J&J Bolsters Tremfya as Stelara Faces Patent Expiry

The competitive landscape for biologics in the treatment of inflammatory bowel disease (IBD) continues to intensify, with Johnson & Johnson's Tremfya positioning itself as a noteworthy contender. Recent phase 3 studies presented at the Digestive Disease Week (DDW) 2024 reveal Tremfya's promising results in treating Crohn's disease (CD) and ulcerative colitis (UC).

Tremfya, tested at two different dosages, demonstrated superior results compared to J&J’s Stelara in patients with moderate to severe Crohn’s disease. After 48 weeks of treatment, 37.2% and 33.2% of patients receiving subcutaneous Tremfya at 200mg every four weeks and 100mg every eight weeks, respectively, achieved endoscopic remission, compared to 24.7% of those on Stelara. However, the difference in clinical remission rates between Tremfya and Stelara was less pronounced. Tremfya achieved clinical remission rates of 70.3% and 65.4%, compared to Stelara’s 62.9%.

Moreover, Tremfya outperformed the placebo in the GALAXI 2 and GALAXI 3 trials on two co-primary endpoints, indicating significant clinical responses at week 12 and either clinical remission or endoscopic responses at week 48.

AbbVie's Skyrizi, the first IL-23 inhibitor approved for Crohn's by the FDA in June 2022, has also shown competitive results. In a direct comparison, Skyrizi achieved a 61% clinical remission rate at week 48, surpassing Stelara's 41%, and doubled the endoscopic remission rate to 32%.

Eli Lilly also presented data for its IL-23 drug, Omvoh, at DDW. Approved for ulcerative colitis in October, Omvoh was compared to a placebo and is yet to present head-to-head data against Stelara.

Johnson & Johnson is anticipating an FDA decision for Tremfya in the treatment of UC, supported by positive phase 3 data from the QUASAR maintenance study. The study showed that Tremfya significantly outperformed the placebo, with 50% and 45.2% of patients achieving clinical remission after 44 weeks at dosages of 200mg every four weeks and 100mg every eight weeks, respectively. In comparison, 18.9% of patients who switched to the placebo from Tremfya showed clinical remission.

The efficacy of Tremfya in the UC study was slightly better than Skyrizi's results in its own maintenance trial. Skyrizi's phase 3 COMMAND trial reported clinical remission rates of 40% and 38% for subcutaneous doses of 180mg and 360mg every eight weeks, respectively, after one year of treatment. Those who switched to placebo had a remission rate of 25%.

In the latest UC study, 33.7% and 34.6% of Tremfya-treated patients showed endoscopic remission, compared to 15.3% in the placebo group. All secondary endpoints in the UC study were met by both Tremfya regimens, although adverse events were reported in 70% and 64.5% of patients on the two Tremfya doses, compared to 68.2% for the placebo.

David T. Rubin, M.D., the lead investigator of the QUASAR study, highlighted the potential of Tremfya to provide durable clinical remission and improve high-bar endpoints such as endoscopic remission and histologic remission, which are crucial for new treatments in IBD.

Before these maintenance findings, the QUASAR induction study found that 22.6% of patients achieved clinical remission at week 12 with Tremfya, versus 7.9% with placebo. J&J filed for FDA approval of Tremfya in UC in March and also sought approval for both UC and CD from the European Medicines Agency in May.

Conversely, AbbVie has submitted Skyrizi to the FDA for potential UC expansion, with a decision expected mid-year. Skyrizi already has approval for Crohn’s disease.

Johnson & Johnson is bolstering Tremfya’s market presence as Stelara approaches its patent expiration. Stelara, J&J's top-selling drug with $10.9 billion in sales in 2023, faces biosimilar competition in Europe this year and in the U.S. by early 2025. Meanwhile, Tremfya’s sales increased by 26% year-over-year to $808 million in the first quarter, while Stelara’s sales remained flat at $2.45 billion. Tremfya now surpasses Stelara in sales for plaque psoriasis and psoriatic arthritis.

Despite this, in the U.S. biologic psoriasis market, Skyrizi leads with a prescription share exceeding 35%, more than double that of its closest competitor. Skyrizi also holds market leadership in U.S. Crohn’s treatments, anticipated to contribute over $1 billion in growth this year.