OBJECTIVES: Describe the baseline characteristics of women enrolled in a real-world prospective study (LOTUS) that evaluates the clinical impact and humanistic benefits of elagolix for the management of moderate to severe endometriosis-associated pain

METHODS: This is a prospective, direct-to-patient survey study with 12-month enrolment and 24-month follow-up ongoing in the United States. Pre-menopausal women aged 18-49 years, with self-reported endometriosis diagnosis and no history of hysterectomy or bilateral oophorectomy, who are not taking part in a clinical trial were enrolled. All patients registered with the elagolix patient support program received an email invitation to participate. At baseline enrolment, patients have not had any exposure to elagolix exposure and were asked to self-assess endometriosis-related pelvic pains using a numeric rating scale (1-10 scale), health-related quality of life (HRQoL) using Endometriosis Health Profile Questionnaire-30 (EHP-30), and fatigue using PROMIS Fatigue SF-6a.

RESULTS: Within the first 6 months of the study, 84 patients were enrolled. Mean (SD) age was 31.4 (7.1) years, and 76.2% were Caucasian. The most reported comorbidities included depression (34.9%), anemia (21.7%), migraine (21.7%), premenstrual syndrome (16.9%), obesity (14.5%), and irritable bowel disease (10.8%). Mean (SD) pain scores for dysmenorrhea, non-menstrual pelvic pain, and dyspareunia were 7.6 (1.8), 5.6 (2.3), and 5.2 (3.3), respectively. Endometriosis-related pain was reported as moderate among 53.8% of enrolled patients and as severe among 40.0%. A HRQoL was significantly impaired as measured by several domain of EHP-30 with mean (SD) scores of [57.8 (17.3), 73.2 (22.1) and 63.3 (29.9] for pain, control and powerlessness and sexual intercourse domain, respectively. of 63.3 (29.9). Mean (SD) fatigue T-score [63.7 (7)] was more than one 1 standard deviation worse than population average (Mean=50).

CONCLUSIONS: Assessment of baseline characteristics indicate substantial burden among endometriosis patients enrolled in the LOTUS study.