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

Pottinger, E., Woolf, R.T., Exton, L.S., Burden, A.D., Nelson‐Piercy, C. and Smith, C.H. (2018) Exposure to biological therapies during conception and pregnancy: a systematic review. British Journal of Dermatology, 178(1), pp. 95-102. (doi: 10.1111/bjd.15802) (PMID:28718898)

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Abstract

Background: Biological therapies are effective treatments for psoriasis and are often prescribed to women of child-bearing age. Objectives: To evaluate the safety of biological therapy in conception and/or pregnancy. Methods: 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. Results: 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. Conclusions: 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.

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Burden, Professor David
Authors: Pottinger, E., Woolf, R.T., Exton, L.S., Burden, A.D., Nelson‐Piercy, C., and Smith, C.H.
College/School:College of Medical Veterinary and Life Sciences > School of Infection & Immunity
Journal Name:British Journal of Dermatology
Publisher:Wiley
ISSN:0007-0963
ISSN (Online):1365-2133

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