GSALT Everyone Talks Professor Chen Baili: Have you mastered all these points to discuss real-world research on IBD and broaden clinical diagnosis and treatment ideas?

• Chief physician
  of the Department of Gastroenterology, The First Affiliated Hospital of Sun Yat-sen University

• Deputy leader of the Inflammatory Bowel Disease Group of the Gastroenterology Branch of Guangdong Medical Association

• Member of the Psychological Collaboration Group of the Inflammatory Bowel Disease Group of the Gastroenterology Branch of the Chinese Medical Association

• Member of the Capsule Endoscopy Collaborative Group of the Digestive Endoscopy Branch of the Chinese Medical Association

• Deputy leader of the Youth Academic Group of the Chinese Journal of Inflammatory Bowel Diseases

• Member of the Standing Committee of the Inflammatory Bowel Disease Professional Committee of the Chinese Medical Education Association

• Member of Gastroenterologist Branch of Guangdong Medical Association

Prof.
Baili Chen: Randomized controlled studies (RCTs) are generally considered to be the gold standard for evaluating the safety and efficacy of drugs, and are commonly used in clinical research of ^drugs2
.
However, RCTs still have some limitations, such as small sample size, high research costs, insufficient representation of research subjects, and timely monitoring of adverse drug reactions
.
RWS refers to research
in which research data comes from a real medical environment and reflects the actual diagnosis and treatment process and the health status of patients under real conditions.
Since the issuance of China's first RWS guideline "China Real-World Research Guidelines 2018 Edition" in 2018 and the issuance and implementation of the "Technical Guidelines for the Use of Real-World Data for Clinical Evaluation of Medical Devices (Trial)" in 2020, the value of RWS has been valued and recognized by the state and gradually entered people's vision
.

Compared with RCTs, RWS includes a more representative group of clinically real patients, with a large sample size, wide coverage of the population.

At the same time, the long research period in the real clinical environment can provide more evidence for the efficacy and safety of drugs, and the analysis of different subgroups can help to find the advantageous population for drug treatment, but there are also problems such as
data bias and lack of efficacy indicators.

RWS is a new opportunity for drug trials, but because RWS is still in its infancy in China, it still faces the following challenges: first, lack of experience and insufficient understanding of RWS; Secondly, different research centers, data collection and content are different, data cannot be integrated and used; Finally, the research data had copyright issues and lacked integrity
.

At present, real-world research is mainly prospective research and retrospective research, due to the limitation of database integrity and accuracy, there are still many challenges in the research, and we look forward to the gradual improvement of our future scientific research tools to provide RWS with higher quality data
.

Prof.
Baili Chen: Long-term clinical remission and endoscopic remission are the goals of ^CD3
.
With the increase in the variety of biologics, evidence of efficacy and safety related to real-world research continues to accumulate, providing more reference information
for clinical decision-making.
A retrospective study by the US VICTORY Alliance confirmed that vedecrolizumab (VDZ) has higher rates of clinical response and mucosal healing in patients with moderate CD compared with anti-tumor necrosis factor (TNF)-α ^drugs4
.

VDZ has been applied in clinical practice in China, bringing new hope
for the treatment of UC and CD patients.
For patients with UC, especially those with moderate UC, VDZ induction therapy and maintenance therapy have significant effects, especially the mucosal healing rate, survival rate, and long-term use failure rate in maintenance therapy are very ideal
.
According to the current research data, the efficacy of VDZ in the treatment of patients with moderate CD is acceptable, but there are concerns about whether it can be applied to patients with severe or complicated CD
.
The WERY Alliance study data gives clinicians certain confidence and dosing evidence
.
There are three reasons for the discrepancy between the results of the analysis and the results of domestic and foreign studies: 1 It is premature
to assess the endpoint of efficacy.
Foreign retrospective studies evaluated the efficacy for 12 months or 24 months, which was relatively long
.
However, the multi-center phase 3 clinical study in China is short of 10 weeks, so there is a difference between the mucosal healing rate and clinical response rate between the two patients, suggesting that the clinical evaluation endpoint time should be moved
back.
2.
Whether intensive treatment
is required.
3.
Whether there are population differences, Asians may not be as effective as Caucasians
.

The results of real-world research provide guidance for clinical practice, on the one hand, RWS has a large sample size and can be analyzed in layers, and the research results can provide a basis for adjusting treatment plans in clinical practice.

Prospective studies have shown that first-line treatment with VDZ is advantageous in bio-naïve patients and those in the early stages of the disease.

On the other hand, the safety of medication, most foreign RWS results show that VDZ has fewer overall adverse reactions, which is preferred for special groups such as children, the elderly, pregnant women, and tumor patients
.