Exposure to biologics during pregnancy or before conception was not associated with an increased risk of miscarriage or congenital malformations among women with psoriasis, report the authors of a new study.
The results suggest that the biologics "are safe and pose an acceptable risk" for pregnant women with psoriasis or before conception, write the authors, Verónica Sánchez-García, MD, of the Alicante Institute for Health and Biomedical Research, Alicante, Spain, and her colleagues. But more research in this area is necessary "to fully characterize the association between psoriasis, treatment, and pregnancy outcomes," they conclude in the study, published online in the Journal of the European Academy of Dermatology and Venereology.
The meta-analysis and systematic review covered 51 observational studies and included 739 women with psoriasis who were treated with biologics in the 3 months before pregnancy or during their pregnancies.
"Our results show that the prevalence of miscarriages and congenital malformations in newborns exposed to biologics during pregnancy are similar to those in the general population," estimated to be 10% to 20% and 2% to 5.5%, respectively, the authors write.
The findings were consistent regardless of the biologic therapy administered.
The results, they add, are also consistent with findings from the PSOLAR registry of pregnancy outcomes for women with psoriasis treated with biologics before or during pregnancy. That study found that rates of miscarriage, neonatal problems, and congenital malformation were similar to rates in the general US population.
Dearth of Data
The course of psoriasis during pregnancy and the postpartum period is unpredictable. It fluctuates as hormone levels change, and "up to 23% of psoriatic women may experience flares and intense disease activity" during pregnancy, Sánchez-García and co-authors write.
Making matters worse is the lack of safety data on the use of biologics during pregnancy, they note. "This dearth of information often leads to the discontinuation of biologics during preconception and pregnancy, favoring disease exacerbations."
To address this gap, the researchers conducted a systematic literature review and meta-analysis of 51 studies — mostly published between 2018 and 2022 — that reported pregnancy outcomes among women exposed to anti-psoriasis biologics during the pregestational and/or gestational period. The majority (84.3%) of the observational studies were retrospective, especially case reports (45.1%) and case series (29.4%).
The median age of women in the studies was 30 years. The most common biologics used by participants were ustekinumab (35.9%), etanercept (19.3%), and infliximab (12.7%). Other agents, used in fewer than 6% of pregnancies, included ixekizumab, adalimumab, tildrakizumab, guselkumab, secukinumab, and certolizumab. None of the newer biologics, such as brodalumab, risankizumab, or bimekizumab, were reported, and in 16.2% of cases, the biologic was unspecified. Administration of therapy occurred mostly in the first trimester (70.4%); the mean duration of exposure was 16.8 weeks.
Following extraction of the available data, Sánchez-García and colleagues used a random-effects model to pool estimates of spontaneous, elective, and total abortions, as well as congenital malformations in newborns.
Risk Similar to That of the General Population
The investigators found that the prevalence of miscarriage and elective abortions was 15.3% and 10.8%, respectively (after five studies were excluded because of a lack of data on those outcomes). After excluding 27 studies because of a lack of data on congenital malformations, the prevalence of congenital malformations was 3%.
Pregnancy outcomes were comparable across different classes of biologics, despite the different mechanisms of action and placental transport.
"Altogether, exposure to biologics for psoriasis during pregnancy and/or conception does not seem to be associated with an increased risk of miscarriage, abortion, or congenital malformations," the authors conclude.
Think Beyond Pregnancy
Approached for an independent comment on the findings, Jenny Murase, MD, assistant clinical professor of dermatology at the University of California, San Francisco, and dermatologist at the Palo Alto Medical Foundation, California, who has been involved with research on this topic, said that such data are "reassuring to have."
But given that most anti-psoriasis biologics cross the placenta, the new meta-analysis doesn't address the critical issue of whether babies of women who take biologics during pregnancy are at a higher risk of being more immunosuppressed than they otherwise would be in the first 6 months of life. "That's the relevant question, since the baby is getting this huge burst of antibodies, including the potential immunosuppression of biologic agents being prescribed," said Murase, who is also founder and chair of the American Academy of Dermatology's Women's Health Expert Resource Group.
"I feel most comfortable prescribing Cimzia," she told Medscape in an interview, referring to the biologic certolizumab. Unlike other tumor necrosis factor blockers, certolizumab does not cross the placental barrier. In contrast, etanercept, infliximab, and adalimumab can cross the placenta in the second trimester, while ustekinumab is usually transported in the third, when the passage of antibodies to the fetus increases exponentially, she said.
"For psoriasis, Cimzia has been demonstrated to work quite well," Murase added. "So I think it's reasonable to put a woman of childbearing age who is considering pregnancy on it prior to conception, because then you don't have to worry about the potential possibility of immunosuppression."
The study was independently supported. The authors report no relevant financial relationships. Murase has participated in advisory boards for Genzyme/Sanofi, Eli Lilly, Leo Pharma, Dermira, and UCB; has participated in disease statement management talks for Regeneron and UCB; and has provided dermatologic consulting services for UpToDate.
J Eur Acad Dermatol Venereol. Published June 1, 2023. Full text
Sandy Ong is a freelance health and science journalist based in Singapore. @sandyong_yx.
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Cite this: Review Finds No Increased Risks With Biologics During Pregnancy in Women With Psoriasis - Medscape - Jul 03, 2023.
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