Adalimumab ( Humira ), a humanized anti-tumour necrosis factor antibody, is an effective treatment in adult patients with refractory Crohn's disease.
The available literature on its efficacy in children remains limited. Researchers have evaluated its real-world efficacy in pediatric Crohn's disease patients and to compare its efficacy between Infliximab ( Remicade ) non-responders and patients who lost response to Infliximab.
All Dutch Crohn’s disease patients receiving Adalimumab before the age of 18 after previous Infliximab therapy, were identified.
Researchers analysed longitudinal disease activity, assessed by the mathematically weighted pediatric Crohn's disease activity index ( wPCDAI ) or the Physician Global Assessment ( PGA ), and adverse events.
Fifty-three Crohn’s disease patients were included. Twelve patients received monotherapy and the others received combination treatment with thiopurines ( n = 21 ), Methotrexate ( n = 11 ), steroids ( n = 7 ) or exclusive enteral nutrition ( n = 2 ).
Median follow-up was 12 months ( IQR 5-23 ). Remission was reached in 34 patients ( 64%, wPCDAI less than 12.5 or PGA = 0 ) after a median of 3.3 months, and maintained by 50% for 2 years.
Eleven patients ( 21% ) have reached response but not remission ( decrease in wPCDAI greater than or equal to 17.5 or decrease in PGA ).
Eighteen patients ( 34% ) failed Adalimumab treatment because of non-response ( n = 4 ), lost response ( n = 11 ) or adverse events ( n = 3 ).
More Infliximab non-responders failed Adalimumab treatment than patients who lost response to Infliximab ( 2/3 vs 8/34, hazard ratio, HR=18.8, CI 1.1-303.6 ).
Only one patient encountered a serious adverse event, a severe but nonfatal infection.
In clinical practice, Adalimumab has shown to induce remission in two-thirds of children with Infliximab refractory Crohn’s disease. ( Xagena )
Cozijnsen M et al, J Pediatr Gastroenterol Nutr 2014; Epub ahead of print