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WHEN CROHN'S RETURNS: CRITICAL RISK FACTORS FOR POST-ILEOCECAL RESECTION RECURRENCE

Affiliations

1 University of Padova, Padova, Italy

2 IBD Center, IRCCS Humanitas Research Hospital, Rozzano, Italy

3 University of Turin, Turin, Italy

4 Policlinico San Martino, Genova, Italy

5 AOU Pisa, Pisa, Italy

6 University of Pisa, Pisa, Italy

7 Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy

8 Ospedale S.Maria degli Angeli, Pordenone, Italy

9 Ospedale Ca'Foncello, Treviso, Italy

10 Ospedale di Santa Maria del Prato di Feltre, Feltre, Italy

11 Ospedale Vittorio Emanuele III, Montecchio, Italy

12 Ospedale San Martino di Belluno, Belluno, Italy

13 San Bortolo Hospital, Vicenza, Italy

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Abstract

Introduction

Postoperative recurrence (POR) after ileocecal resection for Crohn's disease (CD) represents a significant clinical challenge

Aims & Methods

This study aimed to identify clinical risk factors for surgical recurrence in patients undergoing ileocecal resection for CD. This multicenter retrospective cohort study included 1,066 patients with CD who underwent ileocecal resection across 13 Italian centers. Univariate and multivariate logistic regression analyses were performed to identify clinical risk factors associated with surgical recurrence.

Results

The cohort comprised 59.0% males with a median age at diagnosis of 29 years [IQR: 22-40]. Most patients presented with stricturing disease (55.2%) or penetrating disease (40.9%), with ileal (49.6%) and ileocolonic (47.6%) locations predominating. Over a median follow-up of 70 months [IQR: 31-131], 101 patients (9.5%) required recurrent surgery. The median time to recurrent surgery was 78.5 months [IQR: 19.0-138.0]. Most patients (72.3%) had at least one clinical risk factor for POR, with penetrating phenotype (40.4%), previous intestinal resections (27.2%), and perianal disease (21.4%) being most common.
Univariate analysis identified significant risk factors for surgical recurrence including prior intestinal resection (OR 5.56, 95% CI 3.62-8.56, p<0.001), perianal disease (OR 3.50, 95% CI 2.28-5.35, p<0.001), large intestinal resection ≥50 cm (OR 4.80, 95% CI 3.04-7.58, p<0.001), and continued smoking after surgery (OR 1.84, 95% CI 1.16-2.94, p=0.010). Disease duration >10 years (OR 2.20, 95% CI 1.44-3.36, p<0.001) and colonic involvement (L2: OR 3.00, 95% CI 1.18-7.65, p=0.021) increased risk, while ileal localization (L1) was protective (OR 0.35, 95% CI 0.22-0.54, p<0.001). Bowel perforation as surgical indication significantly increased recurrence risk (OR 2.58, 95% CI 1.29-5.16, p=0.007). Multivariate analysis confirmed perianal disease (aOR 2.58, 95% CI 1.56-4.26, p<0.001), previous intestinal resection (aOR 5.70, 95% CI 3.52-9.23, p<0.001), and large resection (aOR 4.04, 95% CI 2.43-6.72, p<0.001) as independent predictors of recurrence. Unlike previous studies, penetrating behavior was not associated with increased risk, while disease duration >10 years and colonic involvement emerged as significant factors. Additionally, this study uniquely identified bowel perforation as a surgical indication distinct from other penetrating complications in predicting recurrence.

Table 1: Independent Risk Factors for Surgical Recurrence After Ileocecal Resection in Crohn's Disease

Risk Factor	Odds Ratio (95% CI)	p-value
Previous intestinal resection	5.70 (3.52-9.23)	<0.001
Large intestinal resection (≥50 cm)	4.04 (2.43-6.72)	<0.001
Perianal disease	2.58 (1.56-4.26)	<0.001
Continued smoking after surgery	2.23 (1.30-3.83)	0.004
Bowel perforation as surgical indication	2.58 (1.29-5.16)	0.007
Disease duration >10 years	2.20 (1.44-3.36)	<0.001
Ileal localization (L1)	0.35 (0.22-0.54)	<0.001

Conclusion

This large cohort study identified several robust predictors of surgical recurrence after ileocecal resection for CD, with some notable differences from prior research. Previous intestinal resection, perianal disease, large intestinal resection, colonic involvement, and continued smoking emerged as particularly strong risk factors, while penetrating disease behavior was not confirmed as a predictor. These findings challenge some aspects of current risk stratification guidelines and can help inform personalized postoperative management strategies.

