Teriflunomide (Aubagio®) may have a beneficial effect in children with relapsing multiple sclerosis (MS), according to the results of the TERIKIDS clinical trial. Teriflunomide may exert this effect by reducing the risk of focal inflammatory activity.
The results of the multicenter, double-blind, phase 3, randomized, placebo-controlled trial were published in The Lancet Neurology.
First author Tanuja Chitnis, MD, and the coauthors of the study funded by Sanofi wrote, “Data from sensitivity and secondary analyses of the TERIKIDS trial provide some support for the use of teriflunomide in this population.” They added that “further evidence would strengthen these findings.”
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There are currently very few treatment options for children with MS, who often have highly active disease. According to the authors of the study, having teriflunomide, which is already approved in many countries for the treatment of adults with relapsing MS, as a treatment option for children could help control the disease. Moreover, the oral administration route of the treatment may increase compliance in this group of patients.
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The aim of the TERIKIDS trial was to assess the safety and efficacy of teriflunomide in children aged 10 to 17 years. It recruited 166 patients with relapsing MS at 57 centers in 22 countries. Of those, 109 were treated with teriflunomide and 57 received a placebo.
The results showed that teriflunomide treatment reduced the number of new or enlarged T2 lesions compared to placebo by 55%. It also reduced the number of gadolinium-enhancing lesions by 75%.
Ninety-six patients given teriflunomide had adverse events, corresponding to 88% of those treated. This percentage was similar in the placebo group, with 47 of 57 patients (82%) experiencing adverse events. Similarly, serious adverse events occurred in 11% of both patients treated with teriflunomide and those given placebo.
Adverse events such as nasopharyngitis, upper respiratory tract infection, alopecia, paresthesia, abdominal pain, and high levels of creatine phosphokinase in the blood were more frequent in patients treated with teriflunomide than in those given placebo. Two patients treated with teriflunomide had acute pancreatitis and 2 others had pancreatic enzyme elevation. Of these, 3 discontinued the treatment.
The trial was completed on October 6, 2021, but an additional optional open-label extension is ongoing.
References
Chitnis T, Banwell B, Kappos L, et al.; TERIKIDS Investigators. Safety and efficacy of teriflunomide in paediatric multiple sclerosis (TERIKIDS): a multicentre, double-blind, phase 3, randomised, placebo-controlled trial. Lancet Neurol. 2021;20(12):1001-1011. doi:10.1016/S1474-4422(21)00364-1
Efficacy, safety and pharmacokinetics of teriflunomide in pediatric patients with relapsing forms of multiple sclerosis (TERIKIDS). ClinicalTrials.gov. July 25, 2014. Updated October 29, 2021. Accessed November 29, 2021.
