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©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
Intestinal complications in patients with Crohn’s disease in the Brazilian public healthcare system between 2011 and 2020
Ligia Yukie Sassaki, Adalberta Lima Martins, Rodrigo Galhardi-Gasparini, Rogerio Saad-Hossne, Alessandra Mileni Versut Ritter, Tania Biatti Barreto, Taciana Marcolino, Bruno Balula, Claudia Yang-Santos
Ligia Yukie Sassaki, Department of Internal Medicine, São Paulo State University - UNESP, Medical School, 18618687, Botucatu, Brazil
Adalberta Lima Martins, Department of Gastroenterology, State Office for Pharmaceutical Assistance at Espírito Santo Health Office, Vitoria 29017-010, Espirito Santo, Brazil
Rodrigo Galhardi-Gasparini, Department of Gastroenterology, SETE – Specialized Medical Center, Marilia 17502-020, Sao Paulo, Brazil
Rogerio Saad-Hossne, Department of Surgery, São Paulo State University - UNESP, Medical School, 18618687, Botucatu, Brazil
Alessandra Mileni Versut Ritter, Bruno Balula, Real World Evidence, IQVIA Brazil, 04719-002, Sao Paulo, Brazil
Tania Biatti Barreto, Taciana Marcolino, Medical Affairs, Takeda Pharmaceuticals Brazil, 04794-000, Sao Paulo, Brazil
Claudia Yang-Santos, Clinical Research, Takeda Pharmaceuticals Brazil, 04794-000, Sao Paulo, Brazil
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.
Supported by Takeda Pharmaceutical Brazil.
Conflict-of-interest statement: Dr. Yang-Santos reports grants from Takeda Pharmaceuticals Brazil, during the conduct of the study; Sassaki LY is a speaker for Janssen and Takeda and participates in the advisory boards of Takeda and AbbVie; Martins AL served on the advisory boards of Takeda, AbbVie, Janssen, Pfizer, and Amgen and is a speaker for Amgen and Janssen; Galhardi-Gasparini R is a speaker for Janssen, Takeda, and AbbVie; Saad-Hossne R is a speaker for Novartis and is on the advisory boards for AbbVie, Takeda, Janssen, Pfizer, Fresenius, and Amgen; Ritter AMV and Balula B are employees of IQVIA, Brazil; Marcolino T, Barreto TB, and Yang-Santos C are employees of Takeda Pharmaceuticals, Brazil.
Data sharing statement: No additional data are available.
STROBE statement: The authors have read the STROBE statement, and the manuscript was prepared and revised according to the STROBE statement.
Open-Access: 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. See:
https://creativecommons.org/Licenses/by-nc/4.0/ 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
Received: January 9, 2023
Peer-review started: January 9, 2023
First decision: February 15, 2023
Revised: February 27, 2023
Accepted: April 6, 2023
Article in press: April 6, 2023
Published online: May 16, 2023
BACKGROUND
This is a secondary database study using the Brazilian public healthcare system database.
AIM
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.
METHODS
This 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).
RESULTS
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.
CONCLUSION
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.
Core Tip: This real-world study assessed intestinal complications (ICs) in patients with Crohn’s disease (CD) undergoing therapy available in the Public Healthcare System in Brazil over the last 10 years. Outcomes suggests that patients that received conventional therapy and eventually anti–tumor necrosis factor therapy have an active and progressive illness, developing relevant ICs that might imply in considerable use of resources from the health system, CD remains a concern which may require additional strategies in the Brazilian public health care system.
