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
© 2023 The Author(s). This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:26 |
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| Enthalten in: |
Archives of Iranian medicine - 26(2023), 11 vom: 01. Nov., Seite 647-653 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Naser Moghadasi, Abdorreza [VerfasserIn] |
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| Links: |
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| Themen: |
5M691HL4BO |
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| Anmerkungen: |
Date Completed 08.02.2024 Date Revised 16.02.2024 published: Electronic Citation Status MEDLINE |
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| doi: |
10.34172/aim.2023.95 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM367999064 |
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| 100 | 1 | |a Naser Moghadasi, Abdorreza |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Safety and Effectiveness of Cinnomer® on Disease Characteristics, Depression, and Quality of Life of Patients with Multiple Sclerosis |b A Phase IV, Post-marketing, Prospective, Multicenter Study |
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| 500 | |a Date Completed 08.02.2024 | ||
| 500 | |a Date Revised 16.02.2024 | ||
| 500 | |a published: Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023 The Author(s). This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Clinical Trial, Phase IV | |
| 650 | 4 | |a Journal Article | |
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| 650 | 4 | |a Cinnomer® | |
| 650 | 4 | |a Clinical trial phase IV | |
| 650 | 4 | |a Glatiramer acetate | |
| 650 | 4 | |a Multiple sclerosis | |
| 650 | 4 | |a Quality of life | |
| 650 | 7 | |a Glatiramer Acetate |2 NLM | |
| 650 | 7 | |a 5M691HL4BO |2 NLM | |
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| 700 | 1 | |a Baghbanian, Seyed Mohammad |e verfasserin |4 aut | |
| 700 | 1 | |a Shaygannejad, Vahid |e verfasserin |4 aut | |
| 700 | 1 | |a Anjidani, Nassim |e verfasserin |4 aut | |
| 700 | 1 | |a Ghadiri, Fereshteh |e verfasserin |4 aut | |
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| 700 | 1 | |a Saeidi, Morteza |e verfasserin |4 aut | |
| 700 | 1 | |a Amirifard, Hamed |e verfasserin |4 aut | |
| 700 | 1 | |a Ayromlou, Hormoz |e verfasserin |4 aut | |
| 700 | 1 | |a Beladi Moghadam, Nahid |e verfasserin |4 aut | |
| 700 | 1 | |a Ranjbar, Mohammad Bagher |e verfasserin |4 aut | |
| 700 | 1 | |a Nazeri, Masoume |e verfasserin |4 aut | |
| 700 | 1 | |a Niknam, Zahra |e verfasserin |4 aut | |
| 700 | 1 | |a Faraji, Fardin |e verfasserin |4 aut | |
| 700 | 1 | |a Afsorde, Afsaneh |e verfasserin |4 aut | |
| 700 | 1 | |a Sahraian, Mohammad Ali |e verfasserin |4 aut | |
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