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Instructions and off-label use of TNF-α inhibitors for rheumatoid arthritis in women of childbearing age
.
From the epidemiological point of view, the incidence of RA in women is higher than that in men, and the incidence and prevalence of RA in women of childbearing age cannot be ignored [1].
In the long-term treatment of women with RA, the specificity of pregnancy planning during their childbearing years should be considered, and the impact of disease activity, contraception, and drug therapy should be considered [2].
At present, the treatment of RA is commonly treated with nonsteroidal anti-inflammatory drugs, glucocorticoids, and antirheumatic drugs (DMARDs).
Biological DMARDs are very important disease control drugs in the field of RA treatment, and the biological agents used clinically in China for the treatment of RA include: peserolizumab, etanercept, adalimumab, infliximab, golimumab, etc
.
Drug inserts are legal documents that contain important information about drugs, and are legal guidelines for the selection of drugs [3], and clinical use of drugs should first follow the instructions
.
【TNF-α inhibitors in the instructions, pregnant and lactating women】
The holder of China's drug instructions is the responsible entity, and the formulation, revision and maintenance are all responsible for its [4].
Medicine and pharmacy are practical disciplines, and drug inserts always lag behind the practice and development of medicine, which leads to certain lags and incompleteness
in drug inserts.
Judging from the current instructions of TNF-α inhibitors in China, its medication instructions for women of childbearing age can no longer meet the actual clinical drug needs [5].
【TNF-α inhibitor off-label medication for pregnant and lactating women】
In actual clinical work, the off-label medication of rheumatology and immunology is particularly prominent
.
In the treatment of RA, special groups related to pregnancy, such as women preparing for pregnancy, pregnancy and lactation, and men preparing for pregnancy, face difficulties
in off-label medication.
The domestic instructions of some drugs mention that they cannot be used in men and women who are trying to conceive, pregnant and lactating women, and the description of domestic TNF-α inhibitors on pregnancy includes that women of childbearing age must take appropriate contraceptive measures to prevent pregnancy, while domestic and foreign guidelines that have been updated in recent years strongly recommend or recommend the use
of drugs in special populations.
The revision of the Medical Practitioners Law of the People's Republic of China has made off-label medication a law to follow, and the diagnosis and treatment guidelines and off-label medication under evidence-based medicine are written into laws and regulations
.
The Chinese expert consensus on the use of super-drug instructions for rheumatoid arthritis in China (2022 version) clearly pointed out that women who are trying to conceive strongly recommend continued use of pecelizumab [5].
TNF-α inhibitors can be continued in pregnant women with RA, but the timing of discontinuation varies from drug to drug
.
It is important to note that because peselizumab does not contain an FC segment, it is rarely transported through the placenta, and the drug can be used throughout pregnancy without the need for dose
adjustment.
Other TNF-α inhibitors (etanercept, infliximab, adalimumab, golimumab, etc.
) contain the lgG1Fc segment and have a high
placental transport rate during pregnancy, especially in the third trimester.
Therefore, TNF inhibitors containing the Fc segment need to be discontinued in the third trimester of pregnancy to reduce the potential risk to the fetus from entering the fetal circulation, and the specific discontinuation time varies according to the half-life of the drug
.
For women with lactating RA, the low milk transport of various TNF-α inhibitors, combined with the effects of intestinal proteolysis, poses little risk to the infant's immune system
.
However, it should be noted that there are some differences in milk transport between biologics, and CRADLE studies have shown that the milk transport of peselizumab is very low or can be considered non-transport [6].
summary
From the above drug inserts and off-label medications, for the treatment of RA patients of childbearing age, the update of the instructions lags behind the domestic and foreign guidelines
.
Under the premise of increasing clinical needs of women of childbearing age in China, the treatment of RA diseases should consider super-population medication according to guidelines, take patients as the center, and scientifically meet the clinical needs
of patients.
Expert profile
: Wu Henglian Chief physician
- Dongguan Hospital of Guangzhou University of Chinese Medicine (Dongguan Hospital of Traditional Chinese Medicine)
- Chief physician of the Department of Rheumatology and Immunology, subject consultant
- Chairman of Guangdong Clinical Medical Association-Dongguan Rheumatology and Immunology Specialty Alliance
- Vice Chairman of the Rheumatology and Immunology Professional Committee of Guangdong Clinical Medical Association
- Vice Chairperson of the Rheumatology and Immunology Professional Committee of Guangdong Women Physicians Association
- Vice Chairman of the Rheumatology and Immunology Professional Committee of Guangdong Geriatric Health Care Association
- Standing Committee Member of Rheumatology Branch of Guangdong Medical Association
- Standing Committee Member of Rheumatology and Immunologist Branch of Guangdong Medical Association
- Member of the Standing Committee of the Rheumatology Branch of Guangdong Association of Integrative Medicine
- Member of the Standing Committee of the Reproductive Professional Committee of Guangdong Clinical Medical Association
- Member of the Chinese Research Committee on Rheumatology and Immunology Related Reproduction and Pregnancy
- Director of China Rheumatology and Immunology Medical Alliance Alliance
- Founding member of the Rheumatology Branch of Dongguan Medical Association and the chairman of the first professional committee
- In 2003, the Department of Rheumatology of Dongguan People's Hospital was established, and in 2017, the Department of Rheumatology and Immunology of Donghua Hospital was established
References[1] Rudan I, et al, J Glob Health.
2015 Jun; 5(1):010409.
[2]Götestam Skorpen C, et al.
Ann Rheum Dis.
2016 May; 75(5):795-810.
[3] FANG Wenhua, YE Hongjun.
Straits Pharmacy,2019,31(12):189-191 [4] Drug Evaluation Center of the State Medical Products Administration, Regulations on the Administration of Drug Instructions and
Labels.
[5] Expert Consensus on the Formulation of Chinese Expert Consensus on the Use of Drugs in Super-drug Labels for Rheumatoid Arthritis.
Chinese Medical Journal,2022,102(15):1076-1085 [6]Clowse MEB, et al.
Ann Rhem Dis.
2017; 76(11):1890–1896.
This article is only for providing scientific information to healthcare professionals and does not represent the position of
the platform.
