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Our January 2024 Month in Review spotlights the FDA approval of a new indication of dupilumab (Dupixent) for pediatric eosinophilic esophagitis, new clinical trial data, and research about the prevention and management of IBD.
Eager to ring in the new year, January was a month bustling with activity in the field of gastroenterology. It was a strong start to 2024, shaped by an early FDA approval for a new indication of dupilumab (Dupixent), promising clinical trial data for a number of agents across several conditions, and new research in inflammatory bowel disease (IBD).
Accompanying our sister site Contemporary Pediatrics’ coverage of the FDA approval of dupilumab for the treatment of eosinophilic esophagitis (EoE) in pediatric patients 1-11 years of age weighing ≥ 15 kg, HCPLive Gastroenterology sat down with Evan Dellon, MD, MPH, director of the Center for Esophageal Diseases and Swallowing at the University of North Carolina Chapel Hill for a Q&A about the use of dupilumab in this patient population.
Results from this phase 1 clinical trial provide early evidence of omadacycline’s ability to achieve high fecal concentrations and produce distinct gut microbiota diversity changes while preserving key Firmicutes groups.
The nonblinded, randomized clinical trial included 16 healthy volunteers with a mean age of 26 (Standard deviation [SD], 5) years and who were predominantly male (62.5%). Participants were randomly assigned to receive a 10-day course of once-daily omadacycline or vancomycin given 4 times daily. Compared to vancomycin, omadacycline produced rapidly detectable fecal concentrations and significant, distinct changes in the microbiome’s beta diversity, suggesting it may be a suitable antibiotic for Clostridioides difficile infection.
Additional efficacy endpoint data from a phase 3 study of linaclotide (Linzess) in pediatric patients 6-17 years of age with functional constipation provided additional support for its US Food and Drug Administration (FDA) approval in 2023 and gave clinicians further insight into the use of this treatment in their patients.
Results showed linaclotide improved patients’ 12-week spontaneous bowel movement frequency rate at a greater rate than placebo, with a statistically significant proportion of linaclotide-treated patients achieving > 2-fold least squares mean change from baseline in spontaneous bowel movement frequency rate compared to placebo (2.220 vs 1.050; P <.0001).
HCPLive Gastroenterology spoke with Julie Khlevner, MD, associate professor of pediatrics and director of the Pediatric Gastrointestinal Motility Center at Columbia University Medical Center, for further insight into the significance of this new data.
Another study reinforcing the safety and efficacy of an already-FDA approved drug, results from the long-term extension of UNIFI highlighted the maintenance of symptomatic remission providing clinical and endoscopic benefit to patients with ulcerative colitis through 4 years of treatment with ustekinumab.
A randomized, double-blind, placebo-controlled, parallel-group, phase 3 protocol, UNIFI included a long-term extension that began after the 44-week maintenance study and spanned through week 220 at the final safety visit. Results showed patients with treatment-refractory moderate-to-severe ulcerative colitis who responded to ustekinumab IV induction and received SC maintenance treatment generally maintained clinical benefit through the extension study.
The exact cause of IBD is not fully understood, but findings from this pooled study of 2 Scandinavian birth cohorts suggests early childhood diet may play an important role. Specifically, investigators highlighted the protective effect of a diet rich in fish and vegetables at 1 year of age. Conversely, they warned of the potential increased risk of IBD associated with consuming sugar-sweetened beverages in early childhood.
Treatment interventions for mood play an important role in addressing mental health disorders, but they also might have the ability to treat general inflammation and IBD-specific biomarkers. This effect was especially pronounced among psychological therapy interventions, which demonstrated greater effect sizes than exercise and antidepressants.