Real‐World Effectiveness and Safety of Upadacitinib in Crohn's Disease: Insights From the Eneida Registry

BACKGROUND: Upadacitinib (UPA) is the first oral Janus kinase (JAK) inhibitor approved for the treatment of Crohn's disease (CD). Real-world data, particularly from large nationwide cohorts, remain limited. This study aimed to evaluate the real-world effectiveness, safety, and treatment persistence of UPA in patients with CD. METHODS: Multicenter observational study including patients with CD who received UPA, using data from a nationwide registry. Patients were classified according to active luminal disease, extraintestinal manifestations (EIMs), or combination therapy with another biological therapy. Disease activity was assessed using the Harvey-Bradshaw Index (HBI), C-reactive protein (CRP), and fecal calprotectin (FC) at baseline and weeks 12, 24, and 52. Endoscopic outcomes were evaluated when available. Adverse events (AEs), hospitalizations, and treatment discontinuations were recorded. RESULTS: 300 patients were included, representing a highly treatment-refractory population, with 98% previously exposed to anti-TNF agents and 59% to three or more advanced therapies. In those treated for active luminal disease, corticosteroid-free clinical remission was achieved in 60%-62% of patients at weeks 12, 24 and 52. CRP normalization increased from 64% at week 12%-74% at week 52, while FC normalization improved from 48% to 64%. Patients treated for EIMs achieved high and sustained remission rates with excellent treatment persistence. Early remission at week 12 was strongly associated with sustained remission and meaningful endoscopic improvement. UPA was discontinued in 98 patients (39%). AEs were reported in 71 patients (24%). CONCLUSIONS: In this large real-world cohort, UPA demonstrated sustained clinical and biochemical effectiveness, meaningful endoscopic response, and a safety profile consistent with clinical trial data. Early response emerged as a key predictor of long-term outcomes, supporting the clinical utility of UPA.

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United European Gastroenterology Journal
Published
2026-04-30
DOI
https://doi.org/10.1002/ueg2.70223
Primary Topic
Inflammatory Bowel Disease
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article

Real‐World Effectiveness and Safety of Upadacitinib in Crohn's Disease: Insights From the Eneida Registry

Alejandro Hernández-Camba, I Ferrer-Bradley, I García de la Filia, M J García et al.
United European Gastroenterology Journal
Inflammatory Bowel Disease
article

Real‐World Effectiveness and Safety of Upadacitinib in Crohn's Disease: Insights From the Eneida Registry

Alejandro Hernández-Camba, I Ferrer-Bradley, I García de la Filia, M J García, M Sierra-Ausín, A Balaguer, C Rodríguez-Gutiérrez, B Sicilia, E Fernández-Velado, J M Paredes, A Gutiérrez-Casbas, M Calafat, Á Ponferrada-Díaz, I Rodríguez-Lago, S Lario, J M Huguet, A Mínguez, L Ramos, S Rodríguez-Sánchez, E Brunet-Mas, E Betoré, D Martín-Rodríguez, M Vicuña, E Rodríguez-González, M Iborra, A Garrido, J Barrio, I Vera, J P Gisbert, C Suárez-Ferrer, L García-Alles, S Castellet-Farrús, A Mancebo, D R de La Cruz, M Chaparro, B Botella, E Domènech, M Barreiro-de Acosta, E Ricart, R Vicente-Lidón, I Ordás, F Argüelles-Arias, N Jiménez, C Martínez-Pascual, D Ceballos, M Moreta, M D Martín-Arranz, J Tosca-Cuquerella, P Varela, P Nos, Y González-Lama, L Almenara-Michelena
article en

