Evidence map›Paper›PMID 40102788›Full record

Observational studyBMC gastroenterology2025

Tofacitinib for ulcerative colitis in Brazil: a multicenter observational study on effectiveness and safety.

Rogério Serafim Parra, Renata de Sá Brito Fróes, Daniela Oliveira Magro, Sandro da Costa Ferreira, Munique Kurtz de Mello, Matheus Freitas Cardoso de Azevedo, Aderson Omar Mourão Cintra Damião, Alexandre de Sousa Carlos, Luísa Leite Barros, Maria Luiza Queiroz de Miranda and 15 more

Abstract readObservational StudyMulticenter Study
In one paragraph

Observational study in BMC gastroenterology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

25 authors.

Rogério Serafim ParraDepartment of Surgery and Anatomy, Ribeirão Preto Medical School, University of São Paulo. Ribeirão Preto, São Paulo, Brazil. rsparra@hcrp.usp.br.ORCID http://orcid.org/0000-0002-5566-9284
Renata de Sá Brito FróesGastromed, Department of Gastroenterology and Endoscopy, Rio de Janeiro, Brazil.ORCID http://orcid.org/0000-0003-3256-4698
Daniela Oliveira MagroDepartment of Surgery, State University of Campinas (UNICAMP), Campinas, SP, Brazil.ORCID http://orcid.org/0000-0002-8180-6254
Sandro da Costa FerreiraDepartment of Medicine, Ribeirão Preto Medical School, University of São Paulo. Ribeirão Preto, São Paulo, Brazil.ORCID http://orcid.org/0000-0001-7698-6599
Munique Kurtz de MelloDepartment of Gastroenterology, University of Vale Do Itajaí. Itajaí, Santa Catarina, Brazil.ORCID http://orcid.org/0009-0000-7728-6068
Matheus Freitas Cardoso de AzevedoDepartment of Gastroenterology, University of São Paulo School of Medicine, São Paulo, Brazil.ORCID http://orcid.org/0000-0001-5487-9418
Aderson Omar Mourão Cintra DamiãoDepartment of Gastroenterology, University of São Paulo School of Medicine, São Paulo, Brazil.ORCID http://orcid.org/0000-0001-7584-7351
Alexandre de Sousa CarlosDepartment of Gastroenterology, University of São Paulo School of Medicine, São Paulo, Brazil.ORCID http://orcid.org/0000-0001-6485-7968
Luísa Leite BarrosDepartment of Gastroenterology, University of São Paulo School of Medicine, São Paulo, Brazil.ORCID http://orcid.org/0000-0002-7782-2825
Maria Luiza Queiroz de MirandaDepartment of Internal Medicine, Santa Casa Sao Paulo Medical School, Sao Paulo, Brazil.ORCID http://orcid.org/0000-0002-1556-4138
Andrea VieiraDepartment of Internal Medicine, Santa Casa Sao Paulo Medical School, Sao Paulo, Brazil.ORCID http://orcid.org/0000-0003-1858-3446
Marcos Paulo Moraes SalesDivision of Gastroenterology, Department of Medicine, Inflammatory Bowel Disease Center, Federal University of Juiz de Fora, Juiz de Fora, Brazil.ORCID http://orcid.org/0000-0002-1449-8386
Gilmara Pandolfo ZabotDepartment of Colon and Rectum Surgery, Moinhos de Vento Hospital, Feevale University, Porto Alegre, Brazil.ORCID http://orcid.org/0000-0002-1253-4945
Ornella Sari CassolDepartment of Colorectal Surgery, Atitus Medical School, Hospital de Clínicas de Passo Fundo, Rio Grande Do Sul, Brazil.ORCID http://orcid.org/0000-0003-0867-6593
Antonio José Tiburcio AlvesDepartment of Surgery, PUC-Campinas Medical School, PUC-Campinas University. Campinas, São Paulo, Brazil.ORCID http://orcid.org/0000-0002-6795-8526
Márcio LubiniPasso Fundo University, Rio Grande Do Sul, Brazil.ORCID http://orcid.org/0000-0003-2779-7841
Marta Brenner MachadoDepartment of Gastroenterology, University Cattholic PUC-RS Porto Alegre, Porto Alegre, Brazil.ORCID http://orcid.org/0000-0003-2266-2542
Cristina FloresInflammatory Bowel Disease Center - DIIMUNO, Rio Grande Do Sul, Brazil.ORCID http://orcid.org/0000-0003-1623-4525
Fabio Vieira TeixeiraGastrosaúde Clinic, Marilia, São Paulo, Brazil.ORCID http://orcid.org/0000-0002-8915-7279
Claudio Saddy Rodrigues CoyDepartment of Surgery, State University of Campinas (UNICAMP), Campinas, SP, Brazil.ORCID http://orcid.org/0000-0002-0916-4138
Cyrla ZaltmanDepartment of Internal Medicine, School of Medicine, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.ORCID http://orcid.org/0000-0002-5236-6501
Liliana Andrade ChebliDivision of Gastroenterology, Department of Medicine, Inflammatory Bowel Disease Center, Federal University of Juiz de Fora, Juiz de Fora, Brazil.ORCID http://orcid.org/0000-0002-7875-1475
Ligia Yukie SassakiDepartment of Internal Medicine, Medical School, São Paulo State University (Unesp), Botucatu, São Paulo State, Brazil.ORCID http://orcid.org/0000-0002-7319-8906
Omar FéresDepartment of Surgery and Anatomy, Ribeirão Preto Medical School, University of São Paulo. Ribeirão Preto, São Paulo, Brazil.ORCID http://orcid.org/0000-0003-3593-0526
Júlio Maria Fonseca ChebliDivision of Gastroenterology, Department of Medicine, Inflammatory Bowel Disease Center, Federal University of Juiz de Fora, Juiz de Fora, Brazil.ORCID http://orcid.org/0000-0003-1527-0663

