Intestinal complications in patients with Crohn's disease in the Brazilian public healthcare system between 2011 and 2020

This is a secondary database study using the Brazilian public healthcare system database. To describe intestinal complications (ICs) of patients in the Brazilian public healthcare system with Crohn's disease (CD) who initiated and either only received conventional therapy (CVT) or also initiate...

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Published in:World journal of clinical cases Vol. 11; no. 14; pp. 3224 - 3237
Main Authors: Sassaki, Ligia Yukie, Martins, Adalberta Lima, Galhardi-Gasparini, Rodrigo, Saad-Hossne, Rogerio, Ritter, Alessandra Mileni Versut, Barreto, Tania Biatti, Marcolino, Taciana, Balula, Bruno, Yang-Santos, Claudia
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Published: United States Baishideng Publishing Group Inc 16-05-2023
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Abstract This is a secondary database study using the Brazilian public healthcare system database. To describe intestinal complications (ICs) of patients in the Brazilian public healthcare system with Crohn's disease (CD) who initiated and either only received conventional therapy (CVT) or also initiated anti-tumor necrosis factor (anti-TNF) therapy between 2011 and 2020. This study included patients with CD [international classification of diseases - 10 revision (ICD-10): K50.0, K50.1, or K50.8] (age: ≥ 18 years) with at least one claim of CVT (sulfasalazine, azathioprine, mesalazine, or methotrexate). IC was defined as a CD-related hospitalization, pre-defined procedure codes (from rectum or intestinal surgery groups), and/or associated disease (pre-defined ICD-10 codes), and overall (one or more type of ICs). In the 16809 patients with CD that met the inclusion criteria, the mean follow-up duration was 4.44 (2.37) years. In total, 14697 claims of ICs were found from 4633 patients. Over the 1- and 5-year of follow-up, 8.3% and 8.2% of the patients with CD, respectively, presented at least one IC, of which fistula (31%) and fistulotomy (48%) were the most commonly reported. The overall incidence rate (95%CI) of ICs was 6.8 (6.5-7.04) per 100 patient years for patients using only-CVT, and 9.2 (8.8-9.6) for patients with evidence of anti-TNF therapy. The outcomes highlighted an important and constant rate of ICs over time in all the CD populations assessed, especially in patients exposed to anti-TNF therapy. This outcome revealed insights into the real-world treatment and complications relevant to patients with CD and highlights that this disease remains a concern that may require additional treatment strategies in the Brazilian public healthcare system.
AbstractList This is a secondary database study using the Brazilian public healthcare system database. To describe intestinal complications (ICs) of patients in the Brazilian public healthcare system with Crohn's disease (CD) who initiated and either only received conventional therapy (CVT) or also initiated anti-tumor necrosis factor (anti-TNF) therapy between 2011 and 2020. This study included patients with CD [international classification of diseases - 10 revision (ICD-10): K50.0, K50.1, or K50.8] (age: ≥ 18 years) with at least one claim of CVT (sulfasalazine, azathioprine, mesalazine, or methotrexate). IC was defined as a CD-related hospitalization, pre-defined procedure codes (from rectum or intestinal surgery groups), and/or associated disease (pre-defined ICD-10 codes), and overall (one or more type of ICs). In the 16809 patients with CD that met the inclusion criteria, the mean follow-up duration was 4.44 (2.37) years. In total, 14697 claims of ICs were found from 4633 patients. Over the 1- and 5-year of follow-up, 8.3% and 8.2% of the patients with CD, respectively, presented at least one IC, of which fistula (31%) and fistulotomy (48%) were the most commonly reported. The overall incidence rate (95%CI) of ICs was 6.8 (6.5-7.04) per 100 patient years for patients using only-CVT, and 9.2 (8.8-9.6) for patients with evidence of anti-TNF therapy. The outcomes highlighted an important and constant rate of ICs over time in all the CD populations assessed, especially in patients exposed to anti-TNF therapy. This outcome revealed insights into the real-world treatment and complications relevant to patients with CD and highlights that this disease remains a concern that may require additional treatment strategies in the Brazilian public healthcare system.
BACKGROUNDThis is a secondary database study using the Brazilian public healthcare system database. AIMTo describe intestinal complications (ICs) of patients in the Brazilian public healthcare system with Crohn's disease (CD) who initiated and either only received conventional therapy (CVT) or also initiated anti-tumor necrosis factor (anti-TNF) therapy between 2011 and 2020. METHODSThis study included patients with CD [international classification of diseases - 10th revision (ICD-10): K50.0, K50.1, or K50.8] (age: ≥ 18 years) with at least one claim of CVT (sulfasalazine, azathioprine, mesalazine, or methotrexate). IC was defined as a CD-related hospitalization, pre-defined procedure codes (from rectum or intestinal surgery groups), and/or associated disease (pre-defined ICD-10 codes), and overall (one or more type of ICs). RESULTSIn the 16809 patients with CD that met the inclusion criteria, the mean follow-up duration was 4.44 (2.37) years. In total, 14697 claims of ICs were found from 4633 patients. Over the 1- and 5-year of follow-up, 8.3% and 8.2% of the patients with CD, respectively, presented at least one IC, of which fistula (31%) and fistulotomy (48%) were the most commonly reported. The overall incidence rate (95%CI) of ICs was 6.8 (6.5-7.04) per 100 patient years for patients using only-CVT, and 9.2 (8.8-9.6) for patients with evidence of anti-TNF therapy. CONCLUSIONThe outcomes highlighted an important and constant rate of ICs over time in all the CD populations assessed, especially in patients exposed to anti-TNF therapy. This outcome revealed insights into the real-world treatment and complications relevant to patients with CD and highlights that this disease remains a concern that may require additional treatment strategies in the Brazilian public healthcare system.
Author Galhardi-Gasparini, Rodrigo
Barreto, Tania Biatti
Marcolino, Taciana
Yang-Santos, Claudia
Martins, Adalberta Lima
Ritter, Alessandra Mileni Versut
Balula, Bruno
Saad-Hossne, Rogerio
Sassaki, Ligia Yukie
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  fullname: Saad-Hossne, Rogerio
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  givenname: Alessandra Mileni Versut
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  organization: Clinical Research, Takeda Pharmaceuticals Brazil, 04794-000, Sao Paulo, Brazil. clausantos2910@gmail.com
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Keywords Intestinal complications
Anti-tumor necrosis factor
Public healthcare system
Conventional therapy
Crohn’s disease
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This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial.
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Author contributions: Sassaki LY, Galhardi-Gasparini R, Martins AL, Saad-Hossne R, Barreto TB, Marcolino T and Yang Santos C participated in designed, interpretation of the data and revised the article critically for important intellectual content; Ritter AMV and Balula B participated in the acquisition, analysis and draft the initial manuscript.
Corresponding author: Claudia Yang-Santos, BPharm, MSc, PhD, Research Scientist, Clinical Research, Takeda Pharmaceuticals Brazil, Av. das Nações Unidas, 14.401 - Torre Jequitibá - 10º, 11º e 12º andares, 04794-000, Sao Paulo, Brazil. clausantos2910@gmail.com
Supported by Takeda Pharmaceutical Brazil.
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BACKGROUNDThis is a secondary database study using the Brazilian public healthcare system database. AIMTo describe intestinal complications (ICs) of patients...
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Title Intestinal complications in patients with Crohn's disease in the Brazilian public healthcare system between 2011 and 2020
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