BACKGROUND: The results of head-to-head comparisons of injectable immunomodulators (interferon β, glatiramer acetate) have been inconclusive and a comprehensive analysis of their effectiveness is needed. OBJECTIVE: We aimed to compare, in a real-world setting, relapse and disability outcomes among patients with multiple sclerosis (MS) treated with injectable immunomodulators. METHODS: Pairwise analysis of the international MSBase registry data was conducted using propensity-score matching. The four injectable immunomodulators were compared in six head-to-head analyses of relapse and disability outcomes using paired mixed models or frailty proportional hazards models adjusted for magnetic resonance imaging variables. Sensitivity and power analyses were conducted. RESULTS: Of the 3326 included patients, 345-1199 patients per therapy were matched (median pairwise-censored follow-up was 3.7 years). Propensity matching eliminated >95% of the identified indication bias. Slightly lower relapse incidence was found among patients treated with glatiramer acetate or subcutaneous interferon β-1a relative to intramuscular interferon β-1a and interferon β-1b (p≤0.001). No differences in 12-month confirmed progression of disability were observed. CONCLUSION: Small but statistically significant differences in relapse outcomes exist among the injectable immunomodulators. MSBase is sufficiently powered to identify these differences and reflects practice in tertiary MS centres. While the present study controlled indication, selection and attrition bias, centre-dependent variance in data quality was likely.

AORN San Giuseppe Moscati Avellino Italy

Assaf Harofeh Medical Center Beer Yaakov Israel

Brain and Mind Research Institute Sydney Australia

Centro Internacional de Restauracion Neurologica Havana Cuba

Cliniques Universitaires Saint Luc Brussels Belgium

Craigavon Area Hospital Portadown UK

Department NEUROFARBA Section of Neurosciences University of Florence Florence Italy

Department of Basic Medical Sciences Neuroscience and Sense Organs University of Bari Bari Italy These authors contributed equally to the manuscript

Department of Medicine University of Melbourne Melbourne Australia and Department of Neurology Royal Melbourne Hospital Melbourne Australia

Department of Medicine University of Melbourne Melbourne Australia Department of Neurology Royal Melbourne Hospital Melbourne Australia and Department of Neurology Box Hill Hospital Monash University Box Hill Australia

Department of Neurology and Center of Clinical Neuroscience 1st Faculty of Medicine General University Hospital and Charles University Prague Czech Republic

Flinders University and Medical Centre Adelaide Australia

Groen Hart Ziekenhuis Gouda the Netherlands

Hôpital Notre Dame Montreal Canada

Hospital Italiano Buenos Aires Argentina

Hospital Universitario Virgen de Valme Seville Spain

Hospital Universitario Virgen Macarena Sevilla Spain

Hotel Dieu de Levis Quebec Canada

INEBA Buenos Aires Argentina

Jewish General Hospital Montreal Canada

John Hunter Hospital Newcastle Australia

Karadeniz Technical University Trabzon Turkey

MS Center Neuroscience Imaging and Clinical Sciences University 'G d'Annunzio' Chieti Italy

National Neurological Institute C Mondino Pavia Italy

Neuro Rive Sud Hôpital Charles LeMoyne Quebec Canada

Orbis Medical Center Sittard the Netherlands

Ospedale di Macerata Macerata Italy

Ospedali Riuniti di Salerno Salerno Italy

St Vincent's Hospital Melbourne Australia

University Hospital San Carlos IdISSC Madrid Spain

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