Abstract

BACKGROUND: Upadacitinib (UPA) is the first oral Janus kinase (JAK) inhibitor approved for the treatment of Crohn's disease (CD). Real-world data, particularly from large nationwide cohorts, remain limited. This study aimed to evaluate the real-world effectiveness, safety, and treatment persistence of UPA in patients with CD. METHODS: Multicenter observational study including patients with CD who received UPA, using data from a nationwide registry. Patients were classified according to active luminal disease, extraintestinal manifestations (EIMs), or combination therapy with another biological therapy. Disease activity was assessed using the Harvey-Bradshaw Index (HBI), C-reactive protein (CRP), and fecal calprotectin (FC) at baseline and weeks 12, 24, and 52. Endoscopic outcomes were evaluated when available. Adverse events (AEs), hospitalizations, and treatment discontinuations were recorded. RESULTS: 300 patients were included, representing a highly treatment-refractory population, with 98% previously exposed to anti-TNF agents and 59% to three or more advanced therapies. In those treated for active luminal disease, corticosteroid-free clinical remission was achieved in 60%-62% of patients at weeks 12, 24 and 52. CRP normalization increased from 64% at week 12%-74% at week 52, while FC normalization improved from 48% to 64%. Patients treated for EIMs achieved high and sustained remission rates with excellent treatment persistence. Early remission at week 12 was strongly associated with sustained remission and meaningful endoscopic improvement. UPA was discontinued in 98 patients (39%). AEs were reported in 71 patients (24%). CONCLUSIONS: In this large real-world cohort, UPA demonstrated sustained clinical and biochemical effectiveness, meaningful endoscopic response, and a safety profile consistent with clinical trial data. Early response emerged as a key predictor of long-term outcomes, supporting the clinical utility of UPA.

United European Gastroenterology JournalVol. 14(4)
Universidad de Las Palmas de Gran Canaria (ES), Universidad Complutense de Madrid (ES), Universitat Autònoma de Barcelona (ES), Hospital Universitario de Canarias (ES), Hospital Universitario La Paz (ES), Instituto de Salud Carlos III (ES), Bellvitge University Hospital (ES), Hospital Universitari i Politècnic La Fe (ES), Research Institute Hospital 12 de Octubre (ES), Hospital Universitario Nuestra Señora de Candelaria (ES), Hospital Universitario Virgen Macarena (ES), Hospital Clínico Universitario de Valencia (ES), Complejo Hospitalario Universitario de Santiago (ES), Hospital Universitario de Gran Canaria Doctor Negrín (ES), Marqués de Valdecilla University Hospital (ES), Hospital Universitario 12 De Octubre (ES), Hospital Sierrallana (ES), Hospital Universitario Puerta de Hierro Majadahonda (ES), Navarre Institute of Health Research (ES), Instituto de Investigación Marqués de Valdecilla (ES), Hospital Universitario Miguel Servet (ES), Centro de Investigación Biomédica en Red (ES), Hospital Clínic de Barcelona (ES), Hospital Universitario de Burgos (ES), Hospital General Universitario de Elche (ES), Hospital de Galdakao (ES), Leitat Technological Center (ES), Hospital de Manises (ES), Junta de Castilla y León (ES), Institut d'Investigacions Biomèdiques de Barcelona (ES), Hospital Universitario Doctor Peset (ES), Hospital General Universitario De Valencia (ES), Hospital Universitario de La Princesa (ES), Institute of Research and Innovation Parc Tauli (ES), Hospital General Universitario de Alicante Doctor Balmis (ES), Instituto Murciano de Investigación Biosanitaria (ES), Instituto de Investigación Sanitaria de Santiago (ES), Hospital Universitario De Cabueñes (ES), Hospital Universitario Virgen de la Arrixaca (ES), Hospital Universitari Germans Trias i Pujol (ES), Hospital General San Jorge (ES), Hospital Universitario Río Hortega (ES), Hospital Universitario Ramón y Cajal (ES), Complejo Asistencial Universitario de Palencia (ES), Hospital Universitario Infanta Leonor (ES), Hospital Universitario Infanta Cristina (ES), Instituto de Investigación Sanitaria La Fe (ES), Universidad Autónoma de Madrid (ES)
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