Safety of Teriflunomide in Multiple Sclerosis Treatment. Management of Hepatic Disorders in Real World Experience (P2.070)

Objective: To find out which proportion of patients under treatment with teriflunomide present hepatic disorders in clinical practice as well as its clinical impact and management. Background: Teriflunomide has been approved by European Medicines Agency as disease modifying drug for treatment of relapsing-remitting multiple sclerosis (RRMS). Nevertheless, monitoring liver enzymes (LE) is recommended every 2 weeks during the first 6 months of treatment due to potential risk of liver failure. Methods: Prospective study in which all patients with RRMS who started treatment with teriflunomide in our center are analyzed. When teriflunomide started, consumption of alcoholic beverages was restricted to patients within first 6 months. Blood test of LE was performed every 2 weeks during the first 6 months and every 8 weeks thereafter until one year of treatment was completed. The results of the LE test were stratified according to the World-Health-Organization toxicity grading scale (grade 0:less than 1.25-fold the upper limit of normal [ULN], grade 1:between 1.26-2.5 ULN, grade 2:between 2.6-5 ULN, grade 3:between 5.1-10 ULN, grade 4:over 10 ULN) Results: We included 64 patients (average age 35.2 [range: 21-53], 65.6[percnt] women). In the first 6 months 26.5[percnt] (n=17) showed asymptomatic elevation of ALT (grade 0:14[percnt], grade 1:10.9[percnt], grade 2:3.1[percnt], grades 3 and 4:0[percnt]. Elevation between 1 and 3 ULN: 21.8[percnt]). Teriflunomide was not interrupted in any case by reasons of ALT. Patients with toxicity grade 1-2 were absolutely forbidden to consume fatty foods and alcoholic beverages, and levels normalized. Conclusion: In our clinical experience, LE elevation between 1 and 3 ULN because of teriflunomide (21.8[percnt]) is lower than the observed on the pooled safety data from the clinical trials Phase 2, TEMSO, TOWER and TOPIC (47.4[percnt]). If treatment with teriflunomide is effective, it should not be suspended or discontinued because of ALT elevation before taking dietary measures. Disclosure: Dr. Meca Lallana has nothing to disclose. Dr. Hernandez Clares has nothing to disclose. Dr. Carreon Guarnizo has nothing to disclose. Dr. Cardan-Sanchez has nothing to disclose. Dr. Sanchez-Vizcaino Buendia has nothing to disclose. Dr. Jimenez-Veiga has nothing to disclose. Dr. Salgado-Cecilia has nothing to disclose. Dr. Leon Hernandez has nothing to disclose. Dr. Martin-Fernandez has nothing to disclose.