Abstract

Abstract Background For paediatric patients with high risk of complicated Crohn’s disease (CD) [stricturing or penetrating disease], paediatric guidelines recommend upfront anti-tumor necrosis factor-alpha (ATA). Early ATA therapy has been demonstrated to result in higher steroid- and surgery-free remission rates at 1 year than induction with conventional treatment (CONV) [Exclusive Enteral Nutrition (EEN) or corticosteroids followed by immunomodulatory therapy]. However, it is unknown whether either type of induction treatment or achieving steroid free remission (SFR) at 3 months is a more important predictor of sustained SFR (SSFR) at 1 year. Therefore, we aimed to evaluate the independent effect of early ATA use after achieving induction of remission on sustained SFR (SSFR) rates at 1 year in an international prospective observational study. Methods Since January 2017, children (0–18 years) with newly-diagnosed CD were prospectively enrolled in 28 European and Asian paediatric IBD centers. Extensive demographic and clinical data were collected at baseline, and at 1, 3, 6 and 12 months. The primary outcome was SSFR at 1 year, defined as a weighted Paediatric CD Activity Index (wPCDAI) <12.5 without steroids at 3, 6, and 12 months. Secondary outcomes included SFR at 3 and 12 months, and treatment escalation to ATA. Outcomes were compared between the early ATA induction treatment group (defined as ATA within 3 months after diagnosis) and the CONV induction treatment group (EEN or corticosteroids), using χ 2 tests. Results Up to July 2021, 235 children with new-onset CD were included and completed at least 1 year of follow-up (61.7% male, median age 13.7 [IQR 11.4–15.0]). At 1 year, 62/203 (30.5%) achieved SSFR. Patients that received early ATA were more likely to achieve SSFR compared to patients with CONV (35/79 [44%] vs. 27/110 [25%], p=0.004). After induction treatment, 99/213 [47%] achieved SFR at 3 months. Patients with early ATA had higher rates of SFR at 3 months (48/84 [57%]) than those with CONV (51/129 [40%], p=0.012), and higher rates of low faecal calprotectin (67% vs. 17%, p<0.001) or low CRP (< 5 mg/l) (82% vs. 53%, p<0.001). Of those patients in SFR at 3 months, 71% achieved SSFR, which was not significantly different between those in SFR at 3 months with early ATA vs. with CONV (35/45 [78%] vs. 27/43 [63%], p=0.12). Conclusion While only one-third of paediatric CD patients achieve SSFR at 1 year, 71% of patients achieve SSFR after having achieved SFR at 3 months. Patients with early ATA had higher rates of SFR at 3 months and SSFR at 1 year than those without early ATA. Remission at 3 months was found to be more important for SSFR than type of induction treatment, highlighting the importance of initial response to induction treatment.

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