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

ABSTRACT

Introduction: Systemic lupus erythematosus (SLE) mainly affects young females during childbearing age; therefore, reproductive issues are of major interest.

Areas covered: Pregnancy planning is crucial to adjust the treatment toward drugs that are safe throughout pregnancy and breastfeeding. The evidence about drug safety is limited to post-marketing surveillance, registries, case series, and case reports, as pregnant patients are excluded from randomized clinical trials. The aim of this review is to report the safety considerations when treating pregnant SLE patients. Regarding maternal side effects of drugs, we focused on metabolic, infectious, and hemorrhagic complications. Fetal safety was analyzed looking at drugs teratogenicity, their possible effects on immune system, and on the long-term neuropsychological development of children.

Expert opinion: The management of pregnancy in SLE has changed when knowledge about the safety of drugs has become available. Keeping SLE disease activity under control before, during and after pregnancy is of fundamental importance to ensure the best possible outcomes for mother and child. All these issues must be discussed with the patient and her family during preconception counseling. International efforts in terms of pregnancy registries and reproductive health guidelines help physicians improve their communication with SLE patients.

KEYWORDS:

• Lupus erythematosus
• systemic
• pregnancy
• high-risk
• immunosuppressive agents
• biological therapy
• child of impaired parents
• preconception care

Article highlights

• Reproductive issues are a major point in the management of SLE, as most of the patients are women of childbearing age.

• Planning a pregnancy in a period of sustained disease remission is crucial to achieve the best maternal and fetal outcomes.

• Increasing knowledge about the safety of antirheumatic drugs during pregnancy supports decision-making.

• Most of the drugs used in the management of SLE are compatible with pregnancy and breastfeeding.

• Methotrexate, cyclophosphamide, mycophenolate mofetil, thalidomide, and warfarin must be stopped because of teratogenic potential.

• A multidisciplinary team, which includes rheumatologists and obstetrician-gynecologists dedicated to high-risk pregnancies, is essential to assess individual risk and personalize treatment.

• Future studies should be focused on the long-term follow-up of children born to mothers with SLE to unravel any association between the in utero exposure to drugs and neurodevelopmental disorders.

This box summarizes key points contained in the article.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.