Clinical trial NCT06446219: Efficacy and Safety Comparison of Upadacitinib and Vedolizumab in Second-line Treatment for Crohn's Disease
Official title: A Retrospective Analysis of the Efficacy and Safety Comparison of Upadacitinib and Vedolizumab in Second-line Treatment for Crohn's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn Disease
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population comprises patients aged 18 and older who were hospitalized for Crohn's Disease between January 2020 and March 2024 at our institution or its branches, and who have been received follow-up for no less than 12 weeks prior to March 2024. The study population should also failure to respond to or tolerate anti-tumor necrosis factor-α inhibitors (Infliximab, Adalimumab). The focus is on adults with a confirmed diagnosis to assess the efficacy in inducing clinical remission and altering disease progression. Exclusion criteria include unclear diagnosis, patients under 18, previously using Upadacitinib/Vedolizumab and absence of clinical data, ensuring a uniform group for valid results.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Steroid-Free Clinical Remission
timeFrame: Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks;
Secondary outcomes:
measure: Clinical Remission
timeFrame: Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks;
measure: Clinical Response
timeFrame: Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks;
measure: Endoscopic Remission
timeFrame: Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks;
measure: Endoscopic Response
timeFrame: Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks;
measure: Mucosal Healing
timeFrame: Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks;
measure: Radiological Remission
timeFrame: Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks;
measure: Radiological Response
timeFrame: Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks;
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the Sixth Affiliated Hospital of Sun Yat-Sen University
state: Guangdong
Study officials:
References: