Help Us Understand the Possible Effects of Benlysta® in Pregnancy

Many people need to take medication during pregnancy to appropriately manage a chronic health condition. In some cases, avoiding or stopping medication use during pregnancy may be more harmful than taking medication. Yet fewer than 10% of medications have enough information to determine their safety for use in pregnancy — this is where you come in!

MotherToBaby is currently enrolling pregnant women in a study examining the use of Benlysta® (belimumab) to treat systemic lupus erythematosus (or SLE, a type of lupus) or active lupus nephritis (lupus-related kidney inflammation) during pregnancy.

Are you currently pregnant? Did you take Benlysta® at any point in your current pregnancy? If you answered “yes” to both of these questions, then you have the opportunity to help us learn more about Benlysta®.

“There is a huge need to generate more data for all of the drugs that people who are pregnant need to take.”

— Christina Chambers, PhD, MPH, Lead Investigator, MotherToBaby Pregnancy Studies

Will you take the next step and become our partner? Make an impact on the health of future families today by joining our Benlysta® & Pregnancy Study!

This sheet is about exposure to belimumab in a pregnancy or while breastfeeding. This information is based on available published literature. It should not take the place of medical care and advice from your healthcare provider.

What is belimumab?

Belimumab is a prescription medication used to treat systemic lupus erythematosus (SLE). Belimumab is prescribed to people who have active SLE and are receiving other lupus medications. Belimumab is a type of protein known as a monoclonal antibody and has also been referred to as a “biologic”. Belimumab is sold under the brand name Benlysta®. MotherToBaby has a sheet on lupus available at: https://mothertobaby.org/fact-sheets/lupus-pregnancy/.

Sometimes when women find out they are pregnant, they think about changing how they take their medication, or stopping their medication altogether. However, it is important to talk with your healthcare providers before making any changes to how you take this medication. Your healthcare providers can talk with you about the benefits of treating your condition and the risks of untreated illness during pregnancy.

I am taking belimumab, but I would like to stop taking it before becoming pregnant. How long does the drug stay in my body?

The time it takes the body to metabolize (to process) medication is not the same for everyone. In healthy adults, it takes up to 4 months, on average, for most of the belimumab to be gone from the body.

I take belimumab. Can it make it harder for me to get pregnant?

Studies have not been done to see if belimumab could make it harder to get pregnant.

Does taking belimumab increase the chance of miscarriage?

Miscarriage is common and can occur in any pregnancy for many different reasons. Based on animal studies done by the manufacturer, a case series, and one study in humans, belimumab is not expected to increase the chance of miscarriage. Lupus itself might increase the chance of miscarriage.

Does taking belimumab increase the chance of birth defects?

Birth defects can happen in any pregnancy for different reasons. Out of all babies born each year, about 3 out of 100 (3%) will have a birth defect. We look at research studies to try to understand if an exposure, like belimumab, might increase the chance of birth defects in a pregnancy.

Animal studies done by the manufacturer (with doses higher than the recommended dose used in people) did not show an increase in birth defects after exposure to belimumab. In humans, 2 case series and 1 study, totaling 77 women, have not found an increased chance for a pattern of birth defects.

Does taking belimumab in pregnancy increase the chance of other pregnancy-related problems?

It is not known if belimumab can cause other pregnancy complications, such as preterm delivery (birth before week 37) or low birth weight (weighing less than 5 pounds, 8 ounces [2500 grams] at birth). One study did not find an increased chance for pregnancy related problems. Active lupus, itself, may increase the chance of pregnancy complications such as preterm delivery and poor growth of the baby.

Does taking belimumab during pregnancy have any effect on my baby after birth?

It is not yet known if belimumab can have an effect on the baby after birth. Monoclonal antibodies, such as belimumab, cross the placenta during the third trimester of pregnancy and in theory might affect the baby’s immune system (the system in the body that helps fight off infections). One small study did not find a risk for a weakened immune system in the infant in the days after birth. Animal studies done by the manufacturer showed a weakened immune system in the offspring of animals exposed to belimumab during pregnancy, but these effects went away after 3 to 12 months.

