title: Safety of teriflunomide for the management of relapsing-remitting multiple sclerosis.
abstract: BACKGROUND
  Teriflunomide is a new oral disease-modifying drug (DMD), recently approved for the first-line treatment of relapsing multiple sclerosis (MS). Since MS is a chronic disease, which often necessitates long-term treatment, data not only on efficacy but also on long-term safety, including pregnancy-related issues, are very important.
  
  
  METHODS
  In this review article, we outline the key preclinical and clinical data on teriflunomide with a focus on its safety profile. We summarize adverse events observed in the Phase II and III clinical trials and the safety data from the long-term extension phases as well as the > 15-year post-marketing experience with the parent drug, leflunomide. We also consider the evidence regarding immune competence and potential fetal risks of the drug.
  
  
  CONCLUSIONS
  Teriflunomide has the advantage of a convenient once-daily oral administration scheme and a large body of evidence suggesting a manageable safety profile (clinical development program with > 6800 patient-years of exposure and post-marketing experience with leflunomide). Further post-marketing data, especially regarding pregnancy outcomes and risks of infections, will help to define the exact place of teriflunomide in the treatment of MS in the future, especially compared with the other oral DMDs.
authors: Department of Neurology, University Hospital Basel , 4031 Basel , Switzerland.
authors: Athina
authors: A
authors: Papadopoulou
authors: Ludwig
authors: L
authors: Kappos
authors: Till
authors: T
authors: Sprenger
mesh_terms: D000284:Administration, Oral; D000818:Animals; D003437:Crotonates / Q000009:adverse effects* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D006885:Hydroxybutyrates; D007166:Immunosuppressive Agents / Q000009:adverse effects* / Q000627:therapeutic use; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy*; D009570:Nitriles; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy; D011256:Pregnancy Outcome; D013997:Time Factors; D014052:Toluidines / Q000009:adverse effects* / Q000627:therapeutic use
chemical_list: D003437:Crotonates; D006885:Hydroxybutyrates; D007166:Immunosuppressive Agents; D009570:Nitriles; D014052:Toluidines; C527525:teriflunomide
keywords: DHODH-inhibition; hair thinning; leflunomide; multiple sclerosis; safety profile; teratogenicity; teriflunomide