American College of Obstetricians and Gynecologists (ACOG):

Endometriosis is a chronic, estrogen-dependent condition that causes dysmenorrhea and pelvic pain that affects 6–10% of women of reproductive age.

Elagolix is an oral, nonpeptide Gonadotropin-releasing hormone (GnRH) antagonist suppressed estradiol production in a dose-dependent manner while demonstrating efficacy and an acceptable safety profile in women with endometriosis.

TAKE HOME MESSAGE:

Elaris Endometriosis (EM)-III and -IV were extension studies that evaluated the efficacy and safety of elagolix, an oral, nonpeptide gonadotropin-releasing hormone antagonist, over 12 months in women with endometriosis-associated pain with two elagolix doses (150 mg once daily and 200 mg twice daily).

Pain responder rates:

In these phase 3 extension studies, responder rates among women with moderate to severe endometriosis-associated pain treated with elagolix 200 mg twice daily were approximately 75–78% for dysmenorrhea, 67–69% for non-menstrual pelvic pain, and 58–60% for dyspareunia after 12 months of treatment.

Although pain responder rates among women treated with elagolix 150 mg once daily were lower than the higher 200-mg twice-daily dose after 12 months of treatment, more than 50% of the women demonstrated a clinically meaningful response in dysmenorrhea (approximately 52%) and nonmenstrual pelvic pain (approximately 67%) and approximately 45% had a clinically meaningful response in dyspareunia.

Decrease use of rescue analgesic agents (eg. Opioid):

In parallel with reduction of pain symptoms, a majority of women demonstrated improved quality of life and a decrease from baseline in the use of rescue analgesic agents after 12 months of elagolix treatment (opioid use: greater than 30% mean reduction at 150 mg once daily, greater than 65% mean reduction at 200 mg twice daily).

Adverse events:

Hot flush was the most common adverse event over 12M of treatment. There were no adverse endometrial changes after 12 months of elagolix treatment at both doses. Decreases from baseline (decrease of 3% or less) in bone mineral density, results were similar for total hip and femoral neck and increases from baseline in lipids were observed after 12 months of treatment.

Elagolix treatment at both doses was associated with decreases in BMD, suggesting that a DXA evaluation at 12 months would be of clinical value to identify those women who might be at risk for falling outside the normal Z-score range with continued therapy.

Conclusion:

Long-term elagolix treatment provided sustained reductions in dysmenorrhea, nonmenstrual pelvic pain, and dyspareunia. The safety was consistent with reduced estrogen levels and no new safety concerns were associated with long-term elagolix use.

Overall the extension studies show sustained efficacy and suggest that administration of elagolix may be safely and effectively prolonged in an appropriately selected population of patients with symptomatic endometriosis.

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