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo assess the real-life, long-term effectiveness and safety of tofacitinib in a large cohort of patients with refractory or difficult-to-treat ulcerative colitis (UC).

methodsThis multicenter, retrospective, observational cohort study included patients with moderately to severely active UC who received tofacitinib for at least 8 weeks. Clinical remission and response, endoscopic response and remission, biochemical response and remission, steroid-free clinical remission, primary and secondary loss of response, drug discontinuation, the need for dose optimization, the need for colectomy, and adverse events were evaluated over up to 30 months.

resultsWe included 127 patients with UC, with a mean age of 40.3 ± 14.2 years; 58.2% were male, 75.6% had pancolitis, and 79.5% had previously failed at least one biological therapy, predominantly anti-TNF agents (70.1%). Clinical remission was observed in 31.5% of patients at weeks 12-16, 46.5% at 26 ± 4 weeks, and 37.0% at 1 year. Steroid-free clinical remission was achieved in 28.6%, 44.8%, and 37.1% of patients at the same time points, respectively. Biochemical remission was achieved in 33.6% of patients at 26 ± 4 weeks and 29.3% at 1 year. Endoscopic response and endoscopic remission within 1 year were observed in 46.0% and 15.3% of patients, respectively. Ten patients (7.9%) required colectomy, and 13 patients (10.2%) required hospitalization, all of whom had been previously exposed to biologics. The colectomy rate was significantly greater in patients with serum albumin levels ≤ 3.5 g/dL (21.4% vs. 4.1%, p = 0.013).

conclusionIn this large, long-term real-world study involving patients with predominantly biologically refractory UC, tofacitinib effectively induced clinical remission and endoscopic improvement and prevented colectomy for more than 30 months, with a favorable safety profile. Notably, baseline hypoalbuminemia was associated with higher colectomy rates.

Indexed as

Colitis, UlcerativeJanus Kinase InhibitorsPiperidinesPyrimidinesAdultBrazilColectomyFemaleHumansMaleMiddle AgedRemission InductionRetrospective StudiesTreatment OutcomeJanus Kinase InhibitorsPiperidinesPyrimidinestofacitinibInflammatory bowel diseaseJak inhibitorsTofacitinib; Real-worldUlcerative colitis

Identifiers

PMID40102788
PMCPMC11921721

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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.