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This systematic review evaluated the efficacy and safety of elagolix, an oral GnRH antagonist, for managing pain associated with endometriosis. By analyzing 20 studies including randomized controlled trials and real-world data, the authors found that elagolix significantly reduced dysmenorrhea, nonmenstrual pelvic pain, and dyspareunia compared to placebo, with benefits sustained over 12 months. The treatment demonstrated a dose-dependent effect where higher doses provided greater relief but increased hypoestrogenic side effects like hot flashes and bone mineral density loss, which could be mitigated with add-back therapy. This paper is centrally about endometriosis — specifically evaluating the clinical management of endometriosis-associated pain using elagolix.
Abstract
Endometriosis is a chronic, estrogen dependent condition affecting up to 10% of women of reproductive age, characterized by dysmenorrhea, dyspareunia, and nonmenstrual pelvic pain. Conventional treatments are often limited by inadequate efficacy or tolerability. Elagolix, an oral nonpeptide gonadotropin releasing hormone (GnRH) antagonist approved by the Food and Drug Administration in 2018, offers dose dependent estrogen suppression with rapid reversibility upon discontinuation. This systematic review synthesizes the current evidence on elagolix for the management of endometriosis associated pain. A comprehensive search was conducted across PubMed, Embase, Cochrane Library, Web of Science, and ClinicalTrials.gov from inception to September 2024. Studies were screened per Preferred Reporting Items for Systematic Reviews and Meta Analyses guidelines and quality appraised using the a measurement tool to assess systematic reviews 2. (AMSTAR 2) checklist. From 103 identified records, 20 studies were included, encompassing Phase II/III randomized controlled trials, long term extension studies, systematic reviews, network meta analyses, real world data analyses, postmarketing safety reports, and cost effectiveness studies. Elagolix significantly reduced dysmenorrhea (up to ~75% responder rate), nonmenstrual pelvic pain (~55%-69%), and dyspareunia (~60%) compared to placebo, with benefits sustained at 12 months. Efficacy was dose dependent; higher doses yielded greater symptom relief but increased hypoestrogenic adverse effects, primarily hot flushes and decreased bone mineral density (BMD). BMD loss remained minimal (<2% annually) with add back estradiol/norethindrone acetate therapy. Network meta analyses demonstrated comparable or superior efficacy versus other oral GnRH antagonists. Elagolix was cost effective compared to leuprolide acetate in the US settings, and patients favored its oral administration. Elagolix represents an effective, patient centered therapeutic option for moderate to severe endometriosis associated pain, with a well characterized safety profile. Future research should address long term safety beyond 48 months, direct comparisons with first line hormonal therapies, and cost effectiveness in non US healthcare settings.
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A Systematic Review of Elagolix for the Management of Endometriosis-associated Pain
- Sana Aafreen
- Ekramul Haque1
- Tushar Kumar2,
Endometriosis is a chronic, estrogen dependent condition affecting up to 10% of women of reproductive age, characterized by dysmenorrhea, dyspareunia, and nonmenstrual pelvic pain. Conventional treatments are often limited by inadequate efficacy or tolerability. Elagolix, an oral nonpeptide gonadotropin releasing hormone (GnRH) antagonist approved by the Food and Drug Administration in 2018, offers dose dependent estrogen suppression with rapid reversibility upon discontinuation. This systematic review synthesizes the current evidence on elagolix for the management of endometriosis associated pain. A comprehensive search was conducted across PubMed, Embase, Cochrane Library, Web of Science, and ClinicalTrials.gov from inception to September 2024. Studies were screened per Preferred Reporting Items for Systematic Reviews and Meta Analyses guidelines and quality appraised using the a measurement tool to assess systematic reviews 2. (AMSTAR 2) checklist. From 103 identified records, 20 studies were included, encompassing Phase II/III randomized controlled trials, long term extension studies, systematic reviews, network meta analyses, real world data analyses, postmarketing safety reports, and cost effectiveness studies. Elagolix significantly reduced dysmenorrhea (up to ~75% responder rate), nonmenstrual pelvic pain (~55%–69%), and dyspareunia (~60%) compared to placebo, with benefits sustained at 12 months. Efficacy was dose dependent; higher doses yielded greater symptom relief but increased hypoestrogenic adverse effects, primarily hot flushes and decreased bone mineral density (BMD). BMD loss remained minimal (<2% annually) with add back estradiol/norethindrone acetate therapy. Network meta analyses demonstrated comparable or superior efficacy versus other oral GnRH antagonists. Elagolix was cost effective compared to leuprolide acetate in the US settings, and patients favored its oral administration. Elagolix represents an effective, patient centered therapeutic option for moderate to severe endometriosis associated pain, with a well characterized safety profile. Future research should address long term safety beyond 48 months, direct comparisons with first line hormonal therapies, and cost effectiveness in non US healthcare settings.
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