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Tremfya®: A New Hope for Ulcerative Colitis Patients in Japan

On May 21, 2025, Johnson & Johnson, through its subsidiary Janssen Pharmaceutical K.K., announced the release of Tremfya® (guselkumab), a groundbreaking treatment for moderately to severely active ulcerative colitis (UC). This marks a significant achievement in the healthcare landscape, as Tremfya® is the first and only dual-acting IL-23p19 inhibitor approved for this condition in Japan.

Overview of Tremfya®

Tremfya® is available in different formulations, including:

• - Tremfya® IV Injection (200 mg): for induction of remission in moderate to severe UC patients where existing treatments have proven inadequate.
• - Tremfya® Subcutaneous Injection (200 mg): available in both syringe and pen forms, used for the maintenance therapy of moderate to severe UC under the same conditions.

According to results from the QUASAR study, after one year of treatment with Tremfya®, the endoscopic remission rate stands impressively at 34-35%, illustrating its efficacy in managing this challenging condition.

Clinical Evidence

The QUASAR trial, a pivotal Phase IIb/III study, evaluated Tremfya®'s safety and effectiveness in patients who had not responded well to existing treatments, including corticosteroids and other biologic therapies. Long-term data showed that by week 92, 72% of participants achieved clinical remission, while 43% reached endoscopic remission. These results were announced during the Digestive Disease Week (DDW) 2025, illustrating the promising long-term effects of this innovative therapy.

Tremfya® operates through a unique mechanism by not only inhibiting IL-23 but also binding to CD64, a receptor on inflammatory monocytes, thus capturing the produced IL-23. This dual action could potentially enhance its therapeutic benefits, making it a game-changer for patients with UC who often experience cycles of flare-ups and remission.

The Need for Effective Treatment

Ulcerative colitis is a chronic inflammatory bowel disease characterized by inflammation of the colon's mucosal layer, leading to various symptoms like rectal bleeding, persistent diarrhea, abdominal pain, and fatigue. The unpredictable nature of UC necessitates a robust treatment approach, as current therapies sometimes fail to bring about the desired outcomes. With an estimated 220,000 patients in Japan struggling with UC, the release of Tremfya® is a timely addition to therapeutic options available for these individuals.

Insights from Leaders at J&J

Shuhei Sekiguchi, President of Johnson & Johnson Innovative Medicine Japan, expressed his enthusiasm about this new treatment option, highlighting its potential impact on improving the quality of life for UC patients in Japan. According to him, the introduction of Tremfya® represents a significant milestone, showcasing the company’s commitment to addressing unmet medical needs in the field of immunology.

Future Directions

This launch now makes Tremfya® the sixth approved indication for the drug in Japan. Currently, clinical applications are being pursued for using Tremfya® in the treatment of Crohn's disease, emphasizing the ongoing commitment to expanding its use for gastrointestinal disorders.

The approval and successful launch of Tremfya® align with Johnson & Johnson’s broader mission to provide innovative healthcare solutions. By leveraging advanced treatment methodologies and ongoing research, the company aims to continue making substantial contributions to patient care and treatment outcomes.

In summary, Tremfya® not only symbolizes a new therapeutic avenue for ulcerative colitis patients but also reflects a transformative shift in the management of chronic inflammatory diseases, strengthening the growing portfolio of effective treatment options available today.

For more details about Tremfya® and Johnson & Johnson’s innovative medicines, you can visit Johnson & Johnson’s website.