Real-World Effectiveness of Elagolix in Reducing Endometriosis Pain: 6-Month Results from Elagolix Longitudinal Outcomes (LOTUS) Study

Abstract

<h3>Study Objective</h3> To evaluate the real-world effectiveness of Elagolix, a GnRH receptor antagonist approved for endometriosis-associated pain management at 150mg once daily (QD) or 200mg twice daily (BID) in the United States (US), Canada, and Israel. <h3>Design</h3> Interim 6-month (M) analysis of a 24M prospective, observational, electronic survey study that collected data through a patient support program in the US. <h3>Setting</h3> US. <h3>Patients or Participants</h3> Pre-menopausal women, aged 18-49yrs with self-reported history of endometriosis. <h3>Interventions</h3> Elagolix 150mg QD or 200mg BID prescribed under physician's guidance. <h3>Measurements and Main Results</h3> Analysis focused on women who reported taking Elagolix every month for 6M (n=44), with 89 women starting Elagolix either at baseline (within 7 days prior to baseline assessment) or by M1 assessment. Monthly pain assessments evaluated dysmenorrhea, non-menstrual pelvic pain (NMPP) and dyspareunia, using the numeric rating scale (NRS) and Patient Global Impression of Change (PGIC). Paired t-tests were used as appropriate. Pain score reduction was 64.2% (8.0±1.5 vs. 2.9±3.1), 47.9% (6.2±1.8 vs. 3.1±2.6), and 46.6% (7.4±2.1 vs. 4.0±3.4), (mean±SD, baseline vs. 6M, all p<0.0001) for women with baseline moderate to severe (M/S) dysmenorrhea (NRS≥4) (n=44), NMPP (n=37) and dyspareunia (n=27), respectively. PGIC, no less than "Much Improved", was reported by 70.5%, 67.5% and 59.2% of women with baseline M/S dysmenorrhea, NMPP, and dyspareunia, respectively. Treatment efficacy and tolerability satisfaction was measured using the Endometriosis Treatment Satisfaction Questionnaire (ETSQ). Satisfaction, no less than "Somewhat Satisfied", at 6M was reported by 78.6%, 77.8% and 73.1% of women for overall treatment effect, and by 64.3%, 61.1% and 42.3% of women for tolerability (lack of bothersome side effects) who had baseline M/S dysmenorrhea, NMPP, or dyspareunia and completed the ETSQ (n=42, 36, and 26, respectively). <h3>Conclusion</h3> This real-world study demonstrated that Elagolix had a beneficial impact by improving endometriosis-associated pain outcomes at 6M, consistent with previously reported 3M real-world data and Elagolix clinical trial results.