In an evaluation in accordance with the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) recently assessed whether IBD drug Entyvio (vedolizumab) from Takeda Pharma (TYO: 4502), Japan’s largest drug maker, offers additional benefits over standard therapies. The conclusion reached by the IQWiG was that the therapeutic benefits of the drug in this setting have not been proven in light of the current data.
Crohn’s disease and ulcerative colitis are the principal types of chronic inflammatory bowel disease that affect the colon and the small intestine. Entyvio (vedolizumab) is a treatment option when conventional therapies or the use of tumor necrosis factor alpha (TNFα) antagonists are not tolerated or are ineffective in treating the disease’s symptoms. Entyvio has been approved in Europe to treat patients with moderate to severe active Crohn’s disease or ulcerative colitis.
The Federal Joint Committee (G-BA) declared TNFα antagonist (adalimumab or infliximab) as an appropriate comparator therapy for both diseases, for which the drug is indicated. When a treatment with a TNFα Antagonist fails, it is an option to switch to a different TNFα Antagonist or adjust the dose.
According to the IQWiG, Takeda Pharma identified no randomized controlled trial (RCT) that directly compared Entyvio/vedolizumab with adalimumab for Crohn’s disease patients, and the company did not compare them indirectly, either. Hence, the added benefit of the drug for Crohn’s disease patients has yet to be proven.
In addition, there were no direct comparative RCTs for the therapeutic indication of moderately to severe active ulcerative colitis in Takeda’s dossier. However, there was an adjusted indirect comparison: an RCT comparing vedolizumab with placebo (study C13006), and 3 RCTs in which adalimumab was tested against placebo (ULTRA 1, ULTRA 2, M10-447). The placebo was used as common comparator.
The indirect comparison does not suit the vedolizumab study for a second reason regarding the side effects were not correctly analyzed. Thus, according to the IQWiG, the added benefit of vedolizumab compared to adalimumab is not proof of its success for patients suffering with moderately to severe active ulcerative colitis.