en Neurology Neurology Original Article Original Article <span style="font-size:14px;"><span style="font-family:Times New Roman;"><span style="color:#0000ff;"><strong><em>Background</em></strong><em>:</em> </span>Fingolimod&nbsp;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&nbsp;fingolide^R, 0.5 mg in Iranian MS patients during one-year follow-up.<br> <span style="color:#0000ff;"><strong><em>Methods</em></strong><em>:</em></span> 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&rsquo;s Expanded Disability Status Scale (EDSS).<br> <span style="color:#0000ff;"><strong><em>Results</em></strong><em>:</em></span> A total of 252 patients with the mean treatment duration of 343&plusmn;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&plusmn;1.29, 95%CI: 1.99to2.32) at baseline to (1.85&plusmn;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&plusmn;0.016, 95%CI: 0.004to0.008) which changed to (0.005&plusmn;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).<br> <span style="color:#0000ff;"><strong><em>Conclusion</em></strong><em>:</em></span> 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.</span></span> Fingolimod, Multiple Sclerosis, Safety, EDSS 263 274 http://caspjim.com/browse.php?a_code=A-10-1583-1&slc_lang=en&sid=1 Rozita Doosti rozita.doosti80@gmail.com 100319475328460029429 100319475328460029429 Yes Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Science, Tehran, Iran Abdorreza Naser Moghadasi abdorrezamoghadasi@gmail.com 100319475328460029430 100319475328460029430 No Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Science, Tehran, Iran Amir Reza Azimi amirreza_azimi@yahoo.com 100319475328460029431 100319475328460029431 No Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Science, Tehran, Iran Shahrokh Karbalai Saleh Saleh6948@tums.ac.ir 100319475328460029432 100319475328460029432 No Department of Cardiology, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran Masoud Etemadifar adifar.1963@gmail.com 100319475328460029433 100319475328460029433 No Department of Functional Neurosurgery, Medical School, Isfahan University of medical science, Isfahan, Iran Vahid Shaygannejad shaygannejad@med.mui.ac.ir 100319475328460029434 100319475328460029434 No Isfahan Neurosciences Research Center, Alzahra Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran Fereshteh Ashtari htari@med.mui.ac.ir 100319475328460029435 100319475328460029435 No Isfahan neuroscience research center, Isfahan University of Medical Sciences, kashani MS center, Isfahan, Iran Mohammad Hossein Harirchian arirchn@hotmail.com 100319475328460029436 100319475328460029436 No Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Imam Khomeini Hospital, Tehran, Iran Bahaadin Siroos bsiroos@gmail.com 100319475328460029437 100319475328460029437 No Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Imam Khomeini Hospital, Tehran, Iran Hormoz Ayramloo uh@gmail.com 100319475328460029438 100319475328460029438 No Departments of Neurology, Imam Reza Hospital, Tabriz University of Medical Sciences, Tabriz, Iran Nastaran Majdinasab N.madjdinasab@gmail.com 100319475328460029439 100319475328460029439 No Department of Neurology, Golestan Hospital, Ahwaz University of Medical Sciences, Iran Seyyed Mohammad Masood Hojjati naser.moghadasi@yahoo.com 100319475328460029440 100319475328460029440 No Department of Neurology, Babol University of Medical Sciences, Babol, Iran Nabiollah Asghari nbasghari@gmail.com 100319475328460029441 100319475328460029441 No Faculty of Medicine, Semnan University of Medical Sciences, Semnan, Iran Seyed Mohammad Baghbanian sm.baghbanian@mazums.ac.ir. 100319475328460029442 100319475328460029442 No Department of Neurology, Booalisina Hospital, Mazandaran University of Medical Sciences, Pasdaran Boulevard, Sari, Iran Hamed Cheraghmakani akani@mazums.ac.ir 100319475328460029443 100319475328460029443 No Department of Neurology, Bu Ali Sina Hospital, Mazandaran University of Medical Sciences, Sari, Iran Mahmoud Abedini abedini@yahoo.com 100319475328460029444 100319475328460029444 No Department of Neurology, Mazandaran University of Medical Sciences, Sari, Iran Behnaz Sedighi behnaz.sedighi@gmail.com 100319475328460029445 100319475328460029445 No Neurology Research Center, Kerman University of Medical Science, Kerman, Iran Negar Mohseni Abbas abadi mohseni@osvahpharma.com 100319475328460029446 100319475328460029446 No R&D Department, Osve Pharmaceutical Co., Tehran, Iran Maedeh Ghasemitabar ghasemi@osvahpharma.com 100319475328460029447 100319475328460029447 No R&D Department, Osve Pharmaceutical Co., Tehran, Iran Sara Talebianpour TalebiyanPour@osvahpharma.com 100319475328460029448 100319475328460029448 No R&D Department, Osve Pharmaceutical Co., Tehran, Iran Tohid Babayi Daylari T.babae@ut.ac.ir 100319475328460029449 100319475328460029449 No R&D Department, Osve Pharmaceutical Co., Tehran, Iran Vahid Dana Vahiddana@yahoo.com 100319475328460029450 100319475328460029450 No R&D Department, Osve Pharmaceutical Co., Tehran, Iran Neda Ghaleh noie Neda.ghalenoe@yahoo.com 100319475328460029451 100319475328460029451 No Quality Assurance Department, Osve Pharmaceutical Co., Tehran, Iran Mohammad Ali Sahraian msahrai@sina.tums.ac.ir 100319475328460029452 100319475328460029452 No Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Science, Tehran, Iran