Teriflunomide reduces relapses with sequelae and relapses leading to hospitalizations: results from the TOWER studyReport as inadecuate

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Journal of Neurology

, Volume 261, Issue 9, pp 1781–1788

First Online: 28 June 2014Received: 29 May 2014Accepted: 01 June 2014


Teriflunomide is a once-daily oral immunomodulator approved for the treatment of relapsing–remitting multiple sclerosis. This post hoc analysis of the Phase III TOWER study evaluated the effects of teriflunomide treatment on five severe relapse outcomes: relapses with sequelae defined by an increase in Expanded Disability Status Scale EDSS-functional system FS score sequelae-EDSS-FS 30 days post relapse; relapses with sequelae defined by the investigator sequelae-investigator; relapses leading to hospitalization; relapses treated with intravenous corticosteroids; and intense relapses using the definition of Panitch et al. from the EVIDENCE study based on specified increases in EDSS for severe relapses. Adjusted annualized rates for the five severe relapse outcomes were derived using a Poisson model with robust error variance, with treatment, baseline EDSS strata and region as covariates. Compared with placebo, teriflunomide significantly reduced annualized rates of relapses with sequelae-EDSS-FS 14 mg, 36.6 % p = 0.0021; 7 mg, 31.3 % p = 0.0104 and sequelae-investigator 14 mg only, 53.5 % p = 0.0004, relapses leading to hospitalization 14 mg only, 33.6 % p = 0.0155, relapses requiring intravenous corticosteroids 14 mg, 35.7 % p = 0.0002; 7 mg, 21.5 % p = 0.0337, and intense relapses 14 mg only, 52.5 % p = 0.0015. Patients treated with teriflunomide 14 mg spent significantly fewer nights in hospital for relapse p = 0.009 and had lower annualized rates of all hospitalizations p = 0.030. Taken together, the positive effects of teriflunomide on severe relapses indicate that teriflunomide may reduce relapse-related healthcare costs.

KeywordsClinical trial Economics Multiple sclerosis Outcome assessment healthcare Teriflunomide Electronic supplementary materialThe online version of this article doi:10.1007-s00415-014-7395-7 contains supplementary material, which is available to authorized users.

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Author: Aaron E. Miller - Richard Macdonell - Giancarlo Comi - Mark S. Freedman - Ludwig Kappos - Mathias Mäurer - Tomas P. Ols

Source: https://link.springer.com/

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