From the Guidelines
Orencia (abatacept) should be discontinued during pregnancy if possible, as the current evidence suggests limited safety data in human pregnancies and potential risks to the developing immune system of the baby. According to the 2020 American College of Rheumatology guideline for the management of reproductive health in rheumatic and musculoskeletal diseases 1, other biologics like Orencia are conditionally recommended to be discontinued during pregnancy due to limited safety data and potential placental transfer, particularly in the second half of pregnancy.
Some key points to consider:
- The guideline conditionally recommends discontinuing Orencia at conception due to limited safety data and potential risks to the fetus 1.
- Orencia crosses the placenta, particularly in the third trimester, which raises concerns about potential effects on the developing immune system of the baby 1.
- If Orencia is used during pregnancy, live vaccines should be avoided in infants for the first 6 months after birth.
- Alternative medications with better-established safety profiles during pregnancy might be recommended, such as hydroxychloroquine, sulfasalazine, or prednisone at low doses 1.
- The decision about continuing or stopping Orencia requires careful consideration of disease severity, pregnancy stage, and individual risk factors, and should be made in consultation with a rheumatologist 1.
In general, the management of rheumatic diseases during pregnancy requires a careful balance between controlling the disease and minimizing potential risks to the fetus, and individualized decisions should be made based on the specific circumstances of each patient.
From the FDA Drug Label
The data with ORENCIA use in pregnant women are insufficient to inform on drug-associated risk. However, there are clinical considerations for administering live vaccines to infants who were exposed to ORENCIA while in utero In reproductive toxicology studies in rats and rabbits, no fetal malformations were observed with intravenous administration of ORENCIA during organogenesis at doses that produced exposures approximately 29 times the exposure at the maximum recommended human dose (MRHD) of 10 mg/kg/month on an AUC basis However, in a pre- and postnatal development study in rats, ORENCIA altered immune function in female rats at 11 times the MRHD on an AUC basis.
The FDA drug label does not provide sufficient information to determine the safety of staying on Orencia during pregnancy. Risks and benefits should be considered prior to continuing treatment with Orencia in pregnant women. It is recommended to consult with a healthcare provider to discuss the potential risks and benefits of continuing Orencia treatment during pregnancy 2.
From the Research
Orencia (Abatacept) Use During Pregnancy
- The use of Orencia (abatacept) during pregnancy is generally not recommended due to the lack of proven safety for the fetus 3, 4, 5.
- Studies suggest that abatacept should be withheld prior to pregnancy, as the risk of teratogenicity is not well understood 3, 4.
- The treatment of rheumatoid arthritis during pregnancy should be tailored to the individual patient, taking into account the potential harmful effects of the treatment and the risk associated with discontinuation 6.
- Other medications, such as tumor necrosis factor inhibitors, antimalarial agents, sulfasalazine, and azathioprine, may be considered safe for use during pregnancy, but the decision should be made on a case-by-case basis 3, 4, 6.
- It is essential to stabilize the disease prior to conception and use medications that are safe throughout pregnancy and lactation 3, 5.
Key Considerations
- The absence of proven safety for the fetus is a significant concern when using abatacept during pregnancy 3, 4.
- The decision to use any medication during pregnancy should be made in consultation with a healthcare provider, taking into account the individual patient's needs and circumstances 6, 5.
- More research is needed to fully understand the safety and efficacy of abatacept and other biologics during pregnancy 7.