%0 Journal Article
%T Adverse Event Burden, Resource Use, and Costs Associated with Immunosuppressant Medications for the Treatment of Systemic Lupus Erythematosus: A Systematic Literature Review
%A A. Oglesby
%A A. J. Shaul
%A T. Pokora
%A C. Paramore
%A L. Cragin
%A G. Dennis
%A S. Narayanan
%A A. Weinstein
%J International Journal of Rheumatology
%D 2013
%I Hindawi Publishing Corporation
%R 10.1155/2013/347520
%X 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每77%), gastrointestinal AEs (3.2每66.7%), and amenorrhea and/or ovarian complications (0每71%). More hematological cytopenias were associated with AZA (14 episodes) than MMF (2 episodes). CYC was associated with more infections than MMF (40每77% versus 12.5每32%, resp.) or AZA (17每77% versus 11每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每36% versus 3.6每6%, resp.) or AZA (32每71% versus 8每18%, resp.). Discontinuation rates due to AEs were 0每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. 1. Introduction Systemic lupus erythematosus (SLE) is a chronic systemic inflammatory autoimmune disease that can affect almost any organ and can present with musculoskeletal, neuropsychiatric, renal, cutaneous, and hematologic manifestations alone or in combination [1每3]. The treatment plan used to manage SLE is dependent upon the severity of the disease and organ systems involved. Antimalarials, nonsteroidal anti-inflammatory drugs (NSAIDs), and low-dose corticosteroids are used to treat mild-to-moderate disease, whereas higher doses of steroids are often used when symptoms remain uncontrolled [4]. Although not approved by the Food and Drug Administration for use in patients with SLE, immunosuppressants (e.g., azathioprine (AZA), cyclophosphamide (CYC), mycophenolate mofetil [MMF], methotrexate (MTX), or cyclosporine (CsA)) are prescribed to patients with moderate-to-severe symptoms to reduce steroid exposure in some patients [4每6]. Based on a clinical trial conducted in North America and Europe, it is estimated that more than half of patients with active SLE receive immunosuppressants as part of standard therapy [7]. However, immunosuppressant drugs are associated with significant short- and long-term side effects and require monitoring to
%U http://www.hindawi.com/journals/ijr/2013/347520/