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*It is only for medical professionals to read for reference.
What can I do to care for you~Rheumatic immune disease mothers and babies? In the group of patients with rheumatism and immunological diseases, there is a very special kind of people-patients during pregnancy
.
It should be understood that the safety of medication for pregnant women not only involves the patient, but also the new life that is being conceived
.
There are so many drugs to control rheumatism, how do we know their safety? In the live broadcast of "ACR 2021 by the Youth Committee of the Society of Rheumatology" held by the medical field, Professor Zhao Jiuliang from Peking Union Medical College Hospital reviewed the relevant topics of the American Academy of Rheumatology 2021 (ACR 2021) for us.
The knowledge of drug safety of pregnant women was shared
.
The safety of medications for rheumatism during pregnancy is a current research hotspot.
In 2016, the European Union against Rheumatism (EULAR) has a certain explanation on the safety of medication during pregnancy.
The ACR 2021 on the topic of medication safety during pregnancy can also give us an understanding of related fields in the past few years.
New developments
.
Figure 1.
2016 EULAR's explanations on the safety of medications during pregnancy for rheumatism and immunological diseases.
A decade of sharpening a sword: Which research is on the way? In the topic, ACR 2021 emphasizes the relevant situation of the MotherToBaby Research Organization (hereinafter referred to as MTB), which has carried out a number of observational studies aimed at providing necessary reference information for the safety of drugs and vaccines for pregnant women.
Observe the safety of mother and child medication under the circumstances of the person
.
Figure 2.
Screenshot of MTB's official website.
In many observational clinical trials of MTB, pecelizumab has always been the focus of research
.
The phase I trial of pecelizumab is about to be completed at the end of 2022.
The trial mainly focused on the collection of clinical data of the 12-month, 16-month, and 36-60-month-old babies of the tested pregnant women
.
The phase II trial of the target drug pecelizumab will also end in the near future, mainly focusing on follow-up of 12-month-old babies
.
In addition, MTB has also paid attention to ulinumumab, tofacitib, tocilizumab, fully humanized interleukin-6 receptor mAb, and belyumumab.
It is believed that the results of clinical trials of these biological agents will be Safe medication during pregnancy provides a new reference
.
At the same time, during the new crown epidemic, the trial enrollment in the MTB was also affected.
The trial allowed subjects infected with the new crown virus to be included in the group for observation.
MTB also monitored the mental health of the pregnant women before and after the epidemic, the completion of the birth check, and the exposure of risk factors.
The conditions and complications were compared
.
I look forward to the publication of these results and provide more in-depth research data for the academic community
.
Based on the current data, there has been a significant increase in pregnant women with increased anxiety scores after the epidemic, and maternity examinations of pregnant women have indeed been affected by the epidemic, and pregnant women with poor weight management have a higher rate of new crown infection
.
Figure 3: The impact of the epidemic on pregnant women tested with MTB As of now, MTB has published some research results, as shown in Figure 4 involving the interleukin 1 blockers anakinra, rituximab and hydroxychloroquine during pregnancy Observe, interested friends can refer to and read on their own, so I won’t repeat them here
.
Figure 4: Some results of MTB medication research during pregnancy have no cause or death: Is it really safe for pregnant women with rheumatism to take medication? Among the research results of MTB, the observation of the medication of hydroxychloroquine is the most worthy of emphasis
.
In the study, pregnant women exposed to hydroxychloroquine due to rheumatism, pregnant women exposed to hydroxychloroquine due to rheumatism, pregnant women exposed to hydroxychloroquine due to diseases, and healthy pregnant women without exposure to hydroxychloroquine were observed for the defects of the babies (defects of the babies, weight/length).
/Abnormal head circumference, etc.
), adverse pregnancy events (natural abortion), and maternal retinopathy history as observational indicators
.
The final study found that, except for the older women exposed to hydroxychloroquine, the subjects with a 1:1 ratio in the three groups had a stable baseline, and the use of hydroxychloroquine did not change the pregnancy outcome, that is, hydroxychloroquine was not severely affected compared to healthy pregnant women.
Maternal and child health
.
Figure 5: The effect of hydroxychloroquine exposure on the maternal and infant health of pregnant women in each group.
The study also pointed out that although the use of hydroxychloroquine in early pregnancy increases the risk of infants' teratogenicity, the benefits of maternal benefits outweigh this risk
.
Figure 6: The benefits of hydroxychloroquine treatment outweigh the risks of teratogenicity.
In addition to related studies on hydroxychloroquine, MTB has also paid attention to and explored the drug safety of breastfeeding women, and published related monographs and research conclusions
.
Figure 7: MTB's work on drug safety in breastfeeding women In one of the observations, the researchers detected methotrexate in breast milk, although it was later pointed out that the concentration of the drug in the breast-fed baby should not exceed the concentration in the mother's body.
However, there is still a lack of strong evidence that trace amounts of methotrexate are safe for infants
.
