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Safety and Effectiveness of Cinnomer® on Disease Characteristics, Depression, and Quality of Life of Patients With Multiple Sclerosis: A Phase Iv, Post-Marketing, Prospective, Multicenter Study Publisher Pubmed



Moghadasi AN1 ; Ashtari F2 ; Baghbanian SM3 ; Shaygannejad V2 ; Anjidani N4 ; Ghadiri F1 ; Sedighi B5 ; Saeidi M6 ; Amirifard H7 ; Ayromlou H8 ; Moghadam NB9 ; Ranjbar MB10 ; Nazeri M11 ; Niknam Z12 Show All Authors
Authors
  1. Moghadasi AN1
  2. Ashtari F2
  3. Baghbanian SM3
  4. Shaygannejad V2
  5. Anjidani N4
  6. Ghadiri F1
  7. Sedighi B5
  8. Saeidi M6
  9. Amirifard H7
  10. Ayromlou H8
  11. Moghadam NB9
  12. Ranjbar MB10
  13. Nazeri M11
  14. Niknam Z12
  15. Faraji F13
  16. Afsorde A14
  17. Sahraian MA1
Show Affiliations
Authors Affiliations
  1. 1. Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran
  2. 2. Isfahan University of Medical Sciences, Kashani Comprehensive MS Center, Isfahan, Iran
  3. 3. Multiple Sclerosis Fellowship, Neurology Department, Boualicina Hospital, Mazandaran University of Medical Sciences, Sari, Iran
  4. 4. Medical Department, Orchid Pharmed Company, Tehran, Iran
  5. 5. Neurology Research Center, Kerman University of Medical Science, Kerman, Iran
  6. 6. Department of Neurology, Ghaem Hospital, Mashhad University of Medical Sciences, Mashhad, Iran
  7. 7. Department of Neurology, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran
  8. 8. Neurology Department, Imam Reza Hospital, Tabriz University of Medical Sciences, Tabriz, Iran
  9. 9. Department of Neurology, Shahid Beheshti University of Medical Sciences, Tehran, Iran
  10. 10. Pastour Building, Shiraz, Iran
  11. 11. Clinical Neurology Research Center, Department of Neurology, Shiraz University of Medical Sciences, Shiraz, Iran
  12. 12. Kosar Hospital, Shiraz, Iran
  13. 13. Department of Neurology, School of Medicine, Arak University of Medical Sciences, Arak, Iran
  14. 14. Sina Building, Shiraz, Iran

Source: Archives of Iranian Medicine Published:2023


Abstract

Background: Every patient diagnosed with definite multiple sclerosis (MS) should begin disease modifying therapies. Cinnomer® contains 40 mg glatiramer acetate (GA) and is available in prefilled syringes and autoinjector devices. Methods: A phase IV multicenter study was conducted to explore the safety and effectiveness of Cinnomer® in the treatment of MS. Study-related data were collected for 14 months. Results: Totally, 368 Iranian relapsing-remitting MS patients in nine cities were enrolled. The patients were either treatment naive (n = 191) or switchers (n = 177). Cinnomer® treatment was associated with a significant reduction in annual relapse rate (ARR) (RR: 0.65, 95% CI: 0.43, 0.98). Final mean Expanded Disability Status Scale (EDSS) scores showed improvement from baseline (difference: -0.21, 95% confidence interval (CI): -0.34, -0.08). There was a significant decrease in gad-enhancing lesions during treatment (difference: -0.38, 95% CI: -0.64, -0.12). The mean score for the depression measure (21-item BDI-II questionnaire) significantly improved (difference: -2.39, 95% CI: -3.74, -1.03). There was a significant change in the psychological well-being dimension (P = 0.02) (in line with BDI-II scores) and rejection MusiQoL dimensions (P = 0.04). The adverse events documented throughout the study were not unexpected for GA and were principally not serious. Conclusion: Safety measures were in line with the known profiles of GA. The results suggest that Cinnomer® is effective with respect to clinical outcomes and from the patient's perspective and in reducing MRI-measured MS activity. © 2023 Academy of Medical Sciences of I.R. Iran. All rights reserved.
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