Papadakis, Konstantinos

INTRODUCTION: Advanced therapies infrequently achieve complete fistula closure in patients with Crohn's disease (CD). The primary objective of the STOMP2 clinical trial was to determine whether the implantable autologous cell therapy AVB-114 is effective in inducing remission of persistent Crohn's perianal fistulas versus standard of care. METHODS: Eligible patients had a single perianal fistula tract and had failed previous treatment or had documented medication intolerance to biologic or conventional CD therapy. All enrolled subjects underwent surgical fistula optimization and adipose tissue biopsy collection (to manufacture AVB-114) followed by 1:1 randomization to either standard of care (repeat fistula optimization including seton replacement) or AVB-114 implantation. The primary end point was combined fistula remission at 36 weeks, defined as closure of the external opening, no drainage of fluid despite gentle finger compression, and no collections >2 cm in at least 2 of the 3 dimensions on MRI. RESULTS: Subjects at 14 US sites were equally randomized to SoC (N = 24) or AVB-114 (N = 24). Week 36 combined remission was 8.3% and 45.8% for subjects randomized to SoC and AVB-114, respectively (38% difference, 95% CI 11%–60%; P = 0.0078). At week 36, MRI revealed no subjects with collections >2 cm, radiological improvement (≥50% decrease in the Magnetic Resonance Novel Index for Fistula Imaging in Crohn's Disease (MAGNIFI-CD) score from baseline) in 1 SoC subject and 3 AVB-114 subjects, and radiological healing (complete resolution of T2-weighted hyperintensity in fistula tract) in 2 SoC subjects and 5 AVB-114 subjects. Through week 36, there were 40 and 56 treatment emergent adverse events for SoC and AVB-114, respectively. There were no serious treatment emergent adverse events in the AVB-114 group through week 36. DISCUSSION: A significantly higher proportion of patients treated with AVB-114 achieved combined remission vs SoC, and the treatment was well tolerated. These data support the safety and efficacy of AVB-114 in persistent Crohn's perianal fistulas.

ABSTRACT Immunoglobulin A vasculitis (IgAV) is an immune-mediated disorder that commonly involves dermatologic, musculoskeletal, renal, and gastrointestinal systems. Drug-induced cases of IgAV are rare and sparsely documented in the literature. We report a case of a patient with Crohn's disease who developed a tender, palpable purpuric rash on the torso and extremities 3 weeks after receiving a dose of ustekinumab. This case underscores the importance of considering IgAV in patients with inflammatory bowel disease who present with cutaneous symptoms while undergoing treatment with advanced therapies.

BACKGROUND: Acute ileitis is most classically associated with inflammatory bowel disease. However, several infections can also cause inflammation or obstruction of the terminal ileum. Clinical presentation is usually acute and characterized by abdominal pain of the right abdomen. CASE REPORT: We report the case of a healthy 24 year-old man who presented with a two month history of right lower quadrant pain, nausea and emesis after returning from a trip to South Africa. Over the subsequent two months, he had continued symptoms and an ileocecal obstruction was demonstrated both on cross-sectional imaging and on colonoscopy. A stool pathogen panel was positive for Campylobacter jejuni, and he completed an empiric three-day course of azithromycin. Endoscopic biopsies were negative for histologic features of inflammatory bowel disease. After three hospitalizations for recurrent obstruction, an ileocecal resection was performed. The resection specimen revealed marked eosinophilia within the muscularis propria and submucosal fibrosis. The patient made an uneventful recovery following his surgery. CONCLUSION: Although inflammatory bowel disease should be excluded during the workup of terminal ileitis, this case illustrates the importance of including infections and post-infectious sequelae in the differential, especially in otherwise healthy patients with recent travel history.