QUASAR LTE Trial Shows Tremfya Produces Sustained Clinical, Endoscopic Remission Through 92 Weeks in Ulcerative Colitis

Credit: Sebastian Kaulitzki | stock.adobe.com

Long-term extension (LTE) data from the Phase IIb/III QUASAR trial (NCT04033445) program show adult patients with moderately to severely active ulcerative colitis (UC) administered Tremfya (guselkumab) achieved significant rates of sustained clinical remission and endoscopic remission 92 weeks. These efficacy findings demonstrated consistency across patients with prior treatment histories, with no new safety signals identified.^1,2

“People living with [UC] seek treatments that both address the challenging symptoms of the disease and provide durable results,” Gary R. Lichtenstein, vice chief, Division of Gastroenterology and Hepatology, Development and Philanthropy at the University of Pennsylvania, said in a press release. “These new data show Tremfya delivers long-term, sustained clinical and endoscopic remission, marking important progress in UC care.”¹

Tremfya was the first FDA-approved, fully-human, dual-acting monoclonal antibody to block interleukin (IL)-23, a significant driver of the pathogenesis of inflammatory diseases.

Tremfya attaches to the p19 subunit of IL-23 and to CD64, a receptor on cells that produce IL-23. The drug is currently indicated to treat adult patients with moderate to severe plaque psoriasis who may benefit from systemic therapy or phototherapy; for adult patients with active psoriatic arthritis; and most recently for adult patients with moderately to severely active UC.³

Data released in October 2024 from the Phase III GALAXI trial (NCT03466411) and the Phase III QUASAR maintenance trial show that Tremfya produced high rates of endoscopic remission in patients with UC and in those with Crohn disease, including among patients who are biologic-naïve and biologic-refractory.⁴

Trial Design

The randomized, double-blind, placebo-controlled, parallel group, multicenter QUASAR program evaluated the efficacy and safety of Tremfya in adults with moderately to severely active UC with a history of inadequate response or intolerance to conventional therapy, biologics, and/or Janus kinase (JAK) inhibitors. The QUASAR program included a Phase IIb dose-ranging induction trial, a confirmatory Phase III induction trial, and a Phase III randomized withdrawal maintenance trial.

Patients enrolled in the induction trial were administered Tremfya 200 mg or placebo via intravenous infusion at weeks zero, four (q4w), and eight (q8w). For the maintenance trial, patients were administered a subcutaneous (SC) maintenance regimen of either Tremfya 100 mg q8w, Tremfya 200 mg q4w, or placebo.

Among 568 patients enrolled in the QUASAR maintenance trial, 42.3% previously showed an inadequate response or intolerance to biologics or JAK inhibitors, 54.4% were biologic or JAK inhibitor naïve, and 3.3% were biologic or JAK inhibitor experienced without a documented history of inadequate response or intolerance. Investigators found that endoscopic remission was achieved by biologic and JAK inhibitor-refractory patients with UC at rates of 31.2% in the Tremfya 100 mg q8w SC injection cohort and 23.9% in the Tremfya 200 mg q4w SC injection cohort, compared with 8% in the placebo cohort.

QUASAR LTE results show that at week 92, 72% of patients administered Tremfya achieved clinical remission and 99% were able to avoid taking corticosteroids for eight weeks or longer through week 92. Further, 43% of patients administered Tremfya achieved endoscopic remission. Of the patients who experienced endoscopic improvement at week 44, 84% were able to maintain this improvement through week 92.

“With these findings, Tremfya shows the powerful impact it can have in achieving longer term remission in patients,” Esi Lamousé-Smith, MD, PhD, vice president, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson Innovative Medicine, said in a press release.¹

References

1. TREMFYA® (guselkumab) delivers sustained clinical and endoscopic remission in ulcerative colitis through two years. News release. Johnson & Johnson. May 5, 2025. Accessed May 5, 2025. https://www.jnj.com/media-center/press-releases/tremfya-guselkumab-delivers-sustained-clinical-and-endoscopic-remission-in-ulcerative-colitis-through-two-years

2. A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis (QUASAR). ClinicalTrials.gov. Updated April 27, 2025. Accessed May 5, 2025. https://clinicaltrials.gov/study/NCT04033445

3. 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. J&J. September 11, 2024. Accessed May 5, 2025. 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

4. TREMFYA® (guselkumab) subcutaneous (SC) induction data support potential to be the first and only in its class to offer the option of both intravenous and SC induction therapy in ulcerative colitis. Johnson & Johnson. News release. February 20, 2025. Accessed May 5, 20. https://www.jnj.com/media-center/press-releases/tremfya-guselkumab-subcutaneous-sc-induction-data-support-potential-to-be-the-first-and-only-in-its-class-to-offer-the-option-of-both-intravenous-and-sc-induction-therapy-in-ulcerative-colitis