Johnson & Johnson (NYSE:JNJ) has announced new long‑term data from the QUASAR LTE study, showing that TREMFYA® (guselkumab) sustained clinical, endoscopic, and histologic outcomes through Week 140 in adults with moderately to severely active ulcerative colitis. More than 80% of patients were in clinical remission, over 50% achieved endoscopic remission, and nearly 79% showed histo‑endoscopic mucosal improvement.
Study Findings
- Clinical remission: 80.8% of patients at Week 140.
- Endoscopic remission: 53.6% of patients.
- Histo‑endoscopic mucosal improvement: 78.6% of patients.
- Retention: 89% of eligible participants completed treatment through Week 140.
- Nearly all patients in remission were corticosteroid‑free for at least eight weeks.
The study confirmed durable efficacy regardless of prior biologic or JAK inhibitor treatment history, with no new safety concerns observed.
Expert Commentary
Dr. Laurent Peyrin‑Biroulet, study investigator, said the results demonstrate TREMFYA’s ability to deliver durable outcomes with consistent efficacy across patient groups. Esi Lamousé‑Smith, Vice President and Gastroenterology Disease Area Lead at Johnson & Johnson, emphasized that patients achieving endoscopic remission experience fewer flare‑ups and reduced need for steroids or surgery.
Mechanism and Approvals
TREMFYA® is the first dual‑acting monoclonal antibody that blocks IL‑23 and binds to CD64, targeting cells that produce IL‑23. It is FDA‑approved for adults with ulcerative colitis and Crohn’s disease, with both IV induction and SC maintenance options. The European Commission has also approved TREMFYA® for ulcerative colitis.
About Johnson & Johnson
Johnson & Johnson (NYSE:JNJ) is a global healthcare leader innovating across medicine and MedTech to prevent, treat, and cure complex diseases. The company develops therapies in immunology, oncology, neuroscience, and other areas, aiming to deliver breakthroughs that improve health worldwide. Learn more at jnj.com
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