Study data published in Clinical Gastroenterology and Hepatology suggest that biologics may reduce the risk for intestinal resection and colectomy in patients with irritable bowel disease (IBD). Patients with Crohn disease (CD) who received biologics were found to be significantly less likely to undergo bowel resection compared with those who did not receive biologics. Biologic therapy also reduced the propensity for colectomy in patients with ulcerative colitis (UC).
Investigators of the retrospective cohort analysis used Explorys Inc.’s commercial database to extract electronic health record data from 26 major integrated health care systems in the United States. Eligible patients included adults with CD or UC who received any biologics between March 2015 and March 2020. Patients with both CD and UC were excluded from the analysis. Biologic use was defined by a prescription for at least 1 of the following drugs during the study period: infliximab, adalimumab, certolizumab pegol, golimumab, natalizumab, vedolizumab, or ustekinumab.
The primary outcome was the prevalence of bowel resection in patients who received biologics. Two control populations were extracted from the same database. The first population comprised patients who underwent bowel resection without receiving biologic therapy at any point; the second included patients with IBD who had never undergone bowel resection. Logistic regression was performed to assess the relationship between biologics use and bowel resection in patients with IBD.
The total study cohort comprised 140,540 patients with CD and 117,450 patients with UC. Biologic use was more common in patients with CD (25,840; 18%) vs patients with CD (9050; 7.8%). The rate of intestinal resection was higher among patients with CD who did not receive biologics. Approximately 9.3% of patients with CD whose treatment regimen included biologics underwent their first episode of intestinal resection at least 60 days after starting biologics compared with 12.1% of patients who never received biologics (P <.001).
In regression models, patients whose CD was treated with biologics were 26% less likely to have intestinal resection than those not exposed to biologics (odds ratio [OR], 0.74; 95% CI, 0.71-0.78; P <.001). Notably, in patients with CD who were treated with biologics, the need for intestinal resection was associated with White race, active smoking status, prior Clostridiodes difficile infection, colon neoplasm, small bowel obstruction, intestinal fistula, anorectal fistula, perianal abscess, anorectal abscess, and anal fissure compared with those who never underwent intestinal resection (all P <.001).
As with CD, the rate of intestinal resection in patients with UC was lower when biologics were administered. Of the 660 patients with UC who received biologics, 7.3% underwent their first episode of colectomy at least 60 days after initiating biologics therapy compared with 11% of patients who did not receive biologics (P <.001). Patients with UC who were treated with biologics were 37% less likely to undergo colectomy than patients with UC who never received biologics (OR, 0.63; 95% CI, 0.58-0.69; P <.001). Biologics use in patients who required colectomy was more likely to be associated with age lower than 65 years, White race, male sex, and prior Clostridiodes difficile infection.
Overall, the data suggest that treating IBD with biologics may reduce rates of intestinal resection and colectomy in patients with CD and UC, respectively. Regarding study limitations, investigators said that the database used to conduct this analysis is an electronic health record-derived data collection from various healthcare systems and is therefore “vulnerable to selection, data and coding entry, missing data, and follow-up limitations and biases.”
The authors were also unable to perform propensity-score matching due to the format of Explorys data. As such, all regression models were unadjusted. Although subgroup analyses were used to identify certain trends, adjustment for potential confounders was lacking. Even so, “[this] study represents one of the largest population-based cohorts of IBD and biologics and furthers the concept that biologics, especially early in the disease course, may reduce the need for future surgery,” the investigators concluded.
Khoudari G, Mansoor E, Click B, et al. Rates of intestinal resection and colectomy in inflammatory bowel disease patients after initiation of biologics: a cohort study . Clin Gastroenterol Hepatol. Published online October 13, 2020. doi: 10.1016/j.cgh.2020.10.008