[Infectious events during the first year of treatment with an antagonist of the tumor necrosis factor].

OBJECTIVE

To assess the incidence of severe infections in patients treated with anti-TNF-??drugs, during the first year of treatment with these drugs.

MATERIALS AND METHOD: Retrospective observational study carried out at a general hospital from a sample of patients receiving their first anti-TNF-??drug, according to approved indications, to treat a rheumatic disease. Each patient follow-up lasted for 2 years: the year before receiving the drug and the year after starting on this therapy. We considered those severe infectious events requiring hospital admission. A cohort study was performed before-after. The incidence rates of number of events (infections) per 100,000 inhabitants/year for the first treatment year and the previous year (control period) were calculated. The relative risk was calculated.

RESULTS

We included 196 patients. Twelve severe infectious events were recorded during the first treatment year, with a relative risk of 2.4. The biological drug most frequently associated to infection was Adalimumab. All patients having an infection had been previously or concomitantly treated with Methotrexate, and 90.6% with glucocorticosteroids. The main location of the infection was the respiratory system (58.3%), and the gram-positive microorganisms were the most frequent (58.3%).

CONCLUSIONS

The use of anti-TNF-??drugs, and mainly Adalimumab, represents a risk factor for suffering severe infections, mainly at the respiratory tract, produced by gram-positive microorganisms. The use of immunosuppressive drugs such as Methotrexate and glucocorticosteroids seems to increase the risk for such events.