Big coffee said the first anniversary of the clinical application of intestinal selective biologics: China's diagnosis and treatment of inflammatory bowel disease has entered a new stage

*Only for medical professionals to read for reference.
IBD experts talked about the treatment changes brought about by the 1st anniversary of the clinical application of veldrizumab
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In March 2020, the first and currently only intestinal selective biologic in the field of inflammatory bowel disease (IBD)-velizumab[1] was approved by the National Medical Products Administration for ulcerative colitis (UC) and Crohn's disease (CD) patients, and officially entered clinical application in China in November of the same year
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 Looking back on the course of this year, clinicians and patients were full of expectations for the clinical performance of vedelizumab at the beginning of the approval
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With the release of various research data and the accumulation of actual clinical experience since then, experts have a better understanding and deeper experience of the use of vedelizumab
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At the end of December 2020, vedelizumab was included in the medical insurance catalog and reimbursed as a Class B drug nationwide, which greatly reduced the burden of treatment for IBD patients
.

 On the one-year anniversary of the clinical application of vedelizumab in China, we specially invited Professor Chen Minhu from the First Affiliated Hospital of Sun Yat-sen University, Professor Qian Jiaming from Peking Union Medical College Hospital, and Professor Wu Kaichun from Xijing Hospital of Air Force Military Medical University as expert representatives to discuss Let me talk about the latest progress in diagnosis and treatment of IBD, and the treatment changes brought about by the clinical application of veldrizumab in China for one year
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To improve the level of IBD diagnosis and treatment in China, three experts expressed their ardent expectations for Professor Chen Minhu: The number of patients with IBD will increase, and higher requirements for diagnosis and treatment.
In the past, IBD was not common in economically underdeveloped areas and was often regarded as a disease of Westerners
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In the past 20 years, the incidence and number of cases of IBD in China has been rising rapidly, and it has become a digestive system disease that affects the quality of life of patients
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It is estimated that by 2050, the number of IBD patients in China will reach 1.
5 million [2]
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 In the face of the ever-increasing patient population, new problems and challenges have also been raised for our clinical diagnosis and treatment
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Professor Chen said that the cause of IBD is unknown, it is a chronic process, prolonged and unhealed, and has a certain degree of disability
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However, due to the low awareness rate of IBD among the general public, primary doctors have limited experience in the diagnosis and treatment of IBD, and delays in diagnosis and misdiagnosis often occur
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In terms of treatment, although a variety of drugs and biological agents have been used in the clinic, some patients fail to achieve clinical remission after treatment, and some patients are effective at the initial stage of treatment, but gradually lose their efficacy over time
.

China has a vast territory, and the medical level varies greatly from place to place.
Strengthening the standardization, homogeneity, and standardization of IBD diagnosis and treatment across the country is very important to improve the quality of IBD diagnosis and treatment
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 For this reason, in March 2018, the Chinese Medical Association Gastroenterology Branch and the IBD Group established the China Inflammatory Bowel Disease Diagnosis, Treatment and Quality Control Evaluation Center (IBDQCC).
With the strong support of colleagues across the country, the center has been certified since its establishment.
More than 60 high-quality IBD regional diagnosis and treatment centers, and issued a number of quality control standards to improve the level of IBD diagnosis and treatment
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Among them, the first edition of China's quality control standards for IBD endoscopy, pathology, and imaging examinations was officially released in July 2020.
This is a milestone progress in China's IBD diagnosis and treatment, and it has also promoted the further standardization of China's IBD diagnosis and treatment
.

 In keeping with the continuous construction and expansion of the IBD regional diagnosis and treatment center, various mainstream biological agents have entered the Chinese market in recent years, bringing more treatment options to clinicians and patients
.

