Tremfya (guselkumab) QUASAR Maintenance Study in UC met its primary endpoint and all major secondary endpoints, including highly statistically significant rates of endoscopic remission
Johnson & Johnson announced the first data from the Phase III QUASAR Maintenance Study (Abstract #759) that showed 50.0 percent (p<0.001) of patients with moderately to severely active ulcerative colitis (uc) receiving subcutaneous (sc) tremfya (guselkumab) 200 mg every four weeks (q4w) and 45.2 percent (p><0.001) of patients receiving sc tremfya 100 mg every eight weeks (q8w) achieved the primary endpoint of clinical remission at week 44 compared to placebo (18.9 percent)
In additional analyses of patients who were in clinical remission, 67 percent and 71 percent, respectively, were also in endoscopic remission at Week 44 (Mayo endoscopic subscore [MES]= 0), indicating they had normal appearance of intestinal mucosa.
“These data suggest the potential of guselkumab to provide durable, clinical remission and improve important high-bar endpoints such as endoscopic remission to the point of normalization and histologic remission, which represent the kind of progress needed in new treatments for this inflammatory bowel disease,” said David T. Rubin, M.D., Chief, Section of Gastroenterology, Hepatology and Nutrition, University of Chicago and lead study investigator. “The clinical results measured at Week 44 in the QUASAR Maintenance Study suggest that treatment with guselkumab is a promising therapy to help ulcerative colitis patients with challenging symptoms that impact their daily lives.”
Both Tremfya treatment groups also met all nine major secondary endpoints with high statistical significance and clinically meaningful improvements versus placebo.
These data are among 28 oral and poster presentations that Johnson & Johnson is presenting at Digestive Disease Week 2024, highlighting the company’s commitment and leadership in advancing the science of inflammatory bowel disease.
ABOUT THE QUASAR PROGRAM (NCT04033445): QUASAR is a randomized, double-blind, placebo-controlled, parallel group, multicenter, seamless Phase IIb/III program designed to evaluate the efficacy and safety of guselkumab, a selective IL-23 inhibitor, in adult patients with moderately to severely active ulcerative colitis who experienced an inadequate response or who demonstrate intolerance to conventional therapy (e.g., thiopurines or corticosteroids), other biologics and/or JAK inhibitors (i.e., tumor necrosis factor [TNF]-alpha antagonists, vedolizumab, or tofacitinib). QUASAR includes a Phase IIb dose-ranging induction study, a confirmatory Phase III induction study, a Phase III randomized withdrawal maintenance study, and a long-term extension study through a total of 5 years. Efficacy, safety, pharmacokinetics, immunogenicity, and biomarkers are assessed at specified time points.
In the Phase III randomized withdrawal QUASAR Maintenance Study, adult patients who demonstrated a clinical response to 12 weeks of Tremfya IV induction in the Phase II and Phase III induction studies were randomized 1:1:1 to three treatment groups: SC Tremfya 200 mg q4w, Tremfya 100 mg q8w or placebo (Tremfya withdrawal)1 The major secondary endpoints included corticosteroid-free clinical remission, maintenance of clinical remission, clinical response, symptomatic remission, endoscopic improvement, histo-endoscopic mucosal improvement, endoscopic normalization, Inflammatory Bowel Disease Questionnaire (IBDQ) remission, and fatigue response at Week 44 (56 weeks after initiation of treatment).
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