Does taking belimumab in pregnancy affect future behavior or learning for the child?

Studies have not been done to see if belimumab can cause behavior or learning issues for the child.

Can my baby receive live vaccines before one year of age if I take belimumab while pregnant?

Since some biologic medications might suppress the immune system of the adult taking it, there is a theoretical concern that the same thing could happen to the baby if they are exposed during pregnancy. It is not known if exposure to belimumab during pregnancy affects a baby’s ability to fight off infection. If someone has a weakened immune system, they may be more likely to develop an infection from a live vaccine. Live vaccines contain a small amount of live virus. Inactivated vaccines do not contain live virus, so they cannot cause the disease they protect against. In the United States, rotavirus is the only live vaccine routinely given in the first year of life. Most people can get inactivated vaccines in the first year of life. Talk with your child’s healthcare provider about your exposure to belimumab during pregnancy. They can talk with you about the vaccines your child should receive and the best time for your child to receive them.

Breastfeeding while taking belimumab:

Belimumab is a large protein and little of the medication is expected to pass into breast milk. Belimumab is not well absorbed from the gut when swallowed. So any medication that would get into breast milk would be unlikely to enter the baby’s system. Be sure to talk to your healthcare provider about all of your breastfeeding questions.

If a man takes belimumab, could it affect fertility or increase the chance of birth defects?

Studies have not been done to see if belimumab could affect a man’s fertility (ability to get a woman pregnant) or increase the chance of birth defects. In general, exposures that men have are unlikely to increase risks to a pregnancy. For more information, please see the MotherToBaby fact sheet Paternal Exposures at https://mothertobaby.org/fact-sheets/paternal-exposures-pregnancy/.

MotherToBaby is currently conducting a study looking at belimumab use in pregnancy. If you are interested in learning more about this study, please call 1-877-311-8972 or visit https://mothertobaby.org/join-study.

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World-Renowned UC San Diego Epidemiologist Leads Groundbreaking Study

SAN DIEGO, CA – Recruitment is underway for a groundbreaking new study on the treatment of lupus during pregnancy.  The observational research, led by world-renowned UC San Diego epidemiologist Christina Chambers, PhD, MPH, is the first of its kind for the non-profit MotherToBaby, a CDC-recommended organization that provides evidence-based information on medications, diseases, vaccines, herbal supplements and more during pregnancy and breastfeeding. 

The study will recruit 400 pregnant people over a five-year period to evaluate use of the lupus drug Benlysta® (belimumab) in pregnancy. Benlysta® is used to treat the most common type of lupus, systemic lupus erythematosus (SLE), as well as lupus nephritis. Currently, there is limited information on the drug’s use in pregnancy.

The study will be MotherToBaby’s first to focus on a treatment specifically for lupus, and participants will be enrolled into the MotherToBaby Pregnancy Studies research program. Chambers, who is the lead investigator for MotherToBaby Pregnancy Studies, Co-Director of the Center for Better Beginnings, and Chief of the Environmental Science and Health Division in the UC San Diego Department of Pediatrics, noted that, “lupus can raise the risk of pregnancy complications, so it’s important for both the mom and her developing baby that this condition be well-managed during pregnancy. So, when treatments for lupus like belimumab are available, we want to do our best to gather information about those pregnancies where this medication has been used.”

The study is enrolling pregnant and recently pregnant people with exposure to Benlysta® and will provide critical information on the use of this medication during pregnancy. Participants will not be asked to change any part of their health care routine, including medications, nor will they be asked to travel.

