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Anti-TNF Withdrawal Leads to High Relapse Rate for IBD Patients

Mesalamine use was linked to fewer relapses in the ulcerative colitis or IBD-unclassified cohorts compared to patients with Crohn’s disease.

Discontinuing anti-tumor necrosis factor agents (anti-TNF) treatment can increase the risk of relapsing for patients with inflammatory bowel disease (IBD).

A team, led by Remi Mahmoud, Department of Gastroenterology and Hepatology, University Medical Center Utrecht, assessed the relapse rate following anti-TNF treatment withdrawal in patients with endoscopic healing and looked at predictors for relapse including the depth of endoscopic healing.

Anti-TNF Withdrawal

Discontinuing anti-TNF treatment is often associated with a higher risk of relapse for patients with IBD. One possible explanation for this is the influence of endoscopic activity at the time of discontinuing therapy.

In the multicenter, prospective study, the investigators examined 81 patients with Crohn’s disease (n = 41; 51%, ulcerative colitis, or IBD-unclassified who discontinued anti-TNF between 2018-2020 in the Netherlands. There was a median follow-up of 2.0 years.

Each participant was evaluated for at least 6 months of corticosteroid-free clinical remission and endoscopic healing.

Relapse Rates

The investigators assessed the relapse rate and evaluated potential predictors including partial (Mayo 1/SES-CD 3-4) versus complete (Mayo 0/SES-CD 0-2) endoscopic healing, anti-TNF trough levels and immunomodulator and/or mesalamine use by performing Kaplan-Meier and Cox regression analyses.

In the study, 49% (n = 40) of patients relapsed. However, the relapse rates in patients with Crohn’s disease and patients with ulcerative colitis or IBD-unclassified were comparable. The investigators found 70% of patients with partial endoscopic healing relapsed at 12 months, compared to 35% of patients with complete endoscopic healing (aHR, 3.28; 95% CI. 1.43-7.50).

They also found mesalamine use was linked to fewer relapses in the ulcerative colitis or IBD-unclassified cohorts (aHR, 0.08; 95% CI, 0.01-0.67).

Finally, 30 patients restarted anti-TNF treatment, with clinical remission regained in 73% of this group at 3 months.

“The relapse risk was high after anti-TNF withdrawal in IBD patients with endoscopic healing, but remission was regained in most cases after anti-TNF reintroduction,” the authors wrote. “Complete endoscopic healing, and mesalamine treatment in UC/IBDU patients, decreased the risk of relapse.”

Efficacy

Earlier this year, investigators found a similar efficacy between anti-TNF and ustekinumab in treating patients with Crohn’s disease.

A team, led by Hisashi Shiga, Tohoku University Graduate School of Medicine, compared the efficacy of anti-TNF agents and ustekinumab in biologic-naïve patients with Crohn’s disease in data presented at the Digestive Disease Week (DDW) 2022 Meeting in San Diego.

Despite positive trial results, there remains a need for larger, longer-term studies comparing the efficacy of anti-TNF agents with ustekinumab in patients with Crohn’s disease.

The cumulative hospitalization rates were similar between the anti-TNF cohort and the ustekinumab group (P = 0.85; 25.3% vs. 26.5% at 1 year, 33.8% vs. 39.8% at 2 years). The cumulative surgery rates were also comparable (P = 0.46; 5.5% vs. 5.1% at 1 year, 8.3% vs. 8.4% at 2 years).

The persistence rate at 1 year was, however, higher in the ustekinumab group (90.8% vs. 92.5%), while at 2 years it was higher in the anti-TNF group (81.2% and 74.6%).

However, there was no significant difference in the cumulative persistence rate between the 2 groups (P = 0.55).

The study, “Complete endoscopic healing is associated with a lower relapse risk after anti-TNF withdrawal in inflammatory bowel disease,” was published online in Clinical Gastroenterology and Hepatology.