Data From Phase 3 QUASAR Long-term Extension (LTE) Study Shows TREMFYA® (guselkumab) Maintains Sustained Remission in Ulcerative Colitis

Johnson & Johnson today announced significant long-term findings from the Phase 3 QUASAR study program, demonstrating that TREMFYA® (guselkumab) delivered sustained rates of clinical remission and endoscopic improvement in adult patients with moderately to severely active ulcerative colitis (UC) through two years of continuous treatment. These compelling results underscore the potential of TREMFYA® as a durable long-term treatment option for this chronic condition.

Advertisement

Data From the QUASAR LTE Study

By Week 92, 72% of patients were in clinical remission, and 99% of those patients had been free of corticosteroids for eight weeks or longer. Endoscopic remission was seen in 43% of the patients.
Eighty-four percent of patients who had endoscopic improvement at Week 44 continued to have it through Week 92.

People living with ulcerative colitis seek treatments that both address the challenging symptoms of the disease and provide durable results,

These new data show TREMFYA delivers long-term, sustained clinical and endoscopic remission, marking important progress in UC care.

Gary R. Lichtenstein

With these findings, TREMFYA shows the powerful impact it can have in achieving longer term remission in patients,

Advertisement

This is a significant step forward in our mission to reshape the standard of care in inflammatory bowel disease.

Esi Lamousé-Smith

TREMFYA® is now taken via an IV induction regimen followed by a SC maintenance regimen. The FDA approved the medication in September 2024 for the treatment of adult patients with moderately to severely active UC. A supplemental biologics license application (sBLA) was filed with the FDA in November 2024 to request approval of a TREMFYA® SC induction regimen for the treatment of people with moderately to severely active ulcerative colitis. Additionally, in March 2025, the FDA authorized TREMFYA® for SC and IV induction options for people with moderately to severely active Crohn’s disease (CD).

Also Read:  Johnson & Johnson's IMAAVY™ (nipocalimab-aahu) Receives U.S. FDA Approval, a Novel FcRn Blocker for Generalized Myasthenia Gravis Patients

Last Modified:

Athulya B S

Next Post

Elecsys PRO-C3: Roche's Precision Test for Liver Fibrosis

Tue May 6 , 2025
One of the most prevalent causes of chronic liver disease in the developed world, MASLD affects about 30% of the population.
Roche

Related Articles