Crohn Disease
Conditions
Brief summary
This study focuses on Upadacitinib, a new oral and small-molecular medication that inhibits specific enzymes involved in inflammation. The goal is to determine efficacy and safety of Upadacitinib for Crohn's Disease patients in China compared with Vedolizumab, which is used to inhibit recruitment of inflammatory cells. Crohn's Disease significantly affects individuals' quality of life and imposes a high burden on society and healthcare systems. Current treatments don't work for everyone, and some patients may need surgery. Upadacitinib has shown promise in other countries for treating Crohn's Disease and related conditions, and has been approved by the US FDA for such use. The investigators' retrospective and multicenter study looks back at patient records from multiple hospitals to analyze the outcomes of those who have received Upadacitinib and Vedolizumab. Investigators aim to enroll patients treated between January 2020 and March 2024, who received follow-up for more than 12 weeks. For patients, families, and healthcare providers, this research could provide a potential new treatment option for Crohn's Disease. Better efficacy and safety of Upadacitinib than Vedolizumab could lead to better management of the disease, possibly reducing the need for surgery and improving the quality of life. The ultimate goal is to provide more personalized and effective treatment strategies for Crohn's Disease patients in China.
Detailed description
This retrospective, multicenter study is designed to compare the efficacy and safety of Upadacitinib and Vedolizumab in second-line treatment for Crohn's Disease, the former is an oral selective enzyme inhibitor, and the latter is a monoclonal antibody targeting integrin α4β7. Crohn's Disease poses a significant impact on the quality of life for individuals and presents a considerable challenge to healthcare systems due to the societal burdens it incurs. While current therapeutic interventions offer relief, these interventions fail to suffice for all patients, with some requiring surgical intervention. Despite the approval of Upadacitinib by the US FDA and its promising application in other nations for Crohn's Disease management, there is a scarcity of data on its effectiveness and safety among Chinese patients. The investigators' research aims to fill this knowledge gap by retrospectively analyzing patient records from multiple hospitals across China. The study targets the adult patients that has received follow-up for more than 12 weeks between January 2020 and March 2024. By assessing the outcomes of these patients, the investigators' objective is to ascertain the potential of Upadacitinib as a viable treatment alternative, which may revolutionize the current Crohn's Disease treatment paradigm in China.The implications of this study are significant for patients, their families, and healthcare providers, as it could herald a new therapeutic avenue for Crohn's Disease management. A clearer understanding of Upadacitinib's role in disease control could enhance patient care by decreasing the necessity for surgical procedures and ameliorating life quality for Crohn's Disease sufferers. The overarching ambition of this research is to pave the way for more individualized and efficacious treatment methodologies for the Crohn's Disease patient populace in China.
Interventions
None listed
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients who were hospitalized in our institution or its branches between January 2020 and March 2024. * Patients aged 18 years or older. * Confirmed as moderately-to-severely active Crohn's disease according to Chinese clinical practice guideline on the management of Crohn's disease (2023,Guangzhou). * Failure to respond to or tolerate anti-tumor necrosis factor-α inhibitors (Infliximab, Adalimumab). * Follow-up time for no less than 12 weeks.
Exclusion criteria
* Patients who have previously used Upadacitinib and Vedolizumab. * With insufficient clinical data at baseline, 12 weeks in the Upadacitinib group and 14 weeks in the Vedolizumab group to evaluate the efficacy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Steroid-Free Clinical Remission | Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks; | Steroid-Free Clinical Remission in Crohn's Disease is defined as a Crohn's disease activity index(CDAI) score of less than 150, achieved without the use of corticosteroids. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Remission | Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks; | Clinical Remission in Crohn's Disease is defined as a Crohn's disease activity index(CDAI) score of less than 150 |
| Clinical Response | Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks; | Clinical Response in Crohn's Disease is a decrease in Crohn's disease activity index(CDAI) score by 70 points or more from baseline. |
| Endoscopic Remission | Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks; | A simple endoscopic score for Crohn's disease(SES-CD) score of 2 or less indicates endoscopic remission |
| Endoscopic Response | Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks; | Endoscopic Response in Crohn's Disease is a decrease in simple endoscopic score for Crohn's disease(SES-CD) score by 50 percent or more from baseline. |
| Radiological Remission | Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks; | Defined as the complete disappearance or minimization of intestinal inflammation on imaging studies, signifying no visible lesions, normalized wall thickness, absence of strictures or obstructions, and no new areas of disease. Radiographic remission is an important indicator of deep remission in disease treatment goals. |
| Radiological Response | Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks; | Typically defined as a significant reduction in the size of affected areas, decreased wall thickness, and decreased markers of inflammation observed through imaging methods such as MRI or CT scans. A radiographic response indicates a reduction in disease activity but may not represent complete disease remission. |
| Mucosal Healing | Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks; | A simple endoscopic score for Crohn's disease(SES-CD) score of 0 is indicative of mucosal healing |
Countries
China
Outcome results
None listed