LAUSR

Study Objective To evaluate the effect of Relugolix combination therapy (Rel-CT) on hemoglobin in women with uterine fibroids (UF) and anemia. Design LIBERTY 1 and 2 are phase 3, multinational, randomized, double-blind, placebo-controlled studies. Setting 80 (L1) and 99 (L2) clinical research centers globally. Patients or Participants Premenopausal women (age 18–50 years) with ultrasound-confirmed UF and heavy menstrual bleeding (HMB; menstrual blood loss [MBL] volume of ≥80 mL/cycle confirmed by alkaline hematin method). Interventions Women were randomized 1:1:1 to once-daily Rel-CT (relugolix 40 mg, estradiol 1 mg, norethindrone acetate 0.5 mg; 24 weeks), Delayed Rel-CT (relugolix 40 mg alone [12 weeks] followed by Rel-CT [12 weeks]), or placebo (24 weeks). Measurements and Main Results Analysis of a subset of women with anemia (hemoglobin ≤10.5 g/dL) at baseline and a documented hemoglobin value at Week 24 are reported for Rel-CT and placebo groups using pooled data from LIBERTY 1 and 2. At baseline, 33% (n=83, Rel-CT group) and 32% (n=83, placebo group) of women were anemic. Anemic women, compared with the overall study population, were more likely to be Black/African American (65.2% vs 51.2%) and from North America (85.9% vs 75.5%); at baseline, they had a larger uterine volume (mean: 488 vs 408 cm3) and MBL volume (mean: 285.5 vs 228.8 mL), and a greater proportion had an MBL volume ≥225 mL (52.0% vs 34.8%). A significantly greater proportion of women experienced a clinically meaningful increase in hemoglobin levels of >2 g/dL in the Rel-CT (55.7%) vs placebo group (11.7%; p Conclusion In women with UF, HMB, and anemia at baseline, Rel-CT significantly improved hemoglobin concentrations, demonstrating how reductions in MBL volume translate into clinically meaningful improvement in anemia.