Infection risk with TNF inhibitors confirmed in juvenile idiopathic arthritis
medwireNews: Study results suggest that tumor necrosis factor-alpha inhibitors (TNFIs) are associated with a higher risk for serious infection than disease-modifying antirheumatic drugs (DMARDs) among children with juvenile idiopathic arthritis (JIA).
“[I]n 2008, the US Food and Drug Administration (FDA) required TNFI manufacturers to include a black box warning in the product label for serious infections leading to hospitalization or death,” explain Glen Schumock (University of Illinois at Chicago, USA) and study co-authors.
“The warning applies to both adults and children, yet most studies evaluating the TNFI-infection association were conducted in adults with RA,” they continue.
In an analysis of data from children and adolescents aged less than 16 years in the Truven Health MarketScan Commercial Claims and Encounters database, the researchers found that 11 of 482 participants initiating treatment with TNFIs experienced serious infections during 404.9 person–years, compared with 18 of 2013 DMARD-treated patients during 1405.4 person–years. Mean follow-up in the two groups was 307 and 255 days, respectively.
These findings translate into a 2.74-fold increased risk for serious bacterial infection associated with TNFIs relative to DMARDs after adjustment for potential confounders including inpatient and outpatient diagnoses, procedures, and medication use, reports the team in Rheumatology.
In both the TNFI and DMARD groups, infections occurred most frequently in the respiratory tract (36.4 and 33.3%), followed by the digestive system (27.3 and 22.2%), other organ systems (18.2 and 22.2%), skin (9.1 and 16.7%), and the genitourinary system (9.1 and 5.6%).
“Our analysis supports the FDA warning about TNFI-associated infection in children with JIA,” say Schumock and colleagues.
However, the authors note that “[a]lthough our results suggest increased risk for infections associated with TNFIs compared with DMARDs, clinicians and patients should consider this risk in light of the benefits of TNFIs.
“Specifically, TNFIs are highly effective drugs that have been shown to improve symptoms, physical functioning, radiographic progression and quality of life.”
They also caution that the study was not sufficiently powered to evaluate the infection risk associated with specific TNFIs, and call for additional larger studies to “confirm our findings and further characterize the risk of infection across individual TNFI agents.”
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