The Use and Safety of TNF Inhibitors during Pregnancy in Women with Psoriasis:A Review

Psoriasis is a chronic immune-mediated inflammatory disease affecting women of childbearing potential. Biologic agents, notably Tumor Necrosis Factor inhibitors (TNFi), are the only current non-contraindicated systemic treatment option during pregnancy. TNFi comprised of complete immunoglobulin G (IgG) antibodies antibodies (adalimumab, golimumab, and infliximab) actively cross the placenta from the second trimester and are detectable in the child up to one year postpartum. Data on safety of TNFi are conflicting; however a trend towards drug-specific harm has been reported, with increased risk of congenital malformations and preterm birth. TNFi exposure may alter the immune system of the infant towards hypersensitivity and reduced response to intracellular infections. Confounding by indication should be considered, as chronic inflammatory disease itself may pose a risk of adverse pregnancy outcomes. The quality of the current evidence is very low and no studies specifically address TNFi safety in women with psoriasis. Nonetheless, risks associated with TNFi treatment must be balanced against the as-yet uncertain risk of adverse outcomes in infants born to women with severe psoriasis. We searched PubMed using Medical Subject Headings (MeSH) terms and identified relevant studies and guidelines. Herein, we present the current knowledge of the use and safety of TNFi during pregnancy in women with psoriasis

Effect of Maternal Psoriasis on Pregnancy and Birth Outcomes: A Population-based Cohort Study from Denmark and Sweden

Studies on pregnancy and birth outcomes in women with psoriasis are scarce and the findings inconsistent. The effect of maternal psoriasis and its severity on the risk of adverse pregnancy and birth outcomes was examined. A cross-national population-based cohort study was performed using prospectively collected data from Denmark and Sweden. Singleton births in women with psoriasis were identified in the national health registers between April 2007 and December 2012 and classified according to disease severity. Lifestyle factors, co-morbidity, pregnancy and birth outcomes were evaluated. A total of 8,097 births were identified in 6,103 women with psoriasis and 964 births in 753 women with psoriatic arthritis. Increased risk of gestational diabetes, gestational hypertension, pre-eclampsia, elective and emergency caesarean delivery was found in women with psoriasis. The risks were higher for women with severe psoriasis, who also had an increased risk of pre-term birth and low birth weight. Pre-conception counselling to improve maternal, pregnancy and birth outcome is encouraged

The Danish National Prescription Registry in studies of a biological pharmaceutical: palivizumab – validation against two external data sources

Ann Haerskjold,1,2 Lonny Henriksen,2 Susanne Way,1 Mikkel Malham,3 Jesper Hallas,4 Lars Pedersen,5 Lone Graff Stensballe1 1The Child and Adolescent Clinic 4072, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark; 2The Research Unit Women's and Children's Health, The Juliane Marie Centre for Women, Children and Reproduction, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark; 3Department of Pediatrics, Hvidovre University Hospital, Hvidovre, Denmark; 4Department of Clinical Pharmacology, Institute of Public Health, University of Southern Denmark, Denmark; 5Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus N, Denmark Background: National prescription databases are important tools in pharmacoepidemiological studies investigating potential long-term adverse events after drug use. Palivizumab is a biological pharmaceutical used as passive prophylaxis against severe infection with respiratory syncytial virus in high-risk children. Objective: To assess the registration of palivizumab in the Danish National Prescription Registry (DNPR) and to examine if palivizumab reimbursement data obtained from the Danish Health and Medicines Authority could serve as a supplement to data from the DNPR. Methods: Registration of palivizumab exposure in the DNPR between 1999 and 2010 was compared to two external data sources: registration of palivizumab exposure in medical records, and palivizumab reimbursement data. Results: During the study period, 182 children with palivizumab exposure were registered in the DNPR. A total of 207 children were registered for palivizumab reimbursement. The sensitivity of palivizumab registration in the DNPR was 26% (20%–34%), and the specificity of no palivizumab registration in the DNPR was 97% (94%–99%), with data from the medical record as the reference. Palivizumab registration sensitivity in reimbursement data was 29% (22%–36%), and the specificity of no palivizumab registration in the DNPR was 97% (94%–99%), with data from the medical record as the reference. Conclusion: Exposure to palivizumab was underestimated in the DNPR. Reimbursement data are a readily accessible data supplement, which only slightly increased the sensitivity of palivizumab registration in the DNPR. Our findings underline the need to improve DNPR information concerning drugs administered in hospitals. Keywords: drug; health register; medical records; respiratory syncytial virus; validation&nbsp