First-line Remicade effective in children with Crohn’s
First-line Remicade therapy was superior to conventional treatment in achieving short-term remission in children with Crohn’s disease, according to study results.
Lissy de Ridder, MD, PhD, from the gastroenterology department at Erasmus MC Sophia Children Hospital in the Netherlands, and colleagues wrote that Remicade (infliximab, Janssen) is usually only started in children with CD if conventional treatments are ineffective.
“In many pediatric patients with CD, however, particularly in those with moderate- to- severe CD, mucosal healing and sustained clinical remission are not achieved with conventional treatment,” they wrote. “First-line infliximab is mentioned in the current pediatric CD treatment guidelines as the preferred strategy only for patients with CD with active perianal fistulizing disease and those at risk of disabling disease.”
Researchers conducted an open-label, randomized controlled trial comprising 100 patients to find out if starting infliximab as a first-line treatment is more effective than conventional therapies.
Investigators included patients aged between 3 and 17 years with a new diagnosis of CD and assigned them to groups that received five infusions of infliximab or oral prednisone or exclusive enteral nutrition (conventional treatment). The primary outcome was clinical remission on azathioprine, defined as a weighted Pediatric CD Activity Index (wPCDAI) score less than 12.5 at week 52 without need for treatment escalation.
At week 10, a higher proportion of patients in the infliximab group achieved clinical (59% vs. 34%, P = .021) and endoscopic remission (59% vs. 17%, P = .001) compared with the conventional group.
Both groups had similar proportions of patients in clinical remission at week 52, however, 41% of patients in the infliximab group were in clinical remission on azathioprine monotherapy without need for escalation compared with 15% of patients in the conventional treatment group (P = .004).
“Despite the similar clinical remission rates at 1 year after diagnosis in both treatment groups, we argue that children and adolescents with moderate-to-severe CD would benefit from first-line infliximab treatment as an insufficiently effective treatment strategy impacts their growth and development,” de Ridder and colleagues wrote. “This innovative treatment was well accepted by children and their parents, which shows the importance of moving forward with protocols to allow us to learn what is best.”