Administration of adalimumab in the treatment of Crohn’s disease of the ileal pouch
Version of Record online: 17 DEC 2008
© 2009 Blackwell Publishing Ltd
Alimentary Pharmacology & Therapeutics
Volume 29, Issue 5, pages 519–526, March 2009
How to Cite
SHEN, B., REMZI, F. H., LAVERY, I. C., LOPEZ, R., QUEENER, E., SHEN, L., GOLDBLUM, J. and FAZIO, V. W. (2009), Administration of adalimumab in the treatment of Crohn’s disease of the ileal pouch. Alimentary Pharmacology & Therapeutics, 29: 519–526. doi: 10.1111/j.1365-2036.2008.03920.x
- Issue online: 30 JAN 2009
- Version of Record online: 17 DEC 2008
- Publication data Submitted 14 October 2008 First decision 25 November 2008 Resubmitted 11 December 2008 Accepted 11 December 2008 Epub Accepted Article 17 December 2008
Background Crohn’s disease (CD) of the pouch can develop in patients with ileal pouch-anal anastomosis (IPAA). Scant data are available on the treatment of this disease entity.
Aim To evaluate efficacy and safety of adalimumab in treating CD of the ileal pouch.
Methods From June 2007 to June 2008, 17 IPAA patients with inflammatory (n = 10), fibrostenotic (n = 2) or fistulizing (n = 5) CD of the pouch treated with adalimumab were evaluated. Inclusion criteria were CD of the pouch who failed medical therapy and were otherwise qualified for permanent pouch diversion or excision. All qualified patients received the standard dosing regimen of subcutaneous injection adalimumab (160 mg at week 0, 80 mg at week 1, and 40 mg every other week thereafter). Complete clinical response was defined as resolution of symptoms. Partial clinical response was defined as improvement in symptoms. Endoscopic inflammation before and after therapy was recorded, using the Pouchitis Disease Activity Index (PDAI) endoscopy subscores.
Results The median age was 36 years with 12 patients (70.6%) being male. At 4 weeks, seven patients (41.2%) had a complete symptom response and 6 (35.3%) had a partial response. There was also a significant improvement in the PDAI endoscopy subscores at week 4 (P < 0.05). At the last follow-up (median of 8 weeks), eight patients (47.1%) had a complete symptom response and 4 (23.5%) had a partial response. Four patients (23.6%) developed adverse effects. Three patients (17.7%) eventually had pouch failure after failing to respond to adalimumab therapy.
Conclusion Adalimumab appeared to be well-tolerated and efficacious in treating CD of the pouch in this open-labelled induction study.