Introduction

Recurrence after ileocecal resection is a major concern in Crohn’s disease. We aimed to compare the effectiveness of early prophylaxis with ustekinumab [UST] and adalimumab [ADA], in patients who had been exposed to at least one line of biologics before surgery.

Aims & Methods

This prospective observational multicentric cohort study involved 14 tertiary centers in France and Belgium. Patients who had been exposed to at least one biologic and who received UST or ADA immediately after surgery were included. The primary endpoint was endoscopic recurrence within the year following surgery as defined by a Rutgeerts score [RS] ≥ i2. We applied a propensity score based analysis using overlap weights, to take into account the imbalance in pre-treatment confounders between groups.

Results

Among the 192 patients who received ADA and UST after surgery, 123 (UST, n=60; ADA, n=63) were enrolled into the cohort as 39 had no available endoscopy at the time of analysis, 22 were bio-naïve, and 8 patients had a delayed colonoscopy (>12 months). Patients’ characteristics are shown in table 1. Patients in the UST group were older (Mean age (SD): 37.49 (12.47) vs 33.24 (11.02), p=0.052), had a numerically longer disease duration in months (136.37 (92.09) vs 108.52 (85.18)) and had been more exposed to biologics (>1 line of biologics): 29 (49.2%) vs 7 (11.3%). Endoscopic recurrence (RS≥ i2) rates were of 58.3% and 47.6% in UST and ADA groups, respectively (p=0.3), and rates of severe lesions (i3-i4) were similar in both groups: 11.7% and 14.3% in UST and ADA groups, respectively. On the weighted population, rates of endoscopic recurrence (UST vs ADA: OR = 1.92 [95% CI: 0.83-4.43]), as well as rates of severe recurrence (UST vs ADA: OR = 0.85 [95% CI: 0.23-3.05])

Conclusion

The effectiveness of UST and ADA in the prevention of early post-operative endoscopic recurrence was not significantly different. Rates of severe endoscopic recurrence were similar.

This study was supported by Janssen.

Disclosure

Nassim Hammoudi has served as a consultant/advisory board member to Janssen and Lilly and speaker for Galapagos, Takeda
Matthieu Allez has served as a consultant/advisory board member to Abbvie, Amgen, Biogen, Boehringer-Ingelheim, Bristol Myers Squibb, Celgene, Celsius, Celltrion, Egle Therapeutics, Endpoint health, Ferring, Galapagos, Genentech, IQVIA, Janssen, Lilly, Novartis, Pfizer, Roche, Takeda, Tillots; speaker for CME activities for Abbvie, Galapagos, Genentech, Janssen, Pfizer, Roche, Takeda, Tillots; grant support from Janssen, Takeda, Genentech/Roche.