Objectives Analysis of the tuberculosis cases reported in France in patients treated with infliximab since its marketing approval, assessment of the effect of changes in the summary of product characteristics and national guidelines.

Methods Based on tuberculosis reports from the national post-marketing adverse drug reaction databank of the manufacturer from January 1, 2000 through June 30, 2003, and records from the national multicenter retrospective survey on opportunistic infections with anti-TNFa, we analyzed all cases of tuberculosis and the impact of the changes made in December 2000 in the summary of product characteristics and the guidelines on the prevention and management of tuberculosis in patients treated with infliximab published in February 2002.

Results 56 cases of tuberculosis were reported: the median interval before diagnosis was 12 weeks with a median of 3 infusions. The presence of Koch bacilli was confirmed in 32 patients; 29 patients had extrapulmonary or disseminated forms of tuberculosis. The tuberculosis rate among patients treated with infliximab was greater than among the general population and differed significantly by period (p ≪ 0.005).

Conclusion Tuberculosis can occur within the first 12 weeks of treatment with infliximab. Information for practitioners must be continued, together with surveillance of the tuberculosis cases in France.