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

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.
Competing Interests: Conflict of interest statement: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: ED, GC, GB, AG, and MB received personal fees from Biogen and Sanofi. ED, GC, GB, AG, PV, and MB received travel funding from Bayer Biogen and Merck. AZ received travel funding from Bayer Schering and Sanofi Genzyme outside the submitted work. PV received personal fees from Biogen, Sanofi, Novartis, and Roche. SC and GS received personal fees for speaking activities from Bayer Biogen, Merck, Novartis, and Teva. PR received travel expenses or honoraria for consultancy from Merck Serono, Biogen idec, Novartis, Sanofi Genzyme, and Teva. RBB served on the advisory board for Almirall and received grants for congress participation from Sanofi and Merck. LMEG and CP served on advisory boards for Bayer, Biogen, Celgene, Merck, Novartis, Roche, Sanofi, and Teva. LMEG and CP also received personal fees for speaking activities at congresses or sponsored symposia. GT, MZ, and FP served on advisory boards for Bayer, Biogen, Celgene, Merck, Novartis, Roche, Sanofi, Teva, and Almirall. GT, MZ, and FP also received personal fees for speaking activities at congresses or sponsored symposia.