Safety considerations when using drugs in pregnant patients with systemic lupus erythematosus

Taulaigo, Anna Viola; Moschetti, Liala; Ganhão, Sara; Gerardi, Maria-Chiara; Franceschini, Franco; Tincani, Anǵela; Andréoli, Laura

doi:10.1080/14740338.2021.1893298

Cited by 3 publications

(16 citation statements)

References 134 publications

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“…Consistent with SLE treatment recommendations, the most common concomitant medications across data sources were antimalarials and corticosteroids. The use of these medications is generally considered safe during pregnancy 1 12 13. Immunosuppressants were also reported for many pregnancies, of which azathioprine was the most common.…”

Section: Discussionmentioning

confidence: 99%

“…[18][19][20] There are also limited birth defect data for novel SLE treatments, such as biologic drugs. 1 Therefore, SLE management often needs to be adjusted when pregnancy is planned, or when unplanned pregnancy is confirmed, to control disease while minimising harm. 1 20 Belimumab is a disease-modifying biologic therapy that inhibits soluble B-lymphocyte stimulator (also known as B-cell activating factor), 21 22 with a distribution and terminal halflife of 1.8 and 19.4 days, respectively.…”

Section: Systemic Lupus Erythematosusmentioning

confidence: 99%

“…Standard SLE therapeutic agents, such as cyclophosphamide, methotrexate and mycophenolate mofetil (MMF), have been implicated in birth defects and pregnancy loss 1 12 13. A recent study suggested that there may be a small increased risk of birth defects after hydroxychloroquine exposure, although this finding is not consistent with other studies 14–17.…”

Section: Introductionmentioning

confidence: 99%

“…Systemic lupus erythematosus (SLE) is an autoimmune disease that predominantly affects women of childbearing age and poses considerable risks to both mother and foetus during pregnancy 1 2. SLE-related factors such as renal disease and presence of antiphospholipid antibodies have been associated with poor pregnancy outcomes, including pre-eclampsia/eclampsia, miscarriage, abortion, preterm birth and maternal death, compared with women without SLE 3…”

Section: Introductionmentioning

confidence: 99%

“…Medical organisations in Europe (European Alliance of Associations for Rheumatology) and in the USA (American College of Obstetrics and Gynecology and American College of Rheumatology (ACR)) recommend against the use of several high-risk agents including cyclophosphamide, MMF, mycophenolic acid, leflunomide and methotrexate during conception and pregnancy 18–20. There are also limited birth defect data for novel SLE treatments, such as biologic drugs 1. Therefore, SLE management often needs to be adjusted when pregnancy is planned, or when unplanned pregnancy is confirmed, to control disease while minimising harm 1 20…”

Section: Introductionmentioning

confidence: 99%

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Belimumab use during pregnancy: a summary of birth defects and pregnancy loss from belimumab clinical trials, a pregnancy registry and postmarketing reports

et al. 2022

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ObjectiveDescribe available data on birth defects and pregnancy loss in women with systemic lupus erythematosus (SLE) exposed to belimumab.MethodsData collected from belimumab clinical trials, the Belimumab Pregnancy Registry (BPR), and postmarketing/spontaneous reports up to 8 March 2020 were described. Belimumab exposure timing, concomitant medications and potential confounding factors were summarised descriptively.ResultsAmong 319 pregnancies with known outcomes (excluding elective terminations), 223 ended in live births from which birth defects were identified in 4/72 (5.6%) in belimumab-exposed pregnancies and 0/9 placebo-exposed pregnancies across 18 clinical trials, 10/46 (21.7%) belimumab-exposed pregnancies in the BPR prospective cohort (enrolled prior to pregnancy outcome) and 0/4 belimumab-exposed pregnancies in the BPR retrospective cohort (enrolled after pregnancy outcome), and 1/92 (1.1%) in belimumab-exposed pregnancies from postmarketing/spontaneous reports. There was no consistent pattern of birth defects across datasets. Out of pregnancies with known outcomes (excluding elective terminations), pregnancy loss occurred in 31.8% (35/110) of belimumab-exposed women and 43.8% (7/16) of placebo-exposed women in clinical trials; 4.2% (2/48) of women in the BPR prospective cohort and 50% (4/8) in the BPR retrospective cohort; and 31.4% (43/137) of belimumab-exposed women from postmarketing/spontaneous reports. All belimumab-exposed women in clinical trials and the BPR received concomitant medications and had confounding factors and/or missing data.ConclusionsObservations reported here add to limited data published on pregnancy outcomes following belimumab exposure. Low numbers of exposed pregnancies, presence of confounding factors/other biases, and incomplete information preclude informed recommendations regarding risk of birth defects and pregnancy loss with belimumab use.

