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Anti-TNF withdrawal may be a safe option in stable IBD

Presented by
Prof. María Chaparro Sánchez , Hospital Universitario de La Princesa, Spain
Medical Writer
Susanne Kammerer
ECCO 2023
Phase 4, EXIT
Patients with inflammatory bowel disease (IBD) who discontinued their anti-tumour necrosis factor (TNF) therapy were not prone to a significantly higher rate of relapses at 1 year of follow-up compared with those who continued their maintenance treatment. The safety of the 2 treatment strategies was similar in the phase 4 EXIT trial.

“Our research question was whether it was possible to withdraw the treatment with anti-TNF in IBD patients in remission without an increased risk of disease relapse,” Prof. María Chaparro Sánchez (Hospital Universitario de La Princesa, Spain) explained [1]. The quadruple-blinded, placebo-controlled, phase 4 EXIT trial (NCT02994836) randomised 140 out of 159 screened patients with Crohn’s disease (44%) or ulcerative colitis (56%). The participants were in ≥6 months of clinical remission on anti-TNF and ≥3 months of concomitant immunosuppressants at stable dosages. Participants with Crohn’s disease with perianal disease were excluded. Depending on the study arm, the participants either withdrew their anti-TNF medication or continued on infliximab (87%) or adalimumab (13%) until month 12 or relapse.

The mean age of the study population was 41 years, the median duration of anti-TNF therapy was between 2.6 and 2.9 years, and 7% had received prior biologics. Remission was sustained in 76% of the withdrawal group and 84% sustained maintenance at month 12 in the intention-to-treat population (see Figure). This difference in rates was not statistically significant, nor were the relapse percentages of 6% for maintenance and 13 % for withdrawal. “The proportion of patients with significant endoscopic lesions was also not statistically different between the groups at the last study visit,” Prof. Chaparro Sánchez indicated.

Figure: Survival curve of clinical remission at the end of follow-up [1]

After 1 year, a significant difference was observed of 33% versus 14% of patients in the withdrawal and the maintenance arm who had a faecal calprotectin >250 µg/g. In addition, a faecal calprotectin level of >250 µg/g at baseline was a significant predictor of clinical relapse. The incidence of adverse and serious adverse events was similar between the study arms.

“Anti-TNF withdrawal in selected IBD patients in clinical, endoscopic, and radiologic remission could be feasible without an increase in the risk of clinical relapse,” Prof. Chaparro Sánchez concluded. However, a long-term follow-up of these patients is warranted.

  1. Chaparro, M. Is the withdrawal of anti-tumour necrosis factor in inflammatory bowel disease patients in remission feasible without increasing the risk of relapse? Results from the randomised clinical trial of GETECCU (EXIT). OP37, ECCO 2023, 01–04 March, Copenhagen, Denmark.

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