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: Cardiac AEs associated with ponesimod treatment initiation included first-degree (1.2%) and second-degree (0.9%; no cases of Mobitz type II) atrioventricular block and bradycardia (2%). All AEs relating to heart rate and rhythm occurred on day 1 when all patients randomised to ponesimod received a dose of 10 mg; there was no need for intervention and no recurrence of these AEs later during treatment. The reduction in heart rate on day 1 reached a maximum at 2–3 h postdose and returned close to predose values 6 h postdose (figure 6A); on up-titration days (days 8 and 15), heart rate changes with the higher doses of ponesimod were small and similar to those observed in the placebo group (figure 6B,C). Nine patients (2.6%) receiving ponesimod discontinued treatment due to cardiac AEs compared with none in the placebo group; in eight of these patients (two randomised to ponesimod 40 mg, two randomised to ponesimod 20 mg and four randomised to ponesimod 10 mg), the onset of cardiac AEs was on day 1, when these patients received ponesimod 10 mg, and ponesimod was discontinued early, usually during the first 2 weeks.
Affiliation: Department of Clinical Neurosciences, Karolinska Institute, Stockholm, Sweden.