About 1 in 5 people have long-lasting conditions caused by type 2 inflammation, and many of these conditions affect women who may become pregnant. During pregnancy, the immune system naturally shifts in a way that can make these conditions worse or even trigger them. Examples include eczema during pregnancy and asthma.
Poor control of these conditions can affect both the mother and the baby. However, doctors often have limited treatment options, since many medications aren’t officially approved for use during pregnancy.
Dupixent (dupilumab) works by blocking IL-4 and IL-13, which are proteins involved in type 2 inflammation. It’s approved for several conditions, including eczema, asthma, chronic sinus disease with nasal polyps, prurigo nodularis, eosinophilic esophagitis, and certain cases of COPD. It’s well studied in the general population, but there isn’t enough research in pregnant women to clearly confirm safety.
This guide explains the latest evidence to support your choices during pregnancy.
Is it safe to take Dupixent while pregnant?
Dupixent is not officially approved for use during pregnancy because there isn’t enough high-quality research in pregnant women. However, some doctors may still prescribe it if the benefits outweigh the potential risks.
Available reports and small studies have not shown clear safety problems, but the data are still limited.
Evidence on Dupixent’s safety during pregnancy
One study used data from the TriNetX global network to compare 293 pregnant women exposed to Dupixent with unexposed women. Researchers assessed outcomes, such as:
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- premature labor
- pregnancy-induced hypertension
- gestational diabetes
- postpartum infections
- spontaneous abortion
The results showed no increased risk of adverse pregnancy outcomes. In fact, women taking Dupixent had about 89% lower risk of premature labor and about 47% lower overall risk of complications compared to those not taking it.
A smaller study from Italy looked at 29 women who discovered they were pregnant while using Dupixent. Most discontinued treatment upon learning of their pregnancy. When researchers compared outcomes with unexposed women matched by age and disease, they found no significant differences in miscarriage, birth defects, or postpartum complications.
In a separate comprehensive review, experts examined 69 pregnancies, where 22.2% used Dupixent throughout pregnancy, and 77.8% used it intermittently or stopped early.
The analysis found that 86.3% of pregnancies had no complications, and 82.5% delivered at full term. The average delivery time was 38.4 weeks, which is normal. About 82% had vaginal births, and the remaining were C-sections.
About 16% ended in spontaneous abortion, but this is roughly similar to general population miscarriage rates, which are often 10-20%.
In terms of baby outcomes,
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- 92.3% had normal birth weight
- 0 congenital defects reported
- No major safety issues identified
The authors concluded that Dupixent appears to have low to minimal risk for major adverse outcomes but emphasized the need for larger prospective studies.
Another analysis pooled data from 15 observational studies, including 115 pregnant women with atopic dermatitis treated with Dupixent. Average exposure during pregnancy was 27.5 weeks, so many used it for a large portion of pregnancy. Results showed that miscarriage risk was not higher than expected, and no birth defects were observed.
Case reports and case series
Case reports share real patient stories. They don’t prove safety, but they help identify possible benefits and risks.
A 28-year-old woman with severe eczema
She was started on Dupixent during her second trimester because topical and systemic steroids failed to control her symptoms. Her pregnancy already had complications, including high blood pressure and a smaller-than-average baby.
Because other medications weren’t suitable, her doctors decided to start Dupixent at 24 weeks of pregnancy. She received a 600 mg loading dose followed by 300 mg every two weeks. Her symptoms improved significantly, and she experienced only mild eye irritation.
She delivered at 37 weeks and 6 days (near full term), and the baby was healthy and weighed 5 lb 14 oz.
A 33-year-old woman with severe eczema since childhood
She had tried many treatments, including strong topical steroids, cyclosporine, and light therapy, but none worked well. She then started Dupixent 300 mg every 2 weeks, which greatly improved her skin.
She became pregnant after 12 months on Dupixent, and after discussing risks, she continued on Dupixent. Early pregnancy tests and ultrasounds were normal.
At 27 weeks, she stopped Dupixent due to uncertainty about safety. Her eczema flared severely, prompting her to restart treatment at 29 weeks. She delivered a healthy baby, weighing 2480 g (about 5.5 lbs), via cesarean section. No postpartum complications, she breastfed, and the baby continued to develop normally.
Case series including paternal exposures
A small series described two men who conceived children while using Dupixent and two women who stopped treatment before conception. The men continued therapy, and their partners had healthy pregnancies without complications.
The women who stopped were advised to wait about 3 months, because it takes around 10-11 weeks for Dupixent to leave the body. They experienced significant eczema flares after stopping treatment. One required systemic steroids and cyclosporine during pregnancy and was induced at 37 weeks due to physical and mental distress from eczema. Fortunately, her baby was healthy.
The findings suggest that a father taking the medication didn’t impact pregnancy. However, stopping treatment triggered flare-ups, and the women who discontinued therapy eventually restarted it.
A 38-year-old woman with severe pemphigoid gestationis
In this case report, she developed an itchy rash at 19 weeks of pregnancy. The rash spread across her stomach, trunk, and arms, forming red plaques and small blisters. Tests confirmed she had pemphigoid gestationis, a rare autoimmune skin condition that can occur during pregnancy.
She received Dupixent at 29 weeks after failing to respond to high-dose prednisone. Her rash improved significantly, and she was able to gradually stop prednisone. By 35 weeks, her skin was completely clear.
She delivered a healthy baby at 39 weeks. No skin problems were found in the baby. She continued Dupixent for 6 weeks postpartum. At 3 months postpartum, her skin remained clear.
