New data from the QUASAR phase III induction study presented at the American College of Gastroenterology (ACG) annual meeting demonstrated early symptom improvement with guselkumab (Tremfya) in ulcerative colitis (UC).
In this exclusive MedPage Today video, investigator Jessica Allegretti, MD, medical director of the Crohn’s and Colitis Center at Brigham and Women’s Hospital in Boston, discusses the results.
Following is a transcript of her remarks:
My name is Jessica Allegretti and I’m the medical director of the Crohn’s and Colitis Center at the Brigham and Women’s Hospital. And today I’m going to be reviewing an abstract that was presented at ACG 2023 in Vancouver entitled “Early Symptomatic Improvement With Guselkumab Induction Treatment in Moderate to Severely Active Ulcerative Colitis: Results From the Phase III QUASAR Induction Study.”
For a little bit of background, the phase III QUASAR induction study was a randomized double-blind, placebo-controlled, parallel-group, multicenter study of guselkumab, which is an interleukin-23 p19 subunit antagonist, in patients with moderate to severely active ulcerative colitis (UC). Here, the early onset of symptom improvement was evaluated. And so in this study, patients were randomized in a 3:2 fashion to receive IV guselkumab 200 mg or placebo at weeks 0, 4, and 8. The primary analysis population included treated patients who had a modified baseline Mayo score of 5 to 9 and a baseline endoscopic score of 2 or greater.
Through week 12, patients did record stool production and episodes of rectal bleeding in a diary. Symptomatic remission at weeks 2, 4, and 12 were major secondary endpoints.
The primary analysis population here included 701 randomized and treated patients. Notably at baseline, about 49% had prior inadequate response or intolerance to advanced therapies for ulcerative colitis. Here we see as early as week 1 and increasing through week 12 we see greater symptomatic improvement was seen in patients treated with guselkumab compared to placebo. At weeks 2, 4, 8, and 12, symptomatic remission was achieved by those treated with guselkumab compared to placebo in, again, incrementally increasing fashion. So 12% compared to 9% at week 2, 22.6% compared to 12.9% at week 4, 39.7% compared to 20.7% at week 8, and we achieve 49.9% compared to 20.7% out at week 12. And those were all statistically significant except for week 2.
I’ll also note that for guselkumab patients compared to placebo, percentages of those with stool frequency subscores as low as 0 or 1 at weeks 2, 4, 8, and 12 were also significantly increased compared to placebo again at weeks 2, 4, 8, and 12.
So in conclusion, guselkumab 200 mg IV induction was effective in improving symptoms, actually as early as week 1 — if you look at all of the data — is where we start to see the lines separate after that first dose in patients with moderate to severely active UC. Symptomatic improvements though certainly did increase through week 12. Thank you so much for your attention.
Source link : https://www.medpagetoday.com/meetingcoverage/acgvideopearls/107209
Publish date : 2023-11-07 13:46:58
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