Trial data of elagolix sodium in the treatment of endometriosis?

A trial of elagolix sodium in the treatment of endometriosis

Endometriosis is a chronic, estrogen-dependent disease that causes dysmenorrhea and pelvic pain. Elagolix is ​​an oral, nonpeptide gonadotropin-releasing hormone (GnRH) antagonist that has been shown to produce partial or nearly complete estrogen suppression in previous studies.

Two similar, double-blind, randomized, 6-month phase 3 trials (Elaris Endometriosis I and II [EM-I, NCT01620528 and EM-II, NCT01931670]) to evaluate two forms of elagolix -- 150 mg once daily (low-dose arm) and 200 mg twice daily (high dose group) - Effects compared to placebo in women with surgically diagnosed endometriosis and moderate or severe endometriosis-related pain.

The two primary efficacy endpoints were: the proportion of women with a clinical response to dysmenorrhea and the proportion of women with a clinical response to nonmenstrual pelvic pain after 3 months.

Test results

A total of 872 women were randomized to Elaris EM-I and 817 to Elaris EM-II; 653 (74.9%) and 632 (77.4%) women, respectively, completed the intervention. After three months, significantly more women taking all doses of elagolix met clinical response criteria for both primary endpoints compared with women taking placebo.

In EM-I, the proportions of clinical responses to dysmenorrhea in the low-dose and high-dose elagolix groups were 46.4% and 75.8%, respectively, compared with 19.6% in the placebo group; in EM-II, the corresponding proportions were 43.4% and 72.4%, respectively, compared with 22.7% in the placebo group (P<0.001 for all comparisons).

In EM-I, the proportion of women with a clinical response to nonmenstrual pelvic pain was 50.4% in the low-dose elagolix group, 54.5% in the high-dose elagolix group, and 36.5% in the placebo group ( P<0.001 in all comparisons); in EM-II, the corresponding proportions were 49.8% and 57.8%, respectively, compared with 36.5% in the placebo group (P=0.003 and P<0.001). Benefits in dysmenorrhea and nonmenstrual pelvic pain were sustained after 6 months.

Women taking elagolix had a higher proportion of hot flashes (mostly mild or moderate), higher serum lipid levels, and a greater decrease in bone density from baseline than women taking placebo; there were no adverse endometrial findings.

Test conclusion

Both high-dose and low-dose elagolix sodium were effective in improving dysmenorrhea and non-menstrual pelvic pain in women with endometriosis-related pain over a 6-month period. Both doses have the adverse effects of hypoestrogenism.

Effects of elagolix sodium

Elagolix, also known as Orilissa or elagolix, is indicated for the treatment of moderate to severe pain associated with endometriosis. The administration of elagolix sodium causes a dose-dependent suppression of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), resulting in reduced blood concentrations of the ovarian sex hormones, estradiol and progesterone. Elagolix sodium belongs to a class of nonsteroidal anti-inflammatory drugs (NSAIDs), which are mainly used to relieve pain and reduce inflammation. It is recommended that patients take medication as directed by their doctor and receive symptomatic treatment.

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References

Taylor HS, Giudice LC, Lessey BA, Abrao MS, Kotarski J, Archer DF, Diamond MP, Surrey E, Johnson NP, Watts NB, Gallagher JC, Simon JA, Carr BR, Dmowski WP, Leyland N, Rowan JP, Duan WR, Ng J, Schwefel B, Thomas JW, Jain RI, Chwalisz K. Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist. N Engl J Med. 2017 Jul 6;377(1):28-40. doi: 10.1056/NEJMoa1700089. Epub 2017 May 19. PMID: 28525302.