The objective of the present study was to evaluate the effectiveness and safety of Adalimumab ( Humira ) in children with Crohn disease ( CD ) who experienced Infliximab ( Remicade ) failure at the population level.
The retrospective study included all of the children with Crohn disease from a pediatric-onset population-based cohort who received Adalimumab before 18 years because of Infliximab failure or intolerance.
Efficacy of Adalimumab was evaluated using the physician's global assessment score, C-reactive protein and orosomucoid, and nutritional and growth indicators.
A total of 27 children with Crohn disease received Adalimumab. Median age at CD diagnosis and at Adalimumab initiation was 11 years ( Q1 = 9; Q3 = 12 ) and 15 years ( 12; 15 ), respectively.
After a median follow-up of 16 ( 8; 26 ) months after Adalimumab initiation, Adalimumab had clinical benefit as measured by the physical global assessment score in 19 patients ( 70% ).
Cumulative probability of failure to treatment with Adalimumab was 38% at 6 months and 55% at 1 year. Eight patients had a primary failure ( 30% ) and 5 of 19 ( 26% ) a secondary failure to Adalimumab.
Furthermore, 11 patients ( 40% ) experienced a total of 19 adverse effects. No serious adverse effects were observed and none resulted in Adalimumab discontinuation.
There was no significant change in growth and nutritional patterns during the study period, but researchers found a significant decrease in median C-reactive protein ( 15 mg/L [ 4; 44 ] vs 9 mg/L [ 3; 19 ]; P = 0.05 ) and orosomucoid ( 1.6 g/L [ 1.5; 2.6 ] vs 1.1 g/L [ 0.8; 1.9 ]; P = 0.001 ) from Adalimumab initiation to maximal follow-up in patients responding to Adalimumab.
In conclusion, in this population-based cohort of pediatric-onset Crohn disease with Infliximab failure, treatment with Adalimumab was safe and effective in two-thirds of patients. ( Xagena )
Fumery M et al, J Pediatr Gastroenterol Nutr 2015;60:744-748