Impact of belimumab on patient-reported outcomes in systemic lupus erythematosus: review of clinical studies

Bangert, Elvira; Wakani, Laura; Merchant, Mehveen G.; Strand, Vibeke; Touma, Zahi

doi:10.2147/prom.s134326

Cited by 20 publications

(14 citation statements)

References 54 publications

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“…Our previous study and numerous other reports found an association between BAFF serum concentrations, disease activity, and the occurrence of lupus nephritis [11–14]. In line with these observations, clinical trials demonstrated the effectiveness of belimumab in reducing the number of autoantibodies and reducing disease activity among SLE patients [8, 15, 16].…”

Section: Introductionsupporting

confidence: 75%

“…In recent years, the treatment of SLE has evolved from conventional drugs providing a general immunosuppressive function to novel biological-targeting strategies, of which belimumab is an important and successful therapeutic agent [7, 8]. Belimumab has been approved as a treatment for SLE and is a human monoclonal antibody directed against soluble B-cell activating factor (BAFF).…”

Section: Introductionmentioning

confidence: 99%

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Susceptibility of BAFF-var allele carriers to severe SLE with occurrence of lupus nephritis

et al. 2019

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Background: Dysregulation of the B-cell activating factor (BAFF) system is involved in the pathogenesis of systemic lupus erythematosus (SLE). Increased serum concentrations of BAFF are related to lupus nephritis and disease activity among SLE patients. Recently, a variant of the BAFF-encoding gene, BAFF-var, was identified to be associated with autoimmune diseases, in particular SLE, and to promote the production of soluble BAFF. The present study aimed to assess the prevalence of BAFF-var in a cohort of 195 SLE patients and to analyze the association of the BAFF-var genotype (TNSF13B) with various manifestations of SLE. Methods: A cohort of 195 SLE patients from Central Europe, including 153 patients from the Swiss SLE Cohort Study and 42 patients from the University Hospital Essen, Germany, underwent genotyping for detection of BAFFvar allele. Results: Of the 195 patients, 18 (9.2%) tested positive for BAFF-var variant according to the minor allele frequency of 4.6%. The presence of BAFF-var was associated with the occurrence of lupus nephritis (p = 0.038) (p = 0.03 and p = 0.003). Among various organ manifestations of SLE, the presence of BAFF-var was associated with the occurrence of lupus nephritis (p = 0.038; odds ratio [OR], 2.4; 95% confidence interval [CI], 0.89-6.34) and renal activity markers such as proteinuria and hematuria (p = 0.03; OR, 2.4; 95% CI, 0.9-6.4 for proteinuria; p = 0.003; OR, 3.9; 95% CI, 1.43-10.76 for hematuria). SLE patients carrying the BAFF-var allele exhibited increased disease activity at study entry, as determined by the physician's global assessment (PGA: p = 0.002; OR, 4.8; 95% CI, 1.54-14.93) and the SLE Disease Activity Index (p = 0.012; OR, 3.5; 95% CI, 1.12-11.18). Consistent with that, the percentage of patients treated with immunosuppressive agents at study entry was higher among those carrying the BAFF-var allele than among those tested negative for BAFF-var (p = 0.006; OR, 3.7; 95% CI, 1.27-10.84). Conclusions: Our results indicate an association between the BAFF-var genotype and increased severity of SLE. Determining the BAFF-var status of SLE patients may improve the risk stratification of patients for whom the development of lupus nephritis is more likely and thus may be helpful in the follow-up care and treatment of SLE patients.

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Section: Introductionsupporting

confidence: 75%

Section: Introductionmentioning

confidence: 99%

Susceptibility of BAFF-var allele carriers to severe SLE with occurrence of lupus nephritis

et al. 2019

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“…The MCID for FACIT-Fatigue scores was set to ≥4 [ 22 , 23 ]. For the EQ-5D VAS, the MCID was defined as ≥10 [ 24 ] and for the EQ-5D utility index score it was set to ≥0.082 [ 25 ].…”

