Zero relapses or milder relapses? What would you choose? #MSBlog #MSResearch
“I always tell MSers that DMTs not only reduce the number, but also the severity of relapses. Therefore it is reassuring to see this analysis from the TEMSO trial showing this with teriflunomide. Is this important? Yes, less severe relapses mean cost savings and probably less impact on quality of life. Health economists working for the NHS, or insurance companies, are always looking for ways to prevent us prescribing expensive new DMTs; essentially they want them to be cost-effective. Reducing healthcare resource utilization in relation to relapses helps Pharma make the argument for charging high prices. The other advantage of having less severe relapses for MSers is fewer course of high-dose steroids and hence less side effects and lower chances of those severe and unpredictable adverse events, for example avascular necrosis of the hip. The other advantage of milder relapses is lower chance of relapse associated disability progression and less impact on social and occupational functioning.”
“Can I reconcile this study with my zero tolerance (ZeTo) approach to managing MS? No. I am firmly believe that we need to treat-to-target (T2T) of no evidence of disease activity (NEDA). Therefore any relapse is a sign that you are not responding to treatment and need to move onto a more effective treatment.”
Epub: O’Connor et al.Teriflunomide reduces relapse-related neurological sequelae, hospitalizations and steroid use. J Neurol. 2013 Jul 14.
Background: MS relapses impose a substantial clinical and economic burden. Teriflunomide is a new oral disease-modifying therapy approved for the treatment of relapsing MS.
Objective: These investigators’ 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.
Methods: 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.
Results: 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 MSers 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).
Conclusions: The impact of teriflunomide on relapse-related neurological sequelae and relapses requiring healthcare resources may translate into reduced healthcare costs.