COMMENTARY

Treatment Considerations for Pregnant Women With COVID-19

Paul G. Auwaerter, MD

Disclosures

October 07, 2021

This transcript has been edited for clarity.

Hello. I'm Paul Auwaerter with Medscape Infectious Diseases. I'd like to spend time in this piece discussing a particularly vulnerable patient population, which is pregnant women who have COVID-19.

Recently, we've seen more patients admitted to our hospitals who are pregnant, in part because this is a population that may be among the least immunized. Estimates are that only a quarter of pregnant women are vaccinated with any of the COVID-19 vaccines, and that number may drop to as little as 10%, particularly in the youngest age groups of women who are pregnant. However, if a pregnant woman does develop COVID-19, I think it's important to consider availing themselves of particular treatments, specifically including monoclonal antibodies if they're an outpatient with mild to moderate disease.

Now, as is true for everything I'll be speaking of, there have been no dedicated prospective trials in pregnant women with any of the COVID-19 treatments. This is, of course, not a unique situation, as pregnant women often are excluded from clinical trials, for obvious reasons. On the other hand, especially with something as widespread as the novel coronavirus in the setting of this pandemic, it is worth considering that this is a particularly at-risk population with high chances of having complicated infection.

Going by particular treatments, the only outpatient treatment modality would be monoclonal antibodies. This could include casirivimab/imdevimab, also bamlanivimab/etesevimab, the two combination monoclonal antibodies, or sotrovimab, the single monoclonal antibody. All of these products do have FDA emergency use authorization for treatment, and the two combination monoclonals also for postexposure prophylaxis.

We know that monoclonals, generally, and human immunoglobulin antibodies can cross the placenta and have the potential also to be transferred from the mother to the fetus. It's unknown if there's any benefit or risk to this, although generally immunoglobulins have not posed major issues. In a cross-reactivity study using human fetal tissues, there were no specific clinical concerns or binding detected.

The American College of Obstetricians and Gynecologists says that monoclonal antibodies can be considered. Of course, this would be a discussion with the pregnant woman, along with her physicians and perhaps consultants, such as infectious diseases physicians.

However, once hospitalized, and especially if there's evidence of lower oxygen saturations, the two standard therapies recommended would be the antiviral remdesivir and potentially corticosteroids. In terms of remdesivir, the limited information available suggests that it may not pose much risk based on animal studies, where there was no effect on embryo fetal development and in clinical studies of compassionate use for remdesivir. For example, 86 pregnant and/or postpartum patients had expected rates of adverse events and appeared to be generally well tolerated. I have these citations in information below. Also, 12 case reports have been published of remdesivir use in pregnant or lactating mothers that did not reveal serious safety concerns.

Corticosteroids typically have been recommended, based on the RECOVERY trial for dexamethasone use, but this particular steroid readily crosses the placenta. Frequently, if steroids are indicated, labor and delivery professionals recommend prednisolone 40 mg daily or hydrocortisone 80 mg IV twice daily. It was also, interestingly, used in the RECOVERY trial for any pregnant patients, although at very low numbers. Both of these medications have lower fetal concentrations with either limited placental crossing or rapid placental metabolism.

If pregnant women are getting more ill, typically considerations are given to the monoclonal antibody that is an anti-interleukin-6 receptor blocker, tocilizumab, or potentially the JAK inhibitor baricitinib. For tocilizumab, there's really few data available regarding use in pregnant patients with COVID-19, but the agent has been around a while for use in rheumatoid arthritis and rheumatologic conditions.

For example, 288 pregnancies in 399 women were studied and found what was considered no substantial increased risk of any fetal malformations. Another retrospective study, this one from Japan, followed 61 pregnancies (women received tocilizumab from conception) and found no increased risk of spontaneous abortion or congenital abnormalities. Patients with refractory rheumatoid arthritis appeared to tolerate tocilizumab well without adverse outcomes.

There have been some small studies in COVID-19. A report from Spain with 12 women who had received tocilizumab in second and third trimesters appeared to tolerate it well without any detrimental effects. Additional case reports have also included successful outcomes, but of course, there could be publication bias in these particular citations.

Baricitinib has been employed increasingly because of tocilizumab shortages. There's really very little literature regarding use of this drug in either pregnancy or pregnancy and COVID-19. Animal studies at high doses in excess of what would be used in typical human dosing have shown embryo and fetal toxicities, including skeletal malformations and reduced fertility. Experience using these drugs in pregnancy is quite limited, with only case reports in patients with rheumatoid arthritis, for example.

There has been a small study of tofacitinib, demonstrating successful use in COVID-19 but without pregnant patients and describing 60 patients without adverse outcomes who received the drug during pregnancy compared with typical background rates.

All in all, I think the key message is, although there's limited information, given the severity of COVID-19 in pregnancy, the recommendation is not to withhold any of these agents necessarily out of safety concerns. They should always be considered, but of course, discussed potentially with shared decision-making based on the data available at the time.

I hope this information was helpful. This is a very challenging patient population to treat, and obviously, is often important to discuss with multiple people as well. Hopefully, there will be additional attention and studies forthcoming that can give clinicians better confidence in making choices for pregnant patients with COVID-19. Thanks very much for listening.

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