1455
JO - ANNALS OF CLINICAL AND TRANSLATIONAL NEUROLOGY
JF - ANNALS OF CLINICAL AND TRANSLATIONAL NEUROLOGY
IS - 6
ER -