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International Journal of Rheumatology
Volume 2013, Article ID 347520, 9 pages
Review Article

Adverse Event Burden, Resource Use, and Costs Associated with Immunosuppressant Medications for the Treatment of Systemic Lupus Erythematosus: A Systematic Literature Review

1GlaxoSmithKline, U.S. Health Outcomes, 5 Moore Drive, Research Triangle Park, NC 27709, USA
2United BioSource Corporation, 7101 Wisconsin Avenue Suite 600, Bethesda, MD 20814, USA
3Human Genome Sciences, Medical Affairs, 14200 Shady Grove Road, Rockville, MD 20850, USA
4Washington Hospital Center, Division of Rheumatology, 110 Irving Street NW, Washington, DC 20010, USA

Received 14 December 2012; Revised 17 February 2013; Accepted 25 February 2013

Academic Editor: Kenneth C. Kalunian

Copyright © 2013 A. Oglesby et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


This paper assessed the burden of adverse events (AEs) associated with azathioprine (AZA), cyclophosphamide (CYC), mycophenolate mofetil (MMF), methotrexate (MTX), and cyclosporine (CsA) in patients with systemic lupus erythematosus (SLE). Thirty-eight publications were included. Incidence of AEs ranged from 42.8% to 97.3%. Common AEs included infections (2.4–77%), gastrointestinal AEs (3.2–66.7%), and amenorrhea and/or ovarian complications (0–71%). More hematological cytopenias were associated with AZA (14 episodes) than MMF (2 episodes). CYC was associated with more infections than MMF (40–77% versus 12.5–32%, resp.) or AZA (17–77% versus 11–29%, resp.). Rates of hospitalized infections were similar between MMF and AZA patients, but higher for those taking CYC. There were more gynecological toxicities with CYC than MMF (32–36% versus 3.6–6%, resp.) or AZA (32–71% versus 8–18%, resp.). Discontinuation rates due to AEs were 0–44.4% across these medications. In summary, the incidence of AEs associated with SLE immunosuppressants was consistently high as reported in the literature; discontinuations due to these AEs were similar across treatments. Studies on the economic impact of these AEs were sparse and warrant further study. This paper highlights the need for more treatment options with better safety profiles.