Analysis of Entyvio (vedolizumab) data in Crohn's disease published in Inflammatory Bowel Diseases- Takeda

Takeda Pharmaceutical announced that an analysis based on pre-specified and post-hoc exploratory outcomes of GEMINI II and GEMINI III data evaluating Entyvio (vedolizumab) therapy in patients with moderately to severely active Crohn's disease (CD) was published in Inflammatory Bowel Diseases. The data demonstrated higher rates of response in patients receiving vedolizumab as a first-line biologic after conventional therapy failure versus patients who had previously experienced tumor necrosis factor-alpha (TNF-alpha) antagonist therapy failure.

Among patients who responded to vedolizumab induction at week six, 48.9 percent of TNF-naïve and 27.7 percent of TNF-failure patients were in remission with vedolizumab at week 52 (vs. 26.8 percent and 12.8 percent with placebo). In this analysis, compared to placebo, treatment with vedolizumab also showed clinical efficacy of vedolizumab maintenance therapy at week 52 irrespective of the number of prior TNF-alpha antagonists failed. Additionally, trends favoring vedolizumab induction were observed across all three measures of TNF-alpha antagonist failure assessed in the study: inadequate response, loss of response or intolerance, and number of prior TNF-alpha antagonists used. As clinical response/remission rates may be diminished when switching to a second or third TNF-alpha antagonist, these results support evaluating a treatment switch to a therapy with a different mode of action, such as vedolizumab.

See: "Vedolizumab as Induction and Maintenance Therapy for Crohn's Disease in Patients Naive to or Who Have Failed Tumor Necrosis Factor Antagonist Therapy." Sands, Bruce E et al. Inflammatory Bowel Diseases, December 07, 2016 doi: 10.1097/MIB.0000000000000979