Persistence, Effectiveness, and Safety of Upadacitinib in Crohn's Disease and Ulcerative Colitis in Real Life: Results From a Spanish Nationwide Study (Ureal Study)

  1. García, María José 8
  2. Brenes, Yanire 9
  3. Vicuña, Miren 18
  4. Bermejo, Fernando 21
  5. Sierra-Ausín, Mónica 22
  6. Vicente, Raquel 13
  7. Arroyo, María Teresa 11
  8. Martínez Montiel, Pilar 19
  9. Villoria, Albert 1
  10. Ferrer, Juan Ángel 14
  11. Hernandez, Vicent 12
  12. Piñero, Alexis 36
  13. Carrillo-Palau, Marta 28
  14. Martín-Arranz, María Dolores 31
  15. Miranda-Bautista, José 5
  16. Pajares, Ramón 23
  17. Arranz Hernández, Laura 6
  18. Bejarano, Ana 29
  19. Guardiola, Jordi 30
  20. Iyo, Eduardo 35
  21. Muñoz-Villafranca, Carmen 32
  22. Talavera, Aurora 2
  23. Alonso-Galán, Horacio 33
  24. Barreiro-de Acosta, Manuel 3
  25. Bosca-Watts, Maia 24
  26. Vázquez Rey, Teresa 16
  27. Echarri, Ana 25
  28. Rodríguez-Grau, María del Carmen 20
  29. Gutiérrez, Ana 10
  30. Huguet, José María 34
  31. López-Martín, M. Carmen 15
  32. Mesonero, Francisco 17
  33. Pérez-Martínez, Isabel 2627
  34. Plaza, Rocío 7
  35. Ramírez de la Piscina, Patricia 4
  36. Gisbert, Javier P. 9
  37. Chaparro, María 9
  38. Mostrar todos os autores +
  1. 1 Gastroenterology Department, Consorci Corporació Sanitària Parc Taulí, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Sabadell, Spain;
  2. 2 Gastroenterology Department, Hospital Infanta Elena, Huelva, Spain;
  3. 3 Gastroenterology Department, Hospital Clínico Universitario de Santiago, Santiago de Compostela, Spain;
  4. 4 Gastroenterology Department, Hospital Universitario Vitoria-Gastéiz, Vitoria, Spain.
  5. 5 Gastroenterology Department, Hospital Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), Madrid, Spain;
  6. 6 Gastroenterology Department, Hospital Universitario Nuestra Señora de la Candelaria, Santa Cruz de Tenerife, Spain;
  7. 7 Gastroenterology Department, Hospital Universitario Infanta Leonor, Madrid, Spain;
  8. 8 Gastroenterology and Hepatology Department, Hospital Universitario Marqués de Valdecilla, Grupo de Investigación Sanitaria Valdecilla (IDIVAL), Universidad de Cantabria, Santander, Spain;
  9. 9 Gastroenterology Department, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Universidad Autónoma de Madrid (UAM) and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain;
  10. 10 Gastroenterology Department, Hospital General Universitario Dr Balmis de Alicante and Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL), CIBERehd, Alicante, Spain;
  11. 11 Gastroenterology Department, Hospital Clínico Universitario “Lozano Blesa”, IIS Aragón and CIBERehd, Zaragoza, Spain;
  12. 12 Gastroenterology Department, Hospital Álvaro Cunqueiro, Instituto de Investigación Sanitaria Galicia Sur (IIS Galicia Sur), SERGAS-UVIGO, Vigo, Spain;
  13. 13 Gastroenterology Department, Hospital Universitario Miguel Servet, Zaragoza, Spain;
  14. 14 Gastroenterology Department, Hospital Universitario Fundación Alcorcón, Madrid, Spain;
  15. 15 Gastroenterology Department, Hospital Universitario Infanta Elena, Madrid, Spain;
  16. 16 Gastroenterology Department, Hospital Universitario de A Coruña, A Coruña, Spain;
  17. 17 Gastroenterology Department, Hospital Universitario Ramón y Cajal, Madrid, Spain;
  18. 18 Gastroenterology Department, Complejo Hospitalario de Navarra, Pamplona, Spain;
  19. 19 Gastroenterology Department, Hospital Universitario 12 de Octubre, Madrid, Spain;
  20. 20 Gastroenterology Department, Hospital Universitario de Henares, Coslada, Spain;
  21. 21 Gastroenterology Department, Hospital Universitario de Fuenlabrada, Madrid, Spain;
  22. 22 Gastroenterology Department, Complejo Asistencial Universitario de León, León, Spain;
  23. 23 Gastroenterology Department, Hospital Universitario Infanta Sofía, San Sebastián de los Reyes, Spain;
  24. 24 Gastroenterology Department, Hospital Clínico Universitario de Valencia, Valencia, Spain;
  25. 25 Gastroenterology Department, Hospital Arquitecto Marcide, Ferrol, La Coruña, Spain;
  26. 26 Gastroenterology Department, Hospital Universitario Central de Asturias, Oviedo, Spain;
  27. 27 Diet, Microbiota and Health Group, Instituto de Investigación Sanitaria del Principado de Asturias (ISPA), Oviedo, Spain;
  28. 28 Gastroenterology Department, Hospital Universitario de Canarias, La Laguna, Spain;
  29. 29 Gastroenterology Department, Hospital Juan Ramón Jiménez, Huelva, Spain;
  30. 30 Gastroenterology Department, Bellvitge University Hospital, Bellvitge Biomedical Research Institute-IDIBELL, University of Barcelona, L'Hospitalet de Llobregat, Barcelona, Spain;
  31. 31 Gastroenterology Department, Hospital Universitario La Paz, Instituto de Investigación Sanitaria La Paz (IdiPaz), Universidad Autónoma de Madrid, Madrid, Spain;
  32. 32 Gastroenterology Department, Hospital Universitario de Basurto, Bilbao, Spain;
  33. 33 Gastroenterology Department, Hospital Universitario Donostia, Instituto Biogipuzkoa, San Sebastián, Spain;
  34. 34 Gastroenterology Department, Hospital General Universitario de Valencia, Valencia, Spain;
  35. 35 Gastroenterology Department, Hospital Comarcal de Inca, Inca, Spain;
  36. 36 Gastroenterology Department, Hospital Universitario de Jerez de la Frontera, Jerez de la Frontera, Spain;
Revista:
American Journal of Gastroenterology