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Section: Discussionmentioning

confidence: 99%

Section: Systemic Lupus Erythematosusmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Belimumab use during pregnancy: a summary of birth defects and pregnancy loss from belimumab clinical trials, a pregnancy registry and postmarketing reports

et al. 2022

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Belimumab use during pregnancy: Interim results of the belimumab pregnancy registry

Juliao

Wurst

Pimenta³

et al. 2022

Birth Defects Research

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Background Belimumab is approved for active, autoantibody‐positive systemic lupus erythematosus (SLE) and lupus nephritis, but limited data exist regarding its use in pregnancy. The Belimumab Pregnancy Registry (BPR, GSK Study BEL114256; NCT01532310) was created to evaluate pregnancy and infant outcomes following belimumab exposure. Methods Individuals with SLE exposed to belimumab from 4 months before and/or during pregnancy can enroll into the BPR. The primary outcome is major birth defects; secondary outcomes include miscarriages, stillbirths, elective termination, pre‐term birth, neonatal death, small for gestational age, and adverse infant outcomes during the first year of life. Belimumab exposure timing, concomitant medications, and other potential confounding factors are also collected. Data up to March 8, 2021, are reported descriptively. Results From an expected sample size target of 500 prospective pregnancies with a known outcome, only 55 were enrolled in the study. Among these, two pregnancy losses and 53 pregnancies with a live birth outcome were reported. Ten of the 53 live birth pregnancies resulted in a major birth defect. Ten pregnancies were enrolled after the pregnancy outcome occurred and were examined retrospectively (four live births with no defects, four miscarriages, and two elective terminations). There was no indication or pattern of birth defects associated with belimumab. Conclusions Low recruitment numbers for the BPR and incomplete information limit the conclusions regarding belimumab exposure during pregnancy. There was no pattern or common mechanism of birth defects associated with belimumab within the BPR data.

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Contraceptive Care in the Rheumatic Diseases

Luche,

Talabi

2024

J Clin Rheumatol

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Contraception can help individuals with rheumatic and musculoskeletal diseases (RMDs) to avoid undesired pregnancies and improve reproductive outcomes. Despite the importance of contraception in the care of females with RMDs, evidence suggests that many of these individuals do not receive consistent or disease-specific counseling regarding contraceptive options. This includes female patients receiving teratogenic prescriptions as part of the management of their RMDs, or who have severe disease activity that might culminate in adverse pregnancy and perinatal outcomes. Contraceptive counseling can help females with RMDs who wish to prevent pregnancy to select a contraceptive method that is best for them. We conducted a narrative review of the primary literature addressing reversible, prescription-based contraception for females with RMDs, framed by published guidelines on contraceptive safety. Many safe and effective contraceptive options are available for females with RMDs. Special considerations must be given to individuals with systemic lupus erythematosus, whose disease activity may be exacerbated by exogenous estrogen. Females with positive antiphospholipid antibodies should avoid estrogen-containing contraception due to an unacceptable risk of thrombosis and should conditionally avoid depot medroxyprogesterone acetate, which appears to have a prothrombotic signature. Limited contraceptive options are available to male patients. Contraceptive care for adolescents with RMDs can be extrapolated from guidelines written for adult patients, with the additional consideration of barrier protection for individuals at risk for sexually transmitted infections. Future research is needed to assess the effects of contraception use on rheumatic disease activity and side effects.

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Safety considerations when using drugs in pregnant patients with systemic lupus erythematosus

Cited by 3 publications

References 134 publications

Belimumab use during pregnancy: a summary of birth defects and pregnancy loss from belimumab clinical trials, a pregnancy registry and postmarketing reports

Belimumab use during pregnancy: a summary of birth defects and pregnancy loss from belimumab clinical trials, a pregnancy registry and postmarketing reports

Belimumab use during pregnancy: Interim results of the belimumab pregnancy registry

Contraceptive Care in the Rheumatic Diseases

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