In an early benefit assessment, the drug vedolizumab (Entyvio) was not proved to provide an added benefit over a comparator therapy in the treatment of moderately to severely active Crohn’s disease or ulcerative colitis.
Vedolizumab is used as an option when conventional therapy is not tolerated or is not effective against the release of symptoms. The drug can also be a tumor necrosis factor alpha antagonist.
In an analysis of the drug dossier by the German Institute for Quality and Efficiency in Health Care, the manufacturer did not identify a randomized controlled trial directly comparing vedolizumab with adalimumab for the treatment of Crohn’s disease patients. The manufacturer also did not conduct an indirect comparison on the basis of randomized controlled trials; therefore, an added benefit of vedolizumab for the therapeutic indication of Crohn’s disease was not proved.
The analysis noted that the dossier compared populations from vedolizumab and adalimumab studies that were not sufficiently similar, because the studies had different designs. It was found that in the vedolizumab study, only the patients who were randomized and treated responded to vedolizumab in the induction phase. In both adalimumab studies, however, responders and nonresponders received continued treatment in the maintenance phase.
Additionally, the manufacturer did not adequately analyze adverse events in the vedolizumab study; therefore, the added benefit of the drug in comparison with adalimumab was not found to be proved.