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Clinical, laboratory and health-related quality of life correlates of Systemic Lupus Erythematosus Responder Index response: a post hoc analysis of the phase 3 belimumab trials.

Furie R, Petri MA, Strand V, Gladman DD, Zhong ZJ, Freimuth WW, BLISS-52 and BLISS-76 Study Grou - Lupus Sci Med (2014)

Bottom Line: Risks for developing any SLE flare or severe flare were reduced in responders by 42% and 87%, respectively (p<0.001).Responders reported greater improvements in Medical Outcomes Survey Short Form version 2 Physical and Mental Components and all domain scores, and Functional Assessment of Chronic Illness Therapy-Fatigue score compared with non-responders (all p<0.001).NCT00424476; NCT00410384.

View Article: PubMed Central - PubMed

Affiliation: Division of Rheumatology and Allergy-Clinical Immunology , North Shore-Long Island Jewish Health System , Great Neck, New York , USA.

ABSTRACT

Objective: Correlates of systemic lupus erythematosus (SLE) Responder Index (SRI) response with clinical trial end points were examined using pooled data from the Study of Belimumab in Subjects with SLE (BLISS) trials (N=1684).

Methods: Changes in clinical, laboratory and health-related quality of life measures from baseline at 52 weeks were compared between SRI responders (n=761) and non-responders (n=923).

Results: More SRI responders than non-responders had ≥4-point (100% vs 3.8%) and ≥7-point (40.3% vs 1.3%) Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index reductions, no new British Isles Lupus Assessment Group (BILAG) A and ≤1 new B scores (91.9% vs 35.9%), and a 25% reduction in corticosteroid dose decrease of 25% from >7.5 mg/d to ≤7.5 mg/d (25.5% vs 13.9%), and fewer had a corticosteroid increase from ≤7.5 mg/d to >7.5 mg/d (4.1% vs 21.3%; all p<0.001). More responders than non-responders had improved organ domains: Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (mean 1.45 vs 0.40), BILAG (2.00 vs 0.39), and greater improvement in Physician's Global Assessment (all p<0.001). Risks for developing any SLE flare or severe flare were reduced in responders by 42% and 87%, respectively (p<0.001). Responders reported greater improvements in Medical Outcomes Survey Short Form version 2 Physical and Mental Components and all domain scores, and Functional Assessment of Chronic Illness Therapy-Fatigue score compared with non-responders (all p<0.001).

Conclusion: Overall, SRI response in patients with active, autoantibody-positive SLE was associated with improvements in clinical, laboratory and patient-reported outcome measures, indicating that SRI response was associated with a global benefit.

Trial registration number: NCT00424476; NCT00410384.

No MeSH data available.


Related in: MedlinePlus

Comparison of SRI responders and non-responders. (A) Mean % change in PGA score, (B) risk for flare by SFI, and (C) corticosteroid use over 52 weeks. *p<0.05; +p<0.01; #p<0.001. PGA, Physician's Global Assessment; SFI, SLE Flare Index; SRI, Systemic Lupus Erythematosus (SLE) Responder Index.
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LUPUS2014000031F1: Comparison of SRI responders and non-responders. (A) Mean % change in PGA score, (B) risk for flare by SFI, and (C) corticosteroid use over 52 weeks. *p<0.05; +p<0.01; #p<0.001. PGA, Physician's Global Assessment; SFI, SLE Flare Index; SRI, Systemic Lupus Erythematosus (SLE) Responder Index.

Mentions: More responders than non-responders achieved a ≥4-point reduction in SELENA-SLEDAI score, with only 3.8% of non-responders meeting this SRI criterion versus 100% of responders (p<0.001) (table 2). A reduction of ≥7 in SELENA-SLEDAI score occurred in 40.3% of responders versus 1.3% of non-responders (p<0.001) at Week 52. Mean numbers of improved organ domains per patient were higher among responders as assessed by SELENA-SLEDAI and BILAG (all p<0.001). Mean improvements in PGA scores in all patients as well as those with no worsening of PGA scores at Week 52 were greater among responders versus non-responders (both p<0.001; 49.3% of non-responders had no worsening at Week 52). Responders had greater improvements in PGA than non-responders as early as Week 4 and this continued through Week 52 (figure 1A).


