Teriflunomide in children with MS: final results of TERIKIDS

The final results of the open-label extension (OLE) period of the TERIKIDS study showed that continuous teriflunomide numerically – but not significantly – lowered the relapse risk and disability progression compared with delayed teriflunomide initiation in paediatric multiple sclerosis (MS) patients. MRI lesion count was significantly reduced and the safety profile was manageable. The beneficial effects of teriflunomide in TERIKIDS are similar to those seen in adults.

Treatment of paediatric MS represents an area of unmet need, as there are limited options. The randomised, double-blind, placebo-controlled TERIKIDS study (NCT02201108), including 166 children aged 10–17 years (median age 14.6 years) with relapsing MS, showed no significant difference between teriflunomide and placebo in time to first confirmed clinical relapse after 2 years [1]. This was possibly due to a higher number of participants switching from double-blind to open-label treatment because of high MRI activity. Teriflunomide numerically reduced relapse risk and significantly reduced new/enlarging T2 and gadolinium-enhancing T1 lesion counts. Prof. Tanuja Chitnis (Brigham and Women’s Hospital, MA, USA) presented the final results from the TERIKIDS OLE period [2].

Of the 166 participants from the initial double-blind phase, 152 participants (91.6%) continued in the OLE, until a maximum of 192 weeks after initial randomisation, and 104 participants (68.4%) completed the OLE. All of them received teriflunomide at a body weight-based dose (the equivalent of 14 mg in adults).

Final study results showed that from randomisation to the end of OLE, relapse risk was numerically lower, but not significantly different, for teriflunomide versus placebo (HR 0.62; 95% CI 0.39–0.98; P=0.11), with a corresponding median time to first clinical relapse of 153.9 versus 86 weeks. The number of gadolinium-enhancing T1 lesions per scan was 1.5 compared with 2.7 in the placebo group: a relative reduction of 43% (P=0.043). The number of new/enlarging T2 lesions was 5.7 compared with 11.1 in the placebo group: a relative reduction of 49% (P=0.001). The teriflunomide group had a numerically lower risk of disability progression sustained for 24 weeks (HR 0.47; 95% CI 0.23–0.96).

Teriflunomide was well tolerated. The incidence of treatment-emergent adverse events (TEAEs) during the OLE was lower in the teriflunomide group (81.0%) than in the placebo group (90.4%), as was the incidence of serious TEAEs (14.0% vs 28.8%). Twelve participants discontinued the open-label treatment due to TEAEs.

1. Chitnis T, et al. Lancet Neurol. 2021;20(12):1001–11.
2. Chitnis T, et al. Teriflunomide in paediatric patients with relapsing multiple sclerosis: results from the open-label TERIKIDS extension. OPR-025, EAN 2022, 25–28 April, Vienna, Austria.

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Posted on 22 August 202225 March 2024