Figure 8: MTB's observation summary on the safety of mothers and infants using methotrexate in breastfeeding women.
It can be seen that even though authoritative societies such as EULAR and ACR focus on safety issues related to rheumatism and pregnancy, there is still a lack of research evidence available for reference.
.
Professor Zhao Jiuliang emphasized that in the absence of medication safety data, the relevant doctors must strictly grasp the medication indications and be responsible for the long-term health of the mother and child
.
At the same time, Professor Zhao Jiuliang said frankly that China has begun a nationwide study on the safe use of drugs for mothers and infants in rheumatism, and hopes that in the future there will be data that are more in line with China's practice for peer reference
.
Expert profile Dr.
Zhao Jiuliang, associate professor, master's supervisor, assistant director of the Department of Rheumatology and Immunology, Peking Union Medical College Hospital
.
Mainly engaged in basic and clinical research on rheumatic immune diseases such as systemic lupus erythematosus, antiphospholipid syndrome, and connective tissue disease-related pulmonary hypertension
.
Participated successively in the national "Eleventh Five-Year Plan", "Twelfth Five-Year Plan" and "Thirteenth Five-Year Plan" scientific and technological support programs related to rheumatism and immunity
.
He has spoken on behalf of the team 19 times at national academic conferences, 9 times at international conferences, and participated in the publication of more than 106 SCI articles, including 28 SCI articles as the first author and corresponding author, and won the International Youth Award of the Japanese Society of Rheumatology and the Youth of the East Asian Society of Rheumatology Award, International Lupus Conference Travel Award, Chinese Medical Association Rheumatology Society Outstanding Paper Award, "Chinese Medical Journal" "Golden Pen Award", 2020 China Medical Journal "Top Ten Young Investigator Award", the second Union Hehe Outstanding Youth Award
.
He is currently the deputy chairman of the Youth Committee of the Chinese Association of Rheumatology, the deputy chairman of the Youth Committee of the Asia-Pacific Rheumatology Alliance (APLAR), the vice chairman of the Youth Committee of the Chinese Association of Rheumatology and Immunology, and the Chinese Research Hospital Association.
Member of the Standing Committee and Secretary-General of the Committee, Member and Secretary of the Beijing Society of Rheumatology, Deputy Editor-in-Chief of "Frontiers in Medicine" (IF 5.
095), Correspondence Editor of "Chinese Medical Journal", "Xiehe Medical Journal", "Chinese Journal of Clinical Immunity and Allergy" Young editorial board member
.
What can I do to care for you~Rheumatic immune disease mothers and babies? In the group of patients with rheumatism and immunological diseases, there is a very special kind of people-patients during pregnancy
.
It should be understood that the safety of medication for pregnant women not only involves the patient, but also the new life that is being conceived
.
There are so many drugs to control rheumatism, how do we know their safety? In the live broadcast of "ACR 2021 by the Youth Committee of the Society of Rheumatology" held by the medical field, Professor Zhao Jiuliang from Peking Union Medical College Hospital reviewed the relevant topics of the American Academy of Rheumatology 2021 (ACR 2021) for us.
The knowledge of drug safety of pregnant women was shared
.
The safety of medications for rheumatism during pregnancy is a current research hotspot.
In 2016, the European Union against Rheumatism (EULAR) has a certain explanation on the safety of medication during pregnancy.
The ACR 2021 on the topic of medication safety during pregnancy can also give us an understanding of related fields in the past few years.
New developments
.
Figure 1.
2016 EULAR's explanations on the safety of medications during pregnancy for rheumatism and immunological diseases.
A decade of sharpening a sword: Which research is on the way? In the topic, ACR 2021 emphasizes the relevant situation of the MotherToBaby Research Organization (hereinafter referred to as MTB), which has carried out a number of observational studies aimed at providing necessary reference information for the safety of drugs and vaccines for pregnant women.
Observe the safety of mother and child medication under the circumstances of the person
.
Figure 2.
Screenshot of MTB's official website.
In many observational clinical trials of MTB, pecelizumab has always been the focus of research
.
The phase I trial of pecelizumab is about to be completed at the end of 2022.
The trial mainly focused on the collection of clinical data of the 12-month, 16-month, and 36-60-month-old babies of the tested pregnant women
.
The phase II trial of the target drug pecelizumab will also end in the near future, mainly focusing on follow-up of 12-month-old babies
.
In addition, MTB has also paid attention to ulinumumab, tofacitib, tocilizumab, fully humanized interleukin-6 receptor mAb, and belyumumab.
It is believed that the results of clinical trials of these biological agents will be Safe medication during pregnancy provides a new reference
.
At the same time, during the new crown epidemic, the trial enrollment in the MTB was also affected.
The trial allowed subjects infected with the new crown virus to be included in the group for observation.
MTB also monitored the mental health of the pregnant women before and after the epidemic, the completion of the birth check, and the exposure of risk factors.
The conditions and complications were compared
.
