Johnson & Johnson and Eli Lilly have both announced positive Phase III trial results for their respective interleukin-23 (IL-23) inhibitors, Tremfya (guselkumab) and Omvoh (mirikizumab), in the treatment of Crohn's disease. Both companies are seeking FDA approval for this new indication, building on existing approvals for ulcerative colitis (UC) and, in the case of Tremfya, plaque psoriasis and psoriatic arthritis.
J&J's Tremfya Shows Strong Remission Rates in GRAVITI Study
The GRAVITI study (NCT05197049) evaluated subcutaneous Tremfya at doses of 100mg every eight weeks and 200mg every four weeks against placebo in 350 patients with Crohn's disease. The results, announced on October 28, demonstrated that 60% of patients on the 100mg Tremfya dose and 66.1% on the 200mg dose achieved clinical remission at 48 weeks, compared to only 17.1% in the placebo group. Improvements in clinical remission were observed as early as week four.
In addition to clinical remission, the study also assessed endoscopic response and remission. Endoscopic response was achieved in 44.3% and 51.3% of Tremfya patients versus 6.8% in the placebo group. Endoscopic remission was achieved in 30.4% and 38.3% of patients in the Tremfya arms versus 6% in the placebo group.
"The GRAVITI results show that induction treatment with subcutaneous guselkumab is as rapid and robust as we have seen with the IV induction, which could offer a welcome new option for Crohn's disease treatment," said Dr. Remo Panaccione, study investigator and director of the Inflammatory Bowel Disease Unit at the University of Calgary.
Lilly's Omvoh Demonstrates Long-Term Efficacy in VIVID-2 Trial
Eli Lilly presented data from the Phase III LUCENT-3 (NCT03519945) trial of Omvoh in patients with moderate-to-severe active UC and the Phase III VIVID-2 trial (NCT04232553), an open-label, long-term extension study in patients with Crohn’s disease. In LUCENT-3, 81% of patients achieved clinical remission and 82% achieved endoscopic remission after two years of treatment. In the long-term extension part of the VIVID-2 trial, 87% of patients achieved clinical remission and 54% of patients achieved endoscopic remission after three years of treatment.
"These multi-year data show mirikizumab is a targeted therapy that can provide intestinal healing over time and improvement in key symptoms that matter most to patients," said Dr. Bruce Sands, chief of the Dr Henry D Janowitz division of gastroenterology, Icahn School of Medicine at Mount Sinai.
Market Projections
Despite both drugs showing promise in treating UC and Crohn’s disease, GlobalData predicts that Tremfya sales will surpass those of Omvoh. By 2030, Tremfya is projected to reach sales of $8.4 billion, while Omvoh is expected to reach $867 million.