Verdrizumab, which was approved in China in March 2020, is an anti-integrin antibody that targets the intestinal tract and inhibits the migration of lymphocytes to the site of inflammation
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Current clinical studies and real-world evidence both show that veldrizumab is better than placebo in the treatment of IBD, and some patients can achieve clinical remission and mucosal healing, which satisfies the unmet needs in the clinical treatment of IBD
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 Professor Chen Minhu also talked about the safety of biological agents
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Both clinical studies and real-world data show that veldrizumab has good safety and low immunogenicity.
Compared with placebo, it does not increase the risk of serious infection or opportunistic infection, nor does it increase the incidence of malignant tumors
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 We will further accumulate more patient experience and data to provide a basis for guiding clinical treatment
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 Professor Qian Jiaming: Comprehensive considerations, various trade-offs, and selection of appropriate treatment options for patients.
In recent years, the incidence of IBD in China has been increasing.
Changes in environmental dietary structure are believed to be related to this change
.

Although with the increase in the number of IBD patients, doctors' awareness of IBD has increased, but there are still some problems in clinical diagnosis and treatment that need to be improved
.

 In terms of diagnosis, IBD currently lacks the gold standard for diagnosis.
It needs to be combined with clinical, laboratory, imaging examination, and endoscopic and histopathological findings for comprehensive analysis.
Therefore, the diagnosis time of patients is relatively long; in addition, IBD is easily linked to infections and other other factors.
If the disease is confused, clinicians need to improve the ability of differential diagnosis [3-4]
.

In terms of treatment, Professor Qian said that there are many drugs to choose from, but there are still 20%-30% of patients unable to achieve clinical response; and patients with co-infection are more common, which undoubtedly raises questions about the safety of drugs.
Higher requirements
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 At present, the treatment of IBD has entered the era of biological preparations.
When talking about the selection of different biological preparations, Professor Qian believes that it is necessary to follow the principle of stratification and classification to treat patients with mild, moderate, and severe IBD
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Among them, for the treatment of patients with moderate to severe IBD, it is recommended to use biological agents earlier to achieve better treatment outcomes; in addition, although the safety of the drug is improved compared with before, it takes into account the risk of patients with opportunistic infections If it is high, it should not be taken lightly in clinical treatment.
It is necessary to pay attention to the monitoring of infection and choose the treatment plan suitable for the patient
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 When asked what kind of changes the clinical application of veldrizumab, currently the only intestinal selective biologic, has brought to patients in one year, Professor Qian expressed her views on UC and CD patients respectively
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Professor Qian said that at present her hospital has widely used veldrizumab in the early treatment of patients with moderate-to-severe and hormone-dependent UC, meeting the needs of patients for long-term efficacy and high safety of the drug; in CD patients In Chinese, Professor Qian said that although the prevalence of CD in the northern region is lower than that in the southern region, Peking Union Medical College Hospital has used velizumab for treatment of various types of CD patients
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In particular, vedelizumab has entered the medical insurance, and the treatment cost has been greatly reduced, which can benefit more patients
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 Professor Wu Kaichun: Improve IBD diagnosis and treatment standards and benefit more patients.
The etiology of IBD is still unclear.
The clinical manifestations of patients are complicated, the disease course is long and easy to relapse, which can easily lead to delays in diagnosis and treatment difficulties, which brings heavy burdens to patients and their families.
Burden
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Regarding this diagnosis and treatment status, Professor Wu said that through multidisciplinary team (MDT) cooperation, it is very important to provide patients with standardized and efficient diagnosis and treatment
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This year, the Inflammatory Bowel Disease Group of the Chinese Medical Association Gastroenterology Branch organized experts in the field of IBD.
After repeated discussions, the "Consensus Opinions on the Diagnosis and Treatment Model of Inflammatory Bowel Disease Multidisciplinary Teams" was compiled and formulated.
Professor Wu said that the consensus opinions are important for promoting The standardized development of IBD-MDT in China is of great significance, allowing clinicians to have rules to follow, and further strengthening the communication and learning between doctors in different departments and benefiting more patients
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 In addition to the release of the above consensus opinion, in October this year, the Inflammatory Bowel Disease Group of the Digestive Disease Branch of the Chinese Medical Association and the China Inflammatory Bowel Disease Diagnosis and Quality Control Evaluation Center also released China's first IBD Blue Book
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Professor Wu gave us a brief introduction to the core results of the Blue Book.
He said that the Blue Book's research spanned 24 provinces across the country, and went deep into 39 hospitals across the country.
351 experts and 1,058 patients participated in the investigation
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From the results, we can see that the current patients' understanding of IBD is still insufficient, and there is widespread diagnosis delay in disease diagnosis
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In terms of treatment, we found that doctors may not fully understand patients’ opinions on medication.
Clinicians may pay more attention to the long-term efficacy and improvement of quality of life, while patients pay more attention to the safety of drugs; in addition, clinicians also overestimate The patient’s knowledge of biological agents
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This indicates that there are different degrees of cognitive differences between the two sides of clinical medicine and patients about diseases and treatments.
In the future, clinicians need to strengthen the education of patients' disease knowledge from many aspects, truly think about problems from the perspective of patients, and make joint decisions between doctors and patients
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 Afterwards, Professor Wu further shared how to deal with the difficult problem of biologics selection that is common in clinical practice.
Professor Wu said that there are various biologics available for patients to choose in clinical practice, and the following three factors need to be considered when selecting:(1 ) Efficacy: Different biological agents have different characteristics, and there are certain differences in clinical remission, mucosal healing, imaging, histological remission, etc.
, and selection should be made according to the characteristics of each patient's disease
.

