ASTRO Trial Shows SC Tremfya Provides Significant Clinical Benefits in Moderately to Severely Active Ulcerative Colitis
Tremfya could become the first IL-23 inhibitor with fully subcutaneous induction and maintenance options in the treatment of moderately to severely active ulcerative colitis.
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Results from the Phase III ASTRO trial (NCT05528510) found that treatment with subcutaneous (SC) Tremfya (guselkumab; Johnson & Johnson) produced a significant improvement in clinical and endoscopic outcomes among adult patients with moderately to severely active ulcerative colitis (UC).1,2 These results follow data from the Phase III QUASAR maintenance trial (NCT04033445), which found that intravenous (IV) Tremfya produced high rates of endoscopic remission in patients with UC.3
“The week 12 results from the ASTRO study build on data from the QUASAR study demonstrating that both guselkumab SC and IV induction achieved clinically differentiated results in patients with moderately to severely active UC,” trial investigator Laurent Peyrin-Biroulet, MD, PhD, head of the Inflammatory Bowel Disease Unit at Nancy University Hospital in France, said in a press release. “The flexibility of a fully SC treatment regimen would be a welcome option for many patients, especially those with busy and active lifestyles.”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—by attaching to the p19 subunit of IL-23 and to CD64, a receptor on cells that produce IL-23. Tremfya 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.4
Trial Design
The randomized, double-blind, placebo-controlled, parallel-group, multicenter, treat-through ASTRO trial analyzed the efficacy and safety of Tremfya in adults with moderately to severely active UC who previously had an inadequate response or intolerance to conventional therapy, prior treatment with biologics, and/or ozanimod or Janus kinase (JAK) inhibitors.
A total of 418 patients were randomly assigned in a 1:1:1 ratio to receive Tremfya at a dose of 400 mg via SC induction at weeks zero, four, and eight, followed by Tremfya 200 mg SC every four weeks; or Tremfya 400 mg SC induction at weeks zero, four, and eight followed by Tremfya 100 mg SC every eight weeks; or placebo.
The regimen of maintenance doses administered in the ASTRO trial matched the dosing levels in the QUASAR trial that demonstrated the efficacy and safety of IV Tremfya followed by SC maintenance in this patient population.
Results show that at 12 weeks of treatment, 27.6% of patients administered Tremfya 400 mg SC induction achieved clinical remission, 65.6% achieved a clinical response, and 37.3% achieved endoscopic improvementcompared to 6.5%, 34.5%, and 12.9%, respectively, of patients administered placebo.
Investigators also conducted prespecified analyses of patient subpopulations defined by prior advanced therapy treatment status, which found that those administered Tremfya showed statistically significant outcomes across endpoints for both biologic- and JAK inhibitor-naïve patients and biologic- and JAK inhibitor-refractory patients.
“We aim to offer treatment options for patients with IBD that allow them to effectively manage their disease while also meeting the daily demands of life. These results further underscore the potential of Tremfya to transform the UC treatment paradigm,” Esi Lamousé-Smith, MD, PhD, vice president, Gastroenterology Disease Area lead, Immunology, Johnson & Johnson Innovative Medicine, said in the release. “Pending approval, Tremfya would be the first IL-23 inhibitor with a fully SC induction and maintenance regimen, increasing options for both patients and healthcare providers.”1
References
1. 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 February 21, 2025. 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
2. A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (ASTRO). ClinicalTrials.gov. February 3, 2025. Accessed February 21, 2025. https://clinicaltrials.gov/study/NCT05528510?term=astro&intr=guselkumab&rank=1
3. TREMFYA® (guselkumab) demonstrates impressive results across biologic-naïve and biologic-refractory patients in Crohn’s disease and ulcerative colitis. News release. Johnson & Johnson. October 10, 2024. Accessed February 21, 2025. https://www.jnj.com/media-center/press-releases/tremfya-guselkumab-demonstrates-impressive-results-across-biologic-naive-and-biologic-refractory-patients-in-crohns-disease-and-ulcerative-colitis.
4. 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 February 21, 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
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