Safety and effectiveness of interferon β-1a intramuscular therapy: results of the postmarketing drug surveillance in Japan
| Autor: | Haruki Makioka, Shinichi Torii, Jun Ichi Kira, Fuyuki Nakaya, Takahiko Saida, Yan Ling |
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| Rok vydání: | 2017 |
| Předmět: |
Adult
Male Drug medicine.medical_specialty Multiple Sclerosis Adolescent Fever media_common.quotation_subject Postmarketing surveillance Pharmacology Injections Intramuscular Young Adult 03 medical and health sciences 0302 clinical medicine Japan Recurrence Internal medicine Product Surveillance Postmarketing medicine Humans 030212 general & internal medicine Adverse effect Aged media_common Expanded Disability Status Scale business.industry Multiple sclerosis Middle Aged medicine.disease Interferon β 1a Treatment Outcome Female Neurology (clinical) Chemical and Drug Induced Liver Injury business Intramuscular injection Interferon beta-1a 030217 neurology & neurosurgery Adverse drug reaction |
| Zdroj: | Rinsho Shinkeigaku. 57:553-561 |
| ISSN: | 1882-0654 0009-918X |
| DOI: | 10.5692/clinicalneurol.cn-001074 |
| Popis: | To investigate the safety and effectiveness of the interferon β-1a intramuscular injection under clinical conditions in Japan, we conducted an all-case postmarketing surveillance with a 2-year follow-up of patients who were registered during the period between November 2006 (product launch) and December 2010. Case reports were collected from 397 institutions. The safety analysis included 1,476 patients, and the effectiveness analysis included 1,441 patients. Of the patients included in the safety analysis, 86.3% had relapsing-remitting multiple sclerosis. The most common adverse drug reaction was pyrexia (19.24%). Serious adverse events included multiple sclerosis relapse (26 cases) and abnormal hepatic function (10 cases). In the effectiveness analysis, the annualized relapse rate improved significantly from 1.07 to 0.29 (P < 0.001). There was also a significant improvement in in the expanded disability status scale from 3.08 to 2.94 (P < 0.001). The results of the safety and effectiveness profile were consistent with those in previous reports. |
| Databáze: | OpenAIRE |
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