Centre de Référence des Maladies Autoinflammatoires, Hôpital Kremlin Bicetre, Paris University of Medicine, Le Kremlin Bicetre, Paris, France.
Arthritis Res Ther. 2011;13(6):R202. doi: 10.1186/ar3535. Epub 2011 Dec 9.
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.
评估完全人源化抗白细胞介素-1β抗体卡那单抗对 Cryopyrin 相关周期性综合征（CAPS）患者症状和健康相关生活质量（HRQoL）的影响。
在这项为期 48 周的 3 期研究中，CAPS 患者接受卡那单抗 150mg 皮下注射，每 8 周一次。所有患者（n=35）在第 1 周到第 8 周接受卡那单抗治疗；第 9 周到第 24 周为双盲安慰剂对照停药期，第 24 周到第 48 周为所有患者接受卡那单抗的开放标签期。对患者和医生的症状、炎症标志物水平和 HRQoL 进行评估。
迅速达到症状缓解，89%的患者在第 8 天无疾病活动或仅有最小疾病活动。接受 8 周卡那单抗治疗的患者持续有反应。在安慰剂对照组的安慰剂对照阶段，反应丢失，在开放标签阶段恢复卡那单抗治疗时，反应恢复。临床反应伴随着血清 C 反应蛋白、血清淀粉样蛋白 A 蛋白和白细胞介素-6 水平的降低。基线时的 HRQoL 评分明显低于一般人群。所有 36 项简明健康调查（SF-36）量表评分在第 8 天均有明显改善。第 8 周时，评分接近或超过美国一般人群，并且在卡那单抗治疗期间保持稳定。身体疼痛和角色身体功能的改善尤为显著，从基线到第 8 周增加了超过 25 分。治疗总体上耐受性良好。
卡那单抗，150mg，每 8 周一次，可迅速诱导并持续缓解 CAPS 患者的症状，同时显著改善 HRQoL。
Clintrials.gov NCT00465985。
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