Relugolix combination therapy reduces uterine fibroid-associated bleeding for Black women

Key takeaways:

• Relugolix combination therapy resulted in reduced heavy menstrual bleeding for 82.9% of Black women with uterine fibroids.
• Relugolix combination therapy also resulted in reduced symptom severity and distress.

Once-daily relugolix combination therapy reduced heavy menstrual bleeding associated with uterine fibroids for most Black women, according to results of the LIBERTY long-term extension study.

“Despite many studies that demonstrate that Black/African American individuals with fibroids have more fibroids, more severe fibroid symptoms and more impairment of their quality of life from fibroids, relugolix combination therapy is an equally effective treatment option for these individuals and is well tolerated,” Elizabeth A. Stewart, MD, professor of obstetrics and gynecology in the division of reproductive endocrinology and infertility at Mayo Clinic and Mayo Clinic Alix School of Medicine, told Healio.

In the LIBERTY long-term extension study, once-daily combination therapy with relugolix 40 mg, estradiol 1 mg and norethindrone acetate 0.5 mg (Myfembree, Myovant Sciences) significantly improved uterine fibroid-associated heavy menstrual bleeding over 52 weeks.

Stewart and colleagues assessed the safety and efficacy of relugolix combination therapy for Black women with uterine fibroids. Researchers evaluated data from 241 Black premenopausal women aged 19 to 50 years with uterine fibroids and heavy menstrual bleeding who completed the 24-week randomized, placebo-controlled, double-blind LIBERTY 1 or LIBERTY 1 trials and were enrolled in the 28-week LIBERTY long-term extension study. In this study, all participants received once-daily relugolix combination therapy.

The primary outcome was the proportion of Black women who responded to relugolix combination therapy treatment, those who achieved a menstrual blood loss volume of less than 80 mL and those who had at least a 50% reduction in menstrual blood loss volume from baseline to the last 35 days of treatment. Secondary outcomes included amenorrhea rates and changes in symptom burden and quality of life.

Overall, 43.6% of women had anemia at baseline. Results, published in the American Journal of Obstetrics and Gynecology, showed that 82.9% of Black women who received continuous relugolix combination therapy had a reduction in heavy menstrual bleeding to less than 80 mL. In addition, researchers observed a substantial menstrual blood loss volume reduction from baseline to 52 weeks, with a mean change of 85% among those who received continuous relugolix combination therapy.

Overall, 64.3% of Black women achieved amenorrhea and 59.1% of those with anemia at baseline had substantial hemoglobin level improvement. Black women treated with relugolix combination therapy reported reduced symptom severity and distress caused by uterine fibroid-associated symptoms as measured by the Uterine Fibroid Symptom and Quality of Life symptom severity and Bleeding and Pelvic Discomfort scale scores. They also reported health-related quality of life improvements throughout the 52-week study period.

Black women who went from placebo to relugolix combination therapy and those in the delayed relugolix groups also had substantial bleeding reductions with a mean change of –88.1% and –90%, respectively, from baseline to 52 weeks, and most also achieved amenorrhea (53.9% and 67.1%, respectively) and a substantial number of women had hemoglobin level improvements (55.6% and 76%, respectively) by 52 weeks.

Adverse events were reported by 30% of women in the relugolix combination therapy group, 51% in the placebo to relugolix group and 63% in the delayed relugolix groups. The most reported adverse events in all three treatment groups were hot flush in 12.9% of women, headache in 5.7% of women and hypertension in 5.7% of women.

According to Stewart, these findings are a major step forward in addressing the health disparities of uterine fibroids.

“It is important to understand what the barriers are to women with fibroids getting medical treatment for their disease since we now understand there are significant long-term risks associated with hysterectomy,” Stewart said. “Are there insurance barriers? Are there concerns about how the medications work? Are providers not presenting it as an option?”

For more information:

Elizabeth A. Stewart, MD, can be reached at stewart.elizabeth@mayo.edu.