Use of belimumab throughout pregnancy to treat active systemic lupus erythematosus—A case report
Introduction
Systemic lupus erythematosus (SLE) is an autoantibody-mediated systemic autoimmune disease that occurs more frequently in women of childbearing age compared to men (F:M ratio of 7:1) [1]. Pregnancy can be challenging to manage in patients with SLE for various reasons, including impact of pregnancy on the disease activity, effect of SLE on maternal and fetal health, the varied presentation of SLE during pregnancy, and the limited treatment options. Here we describe a patient with lupus nephritis who was successfully managed with belimumab throughout pregnancy. As far as we know, this is the first report of an uneventful pregnancy in a patient with lupus nephritis treated with belimumab throughout pregnancy.
Section snippets
Objective
To describe a patient with active SLE (including lupus nephritis) who was successfully managed with the use of belimumab throughout pregnancy.
Methods
A case report and review of relevant literature is presented.
Case report
A 38-year-old Caucasian woman with SLE was seen with her husband for advice regarding planning a pregnancy and management of lupus during pregnancy. She was diagnosed to have SLE at the age of 27 years based on biopsy-proven discoid lupus erythematosus, polyarticular arthralgia, angioedema, leukopenia (lymphopenia as well as neutropenia), thrombocytopenia, positive ANA (1:2560) in homogenous pattern, positive dsDNA (>200 IU/ml), SSA antibody, antigranulocyte antibodies, and low complements. The
Lupus management during pregnancy
After a year on belimumab, she became pregnant. Being a high-risk pregnancy, she was closely followed up by specialists in maternal–fetal medicine, rheumatology, and hematology. Warfarin was switched to a low-molecular-weight heparin, enoxaparin. SLE was treated with low-dose prednisone (2.5 mg daily), hydroxychloroquine 400 mg daily, and belimumab 10 mg/kg monthly infusions. Since patients with lupus nephritis are at high risk of preeclampsia, preterm delivery, and worsening nephritis, it was
Delivery and postpartum course
The patient delivered by cesarean section at term, after the failure of external cephalic version that attempted for breech presentation. The female baby was 19-in long and weighed 5 lb 15 oz and was found to have normal APGAR scores at birth. However, the baby had mild Ebstein׳s anomaly (mild displacement of tricuspid valve with mild to moderate regurgitation) on ECHO preformed at day 1 of her life. EKG did not show any heart blocks or signs of pre-excitation.
At the serial follow-up
Discussion
We describe the first case of belimumab use throughout pregnancy in a patient with difficult-to-control SLE. Our patient had very limited treatment choices left to control her persistently active SLE, and none of the choices were suitable for use in pregnancy. After a careful assessment and counseling, we embarked on belimumab therapy, as the benefits of the treating her SLE outweighed the risks to the fetus.
There are no human clinical studies available evaluating the use of belimumab in
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A Systematic Review of the safety of non-TNF inhibitor biologic and targeted synthetic drugs in rheumatic disease in pregnancy
2021, Seminars in Arthritis and RheumatismPregnancy outcomes in patients treated with belimumab: Report from real-world experience
2021, Seminars in Arthritis and RheumatismCitation Excerpt :Most previous reports on the use of belimumab in human pregnancy have been case reports or data from clinical trials for SLE. One case reported the use of belimumab throughout pregnancy, in which the pregnancy ended in a live birth with Ebstein's anomaly [6]. However, another case used belimumab until the 24th week of gestational age, and the pregnancy ended in a healthy live birth [5].
The use of biological agents in pregnant women affected by autoimmune disorders: Why we need more research of this neglected area
2021, Pharmacological ResearchCitation Excerpt :Belimumab is a fully humanized mAb inhibiting the cytokine B-lymphocyte stimulator and was approved by the FDA and the EMA to treat adult patients with autoantibody-positive SLE [107]. Human pregnancy data are very limited [108,109]; findings from phase II to III clinical trials reported outcomes of 83 unplanned pregnancies among women with SLE treated with belimumab. Spontaneous miscarriage (28%), stillbirth (2.4%) and congenital anomalies (1: a chromosomal translocation, also present in the mother) were reported [109].
Safety issues and recommendations for successful pregnancy outcome in systemic lupus erythematosus
2018, Journal of Autoimmunity