Sustained remission of symptoms and improved health-related quality of life in patients with cryopyrin-associated periodic syndrome treated with canakinumab: results of a double-blind placebo-controlled randomized withdrawal study.
Sustained remission of symptoms and improved health-related quality of life in patients with cryopyrin-associated periodic syndrome treated with canakinumab: results of a double-blind placebo-controlled randomized withdrawal study.
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DOI：
10.1186/ar3535
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发表时间：
2011
影响因子：
4.9
通讯作者：
Canakinumab in CAPS Study Group
中科院分区：
文献类型：
--
作者：
Koné-Paut I;Lachmann HJ;Kuemmerle-Deschner JB;Hachulla E;Leslie KS;Mouy R;Ferreira A;Lheritier K;Patel N;Preiss R;Hawkins PN;Canakinumab in CAPS Study Group
目的：评估Canakinumab对低温比林相关周期综合征(CAPS)患者症状和健康相关生活质量的影响，Canakinumab是一种完全人类抗白细胞介素1β抗体。在这项为期48周的第三阶段研究中，患有CAPS的患者每隔8周皮下注射Canakinumab 150 mg。所有患者(n=35)在第1至8周期间接受Canakinumab治疗；第9至24周为双盲安慰剂对照停药阶段，第24至48周为开放标签阶段，在此阶段所有患者均接受Canakinumab治疗。患者和医生对症状、炎症标志物水平和HRQL进行了评估。症状迅速缓解，%的患者在第8天没有或仅有轻微的疾病活动。接受8周Canakinumab治疗的患者持续有效。安慰剂组的反应在安慰剂控制阶段消失，在开放标签阶段恢复Canakinumab治疗后恢复。临床反应伴随着血清C反应蛋白、血清淀粉样蛋白A和白细胞介素6水平的下降。基线时的HRQOL得分明显低于一般人群。到第8天，所有36项简明健康调查(SF-36)领域的分数都有明显的改善。到第8周，分数接近或超过美国普通人群，并在Canakinumab治疗期间保持稳定。身体疼痛和角色-体力方面的改善尤其显著，从基线到第8周增加了超过25分。治疗总体耐受性良好。Canakinumab 150 mg，每周8次，可使CAPS患者的症状迅速持续缓解，同时显著改善HRQOL。Clintrials.gov NCT00465985
To assess the effect of canakinumab, a fully human anti-interleukin-1β antibody, on symptoms and health-related quality of life (HRQoL) in patients with cryopyrin-associated periodic syndrome (CAPS). In this 48-week, phase 3 study, patients with CAPS received canakinumab 150 mg subcutaneously at 8-week intervals. All patients (n = 35) received canakinumab during weeks 1 through 8; weeks 9 through 24 constituted a double-blind placebo-controlled withdrawal phase, and weeks 24 through 48 constituted an open-label phase in which all patients received canakinumab. Patient and physician assessments of symptoms, levels of inflammatory markers, and HRQoL were performed. Rapid symptom remission was achieved, with 89% of patients having no or minimal disease activity on day 8. Responses were sustained in patients receiving 8-weekly canakinumab. Responses were lost during the placebo-controlled phase in the placebo group and were regained on resuming canakinumab therapy in the open-label phase. Clinical responses were accompanied by decreases in serum levels of C-reactive protein, serum amyloid A protein, and interleukin-6. HRQoL scores at baseline were considerably below those of the general population. Improvements in all 36-item Short-Form Health Survey (SF-36) domain scores were evident by day 8. Scores approached or exceeded those of the general U.S. population by week 8 and remained stable during canakinumab therapy. Improvements in bodily pain and role-physical were particularly marked, increasing by more than 25 points from baseline to week 8. Therapy was generally well tolerated. Canakinumab, 150 mg, 8-weekly, induced rapid and sustained remission of symptoms in patients with CAPS, accompanied by substantial improvements in HRQoL. Clintrials.gov NCT00465985
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影响因子：
158.5
作者：
Lachmann, Helen J.;Kone-Paut, Isabelle;Hawkins, Philip N.
通讯作者：
Hawkins, Philip N.
DOI：
10.1084/jem.20082481
发表时间：
2009-05-11
期刊：
The Journal of experimental medicine
影响因子：
--
作者：
Lachmann HJ;Lowe P;Felix SD;Rordorf C;Leslie K;Madhoo S;Wittkowski H;Bek S;Hartmann N;Bosset S;Hawkins PN;Jung T
通讯作者：
Jung T
影响因子：
2.3
作者：
Stych, Beate;Dobrovolny, Diana
通讯作者：
Dobrovolny, Diana
影响因子：
--
作者：
Leslie, Kieron S.;Lachmann, Helen J.;Hawkins, Philip N.
通讯作者：
Hawkins, Philip N.
影响因子：
3
作者：
WARE, JE;SHERBOURNE, CD
通讯作者：
SHERBOURNE, CD