Top-down Remicade superior to step-up therapy in pediatric Crohn’s
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Administration of Remicade using a top-down approach was superior to step-up therapy in achieving clinical remission in children with Crohn’s disease, according to research from Digestive Disease Week.
Maria Jongsma, MD, from the department of pediatric gastroenterology at Erasmus University Medical Center in the Netherlands, said in a recorded audio presentation that Remicade (infliximab, Janssen) can be effective for the control of inflammatory activity in these patients, but it is often reserved for refractory patients or those who are steroid dependent.
“The ultimate goal of treatment of pediatric Crohn’s disease patients is to have an early control of the inflammatory cascade and induce mucosal healing,” she said. “Our hypothesis was that the initiation of infliximab directly after diagnosis in moderate-to-severe pediatric CD patients prevents the inflammatory cascade.”
Researchers conducted a randomized controlled trial comprising 97 patients aged between 3 and 17 years with new-onset, untreated CD. The patients all had a weighted pediatric CD activity index (wPCAI) greater than 40.
Patients who underwent top-down therapy received five infliximab infusions of 5 mg/kg combined with azathioprine. After the five infusions, they stopped infliximab and continued azathioprine as maintenance. Patients in the step-up group underwent induction therapy with exclusive enteral nutrition or oral prednisolone combined with azathioprine as maintenance. In both groups, patients could start or restart infliximab based on predefined conditions.
The primary endpoint of the study was sustained clinical remission (wPCAI < 12.5) at week 52 without need for additional therapy or surgery. Investigators also evaluated the impact on mucosal health and fecal calprotectin levels.
At week 52, 41% of patients in the top-down group were in clinical remission without a need for treatment intensification or surgery, while just 7 of 48 patients in the step-up group met the same outcome (P = .004). The top-down group also had more patients in clinical remission at week 10 (P = .033).
After induction, 36% of patients in the top-down group restarted infliximab, while 60% of patients in the step-up group had to begin the drug (P = .02). Endoscopic remission rates were also higher in the top-down group among the 57 patients who consented to endoscopy at week 10 (59% vs. 17%; P = .001).
“We have shown that top-down induces significantly more often mucosal healing,” she said, before concluding by asking if it was time to change daily clinical practice by starting with infliximab directly after diagnosis. – by Alex Young
Reference:
Jongsma M, et al. Abstract 947. Presented at: Digestive Disease Week; May 2-5, 2020; Chicago (meeting canceled).
Disclosures: Jongsma reports no relevant financial disclosures. Please see the study abstract for all other authors’ relevant financial disclosures.