Background Behçet’s disease (BD) is a multisystemic, chronic relapsing inflammatory disease classified among the vasculitis. Literature data show growing data reporting effectiveness of TNF-alpha blockers in inducing remission for sight- and life-threatening involvement in BD. Tumor necrosis factor (TNF) plays an important role in host defense and tumor growth control, therefore, anti-TNF antibody therapies may increase the risk of serious infections.
Objectives the primary objective of the study was to assess the rate of serious infections associated with the use of biologic therapy (infliximab, adalimumab) in patients with BD; the secondary aims were: to quantify the latency period between the beginning of biologic therapy and the onset of infection and to study any potential correlation among clinical-epidemiological data and frequency of infections.
Methods twenty-five patients (M/F:14/10; mean age 38,5 years, min-max 25:52; mean age at disease onset: 25 years; mean disease duration 13,4 years) were prospective evaluated. The rate of serious infections was expressed in terms of incidence rate ratio (IRR). The latency period between the beginning of biologic therapy and the onset of infection was evaluated both in terms of weeks and number of infusions received.
Results The patients received infliximab at the dose of 3-5 mg/kg at week 0, 2, 4 and then every 8 weeks.; moreover after a minimum period of 44 weeks and maximum of 96 weeks, 3 patients was switched for loss of efficacy to adalimumab, at the dose of 40 mg every 2 weeks. During the follow-up, we found 3 cases of serious infections (12%): one case of pneumonia, one of myopericarditis and a mononucleosis, all cases receiving infliximab therapy. The incidence rate ratio (IRR) was 4.3/1000 person-months (95% CI 1-12). Moreover, the latency period between the beginning of therapy and the onset of each infection was 192, 428 and 168 weeks respectively, with the following number of infusions: 26, 55 and 23. Any correlations was found among clinical and epidemiological features and frequency of infections.
Conclusions These findings show that overall, rate of serious infections in Behcet’s disease patients receiving biologic therapies is not so different from the rate of serious infections reported in rheumatoid arthritis. However, in order to balance benefits and risks, it is desirable that results from long-term observational studies and clinical trials may allow the scientific community to reach the target of a suspension schedule of biologic therapies.
Disclosure of Interest None Declared