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It is only for medical professionals to read for reference.
Patients with IBD are prone to opportunistic infections.
Proper vaccination is essential! Official announcement! On December 31, 2020, the State Council’s Joint Prevention and Control Mechanism held a press conference to announce that my country’s first inactivated vaccine for the new coronavirus has been approved by the National Medical Products Administration (NMPA) and will be provided free of charge to all people [1].
At present, the new crown vaccination work has been carried out in many places one after another, and the vaccination volume has exceeded 24 million doses [2].
However, patients with inflammatory bowel disease (IBD) who are using biological agents have many questions.
Can IBD patients be treated with the new crown vaccine? Can you fight with biological agents? Will biological agents affect the efficacy of the new crown vaccine, etc.
.
.
In fact, it is not only the IBD patients who have questions during the injection of the new crown vaccine, but also some patients who repeatedly ask the clinician when they are injected with tetanus, hepatitis B and other vaccines.
Biological agents have Immune regulation, can a vaccine be given when using biological agents? Let us do some discussion below.
1 The risk of opportunistic infections in IBD patients has increased.
In recent years, with the continuous progress of new drug development and clinical research, the efficacy of glucocorticoids, immunosuppressants and biological agents in the treatment of IBD has been significantly improved, and the disease complications and mortality of patients have been obvious.
Downtrend.
However, while significantly changing the immune status of patients to achieve the purpose of treatment, these drugs also bring some corresponding risks, especially increasing the risk of opportunistic infections [3].
The results of multiple studies have shown that anti-tumor necrosis factor (TNF) drug therapy can increase the risk of infection in patients with IBD, and the risk of infection in combination with immunosuppressive agents is higher than that of monotherapy [4,5].
Table 1: The risk of infection of immunosuppressive agents, anti-TNF drugs used alone or in combination, but not all biological agents are closely related to infection.
The anti-integrin vedelizumab is an intestinal selective biological agent that avoids the system Systemic adverse reactions caused by sexual immunosuppression, which have the same safety and low immunogenicity as placebo, have nothing to do with the increased risk of serious infections or opportunistic infections [6,7].
2 To reduce the occurrence of infection, vaccination is crucial.
The latest review published in INFLAMMATORY BOWEL DISEASES in January 2021 pointed out that due to lack of relevant knowledge and concerns about vaccine safety, the vaccination rate of IBD patients is lower than that of the general population[8] .
In fact, the European Crohn’s Disease and Colitis Organization (ECCO) consensus on opportunistic infections in inflammatory bowel disease pointed out that the use of glucocorticoids, immunomodulators, biological agents and other treatments for IBD patients are all immunocompromised individuals and are at risk of opportunistic infections.
Increasingly, this part of the population needs to consider the application of vaccines for opportunistic pathogens [3].
In the clinic, the immune status of newly-visited IBD patients should be checked, and it is recommended to vaccinate as soon as possible in the early stage of the disease.
Necessary and reasonable vaccination can help reduce the occurrence of infection [3,9].
There are two main types of vaccines commonly used in clinical practice, namely, live attenuated vaccines and inactivated vaccines [8].
Generally speaking, for patients with IBD, inactivated vaccines should be routinely vaccinated, such as tetanus, diphtheria, diphtheria, and polio vaccines [3,8]; while live attenuated vaccines, such as measles and mumps vaccines, should be vaccinated.
Try to avoid using [8,10].
As for the issue of new crown vaccination that IBD patients are currently concerned about, NMPA has conditionally approved 4 domestic new crown vaccines for the market, of which three are inactivated vaccines and one is an adenovirus vector vaccine [11-13].
Table 2: Recommendations and precautions for different vaccination of patients with IBD [14] 3 Different biological agents have different effects on vaccine immune response.
There are many biological agents on the market, including the classic TNF-α inhibitors Infliximab and Ada Lumumab and new biological agents vedelizumab, usnumab, etc.The immunogenicity of different biological agents is different, and the impact on the immune response of the vaccine is also different.
The latest review published in 2021 pointed out [8] that patients receiving anti-TNF drug therapy, especially when combined with azathioprine or methotrexate, may have weakened initial and maintenance immune responses to inactivated vaccines.
