Johnson & Johnson (J&J) and Eli Lilly have both revealed the efficacy of their interleukin-23 (IL-23) inhibitors to treat Crohn’s disease.
Both companies touted data from Phase III trials on 28 October, sharing their IL-23 inhibitors Tremfya (guselkumab) and Omvoh (mirikizumab), and are both eyeing US Food and Drug Administration (FDA) approval in Crohn’s disease, having each submitted their application. Both drugs have already received FDA approval for ulcerative colitis (UC), however, Tremfya is also approved for the treatment of plaque psoriasis and psoriatic arthritis.
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J&J’s GRAVITI study (NCT05197049), investigated subcutaneous Tremfya at 100mg every eight weeks and 200mg every four weeks versus placebo in 350 patients with Crohn’s disease.
In the trial, 60% of patients on 100mg Tremfya and 66.1% of patients on 200mg Tremfya achieved clinical remission compared to 17.1% of patients in the placebo cohort at 48 weeks. Greater improvements in clinical remission were seen as early as week four with Tremfya compared with placebo.
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.
In May 2024, J&J announced that Tremfya was superior to Stelara in Crohn’s disease in the Phase II/III GALAXI trial (NCT03466411).
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By GlobalDataDr Remo Panaccione, study investigator and director of the Inflammatory Bowel Disease Unit at the University of Calgary said: “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.”
Meanwhile, Eli Lilly has announced 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 expansion study which investigated the candidate in patients with Crohn’s.
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.
Earlier this month, Lilly touted data showing Omvoh was superior to Stelara in treating Crohn’s disease.
Dr Bruce Sands, chief of the Dr Henry D Janowitz division of gastroenterology, Icahn School of Medicine at Mount Sinai, said: “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.”
Despite both showing real promise in both UC and Crohn’s disease, GlobalData predicts Tremfya sales to eclipse those of Omvoh, with J&J’s drug set to reach sales of $8.4bn in 2030 compared to sales of $867m for Lilly’s drug in the same year.
GlobalData is the parent company of the Clinical Trials Arena.
