Teriflunomide reduces relapse-related neurological sequelae, hospitalizations and steroid use

Abstract

Multiple sclerosis (MS) relapses impose a substantial clinical and economic burden. Teriflunomide is a new oral disease-modifying therapy approved for the treatment of relapsing MS. We evaluated the effects of teriflunomide treatment on relapse-related neurological sequelae and healthcare resource use in a post hoc analysis of the Phase III TEMSO study. Confirmed relapses associated with neurological sequelae [defined by an increase in Expanded Disability Status Scale/Functional System (sequelae-EDSS/FS) ≥30 days post relapse or by the investigator (sequelae-investigator)] were analyzed in the modified intention-to-treat population (n = 1086). Relapses requiring hospitalization or intravenous (IV) corticosteroids, all hospitalizations, emergency medical facility visits (EMFV), and hospitalized nights for relapse were also assessed. Annualized rates were derived using a Poisson model with treatment, baseline EDSS strata, and region as covariates. Risks of sequelae and hospitalization per relapse were calculated as percentages and groups were compared with a χ2 test. Compared with placebo, teriflunomide reduced annualized rates of relapses with sequelae-EDSS/FS [7 mg by 32 % (p = 0.0019); 14 mg by 36 % (p = 0.0011)] and sequelae-investigator [25 % (p = 0.071); 53 % (p < 0.0001)], relapses leading to hospitalization [36 % (p = 0.015); 59 % (p < 0.0001)], and relapses requiring IV corticosteroids [29 % (p = 0.001); 34 % (p = 0.0003)]. Teriflunomide-treated patients spent fewer nights in hospital for relapse (p < 0.01). Teriflunomide 14 mg also decreased annualized rates of all hospitalizations (p = 0.01) and EMFV (p = 0.004). The impact of teriflunomide on relapse-related neurological sequelae and relapses requiring healthcare resources may translate into reduced healthcare costs.Electronic supplementary materialThe online version of this article (doi:10.1007/s00415-013-6979-y) contains supplementary material, which is available to authorized users.

Teriflunomide reduces relapses with sequelae and relapses leading to hospitalizations: results from the TOWER study

“…These results are consistent with those observed in a similar analysis of the Phase III TEMSO study [13]. Thus, in conclusion, teriflunomide has demonstrated consistent and beneficial outcomes on relapses with sequelae and relapses requiring healthcare resources compared with placebo across two Phase III clinical trials.…”

“…These results are consistent with those seen in the TEMSO study [13] and supplement the limited number of studies associating disease-modifying therapies with fewer hospitalizations [16–19]. Limiting the number of nights spent in hospital is a challenge.…”

“…Consistent with observations in TOWER and TEMSO [13], respectively, teriflunomide significantly reduced occurrence of severe relapses, including relapses with sequelae and relapses requiring healthcare resources vs. placebo (Supplementary Table 1). In addition, the annualized rate of all hospitalizations was significantly reduced with teriflunomide 14 mg but not with teriflunomide 7 mg vs. placebo (Supplementary Table 2).…”

Teriflunomide for multiple sclerosis in real-world setting

“…3,4 Resting and slowly dividing cells are less affected, because the DHODH-independent salvage pathway provides enough pyrimidine. [8][9][10][11][12][13][14][15] In another phase 3 trial (TENERE), the efficacy of 14 mg teriflunomide was similar to high-dose subcutaneous interferon-beta-1a, but treatment satisfaction was greater. [5][6][7] The efficacy and safety of teriflunomide were examined in several clinical trials and follow-up studies.…”

“…In the two phase 3 trials of TEMSO and TOWER, 14 mg teriflunomide daily reduced the annualized relapse rate by 31.5% and 36.3%, compared to placebo. [8][9][10][11][12][13][14][15] In another phase 3 trial (TENERE), the efficacy of 14 mg teriflunomide was similar to high-dose subcutaneous interferon-beta-1a, but treatment satisfaction was greater. 16 A fourth phase 3 trial showed reduced risk of relapses defining clinically definite multiple sclerosis (TOPIC).…”