Relugolix combination therapy effective against symptomatic uterine fibroids

Quality of life is significantly improved in women with symptomatic uterine fibroids following 24 weeks of relugolix combination therapy, according to a recent study published in the American Journal of Obstetrics & Gynecology.

Patients with symptomatic uterine fibroids often live with distress from symptoms, with daily activities and health-related quality of life negatively impacted. Symptoms include heavy menstrual bleeding, pain, and anemia.

To assess the safety and efficacy of relugolix combination therapy in women with symptomatic uterine fibroids, investigators conducted 2 replica, multinational, double-blind, 24-week, randomized, placebo-controlled, phase 3 studies.

Participants in the studies, LIBERTY 1 and LIBERTY 2, included premenopausal women with uterine fibroid–associated heavy menstrual bleeding, defined as 80 mL or more per cycle for 2 cycles or 160 mL or more for a single cycle. Oral relugolix combination therapy included 40 mg relugolix, 1 mg estradiol, and 0.5 mg norethindrone acetate once per day.

Secondary endpoints in the study included symptom burden and health-related quality of life, assessed using the validated Uterine Fibroid Symptom and Quality of Life questionnaire. The questionnaire was completed by participants at baseline, week 12 of treatment, and week 24 of treatment.

A Symptom Severity scale and a Health-Related Quality of Life scale were included in the Uterine Fibroid Symptom and Quality of Life questionnaire. There were 6 subscales in the Health-Related Quality of Life scale: activities, concern,control, energy or mood, self-consciousness, and sexual function.

The Bleeding and Pelvic Discomfort subscale was used to evaluate symptom burden. To compare treatments, investigators used a stratified Cochran-Mantel-Haenszel test. 

There were 509 women between both trials, randomized to a relugolix combination therapy or placebo group. Compared to placebo, significant reductions in symptom severity and the Bleeding and Pelvic Discomfort subscale were measured in the relugolix combination therapy group from baseline to week 24. 

Health-Related Quality of Life scoresat week 24 also saw significant improvements in the relugolix combination therapy group. Social and physical activities improved in this group, showing clinically significant safety and efficacy results from oral relugolix combination therapy.

Reference

Stewart EA, Lukes AS, Venturella R, et al. Quality of life with relugolix combination therapy for uterine fibroids: LIBERTY randomized trials. American Journal of Obsetrics and Gynecology. 2022:228(3):320.E1-320.E1. doi:10.1016/j.ajog.2022.11.1278