.
Compared with healthy controls, vedelizumab does not affect the response of IBD patients to influenza vaccine, whether it is monotherapy or combined with immunosuppressive agents.
One of the largest prospective analysis studies to assess the impact of veldrizumab on the immune response of vaccines[15,16], a total of 160 vaccination doses were included in patients, and the vaccines included influenza, pneumococcal (PVC13, PPSV23) and/or hepatitis B vaccine.
At the same time, the patients were divided into 4 groups according to their medication regimen: vedelizumab monotherapy group (group 1), vedelizumab combined immunomodulator therapy group (group 2), and anti-TNF drug combined immunization Modulator treatment group (group 3), control group without immunosuppressive therapy (group 4).
Figure 1: The vaccination status of the enrolled patients.
The results show that compared with other treatments, velizumab treatment did not reduce the immunogenicity of the vaccine.
For the influenza vaccine, the responses between the 4 treatment groups were similar, and there was no significant difference; for the pneumococcal vaccine, immune responses were observed in all treatment groups, and there was also no significant difference between the groups.
For the hepatitis B vaccine, if the hepatitis B surface antibody (anti-HBs) level is ≥10mIU/mL, the subject is considered to be protected from hepatitis B infection.
In the vedelizumab group (single or combination therapy), control group and anti-TNF treatment group, 62.
5%, 33.
3%, and 28.
5% of patients achieved HBs antibody levels greater than 10mIU/mL, respectively.
It is worth mentioning that none of the subjects participating in the study had serious adverse events or significant changes in disease activity.
Figure 2: The response level of patients receiving hepatitis B vaccine.
The product specification of vedelizumab also pointed out that patients who received veldrizumab can continue to receive non-live vaccination. Data on the spread of secondary infections after live vaccination in patients treated with vedelizumab are not yet available.
Live vaccines, especially oral live vaccines, should be used with caution when receiving vedelizumab treatment.
Only when the benefits clearly outweigh the risks, can veldrizumab and other live vaccines be used at the same time [17].
Summary IBD patients are prone to accompany opportunistic infections.
Therefore, patients should be tested for pathogen immune status during disease diagnosis, before applying biological agents, and during drug application, and assess whether they need to be vaccinated against infection according to the patient's individual situation.
Verdrizumab is an intestinal selective biologic with very low immunogenicity and risk of infection.
Vaccination of the inactivated vaccine is safe in IBD patients treated with veldrizumab, and can produce a vaccine immune response similar to that of the non-immunosuppressive treatment group.
Small research: reference source: 1.
Free for all! China’s first conditional listing of the new coronavirus vaccine injects confidence in the global victory over the epidemic.
http:// China Centers for Disease Control and Prevention: New coronavirus vaccination volume Accumulated over 24 million doses.
https://finance.
sina.
com.
cn/jjxw/2021-01-31/doc-ikftssap2068824.
shtml 3.
Qian Jiaming, et al.
Journal of Gastroenterology and Hepatology.
2016; 25(10): 1081-1083.
4.
Kirchgesner J, et al.
Gastroenterology.
2018 Aug;155(2):337-346.
e10.
5.
Nyboe-Andersen et al.
BMJ.
2015 Jun 5;350:h2809 doi: 10.
1136/bmj.
h2809.
6.
Zhou Qingyang, et al.
Chinese Journal of Digestion.
2020; 40(02): 141-144.
7.
Colombel JF, et al.
Gut.
2017 May;66(5):839- 851.
8.
Caldera F, et al.
Inflamm Bowel Dis.
2021 Jan 1;27(1):123-133.
9.
Sun Qinghua, et al.
Journal of Gastroenterology and Hepatology.
2015; 24(12): 1522-1526.
10.
Malhi G, et al.
J Crohns Colitis.
2015 Jun;9(6):439-44.
11.
Another new coronavirus vaccine in China is listed conditionally.
http:// content_5585509.
htm.
12.
The State Food and Drug Administration has conditionally approved the registration application of the new coronavirus inactivated vaccine (Vero cell) of Sinopharm Zhongsheng Wuhan Company.
https:// .
