Background Prescribing of anti-rheumatic and immunosuppressive drugs in men with active rheumatic disease trying to conceive is required to control disease activity. This increases the chance of successful conception. However it is complicated by concerns regarding the safety of these drugs. They arise from safety information based mainly on experimental and animal studies as human data is limited. Previous systematic reviews have identified a risk of oligospermia with sulfasalazine and gonadal toxicity with cyclophosphamide in men trying to conceive, as well as theoretical concerns for leflunomide and biologics. We have undertaken a systematic review to update information on this subject. Objectives This systematic review aims to update information on the safety fo prescribing these drugs in men trying trying to conceive. Methods A systematic search of PubMed and Embase was carried out using relevant keywords for pregnancy, men, conception and drugs commonly prescribed in patients with rheumatic disease from 1966 onwards. The drug categories included analgesics, disease modifying anti-rheumatic drugs, biologics and steroids. Review articles and non-English language papers were excluded. Results 21 studies were selected for detailed review, describing relevant drug use in men with rheumatic disease, inflammatory bowel disease, post-transplantation, psoriasis, multiple sclerosis and leukaemia. The studies included 3 case reports, 4 case series, 10 cohort studies and 1 case-controlled study. These studies identified 2214 drug exposures (705 NSAIDs, 517 steroids, 343 azathioprine, 287 ciclosporine, 100 methotrexate, 120 sulfasalazine, 44 etanercept, 66 infliximab, 13 hydroxychloroquine, 11 rituximab, 6 adalimumab, 2 leflunomide) in 1963 men trying to conceive, leading to 2112 pregnancies. There were limited reports of the effects upon fertility (in 133 men) and one retrospective questionnaire study1 of 30 men taking azathioprine reported an increased rate of infertility (>1yr to conception) of 15.2% vs 8.3% of controls. The confounding effects however, of underlying (Crohn's) disease and the possibility of female infertility, were a limitation of this study. Of the 1778 live births, 33 congenital malformations were reported which were not specific to any drug. In the remaining 78 pregnancies that miscarried, the precise number of elective terminations was not stated in all studies. Conclusions This systematic review did not find an increased risk of adverse pregnancy outcomes in partners of men taking anti-rheumatic, immunosuppressive and biologic drugs whilst trying to conceive. However there remains insufficient evidence to advocate the safe use of these drugs. This information however, is useful when counselling men of potential risk particularly after accidental conception. References Teruel C et al. Outcomes of Pregnancies Fathered by IBD patients exposed to thiopurines. The American Journal of Gastroenterology 2010; 105:2003-2008 Disclosure of Interest None declared DOI 10.1136/annrheumdis-2...
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 Drug No. of pregnancies exposed to drug Live births related to exposed drug Elective terminations Spontaneous 1st trimester loss Spontaneous 2nd/3rd trimester loss Major malformations Minor malformations No. Studies Prednisolone 176 Min 110 0 1 1 9 1 11 Methotrexate 15 Min 5 2 2 0 0 0 5 Leflunomide 80 Min 78 1 0 0 7 63# 8 Sulphasalazine 57 Min 1 0 0 0 0 0 3 Azathioprine 210 208 14 4 5 8 0 7 HCQ 189 Min 142 0 14 0 10 0 8 Biologics (Inflix, etan, ada)* 118 88 10 29 4 0 4 1 Rituximab 155† 92 28 33 3 3** 1 3 *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. Furthe...
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