Relugolix efficacious, preserves bone for perimenopausal women with uterine fibroids
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Potentially perimenopausal women who took relugolix combination therapy for uterine fibroids and heavy menstrual bleeding experienced significant reductions in menstrual bleeding and fibroid-related pain vs. those who took placebo.
Another study of potentially perimenopausal women revealed that there were no significant differences in bone mineral density (BMD) between women who were and were not exposed to relugolix combination therapy (Myfembree; Myovant Sciences and Pfizer).
Both studies’ findings were presented at the NAMS Annual Meeting in Atlanta.
“Uterine fibroids are highly prevalent in women who are approaching menopausal age,” Rachel McLean, DO, director of clinical development at Myovant Sciences, told Healio. “Consistent with the ACOG clinical positions, with different medical and surgical options available, a patient-centered discussion should take into account a patient’s future reproductive desires, personal values and logistics when making a shared treatment plan. Not all patients are eligible for surgery or want to undergo surgery, and the medical treatment options have been limited.”
Efficacy in potentially perimenopausal women
McLean and colleagues pooled data from the LIBERTY 1 and 2 trials, which found relugolix combination therapy to be efficacious in the treatment of uterine fibroids and heavy menses in premenopausal women aged 18 to 50 years. For the LIBERTY trials, participants were randomly assigned 1:1:1 to relugolix combination therapy — comprising 40 mg relugolix, 1 mg estradiol and 0.5 mg norethindrone — or placebo for 24 weeks, or to delayed relugolix combination therapy. Delayed relugolix combination therapy entailed 12 weeks of monotherapy with 40 mg relugolix followed by 12 weeks relugolix combination therapy.
At baseline, all women had uterine fibroids and lost at least 80 mL of menstrual blood per cycle. For this analysis, McLean and colleagues included 282 women aged 45 years or older — deemed potentially perimenopausal — who had been randomly assigned to relugolix combination therapy (n = 95) or placebo (n = 94).
Results among potentially perimenopausal women were in line with those in the general study population.
Compared with potentially perimenopausal women taking placebo, a significantly greater proportion of those taking relugolix combination therapy achieved a blood loss volume less than 80 mL and at least a 50% reduction of blood loss from baseline over the last 35 days of treatment (difference, 62.95%; 95% CI, 51.43%-73.9%). Additionally, a significantly greater proportion of women taking relugolix combination therapy vs. placebo achieved amenorrhea (62.11% vs. 8.51%).
Women taking relugolix combination therapy had a greater mean reduction in menstrual blood loss from baseline to week 24 compared with those taking placebo (–89 mL vs. –15.5 mL). They also experienced significantly greater improvements in hemoglobin levels, uterine fibroid-associated pain and quality of life and greater reductions in uterine fibroid volume.
“Relugolix combination therapy offers to patients a uterus-preserving and noninvasive treatment [that] is effective, well tolerated and may provide a possibility to bridge to menopause, which will physiologically lead to fibroid shrinkage and minimization of symptoms,” McLean said.
Impact on bone mineral density
In the second study, McLean and colleagues assessed BMD among potentially perimenopausal women who were enrolled in the LIBERTY 1 and 2 trials and the subsequent LIBERTY long-term extension study through 52 weeks. They compared changes in BMD in this population with changes in an age-matched independent cohort of women with uterine fibroids who participated in a natural history study and who were not exposed to relugolix combination therapy.
The researchers included 95 women from the natural history study and 63 from the relugolix combination therapy group in the LIBERTY extension study for analyses.
Comparisons between women who were and were not exposed to relugolix combination therapy revealed that differences in mean percent changes in lumbar spine and total hip BMD were not significant at 52 weeks, indicating that women who were exposed to relugolix combination therapy maintained BMD.
“It is recognized that BMD decline occurs with aging in the general population,” McLean said. “Therefore, the trends observed in our analyses are consistent with what is known and showed that relugolix [combination therapy] in perimenopausal women did not have a deleterious effect beyond what might be seen in an age-matched group of women.”
McLean said research evaluating the contraceptive efficacy of relugolix combination therapy is ongoing.
References:
- Archer DF, et al. Abstract P-3. Presented at: North American Menopause Society Annual Meeting; Oct. 12-15, 2022; Atlanta.
- Al-Hendy A, et al. Abstract P-47. Presented at: North American Menopause Society Annual Meeting; Oct. 12-15, 2022; Atlanta.