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DOI 10.1016/j.clineuro.2024.108552

Медицинская библиотека · Clinical neurology and neurosurgery · 2024

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

Abolfazli Roya, Nabavi Seyed Massood, Azimi Amirreza, Nahayati Mohammadali, Gharagozli Kurosh, Torabi Hamidreza, Ghazaeian Monireh, Rezagholi Zahra, Samadzadeh Sara

СтатьяНаблюдательное исследованиеКлиническое исследование IV фазыПеревод в очереди

Аннотация

BACKGROUND

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.

MATERIALS AND

METHODS

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.

RESULTS

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.

CONCLUSION

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.

Для цитирования: Abolfazli Roya, Nabavi Seyed Massood, Azimi Amirreza, Nahayati Mohammadali, Gharagozli Kurosh, Torabi Hamidreza, Ghazaeian Monireh, Rezagholi Zahra, Samadzadeh Sara. The patient-reported outcomes for the new brand-generic teriflunomide in relapsing-remitting multiple sclerosis.. Clinical neurology and neurosurgery. 2024. DOI: 10.1016/j.clineuro.2024.108552.

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