J&J Reports Positive Phase 3 ASTRO Results for Tremfya in Ulcerative Colitis

"Johnson & Johnson (J&J) announced data from the phase 3 ASTRO study of Tremfya (guselkumab) subcutaneous (SC) induction therapy in adults with moderately to severely active ulcerative colitis (UC) at the 20th Congress of the European Crohn's and Colitis Organization (ECCO). Study findings through Week 12 showed statistically significant and clinically meaningful improvements compared to placebo across all clinical and endoscopic measures consistent with the US Food and Drug Administration (FDA)-approved intravenous (IV) induction regimen in this population.

""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,"" said Laurent Peyrin-Biroulet, M.D., Ph.D., head of the inflammatory bowel disease (IBD) Unit at Nancy University Hospital in France and study investigator. ""The flexibility of a fully SC treatment regimen would be a welcome option for many patients, especially those with busy and active lifestyles.""

At Week 12, significantly greater proportions of patients treated with Tremfya 400 mg SC induction compared with patients receiving placebo achieved all of the following multiplicity-controlled endpoints:

•    Clinical remission (27.6% vs 6.5%; P<0.001)
•    Clinical response (65.6% vs 34.5%; P<0.001)
•    Endoscopic improvement (37.3% vs 12.9%; P<0.001)

In prespecified analyses of subpopulations defined by prior advanced therapy treatment status, Tremfya demonstrated statistically significant results across endpoints in both biologic and JAK inhibitor-naïve and biologic and JAK inhibitor-refractory patients.   

Safety data from the ASTRO study were consistent with the well-established safety profile of Tremfya. The proportions of patients with =1 adverse event (AE), serious AE, or AE leading to treatment discontinuation were similar across the Tremfya and placebo treatment groups.

""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,"" said Esi Lamousé-Smith, M.D., Ph.D., vice president, gastroenterology disease area lead, immunology, Johnson & Johnson Innovative Medicine. ""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.""

Tremfya is the first and only approved fully-human, dual-acting monoclonal antibody that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including UC.

Applications seeking approval of Tremfya for both UC and Crohn's disease (CD) have been submitted in Europe. Tremfya received FDA approval in September 2024 for the treatment of adult patients with moderately to severely active UC and is currently administered via an IV induction regimen, followed by a SC maintenance regimen. In November 2024, a supplemental Biologics License Application (sBLA) was submitted to the FDA seeking approval of a SC induction regimen of Tremfya for the treatment of adults with moderately to severely active UC. An application for the treatment of adults with moderately to severely active CD has also been submitted in the US.

ASTRO is a randomized, double-blind, placebo-controlled, parallel-group, multicenter, treat-through phase 3 study designed to evaluate the efficacy and safety of Tremfya SC induction therapy (400 mg at Weeks 0, 4, and 8) in adults with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to conventional therapy (e.g., thiopurines or corticosteroids), prior biologics (TNF antagonists or vedolizumab) and/or ozanimod or approved JAK inhibitors. Patients (n = 418) were randomized 1:1:1 to receive Tremfya 400 mg SC induction at Weeks 0, 4 and 8 followed by Tremfya 200 mg SC every 4 weeks (q4w); or Tremfya 400 mg SC induction at Weeks 0, 4 and 8, followed by Tremfya 100 mg SC every 8 weeks (q8w); or placebo. The maintenance dose regimens in ASTRO (200 mg SC q4w and 100 mg SC q8w) are the same as those evaluated in the phase 3 QUASAR programme which established the efficacy and safety profile of IV induction followed by SC maintenance therapy in patients with moderate to severely active UC.

QUASAR is a randomized, double-blind, placebo-controlled, parallel group, multicenter, phase 2b/3 programme designed to evaluate the efficacy and safety of Tremfya in adults with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to conventional therapy (e.g., thiopurines or corticosteroids), prior biologics (TNF antagonists or vedolizumab) and/or JAK inhibitors (tofacitinib). QUASAR included a phase 2b dose-ranging induction study, a confirmatory phase 3 induction study, and a phase 3 randomized withdrawal maintenance study. In the phase 3 induction study, patients received either Tremfya 200 mg or placebo by IV infusion at Weeks 0, 4, and 8. In the phase 3 maintenance study, patients received a SC maintenance regimen of either Tremfya 200 mg q4w, Tremfya 100 mg q8w, or placebo.

Ulcerative colitis (UC) is a chronic disease of the large intestine, also known as the colon, in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers, that produce pus and mucus. It is the result of the immune system's overactive response. Symptoms vary but may typically include loose and more urgent bowel movements, rectal bleeding or bloody stool, persistent diarrhoea, abdominal pain, loss of appetite, weight loss, and fatigue.   

Crohn's disease is one of the two main forms of inflammatory bowel disease, which affects an estimated three million Americans. Crohn's disease is a chronic inflammatory condition of the gastrointestinal tract with no known cause, but the disease is associated with abnormalities of the immune system that could be triggered by a genetic predisposition, diet, or other environmental factors. Symptoms of Crohn's disease can vary, but often include abdominal pain and tenderness, frequent diarrhoea, rectal bleeding, weight loss, and fever.

Developed by Johnson & Johnson, Tremfya is the first approved fully-human, dual-acting monoclonal antibody designed to neutralize inflammation at the cellular source by blocking IL-23 and binding to CD64 (a receptor on cell that produce IL-23). Findings for dual-acting are limited to in vitro studies that demonstrate guselkumab binds to CD64, which is expressed on the surface of IL-23 producing cells in an inflammatory monocyte model. The clinical significance of this finding is not known.

Tremfya is a prescription medicine approved in the US to treat: adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light); adults with active psoriatic arthritis.
adults with moderately to severely active ulcerative colitis.

Tremfya is approved Europe, Canada, Japan, and a number of other countries for the treatment of adults with moderate-to-severe plaque psoriasis and for the treatment of adults with active psoriatic arthritis.

Johnson & Johnson maintains exclusive worldwide marketing rights to Tremfya.

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