DOP043Post-Operative Crohn’s Disease Outcomes in Children (The POPCORN trial): a prospective comparative non-interventional multi-center open study from the Porto Group of ESPGHAN

Abstract Background Ileocecal resection is the most frequent surgical intervention required in complicated or treatment-refractory Crohn’s disease (CD). We aimed to evaluate the long-term outcomes of children with CD following ileocecal resection and the effect of post-op biologic/anti-tumor necrosis factor (anti-TNF) prophylactic therapy on clinical and endoscopic disease recurrence. Methods This prospective multi-center study enrolled patients following surgery before the first endoscopic evaluation. Clinical disease activity, use of post-op prophylactic therapy and endoscopic disease recurrence were monitored up to 24 months following surgery. Primary outcomes included endoscopic recurrence at first follow-up endoscopy and clinical recurrence (defined as PCDAI ≥10 points) within 2 years of follow-up. Results A total of 100 patients)51 males; 51%, median age 12.8 IQR 11.0–15.0 years, 50 50% with ileocecal (L3) involvement, 11 11% with perianal disease) were included. Preoperative anti-TNF therapy was administered in 93% of patients. Median disease duration before surgery was 23 (IQR 4–42) months, while the indication for surgery included complicated phenotype (75%) and medical-refractory inflammatory disease (43%). Postoperative prophylactic biologic treatment was used in 76%. Clinical recurrence was observed in 13% of patients during the first year and in additional 8% during the second year following surgery. Macroscopic recurrence (Rutgeerts score ≥i2) by endoscopy was observed in 58% (Figure 1). Risk factors associated with endoscopic recurrence included younger age at diagnosis (HR = 1.03, 95% CI 1.01-1.05, p = 0.02), penetrating phenotype (HR = 1.67, 95% CI 1.12-2.50, p = 0.01), perianal involvement (HR = 1.85, 95% CI 1.05-3.24, p = 0.003), and presence of residual disease (HR = 2.4, 95% CI 1.3-4.3, p = 0.004). Biologic prophylactic therapy significantly reduced the risk of endoscopic recurrence (HR = 0.58, 95% IC 0.3-0.8, p = 0.005) (Figure 2). Conclusion Post-operative recurrence of CD in children is common. Residual disease, perianal involvement, and penetrating phenotype were associated with endoscopic recurrence, while prophylactic biologic therapy reduced recurrence risk, highlighting the importance of post-op prophylactic biological therapy. Conflict of interest: Matar, Manar: No conflict of interest Wine, Eytan: Personal Fees: Janssen, AbbVie, Nestle Health Sciences, Mead Johnson Nutrition, Pfizer, BioJamp Huynh, Hien: Grant: AbbVie and Janssen, Takada Personal Fees: Abbvie adboard Other: Abbvie and Janssen education support Copova, Ivana: No conflict of interest Yerushalmy-Feler, Anat: No conflict of interest Hojsak, Iva: No conflict of interest van Waas, Marjolein: No conflict of interest Tzivinikos, Christos: Speaker honoraria by Abbvie, IPSEN, Sanofi, Mirum, Nutricia, Abbott, Novalac Advisory board fees by Abbott, Mirum, NAPO therapeutics, IPSEN, Nutricia, Nestle, novalac Lev Zion, Raffi: None. Schwerd, Tobias: No conflict of interest Norsa, Lorenzo: No conflict of interest Granot, Maya: No conflict of interest Magen Rimon, Ramit: No conflict of interest Wlazło, Magdalena: No conflict of interest Cenni, Sabrina: No conflict of interest Sansotta, Naire: No conflict of interest Mårild, Karl: No conflict of interest Zifman, Eyal: No conflict of interest Trindade, Eunice Claudia Moreno: None Catassi, Giulia: No conflict of interest Cococcioni, Lucia: No conflict of interest Shouval, Dror: Lecturing fee - Takeda SAB - Tracells Shamir, Raanan: No conflict of interest Turner, Dan: Consultation fee: Janssen, Pfizer, Ferring, Abbvie, Takeda, Prometheus Biosciences, Lilly, SorrisoPharma, Boehringer Ingelheim, Galapagos, BMS, AlfaSigma, Merck, Gentech Research support: Janssen, Abbvie, Takeda, Pfizer Royalties: Shaare Zedek Medical Center, Hospital for Sick Children Assa, Amit: None