Phase III Tremfya data in inflammatory bowel disease show positive induction results among patients with moderately to severely active ulcerative colitis.- Eli Lilly

The data show statistically significant and clinically meaningful improvements across symptomatic and histo-endoscopic outcome measures.

Safety data were also consistent with the known safety profile of Tremfya in approved indications.

“Many people living with ulcerative colitis, especially those who have had inadequate response to other treatments, live with uncertainty and continue to experience debilitating symptoms,” said study author Jessica R. Allegretti, M.D., M.P.H., Medical Director, Crohn’s and Colitis Center at the Brigham and Women’s Hospital, Boston, MA, USA. “These Phase III data represent an important step in the advancement of a new treatment for moderately to severely active ulcerative colitis, as researchers continue to investigate therapeutic options that have the potential to provide relief for individuals at all stages of disease.”

QUASAR Phase III Induction Study Outcomes (Abstract #913b):Among 701 patients randomized 3:2 to receive intravenous (IV) Tremfya 200 mg or placebo at Weeks 0, 4, and 8, and observed through Week 12, results demonstrate : i. A significantly greater proportion of patients treated with Tremfya compared with placebo (22.6 percent versus 7.9 percent, p<0.001,) achieved clinical remission (a mayo stool frequency subscore of 0 or 1 and not increased from baseline, a mayo rectal bleeding subscore of 0 and a mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy) at week 12, the study’s primary endpoint. ii. at week 4, 22.6 percent of patients receiving tremfya achieved symptomatic remission ( a stool frequency subscore of 0 or 1 and not increased from baseline and a rectal bleeding subscore of 01) versus 12.9 percent placebo (p><0.001,). at week 12, 49.9 percent of patients achieved symptomatic remission versus 20.7 percent placebo (p><0.001). iii. compared to placebo, a greater proportion of tremfya-treated patients at week 12 achieved: a. clinical response (61.5 percent versus 27.9 percent placebo [p><0.001,33.8 percent). b. endoscopic improvement (26.8 percent versus 11.1 percent placebo [p><0.001, 6.0 percent] . c. histo-endoscopic mucosal improvement (23.5 percent versus 7.5 percent placebo [p><0.001, 16.2 percent]). d. endoscopic normalization (15.0 percent versus 5.0 percent placebo [nominal p><0.001, 10.1 percent]).iv. frequencies of treatment-emergent adverse events (aes) in tremfya-treated patients were generally comparable to placebo. v. there were numerically fewer serious aes (2.9 percent tremfya versus 7.1 percent placebo) and aes leading to discontinuation (1.7 percent tremfya versus 3.9 percent placebo) in tremfya-treated patients compared with placebo. vi. overall, safety results through week 12 were consistent with the known safety profile of tremfya in approved indications.></0.001,></0.001,></0.001,></0.001,33.8></0.001).></0.001,).></0.001,)>

“Results from the QUASAR study offer insights into the potential utility of Tremfya for people living with this lifelong chronic condition and reinforce the known safety profile of Tremfya observed in approved indications,” said Kavitha Goyal, M.D., Head of Global Medical Affairs, Gastroenterology, Janssen Global Services, LLC. “Janssen continues to investigate IL-23 pathway science with Tremfya for treatment of complex immune-mediated diseases like ulcerative colitis, so that healthcare providers can have a range of treatment options that best fit patients’ needs and can bring them closer to the goal of remission.”

Further research is currently being conducted on Tremfya for the treatment of patients with inflammatory bowel disease, which includes ongoing Phase III trials in Crohn’s disease (NCT03466411, NCT05197049) and UC (NCT04033445, NCT05528510).