Adalimumab in the treatment of chronic pouchitis. A randomized double-blind, placebo-controlled trial

Mie Dilling Kjær*, Niels Qvist, Inge Nordgaard-Lassen, Lisbet Ambrosius Christensen, Jens Kjeldsen

*Corresponding author for this work

Research output: Contribution to journalJournal articleResearchpeer-review

Abstract

Background: Pouchitis is a complication of ileal pouch-anal anastomosis and occurs in up to 50% of patients 10 years after IPAA with 10% developing refractory pouchitis. Objective: To evaluate the effect of a TNF-α inhibitor (Adalimumab) in the treatment of refractory pouchitis. Materials and methods: A multicenter, randomized double-blind, placebo-controlled trial includes patients with refractory pouchitis for more than 4 weeks despite antibiotic treatment. Patients were randomized to Adalimumab or placebo for 12 weeks. Primary outcome was reduction in clinical pouchitis disease activity index (PDAI) of ≥2 at any time. Secondary endpoints were remission of pouchitis, endoscopic and histologic effect and quality of life. Results: Thirteen patients were included; six patients received active treatment and seven patients received placebo. Nine patients (5/4, Adalimumab/placebo) completed the 12-week program. Reduction in clinical PDAI ≥ 2 was achieved in three patients in each group (50%/43%, Adalimumab/placebo, p >.5). Total PDAI improved in six patients treated with Adalimumab and two patients on placebo (100%/29%, p =.13). There were no differences in secondary endpoints between the groups. Conclusions: In this randomized controlled trial of treatment with Adalimumab in patients with refractory pouchitis, we were not able to identify any clinical benefit in the primary or secondary endpoints.

Original languageEnglish
JournalScandinavian Journal of Gastroenterology
Volume54
Issue number2
Pages (from-to)188-193
ISSN0036-5521
DOIs
Publication statusPublished - 10. Feb 2019

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Pouchitis
Placebos
Adalimumab
Colonic Pouches

Keywords

  • Ileal pouch-anal anastomosis
  • inflammatory bowel disease
  • pouchitis
  • TNF-α inhibitor
  • ulcerative colitis

Cite this

@article{fdf2ec507e404916a7ebcde6dd10f1aa,
title = "Adalimumab in the treatment of chronic pouchitis. A randomized double-blind, placebo-controlled trial",
abstract = "Background: Pouchitis is a complication of ileal pouch-anal anastomosis and occurs in up to 50{\%} of patients 10 years after IPAA with 10{\%} developing refractory pouchitis. Objective: To evaluate the effect of a TNF-α inhibitor (Adalimumab) in the treatment of refractory pouchitis. Materials and methods: A multicenter, randomized double-blind, placebo-controlled trial includes patients with refractory pouchitis for more than 4 weeks despite antibiotic treatment. Patients were randomized to Adalimumab or placebo for 12 weeks. Primary outcome was reduction in clinical pouchitis disease activity index (PDAI) of ≥2 at any time. Secondary endpoints were remission of pouchitis, endoscopic and histologic effect and quality of life. Results: Thirteen patients were included; six patients received active treatment and seven patients received placebo. Nine patients (5/4, Adalimumab/placebo) completed the 12-week program. Reduction in clinical PDAI ≥ 2 was achieved in three patients in each group (50{\%}/43{\%}, Adalimumab/placebo, p >.5). Total PDAI improved in six patients treated with Adalimumab and two patients on placebo (100{\%}/29{\%}, p =.13). There were no differences in secondary endpoints between the groups. Conclusions: In this randomized controlled trial of treatment with Adalimumab in patients with refractory pouchitis, we were not able to identify any clinical benefit in the primary or secondary endpoints.",
keywords = "Ileal pouch-anal anastomosis, inflammatory bowel disease, pouchitis, TNF-α inhibitor, ulcerative colitis",
author = "Kj{\ae}r, {Mie Dilling} and Niels Qvist and Inge Nordgaard-Lassen and Christensen, {Lisbet Ambrosius} and Jens Kjeldsen",
year = "2019",
month = "2",
day = "10",
doi = "10.1080/00365521.2019.1569718",
language = "English",
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Adalimumab in the treatment of chronic pouchitis. A randomized double-blind, placebo-controlled trial. / Kjær, Mie Dilling; Qvist, Niels; Nordgaard-Lassen, Inge; Christensen, Lisbet Ambrosius; Kjeldsen, Jens.

