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GSALT Talk about Professor Zhang Yan: Guided by clinical needs, how RWS can "ride the wind and waves" in the field of IBD?

 Last Update: 2023-02-01
 Source: Internet
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How to carry out RWS research in the field of IBD with Chinese characteristics?

With the in-depth study of the pathogenesis of inflammatory bowel disease (IBD), scientists have developed biologics for different targets, including systemic anti-cytokines and enteroselective anti-lymphocyte migration (GSALT) drugs, and IBD treatment has also entered the era of biologics in a variety of ^{flowers [1].}
。 In recent years, clinical needs-oriented real-world studies (RWS) have attracted much attention and become a hot topic
in the field of IBD.
Recently, we specially invited Professor Zhang Yan from West China Hospital of Sichuan University to share the current status of RWS in the field of IBD in China and the future exploration direction, in order to provide reference
for clinical practice.

Q1: What are the current opportunities and challenges faced by RWS in drug research and development in the field of IBD in China?
Professor
Zhang Yan: The development of RWS in the field of IBD in China is both challenging and opportunity
.
We are now in the era of evidence-based medicine, where research evidence is a core foundation
for improving the efficiency of clinical and medical decision-making.
RWS results are referred to as real-world evidence
when used in clinical and medical decision-making.
Compared with randomised controlled trials (RCTs), RWS is closer to the real care setting, and a large number of sample data can be obtained, supplementing the information
that cannot be provided by RCTs.
However, it also has certain problems, such as the broad inclusion criteria of RWS and the uneven quality of scientific research data, which may lead to difficult analysis of data or bias of results ^[2].
In addition, the lack of systematic theoretical support for the development of RWS in China has led to certain misunderstandings in the research design and data analysis of some studies, which is also a problem
faced by the development of RWS in the field of IBD in China.

In recent years, China has paid more and more attention to the development of RWS, successively issued a number of RWS-related documents, and set up a multidisciplinary clinical scientific research center, such as our hospital opened a "scientific research clinic", researchers like diagnosing diseases, pointing out the problems in the process of clinicians' experiments, including the standardization of research design, the selection of statistical methods, etc.
It has greatly improved the quality of
multidisciplinary clinical research in our hospital, including IBD.
In addition, with the continuous accumulation and aggregation of big data, the continuous development of artificial intelligence technology has also played a role in promoting the development of RWS ^[2].
Imagine if China could establish a unified IBD electronic case file, standardize data entry, and share data between hospitals, then we could get a larger sample of IBD research and more reliable research results
.

Q2: How do you see the value of RWS data for clinical practice guidance? What advice do you have for RWS in IBD?
Professor
Zhang Yan generally believes that RCTs are the gold standard for evaluating the efficacy and safety of drugs, which can minimize the influence of other factors on efficacy estimates, so that the research conclusions are more certain, and the evidence formed is highly reliable ^{[ 3]}
。 However, its inclusion criteria were very strict and excluded many patients, which led to poor population representation in RCTs
.
In addition, RCTs have relatively small sample sizes and limited study periods, and in some rare disease studies, trials are not even possible because the number of patients who meet the criteria is too small
.
RWS, on the other hand, avoids this problem and is therefore becoming more and more popular with researchers
.
RWS is more of a guideline-recommended practiced procedure than an RCT, and the results can better help clinicians understand the full course of
new drug treatments.

At present, most of the RWS carried out in the field of IBD come from abroad, but due to genetic, environmental and other differences, these research conclusions may not be suitable for Chinese groups
.
For clinicians, these data can be used for reference, but in clinical practice, the selection of drug types and the adjustment of drug doses need to be made according to the individual situation of patients
.
Therefore, if the clinical development of a predictive model of drug efficacy will be more helpful in guiding
the selection of subsequent therapeutic drugs.
For example, researchers from the Victoria Research Alliance in the United States established a prediction model based on the phase 3 clinical study of vedelizumab ^[4], and verified it in the real-world multicenter Victoria research cohort to develop a vedelizumab exclusive clinical decision support tool (V-CDST).

