Conventional synthetic disease-modifying antirheumatic drugs (csDMARD) in rheumatoid arthritis during pregnancy and lactation: a review

  • Yulianasari Pulungan Master Program of Clinical Pharmacy, Faculty of Pharmacy, Universitas Gadjah Mada, Yogyakarta
  • Andy Kurniawan Saputra Master Program of Clinical Pharmacy, Faculty of Pharmacy, Universitas Gadjah Mada, Yogyakarta
  • Desy Purnamasari Master Program of Clinical Pharmacy, Faculty of Pharmacy, Universitas Gadjah Mada, Yogyakarta
  • Nunuk Wijayanti Master Program of Clinical Pharmacy, Faculty of Pharmacy, Universitas Gadjah Mada, Yogyakarta
  • Laras Ratna Sari Master Program of Clinical Pharmacy, Faculty of Pharmacy, Universitas Gadjah Mada, Yogyakarta
Keywords: csDMARD, lactation, pregnancy, rheumatoid arthritis, safety

Abstract

Rheumatoid arthritis (RA) is an autoimmune and prominent inflammatory disorder that can affect wide of variety body systems, mainly joints. In Indonesia, the prevalence of RA is about 7.3% and mostly are women. The majority of women with RA are at childbearing and can be worsening throughout pregnancy and lactation. Conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) are the most common used medicine in RA for pregnancy and lactation. This scoping review was conducted using publications obtained from PubMed, Embase, The Cochrane Library, POPLINE, and Google Scholar concerning the safety of csDMARD in rheumatoid arthritis during pregnancy and lactation from 2011 to 2021. Among csDMARDs reviewed, sulfasalazine, hydroxychloroquine, chloroquine, and cyclosporine are relatively safe for pregnant and lactating women. However, they should be used in caution by considering the risk and benefit as well as under clinical supervision.

References

Testa D, Calvacchi S, Petrelli F, Giannini D, Bilia S, Alunno A, et al. One year in review 2021: Pathogenesis of rheumatoid arthritis. Clin Exp Rheumatol 2021; 39(3):445-52.

Kementerian Kesehatan Republik Indonesia. Laporan Nasional RIKERDAS 2018. Badan Penelitian dan Pengembangan Kesehatan; 2018.

Perhimpunan Reumatologi Indonesia. Diagnosis dan pengelolaan artritis reumatoid. Perhimpunan Reumatologi Indonesia; 2021.

Fraenkel L, Bathon JM, England BR, St Clair EW, Arayssi T, Carandang K, et al. 2021 American college of rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Rheumatol 2021; 73(7):1108-23.

https://doi.org/10.1002/art.41752

Förger F, Villiger PM. Treatment of rheumatoid arthritis during pregnancy: present and future. Expert Rev Clin Immunol 2016; 12(9):937-44.

https://doi.org/10.1080/1744666X.2016.1184973

Krause ML, Amin S, Makol A. Use of DMARDs and biologics during pregnancy and lactation in rheumatoid arthritis: what the rheumatologist needs to know. Ther Adv Musculoskelet Dis 2014; 6(5)169-84.

https://doi.org/10.1177/1759720X14551568

Schrezenmeier E, Dörner T. Mechanisms of action of hydroxychloroquine and chloroquine: implications for rheumatology. Nat Rev Rheumatol 2020; 16(3):155-66.

https://doi.org/10.1038/s41584-020-0372-x

Ben-Zvi I, Kivity S, Langevitz P, Shoenfeld Y. Hydroxychloroquine: from malaria to autoimmunity. Clin Rev Allergy Immunol 2012; 42(2):145-53.

https://doi.org/10.1007/s12016-010-8243-x

Huybrechts KF, Bateman BT, Zhu Y, Straub L, Mogun H, Kim SC, et al. Hydroxychloroquine early in pregnancy and risk of birth defects. Am J Obstet Gynecol 2021; 224(3):290.e1-e22.

https://doi.org/10.1016/j.ajog.2020.09.007

ElShishtawy MA, Elgendy FS, Ramzy R. Comparative toxicity study of chloroquine and hydroxychloroquine on adult Albino rats. Mansoura J Foren Med Clin Toxicol 2013; 21(2):15-28.

