Tofacitinib as safe as other biologics in UC patients undergoing colectomy

Preoperative treatment with tofacitinib results in adverse events (AEs) rates in the postoperative setting that are similar to that with biologic therapy among patients with ulcerative colitis (UC) undergoing colectomy, a study has shown.

On the other hand, “[u]rgent surgery and high doses of steroids before surgery were confirmed to be associated with a higher risk of early surgical complications,” the investigators said.

This multicentre, retrospective, observational study included 300 patients with UC who underwent total colectomy for medically refractory disease and were exposed to tofacitinib or a biologic prior to surgery.

The occurrence of any complication within 30 (early) and 90 (late) days after surgery was the primary outcome. Other outcomes assessed were the occurrence of infections, sepsis, surgical site complications, venous thromboembolic events (VTE), hospital readmissions, and redo surgery within the same timepoints.

Of the patients, 64 received tofacitinib, 162 antitumour necrosis factor-α (anti-TNF) agents, 54 vedolizumab, and 21 ustekinumab. Outcomes did not significantly differ among these agents, except for higher rates of early VTE with anti-TNF agents (p=0.047) and of late VTE with vedolizumab (p=0.03).

Multivariate analysis revealed no association between drug class and a higher risk of any early and late complications. [Am J Gastroenterol 2024;119:1525-1535]

Additionally, urgent colectomy resulted in a higher risk of any early (odds ratio [OR], 1.92, 95 percent confidence interval [CI], 1.06‒3.48) complications, early hospital readmission (OR, 4.79, 95 percent CI, 1.12‒20.58), and early redo surgery (OR, 7.49, 95 percent CI, 1.17‒47.85).

Patients who received a high steroid dose experienced an elevated risk of any early complications (OR, 1.96, 95 percent CI, 1.08‒3.57), as well as early surgical site complications (OR, 2.03, 95 percent CI, 1.01‒4.09) and early redo surgery (OR, 7.52, 95 percent CI, 1.42‒39.82).

On the other hand, patients who underwent laparoscopic surgery had a reduced risk of any early complications (OR, 0.54, 95 percent CI, 0.29‒1.00), early infections (OR, 0.39, 95 percent CI, 0.18‒0.85), and late hospital readmissions (OR, 0.34, 95 percent CI, 0.12‒1.00).

“The impact of preoperative exposure to biologics on postoperative complications has been widely investigated in the literature,” the investigators said.

“Despite initial controversies, it is now accepted that the occurrence of postoperative complications is more commonly related to the severity of inflammatory bowel disease (IBD) per se and the surgical circumstances rather than the use (and the type) of biologics,” they added. [Clin Gastroenterol Hepatol 2020;18:1356-1366]

An earlier study (PUCCINI) reported a similar early infection rate in IBD patients either treated with infliximab or unexposed to infliximab prior to surgery (18 percent vs 20 percent; p=0.47). [Gastroenterology 2022;163:204-221]

“In our study, the occurrence of early infectious complications in the anti-TNF group was similar to that of the PUCCINI study (22.8 percent, when combining infections and sepsis),” according to the investigators.

“Larger and prospective studies are necessary to confirm these findings,” they said.