Patients with ulcerative colitis (UC) and inflammatory bowel disease unclassified (IBDU) who had complete endoscopic healing and received treatment with mesalamine experienced a decreased risk for relapse after discontinuing anti-tumor necrosis factor-α (anti-TNF) treatment, according to study findings in Clinical Gastroenterology and Hepatology.
For the multicenter, prospective study, researchers evaluated 81 patients with Crohn disease (CD; n=41) and UC or IBDU (n=40) for relapse rate, predictors of relapse, degree of endoscopic healing, and treatment outcomes after discontinuing anti-TNF therapy.
Study participants had at least 6 months of corticosteroid-free clinical remission and endoscopic healing (Mayo score of <2 or a simple endoscopic score for CD [SES-CD] of <5). All patients discontinued anti-TNF therapy (infliximab or adalimumab). Patients were permitted to start mesalamine or an immunomodulatory treatment (thiopurine or methotrexate) at the discretion of their provider. Researchers used Kaplan-Meier and Cox regression analyses to calculate potential predictors and relapse rate.
Degree of endoscopic healing was subcategorized into partial healing (Mayo, 1; SES-CD, 3-4) and complete healing (Mayo, 0; SES-CD, 0-2).
The primary outcome was relapse, which included clinical and biochemical relapse, endoscopic relapse, escalation of IBD therapy, IBD-related hospitalizations or surgical procedures, and more. Secondary outcomes included the degree of endoscopic relapse, hospitalizations and operations for IBD, predictors of relapse, and outcomes following the reintroduction of anti-TNF treatment.
Of the 49% of participants who relapsed, 83% of cases were confirmed by either endoscopy, fecal calprotectin, or C-reactive protein, and 17% were confirmed by treatment escalation.
Patients with partial endoscopic healing experienced higher risk for relapse compared with those with complete endoscopic healing (adjusted hazard ratio [aHR], 3.28; 95% CI, 1.43-7.50). A similar trend was observed in the 12-month follow up; 70% of patients with partial endoscopic healing experienced relapse compared with 35% of patients who had complete endoscopic healing.
Treatment with mesalamine was associated with a lower risk for relapse in patients with UC or IBDU (aHR, 0.08; 95% CI, 0.01-0.67).
Among the patients who relapsed, 30 patients resumed anti-TNF treatment, and 26 of these patients restarted the same anti-TNF agent. After restarting the anti-TNF agents, patients were in remission at 3 months (73%) and 12 months (90%).
Study limitations include enrolling few patients with partial endoscopic healing.
“Among selected patients with IBD in clinical remission and with endoscopic healing, the risk of relapse after withdrawal of anti-TNF therapy remained high, but reintroduction of anti-TNF treatment was successful in most cases,” the study authors wrote. “Applying strict criteria for endoscopic healing, and mesalamine treatment for patients with UC or IBDU, may lower the risk of relapse after withdrawal of anti-TNF treatment.”
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Mahmoud R, Savelkoul EHJ, Mares W, et al. Complete endoscopic healing is associated with a lower relapse risk after anti-TNF withdrawal in inflammatory bowel disease. J Clin Gastroenterol Hepatol. Published online August 30, 2022. doi:10.1016/j.cgh.2022.08.024