Elagolix Improves Quality of Life Among Uterine Fibroids Patients With Heavy Menstrual Bleeding in Phase III Trials [31M

Abstract

INTRODUCTION: Uterine Fibroids (UF) are associated with impaired health-related quality of life (HRQL). The impact of elagolix, an oral gonadotrophin-releasing hormone antagonist, on the HRQL of women with heavy menstrual bleeding (HMB) associated with UF was evaluated. METHODS: Premenopausal women aged 18 to 51 with HMB (>80 mL/cycle menstrual blood loss) associated with UF were enrolled in two replicate 6-months phase III placebo-controlled randomized clinical trials (Elaris UF-1, Elaris UF-2). Women were randomized in 1:1:2 fashion to placebo, elagolix 300mg twice daily (BID) and elagolix 300mg BID in combination with 1mg estradiol (E2)/0.5 mg norethindrone acetate (NETA) once-daily add-back therapy (BID+E2/NETA). HRQL was measured using Uterine Fibroids Symptoms Severity and Health-Related Quality of life questionnaire (UFS-QOL) at baseline, months 3 and 6 of treatment. Changes from baseline in Symptom Severity (lower scores indicate lesser symptoms) and HRQL total scores (higher scores indicate better HRQL) were compared between elagolix arms and placebo using ANCOVA models controlling for baseline scores. RESULTS: In Elaris UF-1, 102, 104, 207 patients were randomized to placebo, elagolix BID and elagolix BID+E2/NETA, respectively. At month 6, mean reduction in Symptom Severity scores was significantly larger for elagolix BID and elagolix BID+E2/NETA compared to placebo (-48.3, -33.2, -10.3; respectively p<0.001). Mean increase in HRQL total score was significantly higher for elagolix BID and elagolix BID+E2/NETA compared to placebo (47.5, 38.0, 10.9; respectively p<0.001). Similar results were observed in Elaris UF-2. CONCLUSION: Elagolix + E2/NETA add-back reduces UF symptoms severity and improves HRQL among women with HMB associated with UF.