At-a-Glance
- QUASAR LTE (NCT04033445) at ECCO 2026 showed TREMFYA® sustained 80.8% clinical remission and 53.6% endoscopic remission at Week 140.
- Trial achieved 89% retention, consistent efficacy across prior therapies, and no new safety signals.
- Lancet Phase 3 data showed 23% induction remission at Week 12 vs 8% placebo and 50% maintenance at Week 44 vs 19%.
- QUASAR LTE ongoing 4 more years, supporting long-term UC control with IV/SC regimens.
Written By: Nikita Jha, BPharm
Reviewed By: Pharmacally Editorial Team
Johnson & Johnson announced compelling long-term data from the QUASAR long-term extension (LTE) study on TREMFYA® (guselkumab), showing sustained clinical, endoscopic, and histologic outcomes through Week 140 in adults with moderately to severely active ulcerative colitis (UC).
These results, presented among 30 company-sponsored abstracts at the European Crohn’s and Colitis Organisation (ECCO) 2026 conference, highlight TREMFYA’s potential for durable disease control.
Dr. Lamousé-Smith, Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson underscores TREMFYA’s strong endoscopic outcomes, elevating expectations for ulcerative colitis management. She notes that endoscopic remission leads to reduced flare-ups, lower steroid reliance, and decreased surgery needs, expressing enthusiasm for these results and J&J’s commitment to therapies enabling sustained disease control.
Key QUASAR LTE Study Results
At Week 140, 80.8% of patients achieved clinical remission, defined as a Mayo stool frequency subscore of 0 or 1 (not increased from baseline), rectal bleeding subscore of 0, and endoscopic subscore of 0 or 1.
Additionally, 78.6% reached histo-endoscopic mucosal improvement (HEMI) combining endoscopic improvement with histologic improvements like minimal neutrophil infiltration and 53.6% attained endoscopic remission (Mayo endoscopic subscore of 0), analyzed as observed data.
Of patients in clinical remission at Week 44, 87.5% maintained it through Week 140, with nearly all Week 140 remitters corticosteroid-free for at least eight weeks. Efficacy held steady regardless of prior biologic or JAK inhibitor exposure, and approximately 89% of eligible participants completed treatment, with no new safety signals identified.
QUASAR Program Overview
The QUASAR program (NCT04033445) is a Phase 2b/3, randomized, placebo-controlled trial evaluating TREMFYA in UC patients with inadequate response to conventional therapies, biologics, or JAK inhibitors. It includes induction (IV 200 mg at Weeks 0, 4, 8), maintenance (SC 100 mg q8w or 200 mg q4w), and a 4-year LTE phase assessing efficacy, safety, and biomarkers.
TREMFYA’s Mechanism and Approvals
TREMFYA, a fully human monoclonal antibody, uniquely blocks IL-23 and binds CD64 on IL-23-producing cells, targeting inflammation at its source based on in vitro studies.
It has U.S. FDA and EU approvals for SC/IV induction and SC maintenance in moderate-to-severe UC and Crohn’s disease, plus other indications like plaque psoriasis and psoriatic arthritis.
Dr. Peyrin-Biroulet, Study Investigator, emphasizes ulcerative colitis as a lifelong condition impacting overall health, stressing the need for long-term effective and well-tolerated treatments. He highlights the QUASAR long-term study’s evidence of TREMFYA’s sustained efficacy, consistent results irrespective of prior biologic or JAK inhibitor use, high patient retention, and absence of new safety issues, bolstering confidence in its prolonged application for ulcerative colitis.
Additional J&J Highlights at ECCO
Two J&J abstracts earned Top 10 oral status: Phase 2b ANTHEM-UC (NCT06049017) data on icotrokinra (JNJ-2113), an oral IL-23 receptor blocker reducing UC biomarkers; and UNITI Jr (NCT04673357) safety results for STELARA® (ustekinumab) in pediatric Crohn’s, showing efficacy without new signals. Full details are at JNJ’s gastroenterology page.
These findings reinforce TREMFYA’s role in achieving lasting mucosal healing, reducing flares, steroid use, and surgery risks in UC a chronic inflammatory condition causing diarrhea, bleeding, and fatigue offering hope for long-term management.
Reference
TREMFYA® (guselkumab) long-term data show sustained clinical and endoscopic remission in ulcerative colitis through 3 years, 21 February 2026, TREMFYA® (guselkumab) long-term data show sustained clinical and endoscopic remission in ulcerative colitis through 3 years
A Study of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis (QUASAR), ClinicalTrials.gov ID NCT04033445, https://clinicaltrials.gov/study/NCT04033445
David T Rubin et al, Guselkumab in patients with moderately to severely active ulcerative colitis (QUASAR): phase 3 double-blind, randomised, placebo-controlled induction and maintenance studies, The Lancet, Volume 405, Issue 10472, 2025, Pages 33-49, https://doi.org/10.1016/S0140-6736(24)01927-5