Teriflunomide in pediatric patients with relapsing multiple sclerosis: Open-label extension of TERIKIDS

Area of Science:

• Pediatric Neurology
• Immunology
• Clinical Trials

Background:

• The TERIKIDS study investigated teriflunomide in pediatric patients with relapsing multiple sclerosis (MS).
• Understanding the long-term efficacy and safety of teriflunomide in this population is crucial.

Purpose of the Study:

• To evaluate the efficacy, safety, and tolerability of continuous teriflunomide treatment in the TERIKIDS open-label extension study.
• Assessing the long-term impact of teriflunomide on disease activity and progression in children with relapsing MS.

Main Methods:

• Children with relapsing MS were initially randomized to placebo or teriflunomide (14 mg adult-equivalent dose) in a double-blind period (up to 96 weeks).
• Participants then entered an open-label extension, receiving teriflunomide for up to 192 weeks post-randomization.
• Efficacy endpoints included clinical relapse risk and MRI lesion burden; safety was monitored throughout.

Main Results:

• Teriflunomide treatment significantly reduced the risk of gadolinium-enhancing T1 lesions (43%) and new/enlarging T2 lesions (49%) compared to placebo.
• A trend towards reduced 24-week sustained disability progression was observed with teriflunomide.
• Incidences of safety-related discontinuations were lower in the teriflunomide/teriflunomide group (4.0%) compared to placebo/teriflunomide (13.5%), though two cases of pancreatitis occurred.

Conclusions:

• Teriflunomide effectively reduced long-term focal inflammatory activity in pediatric relapsing MS.
• The drug exhibited generally manageable tolerability with no new safety signals identified.
• Further research may strengthen the clinical efficacy findings, but teriflunomide shows promise for treating pediatric MS.