Real-world long-term effectiveness of ustekinumab in Crohn's disease: results from the ENEIDA registry

August 24, 2020

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Publicated to: Alimentary Pharmacology & Therapeutics. 52 (6): 1017-1030 - 2020-09-01 52(6), DOI: 10.1111/apt.15958

Authors: Iborra, Marisa; Beltran, Belen; Fernandez-Clotet, Agnes; Iglesias-Flores, Eva; Navarro, Pablo; Rivero, Montserrat; Gutierrez, Ana; Sierra-Ausin, Monica; Mesonero, Francisco; Ferreiro-Iglesias, Rocio; Hinojosa, Joaquin; Calvet, Xavier; Sicilia, Beatriz; Gonzalez-Munoza, Carlos; Antolin, Beatriz; Gonzalez-Vivo, Maria; Carbajo, Ana Y.; Garcia-Lopez, Santiago; Martin-Cardona, Albert; Suris, Gerard; Dolores Martin-Arranz, Maria; de Francisco, Ruth; Canete, Fiorella; Domenech, Eugeni; Nos, Pilar;GETECCU Grp Grp Espanol Trabajo En

Affiliations

Complejo Asistencial Univ Leon, Leon, Spain - Author

Corp Sanitaria Parc Tauli Sabadell, Sabadell, Spain - Author

Ctr Invest Biomed Red Enfermedades Hepat & Digest, Barcelona, Spain - Author

Hosp Cent Univ Asturias, Oviedo, Spain - Author

Hosp Clin Univ Valencia, Valencia, Spain - Author

Hosp Clin Univ Valladolid, Valladolid, Spain - Author

Hosp Gen Alicante, Alicante, Spain - Author

Hosp Germans Trias I Pujol, Badalona, Spain - Author

Hosp Manises, Manises, Spain - Author

Hosp Mutua Terrassa, Terrassa, Spain - Author

Hosp Parc Salut Mar, Barcelona, Spain - Author

Hosp Ramon Y Cajal Madrid, Madrid, Spain - Author

Hosp Santa Creu & Sant Pau, Barcelona, Spain - Author

Hosp Univ Bellvitge, Barcelona, Spain - Author

Hosp Univ Burgos, Burgos, Spain - Author

Hosp Univ Germans Trias I Pujol, Badalona, Spain - Author

Hosp Univ La Paz, Madrid, Spain - Author

Hosp Univ Marques Valdecilla, Santander, Spain - Author

Hosp Univ Miguel Servet, Zaragoza, Spain - Author

Hosp Univ Reina Sofia Cordoba, Cordoba, Spain - Author

Hosp Univ Rio Hortega, Valladolid, Spain - Author

Hosp Univ Santiago, Santiago, Spain - Author

Inst Invest Biometr August Pi I Sunyer IDIBA, Inflammatory Bowel Dis Grp, Barcelona, Spain - Author

La Fe Univ, Inflammatory Bowel Dis Unit, Valencia, Spain - Author

Polytech Hosp, Valencia, Spain - Author

Abstract

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.

Keywords

Anti-tnfInflammatory-bowel-diseaseOutcomesPlaceTherapyVedolizumab

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The work has been published in the journal Alimentary Pharmacology & Therapeutics due to its progression and the good impact it has achieved in recent years, according to the agency WoS (JCR), it has become a reference in its field. In the year of publication of the work, 2020, it was in position 13/276, thus managing to position itself as a Q1 (Primer Cuartil), in the category Pharmacology & Pharmacy. Notably, the journal is positioned above the 90th percentile.

From a relative perspective, and based on the normalized impact indicator calculated from World Citations provided by WoS (ESI, Clarivate), it yields a value for the citation normalization relative to the expected citation rate of: 1.36. This indicates that, compared to works in the same discipline and in the same year of publication, it ranks as a work cited above average. (source consulted: ESI Nov 13, 2025)

Specifically, and according to different indexing agencies, this work has accumulated citations as of 2025-12-15, the following number of citations:

WoS: 29

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