(2) Safety: Most biological agents affect the patient's immune system, and the level of safety directly affects the patient's treatment options
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(3) The characteristics and needs of the patients themselves: the needs of different patients are different.
Elderly patients have a higher risk of opportunistic infections, and safety needs to be fully considered when choosing drugs; while young patients need to receive long-term treatment, which is caused by drugs.
Tumor risk needs to be taken as an important consideration; in addition, whether the patient has intestinal fistula, extraintestinal manifestations, etc.
also affect the patient's treatment choice, so the patient's characteristics and treatment willingness should be fully considered when making treatment decisions
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 Real-world data from the Chinese population proves the efficacy and safety of veldrizumab.
From the introduction of the three experts above, we can see that the diagnosis and treatment of IBD has made great progress in recent years, but there are still many problems that need to be solved urgently
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Among them, the approval of new drugs in China has brought new treatment weapons to clinicians, made up for the deficiencies of existing drugs, and also brought new treatment experiences to patients
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 For the use of new drugs, accumulation of practical experience is important, as is the accumulation of research data
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In the past year, Verdrizumab has also accumulated a lot of real-world data on the Chinese population.
Let’s take a look at its performance? UC patients At the Asian Organization for Crohn’s Disease and Colitis Annual Conference (AOCC) held in October this year, a multi-center, retrospective evaluation of the efficacy of veldrizumab in the induction treatment of UC patients in China’s real-world environment The research abstract was officially announced [5]
.

 A total of 43 patients with UC were included in the study, of which 88.
4% of patients had moderate-severe UC, and 67.
4% of patients had not previously received biologics treatment
.

The results showed that 86.
0% and 44.
1% of the patients achieved clinical response and clinical remission after 14 weeks of velolizumab treatment; the C-reactive protein level of the patients decreased from the baseline 17.
4 mg/L to 2.
7 mg/L (P=0.
001)
.

 In addition, 20 patients underwent colonoscopy at 14 weeks, and 45% of them achieved endoscopic remission (MES score=0)
.

This small-sample real-world study confirms that veldrizumab is an effective induction therapy for Chinese UC patients
.

Figure 1: The clinical response rate, clinical remission rate, and endoscopic remission rate of vedelizumab treatment for 14 weeks in CD patients at the European Crohn’s Disease and Colitis Organization (ECCO) conference held in July this year.
The real-world VIOLET study conducted in Taiwan, China has attracted much attention.
The study evaluated the effectiveness and safety of vedelizumab in patients with CD and UC in Taiwan, China, and the recurrence of IBD after drug withdrawal [6]
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 A total of 274 patients with IBD were included in the study (CD: 127; UC: 147)
.

