AN UPDATE AND SYSTEMATIC REVIEW ON USING BIOLOGICALS DURING PREGNANCY IN INFLAMMATORY AUTOIMMUNE DISEASES

Background: The 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. Objectives: In 2015 EULAR published a broad review article on this matter. Our aim was to update the data based on newly published articles. Methods: A 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. Results: Totally 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 1 Results 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. Drug Maternal exposed pregnancies Abortion Live birth Preterm birth Major congenital malformations Serious infections in children ADRs to vaccine Elective Spontaneous Abatacept 153 13.1% (20/153) 26.1% (40/153) 60.8% (93/153) - 6.8% (6/88) - 0.0% (0/93) Adalimumab 2518 0.1% (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 ) Anakinra 34 2.9% (1/34) 2.9% (1/34) 94.2% (32/34) 20.0% (2/10) 3.4% (1/29 ) 0.0% (0/30) - Certolizumab pegol 767 4.7% (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) Etanercept 801 7.6% (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) Infliximab 2174 5.1% (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) Rituximab 27 0.0% (0/11) 12.5% (2/16) 87.5% (14/16) 18.2% (2/11) 0.0% (0/8) 0.0% (0/18) - Tocilizumab 368 14.6% (37/254) 20.9% (53/254) 64.2% (163/254) 18.1% (32/177) 4.9% (8/164) 0.0% (0/3) - Tofacitinib 47 19.5% (8/41) 17.1% (7/41) 63.4% (26/41) 7.7% (2/26) 3.8% (1/26) 0.0% (0/26) - Ustekinumab 46 0.0% (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) Vedolizumab 59 11.1% (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 neurohypophysis. £ Just one article had information in this regard. Conclusion: From 2015 onwards, there have been many articles published regarding use of biologicals during pregnancy. Despite limitations of our study, such as heterogeneity in being prospective or retrospective and quality of the included articles, no alarm is raised concerning safety issues. Disclosure of Interests: Nafise Ghalandari: None declared, Radboud Dolhain Grant/research support from: UCB Pharma B.V, Johanna Hazes: None declared, Eugène van Puijenbroek: None declared, Manavi Kapur: None declared, Hubertina Johanna Maria Josephina Crijns: None declared DOI: 10.1136/annrheumdis-2019-eular.7108Citation: Ann Rheum Dis, volume 78, supplement 2, year 2019, page A1649Session: Rheumatoid arthritis - biological DMARDs (Scientific Abstracts)