First-Line Infliximab Beneficial in Kids With Moderate-to-Severe Crohn's

By Megan Brooks

January 08, 2021

NEW YORK (Reuters Health) - Children and adolescents with newly diagnosed moderate-to-severe Crohn's disease benefit from early, first-line therapy with infliximab, according to results of a randomized controlled trial from the Netherlands.

"In pediatric moderate-to-severe Crohn's disease the first blow is half the battle. To achieve and maintain clinical and endoscopic remission, thereby avoiding complicated disease, first-line infliximab treatment is very effective," Dr. Lissy de Ridder, Erasmus Medical Center, in Rotterdam, told Reuters Health by email.

"Children deserve optimal treatment from diagnosis instead of failing less effective treatment first before infliximab initiation," she said, adding that first-line infliximab will "positively impact their wellbeing, including growth, pubertal development and education."

In adults with Crohn's disease, early infliximab therapy has been shown to alter the natural course of the disease, yielding fewer disease complications, the researchers note in Gut.

In pediatric Crohn's, infliximab is usually reserved for disease that is refractory to corticosteroids and immunomodulator therapy, despite the known negative impact corticosteroids have on growth and development in children and adolescents, they point out.

Their open-label study showed that first-line infliximab (FL-IFX) worked better than conventional treatment in achieving short-term clinical and endoscopic remission.

The researchers included 100 untreated children with a new diagnosis of Crohn's disease. Half received FL-IFX consisting of five infusions of 5 mg/kg at weeks zero, two, six, 14 and 22 and half received conventional treatment consisting of exclusive enteral nutrition or oral prednisolone (1 mg/kg, maximum 40 mg).

At week 10, more children in the FL-IFX group than in the conventional group had achieved clinical (59% vs. 34%, P=0.021) and endoscopic remission (59% vs. 17%, P=0.001).

At week 52, the proportion of patients in clinical remission was not significantly different (P=0.421).

However, 19 of 46 (41%) children in the FL-IFX group were in clinical remission on azathioprine monotherapy with no need for corticosteroids or further biologics, versus only seven of 48 (15%) in the conventional group (P=0.004).

"Doctors can make recommendations based on these study results. Children and adolescents diagnosed with moderate-to-severe Crohn's disease will benefit from first-line infliximab," Dr. de Ridder told Reuters Health.

"A key cautionary note is the need for longer-term follow-up data," she said. "A second cautionary note is whether infliximab can be safely stopped after achieving remission, and in case yes, in which patient and on which conditions. To answer these questions longer-follow-up data are needed which now are being collected, next to studies focusing on stopping strategies."

The study was partly supported by ZonMw (The Netherlands Organization for Health Research and Development), Crocokids (a Dutch fundraising organization to support research on IBD in children) and an investigator-sponsored research award from Pfizer. Dr. de Ridder reports grants from ZonMw, Crocokids and Pfizer and consultancy fees from Abbvie during the conduct of the study.

SOURCE: Gut, online December 31, 2020.