Biologics Increase Incidence, Not Mortality From Opportunistic Infections Interview with:
Eleftherios Mylonakis, M.D., Ph.D., FIDSA
Dean’s Professor of Medical Science
Chief, Infectious Diseases Division
Alpert Medical School and Brown University

and Dr. Irene Kourbeti MD
Research Associate
Infectious Disease Division
Rhode Island Hospital, Providence, RI What are the main findings of the study?

Answer : There was high quality of evidence that biologic agents are associated with increased risk of all opportunistic infections, but there was no difference in mortality attributed to the opportunistic infections. Patients receiving biologics were twice more likely to develop opportunistic infections (OIs) compared to controls (OR 1.79; 95% CI, 1.17-2.74) with a number needed to harm (NNH) of 582 patients. That means that 1 opportunistic infection  would occur in every 582 patients receiving biologics. The opportunistic infections usually occurred at the commencement of the use of the biological agent and they were not statistically more in patients with a previous exposure to anti-TNF agents as compared to the patients that had never received an anti-TNF agent.. Were any of the findings unexpected?

Answer: The effects of the biologics on the development of opportunistic infections became evident only after randomized controlled studies (RCTs) performed in or after the year 2004 were included. The risk for tuberculosis became evident after the inclusion of studies published in 2007. This was six years after the increased prevalence of tuberculosis in patients using biological agents was described in data delivered from post-marketing surveillance. What should clinicians and patients take away from your report?

Answer: Overall, biologics appear to be safe medications for the treatment of rheumatoid arthritis (RA) when it comes to the development of opportunistic infections which are rare events. Tuberculosis was confirmed as a very important opportunistic infection in patients receiving biological agents. Mortality was not affected. What recommendations do you have for future research as a result of this study?

Answer: We believe that large registries are needed in order to define the exact incidence of opportunistic infections among patients receiving biologics.


Biological Therapies in Rheumatoid Arthritis and the Risk of Opportunistic Infections: A meta-analysis