J Pediatr Pharmacol Ther. 2022;27(1):63-71. doi: 10.5863/1551-6776-27.1.63. Epub 2021 Dec 22.

Maria Consiglia Trotta ¹, Roberto Alfano ², Giovanna Cuomo ³, Ciro Romano ², Antonietta Gerarda Gravina ³, Marco Romano ³, Marilena Galdiero ¹, Maria Vittoria Montemurro ⁴, Antonio Giordano ⁵, Michele D'Amico ⁶

Author information

¹Department of Experimental Medicine, University of Campania "Luigi Vanvitelli" (MCT, MG) Naples, Italy.

²Department of Advanced Medical and Surgical Sciences "DAMSS", University of Campania "Luigi Vanvitelli" (RA, CR), Naples, Italy.

³Department of Precision Medicine, University of Campania "Luigi Vanvitelli" (GC, MR, AGG), Naples, Italy.

⁴Medical Direction, University Polyclinic "Luigi Vanvitelli" (MVM), Naples, Italy.

⁵General Directorate, University Polyclinic "Luigi Vanvitelli" (AG), Naples, Italy.

⁶Therapeutic Monitoring Unit for Biological Drugs, University "Luigi Vanvitelli" (MDA), Naples, Italy.

Abstract

Objective: To compare the timing of serum anti-drug antibodies in adult and pediatric age groups, males and females, treated for inflammatory bowel disease or arthritis with adalimumab or infliximab by retrospectively combining data collected during a 2-year therapeutic drug monitoring period.

Methods: Four hundred thirty sera were divided in groups collected at 0, 3, 6, 12, and 24 months (T0, T3, T6, T12, and T24) after initiation of therapy and assayed for drug and relative anti-drug antibodies levels. At each time point, the percentage of sera presenting anti-drug antibodies, as well as the drug concentrations, were calculated and correlated with patient age and sex.

Results: Anti-drug antibodies were present in 31.5% of sera and were significantly higher in the pediatric age group than in the adult age group, through all time points. The percentages of sera showing anti-drug antibodies were significantly different as early as 3 months and were sera from pediatric female group. The percentages of sera showing anti-drug antibodies reached the highest value at 6 months in the pediatric age group and at 12 months in the adult age group.

Conclusions: Sera from pediatric had an earlier presence of anti-drug antibodies than adults. In particular, pediatric females sera showed the fastest anti-drug antibodies development.