First-line infliximab (IFX) therapy for pediatric Crohn disease (CD) was superior to conventional therapy for achieving short- and long-term remission. These findings, from a multicenter, open-label, randomized controlled trial, were published in the journal Gut.
This study was an investigator-initiated trial conducted at 12 centers in the Netherlands, Croatia, and Finland between 2015 and 2018. Pediatric patients (N=99) with a new diagnosis of moderate to severe CD were randomly assigned in a 1:1 ratio to receive 5 mg/kg IFX infusions at weeks 0, 2, 6, 14, and 22 (n=49) or conventional treatment with exclusive enteral nutrition or oral prednisolone (n=50). All patients received maintenance therapy of azathioprine monotherapy. Outcomes were assessed through week 52. Clinical remission was defined as a weighted Pediatric CD Activity Index (wPCDAI) score <12.5.
Patients in the IFX and conventional cohorts were aged median 15.1 (IQR, 11.9-16.6) and 14.1 (IQR, 11.3-16.1) years, 49.0% and 54.0% were boys, and wPCDAI scores were 57.5 (IQR, 47.5-67.5) and 57.5 (IQR, 47.5-73.8) points, respectively. The median time from diagnostic endoscopy to start of treatment was 8 (IQR, 4-14) days.
At 10 weeks, clinical remission occurred among more IFX recipients (59% vs 34%; P =.021). Among patients who underwent endoscopy at 10 weeks (n=57), more patients in the IFX cohort had achieved endoscopic remission (59% vs 17%; P =.001).
In addition, the IFX cohort had lower C-reactive protein levels (median, 2.0 vs 8.4 mg/L; P <.001), total leukocyte count (median, 5.5 x 109 vs 7.3 x 109/L; P =.001), erythrocyte sedimentation rate (median, 6.5 vs 17 mm/h; P =.003), and fecal calprotectin (median, 286 vs 545 mg/g; P =.004).
At all time points, mean wPCADI scores were 9.8 among the IFX and 14.2 among the conventional treatment groups (P =.07).
Over the 52-week study, 43% of IFX recipients and 75% of the conventional cohort required treatment escalation (P =.001). At week 52, clinical remission without the need for treatment escalation was achieved by 41% of IFX and 15% of conventional treatment recipients (absolute difference, 26%; P =.004).
Median height-for-age improved from -0.07 to 0.02 (P =.045) in the IFX cohort and decreased from -0.53 to -0.66 (P =.020) in the conventional cohort.
A similar proportion of patients in either group reported adverse events (P =.125). A total of 6 and 9 serious adverse events occurred among the IFX and conventional cohorts, respectively.
This study may have been biased by the differing induction protocols for the cohorts, in which IFX was administered over 22 weeks while conventional therapy induction lasted between 6 to 10 weeks.
This study found that first-line IFX increased rates of clinical and endoscopic remission at 10 weeks and increased the likelihood of achieving long-term remission with azathioprine monotherapy compared with conventional therapy.
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Jongsma MME, Aardoom MA, Cozijnsen MA, et al. First-line treatment with infliximab versus conventional treatment in children with newly diagnosed moderate-to-severe Crohn’s disease: an open-label multicentre randomised controlled trial. Gut. 2022;71(1):34-42. doi:10.1136/gutjnl-2020-322339