Biologic therapy for the treatment of inflammatory bowel disease ( IBD ) continues to evolve. Phase I and phase II studies have demonstrated the efficacy of Vedolizumab ( Entyvio ) for the induction of clinical remission in both Crohn’s disease and ulcerative colitis. Furthermore, phase II studies suggest that short-term Vedolizumab use is safe with an adverse event rate in Vedolizumab-treated individuals no higher than that observed in patients receiving placebo.
Emerging phase III studies support the use of Vedolizumab in patients with moderately-to-severely active ulcerative colitis who have failed at least one prior therapy including prior TNF-alpha inhibitors. Although the total number of patients studied remains relatively small, no cases of JC viremia or progressive multifocal leukoencephalopathy ( PML ) have developed as a result of Vedolizumab therapy. One case of primary cytomegalovirus did occur, but the patient improved without antiviral therapy.
Upon completion of the remaining phase III studies and pending approval from the FDA ( Food and Drug Administration ), Vedolizumab may represent a promising new alternative treatment for moderate-to-severe cases of ulcerative colitis and Crohn’s disease.
Importantly, Vedolizumab will become an attractive treatment option for ulcerative colitis patients not responsive to, or losing response to, Infliximab ( Remicade ), and for Crohn’s disease patients not responsive to, or losing response to, one or more TNF-alpha inhibitors.
Since Vedolizumab, like Natalizumab, targets leukocyte adhesion molecules, adoption of Vedolizumab for treatment of patients not previously exposed to TNF-alpha inhibitors may initially be limited due to concerns regarding the safety of anti-integrin molecules, although evidence to date suggests that Vedolizumab is unlikely to be associated with PML. If there continues to be no association with progressive multifocal leukoencephalopathy with long-term use and the safety profile continues to be excellent, Vedolizumab is likely to supplant Natalizumab for the management of Crohn’s disease patients previously exposed to TNF-alpha inhibitors and offer an additional option for the treatment of ulcerative colitis patients previously exposed to Infliximab or immune suppressants.
As physician and patient comfort with this more selective agent grows, Vedolizumab may also be used for the treatment of patients with ulcerative colitis or Crohn’s disease without prior exposure to TNF-alpha inhibitors, rather than as a second-line agent. ( Xagena )
Source: Immunotherapy, 2012