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

Biological therapies are effective treatments for psoriasis and are often prescribed to women of child-bearing age.

To evaluate the safety of biological therapy in conception and/or pregnancy.

We performed a systematic review of PubMed, MEDLINE, Embase and Cochrane databases for multivariate-adjusted studies of women exposed to biologics relevant to the treatment of psoriasis during conception and/or pregnancy.

We identified four population-based cohort studies involving 1300 women exposed to tumour necrosis factor (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 [three studies; odds ratio (OR) range 1·32-1·64] and preterm birth (one study; OR 1·69, 95% confidence interval 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 means 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 interleukin (IL)-17 and IL-12/23 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; ongoing pharmacovigilance via registries remains essential to address this evidence gap.