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.
| Original language | English |
|---|---|
| Pages (from-to) | 738-750 |
| Number of pages | 13 |
| Journal | Journal of Crohn's & Colitis |
| Volume | 18 |
| Issue number | 5 |
| DOIs | |
| Publication status | Published - 1 May 2024 |
| Externally published | Yes |
Bibliographical note
Funding Information:The PIBD-SETQuality inception cohort study is supported by the European Union\u2019s Horizon 2020 Research and Innovation Programme grant (grant agreement number 668023 [to NM Croft and Lde R]). The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, and approval of the manuscript; and decision to submit the manuscript for publication.
Publisher Copyright:
© 2023 The Author(s).
Keywords
- Adolescent
- Child
- Female
- Humans
- Male
- Adalimumab/therapeutic use
- Crohn Disease/drug therapy
- Gastrointestinal Agents/therapeutic use
- Infliximab/therapeutic use
- Prospective Studies
- Remission Induction/methods
- Severity of Illness Index
- Treatment Outcome
- Tumor Necrosis Factor-alpha/antagonists & inhibitors
- Child, Preschool