Safety and efficacy of fingolimod in Iranian patients with relapsing-remitting multiple sclerosis: An open-label study
Background: Fingolimod was the first oral therapy approved for treating relapsing-remitting multiple sclerosis (RRMS) in 2010. This open-label study evaluated the safety and efficacy of fingolideR, 0.5 mg in Iranian MS patients during one-year follow-up. Methods: A multicenter, open-label, longitudi...
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Format: | Article |
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Babol University of Medical Sciences
2021-04-01
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Series: | Caspian Journal of Internal Medicine |
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Online Access: | http://caspjim.com/article-1-2280-en.html |
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DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Rozita Doosti Abdorreza Naser Moghadasi Amir Reza Azimi Shahrokh Karbalai Saleh Masoud Etemadifar Vahid Shaygannejad Fereshteh Ashtari Mohammad Hossein Harirchian Bahaadin Siroos Hormoz Ayramloo Nastaran Majdinasab Seyyed Mohammad Masood Hojjati Nabiollah Asghari Seyed Mohammad Baghbanian Hamed Cheraghmakani Mahmoud Abedini Behnaz Sedighi Negar Mohseni Abbas abadi Maedeh Ghasemitabar Sara Talebianpour Tohid Babayi Daylari Vahid Dana Neda Ghaleh noie Mohammad Ali Sahraian |
spellingShingle |
Rozita Doosti Abdorreza Naser Moghadasi Amir Reza Azimi Shahrokh Karbalai Saleh Masoud Etemadifar Vahid Shaygannejad Fereshteh Ashtari Mohammad Hossein Harirchian Bahaadin Siroos Hormoz Ayramloo Nastaran Majdinasab Seyyed Mohammad Masood Hojjati Nabiollah Asghari Seyed Mohammad Baghbanian Hamed Cheraghmakani Mahmoud Abedini Behnaz Sedighi Negar Mohseni Abbas abadi Maedeh Ghasemitabar Sara Talebianpour Tohid Babayi Daylari Vahid Dana Neda Ghaleh noie Mohammad Ali Sahraian Safety and efficacy of fingolimod in Iranian patients with relapsing-remitting multiple sclerosis: An open-label study Caspian Journal of Internal Medicine fingolimod multiple sclerosis safety edss |
author_facet |
Rozita Doosti Abdorreza Naser Moghadasi Amir Reza Azimi Shahrokh Karbalai Saleh Masoud Etemadifar Vahid Shaygannejad Fereshteh Ashtari Mohammad Hossein Harirchian Bahaadin Siroos Hormoz Ayramloo Nastaran Majdinasab Seyyed Mohammad Masood Hojjati Nabiollah Asghari Seyed Mohammad Baghbanian Hamed Cheraghmakani Mahmoud Abedini Behnaz Sedighi Negar Mohseni Abbas abadi Maedeh Ghasemitabar Sara Talebianpour Tohid Babayi Daylari Vahid Dana Neda Ghaleh noie Mohammad Ali Sahraian |
author_sort |
Rozita Doosti |
title |
Safety and efficacy of fingolimod in Iranian patients with relapsing-remitting multiple sclerosis: An open-label study |
title_short |
Safety and efficacy of fingolimod in Iranian patients with relapsing-remitting multiple sclerosis: An open-label study |
title_full |
Safety and efficacy of fingolimod in Iranian patients with relapsing-remitting multiple sclerosis: An open-label study |
title_fullStr |
Safety and efficacy of fingolimod in Iranian patients with relapsing-remitting multiple sclerosis: An open-label study |
title_full_unstemmed |
Safety and efficacy of fingolimod in Iranian patients with relapsing-remitting multiple sclerosis: An open-label study |
title_sort |
safety and efficacy of fingolimod in iranian patients with relapsing-remitting multiple sclerosis: an open-label study |
publisher |
Babol University of Medical Sciences |
series |
Caspian Journal of Internal Medicine |
issn |
2008-6164 2008-6172 |
publishDate |
2021-04-01 |
description |
Background: Fingolimod was the first oral therapy approved for treating relapsing-remitting multiple sclerosis (RRMS) in 2010. This open-label study evaluated the safety and efficacy of fingolideR, 0.5 mg in Iranian MS patients during one-year follow-up.
Methods: A multicenter, open-label, longitudinal was designed to evaluate the safety and efficacy of fingolideR, 0.5 mg over a one-year follow-up period across 11 centers. The patients were visited by their neurologists every two months to evaluate possible adverse events and clinical disease activity considered by recording Kurtzke’s Expanded Disability Status Scale (EDSS).
Results: A total of 252 patients with the mean treatment duration of 343±45.70 days were. 20 patients experienced adverse events (AEs) and serious adverse events (SAEs) such as resistant urinary tract infection (UTI), premature atrial contraction (PAC), skin allergic reaction, macular edema, chicken pox, zona, panic attacks, and exacerbations associated with steroids treatment, all of which led to FingolideR discontinuation. The mean EDSS decreased from (2.15±1.29, 95%CI: 1.99to2.32) at baseline to (1.85±1.22, 95%CI: 1.68to2.02) at 12th month (final visit) while a p-value revealed significant differences comparing baseline and final EDSS (p<0.001). Mean annualized relapse rate (ARR) of the patients in one year prior to the study was (0.006±0.016, 95%CI: 0.004to0.008) which changed to (0.005±0.016, 95%CI: 0.003to0.007) at the end of the study period. Patients with a 12-month period of fingolideR treatment experienced sustained ARR and disease progression (p<0.001).
