Review Suggests Psoriasis Biologics Not Linked With Adverse Outcomes in Pregnant Patients

Exposure to biologics for psoriasis during pregnancy and/or conception does not appear to be linked with an increased risk of miscarriage/abortion or congenital malformations, according to new results of a systematic review and meta-analysis.

Findings were published in the Journal of the European Academy of Dermatology and Venereology.

Overall, data suggest “biologic drugs are safe and pose an acceptable risk to the fetuses/neonates,” authors wrote.

Psoriasis affects between 1% and 3% of the world’s population and the condition typically presents before age 40. Previous research has shown the condition’s course can change throughout pregnancy as women’s hormone levels fluctuate. Elevated tumor necrosis factor (TNF)-alpha, which is part of psoriasis’ pathophysiology, might also increase the risk of preterm delivery, miscarriage, and intrauterine growth restriction.

Although specific treatment with biologics should control these adverse events, decisions about initiating or continuing biologic therapy in pregnant women remain complex thanks to limited available knowledge on safety, authors explained. This is due in part to the exclusion of pregnant women from prospective clinical trials.

In an effort to address this evidence gap, investigators conducted a systematic literature review and meta-analysis. They set out to describe the characteristics and pregnancy outcomes in women with psoriasis exposed to biologics within three months before or during pregnancy. They also aimed to estimate the pooled prevalence of spontaneous, elective and total abortions and newborn congenital malformations.

Researchers carried out the review by searching for relevant literature on PubMed, Embase, Scopus and Web of Science published up until April 14, 2022. Any study that focused on rheumatologic or gastroenterological immune-mediated inflammatory diseases was excluded from the review.

A total of 51 observational studies were included, involving 739 pregnancies exposed to psoriasis biologics. 

The analysis revealed:

• Administration was mostly (70.4%) limited to the first trimester, and the most common drug taken was ustekinumab (36.0%)
• The estimated prevalence of miscarriage was 15.3% (95% CI, 12.7–18.0) and elective abortions, 10.8% (95% CI, 7.7–14.3)
• Congenital malformations occurred in about 3% (95% CI, 1.6–4.8) of live births exposed to biologics during pregnancy
• Rates of miscarriage/abortion among pregnant patients exposed to biologics were similar to the general population

To the authors’ knowledge, the meta-analysis is the first of its kind to study any potential impacts of biologics on pregnant women with psoriasis.

Around 45% of included studies were case reports and 29% were case series. No studies reported on newer anti-psoriatic biologics like brodalumab, risankizumab, or bimekizumab, the authors wrote, adding that the omission “underlines the remaining gaps in the current body of evidence.”

Data showed preterm birth rates among pregnant women exposed to biologics for psoriasis were higher than the general European population, researchers said. However, they cautioned the actual relationship between psoriasis and preterm birth is unclear.

“Further studies are needed to clarify whether there is an increased risk of preterm delivery due to exposure to biologic drugs or due to the disease itself,” they wrote.

In addition, pregnancy outcomes were comparable across different biologic classes with significant differences only in the frequency of elective abortions in women exposed to tildrakizumab (28.6%) and ixekizumab (25%).

When it comes to baseline maternal characteristics, the review showed the most frequent comorbidity was tobacco use. Other conditions included psoriatic arthritis, psychiatric disease, and metabolic syndrome.

Different definitions of outcomes between studies marks a limitation to the review, while only a few studies performed long-term follow-up in newborns.

“Further studies are still needed to determine the true indication for biologic therapy in pregnant patients with psoriasis and to fully characterize the association between psoriasis, treatment, and pregnancy outcomes,” authors concluded.

Reference

Sánchez-García V, Hernández-Quiles R, de-Miguel-Balsa E, Giménez-RicharteÁ, Ramos-Rincón JM, and Belinchón-Romero I. Exposure to biologic therapy before and during pregnancy in patients with psoriasis. Systematic review and meta-analysis. J EurAcad Dermatol Venereol. Published online June 1, 2023. doi:10.1111/jdv.19238