Present results from the TERIKIDS study (NCT02201108), examining the efficacy and safety of teriflunomide in pediatric patients with relapsing forms of MS (RMS).

Additional therapeutic options are needed for pediatric MS patients. Teriflunomide is approved for adults with RMS in >80 countries. In phase 3 clinical trials of adult patients with RMS (NCT00134563, NCT00751881) or clinically isolated syndrome (CIS, per McDonald 2005 criteria; NCT00622700), teriflunomide demonstrated significant efficacy versus placebo, with well-characterized safety. 

TERIKIDS is a 96-week, randomized, double-blind, placebo-controlled, parallel-group phase 3 study of teriflunomide in pediatric RMS patients aged 10−17 years, with a subsequent 96-week, open-label extension; earlier extension entry is possible for clinical relapse or high MRI activity above protocol-defined thresholds. Patients receive placebo or a teriflunomide dose based on body weight equivalent to 14 mg in adults. Primary endpoint is time to first confirmed relapse, with sensitivity analysis including high MRI activity as relapse equivalent; secondary endpoints include proportion relapse-free, MRI lesion number and volume, brain volume loss, cognition outcomes, and safety and tolerability.

Target enrollment was met (N=166). At baseline, mean age was 14.6 years (67% female). Average time since first MS symptoms/diagnosis was 2.3 years/1.4 years. Mean number of relapses in the past year was 1.5 (42% experienced ≥2 relapses); average time since most recent relapse was 5.2 months. Mean (median) EDSS score and number of gadolinium-enhancing lesions were 1.3 (1.5) and 3.8 (1.0), respectively. In the previous 2 years, 23% received disease-modifying therapy. Analyses are ongoing, and efficacy and safety results will be presented.

At baseline, patients enrolled in TERIKIDS had high relapse and MRI lesion activity and a relatively short disease duration. Results of this study will provide insight into the efficacy, safety, and tolerability of teriflunomide, and may help further understanding RMS in the pediatric population.