Comparable efficacy and safety of dimethyl fumarate and teriflunomide treatment in Relapsing-Remitting Multiple Sclerosis: an Italian real-word multicenter experience. (September 2018)

• Record Type: Journal Article
• Authors: D'Amico, Emanuele; Zanghì, Aurora; Callari, Graziella; Borriello, Giovanna; Gallo, Antonio; Graziano, Giusi; Valentino, Paola; Buccafusca, Maria; Cottone, Salvatore; Salemi, Giuseppe; Ragonese, Paolo; Bossio, Roberto Bruno; Docimo, Renato; Grimaldi, Luigi Maria Edoardo; Pozzilli, Carlo; Tedeschi, Gioacchino; Zappia, Mario; Patti, Francesco
• Is Part Of: Therapeutic advances in neurological disorders. Volume 11(2018)
• Publication Date: 2018-09
• Subjects: dimethyl fumarate -- efficacy -- no evidence of disease activity 3 -- safety -- teriflunomide; Nervous system -- Diseases -- Periodicals; Nervous system -- Degeneration -- Periodicals; Nervous system -- Diseases -- Treatment -- Periodicals; Nervous System Diseases -- therapy -- Periodicals; Neurodegenerative Diseases -- Periodicals; Système nerveux -- Maladies -- Périodiques; Système nerveux -- Dégénérescence -- Périodiques; Système nerveux; Système nerveux -- Maladies -- Traitement -- Périodiques; 616.805
• DOI: 10.1177/1756286418796404
• Languages: English
• ISSNs: 1756-2856

Abstract

Background: The aim of the study was to evaluate the achievement of 'no evidence of disease activity' (NEDA) over a 12-month period in a large multicenter population with relapsing remitting multiple sclerosis (RRMS) treated with delayed-release dimethyl fumarate (DMF) and teriflunomide (TRF) using a propensity-score adjustment. Methods: A time-to-event method was used to determine the percentages of patients with RRMS (pwRRMS) in both groups achieving NEDA 3 (no relapses, no 12-week confirmed disability progression, and no new T2/gadolinium-enhancing brain lesions). We described the safety profile of the investigated drugs. Results: Of the 587 pwRRMS treated with DMF and the 316 pwRRMS treated with TRF, 468 pwRRMS were successfully paired by propensity score: 234 on DMF and 234 on TRF. The percentages of pwRRMS who achieved NEDA 3 were 80.3% in the DMF group and 77.2% in the TRF group. Serious adverse events occurred in four (1.9%) pwRRMS on DMF and in three (1.3%) pwRRMS on TRF. Conclusions: DMF and TRF significantly impacted RRMS disease activity in our study. Serious safety concerns were recorded in less than 2% of the studied population.