High doses of anakinra, however, may raise the risk of serious infection, particularly in patients with multiple comorbidities, according to the report in the January issue of the Annals of the Rheumatic Diseases.
To examine the safety of these biologic agents, Dr. Carine Salliot and colleagues, from Rene-Descartes University, Paris, searched PUBMED, EMBASE, and other sources for randomized trials of these agents with data on serious infections. Included were 12 trials which featured 745, 1960, 2062, and 2112 subjects who received rituximab, abatacept, anakinra, and placebo, respectively.
As noted, neither rituximab nor abatacept appeared to affect the risk of serious infection, the researchers found.
High doses of anakinra, by contrast, did seem to raise the risk. Compared with low-dose anakinra and placebo, high-dose anakinra increased the odds of serious infection by 9.63- and 3.40-fold, respectively. The risks were lower when patients with comorbidities were excluded.
The implications of the current findings are unclear since “clinical trials select patients who are not representative of all patients with rheumatoid arthritis in daily practice,” the authors note. “Thus the use of these biological agents will require careful monitoring in daily practice especially in patients with (comorbid) conditions and with concomitant treatments, such as steroids.”
Ann Rheum Dis 2009;68:25-32.