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SAFETY AND TOLERABILITY OF TERIFLUNOMIDE IN CLINICAL STUDIES
  1. David Barnes1,
  2. Thomas Leist2,
  3. Mark Freedman3,
  4. Tomas Olsson4,
  5. Aaron Miller5,
  6. Jerry Wolinsky6,
  7. Paul O'Connor7,
  8. Myriam Benamor8,
  9. Philippe Truffinet8,
  10. Giancarlo Comi9
  1. 1St George's Hospital
  2. 2Comprehensive Multiple Sclerosis Center, Thomas Jefferson University Hospital
  3. 3University of Ottawa and the Ottawa Hospital Research Institute
  4. 4Karolinska Institute
  5. 5Icahn School of Medicine at Mount Sinai
  6. 6University of Texas Health Science Center at Houston
  7. 7University of Toronto
  8. 8Genzyme, a Sanofi company
  9. 9University Vita-Salute San Raffaele

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).

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