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

Haruki Makioka, Fuyuki Nakaya, Yan Ling, Shinichi Torii, Takahiko Saida, Jun ichi Kira

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
Pages (from-to)553-561
Number of pages9
JournalClinical Neurology
Volume57
Issue number10
DOIs
Publication statusPublished - Jan 1 2017

Fingerprint

Postmarketing Product Surveillance
Interferons
Japan
Safety
Recurrence
Relapsing-Remitting Multiple Sclerosis
Intramuscular Injections
Therapeutics
Drug-Related Side Effects and Adverse Reactions
Multiple Sclerosis
Fever
Liver

All Science Journal Classification (ASJC) codes

  • Clinical Neurology

Cite this

Safety and effectiveness of interferon β-1a intramuscular therapy : results of the postmarketing drug surveillance in Japan. / Makioka, Haruki; Nakaya, Fuyuki; Ling, Yan; Torii, Shinichi; Saida, Takahiko; Kira, Jun ichi.

In: Clinical Neurology, Vol. 57, No. 10, 01.01.2017, p. 553-561.

Research output: Contribution to journalArticle

Makioka, Haruki ; Nakaya, Fuyuki ; Ling, Yan ; Torii, Shinichi ; Saida, Takahiko ; Kira, Jun ichi. / Safety and effectiveness of interferon β-1a intramuscular therapy : results of the postmarketing drug surveillance in Japan. In: Clinical Neurology. 2017 ; Vol. 57, No. 10. pp. 553-561.
@article{c9a4095bf6ff486a954580734fcbfd63,
title = "Safety and effectiveness of interferon β-1a intramuscular therapy: results of the postmarketing drug surveillance in Japan",
abstract = "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.",
author = "Haruki Makioka and Fuyuki Nakaya and Yan Ling and Shinichi Torii and Takahiko Saida and Kira, {Jun ichi}",
year = "2017",
month = "1",
day = "1",
doi = "10.5692/clinicalneurol.cn-001074",
language = "English",
volume = "57",
pages = "553--561",
journal = "Clinical Neurology",
issn = "0009-918X",
publisher = "Societas Neurologica Japonica",
number = "10",

}

TY - JOUR

T1 - Safety and effectiveness of interferon β-1a intramuscular therapy

T2 - results of the postmarketing drug surveillance in Japan

AU - Makioka, Haruki

AU - Nakaya, Fuyuki

AU - Ling, Yan

AU - Torii, Shinichi

AU - Saida, Takahiko

AU - Kira, Jun ichi

PY - 2017/1/1

Y1 - 2017/1/1

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=85036644666&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85036644666&partnerID=8YFLogxK

U2 - 10.5692/clinicalneurol.cn-001074

DO - 10.5692/clinicalneurol.cn-001074

M3 - Article

C2 - 28966229

AN - SCOPUS:85036644666

VL - 57

SP - 553

EP - 561

JO - Clinical Neurology

JF - Clinical Neurology

SN - 0009-918X

IS - 10

ER -