New J&J data signals progress in ulcerative colitis treatment landscape

New clinical findings show that Johnson & Johnson’s monoclonal antibody Tremfya ^® (guselkumab) enabled sustained clinical and endoscopic efficacy for ulcerative colitis patients at two years.

This is based on the long-term extension study of the Phase III QUASAR trial, which evaluated adults with moderately-to-severely active forms of the disease.

At Week 92, Tremfya enabled:

• Clinical remission in 72 percent of patients
• Of these patients, 99 percent were not taking corticosteroid treatment for eight weeks or longer
• Endoscopic remission in 43 percent of patients in the long-term extension study
• Of patients who attained an improved endoscopic result at Week 44, 84 percent were able to maintain this through Week 92.

Tremfya is the first approved dual-acting monoclonal antibody that blocks the cytokine IL-23 while simultaneously binding to CD64, a receptor that produces IL-23, Johnson & Johnson shared.

“With these findings, Tremfya shows the powerful impact it can have in achieving longer term remission in [ulcerative colitis] patients,” commented Dr Esi Lamousé-Smith, PhD, Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson Innovative Medicine.

Safety data were consistent with the previous reported safety profile for Tremfya in inflammatory bowel disease (IBD).

The new findings are being shown at Digestive Disease Week (DDW) 2025 (presentation #4241842).

Building on clinical evidence for Tremfya in ulcerative colitis and Crohn’s disease

This new data adds to earlier clinical results released in May 2024 from a maintenance study of Tremfya in ulcerative colitis.

The US Food and Drug Administration (FDA) most recently approved Tremfya in March 2025 for adult patients with Crohn’s disease, for subcutaneous and intravenous induction administration options.

In October last year, Johnson & Johnson presented promising Phase III data for the monoclonal antibody in Crohn’s disease at the American College of Gastroenterology (ACG) 2024 conference.

In September 2024, the US FDA granted approval for intravenous administration of the drug in adults with ulcerative colitis. This indication consists of follow up subcutaneous maintenance treatment.