Anti-TNF therapy for ulcerative colitis in Brazil: a comparative real-world national retrospective multicentric study from the Brazilian study group of IBD (GEDIIB)

Detalhes bibliográficos
Autor(a) principal: Ligia Yukie Sassaki
Data de Publicação: 2022
Outros Autores: Marley Ribeiro Feitosa, Carlos Henrique Marques Dos Santos, Manoel Alvaro de Freitas Lins Neto, Abel Botelho Quaresma, Sergio Figueiredo de Lima Junior, Graciana Bandeira Salgado de Vasconcelos, Ornella Sari Cassol, Arlene Dos Santos Pinto, Gustavo Kurachi, Francisco de Assis Goncalves Filho, Daniela Oliveira Magro, Rodrigo Galhardi Gasparini, Thaísa Kowalski Furlan, Wilson Roberto Catapani, Cláudio Saddy Rodrigues Coy, Vivian de Souza Menegassi, Marilia Majeski Colombo, Renata de sá Brito Fróes, Fabio Vieira Teixeira, Antonio Carlos Moraes, Genoile Oliveira Santana, Rogerio Saad-hossne, José Miguel Luz Parente, Eduardo Garcia Vilela, Natália Sousa Freitas Queiroz, Paulo Gustavo Kotze, Julio Pinheiro Baima, Cristina Flores, Lucianna Motta Correia, Lívia Medeiros Soares Celani, Maria de Lourdes de Abreu Ferrari, Patricia Zacharias
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da UFMG
Texto Completo: https://doi.org/10.1186/s12876-022-02341-7
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Resumo: Background Anti-TNF therapy represented a landmark in medical treatment of ulcerative colitis (UC). There is lack of data on the efficacy and safety of these agents in Brazilian patients. The present study aimed to analyze rates of clinical and endoscopic remission comparatively, between adalimumab (ADA) and infliximab (IFX), in Brazilian patients with UC, and evaluate factors associated with clinical and endoscopic remission after 1 year of treatment. Methods A national retrospective multicenter study (24 centers) was performed including patients with UC treated with anti-TNF therapy. Outcomes as clinical response and remission, endoscopic remission and secondary loss of response were measured in different time points of the follow-up. Baseline predictive factors of clinical and endoscopic remission at week 52 were evaluated using logistic regression model. Indirect comparisons among groups (ADA and IFX) were performed using Student's t, Pearson χ2 or Fisher's exact test when appropriated, and Kaplan Meier analysis. Results Overall, 393 patients were included (ADA, n = 111; IFX, n = 282). The mean age was 41.86 ± 13.60 years, 61.58% were female, most patients had extensive colitis (62.40%) and 19.39% had previous exposure to a biological agent. Overall, clinical remission rate was 66.78%, 71.62% and 82.82% at weeks 8, 26 and 52, respectively. Remission rates were higher in the IFX group at weeks 26 (75.12% vs. 62.65%, p < 0.0001) and 52 (65.24% vs. 51.35%, p < 0.0001) when compared to ADA. According to Kaplan–Meier survival curve loss of response was less frequent in the Infliximab compared to Adalimumab group (p = 0.001). Overall, endoscopic remission was observed in 50% of patients at week 26 and in 65.98% at week 52, with no difference between the groups (p = 0.114). Colectomy was performed in 23 patients (5.99%). Age, non-prior exposure to biological therapy, use of IFX and endoscopic remission at week 26 were associated with clinical remission after 52 weeks. Variables associated with endoscopic remission were non-prior exposure to biological therapy, and clinical and endoscopic remission at week 26. Conclusions IFX was associated with higher rates of clinical remission after 1 year in comparison to ADA. Non-prior exposure to biological therapy and early response to anti-TNF treatment were associated with higher rates of clinical and endoscopic remission.
