1Roya Abolfazli, 2Seyed Massood Nabavi, 3Amirereza Azimi, 4Mohammadali Nahayati, 5Koroush Gharegozli, 6Monireh Ghazaeian, 7Hamid Reza Torabi, 8Shahrzad Shahrokhi, 1Sara Samadzadeh
1Tehran University of Medical Sciences – Amiralam Hospital, Department of Neurology, Tehran, Iran; 2Shahed University of Medical Sciences, Department of Neurology, Tehran, Iran; 3Tehran University of Medical Sciences, Sina Hospital, Multiple Sclerosis Research Center, Tehran, Iran; 4Mashhad University of Medical Sciences, Department of Neurology, Mashhad, Iran; 5Shahid Beheshti University of Medical Sciences, Department of Neurology, Tehran, Iran; 6Mazandaran University of Medical Sciences – Faculty of Pharmacy, Department of Clinical Pharmacy, Sari, Iran; 7Jam Hospital, Tehran, Iran; 8Zistdaru Danesh Pharmaceutical Company, Medical Department, Tehran, Iran
Patient-reported outcomes (PROs) is a useful way to determine the various effects of disease modifying therapy (DMT) on patients daily lives and their disease course. This study aimed to evaluate the patients’ treatment satisfaction after switching to a brand-generic Teriflunomide product (Tebazio®, 14 mg tablet) produced by Zistdaru Danesh biopharmaceutical company and report the tolerability and safety concerns during the period of the treatment.
Material(s) and Method(s):
The study was conducted on patients with confirmed diagnosis of multiple sclerosis (MS) as defined by the Revised McDonald Criteria (2015) from Nov 2019 to Nov 2020. They were ambulatory with a EDSS of 0 to 5.5, and their treatment by Teriflunomide 14 mg was just started. Study outcomes included patients’ satisfaction was measured by Treatment Satisfaction Questionnaire for Medication [Version 1.4] (TSQM) at baseline and week 24, disability status measured by Expanded Disability Status Scale [EDSS] score at baseline and week 24, safety and tolerability evaluated over 6 months.
Of 200 patients enrolled, 100 patients completed the study protocol and evaluated. Patients reported significant improvements in treatment satisfaction scores of convenience and side effects domains of TSQM scores at week 24 following the switch to teriflunomide (Effectiveness: baseline, 66.53, Week 24, 68.97; Convenience: baseline, 66.31, Week 24, 78.97; Side effect: baseline, 67.13, Week 24, 75.60; Overall Satisfaction: baseline, 63 Week 24, 65.42; P < 0.001 in all comparisons). The most common adverse drug reactions were hair thinning (36%), dermatologic (17%), gastrointestinal (23%), liver function test (LFT) dysfunction (11%), and neurologic side effects (9%) which rarely caused treatment discontinuation.
Patients reported significant satisfaction regarding TSQM scores after switching to Tebazio at week 24 which can be impressive to increase patient compliance. The 14 mg brand-generic Teriflunomide product was well tolerated in Iranian RRMS patients and no new alarming signal was detected during the study period.