Tremfya® Receives Approval for Treating Moderate to Severe Ulcerative Colitis with Subcutaneous Injection

Tremfya® Approved for Subcutaneous Treatment of UC

On October 19, Johnson & Johnson, also known as Janssen Pharmaceutical K.K., announced that Tremfya® (generic name: Guselkumab) has received approval for a change in manufacturing and sales approval. This approval allows Tremfya® to be used for the induction therapy of moderate to severe ulcerative colitis (UC) patients who have not responded adequately to existing treatments.

Tremfya® is the first IL-23p19 inhibitor that offers subcutaneous administration for the induction and maintenance therapy of both UC and Crohn's Disease (CD). The approval is based on the results of the Phase III treat-through ASTRO trial (NCT05528510), which assessed the efficacy and safety of Tremfya® in patients with moderate to severe active UC who have previously shown inadequate response or poor tolerance to conventional therapies, including thiopurines, steroids, biological products (TNF-alpha inhibitors, Vedolizumab), and/or JAK inhibitors (tofacitinib).

Clinical Trials and Efficacy Findings

The ASTRO trial demonstrated a statistically significant improvement compared to a placebo, with greater clinical remission rates and endoscopic improvements observed at 12 weeks. For patients receiving Tremfya® through subcutaneous injection, the clinical remission rates were 28% for Tremfya® compared to 6% for the placebo (p<0.001), along with an endoscopic improvement rate of 37% versus 13% (p<0.001). Additionally, the percentage of patients achieving histologic-endoscopic mucosal improvement (HEMI) was 30% in the Tremfya® group compared to 11% in the placebo group.

Notably, benefits were observed as early as two weeks after administration, with sustained effects lasting to 24 weeks. The consistency of the results aligns with findings from previous intravenous administration studies, confirming the efficacy of both subcutaneous and intravenous routes for severe or refractory patients.

Expert Opinions on Approval

Professor Riichi Hisamatsu from Kyorin University, who served as the principal investigator for the trial, highlighted the significance of this approval, stating, "The introduction of subcutaneous therapy with Tremfya® provides a new treatment option, showcasing a consistent safety and efficacy profile compared to previous intravenous administration trials. Having both subcutaneous and intravenous options is beneficial for patients and eases the burden on healthcare providers."

According to Chris Rieger, the President of Johnson & Johnson Innovative Medicine Japan, this approval represents a vital milestone not only for UC treatment but also for the management of chronic immune-mediated diseases. He emphasized the need for flexible treatment options that allow patients to maintain their academic and professional commitments while managing their health challenges.

In Japan, it is estimated that about 310,000 individuals live with UC, and the number continues to rise. As an intractable designated disease in Japan, the approval of Tremfya® is expected to alleviate the growing burden of UC among patients, offering a potentially significant improvement in quality of life.

Background of Tremfya®

Tremfya® was developed by Johnson & Johnson and represents the first fully human monoclonal antibody specifically targeting the p19 subunit of IL-23. With its dual-action ability to bind and capture IL-23, Tremfya® stands out as a significant innovation in the field of autoimmune diseases. This product has already received approval in various countries, including the U.S. and Canada, for treating conditions like psoriasis, psoriatic arthritis, and now UC and CD in Japan.

As Johnson & Johnson continues to lead health care innovation through its medical expertise in Immunology and MedTech, the company aims to create advancements that address complex diseases and significantly improve patient outcomes.

Conclusion

The recent approval of Tremfya® showcases ongoing efforts to innovate and improve the lives of individuals living with ulcerative colitis. Moving forward, it is expected that Tremfya® will play a critical role in combining effective treatment with the necessity of maintaining daily life, ultimately enhancing patient care in this challenging domain.

For further details on Tremfya®, please visit Johnson & Johnson Innovative Medicine Japan.