Maria Pia Sormani1, Mark S Freedman2, Julie Aldridge3, Kurt Marhardt4, Ludwig Kappos5, Nicola De Stefano6. 1. Department of Health Sciences (DISSAL), University of Genoa and Ospedale Policlinico San Martino IRCCS, Via Pastore 1, 16132, Genova, Italy. Electronic address: mariapia.sormani@unige.it. 2. University of Ottawa and the Ottawa Hospital Research Institute, 501 Smyth Box 511, Ottawa, ON K1H 8L6, Canada. 3. EMD Serono Research & Development Institute Inc., 45 Middlesex Turnpike, Billerica, MA 01821-3936, USA. 4. Merck GmbH, Zimbagasse 5, 1147 Vienna, Austria. 5. Research Center Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Departments of Medicine, Clinical Research and Biomedical Engineering, University Hospital and University of Basel, Switzerland. 6. Department of Medicine, Surgery and Neuroscience, University of Siena, Viale Bracci 2, 53100, Siena, Italy.
Abstract
BACKGROUND: Subcutaneous (sc) interferon (IFN) β-1a reduces relapse rates and delays disability progression in patients with MS. We examined the association of the year 1 Magnetic Resonance Imaging in MS (MAGNIMS) score with long-term clinical disease activity (CDA) -free status and confirmed disability progression in patients treated with sc IFN β-1a in PRISMS. METHODS: Patients treated with sc IFN β-1a three-times-weekly (22 or 44 μg; pooled data) were classified by MAGNIMS score (0, n = 129; 1, n = 108; 2, n = 130) at year 1. Hazard ratios (HR; 95% confidence intervals [CI]) for risk of CDA and confirmed Expanded Disability Status Score (EDSS) progression were calculated by MAGNIMS score for up to 15 years of follow-up. RESULTS: The risk of CDA was higher with a year 1 MAGNIMS score of 1 versus 0 (HR 1.82 [1.38-2.41]), 2 versus 0 (2.63 [2.01-3.45]) and 2 versus 1 (1.45 [1.11-1.89], all p < 0.0001). The same outcome was observed with the risk of confirmed EDSS progression (1 versus 0: 1.93 [1.23-3.02]; 2 versus 0: 2.95 [1.95-4.46]; 2 versus 1: 1.53 [1.05-2.23]; all p < 0.0001). CONCLUSION: In PRISMS, MAGNIMS score at Year 1 predicted risk of CDA and confirmed disability progression in sc IFN β-1a-treated patients over up to 15 years. PRISMS-15 clinicaltrial.gov identifier: NCT01034644.
BACKGROUND: Subcutaneous (sc) interferon (IFN) β-1a reduces relapse rates and delays disability progression in patients with MS. We examined the association of the year 1 Magnetic Resonance Imaging in MS (MAGNIMS) score with long-term clinical disease activity (CDA) -free status and confirmed disability progression in patients treated with sc IFN β-1a in PRISMS. METHODS:Patients treated with sc IFN β-1a three-times-weekly (22 or 44 μg; pooled data) were classified by MAGNIMS score (0, n = 129; 1, n = 108; 2, n = 130) at year 1. Hazard ratios (HR; 95% confidence intervals [CI]) for risk of CDA and confirmed Expanded Disability Status Score (EDSS) progression were calculated by MAGNIMS score for up to 15 years of follow-up. RESULTS: The risk of CDA was higher with a year 1 MAGNIMS score of 1 versus 0 (HR 1.82 [1.38-2.41]), 2 versus 0 (2.63 [2.01-3.45]) and 2 versus 1 (1.45 [1.11-1.89], all p < 0.0001). The same outcome was observed with the risk of confirmed EDSS progression (1 versus 0: 1.93 [1.23-3.02]; 2 versus 0: 2.95 [1.95-4.46]; 2 versus 1: 1.53 [1.05-2.23]; all p < 0.0001). CONCLUSION: In PRISMS, MAGNIMS score at Year 1 predicted risk of CDA and confirmed disability progression in sc IFN β-1a-treated patients over up to 15 years. PRISMS-15 clinicaltrial.gov identifier: NCT01034644.
Authors: Ingrid Anne Lie; Sezgi Kaçar; Kristin Wesnes; Iman Brouwer; Silje S Kvistad; Stig Wergeland; Trygve Holmøy; Rune Midgard; Alla Bru; Astrid Edland; Randi Eikeland; Sonia Gosal; Hanne F Harbo; Grethe Kleveland; Yvonne S Sørenes; Nina Øksendal; Kristin N Varhaug; Christian A Vedeler; Frederik Barkhof; Charlotte E Teunissen; Lars Bø; Øivind Torkildsen; Kjell-Morten Myhr; Hugo Vrenken Journal: J Neurol Neurosurg Psychiatry Date: 2022-06-01 Impact factor: 13.654