This actually provides us with a good idea, if we can develop a variety of biologics prediction models and calculate the appropriate biologics type by entering patient data, this will be a breakthrough for
IBD's clinical decision-making.

Q3: Is there an advantage in clinical use of vedelizumab for IBD?
Professor
Zhang Yan In the treatment of ulcerative colitis (UC), vedelizumab is recommended as a first-line biologic in domestic and international guidelines, and the 2019 American Gastroenterological College (ACG) guidelines state that both hormonal and biologic agents are highly recommended for induction therapy in patients with moderate/severe UC ^[5].
In the process of clinical application, we found that vedelizumab is a "thick accumulation" biological agent, which has a slow onset of action, but is full of "stamina", and once the patient's condition is stable, the time to maintain the efficacy is also longer; Therefore, it is recommended to evaluate
after 5 infusions.
In addition, some patients can optimize the duration of treatment for better outcomes
.
For the treatment of severe UC, a combination of hormonal and vedolizumab may be considered; If patients with severe UC are accompanied by other complications such as diabetes and tuberculosis, vedelizumab can be considered as the drug of choice for treatment
based on the safety of the drug.

Q4: How do you think RWS should be carried out in China in the future to better guide clinical practice? What are your expectations for the future clinical use of biologics?
Professor
Zhang Yan RWS needs more attention, and foreign RWS data can only provide us with reference
.
More real and reliable test data with guiding value need to be based on "Chinese soil"
.
For clinicians, RWS research needs to be clinical problem-oriented, and it is necessary to think about the clinical problems to be solved, the treatment options to be selected, and the grouping at the beginning of the design
.
In addition, more attention should be paid to the development of multi-center, large-sample RWS, and big data can make the conclusions of RWS more scientific
.

For patients with severe UC or Crohn's disease (CD) with complications, the disease progression is usually faster, and we want to achieve "standard treatment", that is, mucosal healing, in the shortest possible time, thereby improving the patient's condition and quality of life, so efficacy is the first consideration
we consider when choosing IBD treatment biologics.
Secondly, the safety of drugs, the treatment of IBD is a relatively long process, and the safety of drugs cannot be ignored
.
The third is the price of drugs, for IBD patients who need lifelong treatment, the price of drugs is also one of the
important factors affecting patients' clinical choice of drugs.
The fourth is the convenience of treatment options
.
Finally, for some refractory CDs, the combination of two biological agents with different mechanisms of action is the direction
that can be considered in the future development of biological agents.

Summary</B149> Expert profile

Professor of Gastroenterology, West China Hospital, Sichuan University, Chief Physician and Doctoral Supervisor
Sichuan Province academic and technical leader, Sichuan Provincial Health and Family Planning Commission academic and technical leader, Sichuan Province overseas high-level study abroad talents
Visiting scholar at Washington University in St.
Louis and San Diego, University of California
Member of the Inflammatory Bowel Disease (IBD) Collaborative Group of the 10th Committee of the Gastroenterology Branch of the Chinese Medical Association
Wu Jieping Medical Foundation Member of the Standing Committee of the China Alliance for Inflammatory Bowel Diseases
Deputy leader of the Inflammatory Bowel Disease Professional Group of the Gastroenterology Professional Committee of Sichuan Medical Association
At present, it has obtained three projects supported by the National Natural Science Foundation of China, two supported projects supported by the Science and Technology Department of Sichuan Province, and published dozens of SCI papers

References[1]ZHENG Hanhan, et al.
New Knowledge of Medicine,2021,31(06):447-454 [2] Qin Xueni, et al.
Progress in Pharmacy,2021,45(07):512-523 [3] Real-world evidence supports guidelines for drug development and review (trial).
Dulai PS, et al.
Gastroenterology.
2018; 155(3):687-695.
e10.
[5]David T,et al.
Am J Gastroenterol 2019; 114:384-413

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