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Table 1.  

Authors Sample size Methodology Key findings
Buyon et al.(see in text reference) 351 Double-blind, placebo-controlled study Results suggest that exogenous estrogen can increase disease activity, but the effect is only recognized in mild/moderate flares. These data suggest that female hormones may play a role in pathogenesis of SLE.
Tseng et al.[3] 180 Double-blind, placebo-controlled study This study suggests that elevation in C3a and dsDNA predict flares, and short-term, moderate doses of PDN prevent severe flares and exposure to high-dose steroids.
Kapitsinou et al. [15*] 18 Retrospective study The conclusion of this study is that MMF appears to be a safe and efficacious alternative treatment in proliferative SLE nephritis, whereas its efficacy in lupus membranous nephropathy remains unclear.
Riskalla et al.[16] 54 Retrospective study In this study the majority of patients tolerated MMF in a range of doses and showed clinical improvement, suggesting that flexible dose scheduling should be considered when using MMF in patients with SLE.
Doria et al. [17*] 42 Prospective uncontrolled study In this study MMF seems to be well tolerated and effective in patients with refractory disease and no different from standard therapy in maintaining GN remission over 9 months of follow-up.
Ginzler et al. [21**] 140 Prospective, multicentric, controlled study The conclusion of this trial was that MMF is better tolerated than IV CYC, with fewer pyogenic or other serious infections; GI side effects did not limit the tolerability of MMF.
Contreras et al. [22**] 59 Prospective, controlled study The conclusion of this study was that for patients with proliferative lupus nephritis, short-term therapy with IV CYC followed by maintenance therapy with MMF or azathioprine appeared to be more efficacious and safer than long-term therapy with IV CYC.
Alarcon-Segovia et al. [31**] 230 Randomized, placebo-controlled trial LJP appeared to be well tolerated; the rate of adverse events was similar to placebo. One patient died in each group. In patients with creatinine more than 1.5 mg/dL, the placebo group had a higher percentage of flares. Higher doses of drug had a better response.
Lisukov et al. [38*] 6 Case series This case series concludes that high-dose immunosuppression with autologous stem cell transplantation achieves prolonged, corticosteroid-free remissions, and that a more judicious selection of patients with less severe disease but with a high risk of relapse or further progression will diminish transplant-related mortality.
Petri et al. [40*] 14 Prospective, uncontrolled study The conclusion was that cyclophosphamide without stem cell transplantation led to rapid hematopoietic reconstitution and has significant clinical benefit in patients with refractory disease.
Karassa et al.[43] Meta-analysis The conclusion of this meta-analysis is that several aspects of the design and reporting of RCT on SLE can be improved, with larger, adequately powered and accurately reported trials needed.

Recent Controlled Trials and Case Series

CYC, cyclophosphamide; GI, gastrointestinal; GN, glomerulonephritis; IV, intranvenous; MMF, mycophenolate mofetil; PDN, prednisone; RCT, randomized controlled trial; SLE, systemic lupus erythematosus.


Systemic Lupus Erythematosus Trials: Successes and Issues

  • Authors: Ellen M Ginzler, MD; Ioana Moldovan, MD
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Target Audience and Goal Statement

This activity is intended for primary care physicians and rheumatologists who care for patients with systemic lupus erythematosus (SLE).

The goal of this activity is to update physicians on the use of standard-care therapies and new agents for SLE and its complications.

Upon completion of this activity, participants will be able to:

  1. List current pharmacologic and nonpharmacologic treatment options for SLE.
  2. Describe limitations and shortcomings of clinical trials on SLE therapies.
  3. Outline the outcomes measures used for determining efficacy of SLE therapies.
  4. List complications of SLE and the main causes of morbidity and mortality.
  5. Identify new agents being developed for SLE and their mechanisms of action.


As an organization accredited by the ACCME, Medscape requires authors and editors to disclose any significant financial relationship during the past 12 months with the manufacturer of any product that may relate to the subject matter of the educational activity, whether or not the activity is commercially supported. Authors are also asked to disclose any mention of investigational products or unapproved uses of products regulated by the U.S. Food and Drug Administration.


  • Ellen M Ginzler, MD

    Rheumatology Division, SUNY Downstate Medical Center, Brooklyn, New York, USA


    Disclosure: Ellen M. Ginzler, MD, has no significant financial interests or relationships to disclose.

  • Ioana Moldovan, MD

    Rheumatology Division, SUNY Downstate Medical Center, Brooklyn, New York


    Disclosure: Ioana Moldovan, MD, has no significant financial interests or relationships to disclose.

CME Author(s)

  • Désirée Lie, MD, MSEd

    Clinical Professor of Family Medicine; Director, Division of Faculty Development, University of California, Irvine School of Medicine, Irvine, California


    Disclosure: Désirée Lie, MD, MSEd, has no significant financial interests or relationships to disclose.

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Systemic Lupus Erythematosus Trials: Successes and Issues

Authors: Ellen M Ginzler, MD; Ioana Moldovan, MDFaculty and Disclosures


Abstract and Introduction


Purpose of Review: The purpose of this review is to discuss the most recent published clinical trials for systemic lupus erythematosus and to identify important issues that have arisen in association with the search for new therapies for systemic lupus erythematosus, as well as new regimens or indications for the use of standard-of-care agents such as corticosteroids and cyclophosphamide.
Recent Findings: Important developments have occurred during the past 2 years as interest in this area has increased, largely because of the participation of pharmaceutical and biotechnical companies in the development and testing of novel agents for systemic lupus erythematosus. Several important large-scale, multicenter, randomized controlled trials have been completed, but none has yet resulted in a new, approved indication for systemic lupus erythematosus. Many issues in the identification of new therapeutic modalities remain. These include the fact that a majority of published reports include either small numbers of patients in controlled trials that lack statistical power to draw conclusions, or are uncontrolled anecdotal series or individual case reports. Among the larger controlled trials, a pervasive issue in the failure to reach statistical significance may be the initial study design. Inclusion of patients with mild and/or stable disease activity does not allow for an effect size sufficient to show differences in treatment arms without recruitment of very large numbers of subjects. Finally, several potentially important trials have been reported only in abstract form to date. Further assessment of the results must await formal publication of these studies.


Clinicians interested in new developments in the challenging treatment of systemic lupus erythematosus (SLE) should find this review useful. SLE is a complex disease, and investigators designing clinical trials are faced with an array of manifestations and difficult-to-measure response to treatment. Ideally, the protocols for clinical trials and ultimate therapeutic decisions should be guided by evidence-based medicine, considering the pathophysiologic mechanisms and epidemiologic principles that influence the clinical course. Few large-scale, prospective, randomized studies have been published, most of them addressing lupus nephritis as the disease manifestation, with better defined end points such as changes in serum creatinine, urine protein excretion, development of end-stage renal disease, and death. Our goal is to provide a comprehensive review of the clinical trials and relevant case series in SLE published during the past 2 years, outlining the important developments and reinforcing some of the most significant issues that arise.