Roche announced the results from its Phase III study programme, which evaluated etrolizumab, for the treatment of ulcerative colitis. When researchers evaluated etrolizumab as induction therapy, there were many results. Also, primary endpoints were not achieved when both studies assessed the drug as a maintenance therapy, which showed no substantial difference in the proportion of people with subcutaneous etrolizumab attaining remission compared to placebo.
In the HIBISCUS I induction study, etrolizumab met the primary endpoint when including people without prior anti-tumour necrosis factor treatment. However, the primary endpoint wasn’t met in the HIBISCUS II induction study, which also involved people without previous anti-tumour necrosis factor treatment. Furthermore, etrolizumab met the primary endpoint at induction but not at maintenance in the HICKORY study, which included people with prior anti-tumour necrosis factor treatment. Also, etrolizumab failed to meet its primary endpoint in the LAUREL maintenance study, which involved people without previous anti-tumour necrosis factor treatment.
“Roche announced an update on Phase III studies of etrolizumab.“
Additional examinations of the data, including secondary endpoints, are on-going.
M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development, Levi Garraway, stated: “We are disappointed with these results because we know that people with ulcerative colitis need new treatment options. We are fully analysing these data to learn more about how we might address the needs of people with this devastating disease. These studies were part of the largest clinical trial programme ever undertaken in inflammatory bowel diseases and we thank all the patients, investigators and healthcare professionals for their participation.”