Approximately 60% of patients with ulcerative colitis treated with guselkumab achieved clinical remission.
New data points to guselkumab (TREMFYA) has a potential treatment option for patients with moderately to severely active ulcerative colitis.
Investigators recently presented data from the phase 2B QUASAR Induction Study 1 where 60.7% of patients achieved a clinical response, defined as a decrease from induction baseline in the modified Mayo score of at least 30% and at least 2 points, with either an at least 1 point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1.
The major secondary endpoints in the 313 patient QUASAR study included clinical remission, symptomatic remission, endoscopic improvement, histo-endoscopic mucosal improvement, and endoscopic normalization at week 12.
The investigators found 25.7% and 25.2% of the 200 mg and 400 mgguselkumab groups achieved clinical remission, compared to 9.5% for the placebo group, while 50.5% and 47.7% achieved symptomatic remission, compared to 20% in the placebo group.
In addition 30.% and 30.8% of the 200 mg and 400 mg guselkumab groups achieved endoscopic improvement, compared to 12.4% in the placebo group, 19.8% and 27.1% achieved histo-endoscopic mucosal improvement, compared to 8.6% in the placebo group and 17.8% and 14% achieved endoscopic normalization, compared to 6.7% in the placebo group.
In an interview with HCPLive®, Axel Dignass, M.D., Ph.D., Head of the Department of Medicine and Professor of Medicine and Gastroenterology at the Agaplesion Markus Hospital, Goethe University, discussed the promise of the treatment and why guselkumab could be a big factor moving forward for patients with ulcerative colitis.