Real-world long-term effectiveness of ustekinumab in Crohn's disease: results from the ENEIDA registry
Por:
Iborra, M, Beltran, B, Fernandez-Clotet, A, Iglesias-Flores, E, Navarro, P, Rivero, M, Gutierrez, A, Sierra-Ausin, M, Mesonero, F, Ferreiro-Iglesias, R, Hinojosa, J, Calvet, X, Sicilia, B, Gonzalez-Munoza, C, Antolin, B, Gonzalez-Vivo, M, Carbajo, AY, Garcia-Lopez, S, Martin-Cardona, A, Suris, G, Martin-Arranz, MD, de Francisco, R, Canete, F, Domenech, E, Nos, P
Publicada:
1 sep 2020
Ahead of Print:
1 ago 2020
Resumen:
Background Data on the long-term administration of ustekinumab in recommended doses are limited. Aim To assess the real-world, long-term effectiveness of ustekinumab in refractory Crohn's disease (CD). Methods Multicenter study of CD patients starting ustekinumab at the recommended dose, followed for 1 year. Values for the Harvey-Bradshaw Index (HBI), endoscopic activity, C-reactive protein (CRP), and faecal calprotectin (FC) were recorded at baseline and at weeks 26 and 52. Demographic and clinical data, previous treatments, adverse events (AEs) and hospitalisations were documented. Potential predictors of remission were examined. Results A total of 407 patients were analysed. The initial maintenance dose of 90 mg SC was administered every 12, 8 and 4 weeks in 56 (14%), 347 (85%) and 4 (1%) patients, respectively. After 52 weeks, treatment was discontinued in 112 patients (27.5%). At baseline, 295 (72%) had an HBI >4 points. Of these, 169 (57%) and 190 (64%) achieved clinical remission at weeks 26 and 52, respectively. FC levels returned to normal in 44% and 54% of patients at weeks 26 and 52, and CRP returned to normal in 36% and 37% of patients at weeks 26 and 52, respectively. AEs were recorded in 60 patients. The use of fewer previous anti-TNF alpha agents and ileal localisation were associated with clinical remission, and endoscopic severity was associated with poor response. No factors correlated with endoscopic remission. Conclusion After 52 weeks, ustekinumab demonstrated effectiveness to induce clinical and endoscopic remission with safety in patients with refractory CD.
Filiaciones:
Iborra, M:
La Fe Univ, Inflammatory Bowel Dis Unit, Valencia, Spain
Polytech Hosp, Valencia, Spain
Ctr Invest Biomed Red Enfermedades Hepat & Digest, Barcelona, Spain
Beltran, B:
La Fe Univ, Inflammatory Bowel Dis Unit, Valencia, Spain
Polytech Hosp, Valencia, Spain
Ctr Invest Biomed Red Enfermedades Hepat & Digest, Barcelona, Spain
Fernandez-Clotet, A:
Inst Invest Biometr August Pi I Sunyer IDIBA, Inflammatory Bowel Dis Grp, Barcelona, Spain
Iglesias-Flores, E:
Hosp Univ Reina Sofia Cordoba, Cordoba, Spain
Navarro, P:
Hosp Clin Univ Valencia, Valencia, Spain
Rivero, M:
Hosp Univ Marques Valdecilla, Santander, Spain
Gutierrez, A:
Ctr Invest Biomed Red Enfermedades Hepat & Digest, Barcelona, Spain
Hosp Gen Alicante, Alicante, Spain
Sierra-Ausin, M:
Complejo Asistencial Univ Leon, Leon, Spain
Mesonero, F:
Hosp Ramon Y Cajal Madrid, Madrid, Spain
Ferreiro-Iglesias, R:
Hosp Univ Santiago, Santiago, Spain
Hinojosa, J:
Hosp Manises, Manises, Spain
Calvet, X:
Corp Sanitaria Parc Tauli Sabadell, Sabadell, Spain
Sicilia, B:
Hosp Univ Burgos, Burgos, Spain
Gonzalez-Munoza, C:
Hosp Santa Creu & Sant Pau, Barcelona, Spain
Antolin, B:
Hosp Clin Univ Valladolid, Valladolid, Spain
Gonzalez-Vivo, M:
Hosp Parc Salut Mar, Barcelona, Spain
Carbajo, AY:
Hosp Univ Rio Hortega, Valladolid, Spain
Garcia-Lopez, S:
Hosp Univ Miguel Servet, Zaragoza, Spain
Martin-Cardona, A:
Ctr Invest Biomed Red Enfermedades Hepat & Digest, Barcelona, Spain
Hosp Mutua Terrassa, Terrassa, Spain
Suris, G:
Hosp Univ Bellvitge, Barcelona, Spain
Martin-Arranz, MD:
Hosp Univ La Paz, Madrid, Spain
de Francisco, R:
Hosp Cent Univ Asturias, Oviedo, Spain
Canete, F:
Hosp Germans Trias I Pujol, Badalona, Spain
Domenech, E:
Ctr Invest Biomed Red Enfermedades Hepat & Digest, Barcelona, Spain
Hosp Univ Germans Trias i Pujol, Badalona, Spain
Nos, P:
La Fe Univ, Inflammatory Bowel Dis Unit, Valencia, Spain
Polytech Hosp, Valencia, Spain
Ctr Invest Biomed Red Enfermedades Hepat & Digest, Barcelona, Spain
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