Health-Related Quality of Life Improvements in Patients With Endometriosis Treated With Elagolix

Hugh S Taylor, Ahmed M Soliman, Beverly Johns, Robin M Pokrzywinski, Michael Snabes, Karin S Coyne, Hugh S Taylor, Ahmed M Soliman, Beverly Johns, Robin M Pokrzywinski, Michael Snabes, Karin S Coyne

Abstract

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.

Figures

Fig. 1.. Proportion of patients meeting responder…
Fig. 1.. Proportion of patients meeting responder definitions for EHP-30 (Endometriosis Health Profile-30) subscales at months 1, 3, and 6 of treatment. The percentages of patients who met responder definitions for the following EHP-30 subscales: pain (A), control and powerlessness (B), emotional well-being (C), social support (D), self-image (E), and sexual intercourse (F). n values indicate the total number of patients with EHP-30 scores for the indicated subscale at each timepoint per treatment arm. Responder definitions were based on the following reductions in subscale scores from baseline: pain, 30-point reduction; control and powerlessness, 35-point reduction; emotional well-being, social support, self-image, and sexual intercourse, 20-point reductions.
Taylor. Elagolix and Meaningful EHP-30 Improvements. Obstet Gynecol 2020.

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Source: PubMed

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