Baseline Burden of Endometriosis-Associated Pain among Women in Two Phase 3 Elagolix Studies [10Q

Abstract

INTRODUCTION: Few data exist on the extent of symptoms in women with endometriosis. This analysis examined baseline pain burden among women with moderate to severe endometriosis pain in two phase 3 studies of elagolix (an oral, non-peptide GnRH antagonist) for the management of endometriosis-associated pain. METHODS: Elaris EM-I and Elaris EM-II were two double-blind, randomized, 6-month, placebo-controlled phase 3 studies evaluating two elagolix doses (150 mg once daily and 200 mg twice daily) in women with endometriosis-associated pain. This analysis included randomized women pooled across studies and treatment groups. Dysmenorrhea (DYS) and non-menstrual pelvic pain (NMPP) scores were recorded in a daily electronic-diary and characterized as ‘none’, ‘mild’, ‘moderate’, and ‘severe’, with definitions that incorporated daily functioning. Days with DYS or NMPP and severity of pain are summarized. Baseline was defined as the average of the last 35 days during the screening period. RESULTS: At baseline, the mean [SD] number of days women reported DYS and NMPP was 8.0 [3.0] days (97.6% of menstruating days) and 20.5 days [5.4] (90.3% of non-menstruating days), respectively (N=1686 for the combined studies). Enrolled women reported moderate/severe DYS and NMPP most days during the baseline phase (mean [SD]: DYS, 80.5% [21.2] of menstruating days; NMPP, 57% [29.0] of non-menstruating days). CONCLUSION: On average in these two phase 3 studies, women with endometriosis-associated pain experienced DYS or NMPP > 90% of days during the baseline phase and moderate/severe pain was reported for a majority of the days when pain was reported.