Conference

UEG Week Berlin 2025

Topics

IBD

Submission format

Abstract

Session

Crohn's disease: Postoperative course and outcomes (Posters)

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Table. Week 48 Outcomes by CRP and Endoscopic Response Status at Week 12
Week 48 outcome by status at Week 12	Guselkumab 200 mg q4w (N=278)	Guselkumab 100 mg q8w (N=268)
CRP>5mg/L at Week 12	107/278 (38.5%)	85/268 (31.7%)
Clinical remission at Week 48	76/107 (71.0%)	46/85 (54.1%)
Endoscopic response at Week 48	54/107 (50.5%)	31/85 (36.5%)
Not in endoscopic response at Week 12	177/278 (63.7%)	156/268 (58.2%)
Clinical remission at Week 48	120/177 (67.8%)	97/156 (62.2%)
Endoscopic response at Week 48	79/177 (44.6%)	50/156 (32.1%)
Clinical remission was defined as CDAI score <150; endoscopic response was defined as ≥50% improvement from baseline in SES-CD or SES-CD ≤2

Week in OLE^a	All Patients (No Rescue or Prior to Rescue), Pooled^b		Initiation of Rescue (Week 0) and Every 24 Weeks Post-Rescue^e	Rescue^c, Pooled^d
Week in OLE^a	AO n/N (%) [95% CI]	mNRI n/N (%) [95% CI]		AO n/N (%) [95% CI]
SF/APS Clinical Remission^f Week 0 Week 24 Week 48 Week 72 Week 96 Week 120 Week 144 CDAI Clinical Remission^g Week 0 Week 24 Week 48 Week 72 Week 96 Week 120 Week 144 Endoscopic Response^h Week 0 Week 96 Endoscopic Remissionⁱ Week 0 Week 96	717/1112 (64.5) [61.7, 67.3] 665/1000 (66.5) [63.6, 69.4] 587/844 (69.5) [66.4, 72.7] 574/798 (71.9) [68.8, 75.0] 523/723 (72.3) [69.1, 75.6] 494/669 (73.8) [70.5, 77.2] 483/637 (75.8) [72.5, 79.1] 763/1112 (68.6) [65.9, 71.3] 693/933 (74.3) [71.5, 77.1] 609/797 (76.4) [73.5, 79.4] 591/755 (78.3) [75.3, 81.2] 547/689 (79.4) [76.4, 82.4] 503/628 (80.1) [77.0, 83.2] 496/599 (82.8) [79.8, 85.8] 588/1068 (55.1) [52.1, 58.0] 573/776 (73.8) [70.7, 76.9] 417/1068 (39.0) [36.1, 42.0] 456/776 (58.8) [55.3, 62.2]	717/1112 (64.5) [61.7, 67.3] 707/1112 (63.6) [60.7, 66.5] 667/1112 (60.0) [57.0, 63.0] 651/1112 (58.5) [55.5, 61.5] 624/1112 (56.1) [53.0, 59.1] 599/1112 (53.8) [50.7, 57.0] 605/1112 (54.4) [51.2, 57.5] 763/1112 (68.6) [65.9, 71.3] 783/1112 (70.4) [67.6, 73.2] 745/1112 (67.0) [64.0, 70.0] 729/1112 (65.5) [62.5, 68.5] 701/1112 (63.0) [60.0, 66.0] 675/1112 (60.7) [57.5, 63.9] 689/1112 (62.0) [58.9, 65.1] 602/1112 (54.1) [51.2, 57.1] 648/1112 (58.3) [55.2, 61.4] 419/1112 (37.7) [34.8, 40.5] 491/1112 (44.2) [41.0, 47.4]	SF/APS Clinical Remission^f At initiation of rescue 24 weeks post-rescue 48 weeks post-rescue 72 weeks post-rescue 96 weeks post-rescue 120 weeks post-rescue 144 weeks post-rescue CDAI Clinical Remission^g At initiation of rescue Week 24 post-rescue Week 48 post-rescue Week 72 post-rescue Week 96 post-rescue Week 120 post-rescue Week 144 post-rescue Endoscopic Response^h At initiation of rescue Week 96 post-rescue Endoscopic Remissionⁱ At initiation of rescue Week 96 post-rescue	3/278 (1.1) [0.4, 3.1] 101/251 (40.2) [34.4, 46.4] 98/185 (53.0) [45.8, 60.0] 74/154 (48.1) [40.3, 55.9] 65/125 (52.0) [43.3, 60.6] 50/92 (54.3) [44.2, 64.1] 38/64 (59.4) [47.1, 70.5] 39/278 (14.0) [10.4, 18.6] 108/226 (47.8) [41.4, 54.3] 99/164 (60.4) [52.7, 67.5] 80/138 (58.0) [49.6, 65.9] 69/111 (62.2) [52.9, 70.6] 55/80 (68.8) [57.9, 77.8] 39/54 (72.2) [59.1, 82.4] 95/265 (35.8) [30.3, 41.8] 102/189 (54.0) [46.9, 60.9] 46/265 (17.4) [13.3, 22.4] 68/189 (36.0) [29.5, 43.0]
Adverse Events Events (E/100PYs)	(N=1112) (PYs=3160.2)		(N=278) (PYs=543.9)
