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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.
Naser Moghadasi, Abdorreza; Ashtari, Fereshteh; Baghbanian, Seyed Mohammad; Shaygannejad, Vahid; Anjidani, Nassim; Ghadiri, Fereshteh; Sedighi, Behnaz; Saeidi, Morteza; Amirifard, Hamed; Ayromlou, Hormoz; Beladi Moghadam, Nahid; Ranjbar, Mohammad Bagher; Nazeri, Masoume; Niknam, Zahra; Faraji, Fardin; Afsorde, Afsaneh; Sahraian, Mohammad Ali.
Afiliación
  • Naser Moghadasi A; Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.
  • Ashtari F; Isfahan University of Medical sciences, Kashani Comprehensive MS Center, Isfahan, Iran.
  • Baghbanian SM; Multiple Sclerosis Fellowship, Neurology Department, Boualicina Hospital, Mazandaran University of Medical Sciences, Sari, Iran.
  • Shaygannejad V; Isfahan University of Medical sciences, Kashani Comprehensive MS Center, Isfahan, Iran.
  • Anjidani N; Medical Department, Orchid Pharmed Company, Tehran, Iran.
  • Ghadiri F; Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.
  • Sedighi B; Neurology Research Center, Kerman University of Medical Science, Kerman, Iran.
  • Saeidi M; Department of Neurology, Ghaem Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.
  • Amirifard H; Department of Neurology, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.
  • Ayromlou H; Neurology Department, Imam Reza Hospital, Tabriz University of Medical Sciences, Tabriz, Iran.
  • Beladi Moghadam N; Department of Neurology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
  • Ranjbar MB; Pastour Building, Shiraz, Iran.
  • Nazeri M; Clinical Neurology Research Center, Department of Neurology, Shiraz University of Medical Sciences, Shiraz, Iran.
  • Niknam Z; Kosar Hospital, Shiraz, Iran.
  • Faraji F; Department of Neurology, School of Medicine, Arak University of Medical Sciences, Arak, Iran.
  • Afsorde A; Sina Building, Shiraz, Iran.
  • Sahraian MA; Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.
Arch Iran Med ; 26(11): 647-653, 2023 Nov 01.
Article en En | MEDLINE | ID: mdl-38310425
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 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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Esclerosis Múltiple Recurrente-Remitente / Esclerosis Múltiple Tipo de estudio: Clinical_trials / Observational_studies / Risk_factors_studies Aspecto: Patient_preference Límite: Humans País/Región como asunto: Asia Idioma: En Revista: Arch Iran Med Año: 2023 Tipo del documento: Article País de afiliación: Irán Pais de publicación: Irán
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Esclerosis Múltiple Recurrente-Remitente / Esclerosis Múltiple Tipo de estudio: Clinical_trials / Observational_studies / Risk_factors_studies Aspecto: Patient_preference Límite: Humans País/Región como asunto: Asia Idioma: En Revista: Arch Iran Med Año: 2023 Tipo del documento: Article País de afiliación: Irán Pais de publicación: Irán