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

doi:10.12998/wjcc.v11.i14.3224

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

World J Clin Cases. 2023 May 16;11(14):3224-3237. doi: 10.12998/wjcc.v11.i14.3224.

Authors

Ligia Yukie Sassaki¹, Adalberta Lima Martins², Rodrigo Galhardi-Gasparini³, Rogerio Saad-Hossne⁴, Alessandra Mileni Versut Ritter⁵, Tania Biatti Barreto⁶, Taciana Marcolino⁶, Bruno Balula⁵, Claudia Yang-Santos⁷

Affiliations

¹ Department of Internal Medicine, São Paulo State University - UNESP, Medical School, 18618687, Botucatu, Brazil.
² Department of Gastroenterology, State Office for Pharmaceutical Assistance at Espírito Santo Health Office, Vitoria 29017-010, Espirito Santo, Brazil.
³ Department of Gastroenterology, SETE - Specialized Medical Center, Marilia 17502-020, Sao Paulo, Brazil.
⁴ Department of Surgery, São Paulo State University - UNESP, Medical School, 18618687, Botucatu, Brazil.
⁵ Real World Evidence, IQVIA Brazil, 04719-002, Sao Paulo, Brazil.
⁶ Medical Affairs, Takeda Pharmaceuticals Brazil, 04794-000, Sao Paulo, Brazil.
⁷ Clinical Research, Takeda Pharmaceuticals Brazil, 04794-000, Sao Paulo, Brazil. clausantos2910@gmail.com.

Abstract

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 - 10^th 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.

Keywords: Anti-tumor necrosis factor; Conventional therapy; Crohn’s disease; Intestinal complications; Public healthcare system.