Results across two studies showed patients sustained stable, long-term remission.
Eli Lilly has shared results from two Phase III clinical trials which show patients treated with mirikizumab sustained stable, long-term remission across two types of inflammatory bowel diseases (IBD), ulcerative colitis (UC), and Crohn's disease. Data will be presented at this year’s American College of Gastroenterology (ACG) Annual Meeting in Philadelphia, PA.1
According to Lilly, mirikizumab is the first and only IL23p19 antagonist to achieve multi-year, long-term sustained efficacy for the treatment of both UC and Crohn’s disease. In October 2023, the FDA approved mirikizumab under the brand name Omvoh for the treatment of moderately to severely active UC in adults.
In the LUCENT-3 study, which evaluated mirikizumab in moderately to severely active UC, patients achieved long-term outcomes, including histologic-endoscopic mucosal remission. Additionally, mirikizumab provided sustained benefit across symptomatic, clinical, endoscopic, and histologic endpoints.
Meanwhile, the VIVID-2 long-term extension study, which evaluated the efficacy of mirikizumab in moderately to severely active Crohn's disease, showed patients maintained high rates of clinical and endoscopic remission.
In a press release, Bruce Sands, MD, MS, Dr. Burrill B. Crohn professor of medicine and chief of the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai said, "Despite continued advances, people living with ulcerative colitis and Crohn's disease are still seeking treatments that can address difficult-to-manage symptoms such as bowel urgency, and provide lasting results over time. 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."
Elsewhere in the Crohn’s disease space, Johnson & Johnson shared new Phase III data from its GRAVITI trial of Tremfya (guselkumab). At 12 weeks, 56.1% of patients achieved clinical remission, and at 48 weeks, rates of remission continued with maintenance doses.2
According to J&J, Tremfya is the first and only IL-23 inhibitor to demonstrate robust results with a fully subcutaneous regimen in both induction and maintenance in Crohn’s disease. The inhibitor was approved by the FDA for adults with moderately to severely active UC earlier in September.
“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,” study investigator Remo Panaccione, MD, FRCPC, professor of medicine and director of the inflammatory bowel disease unit at the University of Calgary, said in a press release. “The one-year results of this study suggest that SC induction with guselkumab is a promising approach to help people with CD manage their symptoms and achieve meaningful endoscopic improvements.”
1. Lilly's mirikizumab is first and only IL23p19 antagonist to report long-term, multi-year, sustained efficacy and safety data for both ulcerative colitis and Crohn's disease. News release. Eli Lilly. October 28, 2024. Accessed October 30, 2024. https://investor.lilly.com/news-releases/news-release-details/lillys-mirikizumab-first-and-only-il23p19-antagonist-report-long
2. TREMFYA® (guselkumab) is the first and only IL-23 inhibitor to demonstrate robust results with a fully subcutaneous regimen in both induction and maintenance in Crohn’s disease. News release. Johnson & Johnson. October 28, 2024. Accessed October 30, 2024. https://www.jnj.com/media-center/press-releases/tremfya-guselkumab-is-the-first-and-only-il-23-inhibitor-to-demonstrate-robust-results-with-a-fully-subcutaneous-regimen-in-both-induction-and-maintenance-in-crohns-disease
Final ENLIVEN Trial Results Confirm Long-Term Benefit of Turalio in Tenosynovial Giant Cell Tumor
July 9th 2025In final data from the Phase III ENLIVEN study, Turalio (pexidartinib) demonstrated durable tumor responses and a consistent safety profile in patients with symptomatic TGCT not amenable to surgery.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
FDA Expands Farapulse PFA Approval to Persistent AF After Strong ADVANTAGE AF Trial Results
July 7th 2025Boston Scientific’s Farapulse Pulsed Field Ablation System is now approved for treating persistent atrial fibrillation, following 12-month data from the ADVANTAGE AF trial showing strong safety, high freedom from AF, and no major complications.
Effect of AI/ML, Real World Evidence and Master Protocols on Trial Success
July 7th 2025How the application of artificial intelligence, broader use of real-world evidence, decentralized clinical trials, master protocols, and risk-based quality monitoring, together with strong ethical oversight and increased collaboration, are contributing to better healthcare delivery and strengthening the role of clinical research in driving global health progress.