ISSN: 0002-9270 1572-0241

Ano de publicación: 2024

Tipo: Artigo

DOI: 10.14309/AJG.0000000000003243 SCOPUS: 2-s2.0-85210756748 GOOGLE SCHOLAR lock_openAcceso aberto editor

Outras publicacións en: American Journal of Gastroenterology

Resumo

Background: Real-world data on the effectiveness of upadacitinib for inflammatory bowel disease (IBD) are limited.Aims: To assess upadacitinib persistence, effectiveness, and safety in a real-world scenario.Methods: Retrospective multicentre study of IBD patients who received upadacitinib before 31st December 2022 and at least 12 weeks before the recruitment date.Clinical effectiveness was assessed based on partial Mayo score for ulcerative colitis (UC) and Harvey-Bradshaw index for Crohn's disease (CD).Results: We included 100 patients (68 with CD, and 32 with UC).Patients had previously received a median of four advanced therapies.Twenty-three discontinued the treatment (median follow-up 7.6 months).CD (vs.UC) (Hazard Ratio[HR] 3.7;95%Confidence Interval (CI):1.04-12.9), and age below 40 years at upadacitinib initiation (HR 2.4;95%CI:1.0-5.8) were associated with treatment discontinuation in multivariable analysis.Clinical remission for IBD was achieved in 59% of patients at week 8, 64% at week 12, and 42% at week 52.The proportion of patients with UC previously exposed to tofacitinib (n=25) who achieved clinical remission was 78% at week 12, and 50% at week 52.Factors associated with clinical remission at week 12 were UC diagnosis (Odds Ratio[OR] 4.6;95%CI:1.3-17), mild or moderate activity at baseline (OR 8;95%CI:1.1-56) and not smoking (OR 4.4;95%CI:1.5-13).Dose escalation recaptured remission in 60% of patients with relapse.Eighty percent of patients with active immune-mediated diseases or extraintestinal manifestations improved with upadacitinib.Forty-three patients reported adverse events, 11 of them serious.Conclusion: Upadacitinib is effective and safe for treating highly refractory IBD patients, even in previously treated with JAK inhibitors.

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