Johnson & Johnson (J&J) and Eli Lilly have both announced positive results from Phase III trials evaluating their respective interleukin-23 (IL-23) inhibitors, Tremfya (guselkumab) and Omvoh (mirikizumab), in the treatment of Crohn's disease. These findings support their applications for FDA approval in Crohn's disease, adding to their existing approvals for ulcerative colitis (UC).
J&J's Tremfya Shows Strong Remission Rates in GRAVITI Study
The GRAVITI study (NCT05197049) assessed the efficacy of subcutaneous Tremfya in 350 patients with Crohn's disease. Patients were administered either 100mg of Tremfya every eight weeks or 200mg every four weeks, compared to a placebo group. At 48 weeks, 60% of patients on the 100mg Tremfya regimen and 66.1% on the 200mg regimen achieved clinical remission, significantly higher than the 17.1% in the placebo group. Improvements in clinical remission were observed as early as week four.
In terms of endoscopic outcomes, 44.3% and 51.3% of Tremfya-treated patients achieved endoscopic response, compared to 6.8% in the placebo group. Endoscopic remission was seen in 30.4% and 38.3% of patients in the Tremfya arms versus 6% in the placebo group. Dr. Remo Panaccione, a study investigator from the University of Calgary, noted that the results indicate subcutaneous guselkumab offers a rapid and robust induction treatment option, comparable to IV induction.
Lilly's Omvoh Demonstrates Long-Term Efficacy in UC and Crohn's
Eli Lilly presented data from the Phase III LUCENT-3 (NCT03519945) trial of Omvoh in patients with moderate-to-severe active UC, as well as from the Phase III VIVID-2 trial (NCT04232553), an open-label, long-term extension study in Crohn’s disease patients. In LUCENT-3, 81% of patients achieved clinical remission and 82% achieved endoscopic remission after two years of Omvoh treatment.
The long-term extension of the VIVID-2 trial showed that 87% of patients achieved clinical remission and 54% achieved endoscopic remission after three years of treatment with mirikizumab. Dr. Bruce Sands, chief of the Dr. Henry D Janowitz division of gastroenterology at Mount Sinai, highlighted that these multi-year data demonstrate mirikizumab's ability to provide intestinal healing and improve key symptoms over time.
Market Projections
Despite the promising results for both drugs in UC and Crohn’s disease, GlobalData predicts that Tremfya will outsell Omvoh, projecting sales of $8.4 billion in 2030 for Tremfya compared to $867 million for Omvoh.
