According to the Zhitong Finance APP, Johnson & Johnson (JNJ.US) recently announced positive results from the GRAVITI Phase 3 clinical study of its white blood cell interleukin-23 (IL-23) targeting antibody Tremfya (guselkumab). The study results showed that at 48 weeks, 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.

It is understood that GRAVITI is a randomized, double-blind, placebo-controlled Phase 3 study designed to evaluate the efficacy and safety of subcutaneous injection of Tremfya in patients with moderate to severe active Crohn's disease. These patients had inadequate response or intolerance to conventional treatments (such as corticosteroids or immunomodulators) or biological products (TNF antagonists or vedolizumab).

Patients received 400 mg of Tremfya induction therapy at weeks 0, 4, and 8, followed by maintenance therapy with 200 mg of Tremfya every 4 weeks (q4w), 100 mg of Tremfya every 8 weeks (q8w), or placebo. The subcutaneous injection results of the GRAVITI study at 48 weeks are as follows:

The clinical remission rate of patients using two maintenance doses of Tremfya was more than three times that of the placebo group. The clinical remission rate of the Tremfya q8w group was 60.0%, the q4w group was 66.1%, and the placebo group was 17.1%.

In terms of endoscopic response, 44.3% and 51.3% of patients in the Tremfya q8w and q4w groups, respectively, achieved endoscopic response, while the placebo group was only 6.8%.

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

Tremfya is a fully human monoclonal antibody. In addition to targeting IL-23, the antibody can also simultaneously bind to the receptor CD64 on cells producing IL-23. IL-23 is a cell factor secreted by activated monocytes/macrophages and dendritic cells, and is a driving factor for immune-mediated diseases such as UC. Tremfya was first approved by the FDA in July 2017 for the treatment of moderate to severe plaque psoriasis in adult patients, and later in July 2020 for the treatment of active psoriatic arthritis in adult patients. In June 2024, johnson & johnson submitted a supplemental biological product license application (sBLA) to the FDA seeking approval for Tremfya in the treatment of moderate to severe active Crohn's disease in adult patients. In September of this year, Tremfya was approved by the FDA for the treatment of moderate to severe active ulcerative colitis (UC) in adult patients. It is reported that Tremfya is the first approved dual-action IL-23 inhibitor for the treatment of active ulcerative colitis.