Evidence map›Paper›PMID 35448949›Full record

ArticleBMC gastroenterology2022

Long-term effectiveness and safety of ustekinumab in bio-naïve and bio-experienced anti-tumor necrosis factor patients with Crohn's disease: a real-world multicenter Brazilian study.

Rogério Serafim Parra, Júlio Maria Fonseca Chebli, Natália Sousa Freitas Queiroz, Aderson Omar Mourão Cintra Damião, Matheus Freitas Cardoso de Azevedo, Liliana Andrade Chebli, Erika Ruback Bertges, Antonio José Tiburcio Alves Junior, Orlando Ambrogini Junior, Bianca Loyo Pona Schiavetti da Silva and 10 more

Open access · goldAbstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC gastroenterology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
4.1field-weighted citation impact, top 6% 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

16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 23 citations in OpenAlex.

  1. Saudi consensus guidance for the diagnosis and management of inflammatory bowel disease in children and adolescents.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2025
    Guideline
  2. Pooled it
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  6. Ustekinumab is safe and effective in pediatric patients with Crohn's disease.Journal of pediatric gastroenterology and nutrition · 2025
    Article
  7. Observational
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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

20 authors at 12 institutions in 1 country.

Rogério Serafim ParraDepartment of Surgery and Anatomy, Ribeirão Preto Medical School, University of São Paulo, Av. Bandeirantes, 3900, Ribeirão Preto, SP, Zip code: 14048-900, Brazil. rsparra@hcrp.usp.br.ORCID http://orcid.org/0000-0002-5566-9284
Júlio Maria Fonseca ChebliFederal University of Juiz de Fora, Juiz de Fora, Brazil.
Natália Sousa Freitas QueirozUniversidade de São Paulo, São Paulo, Brazil.
Aderson Omar Mourão Cintra DamiãoUniversidade de São Paulo, São Paulo, Brazil.
Matheus Freitas Cardoso de AzevedoUniversidade de São Paulo, São Paulo, Brazil.
Liliana Andrade ChebliFederal University of Juiz de Fora, Juiz de Fora, Brazil.
Erika Ruback BertgesFederal University of Juiz de Fora, Juiz de Fora, Brazil.
Antonio José Tiburcio Alves JuniorPontifícia Universidade Católica, Campinas, Brazil.
Orlando Ambrogini JuniorFederal University of São Paulo, São Paulo, Brazil.
Bianca Loyo Pona Schiavetti da SilvaPrefeitura Municipal de Santos, Santos, Brazil.
Marcio LubiniPasso Fundo University, Passo Fundo, Brazil.
Mauro BafuttoFederal University of Goiás, Goiânia, Brazil.
Cristina FloresFederal University of Rio Grande do Sul, Porto Alegre, Brazil.
Eduardo Garcia VilelaFederal University of Minas Gerais, Belo Horizonte, Brazil.
Sandra Felice BorattoCentro Universitário Saúde ABC, Santo André, Brazil.
Newton Luiz Tricarico Gasparetti JuniorHospital Vivalle Rede D'Or, São José dos Campos, Brazil.
Flavio SteinwurzHospital Israelita Albert Einstein, São Paulo, Brazil.
Nayara Salgado CarvalhoHospital Israelita Albert Einstein, São Paulo, Brazil.
Omar FéresDepartment of Surgery and Anatomy, Ribeirão Preto Medical School, University of São Paulo, Av. Bandeirantes, 3900, Ribeirão Preto, SP, Zip code: 14048-900, Brazil.
José Joaquim Ribeiro da RochaDepartment of Surgery and Anatomy, Ribeirão Preto Medical School, University of São Paulo, Av. Bandeirantes, 3900, Ribeirão Preto, SP, Zip code: 14048-900, Brazil.
Universidade de São Paulo · BRUniversidade Federal de Juiz de Fora · BRHospital Israelita Albert Einstein · BRFaculdade de Medicina do ABC · BRPontifícia Universidade Católica de Campinas · BRPrefeitura Municipal de Vitória · BRUniversidade de Passo Fundo · BRUniversidade de Ribeirão Preto · BRUniversidade Federal de Goiás · BRUniversidade Federal de Minas Gerais · BRUniversidade Federal de São Paulo · BRUniversidade Federal do Rio Grande do Sul · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe effectiveness of ustekinumab (UST) in the treatment of Crohn's disease (CD) has been demonstrated in the pivotal Phase 3 UNITI 1 and 2 and IM-UNITI studies in both anti-TNF-naïve and anti-TNF-exposed patients. Given the selective nature of pivotal trial designs, real-world effectiveness and safety studies are warranted. We report our experience with UST treatment in a large, real-world multicenter cohort of Brazilian patients with CD.

methodsWe performed a retrospective multicenter study including patients with CD, predominantly biologically refractory CD, who received UST. The primary endpoint was the proportion of patients in clinical remission at weeks 8, 24 and 56. Possible predictors of clinical and biological response/remission and safety outcomes were also assessed.

resultsOverall, 245 CD (mean age 39.9 [15-87]) patients were enrolled. Most patients (86.5%) had been previously exposed to biologics. According to nonresponder imputation analysis, the proportions of patients in clinical remission at weeks 8, 24 and 56 were 41.0% (n = 98/239), 64.0% (n = 153/239) and 39.3% (n = 94/239), respectively. A biological response was achieved in 55.4% of patients at week 8, and 59.3% were in steroid-free remission at the end of follow-up. No significant differences in either clinical or biological remission were noted between bio-naïve and bio-experienced patients. Forty-eight patients (19.6%) presented 60 adverse events during the follow-up, of which 8 (13.3%) were considered serious adverse events (3.2% of 245 patients). Overall, a proximal disease location, younger age, perianal involvement, and smoking were associated with lower rates of clinical remission over time.

conclusionsUST therapy was effective and safe in the long term in this large real-life cohort of Brazilian patients with refractory CD, regardless of previous exposure to other biological agents.

Indexed as

Crohn DiseaseUstekinumabAdultBrazilHumansRemission InductionRetrospective StudiesTreatment OutcomeTumor Necrosis Factor-alphaTumor Necrosis Factor InhibitorsTumor Necrosis Factor-alphaTumor Necrosis Factor InhibitorsUstekinumabBiological therapyCrohn’s diseaseInflammatory bowel diseaseUstekinumab

Identifiers

PMID35448949
PMCPMC9027080
OpenAlexW4224299384

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.