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spelling 2023-12-07T21:25:38Z2023-12-07T21:25:38Z2022-05-2922268112https://doi.org/10.1186/s12876-022-02341-71471-230Xhttp://hdl.handle.net/1843/61841http://orcid.org/0000-0002-7319-8906http://orcid.org/0000-0002-8180-6254http://orcid.org/0000-0002-8166-0304http://orcid.org/0000-0002-4035-3113http://orcid.org/0000-0003-1623-4525http://orcid.org/0000-0002-5621-2657http://orcid.org/0000-0002-2122-5538http://orcid.org/0000-0002-7890-0848http://orcid.org/0000-0002-4440-2023http://orcid.org/0000-0002-1181-7329http://orcid.org/0000-0003-1903-844Xhttp://orcid.org/0000-0002-3985-7402http://orcid.org/0000-0002-1250-2628http://orcid.org/0000-0002-2132-8780http://orcid.org/0000-0003-0867-6593http://orcid.org/0000-0001-7509-7730http://orcid.org/0000-0003-0344-9631http://orcid.org/0000-0003-0153-4349http://orcid.org/0000-0002-1032-5349http://orcid.org/0000-0002-9516-0378http://orcid.org/0000-0002-0412-2182http://orcid.org/0000-0002-0916-4138http://orcid.org/0000-0003-3046-2399http://orcid.org/0000-0001-6684-8061http://orcid.org/0000-0003-3256-4698http://orcid.org/0000-0002-8915-7279http://orcid.org/0000-0002-5533-5401http://orcid.org/0000-0003-4563-2784http://orcid.org/0000-0002-5443-7553http://orcid.org/0000-0003-2857-0825http://orcid.org/0000-0002-2053-5315Background Anti-TNF therapy represented a landmark in medical treatment of ulcerative colitis (UC). There is lack of data on the efficacy and safety of these agents in Brazilian patients. The present study aimed to analyze rates of clinical and endoscopic remission comparatively, between adalimumab (ADA) and infliximab (IFX), in Brazilian patients with UC, and evaluate factors associated with clinical and endoscopic remission after 1 year of treatment. Methods A national retrospective multicenter study (24 centers) was performed including patients with UC treated with anti-TNF therapy. Outcomes as clinical response and remission, endoscopic remission and secondary loss of response were measured in different time points of the follow-up. Baseline predictive factors of clinical and endoscopic remission at week 52 were evaluated using logistic regression model. Indirect comparisons among groups (ADA and IFX) were performed using Student's t, Pearson χ2 or Fisher's exact test when appropriated, and Kaplan Meier analysis. Results Overall, 393 patients were included (ADA, n = 111; IFX, n = 282). The mean age was 41.86 ± 13.60 years, 61.58% were female, most patients had extensive colitis (62.40%) and 19.39% had previous exposure to a biological agent. Overall, clinical remission rate was 66.78%, 71.62% and 82.82% at weeks 8, 26 and 52, respectively. Remission rates were higher in the IFX group at weeks 26 (75.12% vs. 62.65%, p < 0.0001) and 52 (65.24% vs. 51.35%, p < 0.0001) when compared to ADA. According to Kaplan–Meier survival curve loss of response was less frequent in the Infliximab compared to Adalimumab group (p = 0.001). Overall, endoscopic remission was observed in 50% of patients at week 26 and in 65.98% at week 52, with no difference between the groups (p = 0.114). Colectomy was performed in 23 patients (5.99%). Age, non-prior exposure to biological therapy, use of IFX and endoscopic remission at week 26 were associated with clinical remission after 52 weeks. Variables associated with endoscopic remission were non-prior exposure to biological therapy, and clinical and endoscopic remission at week 26. Conclusions IFX was associated with higher rates of clinical remission after 1 year in comparison to ADA. Non-prior exposure to biological therapy and early response to anti-TNF treatment were associated with higher rates of clinical and endoscopic remission.engUniversidade Federal de Minas GeraisUFMGBrasilMED - DEPARTAMENTO DE CLÍNICA MÉDICAMEDICINA - FACULDADE DE MEDICINABMC GastroenterologyColite UlcerativaAdalimumabBrasilAnti-TNF therapyAdalimumabInfiximabClinical remissionUlcerative colitisAnti-TNF therapy for ulcerative colitis in Brazil: a comparative real-world national retrospective multicentric study from the Brazilian study group of IBD (GEDIIB)info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articlehttps://bmcgastroenterol.biomedcentral.com/articles/10.1186/s12876-022-02341-7Ligia Yukie SassakiMarley Ribeiro