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.