Exposure to biologic therapy before and during pregnancy in patients with psoriasis: Systematic review and meta‐analysis

Abstract

Biologicals have transformed the management of severe disease phenotypes in psoriasis and are often prescribed in women of childbearing age. However, information on safety of biologicals in pregnancy are lacking. We conducted a systematic review and meta‐analysis aimed to describe the characteristics and pregnancy outcomes in women with psoriasis exposed to biologics within 3 months before or during pregnancy, and to estimate the pooled prevalence of spontaneous, elective and total abortions, and congenital malformations in their newborns. Bibliographic searches were performed in the PubMed, Embase, Scopus and Web of Science databases up to 14 April 2022. No restrictions on sample size or publication date were applied. Review performance complied with PRISMA guidelines, and two reviewers assessed randomized controlled trials and nonrandomized studies reporting pregnancy outcomes in women exposed to biologics indicated for psoriasis during the pre‐gestational and/or gestational period. Studies focusing on rheumatologic or gastroenterological immune‐mediated inflammatory diseases were excluded. Regardless of data heterogeneity, a random‐effects model was used to pool prevalence estimates. We included 51 observational studies, involving 739 pregnancies exposed to approved biologics for psoriasis. Administration was mostly (70.4%) limited to the first trimester, and the most common drug was ustekinumab (36.0%). The estimated prevalence of miscarriage was 15.3% (95% confidence interval [CI] 12.7–18.0) and elective abortions, 10.8% (95% CI 7.7–14.3). Congenital malformations occurred in about 3.0% (95% CI 1.6–4.8) of live births exposed to biologics during pregnancy. 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, showing similar rates to the general population. These results suggest that biologic drugs are safe and pose an acceptable risk to the foetuses/neonates.

Reproductive Safety Issues of Novel Small Molecules for the Treatment of Inflammatory Bowel Disease: A Systematic Review

“…O’Byrne et al found that for TNF-α inhibitors, there was still no definitive statistical link between exposure to biologics and the development of a congenital abnormality and that its incidence was 4% overall [ 32 ]. Similarly, a meta-analysis of pregnancies exposed to biologics used in psoriasis indicated that 3% reported congenital abnormalities [ 34 ].…”

Ustekinumab in the Treatment of Generalized Pustular Psoriasis in a Pregnant Patient

“…3 However, currently reported safety information on the use of biologics in patients with generalized pustular psoriasis and who are pregnant, planning to become pregnant, or who are breastfeeding, remains limited. 4 We herein report successful treatment with ustekinumab (STELARA ® ) in a pregnant patient with generalized pustular psoriasis.…”

Biologic drugs in hidradenitis suppurativa: what does the GP have to know? A narrative review

“…There is mixed evidence for the use of biologics prior to pregnancy in terms of conception rates. In the psoriasis population, exposure to biologics during conception does not appear to have any adverse reactions, but more research in the field and in HS populations is warranted ( 69 ).…”