Prevalence of Flare and Influence of Demographic and Serologic Factors on Flare Risk in Systemic Lupus Erythematosus: A Prospective Study

Petri, Michelle; Singh, Sukhminder; Tesfasyone, H; Malik, Ashima

doi:10.3899/jrheum.090019

Cited by 77 publications

(99 citation statements)

References 18 publications

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“…8 Increases in serologic activity and proteinuria have been associated with lupus nephritis, general SLE flares, and worsening disease activity. [10][11][12][13] Normalization of C3 or anti-dsDNA, irrespective of SLE therapy, was a predictor of reduced risk of severe SLE flare, and normalization of C4 was a predictor of an SRI response in the BLISS trials. 20 Mycophenolate mofetil is commonly used in the treatment of lupus nephritis.…”

Section: Discussionmentioning

confidence: 99%

“…8 Levels of anti-dsDNA and C3 and C4 may predict disease activity, disease exacerbations such as flares, and patient response to treatment. 8,[10][11][12][13] The present post-hoc pooled analysis of the BLISS trials was, therefore, performed to evaluate the effect of belimumab on renal parameters in patients with active SLE and renal involvement at baseline.…”

Section: Introductionmentioning

confidence: 99%

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Effect of belimumab treatment on renal outcomes: results from the phase 3 belimumab clinical trials in patients with SLE

Dooley

Houssiau

Aranow

et al. 2012

Lupus

253

139

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A pooled post-hoc analysis of the phase 3, randomized, placebo-controlled BLISS trials (1684 patients with active systemic lupus erythematosus (SLE)) was performed to evaluate the effect of belimumab on renal parameters in patients with renal involvement at baseline, and to explore whether belimumab offered additional renal benefit to patients receiving mycophenolate mofetil at baseline. In addition to belimumab or placebo, all patients received standard SLE therapy. Patients with severe active lupus nephritis were excluded from the trials. Over 52 weeks, rates of renal flare, renal remission, renal organ disease improvement (assessed by Safety of Estrogens in Lupus Erythematosus National Assessment–Systemic Lupus Erythematosus Disease Activity Index and British Isles Lupus Assessment Group), proteinuria reduction, grade 3/4 proteinuria, and serologic activity favored belimumab, although the between-group differences in most renal outcomes were not significant. Among the 267 patients with renal involvement at baseline, those receiving mycophenolate mofetil or with serologic activity at baseline had greater renal organ disease improvement with belimumab than with placebo. Limitations of this analysis included the small patient numbers and the post-hoc nature of this pooled analysis. The results suggest that belimumab may offer renal benefit in patients with SLE. Further study is warranted in patients with severe active lupus nephritis.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Effect of belimumab treatment on renal outcomes: results from the phase 3 belimumab clinical trials in patients with SLE

Dooley

Houssiau

Aranow

et al. 2012

Lupus

253

139

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“…Compared with European Americans, African Americans are at higher risk of developing SLE and tend to be diagnosed earlier and suffer from a more severe disease with a higher rate of flares and progression to lupus nephritis (LN) and increased risk of death due to LN-related end-stage-renal disease. Although these disparities can be explained by the genetic background at disease onset, other factors such as poor socioeconomic status, lack of social support, or lower access to healthcare are major contributors to the accelerated and more severe course of disease (3)(4)(5)(6). Little is known about the immunological mechanisms of SLE that could account for the variations in susceptibility and severity in different ethnic groups.…”

Section: Introductionmentioning

confidence: 99%

B cells from African American lupus patients exhibit an activated phenotype

et al. 2016

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“…Worsening disease activity was predicted by rises in serum BLyS concentrations using the Safety of Estrogen in Lupus Erythematosus National Assessment-SLE Disease Activity Index (SELENA-SLEDAI) and elevated anti-dsDNA antibody titers 15 . Levels of anti-dsDNA and complement (C3 and C4) may predict disease activity and exacerbations, and response to treatment 16,17,18,19,20,21 .…”

mentioning

confidence: 99%

Disease Control and Safety of Belimumab Plus Standard Therapy Over 7 Years in Patients with Systemic Lupus Erythematosus

Ginzler

Wallace²,

Merrill³

et al. 2013

J Rheumatol

164

116

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Objective.To evaluate the efficacy/safety of belimumab plus standard therapy in patients (n = 449) with active systemic lupus erythematosus (SLE) treated up to 7 years (n = 177 currently ongoing).Methods.Patients (n = 345) who completed a double-blind, placebo-controlled, 52-week study of belimumab 1, 4, or 10 mg/kg and 24-week extension of belimumab (placebo switched to 10 mg/kg; belimumab same dose or switched to 10 mg/kg) could receive belimumab 10 mg/kg in an open-label continuation study (n = 296). Disease activity was analyzed in patients with active SLE at baseline of the initial study. Biomarker and SLE medication changes were evaluated, and adverse events (AE) were monitored throughout the study.Results.Total belimumab exposure over 7 years (double-blind and open-label periods): 1746 patient-years. SLE Responder Index (SRI) response rates at Week 52 in autoantibody-positive patients: placebo, 29%; belimumab, 46% (p < 0.05). In the continuation study, 57% of auto-antibody-positive patients had an SRI response by Year 2 and 65% by Year 7; severe flares occurred in 19% with placebo and 17% with belimumab during the first year, with the annual rate declining to 2%–9% during years 2–7. Anti-dsDNA autoantibodies in patients positive for them at baseline had a progressive decline of 40%–60% from baseline over 2–7 years with belimumab. Corticosteroid use decreased over time with ≥ 50–55% reduction in median dose during years 5–7. Serious and overall annual AE rates, including infections, were generally stable or decreased during 7-year treatment.Conclusion.Disease control and safety profile were maintained in patients with active SLE taking belimumab plus standard therapy for up to 7 years. [ClinicalTrials.gov numbers: NCT00071487 and NCT00583362]

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Prevalence of Flare and Influence of Demographic and Serologic Factors on Flare Risk in Systemic Lupus Erythematosus: A Prospective Study

Cited by 77 publications

References 18 publications

Effect of belimumab treatment on renal outcomes: results from the phase 3 belimumab clinical trials in patients with SLE

Effect of belimumab treatment on renal outcomes: results from the phase 3 belimumab clinical trials in patients with SLE

B cells from African American lupus patients exhibit an activated phenotype

Disease Control and Safety of Belimumab Plus Standard Therapy Over 7 Years in Patients with Systemic Lupus Erythematosus

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