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This research indicates biologics may be safe for women of childbearing age, to whom they are often prescribed, as they pose an acceptable risk to fetuses/neonates.
Biologic exposure for women with psoriasis, during either conception or pregnancy, is not associated with higher risk of congenital malformations or miscarriage, according to recent findings.1
This research—authored by J.M. Ramos Rincón, MD, PhD from the Department of Clinical Medicine at Miguel Hernández University in Spain—resulted from a systematic review and meta-analysis conducted to assess both the characteristics and pregnancy outcomes in psoriasis patients exposed to biologics within 3 months prior to pregnancy or during.
The processes of psoriasis involve cytokine and chemokine dysfunction, with significantly elevated tumor necrosis factor (TNF)-alpha. The investigators note that this can raise the risk of intrauterine growth restriction, preterm delivery, and even miscarriage.2
“This study was conceived to address this evidence gap, with the aim of characterizing pregnancy outcomes and estimating the prevalence of spontaneous, elective, and total abortions and congenital malformations in women with psoriasis exposed to biologics in the preconception period or during gestation,” Rincón and colleagues wrote.
The investigators used a systematic review which they conducted using multiple databases to identify studies on pregnancy outcomes in women exposed to biologics for their cases of psoriasis. The review followed PRISMA guidelines and used both randomized controlled trials and nonrandomized studies.
The team’s search yielded 51 observational studies, involving 739 pregnancies exposed to approved biologics. The administration of biologics was primarily limited to the initial trimester of pregnancy, and the most commonly used drug ended up being ustekinumab.
The investigators sought to include papers written in English, Spanish, or Italian that met specific inclusion criteria. These criteria involved patients with psoriasis who were pregnant or planning to conceive and had also been exposed to biologics for psoriasis treatment during the pregnancy at some point.
The research team focused on examining pregnancy outcomes and included various study designs: cohort studies, randomized controlled trials, patient registries, case-control studies, case report studies, and case series. They did not restrict the sample size and publication date did not affect limitations.
The research team used a random-effects model to pool prevalence estimates, taking into account the heterogeneity of the data. Studies focusing on immune-mediated inflammatory diseases other than psoriasis were excluded by the investigators from their analysis.
Overall, the investigators found that the estimated prevalence of miscarriage among pregnant women exposed to biologics for psoriasis was shown to be 15.3%, while elective abortions accounted for 10.8%.
The research team added that occurrence of congenital malformations in live births exposed to biologics was approximately 3.0%. However, they did not find evidence of a risk increase for miscarriage/abortion or congenital malformations linked to biologic drug exposure during pregnancy and/or conception.
The team observed rates which were similar to those in the general population. These findings indicate that biologic drugs can be safe and also carry an acceptable risk for the fetuses and neonates.
“These results are consistent regardless of the biologic therapy administered, suggesting the drugs are safe and pose an acceptable risk,” they wrote. “However, we emphasize the apparent needs of research in this field. 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.”