Tremfya (guselkumab) delivers sustained clinical and endoscopic remission in ulcerative colitis through two years - Johnson & Johnson

Johnson & Johnson announced new data from the Tremfya (guselkumab) Phase III QUASAR long-term extension (LTE) study in adults with moderately-to-severely active ulcerative colitis (UC). Data from the QUASAR LTE study demonstrate patients treated with Tremfya sustained clinical and endoscopic efficacy at Week 92: i) 72% of patients were in clinical remission with 99% of those patients remaining corticosteroid free for 8 or more weeks through Week 92. ii) 43% of patients were in endoscopic remission. iii) Among patients achieving endoscopic improvement at Week 44, 84% maintained endoscopic improvement through Week 92. Patients treated with Tremfya sustained clinical and endoscopic remission regardless of prior biologic and/or JAK inhibitor treatment history.

“People living with ulcerative colitis seek treatments that both address the challenging symptoms of the disease and provide durable results,” said Gary R. Lichtenstein, Vice Chief, Division of Gastroenterology and Hepatology, Development and Philanthropy at the University of Pennsylvania. “These new data show Tremfya delivers long-term, sustained clinical and endoscopic remission, marking important progress in UC care.”

Safety data were consistent with the well-established safety profile of Tremfya in inflammatory bowel disease (IBD) with no new safety concerns identified.

“With these findings, Tremfya shows the powerful impact it can have in achieving longer term remission in patients,” said Esi Lamousé-Smith, MD, PhD, Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson Innovative Medicine. “This is a significant step forward in our mission to reshape the standard of care in inflammatory bowel disease.”

Tremfya is the first and only approved, dual-acting monoclonal antibody that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including UC.

Tremfya received FDA approval in September 2024 for the treatment of adult patients with moderately to severely active UC and is currently administered via an IV induction regimen, followed by a SC maintenance regimen. In November 2024, a supplemental Biologics License Application (sBLA) was submitted to the FDA seeking approval of a SC induction regimen of Tremfya for the treatment of adults with moderately to severely active UC. Tremfya was also approved by the FDA in March 2025 for SC and IV induction options for the treatment of adults with moderately to severely active Crohn’s disease (CD).

ABOUT THE QUASAR PROGRAM (NCT04033445)
QUASAR is a randomized, double-blind, placebo-controlled, parallel group, multicenter, Phase IIb/III program designed to evaluate the efficacy and safety of Tremfya in adults with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to conventional therapy (e.g., thiopurines or corticosteroids), prior biologics (TNF antagonists or vedolizumab) and/or JAK inhibitors (tofacitinib). QUASAR included a Phase IIb dose-ranging induction study, a confirmatory Phase III induction study, and a Phase III randomized withdrawal maintenance study. In the Phase III induction study, patients received either Tremfya 200 mg or placebo by IV infusion at Weeks 0, 4, and 8. In the Phase III maintenance study, patients received a SC maintenance regimen of either Tremfya 200 mg q4w, Tremfya 100 mg q8w, or placebo. The ongoing long-term extension study provides an additional 4 years of treatment. Efficacy, safety, pharmacokinetics, immunogenicity, and biomarkers are assessed at specified time points.