A patient-preference, randomised controlled trial assessed the radiological healing 18 months after anti-TNF (n=56) or anti-TNF plus surgical closure (n=38) in CD patients with high perianal fistulas with a single internal opening [1]. Radiological healing was defined as a complete fibrotic fistula observed on MRI or a magnetic resonance novel index for fistula imaging in CD (MAGNIFI-CD) score ≤5. Ms Elise Meima-van Praag (Amsterdam University Medical Centre, the Netherlands) presented the findings of the study.
In the intention-to-treat analysis, patients in the surgical closure arm demonstrated a higher rate of radiological healing than patients in the anti-TNF arm (42.1% vs 12.5%; P<0.001). Clinical closure rates were not significantly different between the surgical closure arm (68%) and the anti-TNF arm (52%) in the intention-to-treat analysis. However, in the per-protocol analysis, the difference in clinical closure between the 2 treatment arms was significant, favouring the surgical closure arm. Furthermore, the median Perianal Disease Activity Index (PDAI) scores were significantly lower in the surgical closure arm at 18 months of follow up. The occurrence of re-intervention was not significantly different between the 2 treatment arms (surgical closure 13% vs anti-TNF 29%). Recurrence rates were similar for the 2 treatment arms. Importantly, patients with observed radiological healing did not have recurrences.
- Meima-van Praag E, et al. Treatment of perianal fistulas in Crohn’s disease: anti-TNF with surgical closure versus anti-TNF alone (PISA-II), a patient preference RCT. OP18, ECCO 2021 Virtual Congress, 2-3 & 8-10 July.
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Table of Contents: ECCO 2021
Featured articles
Biologics Updates
Similar efficacy of ustekinumab and adalimumab for moderate-to-severe CD
Ustekinumab safe and effective in elderly CD patients
Early clinical remission and response following risankizumab therapy in CD
Risk of hospitalisation and surgery linked to IBD biological
Obesity increases the risk of immunogenicity to adalimumab in IBD
Improvements in Small Molecules
Upadacitinib meets primary endpoint for moderate-to-severe UC
Promising safety and pharmacokinetic data on BT051 for UC
Surgical closure plus anti-TNF outperforms anti-TNF alone for perianal fistula
Novel Biomarkers
Blood proteins predicting relapse in CD identified
Extracellular RNA has potential as a non-invasive biomarker in IBD
Risk Mitigation
No increased risk of (severe) COVID-19 among IBD patients
Oral faecal microbiota transplant therapy efficacious in UC
Artificial intelligence outperforms human classifying of endoscopic images in UC
Increased risk of rectal cancer after colectomy in IBD
Risk of colorectal cancer is detected by low-pass whole genome sequencing
Large variability in IBD care and education across Europe
Ultra-processed food intake associated with IBD
Factors of coping difficulties in IBD revealed
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