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New types of biologics have brought advantages in therapy strategies for Crohn's disease. However, clinical data evaluating their efficacy and adverse in China is lacking. We aimed to evaluate the short-term and long-term therapeutic effect as well as drug adverse of Ustekinumab (UST) and Vedolizumab (VED). Besides, we aim to figure out the independent factors predicting the effectiveness of new biologics. Relations between drug exposure (trough concentration and antibody concentration) and therapeutic efficacy are study in-depth by this retrospective observational study.
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| Measure | Description | Time Frame |
|---|---|---|
| endoscopic remission | Endoscopic remission referred to those with simple endoscopic score for Crohn's disease (SES-CD)≤2 | short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| clinical remission | Clinical remission was defined as Crohn's disease activity index (CDAI) below 150 | short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks) |
| clinical response |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive adult patients with confirmed diagnosis of Crohn's disease and administration of new type biologics
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Sixth Affiliated Hospital of Sun Yat-Sen University | Guangzhou | Guangdong | 501655 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37554510 | Derived | Yao J, Peng X, Zhong Y, Su T, Bihi A, Zhao J, Liu T, Wang W, Hu P, Zhang M, Zhi M. Extra intravenous Ustekinumab reinduction is an effective optimization strategy for patients with refractory Crohn's disease. Front Med (Lausanne). 2023 Jul 24;10:1105981. doi: 10.3389/fmed.2023.1105981. eCollection 2023. | |
| 34663208 | Derived |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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intestinal mucosa biopsy
endoscopic response referred to those with a reduction of SES-CD > 50% baseline
| short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks) |
| endoscopic response | endoscopic response referred to those with a reduction of SES-CD > 50% baseline | short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks) |
| Yao JY, Zhang M, Wang W, Peng X, Zhao JZ, Liu T, Li ZW, Sun HT, Hu P, Zhi M. Ustekinumab trough concentration affects clinical and endoscopic outcomes in patients with refractory Crohn's disease: a Chinese real-world study. BMC Gastroenterol. 2021 Oct 18;21(1):380. doi: 10.1186/s12876-021-01946-8. |
| D003092 | Colitis |
| D003108 | Colonic Diseases |