Impact of Elagolix on Quality of Life Among Endometriosis Patients: A Pooled Analysis of 2 Phase III Clinical Trials [13J]

INTRODUCTION: Endometriosis-associated symptoms are associated with reduction in health-related quality of life (HRQL). This analysis evaluated the impact of Elagolix, an oral gonadotrophin releasing-hormone antagonist, on the HRQL of women with moderate to severe pain associated with endometriosis. METHODS: Data were pooled from two phase III randomized, placebo-controlled trials of elagolix (150mg once daily “Elagolix QD” or 200 mg twice daily “Elagolix BID”) in premenopausal women with moderate-to-severe endometriosis-associated pain. The Endometriosis Health profile (EHP-30), HRQL questionnaire was administered at baseline and months 1, 3 and 6 of treatment. Changes in the 5 core scales (pain, control and powerlessness, social support, emotional well-being, and self-image) and sexual intercourse modular scale scores of EHP-30 from baseline to month 3 and 6 were compared between each Elagolix dose and placebo using ANCOVA models that controlled for baseline scores. RESULTS: Final sample included 1686 patients. Both doses of elagolix exhibited a significantly greater reduction in all 6 scale scores than placebo (lower scores indicate better HRQL) at Month 3 in a dose-dependent fashion (pain: -18.49, -26.79, -35.59; control and powerlessness:-24.86, -32.81, -42.28; emotional well-being:-13.67, -17.75, -21.15; social support: -12.54, -18.0, -24.14; self-image:-11.16, -16.54, -21.08 and sexual intercourse: -13.54, -17.22 and -25.85 for placebo, Elagolix QD and Elagolix BID respectively; P <0.05 for all Elagolix group comparisons to placebo). Larger reductions were also observed for Elagolix groups at month 6 which were statistically significant for all scales except for self-image and sexual intercourse. CONCLUSION: Elagolix significantly improves HRQL among women with moderate to severe pain associated with endometriosis.