Problems of interchangeability of systemic interferons for treatment of multiple sclerosis
Problems of interchangeability of systemic interferons for treatment of multiple sclerosis are described. An analysis of 1,643 spontaneous reports existing in the Russian database for the period 2009 to 2015 was made in order to identify information on adverse reactions that occurred after replaceme...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | Russian |
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Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
2018-02-01
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| Series: | Безопасность и риск фармакотерапии |
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| Online Access: | https://www.risksafety.ru/jour/article/view/86 |
| _version_ | 1826566381940768768 |
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| author | I. I. Snegireva E. Yu. Pasternak K. E. Zatolochina M. A. Darmostukova R. N. Alyautdin V. A. Polivanov |
| author_facet | I. I. Snegireva E. Yu. Pasternak K. E. Zatolochina M. A. Darmostukova R. N. Alyautdin V. A. Polivanov |
| author_sort | I. I. Snegireva |
| collection | DOAJ |
| description | Problems of interchangeability of systemic interferons for treatment of multiple sclerosis are described. An analysis of 1,643 spontaneous reports existing in the Russian database for the period 2009 to 2015 was made in order to identify information on adverse reactions that occurred after replacement of systemically used interferons. Since 2010-2011 there have been reports on adverse reactions and lack of efficacy caused by the replacement of one systemic interferon for treatment of multiple sclerosis with another one with the same INN. Most of the reports indicated a «possible» degree of reliability of the cause-effect relationship. Most of the spontaneous reports of adverse reactions when replacing interferons beta-1a and beta-1b contained information about adult patients. More than half of the spontaneous reports of adverse reactions contained information on clinically signifiant events. When interferons beta-1a and beta-1b were replaced, there were mainly general disorders, reactions at the injection site, musculoskeletal disorders and neurologic disorders observed. The reference medication was well tolerated but replacing for a bioanalogous drug resulted in ineffectiveness or development of adverse reactions. The results of the study demonstrated that the data of spontaneous reports are important for making decision on the interchangeability of systemic interferons for the treatment of multiple sclerosis. |
| first_indexed | 2024-03-08T22:27:08Z |
| format | Article |
| id | doaj.art-279e65bab78244719c07b0863f99fbf3 |
| institution | Directory Open Access Journal |
| issn | 2312-7821 2619-1164 |
| language | Russian |
| last_indexed | 2025-03-14T10:50:45Z |
| publishDate | 2018-02-01 |
| publisher | Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» |
| record_format | Article |
| series | Безопасность и риск фармакотерапии |
| spelling | doaj.art-279e65bab78244719c07b0863f99fbf32025-03-02T10:50:03ZrusMinistry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»Безопасность и риск фармакотерапии2312-78212619-11642018-02-015416116986Problems of interchangeability of systemic interferons for treatment of multiple sclerosisI. I. Snegireva0E. Yu. Pasternak1K. E. Zatolochina2M. A. Darmostukova3R. N. Alyautdin4V. A. Polivanov5Scientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsPeoples’ Friendship University of RussiaScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsInformation and Methodological Centre for Expert Evaluation, Recording and Analysis of Circulation of Medicinal ProductsProblems of interchangeability of systemic interferons for treatment of multiple sclerosis are described. An analysis of 1,643 spontaneous reports existing in the Russian database for the period 2009 to 2015 was made in order to identify information on adverse reactions that occurred after replacement of systemically used interferons. Since 2010-2011 there have been reports on adverse reactions and lack of efficacy caused by the replacement of one systemic interferon for treatment of multiple sclerosis with another one with the same INN. Most of the reports indicated a «possible» degree of reliability of the cause-effect relationship. Most of the spontaneous reports of adverse reactions when replacing interferons beta-1a and beta-1b contained information about adult patients. More than half of the spontaneous reports of adverse reactions contained information on clinically signifiant events. When interferons beta-1a and beta-1b were replaced, there were mainly general disorders, reactions at the injection site, musculoskeletal disorders and neurologic disorders observed. The reference medication was well tolerated but replacing for a bioanalogous drug resulted in ineffectiveness or development of adverse reactions. The results of the study demonstrated that the data of spontaneous reports are important for making decision on the interchangeability of systemic interferons for the treatment of multiple sclerosis.https://www.risksafety.ru/jour/article/view/86взаимозаменяемостьинтерфероныспонтанные сообщенияфармаконадзорinterchangeabilityinterferonsspontaneous reportspharmacovigilance |
| spellingShingle | I. I. Snegireva E. Yu. Pasternak K. E. Zatolochina M. A. Darmostukova R. N. Alyautdin V. A. Polivanov Problems of interchangeability of systemic interferons for treatment of multiple sclerosis Безопасность и риск фармакотерапии взаимозаменяемость интерфероны спонтанные сообщения фармаконадзор interchangeability interferons spontaneous reports pharmacovigilance |
| title | Problems of interchangeability of systemic interferons for treatment of multiple sclerosis |
| title_full | Problems of interchangeability of systemic interferons for treatment of multiple sclerosis |
| title_fullStr | Problems of interchangeability of systemic interferons for treatment of multiple sclerosis |
| title_full_unstemmed | Problems of interchangeability of systemic interferons for treatment of multiple sclerosis |
| title_short | Problems of interchangeability of systemic interferons for treatment of multiple sclerosis |
| title_sort | problems of interchangeability of systemic interferons for treatment of multiple sclerosis |
| topic | взаимозаменяемость интерфероны спонтанные сообщения фармаконадзор interchangeability interferons spontaneous reports pharmacovigilance |
| url | https://www.risksafety.ru/jour/article/view/86 |
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