Clinical, laboratory and health-related quality of life correlates of Systemic Lupus Erythematosus Responder Index response: a post hoc analysis of the phase 3 belimumab trials.

Furie R, Petri MA, Strand V, Gladman DD, Zhong ZJ, Freimuth WW, BLISS-52 and BLISS-76 Study Grou - Lupus Sci Med (2014)

Comparison of SRI responders and non-responders. (A) Mean % change in PGA score, (B) risk for flare by SFI, and (C) corticosteroid use over 52 weeks. *p<0.05; +p<0.01; #p<0.001. PGA, Physician's Global Assessment; SFI, SLE Flare Index; SRI, Systemic Lupus Erythematosus (SLE) Responder Index.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4225741&req=5

LUPUS2014000031F1: Comparison of SRI responders and non-responders. (A) Mean % change in PGA score, (B) risk for flare by SFI, and (C) corticosteroid use over 52 weeks. *p<0.05; +p<0.01; #p<0.001. PGA, Physician's Global Assessment; SFI, SLE Flare Index; SRI, Systemic Lupus Erythematosus (SLE) Responder Index.
Mentions: More responders than non-responders achieved a ≥4-point reduction in SELENA-SLEDAI score, with only 3.8% of non-responders meeting this SRI criterion versus 100% of responders (p<0.001) (table 2). A reduction of ≥7 in SELENA-SLEDAI score occurred in 40.3% of responders versus 1.3% of non-responders (p<0.001) at Week 52. Mean numbers of improved organ domains per patient were higher among responders as assessed by SELENA-SLEDAI and BILAG (all p<0.001). Mean improvements in PGA scores in all patients as well as those with no worsening of PGA scores at Week 52 were greater among responders versus non-responders (both p<0.001; 49.3% of non-responders had no worsening at Week 52). Responders had greater improvements in PGA than non-responders as early as Week 4 and this continued through Week 52 (figure 1A).

Bottom Line: Risks for developing any SLE flare or severe flare were reduced in responders by 42% and 87%, respectively (p<0.001).Responders reported greater improvements in Medical Outcomes Survey Short Form version 2 Physical and Mental Components and all domain scores, and Functional Assessment of Chronic Illness Therapy-Fatigue score compared with non-responders (all p<0.001).NCT00424476; NCT00410384.

View Article: PubMed Central - PubMed

Affiliation: Division of Rheumatology and Allergy-Clinical Immunology , North Shore-Long Island Jewish Health System , Great Neck, New York , USA.

ABSTRACT

Objective: Correlates of systemic lupus erythematosus (SLE) Responder Index (SRI) response with clinical trial end points were examined using pooled data from the Study of Belimumab in Subjects with SLE (BLISS) trials (N=1684).

Methods: Changes in clinical, laboratory and health-related quality of life measures from baseline at 52 weeks were compared between SRI responders (n=761) and non-responders (n=923).

Results: More SRI responders than non-responders had ≥4-point (100% vs 3.8%) and ≥7-point (40.3% vs 1.3%) Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index reductions, no new British Isles Lupus Assessment Group (BILAG) A and ≤1 new B scores (91.9% vs 35.9%), and a 25% reduction in corticosteroid dose decrease of 25% from >7.5 mg/d to ≤7.5 mg/d (25.5% vs 13.9%), and fewer had a corticosteroid increase from ≤7.5 mg/d to >7.5 mg/d (4.1% vs 21.3%; all p<0.001). More responders than non-responders had improved organ domains: Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (mean 1.45 vs 0.40), BILAG (2.00 vs 0.39), and greater improvement in Physician's Global Assessment (all p<0.001). Risks for developing any SLE flare or severe flare were reduced in responders by 42% and 87%, respectively (p<0.001). Responders reported greater improvements in Medical Outcomes Survey Short Form version 2 Physical and Mental Components and all domain scores, and Functional Assessment of Chronic Illness Therapy-Fatigue score compared with non-responders (all p<0.001).

Conclusion: Overall, SRI response in patients with active, autoantibody-positive SLE was associated with improvements in clinical, laboratory and patient-reported outcome measures, indicating that SRI response was associated with a global benefit.

Trial registration number: NCT00424476; NCT00410384.

No MeSH data available.


Related in: MedlinePlus