J&J's subcutaneous Tremfya shines in Crohn's disease trial

Johnson & Johnson's Tremfya has demonstrated promising results in treating Crohn’s disease, marking a significant advancement in the company's immunology portfolio. This is particularly crucial as Johnson & Johnson (J&J) braces for the upcoming loss of exclusivity on Stelara, their established immunology drug.

In May, J&J highlighted the effectiveness of an intravenous (IV) formulation of Tremfya, which outperformed Stelara in head-to-head trials for Crohn’s disease. Shortly after, in June, a subcutaneous (SC) version of Tremfya showed remarkable results as an induction therapy in a Phase 3 study for the same condition.

The GRAVITI trial, which assessed Tremfya SC induction therapy, met its co-primary endpoints. The drug demonstrated significant improvements compared to a placebo at the 12-week mark in terms of remission and endoscopic response. According to J&J, achieving these results in three distinct studies positions Tremfya to be the first IL-23 inhibitor offering two induction options for Crohn’s disease.

David Lee, M.D., Ph.D., J&J’s global therapeutic head for immunology, emphasized the advantage of having both SC and IV induction options, noting that this provides greater flexibility and choice for patients and healthcare providers. He also pointed out that Tremfya is set to become the only IL-23 inhibitor offering a full SC therapy regimen for both induction and maintenance in Crohn’s disease.

J&J plans to present full data from the GRAVITI trial at forthcoming medical conferences and intends to share these results with regulatory bodies. The study focused on patients with moderate to severe Crohn’s disease who had an inadequate response to or could not tolerate conventional treatments such as corticosteroids, immunomodulators, or other biologic drugs like TNF agonists or Takeda’s Entyvio.

In addition to meeting its primary endpoints, the GRAVITI trial also achieved statistical significance in all secondary objectives compared to placebo. These secondary measures included various remission and response rates over time and the rates of adverse events leading to treatment discontinuation.

AbbVie’s Skyrizi was the first IL-23 inhibitor approved for treating Crohn’s disease in 2022. Last year, Skyrizi surpassed Stelara in a direct comparison study, with 61% of patients achieving remission by week 48 compared to 41% for Stelara.

Tremfya is becoming one of J&J’s key products. Initially approved for plaque psoriasis in 2017, it later gained approval for psoriatic arthritis in 2020. J&J also submitted an application for Tremfya to treat ulcerative colitis earlier this year. In 2023, Tremfya generated $3.1 billion in sales, reflecting an 18% increase from the previous year.

The rise of Tremfya is timely as J&J anticipates the loss of exclusivity for Stelara, which generated $10.9 billion in sales in 2023, accounting for 13% of the company’s total revenue. With Stelara biosimilars expected to launch in Europe this year and U.S. versions anticipated early next year, Tremfya's success in Crohn’s disease can provide a crucial buffer for J&J.

In summary, Tremfya’s recent clinical success in multiple studies positions it as a versatile treatment option for Crohn’s disease, offering both IV and SC induction therapies. This development is particularly important for J&J as it prepares to face Stelara's patent expiration and subsequent market competition from biosimilars.

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