SAFETY AND TOLERABILITY OF TERIFLUNOMIDE IN CLINICAL STUDIES. Issue 11 (14th October 2015)

• Record Type: Journal Article
• Authors: Barnes, David; Leist, Thomas; Freedman, Mark; Olsson, Tomas; Miller, Aaron; Wolinsky, Jerry; O'Connor, Paul; Benamor, Myriam; Truffinet, Philippe; Comi, Giancarlo
• Is Part Of: Journal of neurology, neurosurgery and psychiatry. Volume 86:Issue 11(2015)
• Page Start: e4
• Page End: e4
• Publication Date: 2015-10-14
• Subjects: Neurology -- Periodicals; Nervous system -- Surgery -- Periodicals; Psychiatry -- Periodicals; 616.8
• DOI: 10.1136/jnnp-2015-312379.121
• Languages: English
• ISSNs: 0022-3050

Abstract

Abstract : Introduction: Teriflunomide, approved for the treatment of relapsing-remitting multiple sclerosis, has a well-characterized safety profile based on individual clinical studies. We report pooled safety and tolerability data from four, double-blind, placebo-controlled trials of teriflunomide. Post-approval updates on hair thinning and pregnancy outcomes, sometimes concerns for patients initiating teriflunomide, are reported. Methods: Data were pooled from phase 2 (NCT01487096 ) and phase 3 TEMSO (NCT00134563 ), TOWER (NCT00751881 ), and TOPIC (NCT00622700 ) studies. Patients were randomized to receive teriflunomide 14 mg, 7 mg, or placebo. Safety analyses were performed for all patients exposed to teriflunomide. Results: The pooled dataset included 3044 patients. Commonly reported adverse events (AEs) were in accordance with individual clinical studies, most being transient and mild-to-moderate in intensity. Incidence of hepatic AEs was higher in teriflunomide groups; however, serious hepatic AEs were similar across groups (∼2–3%). Hair thinning was higher in teriflunomide than placebo groups, but typically resolved on treatment without intervention and led to discontinuation in <2% of patients. No structural or functional abnormalities were reported in 42 newborns from teriflunomide-exposed parents. Conclusions: These data from >6800 patient-years of teriflunomide exposure were consistent with individual studies and no new, unexpected safety signals were observed. (Study supported by Genzyme, a Sanofi company).