Section: Methodsmentioning

confidence: 99%

Impact of overweight and obesity on patient-reported health-related quality of life in systemic lupus erythematosus

et al. 2020

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Objectives Associations between BMI and health-related quality of life (HRQoL) in SLE have been implied, but data are scarce. We determined the impact of overweight and obesity on HRQoL in a large SLE population. Methods We pooled cross-sectional baseline data from the BLISS-52 (NCT00424476) and BLISS-76 (NCT00410384) trials (N = 1684). HRQoL was evaluated using the 36-item Short Form Health Survey (SF-36), Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale and the European Quality of Life 5-dimension questionnaire (EQ-5D). Comparisons between BMI groups were conducted using the Mann–Whitney U test and adjustments using linear regression. Clinical relevance was determined by minimal clinically important differences (MCIDs). Results In total, 43.2% of the patients had BMI above normal and 17.4% were obese. Overweight and obese patients reported worse SF-36 physical component summary (PCS), physical functioning, role physical, bodily pain and FACIT-Fatigue scores than normal weight patients. Divergences were greater than corresponding MCIDs and more prominent with increasing BMI. Despite no clinically important difference in SF-36 mental component summary scores across BMI categories, patients experienced progressively diminished vitality and social functioning with increasing BMI. In linear regression analysis, BMI above normal and obesity were associated with worse PCS (standardized coefficient β = −0.10, P < 0.001 and β = −0.17, P < 0.001, respectively), FACIT-Fatigue (β = −0.11, P < 0.001 and β = −0.16, P < 0.001) and EQ-5D (β = −0.08, P = 0.001 and β = −0.12, P < 0.001) scores, independently of demographic and disease-related factors. The impact of BMI on the PCS and FACIT-Fatigue was more pronounced than that of SLE activity. Conclusion Patients with SLE and BMI above normal experienced clinically important HRQoL diminutions in physical aspects, fatigue and social functioning. A survey of potential causality underlying this association is warranted.

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“…Apart from numerical and statistical differences, we endorsed the concept of minimal clinically important differences (MCIDs), and registered fulfilment of MCIDs in comparisons between AMA users and non-users. Based on previous literature, we set the MCID for SF-36 PCS and MCS scores to ≥2.5 points and for SF-36 subscales to ≥5.0 points [ 25 ], for FACIT-Fatigue scores to ≥4 points [ 26 ], for EQ-5D utility index scores to ≥0.040 points, used for scores calculated using the US valuation algorithm [ 27 ], and for EQ-5D VAS scores to ≥10 points [ 28 ]. For MCIDs that in previous studies were meant for evaluation of changes of the HRQoL between different time points, with different benchmarks for improvement and worsening, we considered the greatest benchmark as the MCID for the respective HRQoL item in the cross-sectional design of the present study.…”

Section: Methodsmentioning

confidence: 99%

Use of Antimalarial Agents Is Associated with Favourable Physical Functioning in Patients with Systemic Lupus Erythematosus

Gomez

Soukka

Johansson

et al. 2020

JCM

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Impaired health-related quality of life (HRQoL) is a major problem in patients with systemic lupus erythematosus (SLE). Antimalarial agents (AMA) are the cornerstone of SLE therapy, but data on their impact on HRQoL are scarce. We investigated this impact using baseline data from the BLISS-52 (NCT00424476) and BLISS-76 (NCT00410384) trials (n = 1684). HRQoL was self-reported using the Medical Outcomes Study short-form 36 (SF-36), functional assessment of chronic illness therapy (FACIT)-Fatigue and 3-level EuroQoL 5-Dimension (EQ-5D) questionnaires. Patients on AMA (n = 1098/1684) performed better with regard to SF-36 physical component summary, physical functioning, role physical, bodily pain, FACIT-Fatigue, EQ-5D utility index and EQ-5D visual analogue scale scores. The difference in SF-36 physical functioning (mean ± standard deviation (SD): 61.1 ± 24.9 versus 55.0 ± 26.5; p < 0.001) exceeded the minimal clinically important difference (≥5.0). This association remained significant after adjustment for potential confounding factors in linear regression models (standardised coefficient, β = 0.07; p = 0.002). Greater proportions of AMA users than non-users reported no problems in the mobility, self-care, usual activities and anxiety/depression EQ-5D dimensions. AMA use was particularly associated with favourable HRQoL in physical aspects among patients with active mucocutaneous and musculoskeletal disease, and mental aspects among patients with active renal SLE. These results provide support in motivating adherence to AMA therapy. Exploration of causality in the relationship between AMA use and favourable HRQoL in SLE has merit.

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Impact of belimumab on patient-reported outcomes in systemic lupus erythematosus: review of clinical studies

Cited by 20 publications

References 54 publications

Susceptibility of BAFF-var allele carriers to severe SLE with occurrence of lupus nephritis

Susceptibility of BAFF-var allele carriers to severe SLE with occurrence of lupus nephritis

Impact of overweight and obesity on patient-reported health-related quality of life in systemic lupus erythematosus

Use of Antimalarial Agents Is Associated with Favourable Physical Functioning in Patients with Systemic Lupus Erythematosus

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