Friday, 16 Nov 2018

You are here

No Increase in Malformations with Etanercept Use During Pregnancy

While there are several reports detailing uncontrolled, observational results of biologic use during pregnancy, most are hampered by low numbers, incomplete data and too small a sample to make reliable judgments regarding the teratogenicity. A company-sponsored claims data analysis has shown that etanercept exposure during pregnancy was not associated with an increase in major congenital malformations (MCMs).

Investigators used claims data to quantify prevalence estimates of pregnancy and infant outcomes including  by etanercept (ETN) exposure among infants born to women with chronic inflammatory arthritis (cIA) or psoriasis (PsO). These findings were compared to general population (GP) estimates from the same dataset.

Prevalence estimates for at least one MCM were 6.1% (ETN exposed), 5.5% (unexposed), and 5.7% (GP cohort) for the cIA cohort. Lower numbers were seen among PsO cohort; MCM estimates were 2.0% (ETN exposed), 4.2% (unexposed), and 4.7% ((GP cohort).

The risk of MCM during ETN-exposure was not increased (OR 1.03; 95%CI 0.51-2.10) in inflammatory arthritis patients,  nor in infants of PsO mothers (OR 0.39; 95%CI 0.05-2.98).

Overall, this study did not identify any new safety concerns associated with the use of etanercept during pregnancy. Etanercept, along with the other TNFis, remains a treatment without well-controlled clinical trials in pregnant women. Patients should continue to consult their doctor regarding benefit risk decisions of TNFi therapy during pregnancy.

Disclosures: 
The author has no conflicts of interest to disclose related to this subject

Add new comment

More Like This

Higher Infection Rates for Infliximab in Psoriasis

A prospective study of psoriasis patients from the British Association of Dermatologists Biologic Interventions Register demonstrated that infliximab therapy yielded 2-3 times more serious infection than seen in those treated with non-biologic DMARDs or methotrexate (MTX).

Biomarker Combo Predicts TNF Inhibitor Responses

Based on clinical trial data, patients starting tumour necrosis factor-alpha inhibitors (TNFi) have roughly a two-thirds chance of achieiving a good clinical response. French investigators have studied a series of potential biomarkers and surmised that the combination of baseline prealbumin, platelet factor 4 and S100A12 can predict a 78% response to TNFi in rheumatoid arthritis (RA) patients.

TNF Inhibitors Don't Increase Cancer Risk in Children

While the risk of neoplasia with tumour necrosis factor inhibitor (TNFi) use has been largely nullified in most inflammatory disorders, this risk in children is less certain. However a recent study shows no risk of increased cancer in children treated with TNFi for juvenile idiopathic arthritis (JIA), pediatric inflammatory bowel disease (pIBD) and pediatric plaque psoriasis (pPsO).

Risk of Psoriasis Complicating TNF Inhibitor Therapy

A population-based study of claims data from Korea shows that among inflammatory bowel disease (IBD) patients receiving tumour necrosis factor inhibitors (TNFi) there is a 3.7 per 100 patient-year risk of paradoxically developing psoriasis - a rate that is roughly 3-fold higher than risk in TNFi-naive IBD patients.

Favorable Certolizumab Safety Profile in Pregnancy

Clowse and colleagues have published an extensive review of the certolizumab pegol (CZP) in pregnancy database, and found no evidence that CZP has a teratogenic effect or contributes to fetal harm when compared to the general population.