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Grand Rounds

Elaris EM-III and Elaris EM-IV Results: Long-Term Endometriosis Outcomes Following Administration of Elagolix

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BACKGROUND AND PURPOSE:

  • Elagolix is an oral, gonadotropin-releasing hormone (GnRH) antagonist
  • Previous studies demonstrated that elagolix reduced endometriosis pain with an acceptable safety profile (See ‘Related ObG Topics’ below)
    • However, these studies provided data up to only  6 months of follow-up
  • Surrey et al. (Obstetrics and Gynecology, 2018) extended the above studies to evaluate the longer term efficacy and safety of elagolix

METHODS:

  • Extension studies of double-blind, placebo-controlled phase 3 trials of elagolix
  • Participants
    • Premenopausal women, between 18 and 49 years old with a surgical diagnosis of endometriosis within the past 10 years
    • Moderate or severe endometriosis pain
  • In these Elaris EM-III and Elaris IM-IV extension studies, there was a 6 month extended treatment phase and a 1 year follow up phase
    • Patients were maintained on the same elagolix dose as previously taken, either elagolix 150 mg daily or elagolix 200 mg twice daily
  • Participants also took 400 international units vitamin D with 500–1,000 mg calcium throughout the study
  • Rescue medications as needed
    • NSAIDs
    • Opioid ‘according to country’
  • Primary efficacy endpoints
    • Proportion of responders: Those with clinically meaningful pain reduction and
    • Stable or decreased rescue analgesic use
  • Secondary assessments include impact on
    • Dyspareunia | Dysmenorrhea | Pelvic pain | Use of rescue analgesic medications
  • Safety assessments were included in these studies, including adverse events that occurred after treatment was begun

RESULTS:

  • 569 subjects were enrolled

After 12 months of treatment

  • Dysmenorrhea responder rate was
    • 150 mg once daily: 52.1% (Elaris EM-III) and 50.8% (Elaris EM-IV)
    • 200 mg twice daily: 78.1% (Elaris EM-III) and 75.9% (Elaris EM-IV)
  • Nonmenstrual pain responder rate was
    • 150 mg once daily: 67.8% (Elaris EM-III) and 66.4% (Elaris EM-IV)
  • Dysmenorrhea responder rate was
    • 150 mg once daily: 45.2% (Elaris EM-III) and 45.9% (Elaris EM-IV)
    • 200 mg twice daily: 60.0% (Elaris EM-III) and 58.1% (Elaris EM-IV)
  • Hot flashes were the most common side effect, while severe adverse events occurred in less than 5% of women in Elaris EM-III and 8% of women in Elaris EM-IV
  • Additionally, decreases from baseline in bone mineral density and increases from baseline in lipids were observed after 12 months of treatment
    • Lipid changes were overall small
      • “Favorable” changes: Increased HDL
      • “Unfavorable” changes: Increased LDL and TG
    • Only 1 woman between the two studies had BMD Z-score below -2.0 (lower bound of normal)
  • Majority of participants reported improved endometriosis associated pain and quality of life improvements were also noted
  • When looking specifically at decreased opioid use for pain management, there was a 30% mean reduction with 150 mg and > 65% mean reduction in those participants taking 200 mg twice daily

CONCLUSION:

  • Long-term elagolix treatment reduced dysmenorrhea, nonmenstrual pelvic pain, and dyspareunia
  • Adverse effects at 12 months similar to those at 6 months, including hot flashes
  • The authors conclude that these findings are consistent with mechanism of drug action, with lowering of estrogen levels
  • In select patients, efficacy of elagolix appears sustained at 1 year

Learn More – Primary Sources:

Long-Term Outcomes of Elagolix in Women With Endometriosis: Results From Two Extension Studies

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Related ObG Topics:

Evaluation and Treatment of Endometriosis
Is Ultrasound or MRI Best When Assessing Colorectal Endometriosis?
Does the Oral GnRH Antagonist Elagolix Improve Endometriosis-Associated Pain?

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