A SYSTEMATIC ANALYSIS OF THE SAFETY OF PRESCRIBING ANTI-RHEUMATIC IMMUNOSUPPRESSIVE AND BIOLOGIC DRUGS IN PREGNANT WOMEN WITH INFLAMMATORY ARTHRITIS

Background: The use of anti-rheumatic drugs in pregnancy is often complicated by concerns over their potential for adverse effects. Given that rheumatic diseases often affect women of childbearing age and may flare during pregnancy, the safety of anti-rheumatic drugs and immunosuppressant's are of particular importance. Practice has relied on information based mainly on experimental and animal studies. Previous systematic reviews have identified risks with various anti-rheumatic drugs and biologics. This systematic review is an update of consensus papers on anti-rheumatic drugs, biological agents and reproduction published in 2006/8. Objectives: This systematic review is an update of consensus papers on anti-rheumatic drugs, biological agents and reproduction published in 2006/8. Methods: A systematic search of PubMed and Embase was carried out using relevant keywords for pregnancy, lactation, rheumatoid arthritis (RA), psoriatic arthritis (PsA), inflammatory arthritis (IA), juvenile idiopathic arthritis (JIA) from 2006 onwards and drugs commonly prescribed in patients with rheumatic disease from 1966 onwards. Review articles and non-English language papers were excluded. Results: The search identified 43 papers published since the 2006/8 consensus papers describing relevant drug use in pregnant women with RA, PsA, IA and JIA. These consisted of 15 case reports, 7 case series, 16 cohort studies and 5 case-control studies. 4145 pregnancies were reported with an inflammatory arthritis. Over 4530 drug exposures were identified which includes steroids (346) DMARDs (AZA 210, HCQ 189, LFL 80, SSZ 57, MTX 15, MMF 1) and biologic therapies (278). Table 1. illustrates the outcomes in pregnancy with some of the common drugs used in inflammatory arthritis. Table 1 DrugNo. of pregnancies exposed to drugLive births related to exposed drugElective terminationsSpontaneous 1st trimester lossSpontaneous 2nd/3rd trimester lossMajor malformationsMinor malformationsNo. Studies Prednisolone176Min 1100119111 Methotrexate15Min 5220005 Leflunomide80Min 781007638 Sulphasalazine57Min 1000003 Azathioprine2102081445807 HCQ189Min 14201401008 Biologics (Inflix, etan, ada)*1188810294041 Rituximab15592283333**13 *No increased risk of minor malformations compared to control group *Data is analysed from Verstappen (2010) only. 29/155 pregnancies were in RA patients. **One of the major congenital abnormalities (Turners syndrome) was diagnosed pre-administration of RTX. No increased risk of minor malformations compared to control group. BSRBR: British Society for Rheumatology Biologics Registers. Conclusions: Evidence supports the safety of HCQ, AZA, SSZ and steroids in pregnancy. Data from a limited number of pregnancies exposed to anti-TNF alpha drugs predominantly in or immediately prior to the first trimester exposures indicates that the number of spontaneous miscarriages and congenital malformations do not appear to be increased. Further registry data is required for biologic drugs, before the safe use of these drugs can be advocated throughout pregnancy in patients with inflammatory arthritis. Disclosure of Interest: None declared DOI: 10.1136/annrheumdis-2014-eular.5548Citation: Annals of the Rheumatic Diseases, volume 73, supplement 2, year 2014, page 106Session: Abstract session: Orphan diseases - what is new? (Oral Presentations )