A study analyzed the prevalence of opportunistic infections in patients with juvenile idiopathic arthritis (JIA).
“During their development, all children experience a natural rate of infections compared to adults. Treatments in JIA with synthetic and biologic [disease-modifying anti-rheumatic drugs] are expected to increase the frequency of common infections and the risk of serious and opportunistic infections (OI), including especially tuberculosis in some geographic areas,” the study authors wrote. They added, “Recent literature seems to confirm the high incidence of infections among JIA patients treated with immunosuppressants, but conclusive data are not available, yet. In particular, little evidence exists about the role of JIA or its immunosuppressive therapy in acquiring OI.”
The study was an analysis of patients in the Pharmachild registry performed by an independent Safety Adjudication Committee (SAC). Pharmachild, or the “Pharmacovigilance in Juvenile Idiopathic Arthritis patients,” was started in 2011 by the Paediatric Rheumatology INternational Trials Organization to handle long-term safety and efficacy evaluations.
The SAC consisted of three pediatric rheumatologists and two pediatric infectious disease specialists. A five-step procedure was implemented to identify and evaluate all severe and serious infections, classified per the MedDRA dictionary and obtained in the Pharmachild registry. The SAC answered six questions about the infections, which were adjudicated with the agreement of three of the five specialists. An evidence-based OI list was made by matching adjudicated infections with the provisional OI list.
Final analysis included 572 eligible JIA patients, in whom 772 infectious events took place; 335 were serious/severe/very severe non-OI and 437 were OI of any intensity/severity per the provisional list. The majority of the infections (n=682, 88.3%) were adjudicated as infections; of these, 603 (88.4%) were common and 119 (17.4%) were OI, per the SAC. The 119 opportunistic events were matched with the provisional list, and 106 were confirmed by the SAC as OI. Of these infections, the most common were herpes viruses (68.0%) and tuberculosis (27.4%).
The results were published in Arthritis Research & Therapy.
“We found a significant number of OI in JIA patients on immunosuppressive therapy. The proposed list of OI, created by consensus and validated in the Pharmachild cohort, could facilitate comparison among future pharmacovigilance studies,” summarized the study authors.