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The phase 3 GEMINI 1 and GEMINI 2 trials evaluated tolebrutinib, an oral brain-penetrant Bruton tyrosine kinase inhibitor, compared with teriflunomide in patients with relapsing multiple sclerosis. In two double-blind, double-dummy, randomised trials, 974 participants were enrolled in GEMINI 1 and 899 in GEMINI 2 and assigned to receive tolebrutinib 60 mg once daily or teriflunomide 14 mg once daily. Median follow-up was 139 weeks. The primary endpoint was the annualised relapse rate, while the key secondary endpoint was confirmed disability worsening sustained for at least 6 months in pooled analyses. In GEMINI 1, annualised relapse rates were 0.13 with tolebrutinib and 0.12 with teriflunomide (rate ratio, 1.06; 95% CI, 0.81–1.39; p=0.67). In GEMINI 2, the rates were 0.11 in both groups (rate ratio, 1.00; 95% CI, 0.75–1.32; p=0.98). In the pooled population, 6-month confirmed disability worsening occurred in 8.3% of participants receiving tolebrutinib and 11.3% receiving teriflunomide (hazard ratio, 0.71; 95% CI, 0.53–0.95); formal hypothesis testing was not performed for this endpoint under the prespecified testing hierarchy. Adverse-event rates were similar, although minor bleeding, including petechiae, was more frequent with tolebrutinib. The authors concluded that tolebrutinib was not superior to teriflunomide for reducing relapse rates, despite a numerical difference in sustained disability worsening that warrants cautious interpretation
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The phase 3 GEMINI 1 and GEMINI 2 trials evaluated tolebrutinib, an oral brain-penetrant Bruton tyrosine kinase inhibitor, compared with teriflunomide in patients with relapsing multiple sclerosis. In two double-blind, double-dummy, randomised trials, 974 participants were enrolled in GEMINI 1 and 899 in GEMINI 2 and assigned to receive tolebrutinib 60 mg once daily or teriflunomide 14 mg once daily. Median follow-up was 139 weeks. The primary endpoint was the annualised relapse rate, while the key secondary endpoint was confirmed disability worsening sustained for at least 6 months in pooled analyses. In GEMINI 1, annualised relapse rates were 0.13 with tolebrutinib and 0.12 with teriflunomide (rate ratio, 1.06; 95% CI, 0.81–1.39; p=0.67). In GEMINI 2, the rates were 0.11 in both groups (rate ratio, 1.00; 95% CI, 0.75–1.32; p=0.98). In the pooled population, 6-month confirmed disability worsening occurred in 8.3% of participants receiving tolebrutinib and 11.3% receiving teriflunomide (hazard ratio, 0.71; 95% CI, 0.53–0.95); formal hypothesis testing was not performed for this endpoint under the prespecified testing hierarchy. Adverse-event rates were similar, although minor bleeding, including petechiae, was more frequent with tolebrutinib. The authors concluded that tolebrutinib was not superior to teriflunomide for reducing relapse rates, despite a numerical difference in sustained disability worsening that warrants cautious interpretation
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