13.
Patients with IBD are prone to opportunistic infections.
Proper vaccination is essential! Official announcement! On December 31, 2020, the State Council’s Joint Prevention and Control Mechanism held a press conference to announce that my country’s first inactivated vaccine for the new coronavirus has been approved by the National Medical Products Administration (NMPA) and will be provided free of charge to all people [1].
At present, the new crown vaccination work has been carried out in many places one after another, and the vaccination volume has exceeded 24 million doses [2].
However, patients with inflammatory bowel disease (IBD) who are using biological agents have many questions.
Can IBD patients be treated with the new crown vaccine? Can you fight with biological agents? Will biological agents affect the efficacy of the new crown vaccine, etc.
.
.
In fact, it is not only the IBD patients who have questions during the injection of the new crown vaccine, but also some patients who repeatedly ask the clinician when they are injected with tetanus, hepatitis B and other vaccines.
Biological agents have Immune regulation, can a vaccine be given when using biological agents? Let us do some discussion below.
1 The risk of opportunistic infections in IBD patients has increased.
In recent years, with the continuous progress of new drug development and clinical research, the efficacy of glucocorticoids, immunosuppressants and biological agents in the treatment of IBD has been significantly improved, and the disease complications and mortality of patients have been obvious.
Downtrend.
However, while significantly changing the immune status of patients to achieve the purpose of treatment, these drugs also bring some corresponding risks, especially increasing the risk of opportunistic infections [3].
The results of multiple studies have shown that anti-tumor necrosis factor (TNF) drug therapy can increase the risk of infection in patients with IBD, and the risk of infection in combination with immunosuppressive agents is higher than that of monotherapy [4,5].
Table 1: The risk of infection of immunosuppressive agents, anti-TNF drugs used alone or in combination, but not all biological agents are closely related to infection.
The anti-integrin vedelizumab is an intestinal selective biological agent that avoids the system Systemic adverse reactions caused by sexual immunosuppression, which have the same safety and low immunogenicity as placebo, have nothing to do with the increased risk of serious infections or opportunistic infections [6,7].
2 To reduce the occurrence of infection, vaccination is crucial.
The latest review published in INFLAMMATORY BOWEL DISEASES in January 2021 pointed out that due to lack of relevant knowledge and concerns about vaccine safety, the vaccination rate of IBD patients is lower than that of the general population[8] .
In fact, the European Crohn’s Disease and Colitis Organization (ECCO) consensus on opportunistic infections in inflammatory bowel disease pointed out that the use of glucocorticoids, immunomodulators, biological agents and other treatments for IBD patients are all immunocompromised individuals and are at risk of opportunistic infections.
Increasingly, this part of the population needs to consider the application of vaccines for opportunistic pathogens [3].
In the clinic, the immune status of newly-visited IBD patients should be checked, and it is recommended to vaccinate as soon as possible in the early stage of the disease.
Necessary and reasonable vaccination can help reduce the occurrence of infection [3,9].
There are two main types of vaccines commonly used in clinical practice, namely, live attenuated vaccines and inactivated vaccines [8].
Generally speaking, for patients with IBD, inactivated vaccines should be routinely vaccinated, such as tetanus, diphtheria, diphtheria, and polio vaccines [3,8]; while live attenuated vaccines, such as measles and mumps vaccines, should be vaccinated.
Try to avoid using [8,10].
As for the issue of new crown vaccination that IBD patients are currently concerned about, NMPA has conditionally approved 4 domestic new crown vaccines for the market, of which three are inactivated vaccines and one is an adenovirus vector vaccine [11-13].
Table 2: Recommendations and precautions for different vaccination of patients with IBD [14] 3 Different biological agents have different effects on vaccine immune response.
There are many biological agents on the market, including the classic TNF-α inhibitors Infliximab and Ada Lumumab and new biological agents vedelizumab, usnumab, etc.The immunogenicity of different biological agents is different, and the impact on the immune response of the vaccine is also different.
The latest review published in 2021 pointed out [8] that patients receiving anti-TNF drug therapy, especially when combined with azathioprine or methotrexate, may have weakened initial and maintenance immune responses to inactivated vaccines.
