ArticleJournal of Crohn's & colitis2026
Stability of infliximab serum concentrations during long-term frozen storage: a paired biobank study.
Article in Journal of Crohn's & colitis, 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
backgroundPharmacokinetic research of infliximab often relies on prospectively collected, long-term frozen serum samples. Although the effect of storage conditions on infliximab stability has been researched extensively, the influence of long-term storage on the reliability of infliximab concentration measurements remains unknown.
methodsIn this proof-of-concept study, infliximab serum concentrations measured after 2, 5, and 8 years of standardized frozen storage at -70 °C were compared with paired samples analyzed directly after collection. Equivalence was assessed using a two one-sided tests framework with predefined margins of 80%-125%, in line with FDA equivalence guidance.
resultsEquivalence was demonstrated at all three storage durations. Geometric mean ratios were 87.0% (90% CI, 80.9%-93.6%), 103.2% (90% CI, 90.3%-117.9%), and 99.3% (90% CI, 92.5%-106.6%) at 2, 5, and 8 years, respectively, all within predefined equivalence margins. A statistically significant reduction was observed in the 2-year group (P = .010), though within equivalence bounds. No concentration-dependent bias was detected (P = .926), and Spearman correlation between fresh and frozen concentrations was high (ρ = 0.908, P < .001).
conclusionInfliximab serum concentrations remain stable after long-term frozen storage of up to 8 years under standardized conditions, supporting the validity of deferred concentration analyses in prospectively stored serum samples.
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