The patient-reported outcomes for the new brand-generic teriflunomide in relapsing-remitting multiple sclerosis

• Published in: Clinical neurology and neurosurgery Vol. 246; p. 108552
• Main Authors: Abolfazli, Roya, Nabavi, Seyed Massood, Azimi, Amirreza, Nahayati, Mohammadali, Gharagozli, Kurosh, Torabi, Hamidreza, Ghazaeian, Monireh, Rezagholi, Zahra, Samadzadeh, Sara
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 01.11.2024; Elsevier Limited
• Subjects: Adverse Events; Clinical outcomes; Drug dosages; Liver diseases; Medication adherence; Multiple sclerosis; Oral diseases; Patient compliance; Patient satisfaction; Patient-Reported Outcomes; Patients; Questionnaires; Teriflunomide; TSQM; Teriflunomide; Patient-Reported Outcomes; TSQM; Adverse Events
• ISSN: 0303-8467; 1872-6968; 1872-6968
• DOI: 10.1016/j.clineuro.2024.108552

Patient-reported outcomes (PROs) provide valuable insights into the impact of disease-modifying therapies (DMTs) on patients' daily lives and disease progression. This study evaluates treatment satisfaction and tolerability among patients using a brand-generic Teriflunomide (Tebazio®, 14 mg tablet) manufactured by Zistdaru Danesh Biopharmaceuticals. A Phase IV observational study was conducted on patients with Relapsing-Remitting Multiple Sclerosis (RRMS) who were either initiated on or switched to Teriflunomide 14 mg. The primary focus was on the medication's safety. Patient satisfaction was measured using the Treatment Satisfaction Questionnaire for Medication [Version 1.4] (TSQM-14). Additionally, medication adherence and discontinuation rates were monitored. Of the 235 RRMS patients enrolled, participated in this study, all received the Teriflunomide treatment orally on a daily basis. Over the 18-month follow-up period, 25.96 % of patients discontinued the treatment. Discontinuation was mainly due to adverse events (11 %), lack of patient willingness to continue (12.7 %), and disease progression (4.2 %). The most commonly reported adverse events included dermatologic disorders, elevated liver enzymes, and gastrointestinal issues. TSQM-14 scores demonstrated significant improvements over the 18-month period. A high medication adherence rate of 98.1 % was also recorded. Patients reported notable satisfaction with Teriflunomide, as reflected in their TSQM scores, which suggests a likelihood of improved patient adherence. The 14 mg brand-generic Teriflunomide was well-accepted by Iranian RRMS patients, with no significant concerns arising during the study. These findings also highlight the significance of patient-reported outcomes in DMTs, with potential benefits for adherence and clinical practice. •Study Focus: Assessed patient satisfaction and tolerability of brand-generic teriflunomide (Tebazio®) in 235 patients with RRMS.•Adverse Events: 26% discontinued due to adverse events (11%), unwillingness to continue (12.7%), or disease progression (4.23%).•Common Adverse Events: Included dermatologic disorders, elevated liver enzymes, and gastrointestinal issues in patients.•Patient Satisfaction: TSQM-14 scores showed significant improvements in effectiveness, side effects, convenience, and satisfaction.•Medication Adherence: A high adherence rate of 98.1% was recorded, indicating strong patient acceptance of the medication.•Conclusion: Tebazio® was well-tolerated with high patient satisfaction, reinforcing its efficacy as a DMT for RRMS in Iran.