Elagolix Plus Add-Back Consistently Improves Uterine Fibroids-Associated Bleeding and Nonbleeding Symptoms Across Subpopulations [ID: 1368059]

Abstract

INTRODUCTION: Patients with heavy menstrual bleeding (HMB) associated with uterine fibroids (UFs) have significantly improved menstrual blood loss (MBL) when taking elagolix+estradiol/norethindrone acetate add-back therapy (ELA+AB) versus placebo. However, data on the effect of ELA+AB on nonbleeding symptoms are limited. METHODS: This post hoc analysis from the duplicate, IRB-approved, randomized, double-blind, placebo-controlled, 6-month, phase 3 Elaris UF-1 and UF-2 studies (NCT02654054 and NCT02691494) evaluated the Patients Global Impression of Change (PGIC). Patients rated symptom change for menstrual bleeding (MB) and nonbleeding symptoms on a 7-point scale from “very much improved” (1) to “very much worse” (7). RESULTS: By 6 months, scores for the PGIC-MB and the domains of “abdominal or pelvic pain,” “abdominal or pelvic pressure,” “abdominal or pelvic cramping,” “back pain,” and “abdominal bloating” were significantly better (P<.001 for all; no adjustment for multiple comparisons were made) in the ELA+AB versus placebo groups, regardless of patient age (<40 years, 40 to <45 years, ≥45 years), baseline MBL (less than median [187.0 mL], greater than or equal to median), International Federation of Gynecology and Obstetrics (FIGO) classification (0–3, 4, 5–8), or baseline uterine volume (less than median [356.5 cm3], greater than or equal to median). Patients receiving ELA+AB reported PGIC domain scores that consistently exceeded “minimally improved” (≤3) and often reached or exceeded “much improved” (≤2) by 6 months. CONCLUSION: ELA+AB provides better bleeding and nonbleeding symptom improvement versus placebo for patients with HMB associated with UFs, regardless of subpopulation investigated. In all populations, PGIC-MB and domain scores consistently reached or exceeded “much improved” by 6 months with ELA+AB.