Qazi Corner, Edition 4: Vonoprazan, Etrasimod, SEQUENCE, and Celiac Guidelines

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The final quarterly issue of the year touches on head-to-head trial data, a new treatment for erosive esophagitis, an ulcerative colitis agent, and the latest ACG recommendations for Celiac disease.e.

It is my pleasure to introduce the final edition of the Qazi Corner for the 2023 calendar year. In this edition, we hope to present research that is groundbreaking at recent meeting, highlighting the role of new therapies for both inflammatory bowel disease (IBD) as well as esophagitis. We also present an article of the recent Celiac disease guidelines, a helpful review for practitioners on the diagnosis and management of celiac disease.

Chiara Maruggi, MD, returns to discuss a recent article reviewing the role of vonoprazan for the management of erosive esophagitis. Vonoprazan, a potassium-competitive acid blocker (PCAB) is a novel therapy for the management of esophagitis. An aspect of PCABs which differentiates them from guideline-recommended proton pump inhibitors (PPIs) are the need for dosing around meals, particular to PPIs only. In a randomized, double-blind, parallel group, multicenter trial, vonoprazan was compared to lansoprazole in adults for the management of erosive esophagitis. A total of 1027 patients were included in the trial, and vonoprazan was found to be superior for the primary endpoint of endoscopic healing of erosive esophagitis at week 8, with a greater effect of healing in patients with severe esophagitis (LA Grade C/D). PCABs represent a novel mechanism for the management of erosive esophagitis and may hold promise for the management of other peptic conditions.

Shubha Bhat, PharmD, MS, BCACP, an IBD leader in clinical pharmacology at the Cleveland Clinic, also reports on the recent approval of a new agent for the management of ulcerative colitis, etrasimod. Etrasimod, a sphingosine 1-phosphate receptor modulator (S1PR), represents a novel, oral therapy for the management of ulcerative colitis. Sharing the data from the phase 3, double-blind randomized controlled trials, ELEVATE UC-12 and ELEVATE UC-52, a higher proportion of patients on the study drug met the outcomes of clinical remission and sustained clinical remission at week 12 and 52. Interestingly, the trial design did feature patients with proctitis and left-sided disease, suggesting another option for advanced therapies in these populations.

Katherine Falloon, MD, returns to discuss the results of the SEQUENCE trial, which represents the third trial comparing biological efficacy for the management of Crohn’s disease. Risankizumab, a selective anti-IL-23 therapy, is compared to ustekinumab, which blocks the activity of both IL-12 and IL-23. Patients in the trial had moderate to severe Crohn’s disease with endoscopic disease activity. Patients were randomized to receive either Ustekinumab or Risankizumab. The results of the study demonstrate the non-inferiority of risankizumab to ustekinumab in the endpoint of clinical remission at week 24, and the superiority of risankizumab to ustekinumab for endoscopic remission at week 48. The trial demonstrates additional evidence of the potential positioning of medications as we enter a world of multiple medical therapies for Crohn’s disease.

Lastly, Lady Katherine Mejía Pérez, MD, presents the most recent guideline update for the diagnosis and management of Celiac disease, by the American College of Gastroenterology (ACG). The article provides a summary of the major recommendations in diagnosis, including the role of serological testing for diagnosis combined with endoscopic evaluation with duodenal biopsies. In situations of discordance, HLA haplotyping can aid in eliminating the diagnosis of celiac disease. In children, diagnosis is often established only through serological testing. Serologic testing can confirm adherence to a gluten free diet as endoscopic healing can take time, especially in adults.

I hope you enjoy the most recent version of HCPLive’s Qazi Corner!