Analysis of GEMINI 1 data of Entyvio (vedolizumab) in ulcerative colitis published in Clinical Gastroenterology and Hepatology - Takeda

Takeda Pharmaceutical announced that an exploratory analysis of the GEMINI 1 data, evaluating Entyvio (vedolizumab) therapy in patients with ulcerative colitis (UC) based on their treatment history with tumor necrosis factor (TNF) antagonists was published in Clinical Gastroenterology and Hepatology. The sub-group analysis, compared TNF-na�ve with TNF-failure patients with moderately to severely active UC. The former had never received TNF antagonist therapy whilst those who had received and failed therapy due to inadequate response, loss of response or intolerance were in the latter group. Approximately 50% of patients with ulcerative colitis do not respond to TNF antagonist therapy, or lose response over time.

Overall, the publication reported a statistically significantly greater efficacy with vedolizumab treatment compared to placebo in both sub-groups of patients. Investigators examined primary and secondary outcomes data from the GEMINI 1 study, after 6 weeks and 52 weeks of vedolizumab therapy in patient sub-groups who were either TNF-na�ve or failed TNF antagonist therapy. The analysis reported that vedolizumab treatment had statistically significantly greater efficacy compared to placebo in inducing and maintaining clinical response in both sub-groups of patients. Furthermore, greater treatment differences favoring vedolizumab treatment at week 6 were observed for TNF-na�ve patients, compared to TNF-failure patients. There were no differences in adverse events among treatment groups in this study.

See: "Efficacy of Vedolizumab Induction and Maintenance Therapy in Patients With Ulcerative Colitis, Regardless of Prior Exposure to TNF Antagonists" Brian G. Feagan et al. Clinical Gastroenterology and Hepatology published online: September 14, 2016 DOI: http://dx.doi.org/10.1016/j.cgh.2016.08.044