Gastroenterology Update: Cendakimab, Mirikizumab Data, Cologuard Plus Approval, and GLP-1 RA Risks
核心洞察
Phase 3 data shows cendakimab provides durable efficacy and safety for eosinophilic esophagitis (搜索) (EoE) treatment, improving symptoms and reducing esophageal eosinophils significantly.
Long-term studies of mirikizumab demonstrate sustained safety and efficacy in treating both ulcerative colitis (搜索) (UC) and Crohn’s disease (搜索) (CD), marking it as a notable IL-23p19 antagonist.
The FDA approved Exact Sciences (搜索)’ Cologuard Plus (搜索) test for colorectal cancer (搜索) screening, showing high cancer sensitivity and advanced precancerous lesion detection.
October saw significant developments in gastroenterology, ranging from promising clinical trial results to new diagnostic approvals and emerging concerns regarding GLP-1 receptor agonists (GLP-1 RAs). Key highlights include data on cendakimab for eosinophilic esophagitis (搜索), mirikizumab for ulcerative colitis (搜索) and Crohn's disease, the FDA approval of Cologuard Plus (搜索), and studies on the impact of GLP-1 RAs on endoscopic procedures.
Cendakimab Shows Promise in Eosinophilic Esophagitis
Late-breaking Phase 3 data presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting revealed the durable efficacy and safety of cendakimab for treating eosinophilic esophagitis (搜索) (EoE) in adults and adolescents. The study demonstrated statistically significant improvements in both symptoms and esophageal eosinophil counts over 24 weeks, with these benefits sustained through 48 weeks compared to placebo. These findings suggest cendakimab could offer a significant advancement in EoE management.
Mirikizumab Demonstrates Long-Term Efficacy in IBD
Long-term data from a pair of Phase 3 studies of mirikizumab reinforced the interleukin-23p19 (IL23p19 (搜索)) antagonist’s sustained safety and efficacy in both ulcerative colitis (搜索) (UC) and Crohn’s disease (搜索) (CD). The LUCENT-3 study in UC and the VIVID-2 long-term extension study in CD highlighted stable, long-term remission among patients treated with mirikizumab. Notably, mirikizumab is the first and only IL23p19 antagonist to report long-term, multi-year sustained safety and efficacy data for both UC and CD, marking a significant milestone in IBD (搜索) treatment.
Bruce Sands, MD, presented these findings at ACG, emphasizing the importance of long-term data in managing chronic conditions like UC and CD.
FDA Approves Cologuard Plus for Colorectal Cancer Screening
The FDA approved Exact Sciences (搜索)’ Cologuard Plus (搜索) test, a next-generation multitarget stool DNA test, for colorectal cancer (搜索) (CRC) screening in adults aged 45 and older at average risk for CRC. The approval was based on the BLUE-C study, which showed the Cologuard Plus test demonstrated 95% overall cancer sensitivity and 43% sensitivity for advanced precancerous lesions at 94% specificity. This noninvasive screening option offers a valuable tool for early CRC detection.
GLP-1 RAs and Endoscopic Procedure Risks
Several studies investigated the impact of GLP-1 RAs on endoscopic procedures. One cross-sectional study indicated an increased risk of retained gastric contents and inadequate bowel preparation during single endoscopic procedures among patients using GLP-1 RAs. Even when patients held GLP-1 RAs for seven days prior to the procedure, they were still more likely to show food retention during upper endoscopy compared to non-users. The study also linked GLP-1 RA use to unsatisfactory bowel preparation for colonoscopies, potentially leading to missed lesions and wasted resources.
However, another study suggested that while GLP-1 RA use is associated with increased rates of residual gastric content, it has a minimal impact on upper endoscopy safety and completion. Braden Kuo, MD, from Massachusetts General Hospital, noted that the rate of negative outcomes is very low when carefully case-matched controls are used. A systematic review and meta-analysis also suggested that patients may not need to stop taking GLP-1 RAs before upper endoscopic procedures, as a clear liquid diet and bowel preparation may mitigate the risk of retained gastric content.
Violeta Popov, MD, PhD, highlighted that these findings suggest a more nuanced approach to GLP-1 RA management before endoscopy may be warranted.
Additional Insights from ACG 2024
Beyond these highlights, ACG 2024 featured numerous presentations on topics ranging from vitamin D deficiency in IBD (搜索) patients to the impact of psychological factors on IBS (搜索) treatment. These studies collectively contribute to a deeper understanding of gastrointestinal health and disease management.