Arch Iran Med. 2023;26(11): 647-653.
doi: 10.34172/aim.2023.95
PMID: 38310425
PMCID: PMC10864943
  Abstract View: 456
  PDF Download: 261

Original Article

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

Abdorreza Naser Moghadasi 1* ORCID logo, Fereshteh Ashtari 2, Seyed Mohammad Baghbanian 3, Vahid Shaygannejad 2, Nassim Anjidani 4, Fereshteh Ghadiri 1, Behnaz Sedighi 5, Morteza Saeidi 6, Hamed Amirifard 7, Hormoz Ayromlou 8, Nahid Beladi Moghadam 9, Mohammad Bagher Ranjbar 10, Masoume Nazeri 11, Zahra Niknam 12, Fardin Faraji 13, Afsaneh Afsorde 14, Mohammad Ali Sahraian 1 ORCID logo

1 Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran
2 Isfahan University of Medical sciences, Kashani Comprehensive MS Center, Isfahan, Iran
3 Multiple Sclerosis Fellowship, Neurology Department, Boualicina Hospital, Mazandaran University of Medical Sciences, Sari, Iran
4 Medical Department, Orchid Pharmed Company, Tehran, Iran
5 Neurology Research Center, Kerman University of Medical Science, Kerman, Iran
6 Department of Neurology, Ghaem Hospital, Mashhad University of Medical Sciences, Mashhad, Iran
7 Department of Neurology, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran
8 Neurology Department, Imam Reza Hospital, Tabriz University of Medical Sciences, Tabriz, Iran
9 Department of Neurology, Shahid Beheshti University of Medical Sciences, Tehran, Iran
10 Pastour Building, Shiraz, Iran
11 Clinical Neurology Research Center, Department of Neurology, Shiraz University of Medical Sciences, Shiraz, Iran
12 Kosar Hospital, Shiraz, Iran
13 Department of Neurology, School of Medicine, Arak University of Medical Sciences, Arak, Iran
14 Sina Building, Shiraz, Iran
*Corresponding Author: Abdorreza Naser Moghadasi, Email: abdorrezamoghadasi@gmail.com


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 naïve (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.

Cite this article as: Moghadasi AN, Ashtari F, Baghbanian SM, Shaygannejad V, Anjidani N, Ghadiri F, et al. 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. Arch Iran Med. 2023;26(11):647-653. doi: 10.34172/aim.2023.95
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Submitted: 18 Oct 2022
Revision: 14 Sep 2023
Accepted: 19 Sep 2023
ePublished: 01 Nov 2023
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