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Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist
Open accessAbstract
BACKGROUND: Endometriosis is a chronic, estrogen-dependent condition that causes dysmenorrhea and pelvic pain. Elagolix, an oral, nonpeptide, gonadotropin-releasing hormone (GnRH) antagonist, produced partial to nearly full estrogen suppression in previous studies. METHODS: We performed two similar, double-blind, randomized, 6-month phase 3 trials (Elaris Endometriosis I and II [EM-I and EM-II]) to evaluate the effects of two doses of elagolix - 150 mg once daily (lower-dose group) and 200 mg twice daily (higher-dose group) - as compared with placebo in women with surgically diagnosed endometriosis and moderate or severe endometriosis-associated pain. The two primary efficacy end points were the proportion of women who had a clinical response with respect to dysmenorrhea and the proportion who had a clinical response with respect to nonmenstrual pelvic pain at 3 months. Each of these end points was measured as a clinically meaningful reduction in the pain score and a decreased or stable use of rescue analgesic agents, as recorded in a daily electronic diary. RESULTS: A total of 872 women underwent randomization in Elaris EM-I and 817 in Elaris EM-II; of these women, 653 (74.9%) and 632 (77.4%), respectively, completed the intervention. At 3 months, a significantly greater proportion of women who received each elagolix dose met the clinical response criteria for the two primary end points than did those who received placebo. In Elaris EM-I, the percentage of women who had a clinical response with respect to dysmenorrhea was 46.4% in the lower-dose elagolix group and 75.8% in the higher-dose elagolix group, as compared with 19.6% in the placebo group; in Elaris EM-II, the corresponding percentages were 43.4% and 72.4%, as compared with 22.7% (P<0.001 for all comparisons). In Elaris EM-I, the percentage of women who had a clinical response with respect to nonmenstrual pelvic pain was 50.4% in the lower-dose elagolix group and 54.5% in the higher-dose elagolix group, as compared with 36.5% in the placebo group (P<0.001 for all comparisons); in Elaris EM-II, the corresponding percentages were 49.8% and 57.8%, as compared with 36.5% (P=0.003 and P<0.001, respectively). The responses with respect to dysmenorrhea and nonmenstrual pelvic pain were sustained at 6 months. Women who received elagolix had higher rates of hot flushes (mostly mild or moderate), higher levels of serum lipids, and greater decreases from baseline in bone mineral density than did those who received placebo; there were no adverse endometrial findings. CONCLUSIONS: Both higher and lower doses of elagolix were effective in improving dysmenorrhea and nonmenstrual pelvic pain during a 6-month period in women with endometriosis-associated pain. The two doses of elagolix were associated with hypoestrogenic adverse effects. (Funded by AbbVie; Elaris EM-I and EM-II ClinicalTrials.gov numbers, NCT01620528 and NCT01931670 .).
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In the citing paper
“In both trials, during the 6 months treatment, elagolix dramatically reduced dysmenorrhea and non-menstrual pelvic discomfort.”
From Hormonal treatments for endometriosis: The endocrine background (2022) · cites this paper as [173]
In the citing paper
“The results of a study in which about 1700 women with moderate or severe pain in endometriosis participated played a part in the above decision. Doses of this drug—150 mg once a day or 200 mg twice a day—significantly reduced the most common types of endometrial pain: pelvic pain and sex-related pain.”
From Endometriosis: Epidemiology, Classification, Pathogenesis, Treatment and Genetics (Review of Literature) (2021) · cites this paper as [117]
In the citing paper
“The latest drug to be approved by the Food and Drug Administration (FDA) is elagolix, a drug for the treatment of moderate to severe pain associated with endometriosis [117].”
From Endometriosis: Epidemiology, Classification, Pathogenesis, Treatment and Genetics (Review of Literature) (2021) · cites this paper as [117]
In the citing paper
“Recently, an oral GnRH antagonist (elagolix) was reported to be effective for reducing endometriosis‐related symptoms.”
