| アブストラクト | BACKGROUND: A warning for tuberculosis was added to the approved labeling for infliximab in October 2001. OBJECTIVE: To describe adverse event reports of tuberculosis during infliximab therapy after labeling changes. DESIGN: Case series. SETTING: Spontaneous adverse event reports maintained in the Adverse Event Reporting System database in the United States. PATIENTS: 130 patients with infliximab-associated tuberculosis. MEASUREMENTS: Clinical and laboratory data. RESULTS: The U.S. Food and Drug Administration received 130 domestic, spontaneous reports of tuberculosis in patients treated with infliximab between 1 November 2001 and 30 May 2006, including 59 (45%) with extrapulmonary disease. The most commonly reported risk factors included concomitant immunosuppressant use (n = 89), history of latent or active tuberculosis (n = 33), and being born into or having spent extensive time in an area where tuberculosis is endemic (n = 25). In the subset of 67 cases with documented initiation of infliximab therapy after the drug labeling change, 34 patients with a negative tuberculin skin test result before initiation of infliximab therapy developed tuberculosis after receiving infliximab. LIMITATION: Conclusions from spontaneous case reports may not be generalizable to the entire infliximab-receiving population. CONCLUSION: Clinicians should be vigilant in screening and monitoring for tuberculosis in patients receiving infliximab. |
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| ジャーナル名 | Annals of internal medicine |
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| Pubmed追加日 | 2007/11/21 |
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| 投稿者 | Raval, Angela; Akhavan-Toyserkani, Gita; Brinker, Allen; Avigan, Mark |
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| 組織名 | U. S. Food and Drug Administration, Silver Spring, Maryland, USA. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/18025446/ |
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