Surgical closure of Crohn’s fistula offers longer-term healing
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Adding surgical closure to anti-tumor necrosis factor therapy in perianal fistula demonstrates more successful and frequent healing with lower long-term perianal disease activity index, according to a presenter at UEG Week Virtual.
“This study demonstrates that radiologic healing at MRI is more often induced after the surgical closure arm compared to the anti-TNF treatment arm and this is associated with a significantly lower [perianal disease activity index] after 18 months,” Elise Maria Meima-van Praag, an MD-PhD fellow at Amsterdam UMC in the Netherlands, said during her presentation. “Based on this data, we believe that Crohn’s perianal fistula patients amenable to surgical closure should be counseled for this therapeutic approach.”
In this multicenter patient preference randomized controlled trial, Meima-van Praag and colleagues counseled patients with Crohn’s disease and high perianal fistula as to their options for therapy: anti-TNF alone or in combination with surgical closure. From September 2013 to December 2019, researchers recruited 94 patients (median age, 33 years; 60% women) from seven hospitals, with 32 randomly assigned as they did not have a preference of treatment. In the end, 38 patients entered the surgical closure arm while 56 received anti-TNF alone.
“At 18 months follow up ... radiological healing was significantly different between both treatment arms in the intention to treat analysis,” Meima-van Praag said. “In contrast, clinical closure was not significantly different in the two treatment arms in the intention to treat analysis. However, in a per protocol analysis, a significant difference between the treatment arms could be demonstrated.”
In the intention-to-treat analysis, radiological healing was seen in 37.5% of the surgical closure arm and 9.8% of the anti-TNF arm (P = .002) while clinical closure occurred in 68% of the surgical arm and 52% of the anti-TNF arm.
In the per-protocol analysis, researchers showed that 36.8% of patients in the surgical closure arm achieved radiological healing as compared with 7.5% of those in the anti-TNF arm (P = .002). The researchers also showed that 71% of the surgical closure arm achieved clinical closure in the per-protocol analysis vs. 50% of the anti-TNF arm (P = .02).
“We also looked at the perianal disease activity index or PDAI. At baseline, median PDAI was comparable between the two treatment arms,” she said, showing that they were 10 and 9 in the anti-TNF and surgical groups, respectively.
“Both decreased to a median of 5 after 6 months follow up which is indicative of non-severe disease activity. PDAI continued to decrease to a median of 3 in the surgical closure arm at 12 months follow up but stagnated in the anti-TNF treatment arm. At 18 months follow up, PDAI was significantly lower in the surgical closure arm with a median of 1 compared with the anti-TNF treatment arm with a median of 4,” she said.
PDAI at 6 and 12 months follow up were not significantly different but at 18 months, the anti-TNF group had a much higher perianal disease activity index (P = .03). Though recurrences and reinterventions were similar between groups, Meima-van Praag said no recurrences occurred in patients who achieved MRI healing.
“We feel that prolonged healing of the perianal fistula should be the aim of treatment with less chance of recurrences and need for reinterventions and in order to achieve that one should strive for radiological healing at MRI,” she said.
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Meima-van Praag EM, et al. Abstract LB08. Presented at: UEG Week; October 3-5, 2021 (virtual meeting).
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