‘It’s Completely Changed My Practice’: Marla Dubinsky, MD, on Intestinal Ultrasound for Crohn’s Disease

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Marla Dubinsky, MD, discusses the use of segmental intestinal ultrasound to address screen failure associated with the SES-CD in clinical trials and for detecting transmural healing.

Segmental intestinal ultrasound may be a viable tool for detecting moderate-to-severe endoscopic inflammation, offering a potential solution to the high rates of screen failure for the minimum Simple Endoscopic Score for Crohn Disease (SES-CD) currently seen in many clinical trials.

Patients often fail these pre-screenings because although they meet clinical criteria such as PRO-2 and Crohn Disease Activity Index (CDAI) for trial inclusion, they do not meet the SES-CD criteria when they are sent for a colonoscopy. Unlike ulcerative colitis (UC) where there is more connectivity between symptoms and endoscopic findings, in CD, patients’ clinical symptoms and endoscopy may not match.

“That disconnect is like 50/50, and that's not probably good enough to get people efficiently into clinical trials,” Marla Dubinsky, MD, chief of the division of pediatric gastroenterology at Mount Sinai Kravis Children’s Hospital, explained in an interview with HCPLive.

Rather, Dubinsky pointed to the viability of a noninvasive ultrasound for detecting active inflammation and correlating results to patients’ symptoms in a quicker, more effective manner: “This is probably one of the biggest advances in the field of intestinal ultrasound, to impact clinical trials and bringing more drugs to patients faster. There's no greater gift, in essence, than to be able to do that.”

Indeed, findings from a single-center, blinded, cross-sectional cohort study of children and young adult patients with CD undergoing segmental intestinal ultrasound and ileocolonoscopy showcased the accuracy of this tool for detecting moderate-to-severe endoscopic inflammation.

Among the 82 patients who underwent segmental intestinal ultrasound and ileocolonoscopy of 323 bowel segments, results showed segmental bowel wall thickness ≤3.1 mm had a similar high accuracy to detect SES-CD ≤2 as segmental intestinal ultrasound scores (area under the receiver operating curve [AUROC], 0.833; 95% CI, 0.76–0.91; 94% sensitivity; 73% specificity). Additionally, segmental bowel wall thickness ≥3.6 mm and ≥4.3 mm had similar high accuracy to detect SES-CD ≥6 (AUROC, 0.950; 95% CI, 0.92–0.98; 89% sensitivity; 93% specificity) in the colon and an SES-CD ≥4 in the terminal ileum (AUROC, 0.874; 95% CI, 0.79–0.96; 80% sensitivity; 91% specificity) as segmental intestinal ultrasound scores.

Beyond the findings highlighted in the study, Dubinsky also called attention to the growing focus on transmural healing and its association with better long-term outcomes. Specifically, she highlighted ultrasound’s ability to detect early signs of response as well as incorporate transmural healing as an endpoint in clinical trials rather than just endoscopic or histologic remission.

Addressing potential roadblocks to the widespread implementation of this approach, Dubinsky pointed to a lack of trained professionals who are able to utilize this approach in the clinical trial space. She also noted the current lack of a central reading platform for centralizing the quality of the read and ensuring agreement about what constitutes response.

“It’s completely changed my practice, and I think it’s going to change everybody’s practice. I’m excited to see how the field evolves, and it’ll be a fun ride,” Dubinsky concluded.

Reference:

Dolinger MT, Aronskyy I, Kellar A, et al. Determining the Accuracy of Intestinal Ultrasound Scores as a Prescreening Tool in Crohn's Disease Clinical Trials. The American Journal of Gastroenterology. doi:10.14309/ajg.0000000000002632

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