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This study is a randomized controlled study conducted at five tertiary university hospitals. Patients who are 20-80 years old, diagnosed as having Inflammatory Bowel Disease(IBD) and who are planned to start thiopurines for the first time for the treatment of IBD are enrolled. Patients are assigned to the genotyping group or to the non-genotyping group. The patients who carry any heterozygotic variant among the three genes receive 50 mg azathioprine (AZA) or 25 mg of 6-mercaptopurine, while those who have any homozygotic variant are recommended to take other alternative drugs. The patients who do not carry any genetic variant or are assigned in non-genotyping group receive the standard dose of thiopurines based on the conventional approach.
Patients in the non-genotyping group receive the standard dose of thiopurines based on the conventional approach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genotyping group | Experimental | The patients undergo pretreatment of genotyping for three genes (TPMT, NUDT15 and FTO) |
|
| Non-genotyping group | Active Comparator | Patients receive standard doses of thiopurines based on the conventional regimen without pretreatment genotyping. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| genotyping for three genes (TPMT, NUDT15 and FTO) | Genetic | Patients who carry any heterozygotic variants receive 50 mg AZA or 25 mg 6-mercaptopurine (6-MP), while those who have any homozygotic variants are recommended to take other alternative drugs instead of thiopurines |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence of myelosuppression | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jae Hee Cheon, MD | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Seoul | 03722 | South Korea | |||
| Ewha Medical Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31446180 | Derived | Chang JY, Park SJ, Jung ES, Jung SA, Moon CM, Chun J, Park JJ, Kim ES, Park Y, Kim TI, Kim WH, Cheon JH. Genotype-based Treatment With Thiopurine Reduces Incidence of Myelosuppression in Patients With Inflammatory Bowel Diseases. Clin Gastroenterol Hepatol. 2020 Aug;18(9):2010-2018.e2. doi: 10.1016/j.cgh.2019.08.034. Epub 2019 Aug 22. |
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| non-genotyping | Other | Patients receive standard doses of thiopurines based on the conventional regimen without pretreatment genotyping. Conventional regimen starts with 50 mg of AZA, then the dose is increased by 25 mg in every 1-2 weeks to 2.0-2.5 mg/kg along with regular monitoring of general blood tests including WBC counts. |
|
| Seoul |
| South Korea |
| Gangnam Severance Hospital | Seoul | South Korea |
| Korea University Hospital | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D005838 | Genotype |
| ID | Term |
|---|---|
| D055614 | Genetic Phenomena |
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