FeitosaCarlos Henrique Marques Dos SantosManoel Alvaro de Freitas Lins NetoAbel Botelho QuaresmaSergio Figueiredo de Lima JuniorGraciana Bandeira Salgado de VasconcelosOrnella Sari CassolArlene Dos Santos PintoGustavo KurachiFrancisco de Assis Goncalves FilhoDaniela Oliveira MagroRodrigo Galhardi GaspariniThaísa Kowalski FurlanWilson Roberto CatapaniCláudio Saddy Rodrigues CoyVivian de Souza MenegassiMarilia Majeski ColomboRenata de sá Brito FróesFabio Vieira TeixeiraAntonio Carlos MoraesGenoile Oliveira SantanaRogerio Saad-hossneJosé Miguel Luz ParenteEduardo Garcia VilelaNatália Sousa Freitas QueirozPaulo Gustavo KotzeJulio Pinheiro BaimaCristina FloresLucianna Motta CorreiaLívia Medeiros Soares CelaniMaria de Lourdes de Abreu FerrariPatricia Zachariasapplication/pdfinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da UFMGinstname:Universidade Federal de Minas Gerais (UFMG)instacron:UFMGLICENSELicense.txtLicense.txttext/plain; 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dc.title.pt_BR.fl_str_mv Anti-TNF therapy for ulcerative colitis in Brazil: a comparative real-world national retrospective multicentric study from the Brazilian study group of IBD (GEDIIB)
title Anti-TNF therapy for ulcerative colitis in Brazil: a comparative real-world national retrospective multicentric study from the Brazilian study group of IBD (GEDIIB)
spellingShingle Anti-TNF therapy for ulcerative colitis in Brazil: a comparative real-world national retrospective multicentric study from the Brazilian study group of IBD (GEDIIB)
Ligia Yukie Sassaki
Anti-TNF therapy
Adalimumab
Infiximab
Clinical remission
Ulcerative colitis
Colite Ulcerativa
Adalimumab
Brasil
title_short Anti-TNF therapy for ulcerative colitis in Brazil: a comparative real-world national retrospective multicentric study from the Brazilian study group of IBD (GEDIIB)
title_full Anti-TNF therapy for ulcerative colitis in Brazil: a comparative real-world national retrospective multicentric study from the Brazilian study group of IBD (GEDIIB)
title_fullStr Anti-TNF therapy for ulcerative colitis in Brazil: a comparative real-world national retrospective multicentric study from the Brazilian study group of IBD (GEDIIB)
title_full_unstemmed Anti-TNF therapy for ulcerative colitis in Brazil: a comparative real-world national retrospective multicentric study from the Brazilian study group of IBD (GEDIIB)
title_sort Anti-TNF therapy for ulcerative colitis in Brazil: a comparative real-world national retrospective multicentric study from the Brazilian study group of IBD (GEDIIB)
author Ligia Yukie Sassaki
author_facet Ligia Yukie Sassaki
Marley Ribeiro Feitosa
Carlos Henrique Marques Dos Santos
Manoel Alvaro de Freitas Lins Neto
Abel Botelho Quaresma
Sergio Figueiredo de Lima Junior
Graciana Bandeira Salgado de Vasconcelos
Ornella Sari Cassol
Arlene Dos Santos Pinto
Gustavo Kurachi
Francisco de Assis Goncalves Filho
Daniela Oliveira Magro
Rodrigo Galhardi Gasparini
Thaísa Kowalski Furlan
Wilson Roberto Catapani
Cláudio Saddy Rodrigues Coy
Vivian de Souza Menegassi
Marilia Majeski Colombo
Renata de sá Brito Fróes
Fabio Vieira Teixeira
Antonio Carlos Moraes
Genoile Oliveira Santana
Rogerio Saad-hossne
José Miguel Luz Parente
Eduardo Garcia Vilela
Natália Sousa Freitas Queiroz
Paulo Gustavo Kotze
Julio Pinheiro Baima
Cristina Flores
Lucianna Motta Correia
Lívia Medeiros Soares Celani
Maria de Lourdes de Abreu Ferrari
Patricia Zacharias
author_role author
author2 Marley Ribeiro Feitosa
Carlos Henrique Marques Dos Santos
Manoel Alvaro de Freitas Lins Neto
Abel Botelho Quaresma
Sergio Figueiredo de Lima Junior
Graciana Bandeira Salgado de Vasconcelos
Ornella Sari Cassol
Arlene Dos Santos Pinto
Gustavo Kurachi
Francisco de Assis Goncalves Filho
Daniela Oliveira Magro
Rodrigo Galhardi Gasparini
Thaísa Kowalski Furlan
Wilson Roberto Catapani
Cláudio Saddy Rodrigues Coy
Vivian de Souza Menegassi
Marilia Majeski Colombo
Renata de sá Brito Fróes
Fabio Vieira Teixeira
Antonio Carlos Moraes
Genoile Oliveira Santana
Rogerio Saad-hossne
José Miguel Luz Parente
Eduardo Garcia Vilela
Natália Sousa Freitas Queiroz
Paulo Gustavo Kotze
Julio Pinheiro Baima
Cristina Flores
Lucianna Motta Correia
Lívia Medeiros Soares Celani
Maria de Lourdes de Abreu Ferrari
Patricia Zacharias
