Tremfya (Guselkumab) Approved by FDA for Ulcerative Colitis Treatment
Key Insights
The FDA has approved Tremfya (guselkumab) for treating adults with moderately to severely active ulcerative colitis (search), marking a new treatment option.
Tremfya is the first and only approved fully-human, dual-acting monoclonal antibody that blocks IL-23 (search) while also binding to CD64 (search).
Clinical trials showed significant improvements in clinical remission and endoscopic remission compared to placebo, supporting the approval.
Johnson & Johnson's Tremfya (guselkumab) has received FDA approval for the treatment of adults with moderately to severely active ulcerative colitis (search) (UC). This marks a significant advancement in the treatment landscape for UC, a chronic inflammatory bowel disease affecting over one million people in the U.S.
Tremfya is the first and only approved fully-human, dual-acting monoclonal antibody that selectively blocks interleukin-23 (IL-23 (search)) while also binding to CD64 (search), a receptor on cells that produce IL-23. IL-23 is a cytokine known to drive immune-mediated diseases, including UC.
Clinical Trial Data
The approval is based on data from the Phase 2b/3 QUASAR study, which evaluated the efficacy and safety of Tremfya in adult patients with moderately to severely active UC who had an inadequate response or intolerance to conventional therapy, biologics, and/or JAK inhibitors. Key findings from the QUASAR study include:
- Clinical Remission: 50% of patients receiving Tremfya 200 mg subcutaneous (SC) maintenance every four weeks and 45% of patients receiving Tremfya 100 mg SC every eight weeks achieved the primary endpoint of clinical remission at week 44, compared to 19% of placebo-treated patients (p<0.001).
- Endoscopic Remission: 34% (200 mg) and 35% (100 mg) of patients achieved endoscopic remission at one year with Tremfya SC maintenance therapy compared to 15% of placebo-treated patients (p<0.001).
"Treatment with Tremfya resulted in significant improvement in the chronic symptoms of ulcerative colitis (search), and importantly, normalization in the endoscopic appearance of the intestinal lining," said David T. Rubin, MD, Director, Inflammatory Bowel Disease Center, University of Chicago Medicine, and lead investigator for the QUASAR program.
Dosage and Administration
For the treatment of UC, Tremfya is administered as a 200 mg induction dose intravenously at weeks zero, four, and eight by a healthcare professional. The recommended maintenance dosage is 100 mg administered by SC injection at week 16, and every 8 weeks thereafter, or 200 mg administered by SC injection at week 12, and every 4 weeks thereafter. The subcutaneous maintenance dose can be self-administered by the patient or administered by a caregiver after proper training.
Safety Profile
The QUASAR results reinforced the well-established safety profile of Tremfya, including in the treatment of patients with UC. The most common adverse reactions (>2%) in patients with UC who received Tremfya in the induction study were respiratory tract infections. In the maintenance study, the most common adverse reactions (>3%) were injection site reactions, arthralgia, and upper respiratory tract infection.
Ulcerative Colitis: A Significant Unmet Need
Ulcerative colitis (search) is a form of inflammatory bowel disease (IBD) characterized by inflammation and damage to the colon lining. Patients experience symptoms such as frequent bowel movements, rectal bleeding, abdominal pain, and fatigue. More than one million people in the U.S. are living with UC, and the prevalence continues to rise.
"There is a significant need for new UC therapies that offer meaningful improvements in symptoms and the promise of remission, both overall clinical remission as well as delivering visible healing of the colon through endoscopic remission," said Christopher Gasink, MD, Vice President, Medical Affairs, Gastroenterology & Autoantibody, Johnson & Johnson Innovative Medicine.
Future Directions
Johnson & Johnson submitted a supplemental Biologics License Application (sBLA) to the FDA seeking approval of Tremfya for the treatment of adult patients with moderately to severely active Crohn’s disease (search) in June 2024.