FDA Approves Guselkumab for Moderate to Severe Ulcerative Colitis

The US Food and Drug Administration (FDA) announced September 11 that it has expanded the approved indications for guselkumab to include moderately to severely active ulcerative colitis (UC).

Guselkumab is approved for plaque psoriasis and psoriatic arthritis and under evaluation for use in the treatment of Crohn’s disease.

The agency action is based on data from the pivotal Phase 2b/3 QUASAR study, which evaluated the efficacy and safety of guselkumab in adult patients with moderately to severely active UC who did not adequately respond to or showed intolerance of other therapies, including biologics and Janus kinase inhibitors.  

Half of patients who received guselkumab 200 mg subcutaneous (SC) maintenance every 4 weeks (q4w) and 45% of patients treated with guselkumab 100 mg SC every 8 weeks (q8w) achieved the primary endpoint of clinical remission at week 44, compared to 19% of placebo-treated patients (p<0.001).

David T. Rubin, MD, director of the Inflammatory Bowel Disease Center at University of Chicago Medicine and lead investigator for the QUASAR study, noted in his presentation on the maintenance phase at Digestive Disease Week that “secondary outcomes, all of which were met by the guselkumab-treated patients compared to placebo patients, included very nice results with endoscopic response defined by a Mayo score of 0 or 1, as well as the endoscopic remission of a Mayo score of 0—which is a stringent definition where essentially the bowel is completely healed—of 34% in both treatment arms.”

The induction dosing for guselkumab to treat UC is 200 mg administered intravenously at weeks 0, 4 and 8. The recommended maintenance dosage is 100 mg administered by subcutaneous 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 SC maintenance dose can be self-administered by the patient or administered by a caregiver. 

This therapy was safe and well tolerated, Dr Rubin added, with a similar safety profile to that of other IL-23 inhibitors. The most common adverse reactions among patients with UC who received guselkumab in the induction study were respiratory tract infections (>2%) .  The most common adverse reactions (>3%) among patients in the maintenance study were injection site reactions, arthralgia, and upper respiratory tract infection.

See Dr Rubin’s recap of his presentation on the QUASAR maintenance study here.

Reference:

TREMFYA^® (guselkumab) receives U.S. FDA approval for adults with moderately to severely active ulcerative colitis, strengthening Johnson & Johnson’s leadership in inflammatory bowel disease. Press release. Johnson & Johnson; September 11, 2024.  Accessed September 12, 2024. https://www.jnj.com/media-center/press-releases/tremfya-guselkumab-receives-u-s-fda-approval-for-adults-with-moderately-to-severely-active-ulcerative-colitis-strengthening-johnson-johnsons-leadership-in-inflammatory-bowel-disease