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Multicenter Study
. 2024 Nov 26;120(7):1593-1604.
doi: 10.14309/ajg.0000000000003243.

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

María José García  1 , Yanire Brenes  2 , Miren Vicuña  3 , Fernando Bermejo  4 , Mónica Sierra-Ausín  5 , Raquel Vicente  6 , María Teresa Arroyo  7 , Pilar Martínez Montiel  8 , Albert Villoria  9 , Juan Ángel Ferrer  10 , Vicent Hernandez  11 , Alexis Piñero  12 , Marta Carrillo-Palau  13 , María Dolores Martín-Arranz  14 , José Miranda-Bautista  15 , Ramón Pajares  16 , Laura Arranz Hernández  17 , Ana Bejarano  18 , Jordi Guardiola  19 , Eduardo Iyo  20 , Carmen Muñoz-Villafranca  21 , Aurora Talavera  22 , Horacio Alonso-Galán  23 , Manuel Barreiro-de Acosta  24 , Maia Bosca-Watts  25 , Teresa Vázquez Rey  26 , Ana Echarri  27 , María Del Carmen Rodríguez-Grau  28 , Ana Gutiérrez  29 , José María Huguet  30 , M Carmen López-Martín  31 , Francisco Mesonero  32 , Isabel Pérez-Martínez  33   34 , Rocío Plaza  35 , Patricia Ramírez de la Piscina  36 , Javier P Gisbert  2 , María Chaparro  2
Affiliations
Multicenter Study

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

María José García et al. Am J Gastroenterol. .

Abstract

Introduction: Real-world data on the effectiveness of upadacitinib for inflammatory bowel disease (IBD) are limited. To assess upadacitinib persistence, effectiveness, and safety in a real-world scenario.

Methods: Retrospective multicenter study of patients with IBD 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 4 advanced therapies. Twenty-three discontinued the treatment (median follow-up 7.6 months). CD (vs UC) (hazard ratio 3.7; 95% confidence interval [CI]: 1.04-12.9) and age below 40 years at upadacitinib initiation (hazard ratio 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.

Discussion: Upadacitinib is effective and safe for treating patients with highly refractory IBD, even in previously treated with Janus kinase inhibitors.

Keywords: Crohn's disease; inflammatory bowel disease; real world evidence; ulcerative colitis; upadacitinib.

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References

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