Post-marketing experience of safety profile of interferon beta 1 b biosimilar product in relapsing remitting multiple sclerosis: 7 years’ follow-up
Publish place: 16th iranian international congress on multiple sclerosis
Publish Year: 1398
نوع سند: مقاله کنفرانسی
زبان: English
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شناسه ملی سند علمی:
MSC16_056
تاریخ نمایه سازی: 11 آذر 1398
Abstract:
Background:Interferon (INF) beta 1b was the first disease modifying drug (DMD) approved by FDA for the treatment of relapsing-remitting multiple sclerosis (RRMS) in 1998. Regarding potentially long-term use of established DMDs in MS treatment, data evaluation of safety profile on a large group of people for an appropriate duration is recommended. The goal of this study is evaluation of long term safety outcomes of biosimilar product of INF beta 1b (Ziferon®; 300 mcg vial) produced by Zistdaru Danesh biopharmaceutical company in Iranian patients with relapsing-remitting MS over 7 years.Method:A non-interventional cohort study was conducted on 5311 patients from Aug 2011 to March 2019. The patients had a confirmed and documented diagnosis of RRMS as defined by the Revised McDonald Criteria (2010), were ambulatory with a Kurtzke Expanded Disability Status Scale score of 0 to 5.5, and their treatment by Ziferon 300 mcg subcutaneously every other day was just started. Adverse drug reactions (ADRs), and its severity and related-laboratory tests were monitored over 7 years. Results:The most common reported ADRs during period of the time were injection site reaction (69.38%), flu-like symptoms (21.99%), central nervous system (3.5%), musculoskeletal system (2.03%), and gastrointestinal (1.96%) which all were mild to moderate and rarely caused treatment discontinuation. Injection site reactions was the most common reason for drug discontinuation.Conclusion:The results confirm long term tolerability and safety outcomes of Ziferon® in Iranian RRMS patients was acceptable and no new alarming signal was detected during the study period.
Authors
r Abolfazli
Tehran University of Medical Sciences - Amiralam Hospital, Department of Neurology, Tehran, Iran.
m Ghazaeian
Mazandaran University of Medical Sciences - Faculty of Pharmacy, Department of Clinical Pharmacy, Sari, Iran.
sh Shahrokhi
zistdaru Danesh Pharmaceutical company, Medical Department, Tehran, Iran.
s Samadzadeh
Tehran University of Medical Sciences, Department of Neurology, Tehran, Iran.