A Prospective Comparison of Ustekinumab and Anti-TNF Therapy in the Treatment of Crohn's-like Disease of the Pouch.

BACKGROUND Many patients with chronic pouchitis and Crohn's-like disease of the pouch (CLDP) are treated with biologics; however, the comparative effectiveness of advanced therapies in this population has not been systematically evaluated. We sought to compare the effectiveness of anti-tumor necrosis factor alpha (anti-TNF) therapies and ustekinumab in patients with chronic inflammatory conditions of the pouch. METHODS We conducted a prospective, multi-center, cohort study. We included patients with chronic pouchitis and CLDP initiating treatment with anti-TNF therapies or ustekinumab. The primary outcome was clinical remission at 6 months after induction. We also evaluated clinical remission at 6 months among patients with chronic pouchitis and CLDP separately. RESULTS Among 132 patients, 106 (80%) had a diagnosis of CLDP and 82 (62%) initiated therapy with ustekinumab. A significantly higher proportion of patients with CLDP treated with ustekinumab were in clinical remission at 6 months as compared to patients treated with anti-TNF therapy (62% vs. 40%, P=0.027) however there was no significant difference among patients with chronic pouchitis (P=0.946). There was no independent statistical significance in the odds of remission at 6 months among patients with CLDP among patients receiving ustekinumab compared to anti-TNF therapy (aOR 1.91, 95% CI 0.69-5.30) after adjusting for presence of a fistula, number of preoperative advanced therapies, and number of advanced therapies after IPAA. CONCLUSION These data suggest the potential benefit of ustekinumab in patients with CLDP and should prompt future novel effectiveness evaluations in this population.