Improvements in health-related quality of life with belimumab, a B-lymphocyte stimulator-specific inhibitor, in patients with autoantibody-positive systemic lupus erythematosus from the randomised controlled BLISS trials.
Improvements in health-related quality of life with belimumab, a B-lymphocyte stimulator-specific inhibitor, in patients with autoantibody-positive systemic lupus erythematosus from the randomised controlled BLISS trials.
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DOI：
10.1136/annrheumdis-2012-202865
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发表时间：
2014-05
影响因子：
27.4
通讯作者：
BLISS-52 and -76 Study Groups
中科院分区：
文献类型：
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作者：
Strand V;Levy RA;Cervera R;Petri MA;Birch H;Freimuth WW;Zhong ZJ;Clarke AE;BLISS-52 and -76 Study Groups
评估贝利木单抗联合标准系统性红斑狼疮（SLE）治疗对活动性自身抗体阳性SLE患者健康相关生活质量（HRQOL）的影响。在两项多中心、随机对照试验中，患者接受标准治疗加安慰剂或贝利木单抗1或10 mg/kg，试验持续时间分别为52周（布利斯-52; N=865）和76周（布利斯-76; N=819）。在第52周通过SLE应答者指数评价应答者。患者报告的结局评估包括SF-36、慢性疾病治疗功能评估（FACIT）-疲乏和EQ-5D。第24周的平均SF-36身体健康总评（PCS）评分是主要次要终点。基线SF-36评分低于年龄/性别匹配的美国标准1.5 SD，各治疗组在第24周时的改善相似。在布利斯-52第52周，贝利木单抗1 mg/kg组（4.20）和10 mg/kg组（4.18）PCS评分较基线的平均变化显著（p<0.05）大于安慰剂组（2.96）。 在布利斯-76中，贝利木单抗1 mg/kg组第52周PCS（贝利木单抗1 mg/kg=4.37，10 mg/kg=3.41 vs安慰剂=2.85）和心理健康总评（MCS）评分（贝利木单抗1 mg/kg=3.14，10 mg/kg=2.70 vs安慰剂=1.40）以及第76周MCS评分（贝利木单抗1 mg/kg=3.05，10 mg/kg=2.28 vs安慰剂=1.36）的改善显著（p<0.05）。 在汇总分析中，两种贝利木单抗剂量组第52周PCS、SF-36活力域和FACIT-疲乏评分的改善显著更大。在接受贝利木单抗和标准治疗的自身抗体阳性活动性SLE患者中，HRQOL出现具有临床意义的改善，这与这些试验中观察到的疾病活动性降低一致。NCT 00424476、NCT 00410384。
Assess the effects of belimumab treatment plus standard systemic lupus erythematosus (SLE) therapy on health-related quality of life (HRQOL) in patients with active, autoantibody-positive SLE. Patients received standard therapy plus placebo or belimumab 1 or 10 mg/kg in two multicentre, randomised controlled trials of 52 (BLISS-52; N=865) and 76 (BLISS-76; N=819) weeks’ duration. Responders were evaluated by SLE Responder Index at week 52. Patient-reported outcome assessments included SF-36, Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue, and EQ-5D. Mean SF-36 Physical Component Summary (PCS) scores at week 24 was a major secondary endpoint. Baseline SF-36 scores were 1.5 SDs below age-/sex-matched US norms with similar improvement at week 24 across treatment groups. Mean changes from baseline in PCS scores were significantly (p<0.05) greater with belimumab 1 mg/kg (4.20) and 10 mg/kg (4.18) versus placebo (2.96) in BLISS-52, week 52. In BLISS-76, significantly (p<0.05) greater improvements were seen with belimumab 1 mg/kg in PCS (belimumab 1 mg/kg=4.37, 10 mg/kg=3.41 vs placebo=2.85) and Mental Component Summary (MCS) scores (belimumab 1 mg/kg=3.14, 10 mg/kg=2.70 vs placebo=1.40) at week 52, and in MCS score at week 76 (belimumab 1 mg/kg=3.05, 10 mg/kg=2.28 vs placebo=1.36). In pooled analysis, significantly greater improvements in PCS, SF-36 vitality domain, and FACIT-Fatigue scores at week 52 were evident with both belimumab doses. The clinically meaningful improvements in HRQOL in autoantibody-positive patients with active SLE treated with belimumab and standard therapy are consistent with the reductions in disease activity observed in these trials. NCT00424476, NCT00410384.
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影响因子：
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作者：
Petri, Michelle;Stohl, William;Freimuth, William
通讯作者：
Freimuth, William
DOI：
10.1002/art.23539
发表时间：
2008-04-15
期刊：
ARTHRITIS & RHEUMATISM-ARTHRITIS CARE & RESEARCH
影响因子：
--
作者：
Camtbell, Robert, Jr.;Cooper, Glinda S.;Gilkeson, Gary S.
通讯作者：
Gilkeson, Gary S.
影响因子：
7.2
作者：
Ware, JE;Gandek, B
通讯作者：
Gandek, B
影响因子：
2.6
作者：
Zonana-Nacach, A;Roseman, JM;Alarcón, GS
通讯作者：
Alarcón, GS
影响因子：
--
作者：
Wallace, Daniel J.;Stohl, William;Furie, Richard A.;Lisse, Jeffrey R.;McKay, James D.;Merrill, Joan T.;Petri, Michelle A.;Ginzler, Ellen M.;Chatham, W. Winn;McCune, W. Joseph;Fernandez, Vivian;Chevrier, Marc R.;Zhong, Z. John;Freimuth, William W.
通讯作者：
Freimuth, William W.