| چکیده انگلیسی مقاله |
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. |
| نویسندگان مقاله |
| Rozita Doosti
Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Science, Tehran, Iran
| Abdorreza Naser Moghadasi
Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Science, Tehran, Iran
| Amir Reza Azimi
Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Science, Tehran, Iran
| Shahrokh Karbalai Saleh
Department of Cardiology, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran
| Masoud Etemadifar
Department of Functional Neurosurgery, Medical School, Isfahan University of medical science, Isfahan, Iran
| Vahid Shaygannejad
Isfahan Neurosciences Research Center, Alzahra Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran
| Fereshteh Ashtari
Isfahan neuroscience research center, Isfahan University of Medical Sciences, kashani MS center, Isfahan, Iran
| Mohammad Hossein Harirchian
Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Imam Khomeini Hospital, Tehran, Iran
| Bahaadin Siroos
Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Imam Khomeini Hospital, Tehran, Iran
| Hormoz Ayramloo
Departments of Neurology, Imam Reza Hospital, Tabriz University of Medical Sciences, Tabriz, Iran
| Nastaran Majdinasab
Department of Neurology, Golestan Hospital, Ahwaz University of Medical Sciences, Iran
| Seyyed Mohammad Masood Hojjati
Department of Neurology, Babol University of Medical Sciences, Babol, Iran
| Nabiollah Asghari
Faculty of Medicine, Semnan University of Medical Sciences, Semnan, Iran
| Seyed Mohammad Baghbanian
Department of Neurology, Booalisina Hospital, Mazandaran University of Medical Sciences, Pasdaran Boulevard, Sari, Iran
| Hamed Cheraghmakani
Department of Neurology, Bu Ali Sina Hospital, Mazandaran University of Medical Sciences, Sari, Iran
| Mahmoud Abedini
Department of Neurology, Mazandaran University of Medical Sciences, Sari, Iran
| Behnaz Sedighi
Neurology Research Center, Kerman University of Medical Science, Kerman, Iran
| Negar Mohseni Abbas abadi
R&D Department, Osve Pharmaceutical Co., Tehran, Iran
| Maedeh Ghasemitabar
R&D Department, Osve Pharmaceutical Co., Tehran, Iran
| Sara Talebianpour
R&D Department, Osve Pharmaceutical Co., Tehran, Iran
| Tohid Babayi Daylari
R&D Department, Osve Pharmaceutical Co., Tehran, Iran
| Vahid Dana
R&D Department, Osve Pharmaceutical Co., Tehran, Iran
| Neda Ghaleh noie
Quality Assurance Department, Osve Pharmaceutical Co., Tehran, Iran
| Mohammad Ali Sahraian
Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Science, Tehran, Iran
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