Asthma Biologics OK During Pregnancy if Patient Agrees, Consensus Statement Says

Biologic drugs for asthma may be initiated or continued while conceiving or during pregnancy or breastfeeding following appropriate risk-benefit discussions and shared decision-making, a consensus statement from an international group of clinicians stated.

The 141 panelists reached at least 75% consensus on the following matters regarding asthma biologics: if the patient is in agreement, the biologics do not need to be halted in those who are trying to conceive or during pregnancy, but use in pregnancy should be recorded in registries; if halted during pregnancy, biologics should be restarted as soon as possible after birth; and inactivated vaccinations for infants don’t need to be avoided if the mother received a biologic during pregnancy.

In all cases, the use of biologics such as omalizumab (Xolair) and reslizumab (Cinqair) should be limited to patients “whose asthma is uncontrolled despite optimizing treatment of their comorbidities, inhaler technique, and treatment adherence,” according to Hitasha Rupani, PhD, of University Hospital Southampton NHS Foundation Trust in England, and colleagues, writing in Lancet Respiratory Medicine.

“There is no specific reason for [biologics] to be risky in pregnancy, but due to the absence of clinical trial data on their safety there are general concerns around any influence on pregnancy, premature birth, development of the fetus, congenital abnormalities, and long-term effects on the baby,” Rupani told MedPage Today.

As the position paper noted, “clinical trials have consistently shown that these biologics reduce exacerbation frequency, are steroid sparing, and improve quality of life in people with severe asthma.” Those trials, however, excluded pregnant women.

The participants in the consensus process were most comfortable prescribing omalizumab, the oldest biologic, and least comfortable prescribing tezepelumab (Tezspire), the newest. In fact, there was no consensus about whether tezepelumab should be continued during pregnancy; some participants noted that it wasn’t yet available in their countries.

“We did not obtain consensus on statements concerning changes to infant live-attenuated vaccination schedules when the mother has received an asthma biologic during pregnancy,” Rupani said. “We felt this probably reflects insufficient evidence and understanding by asthma clinicians in this area.”

Dharani Narendra, MD, of Ben Taub Hospital in Houston, who did not take part in the report, praised the consensus statement and said its recommendations are “reassuring.”

Narendra also noted that “the primary concern with using biologics in pregnancy stems from their potential to cross the placenta, especially in the third trimester, and affect fetal development. Although data from limited studies and case reports suggest no strong signal of harm, there is concern about immunosuppressive effects, particularly with newer biologics like tezepelumab, which have less safety data available.”

San Diego allergist/immunologist Jennifer Namazy, MD, pointed out that there are still no major society guidelines regarding the use of asthma biologics during pregnancy. “This paper is not a substitute for human data from clinical trials and registries,” she told MedPage Today. “There is still a lot of work to be done.”

“This report should not be interpreted as a statement that all asthma biologics are ‘safe’ to use during pregnancy and that further research is unnecessary,” added Namazy, who also did not take part in the position paper.

In a commentary accompanying the publication, Ian Pavord, MA, DM, of the University of Oxford/John Radcliffe Hospital in England, and colleagues wrote that the position paper “provides a consensus and framework to support clinicians and pregnant patients with severe asthma.” They added that “specialist care input and shared decision-making are crucial for good outcomes and fostering patient trust.”

The commentary authors also noted that registries for mepolizumab (Nucala) and dupilumab (Dupixent) have finished recruitment, and another registry for dupilumab is recruiting.

For the consensus statement, Rupani and co-authors consulted 141 clinicians from 32 countries who were active members of international and national severe asthma registries. The panelists were mainly respiratory physicians (72%), specialist nurses or allergists (9% each), and pharmacists (7%).

The panel reached consensus on these matters regarding asthma biologics in pregnancy:

Conception: “1. All patients who are of childbearing age should have documented discussions with their specialist team about the use of asthma biologics in pregnancy at the point of commencing treatment. 2. If clinically indicated and agreed by the patient, asthma biologics can be initiated in people trying to conceive; they do not need to be stopped in people trying to conceive.”

Care delivery: “3. All people with severe asthma who become pregnant should have a review by a trained asthma healthcare professional within the first trimester and have shared input from respiratory and obstetric teams throughout their pregnancy. 4. Pregnant people on asthma biologics should be recorded on a national or international registry. 5. During pregnancy, the place of administration of asthma biologics (i.e., home or hospital or clinical setting) does not need to change.”

Initiation or continuation of biologics for asthma: “6. Assuming the patient is in agreement, and the risks and benefits have been discussed, people with severe asthma can be initiated on asthma biologic therapy during pregnancy in line with national prescribing criteria for non-pregnant patients. 7. The presence of one or more steroid-related side-effects, a hospital admission, or intensive care admission due to asthma within the past 12 months lowers the threshold for initiating an asthma biologic during pregnancy. 8. Asthma biologics commenced before conception can be continued throughout pregnancy, including the third trimester [with the exception for tezepelumab].”

Postpartum care: “9. If stopped, asthma biologics can be restarted as soon as possible after birth. 10. Assuming the patient is in agreement, and the risks and benefits have been discussed, asthma biologics can be initiated or continued whilst breastfeeding. 11. After birth, there is no need to avoid inactivated vaccinations for the infant if the mother received an asthma biologic during pregnancy [with the exception for tezepelumab].”