Evidence map›Paper›PMID 35166347›Full record

ArticleInflammatory bowel diseases2022

Long-Term Real-World Effectiveness and Safety of Ustekinumab in Crohn's Disease Patients: The SUSTAIN Study.

María Chaparro, Iria Baston-Rey, Estela Fernández-Salgado, Javier González García, Laura Ramos, María Teresa Diz-Lois Palomares, Federico Argüelles-Arias, Eva Iglesias Flores, Mercedes Cabello, Saioa Rubio Iturria and 57 more

Open access · greenAbstract readMulticenter Study
In one paragraph

Article in Inflammatory bowel diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 1 pooled it
11.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 1 synthesis or guideline pooled it, 59 citations in OpenAlex.

  1. Efficacy of Dose Escalation of Ustekinumab in Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis.Medical principles and practice : international journal of the Kuwait University, Health Science Centre · 2025
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  15. New Interleukin-23 Antagonists' Use in Crohn's Disease.Pharmaceuticals (Basel, Switzerland) · 2025
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  17. Clinical effectiveness and safety of ustekinumab in youth with refractory inflammatory bowel disease: A retrospective cohort study.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

67 authors at 20 institutions in 1 country.

María ChaparroGastroenterology Department, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa, Universidad Autónoma de Madrid, and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Madrid, Spain.ORCID 0000-0002-9275-4242
Iria Baston-ReyGastroenterology Department, Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain.
Estela Fernández-SalgadoGastroenterology Department, Complejo Hospitalario de Pontevedra, Pontevedra, Spain.
Javier González GarcíaGastroenterology Department, Hospital Público Comarcal la Inmaculada, Almería, Spain.
Laura RamosGastroenterology Department, Hospital Universitario de Canarias, Tenerife, Spain.
María Teresa Diz-Lois PalomaresGastroenterology Department, Hospital Universitario A Coruña, A Coruña, Spain.
Federico Argüelles-AriasGastroenterology Department, Hospital Universitario Virgen Macarena, Facultad de Medicina, Universidad de Sevilla, Seville, Spain.ORCID 0000-0003-3646-8919
Eva Iglesias FloresGastroenterology Department, Hospital Universitario Reina Sofía, Universidad de Córdoba, Instituto Maimónides de Investigación Biomédica de Córdoba, Córdoba, Spain.
Mercedes CabelloGastroenterology Department, Hospital Universitario Virgen de Valme, Seville, Spain.
Saioa Rubio IturriaGastroenterology Department, Complejo Hospitalario de Navarra, Pamplona, Spain.
Andrea Núñez OrtizGastroenterology Department, Hospital Universitario Virgen del Rocío, Seville, Spain.
Mara CharroGastroenterology Department, Hospital de Barbastro, Barbastro, Spain.
Daniel GinardGastroenterology Department, Hospital Universitario Son Espases, Palma, Spain.
Carmen Dueñas SadornilGastroenterology Department, Hospital San Pedro de Alcántara, Cáceres, Spain.
Olga Merino OchoaGastroenterology Department, Hospital Universitario Cruces, Barakaldo, Spain.
David BusquetsGastroenterology Department, Hospital Universitari de Girona Doctor Josep Trueta, Girona, Spain.ORCID 0000-0002-9385-1415
Eduardo IyoGastroenterology Department, Hospital Comarcal de Inca, Inca, Spain.
Ana Gutiérrez CasbasGastroenterology Department, Hospital General Universitario de Alicante, Instituto de Investigación Sanitaria y Biomédica de Alicante, Alicante, Spain.ORCID 0000-0002-5460-4139
Patricia Ramírez de la PiscinaGastroenterology Department, Hospital Universitario de Araba-Txagorritxu, Araba-Txagorritxu, Spain.
Marta Maia Boscá-WattsGastroenterology Department, Hospital Clínico Universitario de Valencia, Valencia, Spain.
Maite ArroyoGastroenterology Department, Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain.
María José GarcíaGastroenterology Department, Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitario Valdecilla (IDIVAL), Santander, Spain.
Esther HinojosaGastroenterology Department, Hospital de Manises, Manises, Spain.
Jordi GordilloGastroenterology Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
Pilar Martínez MontielGastroenterology Department, Hospital Universitario 12 de Octubre, Madrid, Spain.
Benito Velayos JiménezGastroenterology Department, Hospital Clínico Universitario de Valladolid, Valladolid, Spain.
Cristina Quílez IvorraGastroenterology Department, Hospital Marina Baixa, Villajoyosa, Spain.
Juan María Vázquez MorónGastroenterology Department, Hospital Universitario Juan Ramón Jiménez, Huelva, Spain.
José María HuguetGastroenterology Department, Hospital General Universitario de Valencia, Valencia, Spain.
Yago González-LamaGastroenterology Department, Hospital Universitario Puerta de Hierro, Majadahonda, Spain.
Ana Isabel Muñagorri SantosGastroenterology Department, Hospital Universitario de Donostia, Donostia-San Sebastián, Spain.
Víctor Manuel AmoGastroenterology Department, Hospital Regional de Málaga, Málaga, Spain.