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Ligia Yukie Sassaki
Marley Ribeiro Feitosa
Carlos Henrique Marques Dos Santos
Manoel Alvaro de Freitas Lins Neto
Abel Botelho Quaresma
Sergio Figueiredo de Lima Junior
Graciana Bandeira Salgado de Vasconcelos
Ornella Sari Cassol
Arlene Dos Santos Pinto
Gustavo Kurachi
Francisco de Assis Goncalves Filho
Daniela Oliveira Magro
Rodrigo Galhardi Gasparini
Thaísa Kowalski Furlan
Wilson Roberto Catapani
Cláudio Saddy Rodrigues Coy
Vivian de Souza Menegassi
Marilia Majeski Colombo
Renata de sá Brito Fróes
Fabio Vieira Teixeira
Antonio Carlos Moraes
Genoile Oliveira Santana
Rogerio Saad-hossne
José Miguel Luz Parente
Eduardo Garcia Vilela
Natália Sousa Freitas Queiroz
Paulo Gustavo Kotze
Julio Pinheiro Baima
Cristina Flores
Lucianna Motta Correia
Lívia Medeiros Soares Celani
Maria de Lourdes de Abreu Ferrari
Patricia Zacharias
dc.subject.por.fl_str_mv Anti-TNF therapy
Adalimumab
Infiximab
Clinical remission
Ulcerative colitis
topic Anti-TNF therapy
Adalimumab
Infiximab
Clinical remission
Ulcerative colitis
Colite Ulcerativa
Adalimumab
Brasil
dc.subject.other.pt_BR.fl_str_mv Colite Ulcerativa
Adalimumab
Brasil
description Background Anti-TNF therapy represented a landmark in medical treatment of ulcerative colitis (UC). There is lack of data on the efficacy and safety of these agents in Brazilian patients. The present study aimed to analyze rates of clinical and endoscopic remission comparatively, between adalimumab (ADA) and infliximab (IFX), in Brazilian patients with UC, and evaluate factors associated with clinical and endoscopic remission after 1 year of treatment. Methods A national retrospective multicenter study (24 centers) was performed including patients with UC treated with anti-TNF therapy. Outcomes as clinical response and remission, endoscopic remission and secondary loss of response were measured in different time points of the follow-up. Baseline predictive factors of clinical and endoscopic remission at week 52 were evaluated using logistic regression model. Indirect comparisons among groups (ADA and IFX) were performed using Student's t, Pearson χ2 or Fisher's exact test when appropriated, and Kaplan Meier analysis. Results Overall, 393 patients were included (ADA, n = 111; IFX, n = 282). The mean age was 41.86 ± 13.60 years, 61.58% were female, most patients had extensive colitis (62.40%) and 19.39% had previous exposure to a biological agent. Overall, clinical remission rate was 66.78%, 71.62% and 82.82% at weeks 8, 26 and 52, respectively. Remission rates were higher in the IFX group at weeks 26 (75.12% vs. 62.65%, p < 0.0001) and 52 (65.24% vs. 51.35%, p < 0.0001) when compared to ADA. According to Kaplan–Meier survival curve loss of response was less frequent in the Infliximab compared to Adalimumab group (p = 0.001). Overall, endoscopic remission was observed in 50% of patients at week 26 and in 65.98% at week 52, with no difference between the groups (p = 0.114). Colectomy was performed in 23 patients (5.99%). Age, non-prior exposure to biological therapy, use of IFX and endoscopic remission at week 26 were associated with clinical remission after 52 weeks. Variables associated with endoscopic remission were non-prior exposure to biological therapy, and clinical and endoscopic remission at week 26. Conclusions IFX was associated with higher rates of clinical remission after 1 year in comparison to ADA. Non-prior exposure to biological therapy and early response to anti-TNF treatment were associated with higher rates of clinical and endoscopic remission.
publishDate 2022
dc.date.issued.fl_str_mv 2022-05-29
dc.date.accessioned.fl_str_mv 2023-12-07T21:25:38Z
dc.date.available.fl_str_mv 2023-12-07T21:25:38Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
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dc.identifier.uri.fl_str_mv http://hdl.handle.net/1843/61841
dc.identifier.doi.pt_BR.fl_str_mv https://doi.org/10.1186/s12876-022-02341-7
dc.identifier.issn.pt_BR.fl_str_mv 1471-230X
dc.identifier.orcid.pt_BR.fl_str_mv http://orcid.org/0000-0002-7319-8906
http://orcid.org/0000-0002-8180-6254
http://orcid.org/0000-0002-8166-0304
http://orcid.org/0000-0002-4035-3113
http://orcid.org/0000-0003-1623-4525
http://orcid.org/0000-0002-5621-2657
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