Time to treatment failure following initiation of fingolimod versus teriflunomide for multiple sclerosis: a retrospective US claims study

Abstract

Objective: Disease modifying therapies (DMTs) for multiple sclerosis (MS) aim to delay progression and reduce relapses. Evidence is limited on the comparative effectiveness of the oral DMTs fingolimod and teriflunomide. This study evaluated time to treatment failure among patients with MS who initiated fingolimod versus teriflunomide in real-world settings.

Methods: The retrospective cohort included 18–64 year old patients diagnosed with MS who initiated fingolimod or teriflunomide during 12 September 2012 to 30 September 2015 within MarketScan Commercial and Medicare Claims. Patients were followed from treatment initiation (index date) until first treatment failure or censoring. Treatment failure was defined as the first occurrence of MS relapse (identified using a validated algorithm) or treatment discontinuation (≥60 day supply gap). Treatment failure was examined through Kaplan–Meier analysis and multivariable Cox regression adjusting for 1 year baseline factors (age, gender, plan type, region, index year, prior DMT use, baseline relapses, Charlson Comorbidity Index [CCI] and MS symptoms).

Results: On average, patients treated with fingolimod (n = 2704) were younger (43.6 versus 49.8 years) with lower CCI (0.4 versus 0.7) and more relapses at baseline (0.46 versus 0.42) than those treated with teriflunomide (n = 1859). Median time to treatment failure was 19.5 months with fingolimod versus 9.6 months with teriflunomide (p < .001). After controlling key demographic and clinical characteristics through multivariable regression, fingolimod was associated with 38.9% lower hazards of treatment failure versus teriflunomide (adjusted hazard ratio = 0.611; 95% CI: 0.559–0.669; p < .001).

Conclusions: In a large cohort of US adults with MS, controlling for key baseline characteristics, fingolimod was associated with significantly longer time to treatment failure and lower risk of treatment failure compared with teriflunomide.

Keywords:

• Multiple sclerosis
• fingolimod
• teriflunomide
• treatment failure
• relapse
• adherence

Transparency

Declaration of funding

This study and the article processing fees were funded by Novartis Pharmaceuticals Corporation. All authors had full access to all of the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis.

Author contributions

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Declaration of financial/other relationships

G.M.C. and V.H. have disclosed that they are employees of, and hold stock and/or stock options in, Novartis. M.C.V. has disclosed that she was an employee of Novartis at the time that the study was conducted. A.G.B. and M.M. have disclosed that they are employees of Analysis Group Inc., which received consultancy fees from Novartis. M.P. has disclosed that she was an employee of Analysis Group at the time that this study was conducted. D.C. has disclosed that he is a staff neurologist at the Mellen Center for Multiple Sclerosis Treatment and Research, Neurological Institute, Cleveland Clinic Foundation; he has received research support paid to his institution by Novartis, and has received consultancy fees from Novartis and Tanabe Laboratories. CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgements

No assistance in the preparation of this article is to be declared.