The IMAgINE 1 study evaluated the safety and efficacy of adalimumab double-blind maintenance dosing regimens following open-label induction for pediatric patients with moderate to severe Crohn's disease.
Dr Jeffrey Hyams and colleagues from Connecticut, USA studied 192 patients with Pediatric Crohn's Disease Activity Index (PCDAI) scores over 30 for whom conventional treatment was unsuccessful.
Patients received open-label induction therapy with subcutaneous adalimumab at weeks 0 and 2.
At week 4, 188 patients were assigned to groups based on achievement of clinical response, and prior exposure to infliximab.
|At week 26, 34% were in clinical remission|
The researchers gave groups double-blind maintenance therapy with adalimumab at high or low doses every other week for 48 weeks.
The research team found that clinical remission (PCDAI ≤10) at week 26 was compared between groups using the Cochran–Mantel–Haenszel test, adjusting for strata, with nonresponder imputation.
The team monitored adverse events to evaluate safety.
A total of 81% of patients completed all 26 weeks of the study.
At week 26, 34% were in clinical remission, with no significant difference between high- and low-dose groups.
The team detected no new safety signals.
Dr Hyams' team concludes, "Adalimumab induced and maintained clinical remission of children with Crohn's disease, with a safety profile comparable to that of adult patients with Crohn's disease."
"More children who received high compared with low dose were in remission at week 26, but the difference between dose groups was not statistically significant."