New results from post-hoc analysis of Simponi (golimumab) in ulcerative colitis- MSD

The results from a post-hoc analysis of the PURSUIT-Maintenance study of Simponi (golimumab), from MSD, show the association of patient symptoms such as stool frequency and rectal bleeding with continuous clinical response (CCR) in patients with moderate to severe ulcerative colitis. CCR, which is defined as a clinical response maintained through week 54, was observed in patients treated with golimumab in the PURSUIT-Maintenance study – a Phase III multicentre, randomised, double-blind, placebo-controlled study.

This post-hoc analysis suggests that patients’ own monitoring of stool frequency and rectal bleeding may be considered to help determine their response to treatment, in addition to conventional endpoints such as physician's global assessment (PGA) and mucosal healing. All trial patients had failed to respond to or had failed to tolerate one or more of the following conventional therapies: 6-mercaptopurine (6-MP), azathioprine (AZA), corticosteroids and/or 5-aminosalicylate (5-ASA); or were corticosteroid dependent. The new findings were presented at United European Gastroenterology week (UEGW) 2015.