Tremfya® Maintains Long-Term Clinical and Endoscopic Remission in Ulcerative Colitis Patients

Tremfya® Shines in Long-term Ulcerative Colitis Study

On May 5, 2025, Johnson & Johnson (J&J) announced promising results from the long-term extension study (QUASAR) of Tremfya® (guselkumab), targeting adults with moderately to severely active ulcerative colitis. The results reveal that over a period extending to 92 weeks, the drug maintained clinical and endoscopic remission in a significant proportion of participants.

Overview of Tremfya®

Tremfya® is a dual-acting, fully human monoclonal antibody that inhibits IL-23, a cytokine playing a critical role in inflammatory diseases, including ulcerative colitis. By binding to the p19 subunit of IL-23 as well as CD64, which is expressed on cells that produce IL-23, Tremfya® effectively neutralizes the overactive immune response typical in such conditions.

In the QUASAR LTE study, the clinical remission rate at week 92 was reported at more than 70%, with over 40% of patients also achieving endoscopic remission. Remarkably, among those achieving endoscopic improvement at week 44, 84% maintained this improvement through week 92. This consistent efficacy, irrespective of prior treatments like biological therapies or JAK inhibitors, suggests a robust profile for Tremfya®.

Expert Insights

Dr. Gary R. Lichtenstein from the University of Pennsylvania emphasized the urgent need for effective treatments that can provide sustained relief for ulcerative colitis patients. The data highlighting Tremfya®'s long-term effectiveness marks a significant advancement in the treatment landscape for this challenging condition, offering hope for sustained health and quality of life.

Esi Lamousé-Smith, M.D., Ph.D., VP of J&J Innovative Medicine, also remarked on the data's implications for establishing new treatment standards in managing inflammatory bowel diseases.

Safety Profile

The safety data from the study align with the previously established safety profile of Tremfya® in inflammatory bowel disease, with no new concerns arising. This consistency further solidifies confidence in the drug’s utility in long-term management.

Regulatory Approvals and Future Directions

Tremfya® received FDA approval in September 2024 for treating moderate to severe active ulcerative colitis in adults. Following this, J&J made submissions for alternative dosing methods, indicating an ongoing commitment to accessible treatment options. By November 2024, a supplemental application for subcutaneous administration was filed for FDA review, alongside approvals for managing moderate to severe Crohn's disease expected by March 2025.

Conclusion

The QUASAR long-term extension trial underlines Tremfya®'s potential as a cornerstone of treatment for ulcerative colitis, demonstrating substantial clinical and endoscopic remission rates. The findings presented highlight a progressive step toward enhanced standard care options for patients suffering from this debilitating condition.

For further details on the QUASAR study and its findings, visit J&J’s immunology news portal.