Treatment

The Diagnosis and Treatment of Endometriosis and Uterine Fibroids

AUTHOR:
Charlotte Owens, MD
Board-Certified Obstetrician and Gynecologist
Former Therapeutic Area Lead for Women's Health, US Medical Affairs, AbbVie
Adjunct Clinical Assistant Professor, Morehouse School of Medicine, Atlanta, Georgia

CITATION:
Owens, C. The diagnosis and treatment of endometriosis and uterine fibroids. Consultant360. Published online September 20, 2021.

Endometriosis is a condition that occurs when the endometrium, the tissue that normally lines the inside of the uterus, grows where it does not belong. Endometriosis can be found on or around the ovaries and fallopian tubes, as well as other locations in the pelvic area. Endometriosis is one of the most pervasive gynecologic disorders, affecting an estimated 1 in 10 women of reproductive age in the United States. The most common symptoms are painful periods, pelvic pain in between periods, and pain with intercourse. Other symptoms include painful bowel movements and urination, heavy menstrual bleeding, bleeding between periods, nausea during a period, fertility issues, and fatigue. 

Uterine fibroids, also known as leiomyomas, are estrogen- and progesterone-dependent benign pelvic tumors, affecting up to 70% of White women and up to 80% of Black women by age 50 years. Uterine fibroid symptoms include heavy menstrual bleeding, pelvic pain, feelings of pelvic discomfort, and bloating, all of which vary from person to person and can be related to the size and the location of a fibroid. Fibroids can also be associated with infertility and some specific pregnancy complications. 

The symptoms of both conditions can also create difficult personal burdens, including lost time at work and school, a reduced ability to participate in important social and family activities, as well as added stress to romantic relationships. Despite the impact of fibroids, there remains a lack of public awareness, research funding, and early diagnosis for patients with both conditions.  

On the subject of endometriosis and uterine fibroids, there were a number of presentations from this year’s American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting regarding the oral gonadotropin-releasing hormone (GnRH) antagonist elagolix.1,2 The presenters discussed positive treatment effects that were seen with elagolix in endometriosis-associated pain and in uterine fibroids with elagolix plus add-back therapy (estradiol and norethindrone acetate) capsules. There is a stigma associated with women’s health conditions. Period pain can be viewed as normal or as part of being a woman, even by health care providers. Open conversations about specific symptoms can lead to a faster diagnosis and a tailored treatment plan to meet the patient’s needs now and in the future. Individualizing the patient’s care plan is imperative for all health conditions women face.  

Another study was a systematic literature review and meta-analysis of quality of life outcomes of patients taking elagolix plus add-back and hysterectomy for the treatment of symptomatic uterine fibroids.3 Results showed that both elagolix plus add-back, and hysterectomy, lead to significant improvement in quality of life of patients with uterine fibroids, with no statistical difference between the 2 treatments. These results were found in the analysis of both therapies, although all the data assessed was based on women with significant impairment in quality of life symptoms before treatment was provided, based on symptom severity scores and overall health-related quality of life measurement.  

The findings of this study suggest that consideration of elagolix plus add-back for patients with uterine fibroids who do not want or are not ideal candidates for a hysterectomy may be important—particularly since uterine fibroids have historically been managed by surgery and are the leading reason for the hysterectomies performed in the United States. 

Additionally, findings from a 3-month interim analysis of the real-world effectiveness of elagolix in patients in the United States from the longitudinal outcomes (LOTUS) prospective cohort study were presented for the first time at the ACOG meeting.4 The analysis included data from the monthly assessments of dysmenorrhea (painful periods), nonmenstrual pelvic pain, and dyspareunia (painful sex) among 155 volunteer premenopausal women, aged 18 to 49 years with a self-reported endometriosis diagnosis. Results from this analysis found that patients taking elagolix self-reported significant reductions in their endometriosis-associated pain, across all 3 types of pain at 3 months, with improvements that were consistent with data reported in the ELARIS EM-I4 and ELARIS EM-II5 clinical studies.  

Current treatments for endometriosis are limited, and women often undergo multiple medical treatments and surgical procedures seeking relief from unresolved pain. Physicians can apply the results from this study to help further illustrate the potential benefit of elagolix as a treatment option to discuss with patients seeking relief from endometriosis-associated pain. 

Lastly, findings from an interim analysis of physician survey data from Adelphi Disease Specific Program, an ongoing survey of gynecologists and their presenting patients in the United States, that assessed the impact of elagolix on endometriosis-associated pain in the real-world from physicians’ perspectives were presented.5 The interim results from this real-world clinical practice survey assessing physician preference suggest that elagolix is associated with greater reduction in physician-perceived endometriosis pain and higher physician satisfaction compared with other currently available endometriosis treatments within 30 days of care. These findings are important, as few studies have been conducted to explain attitudes in physicians treating patients with endometriosis. This study demonstrates physician preference of elagolix over other currently available endometriosis treatments in a real-world setting, given patient and physician satisfaction with the results for endometriosis-associated pain.  

The data at ACOG signifies a growing shift in available treatment options and potential for more personalized care planning approaches for patients with endometriosis and uterine fibroids. Elagolix data continues to show that patients now have new alternatives to surgery to manage their endometriosis-associated pain and heavy menstrual bleeding associated with uterine fibroids in a safe and efficacious way, and we are grateful for a platform like the ACOG Annual Clinical and Scientific Meeting to share these latest findings that we hope will further benefit physicians and patients.

This commentary is based on a Q&A interview conducted by our sister publication Population Health Learning Network. To read the original interview, click here.

References

  1. Surrey ES, Soliman AM, Johns B, Vora J, Cross S, Agarwal SK. Real-world effectiveness of elagolix in reducing endometriosis-associated pain: interim results from the elagolix longitudinal outcomes (LOTUS) prospective cohort study. ACOG Annual Clinical and Scientific Meeting; April 30-May 2, 2021; Virtual.
  2. Taylor H, et al. Physician-reported satisfaction with treatment and pain reduction in endometriosis patients receiving elagolix compared with other prescribed treatments. ACOG Annual Clinical and Scientific Meeting; April 30-May 2, 2021; Virtual.
  3. Aggarwal S, et al. Meta-analysis of quality of life outcomes for treatment with elagolix+ab and hysterectomy for symptomatic uterine fibroids. ACOG Annual Clinical and Scientific Meeting; April 30-May 2, 2021; Virtual.
  4. A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain (ELARIS EM-I). ClinicalTrials.gov. Published June 15, 2012. Updated September 18, 2018. Accessed September 16, 2021. https://clinicaltrials.gov/ct2/show/NCT01620528 
  5. A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain (ELARIS EM-II). ClinicalTrials.gov. Published August 29, 2013. Updated September 7, 2018. Accessed September 16, 2021. https://clinicaltrials.gov/ct2/show/NCT01931670