.
Compared with healthy controls, vedelizumab does not affect the response of IBD patients to influenza vaccine, whether it is monotherapy or combined with immunosuppressive agents.
One of the largest prospective analysis studies to assess the impact of veldrizumab on the immune response of vaccines[15,16], a total of 160 vaccination doses were included in patients, and the vaccines included influenza, pneumococcal (PVC13, PPSV23) and/or hepatitis B vaccine.
At the same time, the patients were divided into 4 groups according to their medication regimen: vedelizumab monotherapy group (group 1), vedelizumab combined immunomodulator therapy group (group 2), and anti-TNF drug combined immunization Modulator treatment group (group 3), control group without immunosuppressive therapy (group 4).
Figure 1: The vaccination status of the enrolled patients.
The results show that compared with other treatments, velizumab treatment did not reduce the immunogenicity of the vaccine.
For the influenza vaccine, the responses between the 4 treatment groups were similar, and there was no significant difference; for the pneumococcal vaccine, immune responses were observed in all treatment groups, and there was also no significant difference between the groups.
For the hepatitis B vaccine, if the hepatitis B surface antibody (anti-HBs) level is ≥10mIU/mL, the subject is considered to be protected from hepatitis B infection.
In the vedelizumab group (single or combination therapy), control group and anti-TNF treatment group, 62.
5%, 33.
3%, and 28.
5% of patients achieved HBs antibody levels greater than 10mIU/mL, respectively.
It is worth mentioning that none of the subjects participating in the study had serious adverse events or significant changes in disease activity.
Figure 2: The response level of patients receiving hepatitis B vaccine.
The product specification of vedelizumab also pointed out that patients who received veldrizumab can continue to receive non-live vaccination. Data on the spread of secondary infections after live vaccination in patients treated with vedelizumab are not yet available.
Live vaccines, especially oral live vaccines, should be used with caution when receiving vedelizumab treatment.
Only when the benefits clearly outweigh the risks, can veldrizumab and other live vaccines be used at the same time [17].
Summary IBD patients are prone to accompany opportunistic infections.
Therefore, patients should be tested for pathogen immune status during disease diagnosis, before applying biological agents, and during drug application, and assess whether they need to be vaccinated against infection according to the patient's individual situation.
Verdrizumab is an intestinal selective biologic with very low immunogenicity and risk of infection.
Vaccination of the inactivated vaccine is safe in IBD patients treated with veldrizumab, and can produce a vaccine immune response similar to that of the non-immunosuppressive treatment group.
Small research: reference source: 1.
Free for all! China’s first conditional listing of the new coronavirus vaccine injects confidence in the global victory over the epidemic.
http:// China Centers for Disease Control and Prevention: New coronavirus vaccination volume Accumulated over 24 million doses.
https://finance.
sina.
com.
cn/jjxw/2021-01-31/doc-ikftssap2068824.
shtml 3.
Qian Jiaming, et al.
Journal of Gastroenterology and Hepatology.
2016; 25(10): 1081-1083.
4.
Kirchgesner J, et al.
Gastroenterology.
2018 Aug;155(2):337-346.
e10.
5.
Nyboe-Andersen et al.
BMJ.
2015 Jun 5;350:h2809 doi: 10.
1136/bmj.
h2809.
6.
Zhou Qingyang, et al.
Chinese Journal of Digestion.
2020; 40(02): 141-144.
7.
Colombel JF, et al.
Gut.
2017 May;66(5):839- 851.
8.
Caldera F, et al.
Inflamm Bowel Dis.
2021 Jan 1;27(1):123-133.
9.
Sun Qinghua, et al.
Journal of Gastroenterology and Hepatology.
2015; 24(12): 1522-1526.
10.
Malhi G, et al.
J Crohns Colitis.
2015 Jun;9(6):439-44.
11.
Another new coronavirus vaccine in China is listed conditionally.
http:// content_5585509.
htm.
12.
The State Food and Drug Administration has conditionally approved the registration application of the new coronavirus inactivated vaccine (Vero cell) of Sinopharm Zhongsheng Wuhan Company.
https:// .
13.
