TREMFYA® Shows Sustained Remission in Ulcerative Colitis Through Week 140
Long-term data from the QUASAR extension study show TREMFYA® maintained clinical remission in over 80% of ulcerative colitis patients at Week 140, with more than half achieving endoscopic remission and no new safety concerns observed.
Johnson & Johnson announced new long-term data from the QUASAR long-term extension study showing that TREMFYA® (guselkumab) sustained clinical, endoscopic, and histologic outcomes through Week 140 in adults with moderately to severely active ulcerative colitis. The data were presented at the European Crohn's and Colitis Organisation (ECCO) 2026 conference on February 21, 2026.
At Week 140, 80.8% of patients taking TREMFYA® were in clinical remission, defined as a Mayo stool frequency subscore of 0 or 1 and not increased from induction baseline, a Mayo rectal bleeding subscore of 0, and a Mayo endoscopic subscore of 0 or 1. Additionally, 78.6% of patients achieved histo-endoscopic mucosal improvement, and 53.6% of patients were in endoscopic remission. Approximately 89% of eligible study participants combined completed treatment through Week 140. Nearly all participants who achieved clinical remission at Week 140 were corticosteroid-free for at least eight weeks.
The study also showed that of those in clinical remission at Week 44, 87.5% maintained clinical remission through Week 140. Efficacy was sustained regardless of prior biologic and/or JAK inhibitor treatment history, and no new safety concerns were observed.
Histo-endoscopic mucosal improvement was defined as a combination of endoscopic improvement and histologic improvement, with neutrophil infiltration in less than 5% of crypts, no crypts destruction, and no erosions, ulcerations or granulation tissue according to the Geboes grading system. Endoscopic remission was defined as a Mayo endoscopic subscore of 0.
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. Findings are based on in vitro studies.
TREMFYA® has received U.S. Food and Drug Administration and European Commission approval for both subcutaneous and intravenous induction options for the treatment of adults with moderately to severely active Crohn's disease and U.S. FDA approval for both subcutaneous and intravenous induction options for the treatment of adults with moderately to severely active ulcerative colitis. TREMFYA® is approved by the European Commission for the treatment of adult patients with moderately to severely active ulcerative colitis and is currently administered via an intravenous induction regimen, followed by a subcutaneous maintenance regimen.
Two other Johnson & Johnson-sponsored abstracts were selected as Top 10 oral abstracts by ECCO. Results from the Phase 2b ANTHEM-UC study of icotrokinra, the first targeted oral peptide that selectively blocks the interleukin-23 receptor, demonstrated its impact on systemic and tissue biomarkers of inflammatory burden in ulcerative colitis. Primary safety results from the UNITI Jr study of STELARA® (ustekinumab) showed that it was effective and well-tolerated, with no new safety signals, in treating pediatric patients with Crohn's disease.