In: Scandinavian Journal of Gastroenterology, Vol. 54, No. 2, 10.02.2019, p. 188-193.

Research output: Contribution to journalJournal articleResearchpeer-review

TY - JOUR

T1 - Adalimumab in the treatment of chronic pouchitis. A randomized double-blind, placebo-controlled trial

AU - Kjær, Mie Dilling

AU - Qvist, Niels

AU - Nordgaard-Lassen, Inge

AU - Christensen, Lisbet Ambrosius

AU - Kjeldsen, Jens

PY - 2019/2/10

Y1 - 2019/2/10

N2 - Background: Pouchitis is a complication of ileal pouch-anal anastomosis and occurs in up to 50% of patients 10 years after IPAA with 10% developing refractory pouchitis. Objective: To evaluate the effect of a TNF-α inhibitor (Adalimumab) in the treatment of refractory pouchitis. Materials and methods: A multicenter, randomized double-blind, placebo-controlled trial includes patients with refractory pouchitis for more than 4 weeks despite antibiotic treatment. Patients were randomized to Adalimumab or placebo for 12 weeks. Primary outcome was reduction in clinical pouchitis disease activity index (PDAI) of ≥2 at any time. Secondary endpoints were remission of pouchitis, endoscopic and histologic effect and quality of life. Results: Thirteen patients were included; six patients received active treatment and seven patients received placebo. Nine patients (5/4, Adalimumab/placebo) completed the 12-week program. Reduction in clinical PDAI ≥ 2 was achieved in three patients in each group (50%/43%, Adalimumab/placebo, p >.5). Total PDAI improved in six patients treated with Adalimumab and two patients on placebo (100%/29%, p =.13). There were no differences in secondary endpoints between the groups. Conclusions: In this randomized controlled trial of treatment with Adalimumab in patients with refractory pouchitis, we were not able to identify any clinical benefit in the primary or secondary endpoints.

AB - Background: Pouchitis is a complication of ileal pouch-anal anastomosis and occurs in up to 50% of patients 10 years after IPAA with 10% developing refractory pouchitis. Objective: To evaluate the effect of a TNF-α inhibitor (Adalimumab) in the treatment of refractory pouchitis. Materials and methods: A multicenter, randomized double-blind, placebo-controlled trial includes patients with refractory pouchitis for more than 4 weeks despite antibiotic treatment. Patients were randomized to Adalimumab or placebo for 12 weeks. Primary outcome was reduction in clinical pouchitis disease activity index (PDAI) of ≥2 at any time. Secondary endpoints were remission of pouchitis, endoscopic and histologic effect and quality of life. Results: Thirteen patients were included; six patients received active treatment and seven patients received placebo. Nine patients (5/4, Adalimumab/placebo) completed the 12-week program. Reduction in clinical PDAI ≥ 2 was achieved in three patients in each group (50%/43%, Adalimumab/placebo, p >.5). Total PDAI improved in six patients treated with Adalimumab and two patients on placebo (100%/29%, p =.13). There were no differences in secondary endpoints between the groups. Conclusions: In this randomized controlled trial of treatment with Adalimumab in patients with refractory pouchitis, we were not able to identify any clinical benefit in the primary or secondary endpoints.

KW - Ileal pouch-anal anastomosis

KW - inflammatory bowel disease

KW - pouchitis

KW - TNF-α inhibitor

KW - ulcerative colitis

U2 - 10.1080/00365521.2019.1569718

DO - 10.1080/00365521.2019.1569718

M3 - Journal article

VL - 54

SP - 188

EP - 193

JO - Scandinavian Journal of Gastroenterology

JF - Scandinavian Journal of Gastroenterology

SN - 0036-5521

IS - 2

ER -