The results showed that more than 50% of CD patients achieved clinical response and clinical remission after 6 months of vedelizumab treatment, while 26.
4% and 12.
0% of patients achieved hormone-free remission and mucosal healing, respectively
.

Among them, the clinical response rate, clinical remission rate and hormone-free remission rate of vedelizumab in patients initially treated with biological agents were significantly better than those of patients treated with biological agents
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Figure 2: The true clinical efficacy of veclizumab in patients with CD in Taiwan, China for 6 months.
During the treatment of veclizumab, no patients had tuberculosis infection, malignant tumors or liver damage
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In addition, the researchers also evaluated the recurrence of the disease after the patients stopped using vedelizumab due to reimbursement policies and other reasons.
The results showed that 64.
2% of CD patients had recurrence, and the median time from withdrawal to recurrence was 4 months.

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This data shows that continuous use of vedelizumab is essential for the control of the condition of patients with CD
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 The small colonic tract selective biological agent velizumab, with its good efficacy and safety advantages, has been recognized by clinicians and patients in the IBD field, and has opened a new stage of IBD treatment in China
.

On the first anniversary of the clinical application of vedelizumab, we look forward to bringing hope and benefit to more patients in the future, and helping patients regain a healthy life! References: 1.
Cross RK, Chiorean M, Vekeman F, et al.
Assessment of the real-world safety profile of vedolizumab using the United States Food and Drug Administration adverse event reporting system[J].
PLoS One.
2019 Dec 4; 14(12):e0225572.
2.
Kaplan G G.
The global burden of IBD: from 2015 to 2025[J].
Nature Reviews Gastroenterology & Hepatology.
2015; 12(12): 720-727.
3.
Liang Jie, Zhou He, Yang Hong, et al.
Consensus opinions on the diagnosis and treatment model of inflammatory bowel disease in a multidisciplinary team[J].
Chinese Journal of Inflammatory Bowel Disease.
2021 05(4): E002-E002.
4.
Li Y, Qian JM.
The Challenge of Inflammatory Bowel Disease Diagnosis in Asia[J].
Inflamm Intest Dis.
2017 Apr;1(4):159-164.
5.
Jian T, Rongbei L, Min L, et al.
The real-world outcomes of vedolizumab induction treatment in patients with active Ulcerative Colitis in China: a multicenter retrospective study.
AOCC 2021.
6.
Wei SC, Lin WC, Chang CH, et al.

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Published more than 500 papers in academic journals, including more than 200 papers included in SCI.
Professor Qian Jiaming Chief Physician/Professor Doctoral Supervisor Peking Union Medical College Hospital Director of Digestion Teaching and Research Office Director of Intestinal Microecology and HP Branch of Beijing Medical Association Chairman of Digestive Branch of Beijing Medical Association Former Chairman, Adviser to the Inflammatory Bowel Disease Group, Digestive Branch of Chinese Medical Association 2018 Asian IBD Alliance (AOCC) Chairman, Chinese Health Promotion Association Digestive Expert Committee, Chief Editor, Medical Reference News "Digestive Channel", Former Director of Gastroenterology, Peking Union Medical College Hospital China Chairman of the Digestive Physician Branch of the Physicians Association Member of the Standing Committee and Deputy Chairman of the Digestive Branch of the Chinese Medical Association, Leader of the IBD and Gastrointestinal Hormones Group, etc.
Professor Kaichun Wu, Chief Physician, Professor, and Doctoral Supervisor, Deputy Dean of Xijing Hospital of Digestive Diseases, Air Force Military Medical University Vice Chairman of the Chinese Medical Association Gastroenterology Branch and leader of the Inflammatory Bowel Disease Group Executive Director of the Chinese Society of Enterology.
Approval number of the Asian Inflammatory Bowel Disease Organization: VV-MEDMAT-56262 Approval Date: November 2021 Statement: This content is only for Chinese medical and health professionals, and is intended to be only for medical and health professionals Provide scientific information for personal study and reference purposes
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