ハリガイ マサヨシ
HARIGAI MASAYOSHI
針谷 正祥 所属 医学部 医学科(東京女子医科大学病院) 職種 教授・基幹分野長 |
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論文種別 | 原著 |
言語種別 | 英語 |
査読の有無 | 査読なし |
表題 | Postmarketing surveillance of the safety profile of infliximab in 5000 Japanese patients with rheumatoid arthritis. |
掲載誌名 | 正式名:Annals of the rheumatic diseases 略 称:Ann Rheum Dis ISSNコード:1468-2060(Electronic)0003-4967(Linking) |
掲載区分 | 国外 |
巻・号・頁 | 67(2),pp.189-94 |
著者・共著者 | Takeuchi T, Tatsuki Y, Nogami Y, Ishiguro N, Tanaka Y, Yamanaka H, Kamatani N, Harigai M, Ryu J, Inoue K, Kondo H, Inokuma S, Ochi T, Koike T |
発行年月 | 2008/02 |
概要 | OBJECTIVES:A large-scale postmarketing surveillance (PMS) study was carried out to determine the safety profile of infliximab in Japanese patients with rheumatoid arthritis (RA).METHODS:The PMS study was performed for all patients with RA who were tMETHODS:reated with infliximab. They were consecutively registered in the PMS study at the initiation of infliximab treatment and were prospectively monitored with all adverse events noted for a period of 6 months. All case reports, which include safety-related events, were collected monthly.RESULTS:Adverse drug reactions (ADRs) were assessed for 6 months in 5000 patients who were consecutively enrolled in the PMS study. The incidence rates of total and serious ADRs were 28.0% and 6.2%, respectively.RESULTS:"RESULTS:InfectionsRESULTS:"RESULTS:orRESULTS:"RESULTS:respiratory disordersRESULTS:"RESULTS:were most commonly observed among serious ADRs. Bacterial pneumonia developed in 2.2%, tuberculosis in 0.3%, suspected Pneumocystis jiroveci pneumonia (PCP) in 0.4% and interstitial pneumonitis in 0.5%. Bacterial pneumonia (for which individuals of male gender, of older age and those with advanced rheumatoid arthritis and comorbid respiratory disease were most at risk) began to develop immediately after the start of treatment, while tuberculosis, PCP and interstitial pneumonitis developed about 1 month later. Serious infusion reactions were observed in 0.5% and were more likely to occur in patients who had participated in previous clinical trials of infliximab.CONCLUSION:This postmarketing surveillance study of patients treated with infliximab showed that infliximab in combination with low-dose MTX was well tolerated in Japanese patients with active RA. |
DOI | 10.1136/ard.2007.072967 |
文献番号 | 17644554 |