Exposure to biologic therapies during conception and pregnancy: a systematic review

Summary

Biologic therapies are effective treatments for psoriasis and are often used in women of childbearing age. To evaluate the safety of biologic therapy in conception and/or pregnancy, we have performed a systematic review of Pubmed, MEDLINE, EMBASE and Cochrane databases for multivariable adjusted studies of women exposed to biologic therapy relevant to the treatment of psoriasis during conception and/or pregnancy. We identified four population-based cohort studies involving 1300 women exposed to TNF-α inhibitors (TNFi) 3 months prior to or during the first 3 months of pregnancy. These studies showed a trend towards drug-specific harm with TNFi exposure in women with different inflammatory diseases, with an increased risk of congenital malformations (3 studies; odds ratio [OR] range: 1.32–1.64) and pre-term birth (one study; OR: 1.69, 95% CI 1.10–2.60). This trend did not reach statistical significance in all studies; study heterogeneity, variation across comparator cohorts, inadequate adjustment for important confounding variables such as co-therapy, and an absence of a common constellation of malformations mean there is uncertainty about the causal role of TNFi. No studies specifically addressed the effect of TNFi exposure in psoriasis during conception and/or pregnancy, or of IL-17 and IL12/23 antagonists in any indication. When counselling women these findings must be balanced against the potential impact of untreated severe psoriasis on conception and/or pregnancy and maternal wellbeing; on-going pharmacovigilance via registries remains essential to address this evidence gap.

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