Ab0378 an Update and Systematic Review on Using Biologicals During Pregnancy in Inflammatory Autoimmune Diseases

Abstract

BackgroundThe effects of biologicals on reproduction are unknown. Therefore pregnancy during biologicals use is discouraged. However biologicals are frequently prescribed in patients of childbearing potential and many patients become pregnant while using these drugs.ObjectivesIn 2015 EULAR published a broad review article on this matter. Our aim was to update the data based on newly published articles.MethodsA search was conducted at 18/10/2017 and then 21/11/2018 in Embase, Medline Ovid, Web Of Science, Cochrane CENTRAL and Google Scholar with specific search terms for each database. Articles were excluded based on title/abstract (double blind, two researchers, NG and HJMJC) and then full text (one researcher, NG). A chart was made based on outcomes of interest(see Table1). The references of included articles were reviewed to include and minimize the missing articles.ResultsTotally 137 articles were included (79 articles at first round, 51 articles at second round and 7 found after screening the references of the included articles). A descriptive analysis was performed to sum up the data on each separate biological and all the biologicals together. The results are shown in Table1. It should be notified that due to heterogeneity of the data the calculated percentages are up to individual interpretations and cannot be compared to each other.Table 1Results of the final chart. The denominator is the sum up of total cases recruited from the articles, for each outcome the denominator is defined as the population for which the specific outcome was reported. The other cases, which haven’t mentioned the outcome in their results, were excluded from the denominator for that specific outcome. Both spontaneous and elective abortion cases are excluded from the denominator of preterm birth and major congenital malformations.DrugMaternal exposed pregnanciesAbortionLive birthPreterm birthMajor congenital malformationsSerious infections in childrenADRs to vaccineElectiveSpontaneousAbatacept15313.1%(20/153)26.1%(40/153)60.8%(93/153)-6.8%(6/88)-0.0%(0/93)Adalimumab25180.1%(3/339)0.4%(16/432)95.5%(424/444)3.2%(7/213)3.7%(23/608)7.9%(4/501)0.5%(1/205*)Anakinra342.9%(1/34)2.9%(1/34)94.2%(32/34)20.0%(2/10)3.4%(1/29†)0.0%(0/30)-Certolizumab pegol7674.7%(27/574)8.2%(47/574)86.9%(527/606)10.7%(41/380)1.9%(10/510)4.0%(2/50)0.0%(0/26)Etanercept8017.6%(30/393)17.4%(69/397)87.4%(702/803)11.5%(40/347)6.2%(37/597)0.0%(0/140)0.4%(1/269)Infliximab21745.1%(90/1759)9.6%(169/1759)79.3%(1483/1869)5.9%(111/1892)10.9%(22/2014)13.7%(21/153)18.2%(6/33)Rituximab270.0%(0/11)12.5%(2/16)87.5%(14/16)18.2%(2/11)0.0%(0/8)0.0%(0/18)-Tocilizumab36814.6%(37/254)20.9%(53/254)64.2%(163/254)18.1%(32/177)4.9%(8/164)0.0%(0/3)-Tofacitinib£ 4719.5%(8/41)17.1%(7/41)63.4%(26/41)7.7%(2/26)3.8%(1/26)0.0%(0/26)-Ustekinumab460.0%(0/28)7.1%(2/28)92.6%(25/27)3.8%(1/26)0.0%(0/21)0.0%(0/10)0.0%(0/3)Vedolizumab5911.1%(6/54)18.5%(10/54)70.4%(38/54)2.9%(1/34)10.0%(2/20)0.0%(0/28)-ADR= Adverse Drug Reaction * mild fever after rotavirus vaccination. † unilateral agenesis and ectopic neu...