S974 Comparison of Surgical Rates in Biologic Naive Crohn's Disease Patients on Ustekinumab and Vedolizumab

Abstract

Introduction: Between 25% to 45% of patients with Crohn’s Disease (CD) require surgical treatment of their disease between 5 and 10 years of diagnosis. Anti-tumor necrosis factor (anti-TNF) therapy has been associated with lower surgical rates in IBD. However, the rate of surgical intervention in ustekinumab- and vedolizumab-treated biologic naïve CD to date patients is unknown. We aimed to investigate the effect of ustekinumab and vedolizumab on intestinal resection rates in bio-naïve CD patients. Methods: A commercial database (Explorys Inc, Cleveland, OH) was utilized, which included electronic health record data from 26 major integrated US healthcare systems. We identified bio-naïve CD patients. The primary outcome was to examine the association between anti-tumor necrosis factor (anti-TNF) medications, ustekinumab, and vedolizumab therapy and the rate of bowel resection in bio-naïve CD patients after at least 12 weeks of treatment. Secondary endpoints were factors associated with increased risk of surgical intervention in these bio-naïve CD patients. Results: The database included over 70 million individuals in which we identified 249,300 (0.35%) adult ( >18 years) patients with CD. Among all CD patients, 1.7% received ustekinumab, 2.4% received vedolizumab, and 16% received anti-TNF as first-line biologic therapy. The rate of intestinal resection was lower among ustekinumab-treated compared to vedolizumab-treated bio-naïve CD patients (11.8% vs. 13.9%, p = 0.001). The rate of intestinal resection was higher among vedolizumab-treated compared to anti-TNF-treated bio-naïve CD patients (13.9% vs. 12.5%, p < 0.0001). However, intestinal resection rates did not significantly differ between ustekinumab-treated compared to anti-TNF-treated bio-naïve CD patients (11.8% vs. 12.5%, p = 0.15). Compared to anti-TNF, tobacco smoking, fistulas, and abscesses were more commonly associated with intestinal resection in ustekinumab- and vedolizumab-treated bio-naïve CD patients. Age < 65 years and intestinal fistulas were commonly associated with ustekinumab-treated bio-naïve CD patients compared to vedolizumab. (Figure) Conclusion: In this large cohort of bio-naïve CD patients, the rate of intestinal resection was lower in ustekinumab-treated and anti-TNF treated patients compared to Vedolizumab after at least 12 weeks of therapy. Further prospective studies are needed to compare the effectiveness and safety of first-line Ustekinumab and Vedolizumab therapy in IBD patients (Table). Figure 1.: Comparison of intestinal resection rates in bio-naive CD patients after at least 12 weeks of ustekinumab, vedolizumab, and anti-TNF. Table 1. - Characteristics of biologic naive CD patients requiring intestinal resection after at least 12 weeks of ustekinumab and vedolizumab Factors UstekinumabN = 510 (%) VedolizumabN = 850 (%) Odds ratio (95% confidence interval), P value Age Adults (18-65y) 460 (90%) 710 (84%) 1.81 (1.28-2.55), 0.0007 Seniors ( >65y) 50 (10%) 140 (16%) 0.55 (0.39-0.77), 0.0007 Race White 460 (90%) 760 (89%) 1.08 (0.75-1.56), 0.64 Non-white 50(10%) 90 (11%) 0.91 (0.63-1.32), 0.64 Gender Female 300 (59%) 460 (54%) 1.21 (0.97-1.51), 0.90 Male 210 (41%) 390 (46%) 0.82 (0.66-1.03), 0.90 Clinical characteristics Tobacco user (current and former) 490 (96%) 820 (96%) 0.89 (0.50-1.59), 0.71 Clostridium difficile infection 70 (14%) 150 (18%) 0.74 (0.54-1.01), 0.05 Small bowel obstruction 10 (2%) 30 (4%) 054 (0.26-1.12), 0.10 Fistula of intestine 230 (45%) 330 (38%) 1.29 (1.03-1.61), 0.02 Anorectal fistula 150 (20%) 230 (27%) 1.12 (0.88-1.43), 0.34 Perianal abscess 100 (20%) 140 (16%) 1.23 (0.93-1.64), 0.14 Anorectal abscess 80 (16%) 130 (15%) 1.03 (0.76-1.39), 0.84 Neoplasm of colon 70 (14%) 160 (19%) 0.68 (0.54-0.93), 0.01 Malignant neoplasm of colon 10 (2%) 30 (4%) 0.54 (0.26-1.12), 0.10