María Dolores Martín-ArranzGastroenterology Department, Hospital Universitario de La Paz, Institute for Health Research La Paz, Universidad Autónoma de Madrid, Madrid, Spain.
Fernando BermejoGastroenterology Department, Instituto de Investigación Sanitaria del Hospital La Paz, Hospital Universitario de Fuenlabrada, Madrid, Spain.ORCID 0000-0003-4610-0886
Jesús Martínez CadillaGastroenterology Department, Hospital Alvaro Cunqueiro, Vigo, Spain.
Cristina Rubín de CélixGastroenterology Department, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa, Universidad Autónoma de Madrid, and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Madrid, Spain.
Paola Fradejas SalazarGastroenterology Department, Hospital Virgen de la Concha, Zamora, Spain.
Antonio López San RománGastroenterology Department, Hospital Universitario Ramón y Cajal, Madrid, Spain.
Nuria JiménezGastroenterology Department, Hospital General Universitario de Elche, Elche, Spain.
Santiago García LópezGastroenterology Department, Hospital Universitario Miguel Servet, Zaragoza, Spain.
Anna FiguerolaGastroenterology Department, Hospital General Universitario de Castellón, Castellón de la Plana, Spain.
Itxaso JiménezGastroenterology Department, Hospital Universitario de Galdakao-Usansolo, Galdakao, Spain.
Francisco José Martínez CerezoGastroenterology Department, Hospital Universitario Sant Joan de Reus, Reus, Spain.
Carlos TaxoneraGastroenterology Department, Instituto de Investigación del Hospital Clínico San Carlos, Hospital Clínico Universitario San Carlos, Madrid, Spain.ORCID 0000-0001-9166-7350
Pilar VarelaGastroenterology Department, Hospital Universitario de Cabueñes, Gijón, Spain.
Ruth de FranciscoGastroenterology Department, Instituto de Investigación Biosanitaria del Principado de Asturias, Hospital Universitario Central de Asturias, Oviedo, Spain.
David MonfortGastroenterology Department, Consorci Sanitari de Terrassa, Terrassa, Spain.
Gema Molina ArrieroGastroenterology Department, Complejo Hospitalario Universitario de Ferrol, Ferrol, Spain.
Alejandro Hernández CambaGastroenterology Department, Hospital Universitario Nuestra Señora de Candelaria, Santa Cruz de Tenerife, Spain.
Francisco Javier García-AlonsoGastroenterology Department, Hospital Universitario Rio Hortega, Valladolid, Spain.ORCID 0000-0003-2090-3445
Manuel Van DomselaarGastroenterology Department, Hospital Universitario de Torrejón, Torrejón de Ardoz, Madrid, Spain.
Ramón Pajares VillarroyaGastroenterology Department, Hospital Universitario Infanta Sofía, Madrid, Spain.
Alejandro NúñezGastroenterology Department, Hospital Clínico Universitario de Salamanca, Salamanca, Spain.
Francisco Rodríguez MorantaGastroenterology Department, Hospital Universitario Bellvitge, Barcelona, Spain.
Ignacio Marín-JiménezServicio de Aparato Digestivo, IiSGM, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
Virginia Robles AlonsoGastroenterology Department, Hospital Universitario Vall d´Hebrón, Barcelona, Spain.
María Del Mar Martín RodríguezGastroenterology Department, Hospital Universitario Virgen de las Nieves, Granada, Spain.
Patricia Camo-MonterdeGastroenterology Department, Hospital Universitario San Jorge, Huesca, Spain.
Iván García TerceroGastroenterology Department, Hospital General Universitario Santa Lucía, Cartagena, Spain.
Mercedes Navarro LlavatGastroenterology Department, Hospital de Sant Joan Despí Moisès Broggi, Sant Joan Despí, Spain.
Lara Arias GarcíaGastroenterology Department, Hospital Universitario de Burgos, Burgos, Spain.
Daniel Hervías CruzGastroenterology Department, Hospital General Universitario de Ciudad Real, Ciudad Real, Spain.
Sara SulleiroJanssen Medical Department, Madrid, Spain.
Cynthia NovellaJanssen Medical Department, Madrid, Spain.
Eugenia VispoJanssen Medical Department, Madrid, Spain.
Manuel Barreiro-de AcostaGastroenterology Department, Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain.
Javier P GisbertGastroenterology Department, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa, Universidad Autónoma de Madrid, and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Madrid, Spain.
Hospital Universitario de La Princesa · ESComplejo Hospitalario Universitario de Santiago · ESBellvitge University Hospital · ESCentro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas · ESCentro de Salud Casa del Barco · ESComplejo Hospitalario de Navarra · ESComplejo Hospitalario de Pontevedra · ESComplejo Hospitalario de Salamanca · ESComplexo Hospitalario Universitario A Coruña · ESConsorci Sanitari de Terrassa · ESHospital Clínico San Carlos · ESHospital Clínico Universitario de Valencia · ESHospital Clínico Universitario de Valladolid · ESHospital Clínico Universitario Lozano Blesa · ESHospital Comarcal de Inca · ESHospital de Cruces · ESHospital de Galdakao · ESHospital de Manises · ESHospital de Sant Joan Despí Moisès Broggi · ESHospital de Sant Pau · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLarge real-world-evidence studies are required to confirm the durability of response, effectiveness, and safety of ustekinumab in Crohn's disease (CD) patients in real-world clinical practice.

