Publications (15) View all
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Article: Efficacy and safety of rituximab in moderately-to-severely active systemic lupus erythematosus: the randomized, double-blind, phase II/III systemic lupus erythematosus evaluation of rituximab trial.
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ABSTRACT: B cells are likely to contribute to the pathogenesis of systemic lupus erythematosus (SLE), and rituximab induces depletion of B cells. The Exploratory Phase II/III SLE Evaluation of Rituximab (EXPLORER) trial tested the efficacy and safety of rituximab versus placebo in patients with moderately-to-severely active extrarenal SLE. Patients entered with >or=1 British Isles Lupus Assessment Group (BILAG) A score or >or=2 BILAG B scores despite background immunosuppressant therapy, which was continued during the trial. Prednisone was added and subsequently tapered. Patients were randomized at a ratio of 2:1 to receive rituximab (1,000 mg) or placebo on days 1, 15, 168, and 182. In the intent-to-treat analysis of 257 patients, background treatment was evenly distributed among azathioprine, mycophenolate mofetil, and methotrexate. Fifty-three percent of the patients had >or=1 BILAG A score at entry, and 57% of the patients were categorized as being steroid dependent. No differences were observed between placebo and rituximab in the primary and secondary efficacy end points, including the BILAG-defined response, in terms of both area under the curve and landmark analyses. A beneficial effect of rituximab on the primary end point was observed in the African American and Hispanic subgroups. Safety and tolerability were similar in patients receiving placebo and those receiving rituximab. The EXPLORER trial enrolled patients with moderately-to-severely active SLE and used aggressive background treatment and sensitive cutoffs for nonresponse. No differences were noted between placebo and rituximab in the primary and secondary end points. Further evaluation of patient subsets, biomarkers, and exploratory outcome models may improve the design of future SLE clinical trials.Arthritis & Rheumatism 01/2010; 62(1):222-33. · 7.87 Impact Factor -
Article: Effects of prasterone on bone mineral density in women with active systemic lupus erythematosus receiving chronic glucocorticoid therapy.
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ABSTRACT: To assess prevention of bone mineral density (BMD) loss and durability of the response during treatment with prasterone in women with systemic lupus erythematosus (SLE) receiving chronic glucocorticoids. 155 patients with SLE received 200 mg/day prasterone or placebo for 6 months in a double-blind phase. Subsequently, 114 patients were re-randomized to receive 200 or 100 mg/day prasterone for 12 months in an open-label phase. Primary efficacy endpoints were changes in BMD at the lumbar spine (L-spine) from baseline to Month 6 and maintenance of BMD from Month 6 to 18 for patients who received prasterone during the double-blind phase. In the double-blind phase, there was a trend for a small gain in BMD at the L-spine for patients who received 200 mg/day prasterone for 6 months versus a loss in the placebo group (mean +/- SD, 0.003 +/- 0.035 vs -0.005 +/- 0.053 g/cm(2), respectively; p = 0.293 between groups). In the open-label phase, there was dose-dependent increase in BMD at the L-spine at Month 18 between patients who received 200 versus 100 mg/day prasterone (p = 0.021). For patients who received 200 mg/day prasterone for 18 months, the L-spine BMD gain was 1.083 +/- 0.512% (p = 0.042). There was no overall change in BMD at the total hip over 18 months with 200 mg/day prasterone treatment. The safety profile reflected the weak androgenic properties of prasterone. This study suggests prasterone 200 mg/day may offer mild protection against bone loss in women with SLE receiving glucocorticoids. (ClinicalTrials.gov Identifiers NCT00053560 and NCT00082511).The Journal of Rheumatology 08/2008; 35(8):1567-75. · 3.69 Impact Factor -
Article: Participatory patient-physician communication and morbidity in patients with systemic lupus erythematosus.
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ABSTRACT: To examine associations between active patient-physician communication and measures of morbidity in patients with systemic lupus erythematosus (SLE). Audiotapes of routine visits between 79 women with SLE and their rheumatologists were coded for active patient participation and the degree of patient-centered communication of the physician, using a validated coding scheme. Measures of SLE activity, functional disability, and permanent organ damage were recorded at the same visit. Permanent organ damage was reassessed in 68 patients after a median of 4.7 years. Patients who participated more actively in their visits had less permanent organ damage, as measured by the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index, and tended to accrue less organ damage over time. There were no associations between either active patient participation or physicians' patient-centered communication scores and measures of SLE activity or functional disability. Patients with SLE who participated more actively in their visits had less permanent organ damage, suggesting that involving patients more in their care may decrease morbidity.Arthritis & Rheumatism 01/2004; 49(6):810-8. · 7.87 Impact Factor -
Article: The role of plasmapheresis in the treatment of severe central nervous system neuropsychiatric systemic lupus erythematosus.
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ABSTRACT: Twenty-six patients, who received plasmapheresis (PP) either alone or synchronized with cyclophosphamide (IV-CYC/PP), are retrospectively reviewed from Medline searches and personal experience from 1976 to 2002. Patients with central nervous system neuropsychiatric systemic lupus erythematosus (CNS-NPSLE) were evaluated according to the American College of Rheumatology (ACR) case definitions of 1999. Eleven of the patients were under the age of 21 years (range 7-21 years), highlighting the need for an aggressive treatment option for young patients who are refractory to other treatments. After treatment with PP or IV-CYC/PP, 74% of patients improved, 13% stabilized, and 13% progressed. Major side-effects occurred from central line placement rather than immunomodulation from PP itself Step-down therapies are needed to supplement IV-CYC/PP once improvement has reached a plateau. Newer combinations of PP and intravenous immunoglobulin (IVIg), human stem cell transplant (HSCT) and rituximab (RTX) should be considered in the future. In the absence of randomized controlled trials (RCT), experienced clinicians must weigh risk, benefit, and cost profiles in considering the treatment of severe CNS-NPSLE with PP.Therapeutic apheresis and dialysis: official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy 05/2003; 7(2):173-82. · 1.39 Impact Factor -
Article: Time perspective predicts the progression of permanent organ damage in patients with systemic lupus erythematosus.
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ABSTRACT: Patients whose perspective is oriented to the future more than to the present may have better long-term health outcomes. We examined if time perspective predicted future organ damage in patients with systemic lupus erythematosus (SLE). We assessed the time perspectives of 87 patients with SLE using a questionnaire at a baseline visit. Permanent organ damage was assessed by the Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index during the same visit, and reassessed after a median of 4.6 years. Patients who were oriented more to the future were less likely to have an increase in the Damage Index than those oriented more to the present. In a multivariate analysis, each 1-point increase in the degree of orientation to the future (on a scale of 1-6) was associated with a 22% decrease in the likelihood that the Damage Index would increase over time (odds ratio 0.78; 95% confidence interval 0.64-0.94; P = 0.009). Other measures that predicted an increase in the Damage Index were lower education levels, greater health locus of control attributed to chance and greater health locus of control attributed to powerful others. In conclusion, time perspective is a significant predictor of future organ damage in SLE. Patients who have a greater orientation to the future are less likely to develop permanent organ damage.Lupus 02/2003; 12(6):443-8. · 2.34 Impact Factor
