Rinsho Shinkeigaku (Clinical Neurology)

Original Article

Safety and effectiveness of interferon β-1a intramuscular therapy:
results of the postmarketing drug surveillance in Japan

Haruki Makioka1), Fuyuki Nakaya, M.S.1), Yan Ling, M.D., Ph.D.1), Shinichi Torii, Ph.D.1), Takahiko Saida, M.D., Ph.D.2)3), Jun-ichi Kira, M.D., Ph.D.4)

1)Biogen Japan Ltd
2)Kansai Multiple Sclerosis Centre
3)Department of Neurology, Kyoto Min-iren Central Hospital
4)Department of Neurology, Neurological Institute, Graduate School of Medical Sciences, Kyushu University

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.
Full Text of this Article in Japanese PDF (579K)

(CLINICA NEUROL, 57: 553|561, 2017)
key words: IFNβ-1a, multiple sclerosis, postmarketing drug surveillance, adverse drug reaction, effectiveness

(Received: 14-Jun-17)