PMID- 34221275 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220424 IS - 2008-6164 (Print) IS - 2008-6172 (Electronic) IS - 2008-6164 (Linking) VI - 12 IP - 3 DP - 2021 Apr TI - Safety and efficacy of fingolimod in Iranian patients with relapsing-remitting multiple sclerosis: An open-label study. PG - 263-274 LID - 10.22088/cjim.12.3.263 [doi] AB - 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 fingolide(R), 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 fingolide(R), 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 Fingolide(R) 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 fingolide(R) treatment experienced sustained ARR and disease progression (p<0.001). CONCLUSION: The obtained findings suggest that the administration of Fingolide(R), 0.5 mg (Fingolimod, Osvahpharma, Tehran, Iran) is safe and efficient for Iranian MS patients. CI - Copyright (c) 2020, Babol University of Medical Sciences. FAU - Doosti, Rozita AU - Doosti R AD - Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran. FAU - Naser Moghadasi, Abdorreza AU - Naser Moghadasi A AD - Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran. FAU - Azimi, Amir Reza AU - Azimi AR AD - Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran. FAU - Karbalai Saleh, Shahrokh AU - Karbalai Saleh S AD - Department of Cardiology, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran. FAU - Etemadifar, Masoud AU - Etemadifar M AD - Department of Functional Neurosurgery, Medical School, Isfahan University of Medical Sciences, Isfahan, Iran. FAU - Shaygannejad, Vahid AU - Shaygannejad V AD - Isfahan Neuroscience Research Center, Alzahra Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran. FAU - Ashtari, Fereshteh AU - Ashtari F AD - Isfahan Neuroscience Research Center, Isfahan University of Medical Sciences, Kashani MS center, Isfahan, Iran. FAU - Harirchian, Mohammad Hossein AU - Harirchian MH AD - Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Imam Khomeini Hospital, Tehran, Iran. FAU - Siroos, Seyed Bahaadin AU - Siroos SB AD - Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Imam Khomeini Hospital, Tehran, Iran. FAU - Ayramloo, Hormoz AU - Ayramloo H AD - Department of Neurology, Imam Reza Hospital, Tabriz University of Medical Sciences, Tabriz, Iran. FAU - Majdinasab, Nastaran AU - Majdinasab N AD - Department of Neurology, Golestan Hospital, Ahwaz University of Medical Sciences, Iran. FAU - Hojjati, Seyyed Mohammad Masood AU - Hojjati SMM AD - Department of Neurology, Babol University of Medical Sciences, Babol, Iran. FAU - Asghari, Nabiollah AU - Asghari N AD - Faculty of Medicine, Semnan University of Medical Sciences, Semnan, Iran. FAU - Baghbanian, Seyed Mohammad AU - Baghbanian SM AD - Department of Neurology, Booalisina Hospital, Mazandaran University of Medical Sciences, Sari, Iran. FAU - Cheraghmakani, Hamed AU - Cheraghmakani H AD - Department of Neurology, Booalisina Hospital, Mazandaran University of Medical Sciences, Sari, Iran. FAU - Abedini, Mahmoud AU - Abedini M AD - Department of Neurology, Mazandaran University of Medical Sciences, Sari, Iran. FAU - Sedighi, Behnaz AU - Sedighi B AD - Neurology Research Center, Kerman University of Medical Science, Kerman, Iran. FAU - Mohseni Abbas Abadi, Negar AU - Mohseni Abbas Abadi N AD - R&D Department, Osve Pharmaceutical Co., Tehran, Iran. FAU - Ghasemitabar, Maedeh AU - Ghasemitabar M AD - R&D Department, Osve Pharmaceutical Co., Tehran, Iran. FAU - Talebianpour, Sara AU - Talebianpour S AD - R&D Department, Osve Pharmaceutical Co., Tehran, Iran. FAU - Babayi Daylari, Tohid AU - Babayi Daylari T AD - R&D Department, Osve Pharmaceutical Co., Tehran, Iran. FAU - Dana, Vahid AU - Dana V AD - R&D Department, Osve Pharmaceutical Co., Tehran, Iran. FAU - Ghaleh Noie, Neda AU - Ghaleh Noie N AD - Quality Assurance Department, Osve Pharmaceutical Co., Tehran, Iran. FAU - Sahraian, Mohammad Ali AU - Sahraian MA AD - Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran. LA - eng PT - Journal Article PL - Iran TA - Caspian J Intern Med JT - Caspian journal of internal medicine JID - 101523876 PMC - PMC8223042 OTO - NOTNLM OT - EDSS OT - Efficacy OT - Fingolimod OT - Multiple Sclerosis OT - Safety EDAT- 2021/07/06 06:00 MHDA- 2021/07/06 06:01 PMCR- 2021/04/01 CRDT- 2021/07/05 10:05 PHST- 2021/07/05 10:05 [entrez] PHST- 2021/07/06 06:00 [pubmed] PHST- 2021/07/06 06:01 [medline] PHST- 2021/04/01 00:00 [pmc-release] AID - 10.22088/cjim.12.3.263 [doi] PST - ppublish SO - Caspian J Intern Med. 2021 Apr;12(3):263-274. doi: 10.22088/cjim.12.3.263.