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Apr 12, 2024

Preparing for baby

Reviewing safety data in patients of reproductive potential.


Katharina Stephanie Shaw, MD, FAAD
Katharina Stephanie Shaw, MD, FAAD

Reproductive safety is of chief concern when considering immunosuppressive, immunomodulatory, and biologic agents to treat autoimmune and inflammatory skin diseases in patients who are pregnant, trying to conceive, or breastfeeding.

In the March 9 session, U053 – Navigating Unchartered Waters: The Management of Autoimmune and Inflammatory Skin Disorders in Pregnant and Breastfeeding Patients, Katharina Stephanie Shaw, MD, FAAD, and Nicole A. Smith, MD, discussed available safety data for novel systemic agents in pregnancy and offered practical guidance on the management of inflammatory/autoimmune skin diseases in this special population. Dr. Shaw is an instructor of dermatology at Perelman School of Medicine at the University of Pennsylvania in Philadelphia with a special interest in rheumatologic-dermatology. Dr. Smith is an associate professor in the division of high-risk maternal fetal medicine at Harvard Medical School in Boston and a certified lactation counselor.

“Dr. Jane Grant-Kels and colleagues recently published an update in the Journal of the American Academy of Dermatology regarding the safety of dermatologic medications in pregnancy and lactation. We applaud this comprehensive and herculean effort to synthesize the available (published) safety data on routinely used topicals and systemics in dermatology,” Dr. Shaw said. “These range from topical steroids and systemic immunosuppressants to biologic therapies and small molecular inhibitors. The summary tables associated with these manuscripts provide an easy-to-use reference for clinicians to look toward when initially considering treatment options for pregnant and breastfeeding patients.”

Research is still nascent

Dsc00897That said, it only serves as a starting point, Dr. Shaw said. It does not account for nuances in any individual patient’s care. When treating pregnant and/or breastfeeding patients with systemic autoimmune and/or autoinflammatory disorders (including severe eczema, psoriasis, blistering disorders, lupus, dermatomyositis, etc.), Dr. Shaw said the risks of the medication must be carefully balanced with the risks of poorly controlled maternal disease. Both can be associated with adverse maternal and/or fetal outcomes.

“Not infrequently, we are faced with pregnant or breastfeeding patients who require treatment with medications with minimal or no human data, and we rely on our high-risk maternal fetal medicine colleagues to provide guidance for best practice,” she said.

During the session, Dr. Shaw engaged in a case-based discussion with Dr. Smith. Cases included a look at recalcitrant dermatomyositis, lupus, pemphigus, and eczema where a medication typically considered “contraindicated” in pregnancy and lactation were prescribed. Drs. Smith and Shaw examined available mechanistic, animal, and (limited) human data in discussing the physiology of pregnancy and lactation as it pertains to the selection of these agents. 

Newer agents

Treatment options have become available in recent years as alternatives to current medications, Dr. Shaw said. For example, although azathioprine and cyclosporine have historically been used to manage autoimmune and inflammatory diseases in pregnancy/lactation due to their more robust safety data, there are instances where newer agents, including anifrolumab, rituximab, and JAK inhibitors (upadacitinib) might be used instead after careful risk-benefit assessment. Such medications have traditionally been considered “contraindicated” in pregnancy and lactation. 

According to Dr. Shaw, dermatologists should ask patients with systemic autoimmune or inflammatory disorders involving the skin if they are trying to conceive as it relates to their topical/systemic treatment regimen and the risks/benefits of continuing these in the event of conception/pregnancy.

“We need to lift the veil on how to approach the management of pregnant/lactating patients with autoimmune and autoinflammatory disorders,” Dr. Shaw said. “We aim to empower dermatologists to look toward novel resources including the LactMed and Reprotox [information systems] and/or maternal-fetal medicine specialists when selecting treatment options for pregnant/lactating patients.”

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