Use of endoscopic ultrasound to guide adalimumab treatment in perianal Crohn's disease results in faster fistula healing

Dawn M. Wiese, Dawn Beaulieu, James C. Slaughter, Sara Horst, Julie Wagnon, Caroline Duley, Kim Annis, Anne Nohl, Alan Joseph Herline, Roberta Muldoon, Tim Geiger, Paul E. Wise, David A. Schwartz

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Abstract

Background: Perianal disease is a manifestation of Crohn's disease (CD) that has poor long-term treatment outcomes. The aim was to determine if rectal endoscopic ultrasound (EUS)-guided therapy with adalimumab (ADA) can improve outcomes for patients with perianal fistulizing CD. Methods: This is a randomized prospective study comparing serial EUS guidance of fistula treatment versus standard of care in fistulizing perianal CD. At enrollment, all patients underwent a rectal EUS and an EUA with seton placement and/or I&D. Treatment was maximized with immunomodulators, antibiotics, and ADA induction. Surgical interventions were determined by the surgeon's discretion in the control group and assisted by every 12th week EUS in the intervention group. Primary and secondary endpoints where complete drainage cessation at week 48 was fistula status per EUS, respectively. Results: Twenty patients were enrolled: 11 control and 9 EUS guidance. At 24 weeks, 7/9 (78%) in EUS group and 3/11 (27%) in control group had drainage cessation (P 0.04). This significant difference was lost at week 48 (P 0.44). Three patients in the EUS and 1 in the control group had additional surgical intervention. Those in the EUS group had more rapid escalation of ADA dosing (P 0.003). There was no difference in the change in PDAI at week 48 versus baseline (P 0.81). Conclusions: Rectal EUS-guided ADA therapy for CD perianal fistulas showed an initial benefit at 24 weeks, which was lost at week 48. This is likely due to small sample size and higher fistula closure in the controls. However, the faster rate of fistula resolution is a clinically significant finding.

Original languageEnglish (US)
Pages (from-to)1594-1599
Number of pages6
JournalInflammatory Bowel Diseases
Volume21
Issue number7
DOIs
StatePublished - May 19 2015

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Crohn Disease
Fistula
Control Groups
Drainage
Therapeutics
Immunologic Factors
Standard of Care
Sample Size
Adalimumab
Prospective Studies
Anti-Bacterial Agents

Keywords

  • Crohn's disease
  • adalimumab
  • endoscopic ultrasound
  • perianal disease

ASJC Scopus subject areas

  • Immunology and Allergy
  • Gastroenterology

Cite this

Wiese, D. M., Beaulieu, D., Slaughter, J. C., Horst, S., Wagnon, J., Duley, C., ... Schwartz, D. A. (2015). Use of endoscopic ultrasound to guide adalimumab treatment in perianal Crohn's disease results in faster fistula healing. Inflammatory Bowel Diseases, 21(7), 1594-1599. https://doi.org/10.1097/MIB.0000000000000409

Use of endoscopic ultrasound to guide adalimumab treatment in perianal Crohn's disease results in faster fistula healing. / Wiese, Dawn M.; Beaulieu, Dawn; Slaughter, James C.; Horst, Sara; Wagnon, Julie; Duley, Caroline; Annis, Kim; Nohl, Anne; Herline, Alan Joseph; Muldoon, Roberta; Geiger, Tim; Wise, Paul E.; Schwartz, David A.

In: Inflammatory Bowel Diseases, Vol. 21, No. 7, 19.05.2015, p. 1594-1599.