Conclusion: The obtained findings suggest that the administration of FingolideR, 0.5 mg (Fingolimod, Osvahpharma, Tehran, Iran) is safe and efficient for Iranian MS patients. |
topic |
fingolimod multiple sclerosis safety edss |
url |
http://caspjim.com/article-1-2280-en.html |
work_keys_str_mv |
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doaj-2454aeef27884e99a3cdacef22aebeba2021-05-30T04:48:38ZengBabol University of Medical SciencesCaspian Journal of Internal Medicine2008-61642008-61722021-04-01123263274Safety and efficacy of fingolimod in Iranian patients with relapsing-remitting multiple sclerosis: An open-label studyRozita Doosti0Abdorreza Naser Moghadasi1Amir Reza Azimi2Shahrokh Karbalai Saleh3Masoud Etemadifar4Vahid Shaygannejad5Fereshteh Ashtari6Mohammad Hossein Harirchian7Bahaadin Siroos8Hormoz Ayramloo9Nastaran Majdinasab10Seyyed Mohammad Masood Hojjati11Nabiollah Asghari12Seyed Mohammad Baghbanian13Hamed Cheraghmakani14Mahmoud Abedini15Behnaz Sedighi16Negar Mohseni Abbas abadi17Maedeh Ghasemitabar18Sara Talebianpour19Tohid Babayi Daylari20Vahid Dana21Neda Ghaleh noie22Mohammad Ali Sahraian23 Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Science, Tehran, Iran Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Science, Tehran, Iran Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Science, Tehran, Iran Department of Cardiology, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran Department of Functional Neurosurgery, Medical School, Isfahan University of medical science, Isfahan, Iran Isfahan Neurosciences Research Center, Alzahra Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran Isfahan neuroscience research center, Isfahan University of Medical Sciences, kashani MS center, Isfahan, Iran Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Imam Khomeini Hospital, Tehran, Iran Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Imam Khomeini Hospital, Tehran, Iran Departments of Neurology, Imam Reza Hospital, Tabriz University of Medical Sciences, Tabriz, Iran Department of Neurology, Golestan Hospital, Ahwaz University of Medical Sciences, Iran Department of Neurology, Babol University of Medical Sciences, Babol, Iran Faculty of Medicine, Semnan University of Medical Sciences, Semnan, Iran Department of Neurology, Booalisina Hospital, Mazandaran University of Medical Sciences, Pasdaran Boulevard, Sari, Iran Department of Neurology, Bu Ali Sina Hospital, Mazandaran University of Medical Sciences, Sari, Iran Department of Neurology, Mazandaran University of Medical Sciences, Sari, Iran Neurology Research Center, Kerman University of Medical Science, Kerman, Iran R;D Department, Osve Pharmaceutical Co., Tehran, Iran R;D Department, Osve Pharmaceutical Co., Tehran, Iran R;D Department, Osve Pharmaceutical Co., Tehran, Iran R;D Department, Osve Pharmaceutical Co., Tehran, Iran R;D Department, Osve Pharmaceutical Co., Tehran, Iran Quality Assurance Department, Osve Pharmaceutical Co., Tehran, Iran Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Science, Tehran, Iran Background: Fingolimod was the first oral therapy approved for treating relapsing-remitting multiple sclerosis (RRMS) in 2010. This open-label study evaluated the safety and efficacy of fingolideR, 0.5 mg in Iranian MS patients during one-year follow-up. Methods: A multicenter, open-label, longitudinal was designed to evaluate the safety and efficacy of fingolideR, 0.5 mg over a one-year follow-up period across 11 centers. The patients were visited by their neurologists every two months to evaluate possible adverse events and clinical disease activity considered by recording Kurtzke’s Expanded Disability Status Scale (EDSS). Results: A total of 252 patients with the mean treatment duration of 343±45.70 days were. 20 patients experienced adverse events (AEs) and serious adverse events (SAEs) such as resistant urinary tract infection (UTI), premature atrial contraction (PAC), skin allergic reaction, macular edema, chicken pox, zona, panic attacks, and exacerbations associated with steroids treatment, all of which led to FingolideR discontinuation. The mean EDSS decreased from (2.15±1.29, 95%CI: 1.99to2.32) at baseline to (1.85±1.22, 95%CI: 1.68to2.02) at 12th month (final visit) while a p-value revealed significant differences comparing baseline and final EDSS (p<0.001). Mean annualized relapse rate (ARR) of the patients in one year prior to the study was (0.006±0.016, 95%CI: 0.004to0.008) which changed to (0.005±0.016, 95%CI: 0.003to0.007) at the end of the study period. Patients with a 12-month period of fingolideR treatment experienced sustained ARR and disease progression (p<0.001). Conclusion: The obtained findings suggest that the administration of FingolideR, 0.5 mg (Fingolimod, Osvahpharma, Tehran, Iran) is safe and efficient for Iranian MS patients.http://caspjim.com/article-1-2280-en.htmlfingolimodmultiple sclerosissafetyedss |