More about MotherToBaby Pregnancy Studies

MotherToBaby Pregnancy Studies are conducted by the non-profit Organization of Teratology Information Specialists (OTIS) and coordinated at the Center for Better Beginnings at UC San Diego. OTIS is a professional scientific society made up of individuals engaged in assessing and evaluating risks to pregnancy and breastfeeding from environmental exposures. Members include, but are not limited to, specialists in the fields of obstetrics and gynecology, pediatrics, genetics, dysmorphology, perinatal epidemiology, teratology, behavioral teratology, pharmacy, genetic counseling, nursing, midwifery, maternal and child health, public health, and include experts that provide MotherToBaby services and researchers that conduct MotherToBaby Pregnancy Studies.

MotherToBaby is a suggested resource by many federal agencies including the Centers for Disease Control and Prevention (CDC). MotherToBaby is supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) as part of an award totaling $6,000,000 with zero percentage financed with non-governmental sources. The contents of this release are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by HRSA, HHS or the U.S. Government. To learn more about MotherToBaby and OTIS, please visit MotherToBaby.org.

Media Contact: Nicole Chavez, nchavez@mothertobaby.org, 619-368-3259

Katie recently reached out to us; she told us that she has lupus and has been taking hydroxychloroquine for years to successfully manage her lupus symptoms. Her concern? “I just found out I am pregnant and my rheumatologist was not sure if I can continue taking hydroxychloroquine during pregnancy. I am worried for my baby but I am also worried about stopping my lupus medication since it helps my symptoms so much. I haven’t had a flare in over a year! I can suffer through the flares if I have to, but I don’t want to harm my baby. I don’t know what to do.’

Katie’s concerns about how to balance the management of her chronic health condition against her baby’s health during pregnancy are not uncommon. Generally, the healthier a woman is during pregnancy, the better it is for both them and their baby. When taking medication during pregnancy, the risks and benefits of taking or not taking the medication should be carefully considered. More specifically, could the untreated condition cause more problems than taking the medication?

What is lupus and how could it affect a pregnancy?

Lupus, also known as systemic lupus erythematosus (SLE), is an autoimmune disease that affects many different parts of the body. The symptoms are variable; however, the kidneys, joints, and skin are commonly affected.  It is very important for both the health of the pregnancy as well as the health of the woman who is pregnant to achieve optimal control of lupus and maintain that control without flares (relapses in symptoms) throughout the pregnancy. For those who are planning a pregnancy, it is generally advised that at least 6 months without flares reduces the chances of pregnancy-related problems.

Lupus, especially if not well controlled, can cause serious health complications for both the woman who is pregnant as well as the baby. These complications include nephritis (inflammation of the kidneys that causes difficulty filtering waste from the body) and blood conditions such as anemia (a condition in which you don’t have enough healthy red blood cells to carry adequate amounts of oxygen to your body’s tissues) and thrombocytopenia (a condition in which the blood does not clot as fast as it should, which can cause excess blood loss). Inflammation in the lungs, heart, or brain can also occur and cause serious health problems.

People who have lupus also have a higher chance to develop high blood pressure during pregnancy and preeclampsia (a pregnancy-related condition that has several symptoms including a dangerous rise in blood pressure). People with lupus, most often the ones who develop high blood pressure or other health problems, may also have a higher chance of having a baby with poor growth which can lead to late miscarriage and preterm delivery (delivery before week 37).

Rare complications for the baby may include being born with symptoms of lupus (called neonatal lupus erythematosus (NLE)). These may be temporary and often disappear by six months of age. NLE is mostly seen in children when the pregnant woman has anti-SSA and anti-SSB antibodies. The most serious complication of neonatal lupus is a heart rhythm problem called congenital heart block which can often be detected on ultrasound and may lead to health complications and death. If these antibodies are present, additional ultrasounds for the heart may be recommended.

Katie was surprised. ‘I thought if I stopped my medications my flares would be painful and uncomfortable, but I never thought it could seriously affect my health or the health of my baby. Can you tell me more what is known about taking my lupus medication during pregnancy?’

