Elagolix plus add-back improves bleeding, non-bleeding uterine fibroid symptoms
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Key takeaways:
- Elagolix plus add-back significantly improved menstrual bleeding, abdominal and pelvic pain, pressure, cramping, back pain and abdominal bloating.
- Improvements were observed even among the subpopulations.
BALTIMORE — Elagolix plus add-back of estradiol and norethindrone improved bleeding and non-bleeding symptoms linked to uterine fibroids among premenopausal women, according to researchers at the ACOG Annual Clinical & Scientific Meeting.
“Elagolix 300 milligrams twice daily plus hormonal add-back of 1 mg estradiol and 0.5 mg norethindrone acetate taken daily is an FDA-approved product and was demonstrated to be superior to placebo in reducing menstrual blood loss in two phase 3 randomized clinical trials,” James A. Simon, MD, reproductive endocrinologist and clinical professor at George Washington University in Washington D.C., said during a presentation. “That treatment elagolix and add-back is approved for treating heavy menstrual bleeding in uterine fibroid patients who are premenopausal. In this investigation, the impact of Elagolix with add-back on bleeding and non-bleeding symptoms was assessed using a validated patient global impression of change.”
In this post-hoc analysis of the randomized, double-blind, placebo-controlled, 6-month phase 3 Elaris UF-1 and UF-2 trials, researchers evaluated elagolix 300 mg twice daily plus hormonal add-back of estradiol 1 mg and norethindrone acetate 0.5 mg, elagolix 300 mg alone twice daily and placebo for women with heavy menstrual bleeding associated with uterine fibroids. Non-bleeding symptoms included abdominal and pelvic pain, pressure, cramping, back pain and abdominal bloating.
Researchers also evaluated treatment in subpopulations of premenopausal women, including those with primary FIBO fibroid classification, menstrual blood loss volume of less than or greater than 187 mL per menstrual cycle, and uterine volume greater than 356.5 cm3; age groups of less than 40 years, 40 to 45 years or older than 45 years; and Black and white race.
In the overall population, elagolix plus add-back was associated with significant improvement in menstrual bleeding, abdominal and pelvic pain, pressure, cramping, back pain and abdominal bloating compared with placebo (P< .001). Improvement continued from month 1 through month 6 compared with placebo even among subpopulations (P < .001).
“Premenopausal women with heavy menstrual bleeding associated with uterine fibroids experienced both rapid improvements in bleeding and non-bleeding symptoms in this post hoc analysis and did so as early as month 1 with sustained and statistically significant improvements up to 6 months by the end of this analysis,” Simon said.