Age-dependent response to initial highly effective treatment in relapsing multiple sclerosis
Year: 2025
Type: article
Study design: Observational Study
Abstract: Objectives: To assess the impact of age on the superiority of highly effective (HE) disease-modifying treatments (DMTs) compared to platform DMTs in a real-world population of relapsing MS patients (pwMS). Methods: A total of 20,984 pwMS were extracted from the Italian Multiple Sclerosis Register with a diagnosis of Clinically Isolated Syndrome or Relapsing-Remitting MS, at least four Expanded Disability Status Scale (EDSS) evaluations and 2 years follow-up, starting DMT. The baseline was the nearest visit to the first DMT starting date. The risk of first 24-week confirmed disability accumulation (CDA) on EDSS in HE versus platform DMTs after 2 years and the entire follow-up was assessed through Cox regression models. Results: After 1:1 propensity score matching, we evaluated 1698 pwMS initiating HE-DMTs and 1698 initiating platforms. After 2 years follow-up, the proportion of CDA events was lower in patients on HE-DMTs (12.2%) than those on platform DMTs (15%), as confirmed by Cox regression analysis (hazard ratio (HR) = 0.22, 95% confidence interval (CI) = 0.10–0.47; p < 0.001). HE-DMTs were more effective in patients under 45 years of age (HR = 0.49, 95% CI = 0.39–0.63; p < 0.001), but not in patients over 45 (HR = 0.77, 95% CI = 0.54–1.08, p = 0.125). Notably, prolonged exposure to any DMT during follow-up reduced disability accumulation even in patients over 45 (HR = 0.13, 95% CI = 0.02–0.99; p = 0.050). Conclusion: This real-world study of relapsing pwMS demonstrates that the benefit of initial HE treatment diminishes with age. However, even in older patients, DMT exposure, regardless of the efficacy level, appears to reduce disability accumulation, and so, on an individual level, initial HE treatment could still be more effective.
Source: Multiple Sclerosis Journal
Authors: Emilio Portaccio, Matteo Betti, Ermelinda De Meo, Luisa Pastò, Lorenzo Razzolini, Francesco Patti, Vincenzo Brescia Morra, Giovanna De Luca, Carlo Pozzilli, Carla Tortorella, Eleonora Cocco, Giuseppe Salemi, Diana Ferraro, Marika Vianello, Giacomo Lus, Alessandra Lugaresi, Matilde Inglese, Gioacchino Tedeschi, Sara Montepietra, Alessia Di Sapio, Mauro Zaffaroni, Pietro Iaffaldano, Marta Simone, Massimo Filippi, Maria Trojano, Maria Pia Amato
Institutions: University of Florence, National Hospital for Neurology and Neurosurgery, UCL Queen Square Institute of Neurology, University College London, University of Catania, Federico II University Hospital, University of Naples Federico II, University of Chieti-Pescara, Ospedale SS. Annunziata, Sapienza University of Rome, Azienda Ospedaliera San Camillo-Forlanini, University of Cagliari, University of Palermo, Azienda Ospedaliero-Universitaria di Modena, Ca' Foncello Hospital, University of Campania "Luigi Vanvitelli", Istituto delle Scienze Neurologiche di Bologna, University of Bologna, Ospedale Policlinico San Martino, University of Genoa, Azienda Sanitaria Unità Locale di Reggio Emilia, Ospedale San Luigi Gonzaga, Azienda Socio Sanitaria Territoriale della Valle Olona, University of Bari Aldo Moro, Vita-Salute San Raffaele University, IRCCS Ospedale San Raffaele, Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele, Don Carlo Gnocchi Foundation
Language: English
Subfield: Pathology and Forensic Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W4411459552