J&J reports positive phase 3 results for subcutaneous Tremfya in ulcerative colitis trial

Johnson & Johnson (J&J) has released promising outcomes from a pivotal phase 3 study examining a subcutaneous (SC) form of Tremfya (guselkumab) for treating ulcerative colitis (UC). This research, known as the ASTRO trial, focuses on utilizing Tremfya SC as an induction therapy for adults suffering from moderate to severe UC.

The findings were unveiled at the annual Congress of the European Crohn’s and Colitis Organization. The results indicated that Tremfya SC at a dosage of 400mg significantly outperformed placebo in terms of clinical and endoscopic outcomes by the 12th week. Specifically, 27.6% of patients receiving Tremfya achieved clinical remission compared to only 6.5% in the placebo group. Additionally, 65.6% of patients in the Tremfya group showed a clinical response, which was notably higher than the 34.5% observed in the placebo cohort. Furthermore, endoscopic improvements were seen in 37.3% of Tremfya-treated patients, in contrast to just 12.9% of those receiving placebo.

Ulcerative colitis is a predominant form of inflammatory bowel disease (IBD), impacting nearly 1% of the US population. It manifests through a variety of unpredictable symptoms, such as frequent and loose bowel movements, bloody stools, abdominal discomfort, and diminished appetite. Tremfya operates by inhibiting IL-23, a key factor in the development of inflammatory conditions. It has already received approval from the US Food and Drug Administration (FDA) for treating adults with moderate to severe UC through an intravenous (IV) induction followed by SC maintenance.

The hope is that a fully subcutaneous treatment plan could provide patients with greater flexibility. Esi Lamousé-Smith, who serves as the vice president and leads the gastroenterology disease area in immunology at J&J Innovative Medicine, emphasized their commitment to offering treatment solutions that enable patients to manage their condition effectively while addressing everyday life demands. Lamousé-Smith noted, “These results further underscore the potential of Tremfya to transform the UC treatment paradigm.”

To advance this innovation, J&J has already submitted a request to the FDA for approval of the Tremfya SC induction regimen for moderate to severe UC cases. Should the FDA approve it, Tremfya would become the first IL-23 inhibitor available with both a full SC induction and maintenance regimen. This development would expand treatment choices for patients and healthcare professionals alike, providing a new path for managing ulcerative colitis effectively.