First-line infliximab shows promise in children with moderate-to-severe CD

Use of infliximab (IFX) in the first line setting appears to yield better results than conventional treatment in children with moderate-to-severe Crohn’s disease (CD), facilitating short-term clinical and endoscopic remission and being associated with a greater likelihood of maintaining clinical remission at week 52 on azathioprine monotherapy, according to a study.

The multicentre open-label trial randomized 100 untreated paediatric patients with a new diagnosis of CD (3–17 years old; weighted Paediatric CD Activity Index score (wPCDAI) >40) to receive five infusions of 5 mg/kg IFX at weeks 0, 2, 6, 14, and 22 (FL-IFX; n=50) or either exclusive enteral nutrition (EEN) or oral prednisolone (1 mg/kg, maximum 40 mg; conventional; n=50).

There were four patients who failed to receive treatment as per protocol. At week 10, significantly more patients in the FL-IFX group than in the conventional group achieved clinical remission (59 percent vs 34 percent, respectively; p=0.021) and endoscopic remission (59 percent vs 17 percent, respectively; p=0.001).

The proportion of patients on clinical remission at week 52 was not markedly different in the two treatment groups (p=0.421).

However, the primary outcome of clinical remission on azathioprine (defined as a wPCDAI <12.5 at week 52, without need for treatment escalation) occurred with greater frequency with FL-IFX (19 out of 46 patients; 41 percent) than with conventional treatment (seven out of 48 patients; 15 percent; p=0.004).

The findings support the initiation of IFX therapy in children with newly diagnosed moderate-to-severe CD. This has important clinical implications, given the detrimental impact of an insufficiently effective treatment strategy on growth, development, and school attendance of this population.