Research output: Contribution to journalArticle

Wiese, DM, Beaulieu, D, Slaughter, JC, Horst, S, Wagnon, J, Duley, C, Annis, K, Nohl, A, Herline, AJ, Muldoon, R, Geiger, T, Wise, PE & Schwartz, DA 2015, 'Use of endoscopic ultrasound to guide adalimumab treatment in perianal Crohn's disease results in faster fistula healing', Inflammatory Bowel Diseases, vol. 21, no. 7, pp. 1594-1599. https://doi.org/10.1097/MIB.0000000000000409
Wiese, Dawn M. ; Beaulieu, Dawn ; Slaughter, James C. ; Horst, Sara ; Wagnon, Julie ; Duley, Caroline ; Annis, Kim ; Nohl, Anne ; Herline, Alan Joseph ; Muldoon, Roberta ; Geiger, Tim ; Wise, Paul E. ; Schwartz, David A. / Use of endoscopic ultrasound to guide adalimumab treatment in perianal Crohn's disease results in faster fistula healing. In: Inflammatory Bowel Diseases. 2015 ; Vol. 21, No. 7. pp. 1594-1599.
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abstract = "Background: Perianal disease is a manifestation of Crohn's disease (CD) that has poor long-term treatment outcomes. The aim was to determine if rectal endoscopic ultrasound (EUS)-guided therapy with adalimumab (ADA) can improve outcomes for patients with perianal fistulizing CD. Methods: This is a randomized prospective study comparing serial EUS guidance of fistula treatment versus standard of care in fistulizing perianal CD. At enrollment, all patients underwent a rectal EUS and an EUA with seton placement and/or I&D. Treatment was maximized with immunomodulators, antibiotics, and ADA induction. Surgical interventions were determined by the surgeon's discretion in the control group and assisted by every 12th week EUS in the intervention group. Primary and secondary endpoints where complete drainage cessation at week 48 was fistula status per EUS, respectively. Results: Twenty patients were enrolled: 11 control and 9 EUS guidance. At 24 weeks, 7/9 (78{\%}) in EUS group and 3/11 (27{\%}) in control group had drainage cessation (P 0.04). This significant difference was lost at week 48 (P 0.44). Three patients in the EUS and 1 in the control group had additional surgical intervention. Those in the EUS group had more rapid escalation of ADA dosing (P 0.003). There was no difference in the change in PDAI at week 48 versus baseline (P 0.81). Conclusions: Rectal EUS-guided ADA therapy for CD perianal fistulas showed an initial benefit at 24 weeks, which was lost at week 48. This is likely due to small sample size and higher fistula closure in the controls. However, the faster rate of fistula resolution is a clinically significant finding.",
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AU - Wiese, Dawn M.

AU - Beaulieu, Dawn

AU - Slaughter, James C.

AU - Horst, Sara

AU - Wagnon, Julie

AU - Duley, Caroline

AU - Annis, Kim

AU - Nohl, Anne

AU - Herline, Alan Joseph

AU - Muldoon, Roberta

AU - Geiger, Tim

AU - Wise, Paul E.

AU - Schwartz, David A.

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N2 - Background: Perianal disease is a manifestation of Crohn's disease (CD) that has poor long-term treatment outcomes. The aim was to determine if rectal endoscopic ultrasound (EUS)-guided therapy with adalimumab (ADA) can improve outcomes for patients with perianal fistulizing CD. Methods: This is a randomized prospective study comparing serial EUS guidance of fistula treatment versus standard of care in fistulizing perianal CD. At enrollment, all patients underwent a rectal EUS and an EUA with seton placement and/or I&D. Treatment was maximized with immunomodulators, antibiotics, and ADA induction. Surgical interventions were determined by the surgeon's discretion in the control group and assisted by every 12th week EUS in the intervention group. Primary and secondary endpoints where complete drainage cessation at week 48 was fistula status per EUS, respectively. Results: Twenty patients were enrolled: 11 control and 9 EUS guidance. At 24 weeks, 7/9 (78%) in EUS group and 3/11 (27%) in control group had drainage cessation (P 0.04). This significant difference was lost at week 48 (P 0.44). Three patients in the EUS and 1 in the control group had additional surgical intervention. Those in the EUS group had more rapid escalation of ADA dosing (P 0.003). There was no difference in the change in PDAI at week 48 versus baseline (P 0.81). Conclusions: Rectal EUS-guided ADA therapy for CD perianal fistulas showed an initial benefit at 24 weeks, which was lost at week 48. This is likely due to small sample size and higher fistula closure in the controls. However, the faster rate of fistula resolution is a clinically significant finding.

AB - Background: Perianal disease is a manifestation of Crohn's disease (CD) that has poor long-term treatment outcomes. The aim was to determine if rectal endoscopic ultrasound (EUS)-guided therapy with adalimumab (ADA) can improve outcomes for patients with perianal fistulizing CD. Methods: This is a randomized prospective study comparing serial EUS guidance of fistula treatment versus standard of care in fistulizing perianal CD. At enrollment, all patients underwent a rectal EUS and an EUA with seton placement and/or I&D. Treatment was maximized with immunomodulators, antibiotics, and ADA induction. Surgical interventions were determined by the surgeon's discretion in the control group and assisted by every 12th week EUS in the intervention group. Primary and secondary endpoints where complete drainage cessation at week 48 was fistula status per EUS, respectively. Results: Twenty patients were enrolled: 11 control and 9 EUS guidance. At 24 weeks, 7/9 (78%) in EUS group and 3/11 (27%) in control group had drainage cessation (P 0.04). This significant difference was lost at week 48 (P 0.44). Three patients in the EUS and 1 in the control group had additional surgical intervention. Those in the EUS group had more rapid escalation of ADA dosing (P 0.003). There was no difference in the change in PDAI at week 48 versus baseline (P 0.81). Conclusions: Rectal EUS-guided ADA therapy for CD perianal fistulas showed an initial benefit at 24 weeks, which was lost at week 48. This is likely due to small sample size and higher fistula closure in the controls. However, the faster rate of fistula resolution is a clinically significant finding.

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