https://doi.org/10.21608/MJFMCT.2013.47674

Hazes JMW, Coulie PG, Geenen V, Vermeire S, Carbonnel F, Louis E, et al. Rheumatoid arthritis and pregnancy: evolution of disease activity and pathophysiological considerations for drug use. Rheumatology (Oxford) 2011; 50(11):1955-68.

https://doi.org/10.1093/rheumatology/ker302

Andersson NW, Skov L, Andersen JT. Fetal safety of chloroquine and hydroxychloroquine use during pregnancy: a nationwide cohort study. Rheumatology (Oxford) 2021; 60(5):2317-26.

https://doi.org/10.1093/rheumatology/keaa592

Kaplan YC, Ozsarfati J, Nickel C, Koren G. Reproductive outcomes following hydroxychloroquine use for autoimmune diseases: a systematic review and meta-analysis. Br J Clin Pharmacol 2016; 81(5):835-48.

https://doi.org/10.1111/bcp.12872

Scott RE, Greenwood SL, Hayes DJL, Baker BC, Jones RL, Heazell AEP. Effects of hydroxychloroquine on the human placenta-Findings from in vitro experimental data and a systematic review. Reprod Toxicol 2019; 87:50-9.

https://doi.org/10.1016/j.reprotox.2019.05.056

Goel P, Gerriets V. Chloroquine. In: StatPearls. Treasure Island (FL): StatPearls Publishing; 2021.

Sammaritano LR, Chakravarty EF. An issue of rheumatic disease clinics of North America. In: Reproductive Health. E-Book: Elsevier Health Sciences; 2017.

https://doi.org/10.1016/S0889-857X(17)30005-4

Sammaritano LR, Bermas BL. Rheumatoid arthritis medications and lactation. Curr Opin Rheumatol 2014; 26(3):354-60.

https://doi.org/10.1097/BOR.0000000000000055

Skorpen CG, Hoeltzenbein M, Tincani A, Fischer-Betz R, Elefant E, Chambers C, et al. The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation. Ann Rheum Dis 2016; 75(5):795-810.

https://doi.org/10.1136/annrheumdis-2015-208840

Bérard A, Sheehy O, Zhao JP, Vinet E, Quach C, Bernatsky S. Chloroquine and hydroxychloroquine use during pregnancy and the risk of adverse pregnancy outcomes using real-world evidence. Front Pharmacol 2021; 12:722511.

https://doi.org/10.3389/fphar.2021.722511

Ngian GS, Briggs AM, Ackerman IN, van Doornum S. Safety of anti-rheumatic drugs for rheumatoid arthritis in pregnancy and lactation. Int J Rheum Dis 2016; 19(9):834-43.

https://doi.org/10.1111/1756-185X.12860

Lu C, Li S, Liu Y. Role of immunosuppressive therapy in rheumatic diseases concurrent with COVID-19. Ann Rheum Dis 2020; 79(6):737-39.

https://doi.org/10.1136/annrheumdis-2020-217460

Millsop JW, Heller MM, Eliason MJ, Murase JE. Dermatological medication effects on male fertility. Dermatol Ther 2013; 26(4):337-46.

https://doi.org/10.1111/dth.12069

Paziana K, del Monaco M, Cardonick E, Moritz M, Keller M, Smith B, et al. Ciclosporin use during pregnancy. Drug Saf 2013; 36(5):279-94.

https://doi.org/ 10.1007/s40264-013-0034-x

Osadchy A, Koren G. Cyclosporine and lactation: when the mother is willing to breastfeed. Ther Drug Monit 2011; 33(2):147-8.

https://doi.org/10.1097/FTD.0b013e318208e3a4

Broen JCA, van Laar JM. Mycophenolate mofetil, azathioprine and tacrolimus: mechanisms in rheumatology. Nat Rev Rheumatol 2020; 16(3):167-78.

https://doi.org/10.1038/s41584-020-0374-8

FDA. Prograf (Tacrolimus) [Internet]. 2012 [cited 2021 Oct 18]. Available from: www.accessdata.fda.gov/drugsatfda_docs/label/2009/065461s000lbl.pdf.

