Reductions in endometriosis-associated pain in women treated with Elagolix are consistent in various demographics or medical histories

Endometriosis can be asymptomatic; women often experience a range of symptoms with dysmenorrhea, non-menstrual pelvic pain (NMPP), and dyspareunia being more common; other symptoms include constipation, dyschezia, dysuria, and infertility.

For many women, the burden of symptoms associated with endometriosis also reduces quality of life and profoundly affects psychological well-being, resulting in depression and anxiety

Elagolix is an oral, gonadotropin-releasing hormone (GnRH) receptor antagonist that significantly reduces dysmenorrhea and non-menstrual pelvic pain (NMPP) in women with moderate to severe endometriosis-associated pain.

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Study results demonstrate that for subgroups of patients with various baseline demographic and disease severity characteristics. The effect of elagolix at 150 mg QD and 200 mg BID doses is consistent among all subgroups, with a greater proportion of responders for both dysmenorrhea and NMPP compared with placebo and significantly improves endometriosis-related pain across all prespecified subgroups.

Additionally, study findings demonstrate that elagolix treatment was generally effective in improving the quality of life of women across these prespecified subgroups.

Given these findings, it may be prudent for physicians to consider elagolix to treat their patients who have unresolved endometriosis pain and who may present with a variety of demographic and clinical characteristics.

These patients may include women who present with various levels of pain related to dysmenorrhea, NMPP, and/or dyspareunia, or those with different treatment histories (eg, previous use of analgesics [opioids, NSAIDs, both, or none], previous GnRH analog therapy, or previous hormonal therapy).

Conclusions:

Overall, this study may aid physicians in identifying elagolix as an effective treatment for a variety of women with endometriosis, despite variations in their demographics or medical histories.

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Abstract

Background

Elagolix is an oral, gonadotropin-releasing hormone (GnRH) receptor antagonist, that significantly reduces dysmenorrhea and non-menstrual pelvic pain (NMPP) in women with moderate to severe endometriosis-associated pain.

Methods

Data were pooled from two 6-month, placebo-controlled, phase 3 studies (Elaris Endometriosis [EM]-I and II) in which 2 doses of elagolix were evaluated (150 mg once daily and 200 mg twice daily). Pooled data from > 1600 women, aged 18–49, were used to evaluate the efficacy of elagolix and health-related quality of life (HRQoL) in prespecified subgroups of women with various baseline characteristics.

Results

Of the 1686 women treated, 1285 (76.2%) completed the studies. The percentages of women with clinically meaningful reductions in dysmenorrhea and NMPP were generally consistent by subgroup. Significant treatment by subgroup interaction was demonstrated for dysmenorrhea response in baseline analgesic use and previous history of pregnancy subgroups, and for NMPP response in the baseline NMPP score and history of pregnancy subgroups. Patient-reported reduction in pain at month 3 was significant across all subgroups taking elagolix 200 mg BID, and significant across most subgroups with elagolix 150 mg QD. Women across subgroups experienced improvement within each domain of the Endometriosis Health Profile-30 (EHP-30), although significant treatment by subgroup interactions was observed in several categories.

Conclusions

Elagolix was effective in reducing dysmenorrhea and NMPP, and improving HRQoL, compared with placebo across numerous subgroups of women with various baseline characteristics, covering a broad segment of the endometriosis disease and patient types.

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