▎WuXiEdited by Kant Content Team

Recently, Johnson & Johnson announced itsInterleukin-23 (IL-23) TargetingPositive Results of Antibody Tremfya (Guselkumab) in GRAVITI Phase 3 Clinical Study. The study results show,At week 48, adult patients with moderate to severe active Crohn's disease (CD) who received Tremfya as induction and maintenance therapy achieved significant clinical remission and endoscopic response compared to placebo.

GRAVITI is a randomized, double-blind, placebo-controlled Phase 3 study designed to evaluate the efficacy and safety of subcutaneous Tremfya in patients with moderate to severe active Crohn's disease who have had an inadequate response or intolerance to conventional therapies (such as corticosteroids or immunomodulators) or biologics (TNF antagonists or vedolizumab).

The patient received 400 mg at weeks 0, 4, and 8.TremfyaInductionTreatment, followed by acceptance200 mg every 4 weeksTremfya(q4w), 100 mg every 8 weeksTremfya（q8w）Or placebo as maintenance treatment.Results of the GRAVITI study at 48 weeks of subcutaneous injection are as follows:

• Use of Two Maintenance DosesTremfyaThe clinical remission rate of patients was more than three times that of the placebo group.Tremfya Q8W GroupClinical Remission RateThe rate was 60.0% in the q4w group, 66.1% in the q4w group, and 17.1% in the placebo group.

• In terms of endoscopic response, 44.3% and 51.3% of patients in the Tremfya q8w group and q4w group, respectively, achieved endoscopic response, compared to only 6.8% in the placebo group.

• In terms of endoscopic remission, 30.4% and 38.3% of patients in the Tremfya q8w and q4w groups, respectively, achieved endoscopic remission, compared to only 6.0% in the placebo group.

Tremfya is a fully human monoclonal antibody. In addition to targetingIL-23, this antibody can also simultaneously bind to the receptor CD64 on IL-23-producing cells.IL-23 is a cytokine secreted by activated monocytes/macrophages and dendritic cells, and is a driving factor in immune-mediated diseases such as UC. Tremfya was first approved by the FDA in July 2017 for the treatment of moderate to severePlaque PsoriasisAdult patients, subsequently approved in July 2020 for the treatment of activePsoriatic ArthritisAdult patients. In June 2024, Johnson & Johnson submitted a supplemental Biologics License Application (sBLA) to the U.S. FDA, seeking approval for Tremfya to treat moderate to severe activeCrohn's DiseaseAdult patients. In September this year, Tremfya was approved.FDA ApprovalFor the treatment of moderate to severe activeUlcerative Colitis (UC)Adult patients. According to the press release,Tremfya is the first dual-mechanism IL-23 inhibitor approved for the treatment of active ulcerative colitis.

References:

[1] TREMFYA® (guselkumab) is the first and only IL-23 inhibitor to demonstrate robust results with a fully subcutaneous regimen in both induction and maintenance in Crohn's disease. Retrieved October 29, 2024 from https://www.investor.jnj.com/news/news-details/2024/TREMFYA-guselkumab-is-the-first-and-only-IL-23-inhibitor-to-demonstrate-robust-results-with-a-fully-subcutaneous-regimen-in-both-induction-and-maintenance-in-Crohns-disease/default.aspx

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