From Extra-pelvic endometriosis: a review. (2020) · cites this paper as [97]
In the citing paper
“In Elaris EM-II, corresponding percentages were 49.8% and 57.8% (compared with 36.5% in the placebo group).”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [102]
In the citing paper
“In the EM-I and -II trials, Taylor et al. [102] reported that mean decreases in BMD in the lumbar spine, femoral neck and total hip after six months of treatment were significantly greater in patients receiving elagolix than in those given a placebo (excluding femoral neck BMD at a dose of 150 mg in Elaris EM-I (Figure 3).”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [102]
In the citing paper
“In Elaris EM-II, corresponding percentages were 43.4% and 72.4% (compared with 22.7% in the placebo group).”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [102]
In the citing paper
“At 200 mg (twice daily), percentages were respectively 42.3%, 47.6%, 72% and 77% [102,103].”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [102]
In the citing paper
“Overall, alleviation of both dysmenorrhea and non-menstrual pelvic pain were sustained for six months (Table 1).”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [102]
In the citing paper
“In both studies, only women treated with elagolix at a dose of 200 mg twice daily showed a statistically significant greater reduction in dyspareunia after three months of treatment (compared with the placebo).”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [102]
In the citing paper
“In conclusion, use of elagolix 200 mg twice daily causes strong suppression of E2 and marked improvements in dysmenorrhea, non-menstrual pelvic pain and dyspareunia, albeit at the cost of more hot flushes and a more pronounced decrease in BMD (Figure 4).”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [102]
In the citing paper
“The percentage of patients with a decrease of >5% from baseline in lumbar spine BMD was higher in the elagolix 200 mg twice daily group in all studies.”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [102]
In the citing paper
“Overall, the pharmacokinetic properties of elagolix at 150 mg once daily and 200 mg twice daily do not appear to be affected, to a clinically meaningful extent, by body weight, body mass index, race/ethnicity or the presence of endometriosis [102,103,107].”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [102]
In the citing paper
“Elagolix causes a dose-dependent decrease in BMD.”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [102]
In the citing paper
“Regarding side effects, the most frequently reported were hot flushes, depending on the dose.”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [102]
In the citing paper
“Percentages of women experiencing hot flushes at a dose of 150 mg (once daily) were respectively 23.7%, 22.6%, 44% and 36% in Elaris-I, -II, -III and -IV.”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [102]
In the citing paper
“In Elaris EM-I, the percentage of women who noted an improvement in non-menstrual pelvic pain was 50.4% with elagolix 150 mg once daily and 54.5% with elagolix 200 mg twice daily (compared with 36.5% in the placebo group).”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [102]
In the citing paper
“The percentage of women who experienced a clinical improvement in dysmenorrhea was 46.4% with elagolix 150 mg once daily and 75.8% with elagolix 200 mg twice daily (compared with 19.6% in the placebo group).”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [102]
In the citing paper
“Even if the majority of patients were satisfied with this therapy, as many as 40% of patients indicated unsatisfactory improvement of pain symptoms ( 69 ).”
From Is intracrinology of endometriosis relevant in clinical practice? A systematic review on estrogen metabolism (2022) · cites this paper as [69]
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Self-citation25 historic papers: an ASRM 75th birthday gift from Fertility and Sterility
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Coyne, K. D., Silverman, P., & LIU, J. H. (2020) · Clinical Breast Cancer · doi:10.1016/j.clbc.2020.05.011 · Cited by 5
Metadata
- Authors
- Taylor, H. S., Giudice, L. C., Lessey, B. A., Abrao, M. S., Kotarski, J., Archer, D. F., Diamond, M. P., Surrey, E., Johnson, N. P., Watts, N. B., Gallagher, J. C., Simon, J. A., Carr, B. R., Dmowski, W. P., Leyland, N., Rowan, J. P., Duan, W. R., Ng, J., Schwefel, B., Thomas, J. W., Jain, R. I., & Chwalisz, K.
- Affiliations
- Creighton University (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2017-07-06
- Volume
- 377
- Issue
- 1
- Pages
- 28-40
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2616333165
- Cited by
- 511
- References
- 36
- Citations by year
- 2026: 53 · 2025: 56 · 2024: 62 · 2023: 53 · 2022: 42 · 2021: 67 · 2020: 74 · 2019: 45 · 2018: 40 · 2017: 18
- FWCI
- 56.56
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) (publishedVersion, other-oa)
- PubMed (publishedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- Creighton Digital Repository (CDR) (submittedVersion)
- Topics
- Health Sciences › Medicine › Reproductive Medicine › Endometriosis Research and Treatment
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Menstrual Health and Disorders
- Health Sciences › Medicine › Obstetrics and Gynecology › Ectopic Pregnancy Diagnosis and Management
- Keywords
- endometriosis, elagolix, GnRH antagonist, dysmenorrhea, estrogen suppression, rescue analgesic consumption, pain management, dose comparison, chronic pelvic pain
- MeSH terms
- Adolescent, Adult, Dose-Response Relationship, Drug, Double-Blind Method, Dysmenorrhea, Endometriosis, Estrogen Antagonists, Female, Humans, Hydrocarbons, Fluorinated, Gonadotropin-Releasing Hormone, Lipids, Middle Aged, Pyrimidines, Bone Density, Premenopause, Pelvic Pain, Hot Flashes, Young Adult
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