Real-world effectiveness of vedolizumab in refractory pouchitis: a focus on biomarker changes during intravenous to subcutaneous transition (POUCHIVED Study)

Leticia Gimeno-Pitarch¹Elena Céspedes-Martínez²Rocio Ferreiro-Iglesias³María Dolores Martín-Arranz⁴Beatriz Sicilia⁵Inma Lorca⁶JOSE MARÍA HUGUET⁷Francisco Mesonero⁸Raquel Vicente-Lidón⁹Alejandro Mínguez¹⁰Pablo Galvez- Martín¹¹Xavier Serra-Ruiz²Manuel Barreiro-de Acosta³Pilar Nos¹²Marisa Iborra^12*

• ¹Gastroenterology Department, Hospital General Universitari de Castelló (HGUCS), Castellón de la Plana, Spain
• ²Gastroenterology Department, Hospital Universitario Vall d’Hebron, Barcelona, Spain
• ³Gastroenterology Department, Hospital Clínico Universitario de Santiago, Santiago, Spain
• ⁴Gastroenterology Department, Hospital La Paz, Madrid, Spain
• ⁵Gastroenterology Department, Hospital Universitario de Burgos., Burgos, Spain
• ⁶Gastroenterology Department, Hospital Clínico Universitario de Valencia, Valencia, Spain
• ⁷Gastroenterology Department, Hospital General Universitario de Valencia, Valencia, Spain
• ⁸Hospital Universitario Ramón y Cajal, Madrid, Spain
• ⁹Gastroenterology Department, Hospital Universitario Miguel Servet, Zaragoza, Spain
• ¹⁰Gastroenterology Department, La Fe University and Polytechnic Hospital, Valencia,, Valencia, Spain
• ¹¹Gastroenterology Department, Hospital Universitario Vall d’Hebron., Barcelona, Spain
• ¹²Gastroenterology Department, La Fe University and Polytechnic Hospital, Valencia, Spain

This multicentre, real-world study is the first to evaluate the long-term effectiveness and safety of vedolizumab in patients with chronic antibiotic-refractory pouchitis (CARP), with a specific focus on the clinical and biochemical impact of transitioning from intravenous (IV) to subcutaneous (SC) administration. Our findings highlight that vedolizumab is not only effective in this challenging population but also that switching to the SC formulation maintains or improves clinical outcomes, with a favourable safety profile and higher serum drug levels. We believe this work adds valuable evidence to the existing literature by exploring an underrepresented patient population—those with CARP following IPAA—and provides practical insights into the optimization of biologic therapy in real-world settings. Furthermore, our results underscore the potential benefit of early vedolizumab use after colectomy, and of therapeutic drug monitoring in this context.