Open-capsule budesonide for the treatment of immune-related enteritis from checkpoint inhibitors.

BACKGROUND: Limited data exist for management strategies targeting immunotherapy-related enteritis (irEnteritis). Systemic corticosteroids are commonly used but often are limited by adverse events. Enteric corticosteroids such as budesonide offer an attractive alternative; however, the ileocolonic release of enteric-coated budesonide has limited utility for diffuse enteritis. Open-capsule budesonide (OCB) is a novel therapeutic approach that offers drug delivery throughout the small bowel. We report outcomes in patients treated with OCB for confirmed or suspected irEnteritis. METHODS: This retrospective cohort included all individuals treated with OCB for irEnteritis at Memorial Sloan Kettering from July 2018 to August 2023. Primary outcomes included clinical response, clinical remission, and corticosteroid-free remission following OCB. Secondary outcomes were OCB-related adverse events and efficacy by gastrointestinal toxicity location. RESULTS: 19 patients (53% female) with irEnteritis were treated with OCB. All patients presented with diarrhea; 15 (79%) reported anorexia with median 6 kg weight loss. 17 patients (89%) underwent esophagogastroduodenoscopy with biopsies revealing enteritis in all; 8 (42%) had concomitant colitis. 15 (79%) patients were treated previously with systemic corticosteroids: 8 (53%) were corticosteroid-dependent while 7 (47%) demonstrated non-response. 18 patients (95%) achieved clinical response, 15 (79%) attained clinical remission, and 11 (58%) had corticosteroid-free remission. Response to OCB was rapid with improvement noted after a median 4 days. 14 (74%) patients restored their pre-irEnteritis weight by OCB cessation. One mild, self-resolving adverse event was reported. CONCLUSIONS: OCB is a safe and effective therapy for irEnteritis. OCB avoids systemic immunosuppression and successfully achieves clinical response and remission even in patients previously nonresponsive to systemic corticosteroids. Future studies are needed to optimize indications and duration.

A surprising culprit for delayed gastrointestinal bleeding after endoscopic ultrasound-guided cholecystoduodenostomy: the double-pigtail stent.

Endoscopic ultrasound-guided gallbladder drainage using a lumen-apposing metal stent has emerged as an accepted option for the treatment of acute cholecystitis in patients unfit for surgery. While metal stents carry a risk of intra- and post-procedural bleeding, the coaxial placement of a double-pigtail stents through lumen-apposing metal stents has been proposed to lower the bleeding risk by preventing tissue abrasion against the stent flanges. We present a case of an 83 year-old male who had previously undergone uncomplicated endoscopic ultrasound-guided cholecystoduodenostomy with this technique. Six months later, he presented with upper gastrointestinal bleeding due to a duodenal pressure ulcer from the coaxial 10-Fr double-pigtail stent originally employed to prevent such bleeding. The 10-Fr stent was replaced with two 7-Fr stents whose increased flexibility and distribution of pressure across multiple points of contact with the duodenal wall was theorized to reduce the likelihood of erosion or perforation. Following the procedure, the patient's clinical course improved significantly with complete resolution of his symptoms of choledocholithiasis and cholecystitis. While 10-Fr double-pigtail stents are generally preferred for this indication due to their stiffness that reduces out-migration, use of more flexible 7-Fr stents may be advisable in thin-walled structures such as the duodenum.