接受 Elagolix 治疗的子宫内膜异位症患者的健康相关生活质量改善。
Health-Related Quality of Life Improvements in Patients With Endometriosis Treated With Elagolix.
机构信息
Yale School of Medicine, New Haven, Connecticut; AbbVie Inc., North Chicago, Illinois; and Evidera, Bethesda, Maryland.
出版信息
Obstet Gynecol. 2020 Sep;136(3):501-509. doi: 10.1097/AOG.0000000000003917.
OBJECTIVE
To evaluate the effects of elagolix on clinically meaningful improvements in health-related quality of life (HRQOL) measured by the EHP-30 (Endometriosis Health Profile-30).
METHODS
Data from two phase III trials of elagolix for moderate to severe pain associated with endometriosis were pooled and analyzed as three groups: placebo, elagolix 150 mg once daily, or elagolix 200 mg twice daily. Patients were administered the EHP-30 questionnaire at baseline, and at months 1, 3, and 6 of treatment. Previously established responder definitions were applied to determine percentages of patients with clinically meaningful EHP-30 improvements. The probability of meeting EHP-30 responder definitions with elagolix compared with placebo at months 3 and 6 was determined by Poisson regression analysis, controlling for baseline scores.
RESULTS
At month 6, the probabilities of meeting EHP-30 subscale responder definitions for pain, control and powerlessness, self-image, social support, emotional well-being, and sexual intercourse were 169% (adjusted relative risk [aRR]: 2.69, 95% CI 2.26-3.21), 129% (aRR 2.29, 95% CI 1.96-2.67), 80% (aRR 1.80, 95% CI 1.54-2.11), 70% (aRR 1.70, 95% CI 1.47-1.97), 67% (aRR 1.67, 95% CI 1.45-1.92), and 62% (aRR 1.62, 95% CI 1.36-1.92) greater, respectively (all P<.001), in the 200-mg group than in the placebo group. Although lower in magnitude than the 200-mg group, the 150-mg group also had greater probabilities of meeting responder definitions than the placebo group for all subscales except sexual intercourse. The probabilities of meeting responder definitions for pain, control and powerlessness, self-image, social support, and emotional well-being were 75% (aRR 1.75, 95% CI 1.44-2.14), 50% (aRR 1.50, 95% CI 1.25-1.80), 22% (aRR 1.22, 95% CI 1.01-1.47), 30% (aRR 1.30, 95% CI 1.09-1.53), and 35% (aRR 1.35, 95% CI 1.16-1.57) greater, respectively (all P<.05), in the 150-mg group than in the placebo group.
CONCLUSION
Patients with moderate to severe pain associated with endometriosis and were treated with elagolix experienced clinically meaningful HRQOL improvements.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, NCT01620528 and NCT01931670.
FUNDING SOURCE
AbbVie Inc.
目的
评估依戈洛昔（elagolix）对子宫内膜异位症相关中度至重度疼痛患者健康相关生活质量（HRQOL）的临床意义改善的影响，采用 EHP-30 量表进行评估。
方法
汇总并分析了两项关于依戈洛昔治疗中度至重度疼痛的 III 期临床试验的数据，分为三组：安慰剂组、每日一次 150mg 依戈洛昔组和每日两次 200mg 依戈洛昔组。患者在基线、治疗 1 个月、3 个月和 6 个月时接受 EHP-30 问卷评估。采用先前建立的应答定义，确定具有临床意义的 EHP-30 改善的患者百分比。采用泊松回归分析，控制基线评分，确定与安慰剂相比，依戈洛昔在第 3 个月和第 6 个月达到 EHP-30 应答定义的概率。
结果
在第 6 个月时，在疼痛、控制和无力感、自我形象、社会支持、情绪健康和性行为等 EHP-30 亚量表达到应答定义的概率分别为 169%（调整后的相对风险[aRR]：2.69，95%CI 2.26-3.21）、129%（aRR 2.29，95%CI 1.96-2.67）、80%（aRR 1.80，95%CI 1.54-2.11）、70%（aRR 1.70，95%CI 1.47-1.97）、67%（aRR 1.67，95%CI 1.45-1.92）和 62%（aRR 1.62，95%CI 1.36-1.92），分别高于安慰剂组（均 P<.001）。虽然与 200mg 组相比，150mg 组的幅度较小，但与安慰剂组相比，所有亚量表均具有更高的可能性达到应答定义，除了性行为。在疼痛、控制和无力感、自我形象、社会支持和情绪健康等亚量表中，达到应答定义的概率分别为 75%（aRR 1.75，95%CI 1.44-2.14）、50%（aRR 1.50，95%CI 1.25-1.80）、22%（aRR 1.22，95%CI 1.01-1.47）、30%（aRR 1.30，95%CI 1.09-1.53）和 35%（aRR 1.35，95%CI 1.16-1.57），分别高于安慰剂组（均 P<.05）。
结论
患有与子宫内膜异位症相关的中度至重度疼痛的患者接受依戈洛昔治疗后，其健康相关生活质量得到了临床意义上的改善。
临床试验注册
ClinicalTrials.gov，NCT01620528 和 NCT01931670。
资金来源
艾伯维公司。
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