2017 Update: Biologics in Pregnancy and Breastfeeding
After my rheumatoid arthritis (RA) diagnosis, one of the biggest challenges my husband and I faced in starting our family was figuring out safe options for keeping my disease under control while I was pregnant and breastfeeding.
Unfortunately, the data on drug safety during pregnancy and breastfeeding was extremely limited at the time. During my first pregnancy, I discontinued all my RA medications except a small dose of prednisone. This ended up being somewhat problematic for me, as prednisone tends to interfere with my blood pressure. I ended up on bed rest and diagnosed with preeclampsia at 35 weeks, and my son had to be born at 37 weeks.
I also stayed off my RA meds while I breastfed my first baby, which left me fighting through a bad postpartum flare without much help. Breastfeeding was very important to me, so I stubbornly soldiered on for three months until I reached a point where I could barely even lift my own baby. It was then that I made the difficult and emotional decision to wean him so I could go back on my RA meds.
Just over five years later I’m pregnant with my third baby, and it’s honestly a bit hard to believe how different the landscape is today when it comes to safe RA treatment options for pregnancy and breastfeeding. With my current pregnancy I made the decision to stay on a biologic, and I intend to continue using it while breastfeeding too. The advancements on this subject over just the past few years have been very exciting!
For women who depend on biologic medications who are currently considering a pregnancy – or would like to consider one in the future – I wanted to share an update on biologics in pregnancy and breastfeeding from the 2017 American College of Rheumatology annual meeting in San Diego, California.
Dr. Megan E. B. Clowse, Associate Professor of Medicine in the Division of Rheumatology and Immunology at Duke University and one of the leading experts in this field, began her presentation with a review of the new FDA pregnancy labeling standards that are currently being phased in. The old labels graded drugs (A, B, C, D, or X) and were simple, but misleading. They were based primarily on animal data and were rarely updated to include new data.
The new FDA labeling system does not include a grade, which makes them a bit more complicated to understand but ultimately more informative. The new labels include data from human pregnancies and, perhaps most importantly, a statement about the baseline risk of untreated disease in pregnancy.
Considering the risk of untreated – and possibly flaring – disease is an important aspect of weighing the risks and benefits of continuing a biologic medication during pregnancy. With RA, active disease during pregnancy is associated with preterm birth and growth restrictions. You also have to consider the risks of other medications that might be used to control flares in place of biologics. For example, Dr. Clowse pointed out that prednisone can increase preterm birth or lead to preeclampsia (as happened to me the first time). Lower risk meds include hydroxychloroquine and sulfasalazine, but these may not be sufficient to control more severe RA.
Today there is sufficient data to show that pregnancy outcomes for TNF inhibitors (Enbrel, Humira, Remicade, Simponi, Cimzia) are actually similar to outcomes seen in the general population (in terms of live birth, miscarriage, and congenital abnormalities). It is still generally recommended that these medications be discontinued during the third trimester, if possible, in order to limit the immunosuppression and risk of infection for the infant in the weeks after delivery. The exception to this rule is Cimzia, which is missing the part of the molecule responsible for crossing the placenta and thus could potentially be continued through delivery.
It’s also important to note that the risk of immune suppression to the infant is mostly theoretical. Another session at the 2017 ACR Annual Meeting presented data showing there is actually no evidence of any increased risk of serious infections in infants exposed to TNF inhibitors in utero, even if exposure occurs late in the third trimester (more details on this study in a separate article!)
If the infant is exposed to TNF inhibitors during pregnancy, the current recommendation is not to give any live vaccines in the first five months of the baby’s life. In the United States, the only recommended live vaccine scheduled for this time period is the Rotovirus vaccine – all other inactive vaccines can be given on the recommended schedule. However, in other parts of the world there may be additional live vaccines that would need to be delayed.
When it came time to discuss breastfeeding, I was thrilled that Dr. Clowse unequivocally told the doctors in the audience that women do not need to choose between taking medication and breastfeeding. She said the guilt mothers face over this choice (a guilt I am personally very familiar with) is entirely unnecessary, because today there are safe options available. The concentrations of TNF inhibitors that cross into breastmilk are extremely low, particularly for Cimzia. Furthermore, any medication that did cross into the breastmilk would likely be destroyed by the baby’s digestive system – which is why we need to have these medications injected or infused in order for them to be effective.
As is probably clear from my own story, the data in this area changes quickly, so Dr. Clowse recommended some great resources to make sure you and your doctor have the most up to date information before making these decisions. These resources include Mother to Baby (a non-profit dedicated to providing evidence-based information), LactMed (a database for drugs and lactation), and a 2016 document from the European League Against Rheumatism (EULAR) (points to consider for the use of antirheumatic drugs during pregnancy and breastfeeding). The exciting news is that the trend seems to be moving towards more and more safe options for women with RA who want to get pregnant or breastfeed their babies! So if you’re considering a pregnancy while living with RA, make sure you know all your options!