methodsA retrospective, multicentre study was conducted in Spain in patients with active CD who had received ≥1 intravenous dose of ustekinumab for ≥6 months. Primary outcome was ustekinumab retention rate; secondary outcomes were to identify predictive factors for drug retention, short-term remission (week 16), loss of response and predictive factors for short-term efficacy and loss of response, and ustekinumab safety.

resultsA total of 463 patients were included. Mean baseline Harvey-Bradshaw Index was 8.4. A total of 447 (96.5%) patients had received prior biologic therapy, 141 (30.5%) of whom had received ≥3 agents. In addition, 35.2% received concomitant immunosuppressants, and 47.1% had ≥1 abdominal surgery. At week 16, 56% had remission, 70% had response, and 26.1% required dose escalation or intensification; of these, 24.8% did not subsequently reduce dose. After a median follow-up of 15 months, 356 (77%) patients continued treatment. The incidence rate of ustekinumab discontinuation was 18% per patient-year of follow-up. Previous intestinal surgery and concomitant steroid treatment were associated with higher risk of ustekinumab discontinuation, while a maintenance schedule every 12 weeks had a lower risk; neither concomitant immunosuppressants nor the number of previous biologics were associated with ustekinumab discontinuation risk. Fifty adverse events were reported in 39 (8.4%) patients; 4 of them were severe (2 infections, 1 malignancy, and 1 fever).

conclusionsUstekinumab is effective and safe as short- and long-term treatment in a refractory cohort of CD patients in real-world clinical practice.

Indexed as

Crohn DiseaseUstekinumabHumansImmunosuppressive AgentsRemission InductionRetrospective StudiesTreatment OutcomeImmunosuppressive AgentsUstekinumabCrohn’s diseaseeffectivenessreal-world evidencesafetyustekinumab

Identifiers

PMID35166347
PMCPMC9629456
OpenAlexW4213088258

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