TREMFYA® Shows Sustained Long-Term Remission in Ulcerative Colitis Patients, According to Phase 3 QUASAR LTE Study
More than 70% of patients in clinical remission and over 40% in endoscopic remission at Week 92
Johnson & Johnson (NYSE: JNJ) today announced new data from its Phase 3 QUASAR long-term extension (LTE) study evaluating TREMFYA® (guselkumab) in adults with moderately to severely active ulcerative colitis (UC). The findings, presented as part of 24 abstracts at Digestive Disease Week (DDW) 2025, highlight the durable efficacy of TREMFYA® through 92 weeks of treatment.
Key results from the QUASAR LTE study include:
- 72% of patients achieved clinical remission, with 99% of those remaining corticosteroid-free for at least 8 weeks through Week 92¹.
- 43% of patients achieved endoscopic remission².
- Among those who had endoscopic improvement³ at Week 44, 84% maintained that improvement through Week 92.
- Clinical and endoscopic remission rates were sustained regardless of prior treatment with biologics or JAK inhibitors.
“These results are a meaningful step for people living with UC, who seek therapies that provide both symptom relief and lasting remission,” said Dr. Gary R. Lichtenstein, Vice Chief of the Division of Gastroenterology and Hepatology at the University of Pennsylvania⁴. “TREMFYA® is demonstrating durable efficacy, which is critical in managing this challenging disease.”
Safety findings were consistent with TREMFYA®’s established profile in inflammatory bowel disease (IBD), with no new safety concerns identified.
“TREMFYA® is showing its potential to deliver long-term remission for patients with UC,” said Dr. Esi Lamousé-Smith, Vice President, Gastroenterology Disease Area Lead, Immunology at Johnson & Johnson Innovative Medicine. “These results underscore our commitment to redefining the standard of care in IBD.”
TREMFYA® is the first and only dual-acting monoclonal antibody approved to treat UC by targeting both IL-23 and CD64, a receptor on cells that produce IL-23. IL-23 is a key cytokine involved in immune-mediated conditions like UC⁵⁻⁹.
Approved by the FDA in September 2024 for adults with moderately to severely active UC, TREMFYA® is currently administered via IV induction followed by subcutaneous (SC) maintenance. A supplemental Biologics License Application (sBLA) was submitted in November 2024 seeking approval for a SC induction regimen. TREMFYA® also received FDA approval in March 2025 for both SC and IV induction regimens for Crohn’s disease (CD).
ABOUT THE QUASAR PROGRAM (NCT04033445)
QUASAR is a randomized, double-blind, placebo-controlled, parallel group, multicenter, Phase 2b/3 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 2b dose-ranging induction study, a confirmatory Phase 3 induction study, and a Phase 3 randomized withdrawal maintenance study. In the Phase 3 induction study, patients received either TREMFYA® 200 mg or placebo by IV infusion at Weeks 0, 4, and 8. In the Phase 3 maintenance study, patients received a SC maintenance regimen of either TREMFYA® 200 mg q4w, TREMFYA® 100 mg q8w, or placebo.7 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.
ABOUT ULCERATIVE COLITIS
Ulcerative colitis (UC) is a chronic disease of the large intestine, also known as the colon, in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers, that produce pus and mucus. It is the result of the immune system’s overactive response. Symptoms vary but may typically include loose and more urgent bowel movements, rectal bleeding or bloody stool, persistent diarrhea, abdominal pain, loss of appetite, weight loss, and fatigue.8
ABOUT TREMFYA® (guselkumab)
Developed by Johnson & Johnson, TREMFYA® is the first approved fully-human, dual-acting monoclonal antibody designed to neutralize inflammation at the cellular source by blocking IL-23 and binding to CD64 (a receptor on cells that produce IL-23). Findings for dual-acting are limited to in vitro studies that demonstrate guselkumab binds to CD64, which is expressed on the surface of IL-23 producing cells in an inflammatory monocyte model. The clinical significance of this finding is not known.
TREMFYA® is a prescription medicine approved in the U.S. to treat:
- adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light).
- adults with active psoriatic arthritis.
- adults with moderately to severely active ulcerative colitis.
- adults with moderately to severely active Crohn’s disease.4
TREMFYA® is approved in Europe, Canada, Japan, and a number of other countries for the treatment of adults with moderate-to-severe plaque psoriasis and for the treatment of adults with active psoriatic arthritis. In addition, TREMFYA ® is approved in Europe, Japan and Brazil for the treatment of adult patients with moderately to severely active UC and in Brazil and China for the treatment of adults with moderately to severely active CD.
