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Infliximab Treatment in Rheumatic Patients Linked to Tuberculosis

Therapy with infliximab is associated with an increased risk of active tuberculosis (TB), according to a multi-centre, active-surveillance report.

The conclusion was drawn after analysis of safety data actively collected in the BIOBADASER (Base de Datos de Productos Biologicos de la Sociedad Espanola de Reumatologia) database that was launched in February 2000 by the Spanish Society of Rheumatology for active monitoring of patients with rheumatic diseases, such as rheumatoid arthritis (RA), psoriatic arthritis, and ankylosing spondylitis.

"Of overriding concern arising from the findings of the present study is that patients with RA treated with infliximab are at high risk for active TB and should be managed appropriately," say Juan J. Gomez-Reino, MD, of the Hospital Clinico Universitario and Universidad de Santiago de Compostela in Santiago, Spain, and colleagues.

Previous studies of tumour necrosis factor (TNF) inhibitors have demonstrated significant efficacy in patients with rheumatoid arthritis (RA) refractory to existing disease-modifying antirheumatic drugs with no major side effects. However, infliximab was recently reported to be associated with TB in patients with Crohn's disease and rheumatoid arthritis.

The researchers collected and analysed BIOBADASER data to determine and describe the long-term safety of 2 TNF inhibitors, infliximab and etanercept, in rheumatic diseases following commercialisation of the drugs.

Data on 1,578 treatments with infliximab (86%) or etanercept (14%) in 1,540 rheumatic patients from 71 participating centres were analysed. For estimated TB risk, the annual incidence rate in patients treated with these agents was compared with the background rate, as well as with the rate in a cohort of patients with rheumatoid arthritis (RA) treated prior to TNF inhibitor availability.

Seventeen cases of TB were identified in patients treated with infliximab. The estimated incidence of TB associated with infliximab in RA patients was 1,893 per 100,000 in the year 2000 and 1,113 per 100,000 in the year 2001.

By comparison, background information in Spain in the year 2000 was 21 cases per 100,000 inhabitants, indicating a significant increased TB risk in infliximab treated individuals.

Furthermore, a significant increase in risk was also noted for infliximab-treated patients in comparison to the RA patient not treated by anti-TNF agents.

Of note, after official guidelines by the Spanish Health Authorities (in collaboration with Sociedad Espanola de Reumatologia) were established in 2002 for TB prevention in patients treated with TNF inhibitors, only 1 new TB case was registered.

Arthritis & Rheumatism 2003;48:8:2122-2127. "Treatment of rheumatoid arthritis with tumor necrosis factor inhibitors may predispose to significant increase in tuberculosis risk: A multicenter active-surveillance report"

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