From conception through to breastfeeding, prescribe them as you would to a non-pregnant person, international experts say.
Asthma biologics can be safely used during conception and continued or initiated throughout pregnancy and breastfeeding, according to a new international consensus statement.
Biologics not only reduce exacerbations but improve quality of life, the authors write, while uncontrolled asthma and exacerbations in pregnancy, as well as oral steroid use, increase the risk of complications.
The exclusion of pregnant people from clinical trials means data is lacking, but in the evidence that exists the safety signal is good.
The consensus statement, published in The Lancet Respiratory Medicine, is based on a literature review and two rounds of surveys of 118 respiratory physicians, allergists, obstetricians and other health practitioners from 32 countries.
The resulting set of agreed-upon statements finds that biologics can be prescribed in pregnant people according to the same criteria as in non-pregnant people, emphasising shared decision-making and the need to discuss risks and benefits without overburdening patients with information.
It was agreed that four or more exacerbations in the previous 12 months was the threshold at which biologics should be initiated during pregnancy.
The consensus statements are, in summary:
Conception
1) Patients of childbearing age should have documented discussions with their specialist team about biologics in pregnancy at the point of commencing treatment
2) If clinically indicated and agreed by the patient, biologics can be initiated in people trying to conceive; they do not need to be stopped when trying to conceive
Care delivery
3) People with severe asthma who become pregnant should be reviewed by a trained asthma healthcare professional within the first trimester and have shared input from respiratory and obstetric teams throughout the pregnancy
4) Pregnant people on asthma biologics should be recorded in a registry
5) During pregnancy, the place of administration of biologics does not need to change
Related
Initiation of asthma biologics
6) People with severe asthma can start biologic therapy during pregnancy in line with prescribing criteria for non-pregnant patients
7) Steroid-related side effects and hospital admissions due to asthma in the past 12 months lowers the threshold for initiating a biologic during pregnancy
Continuation of asthma biologics
8) Biologics already initiated can continue throughout pregnancy
Postpartum care
9) If stopped, biologics can restart immediate after birth
10) Biologics can be initiated or continued while breastfeeding
11) There is no need to avoid inactivated vaccines for the baby when the mother has received an asthma biologic during pregnancy – except for tezepelumab, where experience is limited
Certain factors were agreed to lower the threshold for initiating biologics in pregnancy, such as an intensive care unit admission within the last 12 months and steroid-related side effects such as gestational diabetes, reduced bone density, and steroid-induced psychosis.
Confidence about use in pregnancy increased with the age of the biologic, with omalizumab, the first biologic to win FDA approval, achieving the strongest level of agreement and tezepelumab, the most recent, the weakest.
The inclusion of a statement regarding timing of live-attenuated vaccines for infants was based on rheumatology guidelines advocating a delay of six months when the mother has received an anti-tumour necrosis factor biologic during pregnancy. Consensus that no delay was needed was only reached when tezepelumab could be excluded.
The authors comment that the consensus about continuing biologics during pregnancy was “unexpected” given the lack of safety data, and that much of the knowledge base is imported from other specialities such as rheumatology, where there is more experience and detailed guidance.
The difference is that in rheumatology there are concerns about the immunosuppressive effects of anti-TNF biologics later in pregnancy, while “biologics targeting the type 2 inflammatory pathway in asthma are not broadly immunosuppressive and are well tolerated in real-world populations without increased risk of or susceptibility to severe infection in adults or children or after exposure during pregnancy”.
