Mathias Granqvist1, Joachim Burman2, Martin Gunnarsson3, Jan Lycke4, Petra Nilsson5, Tomas Olsson1, Peter Sundström6, Anders Svenningsson7, Magnus Vrethem8, Thomas Frisell9, Fredrik Piehl1. 1. Department of Clinical Neuroscience, Center for Molecular Medicine (CMM), Karolinska Institutet, Stockholm, Sweden. 2. Department of Neuroscience, Uppsala University, Uppsala, Sweden. 3. School of Medical Sciences, Örebro University, Örebro, Sweden. 4. Department of Neuroscience and Physiology, Sahlgrenska University Hospital, Göteborg, Sweden. 5. Neurology Clinic, Skåne University Hospital, Lund, Sweden. 6. Department of Pharmacology and Clinical Neuroscience, Umeå University, Umeå, Sweden. 7. Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden. 8. Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden. 9. Clinical Epidemiology Unit, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.
Abstract
BACKGROUND: Population-based real-world evidence studies of the effectiveness and tolerability of dimethyl fumarate in relation to common treatment alternatives are still limited. OBJECTIVE: To evaluate the clinical effectiveness and tolerability of dimethyl fumarate (DMF) as the initial and secondary treatment for relapsing-remitting multiple sclerosis (RRMS) patients compared with common treatment alternatives in Sweden. METHODS: We conducted a nationwide retrospective observational cohort study of all RRMS patients identified through the Swedish MS registry initiating DMF (n = 641) or interferons/glatiramer acetate (IFN/GA; n = 555) as the initial therapy, or DMF (n = 703) or fingolimod (FGL; n = 194) after switch from IFN/GA between 1 January 2014 and 31 December 2016. RESULTS: The discontinuation rate was lower with DMF as the initial treatment than IFN/GA (adjusted hazard rate (HR): 0.46, 95% confidence interval (CI): 0.37-0.58, p < 0.001), but higher than FGL as the secondary treatment (HR: 1.51, CI: 1.08-2.09, p < 0.05). Annualized relapse rate (ARR) was lower with DMF compared to IFN/GA (0.04, CI: 0.03-0.06 vs 0.10, CI: 0.07-0.13; p < 0.05), but not FGL (0.03, CI: 0.02-0.05 vs 0.02, CI: 0.01-0.04; p = 0.41). Finally, time to first relapse (TTFR) was longer with DMF as the initial, but not secondary, therapy (p < 0.05 and p = 0.20, respectively). CONCLUSION: Our findings indicate that DMF performs better than IFN/GA as the initial treatment for RRMS. Compared to FGL, DMF displayed a lower tolerability, but largely similar effectiveness outcomes.
BACKGROUND: Population-based real-world evidence studies of the effectiveness and tolerability of dimethyl fumarate in relation to common treatment alternatives are still limited. OBJECTIVE: To evaluate the clinical effectiveness and tolerability of dimethyl fumarate (DMF) as the initial and secondary treatment for relapsing-remitting multiple sclerosis (RRMS) patients compared with common treatment alternatives in Sweden. METHODS: We conducted a nationwide retrospective observational cohort study of all RRMS patients identified through the Swedish MS registry initiating DMF (n = 641) or interferons/glatiramer acetate (IFN/GA; n = 555) as the initial therapy, or DMF (n = 703) or fingolimod (FGL; n = 194) after switch from IFN/GA between 1 January 2014 and 31 December 2016. RESULTS: The discontinuation rate was lower with DMF as the initial treatment than IFN/GA (adjusted hazard rate (HR): 0.46, 95% confidence interval (CI): 0.37-0.58, p < 0.001), but higher than FGL as the secondary treatment (HR: 1.51, CI: 1.08-2.09, p < 0.05). Annualized relapse rate (ARR) was lower with DMF compared to IFN/GA (0.04, CI: 0.03-0.06 vs 0.10, CI: 0.07-0.13; p < 0.05), but not FGL (0.03, CI: 0.02-0.05 vs 0.02, CI: 0.01-0.04; p = 0.41). Finally, time to first relapse (TTFR) was longer with DMF as the initial, but not secondary, therapy (p < 0.05 and p = 0.20, respectively). CONCLUSION: Our findings indicate that DMF performs better than IFN/GA as the initial treatment for RRMS. Compared to FGL, DMF displayed a lower tolerability, but largely similar effectiveness outcomes.
Authors: Belen Pilo de la Fuente; Julia Sabín; Victoria Galán; Israel Thuissard; Susana Sainz de la Maza; Lucienne Costa-Frossard; Mayra Gómez-Moreno; Judit Díaz-Díaz; Celia Oreja-Guevara; Alberto Lozano-Ros; José M García-Domínguez; Laura Borrego; Lucía Ayuso; Andy Castro; Pedro Sánchez; Virginia Meca-Lallana; Carmen Muñoz; Ignacio Casanova; Carlos López de Silanes; Hugo Martín; Elena Rodríguez-García; Cristina Andreu-Vázquez; Rosario Blasco; Juan A García-Merino; Yolanda Aladro Journal: CNS Drugs Date: 2020-11-23 Impact factor: 5.749