Intestinal complications in Brazilian patients with ulcerative colitis treated with conventional therapy between 2011 and 2020

BACKGROUND This was an observational, descriptive, and retrospective study from 2011 to 2020 from the Department of Informatics of the Brazilian Healthcare System database.AIM To describe the intestinal complications(IC) of patients with ulcerative colitis(UC) who started conventional therapies in Brazil’s public Healthcare system.METHODS Patients ≥ 18 years of age who had at least one claim related to UC 10th revision of the International Statistical Classification of Diseases and Related Health Problems(ICD-10) code and at least 2 claims for conventional therapies were included. IC was defined as at least one claim of: UC-related hospitalization, procedures code for rectum or intestinal surgeries, and/or associated disease defined by ICD-10 codes(malignant neoplasia of colon, stenosis, hemorrhage, ulcer and other rectum or anus disease, megacolon, functional diarrhea volvulus, intussusception and erythema nodosum). Descriptive statistics, annual incidence, and incidence rate(IR) [per 100 patient-years(PY)] over the available follow-up period were calculated.RESULTS In total, 41229 UC patients were included(median age, 48 years;65% women) and the median(interquartile range) follow-up period was 3.3(1.8-5.3) years. Conventional therapy used during follow-up period included: mesalazine(87%), sulfasalazine(15%), azathioprine(16%) or methotrexate(1%) with a median duration of 1.9(0.8-4.0) years. Overall IR of IC was 3.2 cases per 100 PY. Among the IC claims, 54% were related to associated diseases, 20% to procedures and 26% to hospitalizations. The overall annual incidence of IC was 2.9%, 2.6% and 2.5% in the first, second and third year after the first claim for therapy(index date), respectively. Over the first 3 years, the annual IR of UC-related hospitalizations ranged from 0.8% to 1.1%;associated diseases from 0.9% to 1.2%-in which anus or rectum disease, and malignant neoplasia of colon were the most frequently reported;and procedure events from 0.6% to 0.7%, being intestinal resection and polyp removal the most frequent ones.CONCLUSION Study shows that UC patients under conventional therapy seem to present progression of disease developing some IC, which may have a negative impact on patients and the burden on the health system.

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

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.