Real-World Data Highlight Teriflunomide Efficacy for RRMS
OCTOBER 28, 2017
By Cavit Boz, MD
Cavit Boz, MDTeriflunomide was found to be an effective first-line therapy option for patients with early relapsing-remitting multiple sclerosis (RRMS) as well as a suitable alternative therapy when switching from other medications in patients with low disease activity, according to findings from a real-world clinical study presented at the 2017 MS Paris Meeting.
In the last 2 decades, numerous treatments for RRMS have been approved with 14 treatment options available worldwide. With so many options, it is important to study these medicines in a real-world environment, to help uncover long-term effectiveness and safety in a large number of patients.
Real-world data enhance and extend the results from randomized clinical trials and include information that cannot easily be obtained in trials, such as treatment efficacy in non-trial populations (e.g. those with co-morbidities, older patients and children) and long-term safety analyses. In RRMS, several important questions can potentially be addressed with real-world data.
Teriflunomide is a once-daily oral immunomodulator approved for the treatment of RRMS. The 14-mg dose is available in Turkey for the treatment of RRMS patients since 2014, after the approval of FDA in 2012 and EMA in 2013. The efficacy and safety of teriflunomide have been documented in two major phase 3 trials. In this real-world study, we aimed to describe relapse and MRI outcomes, treatment persistence, and safety in patients treated with teriflunomide in real-world clinical settings.
Using the Imed MS registry, RRMS patients who had been prescribed teriflunomide in 12 MS centers in Turkey were retrospectively analyzed. A total of 532 patients with RRMS (356 females, 176 males; 2:1 ratio) treated with teriflunomide were included in the study. Mean age at teriflunomide initiation was 40.9 ±10.8 years (range, 19-76). Before treatment initiation, the mean annualized relapse rate was 0.66 and the median EDSS was 2.2 (range, 0-5.5). Teriflunomide was first-line drug in 30% of the patients. Three hundred and seventy-two patients switched to teriflunomide from other treatments (76% switched from injectables, 8% from fingolimod, 5% from natalizumab, 11% from others) due to loss of tolerability or inefficacy.
The average duration for drug treatment was 1.4 years (range, 1 month to 10 years). In 295 patients, treatment duration was more than a year and more than 2 years for 77 patients. Annualized relapse rates were 0.26 in year 1 and 0.21 in year 2. MRIs showed new or gadolinium enhanced lesions in 21% of patients in the first year. Fifty-nine patients (11.1%) stopped teriflunomide mainly due to lack of tolerance (15 patients), lack of efficacy (n = 23), adverse events (n = 18), and 3 for planned pregnancy. Four patients discontinued due to hair loss. No life-threatening adverse events were encountered.
Even with the limitations of an open-label observational study, we found that efficacy and safety of teriflunomide in real-life settings were similar to data obtained by the pivotal trials. In this teriflunomide treated patient cohort, the female to male ratio were similar to the MS population treated with other drugs. Relapse rates decreased during the first and second years of treatment with teriflunomide compared to pretreatment. We conclude that teriflunomide is a well-tolerated and effective option for early RRMS patients as first-line therapy and switch therapy from other medications in patients without high disease activity.
Article provided by Cavit Boz, MD, Karadeniz Technical University, Trabzon.
Boz C, Ozakbas S, Terzi M, et al. Real world efficacy and safety of teriflunomide in patients with relapsing-remitting multiple sclerosis. Presented at: 7th Joint ECTRIMS - ACTRIMS Meeting; October 25-28, 2017, Paris, France. Abstract P679.