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Our February 2024 month in review highlights EoE pipeline news, new FMT guidelines, and research about endoscopic inflammation and disease activity in IBD.
Coming off of a strong start to 2024 with a bustling January, February saw equal excitement in the field of gastroenterology. Characterized by another FDA approval in eosinophilic esophagitis (EoE) following last month’s dupilumab decision, transformative guidelines steering the use of fecal microbiota transplant (FMT) in gastrointestinal diseases, and new insight about the role of intestinal ultrasound for detecting endoscopic inflammation in Crohn disease, our February 2024 month in review spotlights some of our top coverage from the past few weeks.
Long Time Coming: Pediatric Gastroenterologists React to New Dupilumab EoE Approval
Carrying over from the FDA approval of dupilumab (Dupixent) in pediatric patients 1-11 years of age weighing ≥ 15 kg in January, we spoke with a trio of pediatric gastroenterologists about the implications of this decision for a previously untreated patient population. Prior to dupilumab’s approval, clinicians relied heavily on off-label prescriptions to treat EoE in younger children. However, EoE-specific dosing remained an issue until its FDA approval for this indication, and questions still remain about its priority of use and eventual approval for patients ≤1 year of age.
FDA Approves Budesonide Oral Suspension (Eohilia) for Eosinophilic Esophagitis
In additional EoE pipeline news, the FDA approved budesonide oral suspension (Eohilia) for patients ≥ 11 years of age with EoE on February 12, making it the first and only FDA-approved oral therapy for this patient population. The decision was based on efficacy and safety data from a pair of multicenter, randomized, double-blind, parallel-group, placebo-controlled 12-week studies in patients ages 11-56 years and 11-42 years, respectively, with EoE, labeled Study 1 and Study 2.
Shared Decision-Making, Routine Monitoring Among Best Practices for Managing EoE
Despite the pipeline movement surrounding EoE, its pathophysiology remains poorly understood – variability in its clinical presentation and uncertainties about optimal long-term management strategies currently hinder its diagnosis and management. This literature review published in Canadian Medical Association Journal calls attention to the rising incidence and prevalence of EoE, providing clinicians with a comprehensive overview of its diagnosis, treatment, and management.
AGA Supports Fecal Microbiota-Based Therapies for C Diff in New Guideline
In the first comprehensive evidence-based guideline on the use of fecal microbiota-based therapies for gastrointestinal disease, the American Gastroenterological Association recommends FMT in most cases of recurrent Clostridioides difficile infection (CDI) but advises against its use in inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS). The 7 guideline recommendations are intended to provide the basis for rational informed decision-making for patients and healthcare professionals using fecal microbiota-based therapies for adults with recurrent CDI or conventional FMT for severe to fulminant CDI, IBD, and IBS.
Experts’ Perspectives: AGA Recommends FMT for C Diff
We spoke with a trio of investigators from the guideline panel for additional insight into uncertainties about the use of fecal microbiota-based therapies prior to the AGA guideline, its impact on how clinicians treat patients with gastrointestinal disease, and potential future uses for FMT beyond CDI.
Histological, Clinical Disease Activity Linked to Reduced Fertility in Women with IBD
Findings from this analysis of data from the Swedish National Patient Register and the Swedish Prescribed Drug Register suggest a significant association between disease activity and fertility in women with IBD. During periods of histological inflammation, the fertility rate was 6.35 (95% CI 5.98 to 6.73) per 100 person-years of follow-up compared to 7.09 (95% CI, 6.48-7.70) per 100 person-years without histological inflammation. Additionally, clinical IBD activity was associated with an aFRR of 0.76 (95% CI, 0.72-0.79) and reduced fertility compared to matched general population comparators (aFRR, 0.84; 95% CI, 0.81-0.88).
Our most popular story of the month features an interview with Marla Dubinsky, MD, chief of the division of pediatric gastroenterology at Mount Sinai Kravis Children’s Hospital, about the use of segmental intestinal ultrasound for detecting moderate-to-severe endoscopic inflammation. She dives into the current problems seen with high rates of screen failure for the minimum Simple Endoscopic Score for Crohn Disease (SES-CD) in many clinical trials and explains what noninvasive ultrasound may offer for detecting active inflammation and correlating results to patients’ symptoms in a quicker, more effective manner.