I look forward to the publication of these results and provide more in-depth research data for the academic community
.
Based on the current data, there has been a significant increase in pregnant women with increased anxiety scores after the epidemic, and maternity examinations of pregnant women have indeed been affected by the epidemic, and pregnant women with poor weight management have a higher rate of new crown infection
.
Figure 3: The impact of the epidemic on pregnant women tested with MTB As of now, MTB has published some research results, as shown in Figure 4 involving the interleukin 1 blockers anakinra, rituximab and hydroxychloroquine during pregnancy Observe, interested friends can refer to and read on their own, so I won’t repeat them here
.
Figure 4: Some results of MTB medication research during pregnancy have no cause or death: Is it really safe for pregnant women with rheumatism to take medication? Among the research results of MTB, the observation of the medication of hydroxychloroquine is the most worthy of emphasis
.
In the study, pregnant women exposed to hydroxychloroquine due to rheumatism, pregnant women exposed to hydroxychloroquine due to rheumatism, pregnant women exposed to hydroxychloroquine due to diseases, and healthy pregnant women without exposure to hydroxychloroquine were observed for the defects of the babies (defects of the babies, weight/length).
/Abnormal head circumference, etc.
), adverse pregnancy events (natural abortion), and maternal retinopathy history as observational indicators
.
The final study found that, except for the older women exposed to hydroxychloroquine, the subjects with a 1:1 ratio in the three groups had a stable baseline, and the use of hydroxychloroquine did not change the pregnancy outcome, that is, hydroxychloroquine was not severely affected compared to healthy pregnant women.
Maternal and child health
.
Figure 5: The effect of hydroxychloroquine exposure on the maternal and infant health of pregnant women in each group.
The study also pointed out that although the use of hydroxychloroquine in early pregnancy increases the risk of infants' teratogenicity, the benefits of maternal benefits outweigh this risk
.
Figure 6: The benefits of hydroxychloroquine treatment outweigh the risks of teratogenicity.
In addition to related studies on hydroxychloroquine, MTB has also paid attention to and explored the drug safety of breastfeeding women, and published related monographs and research conclusions
.
Figure 7: MTB's work on drug safety in breastfeeding women In one of the observations, the researchers detected methotrexate in breast milk, although it was later pointed out that the concentration of the drug in the breast-fed baby should not exceed the concentration in the mother's body.
However, there is still a lack of strong evidence that trace amounts of methotrexate are safe for infants
.
Figure 8: MTB's observation summary on the safety of mothers and infants using methotrexate in breastfeeding women.
It can be seen that even though authoritative societies such as EULAR and ACR focus on safety issues related to rheumatism and pregnancy, there is still a lack of research evidence available for reference.
.
Professor Zhao Jiuliang emphasized that in the absence of medication safety data, the relevant doctors must strictly grasp the medication indications and be responsible for the long-term health of the mother and child
.
At the same time, Professor Zhao Jiuliang said frankly that China has begun a nationwide study on the safe use of drugs for mothers and infants in rheumatism, and hopes that in the future there will be data that are more in line with China's practice for peer reference
.
Expert profile Dr.
Zhao Jiuliang, associate professor, master's supervisor, assistant director of the Department of Rheumatology and Immunology, Peking Union Medical College Hospital
.
Mainly engaged in basic and clinical research on rheumatic immune diseases such as systemic lupus erythematosus, antiphospholipid syndrome, and connective tissue disease-related pulmonary hypertension
.
Participated successively in the national "Eleventh Five-Year Plan", "Twelfth Five-Year Plan" and "Thirteenth Five-Year Plan" scientific and technological support programs related to rheumatism and immunity
.
He has spoken on behalf of the team 19 times at national academic conferences, 9 times at international conferences, and participated in the publication of more than 106 SCI articles, including 28 SCI articles as the first author and corresponding author, and won the International Youth Award of the Japanese Society of Rheumatology and the Youth of the East Asian Society of Rheumatology Award, International Lupus Conference Travel Award, Chinese Medical Association Rheumatology Society Outstanding Paper Award, "Chinese Medical Journal" "Golden Pen Award", 2020 China Medical Journal "Top Ten Young Investigator Award", the second Union Hehe Outstanding Youth Award
.
He is currently the deputy chairman of the Youth Committee of the Chinese Association of Rheumatology, the deputy chairman of the Youth Committee of the Asia-Pacific Rheumatology Alliance (APLAR), the vice chairman of the Youth Committee of the Chinese Association of Rheumatology and Immunology, and the Chinese Research Hospital Association.
Member of the Standing Committee and Secretary-General of the Committee, Member and Secretary of the Beijing Society of Rheumatology, Deputy Editor-in-Chief of "Frontiers in Medicine" (IF 5.
095), Correspondence Editor of "Chinese Medical Journal", "Xiehe Medical Journal", "Chinese Journal of Clinical Immunity and Allergy" Young editorial board member
.
