The prevalence of ulcerative colitis (UC), which is one of the inflammatory bowel diseases, is known to be increasing and the majority of patients (≥ 85%) have experienced mild or moderate severity. 5-Aminosalicylic acid (5-ASA), immunomodulator, or biologics, etc are prescribed to treat UC, however 5-ASA is generally considered the first-line therapy. The recent UC treatment guideline in Korea and the United States/ European Union (US/EU) have recommended higher daily dose for patients with mild or moderate severity than the previous guidelines since 2017. Accordingly, it is assumed that the average daily treatment dose of 5-ASA would increase in patients who were initially diagnosed with UC in real-world clinical practice in Korea. However, there are not many studies evaluating the treatment patterns and health outcomes of 5-ASA based on the recent treatment guideline in South Korea. This study, hence, aims to investigate the impact of changes in daily dose of 5-ASA on the treatment patterns and health outcomes such as recurrence rate, hospitalization rate, and surgery rate in real world practice using Health Insurance Review and Assessment (HIRA) claims database.
Study Type
OBSERVATIONAL
Enrollment
11,385
The 5-ASAs of interest in the study are mesalazine (5-ASA); sulfasalazine (5-ASA+sulfapyridine); and balsalazide (5-ASA) and will be grouped together as 5-ASA. For sulfasalazine and balsalazide, the equivalent dose to 5-ASA will be calculated as: balsalazide 6.75g is equivalent to 2.4g of mesalamine; and Sulfasalazine 4g is equivalent to 1.6g of mesalamine. The dose will be stratified by oral monotherapy, rectal monotherapy, oral and rectal combination therapy.
Severance Hospital
Seoul, Seodaemun-gu, South Korea
Changes in initial 3-months average daily dose of 5-ASA
Initial average daily dose is defined as the average dose of 5-ASA prescribed over the 3-month period following the first prescription date of 5-ASA (i.e. prescription index date). Dose of 5-ASA includes those of mesalamine, sulfasalazine, and balsalazide. The dose will be stratified by oral monotherapy, rectal monotherapy, oral and rectal combination therapy. Oral and rectal combination therapy will be identified when the percentage of rectal therapy over the 3-months following the first prescription date of 5-ASA is more than 25%. For oral and rectal combination therapy, only oral formulation will be considered to calculate the dose of a combination therapy. The average daily dose of 5-ASA will be categorized as: Oral mono high dose (\>=3g), oral mono standard dose (2-3g), oral mono low dose (\<2g); Oral combination high dose (\>=3g), oral combination standard dose (2-3g); oral combination low dose (\<2g); Rectal monotherapy.
Time frame: From prescription index date up to 3 months
Prescription patterns of 5-ASA
The prescription patterns will be categorized into: oral monotherapy; rectal monotherapy; oral and rectal combination therapy based on the exposure medications (mesalazine, sulfasalazine, and/or balsalazide) prescribed.
Time frame: From 01 January 2009 to 31 March 2019
Non-response to 5-ASA by the average daily dose of 5-ASA
The non-response to 5-ASA is defined as: \>=1 claims with international statistical classification of diseases 10th revision (ICD-10) code for UC as primary diagnosis and with pre-defined medications prescribed to those who are not responsive to 5-ASA. Medications for non-response are defined as add-on or switching to steroids, immunosuppressants, and/or biologics.
Time frame: From 01 January 2009 to 31 March 2019
Ulcerative Colitis Related hospitalization by the average daily dose of 5-ASA
The hospitalization is defined as: \>=1 length of stay (days); admission to the department for gastroenterology; and at least one surgery code or UC medications. The UC surgery includes small bowel resection, colon resection, and/or low anterior resection, defined using surgery code. The UC medication is defined as moderate- to high-dose steroids, immunosuppressants, and/or biologics.
Time frame: From 01 January 2009 to 31 March 2019
Ulcerative Colitis related surgery by the average daily dose of 5-ASA
Surgeries include small bowel resection, colon resection, and/or low anterior resection, which will be identified using surgery code.
Time frame: From 01 January 2009 to 31 March 2019
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