Emanuele D'Amico1, Aurora Zanghì2, Mariangela Sciandra3, Roberta Lanzillo4, Graziella Callari5, Antonio Cortese6, Giacomo Lus7, Matteo Lucchini8, Maria Buccafusca9, Simona Bonavita10, Antonio Gallo11, Erica Curti12, Alberto Gajofatto13, Elisabetta Signoriello7, Alvino Bisecco11, Francesca Gobbin13, Maria Teresa Ferrò14, Gina Ferrazzano15, Maddalena Sparaco10, Paola Valentino16, Massimiliano Mirabella8, Franco Granella12, Vincenzo Bresciamorra4, Luigi Maria Edoardo Grimaldi5, Francesco Patti2. 1. Department "G.F. Ingrassia", MS Center University of Catania, Policlinico G. Rodolico, V. Santa Sofia 78, 95123, Catania, Italy. emanuele.damico@unict.it. 2. Department "G.F. Ingrassia", MS Center University of Catania, Policlinico G. Rodolico, V. Santa Sofia 78, 95123, Catania, Italy. 3. Department of Economics, Business and Statistics", University of Palermo, Palermo, Italy. 4. Multiple Sclerosis Clinical Care and Research Centre, Department of Neuroscience, Reproductive Science and Odontostomatology, Federico II University of Naples, Naples, Italy. 5. Institute Foundation "G. Giglio", Cefalù, Italy. 6. San Filippo Neri Hospital - ASL, Roma 1, Rome, Italy. 7. Multiple Sclerosis Center, II Division of Neurology, Department of Clinical and Experimental Medicine, Second University of Naples, Naples, Italy. 8. Fondazione Policlinico Universitario "Gemelli", Catholic University of Sacred Heart, Rome, Italy. 9. Azienda Ospedaliera Universitaria "G. Martino", Messina, Italy. 10. Department of Advanced Medical and Surgical Sciences, University of Campania "Luigi Vanvitelli", Naples, Italy. 11. University of Campania Luigi Vanvitelli, 1st Clinic of Neurology, Naples, Italy. 12. AOU Maggiore, Parma, Italy. 13. Policlinico G.B. Rossi, Verona, Italy. 14. Neuroimmunology, Center for Multiple Sclerosis, ASST, Crema, Italy. 15. University La Sapienza, Rome, Italy. 16. Azienda Ospedaliera Universitaria "Mater Domini", Catanzaro, Italy.
Abstract
BACKGROUND: The introduction of oral disease-modifying therapies (DMTs) for relapsing-remitting multiple sclerosis (RRMS) changed algorithms of RRMS treatment. OBJECTIVES: To compare the effectiveness of treatment with dimethyl fumarate (DMF) and teriflunomide (TRF) in a large multicentre Italian cohort of RRMS patients. MATERIALS AND METHODS: Patients with RRMS who received treatment with DMF and TRF between January 1st, 2012 and December 31st, 2018 from twelve MS centers were identified. The events investigated were "time-to-first-relapse", "time-to-Magnetic-Resonance-Imaging (MRI)-activity" and "time-to-disability-progression". RESULTS: 1445 patients were enrolled (1039 on DMF, 406 on TRF) and followed for a median of 34 months. Patients on TRF were older (43.5 ± 8.6 vs 38.8 ± 9.2 years), with a predominance of men and higher level of disability (p < 0.001 for all). Patients on DMF had a higher number of relapses and radiological activity (p < .05) at baseline. Time-varying Cox-model for the event "time-to-first relapse" revealed that no differences were found between the two groups in the first 38 months of treatment (HRt < 38DMF = 0.73, CI = 0.52 to 1.03, p = 0.079). When the time-on-therapy exceeds 38 months patients on DMF had an approximately 0.3 times lower relapse hazard risk than those who took TRF (HRt>38DMF = 3.83, CI = 1.11 to 13.23, p = 0.033). Both DMTs controlled similarly MRI activity and disability progression. CONCLUSIONS: Patients on DMF had higher relapse-free survival time than TRF group after the first 38 months on therapy.
BACKGROUND: The introduction of oral disease-modifying therapies (DMTs) for relapsing-remitting multiple sclerosis (RRMS) changed algorithms of RRMS treatment. OBJECTIVES: To compare the effectiveness of treatment with dimethyl fumarate (DMF) and teriflunomide (TRF) in a large multicentre Italian cohort of RRMS patients. MATERIALS AND METHODS:Patients with RRMS who received treatment with DMF and TRF between January 1st, 2012 and December 31st, 2018 from twelve MS centers were identified. The events investigated were "time-to-first-relapse", "time-to-Magnetic-Resonance-Imaging (MRI)-activity" and "time-to-disability-progression". RESULTS: 1445 patients were enrolled (1039 on DMF, 406 on TRF) and followed for a median of 34 months. Patients on TRF were older (43.5 ± 8.6 vs 38.8 ± 9.2 years), with a predominance of men and higher level of disability (p < 0.001 for all). Patients on DMF had a higher number of relapses and radiological activity (p < .05) at baseline. Time-varying Cox-model for the event "time-to-first relapse" revealed that no differences were found between the two groups in the first 38 months of treatment (HRt < 38DMF = 0.73, CI = 0.52 to 1.03, p = 0.079). When the time-on-therapy exceeds 38 months patients on DMF had an approximately 0.3 times lower relapse hazard risk than those who took TRF (HRt>38DMF = 3.83, CI = 1.11 to 13.23, p = 0.033). Both DMTs controlled similarly MRI activity and disability progression. CONCLUSIONS:Patients on DMF had higher relapse-free survival time than TRF group after the first 38 months on therapy.
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