Real-world surveillance data
Researchers searched the World Health Organization’s global adverse drug reaction database for reports of pregnancy and perinatal outcomes associated with dupilumab. Among more than 94,000 side effect reports, 36 reports involved pregnancy-related outcomes.
Among those 36 pregnancy-related reports:
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- 21 (58.3%) were miscarriages
- 8 (22.2%) were just reports of exposure during pregnancy
- 2 abortions were reported
- 1 rare case of heterotopic pregnancy (very uncommon)
However, researchers found no evidence linking Dupixent to these outcomes. The study concluded that Dupixent appears safe in pregnancy but urged continued monitoring.
MotherToBaby, a nonprofit organization providing evidence-based information about exposures during pregnancy and lactation, shared on their fact sheet that more than 50 pregnancies exposed to dupilumab in the first trimester showed no increased chance of birth defects.
In other countries like the UK, about 95 pregnancies exposed to dupilumab have been documented. Experts found no increased risk of miscarriage, congenital anomalies, neonatal complications, or developmental impairments. A few cases involved smaller babies or early delivery, but these were likely linked to underlying maternal conditions rather than medication.
Dupixent and pregnancy considerations
Here’s what to consider if you are pregnant or planning to become pregnant while using Dupixent.
1. Discuss with your healthcare provider
Every pregnancy and every case of atopic dermatitis or asthma is different. If you’re planning to become pregnant or find out you’re pregnant while taking Dupixent, schedule an appointment with your dermatologist, allergist, or obstetrician.
Talk about how severe your condition is, what treatments you’ve tried, possible alternatives, and your personal preferences. Your provider will help weigh the risks of uncontrolled disease against the limited but reassuring safety data. Making this decision together ensures you get the guidance and support you need.
2. Weigh the benefits and potential risks
Based on current evidence, taking Dupixent does not appear to increase the risk of miscarriage, birth defects, or serious pregnancy complications. However, because the medication is relatively new, long-term effects are still being studied.
If your condition is severe and not controlled with safer options, your doctor may recommend continuing Dupixent during pregnancy. If your symptoms are mild, your provider may suggest a more cautious approach, such as using topical treatments or phototherapy instead.
The decision often comes down to how much the medication helps you and whether stopping it could lead to flare-ups that require steroids or other higher-risk treatments.
3. Manage flares and postpartum care
If you stop Dupixent during pregnancy, your symptoms may flare up, sometimes within a few weeks. These flare-ups can be severe in some cases. If that happens, your doctor may recommend other options such as topical corticosteroids for active areas, calcineurin inhibitors like tacrolimus for sensitive skin, or narrow-band UVB phototherapy. Short courses of oral steroids may also be used for severe flares, but only when necessary.
After delivery, some women restart Dupixent to regain control of their condition. If you are breastfeeding, talk with your healthcare provider about when to resume treatment. Only small amounts of the medication are expected to pass into breast milk, and many experts believe it is unlikely to harm a nursing baby.
4. Breastfeeding and infant vaccination
Information about Dupixent in breast milk is limited. Because it’s a large antibody, only very small amounts are expected to pass into breast milk, and even less is likely to be absorbed by the baby. A few reported cases of breastfeeding while on Dupixent have not shown problems in infants.
Since data are still limited, you and your healthcare provider should weigh the benefits of breastfeeding against any theoretical risks. If your baby was exposed during pregnancy, some experts recommend delaying live vaccines, such as the rotavirus vaccine, for the first six months. Regular inactivated vaccines should still be given on schedule.
5. Enroll in pregnancy registries
If you use Dupixent during pregnancy, you may have the option to join a pregnancy registry. These programs track outcomes for both you and your baby to help researchers better understand safety. The information collected can improve future guidance for pregnant patients.
If you plan to continue or start Dupixent while pregnant, ask your healthcare provider whether a registry is available and how you can enroll.
6. Consider other biologics
Dupixent is not the only biologic used for asthma. Other options include omalizumab (Xolair), mepolizumab (Nucala), and benralizumab (Fasenra). Among these, omalizumab has the most pregnancy data and is generally considered relatively safe. There is less information for mepolizumab and benralizumab, but early evidence suggests they may also be low risk.
If you have severe asthma, talk with your pulmonologist about which biologic is most appropriate during pregnancy. Keeping asthma well controlled is important, since uncontrolled asthma can affect both you and your baby.
7. Manage eczema stress during pregnancy
Stress can trigger eczema flare-ups, and pregnancy may increase stress because of body changes, labor, and preparing for a new baby. Finding healthy ways to manage stress may help keep your symptoms under control. You can try prenatal yoga, meditation, breathing exercises, light physical activity approved by your obstetrician, or talking with friends or a counselor.
Keeping a consistent skincare routine also helps. Use fragrance-free moisturizers, avoid known triggers like harsh soaps or sudden temperature changes, and take care of your overall health. Getting enough sleep, staying hydrated, and eating well can also support your skin.
Bottom line
Current evidence suggests Dupixent is unlikely to pose major risks during pregnancy, although data remain limited. Studies and case reports show that continuing treatment may prevent severe flares and reduce the need for riskier medications.
Because long-term data are still emerging, decisions should be individualized. You and your healthcare provider should weigh the benefits of disease control against potential risks. Open communication and ongoing research will continue to clarify safety, but available evidence is reassuring that Dupixent may be a reasonable option for some women during pregnancy.
Frequently Asked Questions
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