The biologics market for inflammatory bowel disease is continually getting more competitive, and now Johnson & Johnson’s Tremfya is the latest medicine angling to make a mark in the space.

As J&J awaits an FDA approval decision for Tremfya in ulcerative colitis (UC), the company has unveiled positive phase 3 data showing the drug works as a maintenance therapy for the disease. The IL-23 inhibitor helped significantly more patients with moderate to severe, active UC achieve clinical remission after 44 weeks of treatment compared with placebo, according to results from the phase 3 QUASAR maintenance study shared during Digestive Disease Week.

Remission was achieved among 50% and 45.2% of patients who received subcutaneous Tremfya at 200mg every four weeks and 100mg every eight weeks, respectively. The rate was 18.9% among those who switched to placebo from infused Tremfya.

Tremfya’s efficacy looks better but not too different from the results achieved by AbbVie’s rival IL-23 inhibitor Skyrizi in its own UC maintenance trial. In the phase 3 COMMAND trial, 40% and 38% of patients who received subcutaneous Skyrizi at 180mg and 360mg every eight weeks, respectively, achieved clinical remission after a year of treatment. The number was 25% for those who transitioned to placebo after Skyrizi infusion as induction.

If approved, Tremfya would also have to compete with Eli Lilly’s Omvoh, which in October became the first IL-23 drug to enter the UC market. The Lilly drug, given every four weeks during the maintenance phase, helped 51% of patients achieve clinical remission after one year, compared with 27% for placebo, in another phase 3 study.

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For Tremfya in the latest study, 33.7% and 34.6% of patients on the two regimens, respectively, showed normal intestinal mucosa, or what’s known as endoscopic remission. That compared with 15.3% of those in the Tremfya withdrawal group.

All told, both Tremfya regimens met all nine major secondary endpoints. The rate of patients with more than one adverse event was 70% and 64.5% for the two Tremfya doses, respectively, versus 68.2% for placebo.

“These data suggest the potential of [Tremfya] to provide durable, clinical remission and improve important high-bar endpoints such as endoscopic remission to the point of normalization and histologic remission, which represent the kind of progress needed in new treatments for this inflammatory bowel disease,” David T. Rubin, M.D., from University of Chicago and lead investigator of the QUASAR study, said in a statement Monday.

Before the latest maintenance readout, the QUASAR induction study had found that Tremfya led to 22.6% rate of clinical remission at week 12, versus 7.9% for placebo

Based on the QUASAR findings, J&J in March filed Tremfya for FDA approval in UC. The company on May 1 said it has applied for both UC and Crohn’s disease—the other form of inflammatory bowel disease—with the European Medicines Agency. J&J will present the Crohn’s disease data later this year.

Meanwhile, AbbVie submitted Skyrizi to the FDA in August for a UC expansion, and the company is expecting a decision in the middle of this year. The drug already boasts a Crohn’s approval.

J&J is shoring up Tremfya’s indications as its predecessor IL-12/23 med, Stelara, inches toward its patent cliff. With $10.9 billion sales in 2023, Stelara was J&J’s biggest brand, accounting for 12.8% of the company’s total revenue last year.

European Stelara biosimilars are expected to debut this year, with U.S. copycats expected to be available in early 2025.