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P505 Real-world short-term effectiveness of ustekinumab in Crohn’s disease: Results from the ENEIDA Registry

M. Iborra*1, B. Beltrán1, A. Fernández2, A. Gutiérrez3, B. Antolín4, J. M. Huguet5, R. de Francisco6, O. Merino7, D. Carpio8, S. García López9, F. Mesonero10, M. Mínguez11, R. Ferreiro12, A. Y. Carbajo13, M. Rivero14, M. Chaparro15, M. C. Piñero-Pérez16, D. Monfort i Miquel17, L. Bujanda18, M. F. García-Sepulcre19, A. Martín-Cardona20, F. Cañete21, C. Taxonera22, M. Sierra-Ausin23, J. Á. Ferrer-Rosique24, M. D. Martín-Arranz25, C. González-Muñosa26, N. Manceñido-Marcos27, I. Rodríguez-Lago28, E. Iglesias-Flores29, A. Forés-Bosch30, M. Navarro-Llavat31, M. Calafat32, R. E. Madrigal-Domínguez33, L. Ramos34, M. Arroyo35, D. Busquets36, R. Lorente37, E. Saiz-Arnau38, A. Hernández-Camba39, V. Jair-Morales40, C. Paredes41, M. Van Domselaar42, D. Hervás43, A. Cañada-Martínez43, P. Nos43

1Hospital Universitario y Politécnico La Fe, Gastroenterology, Valencia, Spain, 2Hospital Clínic de Barcelona, Barcelona, Spain, 3Hospital General Universitario de Alicante, Alicante, Spain, 4Hospital Clínico Universitario de Valladolid, Valladolid, Spain, 5Hospital General Universitario de Valencia, Valencia, Spain, 6Hospital Universitario Central de Asturias, Oviedo, Spain, 7Hospital Universitario Cruces, Barakaldo, Spain, 8Complexo Hospitalario Universitario de Pontevedra, Pontevedra, Spain, 9Hospital Universitario Miguel Servet, Zaragoza, Spain, 10Hospital Universitario Ramón y Cajal, Madrid, Spain, 11Hospital Clínico Universitario de Valencia, Valencia, Spain, 12Hospital Universitario de Santiago, Santiago de Compostela, Spain, 13Hospital Universitario Río Hortega, Valladolid, Spain, 14Hospital Universitario Marqués de Valdecilla, Santander, Spain, 15Hospital Universitario La Princesa, Madrid, Spain, 16Hospital Clínico Universitario de Salamanca, Salamanca, Spain, 17Consorci Sanitari de Terrassa, Terrassa, Spain, 18Hospital Universitario Donostia, Donostia-San Sebastián, Spain, 19Hospital General Universitario de Elche, Elche, Spain, 20Hospital Mutua de Terrassa, Terrassa, Spain, 21Hospital Universitario Germans Trias i Pujol, Badalona, Spain, 22Hospital Universitario Clínico San Carlos, Madrid, Spain, 23Complejo Asistencial Universitario de León, León, Spain, 24Hospital Universitario Fundación Alcorcón, Alcorcón, Spain, 25Hospital Universitario La Paz, Madrid, Spain, 26Hospital Santa Creu i Sant Pau, Barcelona, Spain, 27Hospital Universitario Infanta Sofía, Madrid, Spain, 28Hospital Universitario de Galdakao, Galdakao, Spain, 29Hospital Universitario Reina Sofía, Córdoba, Spain, 30Hospital General Universitario de Castellón, Castellón, Spain, 31Hospital de Sant Joan Despí Moisès Broggi, Barcelona, Spain, 32Hospital Universitario Son Llàtzer, Palma de Mallorca, Spain, 33Complejo Hospitalario de Palencia, Palencia, Spain, 34Hospital Universitario de Canarias, Las Palmas, Spain, 35Hospital Central Universitario Lozano Blesa, Zaragoza, Spain, 36Hospital Universitario de Girona Dr J. Trueta, Girona, Spain, 37Hospital General Universitario de Ciudad Real, Ciudad Real, Spain, 38Hospital Universitari Arnau de Vilanova, Lleida, Spain, 39Hospital Universitario Nuestra Sra. de la Candelaria, Tenerife, Spain, 40Hospital General de Granollers, Granollers, Spain, 41Hospital Universitario Doctor Peset, Valencia, Spain, 42Hospital Universitario de Torrejón, Torrejón de Ardoz, Spain, 43Hospital Universitario y Politécnico La Fe, Valencia, Spain

Background

Ustekinumab is a monoclonal antibody targeting interleukins 12 and 23. Its effectiveness in clinical practice has not yet been demonstrated. The aim of this study was to assess the real-world, short-term effectiveness of ustekinumab in medically refractory Crohn’s disease (CD) (CROHNUSK study).

Methods

Multi-centre study of CD patients receiving ustekinumab after June 2017 (when it was approved in Spain) and at the recommend dose (a single iv infusion of 6 mg/kg followed by a sc injection of 90 mg at Week 8). The Harvey‐Bradshaw Index (HBI) was used to evaluate clinical remission (HBI score ≤4). Values for HBI, C-reactive protein (CRP), and faecal calprotectin (FC) were recorded at baseline and at Weeks 8 and 14. Demographic and clinical data, endoscopy at baseline when available, previous treatments, adverse events (AEs), and hospitalisations were documented. Possible predictors of clinical remission were examined.

Results

A total of 305 CD patients were analysed (Table 1).

Characteristics of study population

At baseline, 217 (72%) had an HBI score of >4 points. Of these, 101 (47%) and 126 (58%) achieved clinical remission at Weeks 8 and 14, respectively. Of the 109 patients who were on corticosteroids at baseline, 52 (48%) were in corticosteroid-free remission at Week 14. FC levels returned to normal (<250 µg/g) in 66 (22%) and 74 (24%) patients at Weeks 8 and 14, respectively. CRP returned to normal levels (<3 mg/l) in 122 (40%) and 106 (35%) patients at Week 8 and 14, respectively. HBI, FC, and CRP values over time are shown in Figure 1.

HBI, FC, and CRP values over time.

AEs were recorded in 12% of patients. A total of 40 patients (13%) were hospitalised, in 7 cases owing to AEs. Intolerance to the most recent anti-TNF agent and fewer previous anti-TNF agents were associated with clinical remission at Week 14. Endoscopic severity, but not previous vedolizumab treatment, was associated with poor response.

Conclusion

This is the first study to show the real-world safety and effectiveness of ustekinumab in a large cohort of highly refractory CD patients.