References
- O'Connor PW, Li D, Freedman MS, on behalf of the Teriflunomide Multiple Sclerosis Trial Group and the University of British Columbia MS/MRI Research Group, et al. A phase II study of the safety and efficacy of teriflunomide in multiple sclerosis with relapses. Neurology. 2006;66(6):894–900.
- O'Connor P, Wolinsky JS, Confavreux C, et al. Randomized trial of oral teriflunomide for relapsing multiple sclerosis. N Engl J Med. 2011;365(14):1293–1303.
- Confavreux C, O'Connor P, Comi G, TOWER Trial Group, et al. Oral teriflunomide for patients with relapsing multiple sclerosis (TOWER): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2014;13(3):247–256.
- Miller AE, Wolinsky JS, Kappos L, TOPIC Study Group, et al. Oral teriflunomide for patients with first clinical episode suggestive of multiple sclerosis (TOPIC): a randomized, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2014;13(10):977–986.
- Comi G, Freedman MS, Kappos K, et al. Pooled safety and tolerability data from four placebo-controlled teriflunomide studies and extensions. Mult Scler Relat Disord. 2016;5:97–104.
- Aubagio (teriflunomide) tablets, for oral use. [cited 2020 Apr 28]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202992s003lbl.pdf
- Cherwinski HM, McCarley D, Schatzman R, et al. The immunosuppressant leflunomide inhibits lymphocyte progression through cell cycle by a novel mechanism. J Pharmacol Exp Ther. 1995;272(1):460–468.,
- Sevilla-Mantilla C, Ortega L, Agundez JAG, et al. Leflunomide-induced acute hepatitis . Dig Liver Dis. 2004;36(1):82–84.
- Niyazi F, Altamimi BA, Tanaka T. Mo1465: Leflunomide induced liver failure requiring liver transplantation. American Association for the Study of Liver Diseases (AASLD) Abstracts. Gastroenterology. 2019;156(6):S-1315–S1316.
- Yuyuan L, Xuqing Z. Leflunomide-induced acute liver failure: a case report. J Med. Coll of PLA. 2010;25(1):62–64.
- Rozman B. Clinical pharmacokinetics of leflunomide. Clin Pharmacokinet. 2002;41(6):421–430.
- Danan G, Benichou C. Causality assessment of adverse reactions to drugs-I. A novel method based on the conclusions of international consensus meetings: application to drug-induced liver injuries . J Clin Epidemiol. 1993;46(11):1323–1330.
- Roussel Uclaf Causality Assessment Method (RUCAM) in Drug Induced Liver Injury. LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. [updated 2019 May 4; cited 2020 Apr 29]. Available form: https://www.ncbi.nlm.nih.gov/books/NBK548272/
- Temple R. Hy's law: predicting serious hepatotoxicity. Pharmacoepidemiol Drug Saf. 2006;15(4):241–243.
- Regev A. Drug-induced liver injury and drug development: industry perspective. Semin Liver Dis. 2014;34(2):227–239.
- Bergner R, Peters L, Schmitt V, et al. Leflunomide in dialysis patients with rheumatoid arthritis – a pharmacokinetic study. Clin Rheumatol. 2013;32(2):267–270.
- AravaTM (leflunomide): product monograph. Bridgewater (NY): Sanofi-Aventis; 2015 Dec 23 [cited 2020 Apr 29]. Available from: http://products.sanofi.ca/en/arava.pdf
- Confavreaux C, Olsson TP, Comi G, et al. P532: Teriflunomide hepatic safety results: pooled data from three placebo-controlled studies. Abstracts from the twenty-third meeting of the European neurological scoiety, 8-11 June, 2013 Barcelona, Spain. J Neurol. 2013;260(Suppl 1):S122.
- Ancello S, Gohel T, Reddy S. 2347: Toxicity in the treatment: the first reported case of DILI induced by multiple sclerosis drug teriflunomide. ACG Annual Meeting Abstracts. Am J Gastroenterol. 2017;112(Suppl 1):S1279–S1280.