So what do we know about lupus medications and pregnancy?

Many medications used to treat lupus are not thought to increase risks to a pregnancy over background chances that all pregnant individuals have. Medications work differently for different people. It is very important to talk with your healthcare providers before making any changes to how you take your medication. It is important to consider (with help of a rheumatologist) which medication works best to treat you. Regarding Katie’s question, the Society of Maternal Fetal Medicine (SMFM) recommends continuing the use of hydroxychloroquine during pregnancy. This recommendation is based on studies which did NOT show an increased risk for pregnancy related problems when hydroxychloroquine is used. Additionally, the studies showed a lower chance of lupus related problems during pregnancy when hydroxychloroquine is used.

There are many other medications such as steroids and biologics that lower the body’s immune system (immunosuppressants) that can also be considered for use during pregnancy.  However, certain medications for lupus are not recommended for use during pregnancy because they can increase the chance for birth defects and other pregnancy-related problems. SMFM recommends that methotrexate should be stopped 1-3 months before pregnancy and mycophenolate mofetil/mycophenolic acid should be stopped at least 6 weeks before attempting pregnancy. NSAIDs (non-steroidal anti-inflammatory drugs), such as ibuprofen, high dose aspirin, etc. are not recommended for use during pregnancy.

For information on specific medications make sure you talk with your healthcare provider or contact MotherToBaby and see our medication fact sheets at https://mothertobaby.org/fact-sheets/ . It is very important to talk with your healthcare providers before making any changes to how you take your medication. 

Katie summarized the information she was given very well, ‘It seems like making sure my lupus is well controlled will set both me and my baby up for the highest chance of being healthy. I feel much more comfortable continuing my medication knowing that with my own health, I am helping my baby to be healthy as well. I will talk with my healthcare providers to plan for monitoring both me and the pregnancy. Is there anything else I should know?’

Other info to know about lupus and pregnancy

It’s not uncommon for new medications to be developed for the treatment of lupus. If there is one thing that these new medications have in common, it’s that they very rarely have adequate, real-world data that describes whether the medication is safe to take during pregnancy. Pregnancy registries are the types of studies that give us this information, which is what allows us to provide risk assessments to people like Katie. That’s why we suggest to any pregnant woman with lupus that they consider joining the pregnancy registry for the medication(s) they are taking if one exists. The U.S. Food and Drug Administration (FDA) maintains a list of ongoing pregnancy registry studies on their website. If you’re planning a pregnancy or are already pregnant, now is a great time to find out more about the benefits of joining a lupus pregnancy study.

Women who are pregnant and have lupus will require some additional monitoring during pregnancy. They should be followed by their rheumatologist to make sure their symptoms are well controlled. Additional monitoring during pregnancy such as blood pressure checks, additional lab tests and additional ultrasounds may be recommended. Make sure you talk with your healthcare provider to discuss the management plan for your pregnancy.

Katie returned to MotherToBaby a few weeks later and told us she has been working together with her rheumatologist as well as her obstetric team including a high-risk pregnancy provider (also called Maternal Fetal Medicine (MFM) specialist) to make sure both her and her baby are as healthy as they possibly can be. ‘I felt empowered by being informed, having all my healthcare providers in my corner and knowing that by taking care of myself, I am taking care of my baby too. Thank you, MotherToBaby!’.

For more information about lupus and pregnancy, including links to lupus-related MotherToBaby Fact Sheets, visit our lupus resources page at https://mothertobaby.org/pregnancy-breastfeeding-exposures/lupus/. You can also contact one of our information specialists for a no-cost risk assessment by visiting https://mothertobaby.org/contact/.

If you are pregnant and taking belimumab (Benlysta®) to treat SLE or lupus nephritis, please consider enrolling into our observational study. This study will give women with lupus better answers about how lupus and its management can affect a pregnancy and a developing baby. You will not be asked to take or change any medications, and you can participate from the comfort of your home.