Background: Our recent study showed the efficacy and safety of vedolizumab in the treatment of chronic antibiotic-refractory pouchitis. However, there are no published studies on its efficacy and safety in Crohn's disease (CD) of the pouch. The aim of this study was to assess the efficacy and safety of vedolizumab in those patients.
Methods: This case series included all eligible patients with CD of the pouch from our prospectively maintained, IRB-approved Pouchitis Registry from 2015 to 2017. Disease activity in pouch patients can be monitored using the modified Pouchitis Disease Activity Index (mPDAI). mPDAI is the 18-point pouchitis disease activity index consisting of three principal component scores: symptom (range, 0-6 points), endoscopy, (range 0-6 points), and histology (range, 2-6 points). Pre- and post- treatment (minimum 6 months) pouchoscopy and clinical visits were used to calculate mPDAI.
Results: A total of 12 patients were included in this study, who had restorative proctocolectomy with ileal pouch anal anastomosis for medically refractory ulcerative colitis (UC). The mean age at the time of pre-colectomy diagnosis of UC was 25.0 ± 11.5 years. The mean current age was 41.0 ± 12.1 years, nine (75.0%) were female, three (25.0%) had smoked and eight (66.7%) had used anti-tumor necrosis factor agents prior to vedolizumab use. The mean duration of vedolizumab use was 1.0 ± 6.4 years. There was a significant reduction in mPDAI symptom subscores after vedolizumab therapy (3.50 ± 1.93 vs 5.08 ± 0.79, P = 0.015). The pre- and post-treatment mean endoscopy subscores were 1.25 ± 1.36 and 0.91 ± 1.50 in the afferent limb (P = 0.583); 2.58 ± 1.68 and 2.27 ± 2.05 (P = 0.701) in the pouch body; and 2.67 ± 1.93 and 2.09 ± 2.12 (P = 0.511) in the cuff, respectively. None of the patients experienced side effects throughout the vedolizumab therapy.
Conclusion: The findings of our study suggests that vedolizumab appears to be effective and safe in reducing the symptoms in patients with CD of the pouch.
Keywords: Anti-tumor necrosis factor agent; Crohn’s disease; ileal pouch; restorative proctocolectomy; vedolizumab.