Long-term Relugolix Combination Therapy for Symptomatic Uterine Leiomyomas

Area of Science:

• Gynecology
• Reproductive Endocrinology
• Pharmacology

Background:

• Heavy menstrual bleeding (HMB) and pain are common symptoms associated with uterine leiomyomas.
• Uterine leiomyomas can significantly impact quality of life and lead to anemia.
• Current treatments for HMB associated with uterine leiomyomas have varying efficacy and safety profiles.

Purpose of the Study:

• To evaluate the long-term efficacy and safety of once-daily relugolix combination therapy for up to 52 weeks in women with HMB and uterine leiomyomas.
• To assess sustained reduction in menstrual blood loss volume and symptom burden.
• To monitor bone mineral density (BMD) and overall safety in patients receiving extended treatment.

Main Methods:

• A 28-week extension study enrolled women who completed the LIBERTY 1 or LIBERTY 2 trials.
• Participants received daily relugolix combination therapy (40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetate).
• Primary efficacy endpoint: proportion of women achieving or maintaining a menstrual blood loss volume < 80 mL and ≥50% reduction from baseline.

Main Results:

• 87.7% of patients treated for 52 weeks were responders, with a mean blood loss reduction of 89.9% and 70.6% achieving amenorrhea.
• Significant improvements were observed in hemoglobin concentration for anemic patients (59.0% improved >2 g/dL).
• Symptom burden (BPD scale) reduced by 51.3 points, with sustained reductions in uterine and leiomyoma volume and preserved BMD.

Conclusions:

• Relugolix combination therapy provides sustained efficacy in managing HMB and associated symptoms in women with uterine leiomyomas up to 52 weeks.
• The treatment demonstrated a favorable safety profile, maintaining BMD without new concerns.
• Long-term treatment offers a viable option for women seeking relief from uterine leiomyoma-related bleeding and pain.