Role of disease-modifying oral drugs in multiple sclerosis: A systematic review with meta-analysis

Abstract

The purpose of the study was to evaluate the efficacy and safety of cladribine tablets compared with all oral therapies used in patients with relapsing-remitting multiple sclerosis (RRMS). A systematic review of the literature was conducted to identify published clinical trials about RRMS and a network meta-analysis was performed to determine the efficacy and safety of available treatments. We identified seven relevant studies, which were selected based on three criteria that allowed us to construct comparisons of efficacy and safety. Regarding the annualized relapse rate (ARR), there were no significant differences with respect to the decrease of this between cladribine tablets, dimethyl fumarate and fingolimod; although teriflunomide and cladribine tablets showed a significant difference. In relation to the mean number of gadolinium-enhanced T1 lesions, dimethyl fumarate showed a lower number of lesions (-0.85 [-1.21; -0.48]), as did cladribine tablets versus placebo. No statistically significant differences were identified between cladribine tablets and fingolimod (-0.08 [-0.35; 0.19]) and cladribine versus teriflunomide (-0.28 [-0.64; 0.08]). While comparing adverse events that caused discontinuation, cladribine tablets showed an adequate safety profile, which was quantitatively similar to the compared drugs. Cladribine tablets demonstrated efficacy in terms of decrease of ARR and gadolinium-enhanced T1 lesions; although there is no significant difference between cladribine tablets, fingolimod and teriflunomide, the ARR is a stronger measure of efficacy compared to the number of T1 lesions made in contrast with long-term RRMS. Cladribine also demonstrated an adequate safety and tolerability profile promoting therapeutic adherence.