INTRODUCTION
Several classes of monoclonal antibody biologics medications are used in dermatology to treat inflammatory dermatoses, including inhibitors of tumor necrosis factor (TNF), interleukin-17 (IL-17), IL-23, IL13, IL4/13, IL-12/23 and CD20. Despite promising therapeutic potential, the safety data for biologic use in pregnant and breastfeeding patients is still limited, as randomized controlled trials are rare. However, data from case studies/series, pregnancy registries, and cohort studies can offer insights into the efficacy and safety profile of individual biologics for both the mother and fetus. Herein, we provide an evidence-based review of the safety of commonly used biologics in dermatology to guide the management of inflammatory skin diseases during pregnancy, breastfeeding, and vaccination administration. Overall recommendations for the preconception, peripartum, and postpartum periods are summarized in Table 1, in addition to the Food and Drug Administration (FDA) pregnancy category for each drug. Specific guidelines from the American College of Rheumatology (ACR) were included if available as they are based on the most comprehensive data available, with European Medicine Agency (EMA) or European Task Force on Atopic Dermatitis (ATFAD) guidelines being included if ACR guidelines were unavailable.
Fertility and Biologics
With the increasing widespread use of biologics, many women of childbearing years are receiving these medications for their dermatologic conditions. Thus, in patients wishing to conceive, it is important to examine the effect of these biologics on the reproductive potential of both men and women. Although the data on this topic is fairly limited, TNF inhibitors remain the most studied biologics in regard to fertility. A majority of studies do not show any decrease in male fertility with anti-TNF agent exposure.2 One study examined the sperm quality in a group of 23 men with ankylosing spondylitis before and after receiving anti-TNF therapy (adalimumab, infliximab, etanercept). Sperm quality of men exposed to TNF inhibitors was found to be comparable to healthy controls, even after long-term treatment.3 Another study in men with ankylosing spondylitis and psoriatic arthritis described multiple men who achieved pregnancy despite infliximab therapy.4 Of note, some case reports noted a decrease in sperm quality, sperm motility, and abnormal morphology in male patients who received TNF inhibitors. However, these reports had several confounding factors, such as the severity of the disease and limitations.5-8 There is currently a lack of publicly available human studies in dermatological conditions investigating the effects of biologics
