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

Abstract

Background: Every patient diagnosed with definite multiple sclerosis (MS) should begin disease modifying therapies. Cinnomer (R) 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 (R) 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 (R) 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 (R) is effective with respect to clinical outcomes and from the patient's perspective and in reducing MRI-measured MS activity.