Rheumatology patients treated with interleukin inhibitors have an increased risk for serious infections, opportunistic infections and cancer, according to data published in JAMA Open Network.
“Although the therapeutic efficacy of these targeted biologics is well established by several clinical trials, systematic reviews and meta-analyses, there is a paucity of data regarding the safety profile of these agents,” Jawad Bilal, MD, of the University of Arizona, and colleagues wrote.
“The increased risk of serious and opportunistic infections with biologics, including IL inhibitors, has been a plausible safety concern secondary to blockade of biological pathways leading to immune dysregulation,” they added. “However, the currently available evidence is not sufficient to draw conclusions regarding the safety of IL inhibitors with regard to the risk of serious infections and cancer.”
To analyze the risk for serious and opportunistic infections, and cancer, among patients treated with IL inhibitors for rheumatic diseases, Bilal and colleagues conducted a systematic review of randomized, placebo-controlled trials that reported on the therapy’s safety. Searching a collection of Ovid databases and Scopus, from inception to Nov. 30, 2018, the researchers identified and included 74 studies, representing 29,214 patients, in their review. Patients included 24,236 with serious infections, 9,998 with opportunistic infections and 21,065 with cancer.
Rheumatology patients treated with ILinhibitors have an increased risk for serious infections, opportunistic infections and cancer, according to data.
Following the review, two researchers independently examined study data and assessed potential bias and certainty of the evidence. The researchers then conducted a fixed-effects meta-analysis to pool odds ratios for infections and cancers regarding IL inhibitors compared with placebo. The main outcomes were the number of infections and cancers among patients treated with IL inhibitors compared with placebo.
According to the researchers, patients treated with IL inhibitors demonstrated a greater risk for serious infections (OR = 1.97; 95% CI, 1.58-2.44), opportunistic infections (OR = 2.35; 95% CI, 1.09-5.05) and cancer (OR = 1.52; 95% CI, 1.05-2.19). The finding regarding the risk for serious infections was of high certainty, while those related to the risks for opportunistic infections and cancer were of moderate certainty, the researchers wrote.
“The results from this study suggest that the risk of serious infections, opportunistic infections and cancer is increased in patients with rheumatologic diseases who are treated with IL inhibitors compared with placebo,” Bilal told Healio Rheumatology. “This analysis provides estimates of toxic effects for infections and cancer associated with the use of IL inhibitors that can inform shared decision-making when patients and clinicians are contemplating the use of IL inhibitors for rheumatologic diseases.” – by Jason Laday
Disclosure: Bilal reports no relevant financial disclosures. Please see the study for a list of all other authors’ relevant disclosures.