Aktürk S, Çelebi ZK, Erdoʇmuş, Kanmaz AG, Yüce T, Şengül, et al. Pregnancy after kidney transplantation: outcomes, tacrolimus doses, and trough levels. Transplant Proc 2015; 47(5):1442-4.

https://doi.org/10.1016/j.transproceed.2015.04.041

Nakagawa K, Kwak-Kim J, Hisano M, Kasahara Y, Kuroda K, Sugiyama R, et al. Obstetric and perinatal outcome of the women with repeated implantation failures or recurrent pregnancy losses who received pre- and post-conception tacrolimus treatment. Am J Reprod Immunol 2019; 82(2):e13142.

https://doi.org/10.1111/aji.13142

Flint J, Panchal S, Hurrell A, van de Venne M, Gayed M, Schreiber K, et al. BSR and BHPR guideline on prescribing drugs in pregnancy and breastfeeding-Part I: standard and biologic disease modifying anti-rheumatic drugs and corticosteroids. Rheumatol (Oxford). 2016; 55(9):1693-7.

https://doi.org/10.1093/rheumatology/kev404

Oranus M, Thamer AK. Azathioprine. Treasure Island (FL): StatPearls Publishing; 2021.

Natekar A, Pupco A, Bozzo P, Koren G. Safety of azathioprine use during pregnancy. Can Fam Physician 2011; 57(12):1401-2.

Liu YP, Xu HQ, Li M, Yang X, Yu S, Fu WL, et al. Association between thiopurine smethyltransferase polymorphisms and azathioprine-induced adverse drug reactions in patients with autoimmune diseases: A meta-analysis. PLoS ONE 2015; 10(12):e0144234.

https://doi.org/10.1371/journal.pone.0144234

Xiong W, Lahita RG. Pragmatic approaches to therapy for systemic lupus erythematosus. Nat Rev Rheumatol 2014; 10(2):97-107.

https://doi.org/10.1038/nrrheum.2013.157

Tamirou F, D’Cruz D, Sangle S, Remy P, Vasconcelos C, Fiehn C, et al. Long-term follow-up of the MAINTAIN Nephritis Trial, comparing azathioprine and mycophenolate mofetil as maintenance therapy of lupus nephritis. Ann Rheum Dis 2016; 75(3):526-31.

https://doi.org/10.1136/annrheumdis-2014-206897

Schmajuk G, Yazdany J. Drug monitoring in systemic lupus erythematosus: a systematic review. Semin Arthritis Rheum 2011; 40(6):559-75.

https://doi.org/ 10.1016/j.semarthrit.2010.07.010

Mc Evoy GK. AHFS Drugs Information. USA: American Society of Health System Pharmacists Inc; 2011.

Makol A, Wright K, Amin S. Rheumatoid arthritis and pregnancy: safety considerations in pharmacological management. Drugs 2011; 71(15):1973-83.

https://doi.org/10.2165/11596240-000000000-00000

Alami Z, Agier MS, Ahid S, Vial T, Dautriche A, Legarce L, et al. Pregnancy outcome following in utero exposure to azathioprine: a French comparative observational study. Therapie 2017; 73(3):199-207.

https://doi.org/10.1016/j.therap.2017.06.006

Partlett R, Roussou E. The treatment of rheumatoid arthritis during pregnancy. Rheumatol Int 2011; 31(4):445-9.

https://doi.org/doi: 10.1007/s00296-010-1643-7

Friedman B, Cronstein B. Methotrexate mechanism in treatment of rheumatoid arthritis. Joint Bone Spine 2019; 86(3):301-7.

https://doi.org/10.1016/j.jbspin.2018.07.004

Grosen A, Kelsen J, Hvas CL, Bellaguarda E, Hanauer SB. The influence of methotrexate treatment on male fertility and pregnancy outcome after paternal exposure. Inflam Bowel Dis 2017; 23(4):561-9.

https://doi.org/10.1097/MIB.0000000000001064

Levy RA, de Jesús GR, de Jesús NR, Klumb EM. Critical review of the current recommendations for the treatment of systemic inflammatory rheumatic diseases during pregnancy and lactation. Autoimmun Rev 2016; 15(10):995-63.

https://doi.org/10.1016/j.autrev.2016.07.014

Cassina M, Johnson DL, Robinson LK, Braddock SR, Xu R, Jimenez JL, et al. Pregnancy outcome in women exposed to leflunomide before or during pregnancy. Arthritis Rheum 2012; 64(7):2085-94.

https://doi.org/10.1002/art.34419

Published
2022-03-31
Section
Articles