Once-daily relugolix combination therapy improves uterine fibroid-associated heavy menstrual bleeding
Uterine fibroids, noncancerous pelvic tumors in premenopausal women, depend on estrogen and progesterone. Age, race, genetic predisposition, and lifestyle are risk factors associated with this condition. Black women have an 89% lifetime UF prevalence, 3-4 times higher than that of other races.
According to a recent study published in the American Journal of Obstetrics and Gynecology, Relugolix combination therapy reduces heavy menstrual bleeding for 82.9% of Black women with uterine fibroids, along with reducing the severity of symptoms and distress.
In the LIBERTY Long-Term Extension study, the once-daily relugolix combination therapy improved heavy menstrual bleeding associated with uterine fibroids in the 52-week treatment period. The study specifically aimed to evaluate the efficacy and safety of the therapy in Black or African American women with uterine fibroids, who often experience a greater disease burden compared to other racial groups and are traditionally underrepresented in clinical trials.
Black/African American premenopausal women with UF and heavy menstrual bleeding who completed 24-week LIBERTY 1 or LIBERTY 2 trials were eligible for the 28-week LIBERTY Long-Term Extension study. The primary goal was achieving a menstrual blood loss volume of less than 80 mL and a reduction of at least 50% menstrual blood loss volume from the baseline to the last 35 days of treatment. Secondary outcomes included rates of amenorrhea and changes in symptom burden and quality of life.
Key findings from the study are:
- 241/477 women enrolled in the study self-identified as Black or African American.
- Among women receiving continuous relugolix combination therapy for 52 weeks, 58/70 women met the treatment responder criteria.
- A reduction in menstrual blood loss volume from baseline to week 52 was demonstrated.
- 64.3% of women achieved amenorrhea; 59.1% of women with anaemia at the pivotal study baseline achieved a substantial improvement (>2 g/dL) in haemoglobin levels, decreased symptom severity and distress, and improved life quality.
- The most frequently reported adverse events were hot flush (12.9%), headache (5.7%), and hypertension (5.7%).
- Bone mineral density was preserved through 52 weeks.
Once-daily relugolix combination therapy improved uterine fibroid-associated heavy menstrual bleeding.
Dr Elizabeth A. Stewart, a professor of obstetrics and gynaecology at Mayo Clinic, said that Black/African American women with fibroids often experience more severe symptoms and a lower quality of life, but relugolix combination therapy is a safe and effective treatment option for them.
Reference:
Stewart, E et al. Relugolix combination therapy in Black/African American women with symptomatic uterine fibroids: LIBERTY Long-Term Extension study. American Journal of Obstetrics and Gynecology. https://doi.org/10.1016/j.ajog.2023.10.030
