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Tool predicted vedolizumab nonresponse in routine practice

Key clinical point: Among patients with ulcerative colitis who were treated in routine practice, a point-based clinical scoring tool predicted nonresponse to vedolizumab therapy.

Major finding: A cutoff of 26 points or less was 93% sensitive (95% confidence interval, 79%-98%) for identifying patients who did not reach corticosteroid-free remission during 26 weeks of treatment and was 88% sensitive (95% CI, 83%-92%) for identifying patients who required colectomy.Study details: Study of 620 patients in the GEMINI 1 trial and 322 patients from the real-world VICTORY study.

Disclosures: An American Gastroenterological Association Research Scholar Award supported the work. Dr. Dulai reported holding a provisional patent for the prediction model and consulting relationships and other ties to Takeda, Janssen, Pfizer, AbbVie. His coinvestigators reported ties to numerous pharmaceutical companies.

Citation:

Dulai PS et al. Clin Gastroenterol Hepatol. 2020 Feb 13. doi: 10.1016/j.cgh.2020.02.010.

Commentary:

The management of moderate to severe ulcerative colitis has become more complex because of the greater number of Food and Drug–approved biologic and small-molecule agents presently available. With more options, practitioners are faced with the challenge of choosing the most appropriate agent based on disease- and patient-specific risk factors. The goals of early intervention are to achieve steroid-free remission with mucosal healing and the associated improvements in quality of life, reduced colectomy, and lower colon cancer risks.

Rather than randomly choosing among treatment options, this study by Dulai and colleagues offers a clinical prediction tool that helps clarify which option, vedolizumab versus anti–tumor necrosis factor (TNF), would be more likely, as a first-line agent, to achieve the desired steroid-free clinical remission outcome. In this tool, they included known high-risk factors for colectomy, severe endoscopic activity, and hypoalbuminemia with other variables, such as prior anti-TNF exposure and disease duration. Importantly, this information is readily accessible in a routine clinical record and, therefore, requires no additional tests or studies to calculate.

The value in these types of tools is to assist in early biologic decision-making by providing a numeric cutoff that can be used to recommend one agent versus the other. Another noted feature of this tool is the potential to identify which patients may benefit from dose optimization because lower or intermediate scores tended to respond to dose escalation in vedolizumab partial responders. However, because this tool predominantly assists with the choice of anti-TNF vs. vedolizumab, one may not be able to extrapolate these results to ustekinumab and tofacitinib positioning in ulcerative colitis. Further studies are needed to determine if these variables similarly affect steroid-free remission for these agents.

Christina Ha, MD, FACG, AGAF, is an associate professor of medicine, Inflammatory Bowel Disease Center, Cedars-Sinai, Los Angeles. She is on the advisory board of AbbVie, Janssen, Takeda, Pfizer, Salix, and InDex Pharmaceuticals; has received grant support from Pfizer; and has received research support from Pfizer and Lilly.