ArticleInflammopharmacology2026
Bone and growth safety profiles of biologic and conventional DMARDs in juvenile idiopathic arthritis: a 21-year FAERS disproportionality analysis.
Article in Inflammopharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundJuvenile idiopathic arthritis (JIA) treatment relies on biologic and conventional disease-modifying anti-rheumatic drugs (b/csDMARDs), but pediatric-specific bone and growth safety remains incompletely characterized. Standard FAERS disproportionality analyses in pediatric polypharmacy may overstate signals through co-medication coding. We aimed to identify drug-specific bone-toxicity (Composite A) and growth/developmental (Composite B) signals and to test whether they survive a Primary-Suspect (PS) restriction designed to isolate reporter-attributed reactions.
methodsPre-specified disproportionality analysis of FAERS Individual Case Safety Reports (2004-2024); pediatric (≤ 17 years) JIA cohort, n = 13,459. Two parallel exposure definitions were applied: PS + SS (Primary or Secondary Suspect, broad) and PS-only (strict). Reporting odds ratios (ROR), proportional reporting ratios with χ
resultsOf 21 drug × composite signals under broad PS + SS analysis, only 5 met the robust-signal definition after PS-only restriction: methotrexate (both composites; bone ROR 2.4, growth ROR 3.7) and infliximab (4.3), tocilizumab (2.8), and abatacept (3.4) for bone toxicity. Etanercept and adalimumab-the two highest-exposure drugs-showed no PS-only signal despite PS + SS Composite A signals. PS + SS magnitudes attenuated by a median 87% under PS-only restriction.
conclusionsMethotrexate was the only drug with robust bone and growth signals, supporting skeletal and growth surveillance during chronic therapy; three biologics showed bone-toxicity signals. In this cohort, conventional PS + SS analysis substantially overstated signal magnitudes, supporting dual-track (PS + SS and PS-only) reporting for pediatric pharmacovigilance.
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