Sheng Jing Hospital

grid.412467.2

Mengyao Wang

DAA082

Cyclosporine is a rapid and effective remedial treatment for inflammatory bowel disease that can effectively control disease activity, especially in patients who are not responding to glucocorticoids, but long-term efficacy is uncertain. We wish to evaluate patients treated with cyclosporine among the 34,755 patients in the IBD Bioresource. We plan to retrospectively analyze these patients to assess the treatment effectiveness, perform time-to-event analysis of treatment escalation, and compare surgery rates in patients who tolerated or did not tolerate cyclosporine. 'Effective' will be defined as not escalating to biologic therapy or surgery while treated with cyclosporine. Descriptive statistics will be first performed for clinical characteristics, with continuous variables expressed as medians (25th-75th percentiles); categorical variables expressed as frequencies and percentages. Duration of cyclosporine treatment will be calculated from the start of treatment to the end of treatment and summarized using Kaplan-Meier estimates. The incidence of adverse events will be compared between UC and CD by X2 test. The Cochran-Mantel-Haenszel (CMH) test will be applied to compare the effects of cyclosporine treatment for UC and CD. Comparative effectiveness of cyclosporine between UC and CD will be assessed using multivariate logistic regression with covariates including age at diagnosis, sex, smoking history, treatment chronology, and time from diagnosis to initiation of cyclosporine. The Kaplan-Meier method will be used to assess time to treatment escalation for biologic therapy or surgery. The log-rank test will be used to compare the differences in distribution between UC and CD. Logistic regression models will be applied to explore the correlation between cyclosporine treatment effects and clinical characteristics within UC and CD, using the same covariates as described above but also including disease location. Cox regression model will be applied to explore the correlation between the timing of surgical outcomes and clinical characteristics within UC and CD. A conservative prespecified p-value threshold of less than 0.005 was considered statistically significant. Statistical analysis methods may vary slightly according to the data obtained. The above findings were used to optimize the immunotherapy strategy, improve the effectiveness of treatment, and maximize the prognosis.

Research

NIHR BioResource Data Access Committee

19/08/2021

De-Personalised

(e) processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller;

(j) processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

The individual to whom the information relates has consented

No

One-off

Release