Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2025
A multicentre, prospective, randomized, open-label pragmatic trial to compare the effectiveness and safety of interferon beta-1a and glatiramer-acetate in paediatric patients affected by Multiple Sclerosis.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеКлиническое исследование III фазыPragmatic Clinical TrialСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Simone Marta, Palumbi Roberto, Achille Mariaclara, Micella Stefania, Pascali Mara, Peschechera Antonia, Gabellone Alessandra, Marzulli Lucia, De Giacomo Andrea, Maggi Giulia, Reggiardo Giorgio, Felisi Mariagrazia, Padula Rosa, Bonifazi Donato, Valeriani Massimiliano, Papetti Laura, Lanzillo Roberta, Clerici Valentina Torri, Margari Lucia
Аннотация
BACKGROUND: Paediatric-onset Multiple Sclerosis (POMS) is a rare, highly active disease requiring timely disease-modifying therapy.
OBJECTIVES: This trial compared the efficacy and safety of intramuscular (i.m.) Interferon beta-1a (IFN-beta 1a) and subcutaneous (s.c.) Glatiramer Acetate (GA).
METHODS: A 96-week, Phase IIIb, multicenter, open-label randomized trial enrolled 30 participants (ages 12-17). Patients were randomized into two groups: 15 received i.m. IFN-beta 1a, and 15 received s.c. GA. The primary endpoint was MRI disease activity-free status; secondary outcomes included annualized relapse rate (ARR), time to first relapse, Expanded Disability Status Scale (EDSS), cognitive and fatigue scores, and quality of life.
RESULTS: The groups differed by age but not sex. MRI disease activity-free status did not differ (p = 0.09). ARR was significantly lower in the GA group (0.20; 95% CI 0.08-0.42) than in the IFN-beta 1a group (0.57; 95% CI 0.31-0.95, p = 0.02). EDSS, cognitive, fatigue, and quality-of-life scores were comparable. Notably, 50% of GA patients and 30% of IFN-beta 1a patients switched to higher efficacy treatments.
CONCLUSIONS: Both treatments showed similar efficacy and safety, but early high-efficacy therapy may be preferable for POMS management.
TRIAL REGISTRATION: EudraCT Number: 2017-005129-18. https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-005129-18/IT.
OBJECTIVES: This trial compared the efficacy and safety of intramuscular (i.m.) Interferon beta-1a (IFN-beta 1a) and subcutaneous (s.c.) Glatiramer Acetate (GA).
METHODS: A 96-week, Phase IIIb, multicenter, open-label randomized trial enrolled 30 participants (ages 12-17). Patients were randomized into two groups: 15 received i.m. IFN-beta 1a, and 15 received s.c. GA. The primary endpoint was MRI disease activity-free status; secondary outcomes included annualized relapse rate (ARR), time to first relapse, Expanded Disability Status Scale (EDSS), cognitive and fatigue scores, and quality of life.
RESULTS: The groups differed by age but not sex. MRI disease activity-free status did not differ (p = 0.09). ARR was significantly lower in the GA group (0.20; 95% CI 0.08-0.42) than in the IFN-beta 1a group (0.57; 95% CI 0.31-0.95, p = 0.02). EDSS, cognitive, fatigue, and quality-of-life scores were comparable. Notably, 50% of GA patients and 30% of IFN-beta 1a patients switched to higher efficacy treatments.
CONCLUSIONS: Both treatments showed similar efficacy and safety, but early high-efficacy therapy may be preferable for POMS management.
TRIAL REGISTRATION: EudraCT Number: 2017-005129-18. https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-005129-18/IT.