Improved Clinical Outcomes With Early Anti-Tumour Necrosis Factor Alpha Therapy in Children With Newly Diagnosed Crohn's Disease: Real-world Data from the International Prospective PIBD-SETQuality Inception Cohort Study

J Crohns Colitis. 2024 May 31;18(5):738-750. doi: 10.1093/ecco-jcc/jjad197.

Abstract

Background and aims: Treatment guidelines for paediatric Crohn's disease [CD] suggest early use of anti-tumour necrosis factor alpha [anti-TNFα] in high-risk individuals. The aim is to evaluate the effect of early anti-TNF in a real-world cohort.

Methods: Children with newly diagnosed CD were prospectively recruited at 28 participating sites of the international observational PIBD-SETQuality study. Outcomes were compared at 3 months, 1 and 2 years between patients receiving early anti-TNF [<90 days after diagnosis] and those not receiving early anti-TNF. Outcomes included sustained steroid-free remission [SSFR] without treatment intensification [specified as SSFR*] and sustained steroid-free mild/inactive disease without treatment intensification [specified as SSFMI*]. Penalised logistic regression model-based standardisation was applied to estimate the relative risks [RR] of early therapy on outcomes. RRs were estimated for high-risk and low-risk patients, based on presence of predictors of poor outcome [POPOs] and disease activity at diagnosis.

Results: In total, 331 children (median age 13.9 years [IQR 12.2-15.3]) were enrolled, with 135 [41%] receiving early anti-TNF. At 1 year, patients on early anti-TNF had higher rates of SSFR* [30% vs 14%, p <0.001] and SSFMI* [69% vs 33%, p <0.001], with RRs of 2.95 [95% CI 1.63-5.36] and 4.67 [95% CI 2.46-8.87], respectively. At 1 year, the RRs for SSFMI* were higher, and statistically significant in high-risk patients, i.e. those with moderate/severe disease compared with mild/inactive disease at diagnosis (5.50 [95% CI 2.51-12.05] vs 2.91 [95% CI 0.92-9.11]), and those with any POPO compared with no POPO (5.05 [95% CI 2.45-10.43] vs 3.41 [95% CI 0.54-21.7]).

Conclusion: In this cohort of children with newly-diagnosed CD, early anti-TNF demonstrated superior effectiveness in high-risk patients.

Keywords: Biologics; early treatment; inflammatory bowel disease; risk-stratification.

Publication types

  • Observational Study
  • Multicenter Study

MeSH terms

  • Adalimumab / therapeutic use
  • Adolescent
  • Child
  • Child, Preschool
  • Crohn Disease* / diagnosis
  • Crohn Disease* / drug therapy
  • Female
  • Gastrointestinal Agents / therapeutic use
  • Humans
  • Infliximab / therapeutic use
  • Male
  • Prospective Studies
  • Remission Induction / methods
  • Severity of Illness Index
  • Treatment Outcome
  • Tumor Necrosis Factor-alpha* / antagonists & inhibitors

Substances

  • Adalimumab
  • Gastrointestinal Agents
  • Infliximab
  • Tumor Necrosis Factor-alpha

Supplementary concepts

  • Pediatric Crohn's disease