Victorian gastroenterologists have developed a simple and novel tacrolimus enema that is very effective in severe refractory proctitis.
Presenting the findings at ECCO 2019 in Copenhagen, Dr Sarah Fehily from the Department of Gastroenterology at St Vincent’s Hospital, Melbourne, said the do-it-yourself tacrolimus enema was effective where conventional immunosuppressive and biologic therapies had failed and could easily be prepared by patients at home.
Speaking to the limbic, she said some patients with refractory rectal ulcerative colitis were unable to use the oral and suppository forms of tacrolimus because they were poorly tolerated or because the products were difficult to obtain.
But since tacrolimus was water soluble, a simple tap water-based enema formulation could be made by dissolving the powder contents of a 1mg tacrolimus capsule in 60ml tap water, she said. A soft catheter can then be used to self deliver the solution rectally.
In a pilot study they trialled the enema in eight male and nine female patients with moderate to severe proctitis that had failed to respond to conventional therapies including steroids (100% of patients had used), 5-ASA (82%), thiopurine (88%) and biologics (71%).
The tacrolimus enema was given over seven days with the dose increasing from 1mg to 3mg per 60ml water.
“The dose in induction can be titrated according to tolerance and the therapeutic response, said Dr Fehily.
She said inflammation resolved in almost all patients after tacrolimus topical enema and pinhole strictures had also resolved to allow colonoscope passage.
In the small trial, 88% of patients had a clinical response, 100% had a biochemical response and 82% had a endoscopic response.
Overall, all but one of the 17 patients (94%) tolerated the tacrolimus enema, and three (18%) experienced pruritus or worsening nausea.
“Simple water based tacrolimus enemas are well tolerated and safe. They should be included in the treatment armamentarium for IBD-related refractory proctitis,” she concluded.