The Study of TOfacitinib for the treatment of chronic PouchITis (STOPit)

Lead investigators: A/Prof Jake Begun, Dr Emi Khoo

Sites: Mater Hospital Brisbane (lead site). This study will be conducted at ~16 sites across QLD, NSW, VIC, SA and WA including 12 ANZ IBD consortium sites. 

Project overview and aims:

Pouchitis is the most common complication following a total proctocolectomy and ileal pouch-anal anastomosis for ulcerative colitis. Despite the curative intent of proctocolectomy, up to 80% of patients develop inflammation of the pouch post-surgery known as pouchitis. Antibiotics remain the first line treatment option, however a small proportion of individuals develop chronic pouchitis, which is either refractory to antibiotic therapy or dependent on antibiotics for symptomatic relief. 

Unfortunately, there are limited studies of the effectiveness of treatments for chronic pouchitis resulting in a lack of guidance for clinicians treating these patients.  The STOPit trial is a randomized, double-blind, placebo-controlled study to test whether tofacitinib (which has recently been approved for treatment of ulcerative colitis) is an effective treatment for chronic pouchitis.

Recruitment:

We are aiming to recruit ~120 patient who meet the inclusion criteria:

• Adult patients age 18 to 65 
• Previous diagnosis of ulcerative colitis (UC) and have undergone total proctocolectomy and ileal pouch-anal anastomosis (IPAA)
• Chronic or recurrent pouchitis ( > 4 weeks of antibiotics in the previous 12 months OR pouchitis that is refractory to antibiotic therapy)
• A total modified pouchitis disease activity index (mPDAI) score > 5 with endoscopic evidence of active disease 

The results of this study will inform whether tofacitinib is effective and safe for treatment of chronic pouchitis.