Elagolix With Add-Back Rapidly Improves Nonbleeding Symptoms in Individuals With Fibroid-Associated Heavy Menstrual Bleeding [ID: 1368052

Abstract

INTRODUCTION: Elagolix+estradiol/norethindrone acetate add-back therapy (ELA+AB) significantly improves heavy menstrual bleeding (HMB) in patients with uterine fibroids (UFs). Data on the effect of ELA+AB on nonbleeding symptoms in HMB-UF patients are limited. METHODS: Elaris UF-1 and UF-2 (NCT02654054 and NCT02691494) were duplicate, IRB-approved, randomized, double-blind, placebo-controlled, 6-month phase 3 studies. This post hoc analysis evaluated the Patients Global Impression of Change (PGIC) for menstrual bleeding (MB) and nonbleeding symptoms. Patients rated symptom change on a 7-point scale from “very much improved” (1) to “very much worse” (7). RESULTS: Among responders (6-month MBL <80 mL and ≥50% MBL reduction from baseline), mean (SD) PGIC-MB and PGIC-abdominal bloating were better for ELA+AB versus placebo as early as 1 month (2.1 [1.3], n=199 versus 2.8 [1.5], n=22; and 3.1 [1.2], n=201 versus 3.7 [1.0], n=21, respectively) through 6 months (1.3 [0.9], n=221 versus 2.9 [1.3], n=13; and 2.3 [1.3], n=221 versus 3.7 [0.9], n=13, respectively). Patients treated with ELA+AB had improvement in symptoms at 3 months compared to placebo and at 6 months reached scores in the domains abdominal/pelvic pain (1.8 [1.1] versus 3.2 [1.0]), abdominal/pelvic pressure (1.9 [1.2] versus 3.4 [0.9]), abdominal/pelvic cramping (1.8 [1.0] versus 2.9 [1.2]), and back pain (2.3 [1.3] versus 3.2 [1.0]). Similar results were observed for the total patient population. CONCLUSION: ELA+AB provides rapid bleeding and nonbleeding symptom improvement for patients with UF-associated HMB. Improvement for ELA+AB–treated patients was observed as early as 1 month, with nonbleeding PGIC scores consistently approaching “much and very much improved” in all domains by 6 months.