From the Guidelines
Belimumab is not recommended for use in pregnancy due to its category C labeling and limited data on its safety, and instead, other medications such as hydroxychloroquine, azathioprine, and glucocorticoids are considered safer options for managing SLE during pregnancy. The use of belimumab in pregnancy is not supported by strong evidence, and its safety profile is not well established 1. In contrast, hydroxychloroquine has been shown to be safe in pregnancy and may decrease the rate of preterm birth and intrauterine growth retardation, whereas withdrawal of hydroxychloroquine has been associated with LN flare 1. Azathioprine and glucocorticoids are also considered safe immunosuppressive treatments during pregnancy, and can be used to manage SLE flares 1.
Some key points to consider when managing SLE during pregnancy include:
- Regular monitoring of lupus activity and fetal development is essential throughout pregnancy
- Hydroxychloroquine, azathioprine, and glucocorticoids are considered safer options for managing SLE during pregnancy
- The use of belimumab in pregnancy is not recommended due to its category C labeling and limited data on its safety
- Low-dose aspirin may also reduce the risk of preeclampsia and intrauterine growth retardation, and can be started at conception or as soon as pregnancy is recognized 1
It's also important to note that the decision to use any medication during pregnancy should be made in consultation with a rheumatologist and obstetrician, weighing the potential benefits against the risks for both mother and fetus. The safety and efficacy of medications during pregnancy should be carefully evaluated, and the most up-to-date evidence should be considered when making treatment decisions 1.
From the Research
Safety of Belimumab in Pregnancy
- Belimumab may be a viable option for pregnant women with difficult-to-control lupus, as it has been shown to be relatively safe in this population 2.
- A study of 16 pregnancies in 12 women with lupus who received belimumab found no cases of pre-eclampsia, gestational diabetes mellitus, or hypertension, and all neonates had normal Apgar scores at birth 2.
- Another study found that belimumab did not increase the risk of adverse effects compared to a control treatment in patients with systemic lupus erythematosus (SLE) 3.
Efficacy of Belimumab in SLE
- Belimumab has been shown to be effective in reducing SLE disease activity and severe flares, and improving SRI response rates 4, 5.
- A phase III study found that belimumab plus standard therapy significantly improved SRI response rates and reduced SLE disease activity and severe flares compared to placebo plus standard therapy 4.
- A long-term study found that belimumab was well-tolerated and effective in patients with SLE, with a low risk of side effects and no increased risk of adverse events 5.
Belimumab vs. Other mAbs
- There is limited data comparing the safety and efficacy of belimumab to other monoclonal antibodies (mAbs) in pregnancy.
- However, belimumab has been shown to be relatively safe and effective in patients with SLE, and may be a viable option for pregnant women with difficult-to-control lupus 2, 4, 5.