Author/Authors :
Doosti, Rozita Multiple Sclerosis Research Center- Neuroscience Institute - Tehran University of Medical Sciences, Tehran , Naser Moghadasi, Abdorreza Multiple Sclerosis Research Center - Neuroscience Institute - Tehran University of Medical Sciences, Tehran , Azimi, Amir Reza Multiple Sclerosis Research Center - Neuroscience Institute - Tehran University of Medical Sciences, Tehran , Karbalai Saleh, Shahrokh Department of Cardiology - Sina Hospital - Tehran University of Medical Sciences, Tehran , Etemadifar, Masoud Department of Functional Neurosurgery - Medical School - Isfahan University of Medical Sciences, Isfahan , Shaygannejad, Vahid Isfahan Neuroscience Research Center - Alzahra Research Institute - Isfahan University of Medical Sciences, Isfahan , Ashtari, Fereshteh Isfahan Neuroscience Research Center - Isfahan University of Medical Sciences - Kashani MS center - Isfahan , Harirchian, Mohammad Hossein Iranian Center of Neurological Research - Neuroscience Institute - Tehran University of Medical Sciences - Imam Khomeini Hospital, Tehran , Siroos, Bahaadin Department of Neurology - Imam Reza Hospital - Tabriz University of Medical Sciences, Tabriz , Ayramloo, Hormoz Department of Neurology - Imam Reza Hospital - Tabriz University of Medical Sciences, Tabriz , Majdinasab, Nastaran Department of Neurology - Golestan Hospital - Ahwaz University of Medical Sciences, Ahwaz , Hojjati, Mohammad Masood Department of Neurology - Babol University of Medical Sciences, Babol , Asghari, Nabiollah Faculty of Medicine - Semnan University of Medical Sciences, Semnan , Baghbanian, Mohammad Department of Neurology - Booalisina Hospital - Mazandaran University of Medical Sciences, Sari , Cheraghmakani, Hamed Department of Neurology - Booalisina Hospital - Mazandaran University of Medical Sciences, Sari , Abedini, Mahmoud Department of Neurology - Mazandaran University of Medical Sciences, Sari , Sedighi, Behnaz Neurology Research Center - Kerman University of Medical Science, Kerman , Mohseni Abbas abadi, Negar R&D Department - Osve Pharmaceutical Co., Tehran , Ghasemitabar, Maedeh R&D Department - Osve Pharmaceutical Co., Tehran , Talebianpour, Sara R&D Department - Osve Pharmaceutical Co., Tehran , Babayi Daylari, Tohid R&D Department - Osve Pharmaceutical Co., Tehran , Dana, Vahid R&D Department - Osve Pharmaceutical Co., Tehran , Ghaleh noie, Neda Quality Assurance Department - Osve Pharmaceutical Co., Tehran , Sahraian, Mohammad Ali Multiple Sclerosis Research Center- Neuroscience Institute - Tehran University of Medical Sciences, Tehran
Abstract :
Background: Fingolimod was the first oral therapy approved for treating relapsingremitting
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.
