TNF-ALPHABETIC INHIBITORS DURING PREGNANCY: STOP OR CONTINUE?Biologics of the TNF-alpha inhibitor type, such as infliximab, adalimumab, etanercept, and certolizumab pegol, are often prescribed for dermatological conditions such as psoriasis, hidradenitis suppurativa, pyoderma gangrenosum, and sarcoidosis.
Young women also use these medications, and the question of what to do with these medications—discontinue or continue—is frequently raised if you have become pregnant or are planning to become pregnant.
Sometimes it is unknown whether a medication can be used safely by women and men who wish to conceive, during pregnancy, or while breastfeeding. The information included in the package insert of the medications is always cautious. Manufacturers often state in the package insert that use during pregnancy and breastfeeding is not permitted due to insufficient safety data. Such data is also lacking for the very latest biologics, because pregnant women are never allowed to participate in studies of new medications.
However, biologics that inhibit TNF-alpha have been in use for many years. It is now known that this group of medications (infliximab, adalimumab, etanercept, and certolizumab pegol) can be used safely during pregnancy, as hundreds of women have used them without any problems for their children. In particular, women who were taking TNF-alpha-inhibiting biologics for Crohn's disease (a bowel disease) or rheumatoid arthritis (inflammation of the joints) did not stop taking them during pregnancy on the advice of their doctor.
Of course, medications should only be prescribed during pregnancy if absolutely necessary. However, sometimes stopping the medication has more serious consequences than continuing, as the disease for which it was prescribed can flare up again.
The condition for which the biologic was prescribed and whether there are alternatives also matter. With pyoderma gangrenosum, it is usually unwise to stop taking it because it can cause large wounds. For psoriasis, there may be alternative treatments such as ointments, light therapy, cyclosporine, or certolizumab. Finding an alternative for sarcoidosis is difficult, but it depends on how extensive the condition was and how severe it is if it flares up again. With hidradenitis suppurativa, the inflammation can flare up again if you stop taking it, and it's unpredictable how much trouble you'll experience during pregnancy. There are some antibiotics that are safe to use during pregnancy (amoxicillin and clindamycin).
If you have become pregnant or are considering becoming pregnant, it is necessary to discuss the pros and cons of stopping or continuing with the prescribed medication with the doctor.
It is also important to read the available information about the risks of continuing TNF-alpha biologics during pregnancy. Only then can you make a well-considered decision.
Possible options include stopping immediately (some women make the principled decision not to use any medication at all during pregnancy), stopping in the last three months of pregnancy, or continuing use throughout the entire pregnancy. Temporarily stopping to assess whether the medication is still necessary, and possibly restarting it if it turns out to be impossible without the biologic, is also an option.
It is important to realize that with every pregnancy, even in healthy women who do not use medication, there is a baseline risk of 10 to 15% of miscarriage and a 2 to 4% of having a baby with a congenital defect. In pregnant women with an inflammatory disease such as psoriasis or Crohn's disease, these percentages are even higher.DO TNF-ALFA INHIBITORS HAVE AN EFFECT ON FERTILITY?Anti-TNF biologics have no adverse effects on male or female fertility. Therefore, women and men who want to have children do not need to stop taking these medications.CAN TNF-ALPHABETIC INHIBITORS CAUSE DEFECTS IN THE UNBORN CHILD OR INCREASE THE RISK OF MISCARRIAGE?The use of anti-TNF biologics does not increase the risk of birth defects or miscarriage. This applies to both women and men.CAN TNF-ALPHABETIC INHIBITORS CAUSE IMMUNE DISEASE IN THE UNBORN CHILD?Yes, that's possible, especially at the end of pregnancy. Early in pregnancy (the first three months, the first trimester), anti-TNF biologics cannot enter the baby's bloodstream. This is because they are antibodies, large proteins that cannot cross the placenta. In the second trimester, this changes, and the biologics can cross the placenta. In the third trimester (the last three months of pregnancy), large proteins such as biologics and antibodies from the mother are actively passed on to the baby. This is a natural protective mechanism: the baby receives all the mother's antibodies against viruses and bacteria and is therefore protected against infections in the first few months of life. But the anti-TNF biologics are also passed on to the baby. The amount of the biologic in the baby's blood can even be higher than in the mother's. This theoretically makes the newborn more susceptible to infections. However, in practice, this has not led to any problems. There are no reports of an increased risk of dangerous infections in newborns whose mothers used biologics during pregnancy.
There is one consequence: newborns whose mothers used biologicals during pregnancy may not be vaccinated with live, attenuated vaccines. Since January 1, 2024, a live, attenuated vaccine has been included in the national vaccination program: the rotavirus vaccine, which is administered at ages 6-9 weeks and 3 months. This vaccination may only be administered later. For infliximab, it may be administered 12 months after the last dose, for adalimumab 5 months, and for etanercept 4 months.
None of the above applies to certolizumab. Certolizumab is an abnormal protein and cannot cross the placenta. Therefore, the newborn's immune system is not disrupted, and the rotavirus vaccine can be administered as usual.CAN TNF-ALPHABETIC INHIBITORS BE USED DURING BREASTFEEDING?Breastfeeding is not a problem. The biologicals only penetrate breast milk to a very limited extent. The amount measured in breast milk is 0.1% to 1% of the amount measured in the mother's blood. Furthermore, the biologicals cannot be absorbed from breast milk and enter the newborn's bloodstream because they are large proteins that cannot pass through the baby's intestinal wall. |
