Impact of Anti-cytomegalovirus Treatment in the Management of Relapsing Ulcerative Colitis Requiring Vedolizumab Therapy
Status:
Recruiting
Trial end date:
2023-07-01
Target enrollment:
Participant gender:
Summary
Ulcerative Colitis (UC) is an inflammatory bowel disease that can require the use of anti-TNF
alpha therapy. When anti-TNF alpha failed to obtain a clinical response, the use of a new
anti-integrin therapy, vedolizumab, can be proposed. The efficacy of vedolizumab has been
assessed in a phase 3 study (GEMINI I), with response rates of 41.1% with vedolizumab vs
25.5% with placebo.
CytoMegaloVirus (CMV) reactivation has been associated with resistance to steroid and to
several lines of immunosuppressive therapy. Antiviral therapy was proven to decrease the
tissue viral load and to restore the response to immunosuppressive therapies (up to 80% in
small group of patients). A recent meta-analysis supports the use of valganciclovir in case
of CytoMegaloVirus (CMV) reactivation in active Ulcerative Colitis (UC).
Moreover, a study showed that the risk of CMV reactivation seems to be more important with
vedolizumab than with anti TNF, and the risk of colectomy is higher in case of
CytoMegaloVirus (CMV) reactivation (p<0.05).