Oral ponesimod in relapsing-remitting multiple sclerosis: a randomised phase II trial.
Bottom Line: The time to first confirmed relapse was increased with ponesimod compared with placebo.Once-daily treatment with ponesimod 10, 20 or 40 mg significantly reduced the number of new T1 Gd+ lesions and showed a beneficial effect on clinical endpoints.NCT01006265.
Affiliation: Department of Clinical Neurosciences, Karolinska Institute, Stockholm, Sweden.Show MeSH
Related in: MedlinePlus
Mentions: In the ponesimod groups, the mean cumulative number of new T1 Gd+ lesions at weeks 12–24 was lower in the ponesimod 10 mg (3.5), 20 mg (1.1) and 40 mg (1.4) groups compared with the placebo group (6.2) (figure 3A); the cumulative number of new T1 Gd+ lesions was significantly reduced by 43% with ponesimod 10 mg (treatment effect [ratio] 0.57, 95% CI 0.337 to 0.952; p=0.0318), by 83% with ponesimod 20 mg (treatment effect [ratio] 0.17, 95% CI 0.100 to 0.289; p<0.0001) and by 77% with ponesimod 40 mg (treatment effect [ratio] 0.23, 95% CI 0.133 to 0.384; p<0.0001) compared with placebo (figure 3A). Exploratory analyses showed a significant dose–response relationship (p<0.0001) for the primary endpoint (figure 3B). The ARR was numerically lower in each ponesimod group compared with placebo: the ARR was reduced by 37% with ponesimod 10 mg (p=0.1619), by 21% with ponesimod 20 mg (p=0.4420) and by 52% (p=0.0363) with ponesimod 40 mg (table 2).
Affiliation: Department of Clinical Neurosciences, Karolinska Institute, Stockholm, Sweden.