Quality of Life Improvements in Women with Uterine Fibroids: Results of Two Phase 3 Trials with Linzagolix

INTRODUCTION: Uterine fibroids (UFs) are a frequent cause of long-term impairment in health-related quality of life (HRQL), including self-image, interpersonal relationships, and sexual function. Linzagolix is an oral GnRH antagonist being developed for treatment of fibroid-related symptoms at doses that result in full or partial estradiol suppression, both with and without add-back therapy (ABT). METHODS: PRIMROSE 1 and 2 are randomized, double-blind, placebo-controlled Phase 3 trials investigating the efficacy and safety of linzagolix 100 mg and 200 mg once daily, +/- ABT in the treatment of UFs for 52 weeks. Health-related qualify of life was assessed using the 3-month recall version of the Uterine Fibroid Symptom Health-Related Quality of Life (UFS QOL) questionnaire (score range: 0-100, a higher score indicating a better HRQL). RESULTS: After 24 weeks, in the pooled population (n=1012), the HRQL total score estimated mean (95% CI) change from baseline was 21.8 (25.6; 18.1), 28.2 (31.8; 24.5), 32.1 (35.6; 28.5), 31.5 (35.2; 27.8) and 12.7 (16.2; 9.1) in the 100 mg, 100 mg+ABT, 200 mg, 200 mg+ABT and placebo groups, respectively. All differences from placebo were significant ( P <.001). The positive changes in HRQL were maintained at 52 weeks. At week 64, 12 weeks after the end of treatment, the improvements decreased in all treatment groups but did not return to baseline, ranging from a mean (SD) of 12.83 (SD 23.64) to 19.45 (SD 23.83) in the linzagolix arms. CONCLUSION: Linzagolix treatment had substantial beneficial effects on HRQL in women with UFs. The benefits persisted, with improvements not fully returning to baseline 12 weeks after treatment termination.