All TEAEs Investigator-defined drug-related AE Severe AE Serious AE AEs leading to study drug discontinuation Death Adverse Events of Special Interest^j Adjudicated MACE Adjudicated anaphylactic reaction Serious infections Opportunistic infections excluding tuberculosis and herpes zoster Herpes zoster Malignant tumors Non-melanoma skin cancer Malignancies excluding NMSC Hypersensitivity Hepatic events Injection site reactions	5067 (160.3) 610 (19.3) 263 (8.3) 385 (12.2) 47 (1.5) 3 (<0.1) 5 (0.2) 0 68 (2.2) 5 (0.2) 22 (0.7) 23 (0.7) 8 (0.3) 15 (0.5) 142 (4.5) 83 (2.6) 141 (4.5)		1187 (218.2) 114 (21.0) 86 (15.8) 109 (20.0) 25 (4.6) 0 2 (0.4) 0 12 (2.2) 4 (0.7) 5 (0.9) 5 (0.9) 2 (0.4) 3 (0.6) 22 (4.0) 24 (4.4) 17 (3.1)
AO, as observed; AE, adverse event; APS, abdominal pain score; CDAI, Crohn’s disease activity index; E, events; OLE, open-label extension; NMSC, nonmelanoma skin cancer; mNRI, modified nonresponder imputation; Q8w, every 8 weeks; MACE, major adverse cardiovascular event; PY, patient years; RZB, risankizumab; SC, subcutaneous; SES-CD, simple endoscopic score for Crohn’s disease; SF, stool frequency; TEAE, treatment-emergent AE; Wk, week. The study population included all patients who received at least one dose of study drug in the FORTIFY OLE. For AO analysis, data were used as is, except for data collected on or after rescue, which were excluded. For mNRI, patients were categorized as nonresponders for visits after premature discontinuation of study drug due to the primary reason of lack of efficacy and initiation of rescue therapy while other missing data were handled by multiple imputation. Patients who received rescue before receiving RZB 180 mg/360 mg treatment at week 0 of the OLE were not included in efficacy analysis. For patients who received rescue during the OLE, data on or after receiving risankizumab rescue therapy are presented as observed. ^aFor patients not receiving rescue, the week denotes the week of the OLE. ^bData for the 180mg + 360mg RZB treatment groups were pooled. Data through wk144 of the OLE were included in the analysis, unless the patient received rescue, in which case only data obtained prior to rescue were included. Data on or after initiation of rescue were excluded from this analysis and are shown in the far-right column (“Rescue, Pooled”). ^cRescue therapy consisted of a single 1200mg intravenous RZB dose, then 360mg SC Q8w, and was given in the case of inadequate response (as determined by increased symptoms plus an objective marker of inflammation). ^dRescue data was pooled, meaning patients may have received either 180mg or 360mg RZB prior to rescue. ^eInitiation of rescue was the last non-missing value prior to or on the initiation of risankizumab rescue therapy in the FORTIFY OLE. Subsequent timepoints are defined as the number of weeks post-rescue. ^fSF/APS clinical remission is defined as average daily SF ≤ 2.8 and not worse than baseline of the induction study and average daily AP score ≤ 1 and not worse than baseline of the induction study. ^gCDAI clinical remission is defined as CDAI < 150. ^hEndoscopic response is defined as decrease in SES-CD > 50% from baseline of the induction study (or for patients with isolated ileal disease and a baseline SES-CD = 4, at least a 2-point reduction from baseline of the induction study). ⁱEndoscopic remission is defined as SES-CD ≤ 4 and at least a 2-point reduction versus baseline of the induction study and no subscore > 1 in any individual variable ^jThere were no events of active tuberculosis or serious hypersensitivity.

Table 1 (²FDA Criteria; FAS)12 week data	Placebo (n)	45mg (n)	60mg (n)
Population
5'ASA Concomitant treatment	81%	87%	90%
Moderate (4≤mMS ≤ 6)	45%	52%	50%
Severe (7≤mMS ≤ 9)	55%	48%	50%
Efficacy
²Clinical Remission^*	13% (4/31)	39% (12/31)	57% (17/30)
²Clinical Response^**	42% (13/31)	87 % (27/31)	80 % (24/30)
²Mucosal Healing	16 % (5/31)	42% (13/31)	67% (20/30)
^delta vs placebo for clinical remission 44% for 60mg (p<0.001) and ^* 26% for the 45mg group (p<0.07)

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