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Medically reviewed by Dr. Shani S. Saks, D.O. on August 23, 2023

Anti-tumor necrosis factor (TNF) therapy with surgical closure was positively associated with radiological healing and improved incontinence in patients with Crohn’s perianal fistulas. The results of this study indicate that surgical closure may be considered in patients responsive to anti-TNF treatment, which can be discontinued once radiological healing is complete.

A previous clinical trial demonstrated more frequent radiological healing of short-term anti-tumor necrosis factor (anti-TNF) treatment followed by surgical closure in Crohn’s perianal fistulas, compared to only anti-TNF therapy for 18 months. The current study aimed to investigate the long-term therapeutic outcomes of these interventions in the healing of Crohn’s perianal fistulas. 

The findings, published in the journal E-Clinical Medicine, indicate that the aim of the treatment should be the radiological healing of perianal fistulas, and surgical closure should be considered in patients amenable to treatment. Anti-TNF treatment can be discontinued in patients demonstrating complete closure on magnetic resonance imaging (MRI).

Study Characteristics

The trial included 94 patients with Crohn’s perianal fistulas, of whom long-term follow-up data were obtained for 91. The median follow-up duration was 5.7 years (IQR 5–7), and the median age of the study participants was 33 years (IQR 26–44).  

Radiological Healing of Crohn’s Perianal Fistulas

During the follow-up period, 25 study participants achieved radiological healing, which was significantly different across short-term anti-TNF therapy and combined therapy with surgical closure arms, with long-term clinical closure evident in 34/55 and 26/36 participants, respectively. A significantly earlier clinical closure was achieved by study participants in the surgical closure with the anti-TNF treatment arm, along with a shorter interval between surgical and clinical closure.

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Recurrence of Crohn’s Perianal Fistulas

The recurrence of perianal fistulas occurred in 9/36 and 19/55 patients in the surgical closure and anti-TNF treatment arms, respectively. Recurrence was not observed in any of the 25 patients who demonstrated radiological healing. By contrast, 27 of the 76 patients who demonstrated clinical closure during the follow-up period had a recurrence. Of these, 9/22 patients who stopped anti-TNF treatment demonstrated a recurrence.

Improvement in Incontinence and Decision Regret Scale Scores

Out of 91 patients, 76 completed the Decision Regret Scale (DRS) and self-rated incontinence questionnaire. Approximately 28% of these patients reported improved continence following treatment; however, there were no significant differences across the treatment arms. 

Conversely, 30% of the patients who completed the questionnaire in the surgical closure arm reported greater complaints of incontinence following the treatment compared to 15% of the patients who completed the questionnaire in the anti-TNF treatment arm. The mean total DRS scores in the surgical closure and anti-TNF treatment arms were 3 (IQR 0–25) and 10 (IQR 0–30), respectively.

Anti-TNF therapy with surgical closure was associated with radiological healing and improved incontinence in patients with Crohn’s perianal fistulas. The results of the study indicate that surgical closure may be considered in patients responsive to anti-TNF treatment, which can be discontinued once radiological healing is complete.

Source

Van Praag, E. M., Becker, M. A., Van Rijn, K. L., Wasmann, K. A., Stoker, J., D’Haens, G. R., Ponsioen, C. Y., Gecse, K. B., Dijkgraaf, M. G., Spinelli, A., Danese, S., Bemelman, W. A., & Buskens, C. J. (2023). Short-term anti-TNF therapy with surgical closure versus anti-TNF therapy alone for Crohn’s perianal fistulas (PISA-II): long-term outcomes of an international, multicentre patient preference, randomised controlled trial. EClinicalMedicine, 61, 102045. https://doi.org/10.1016/j.eclinm.2023.102045