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Improving Treatment Outcomes for Endometriosis and Uterine Fibroids
In this interview, Charlotte Owens, MD, FACOG, former therapeutic area lead, women's health, US medical affairs, AbbVie, explains the impact of endometriosis and uterine fibroids, reviews data from the American College of Obstetricians and Gynecologists Annual Clinical and Scientific Meeting, including study findings that demonstrate physician preference in the real-world setting of elagolix over other currently available endometriosis treatments given patient and physician satisfaction with the results for endometriosis-associated pain.
Tell me about endometriosis and uterine fibroids. How do these conditions affect women’s lives?
Endometriosis is a condition that occurs when the endometrium, the tissue that normally lines the inside of the uterus, grows where it doesn’t 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 one in 10 women of reproductive age in the US. The most common symptoms are painful periods, pelvic pain in between periods and pain with sex. 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 Caucasian women and up to 80% of African-American women by age 50. Uterine Fibroid symptoms including 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 their impact, there remains a lack of public awareness, research funding and early diagnosis for patients with both conditions.
At the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting, what were some of the key takeaways from data presented on elagolix regarding endometriosis and uterine fibroids? How can providers become more involved to better address these conditions?
On the subject of endometriosis and uterine fibroids, there were a number of presentations from this year’s ACOG Annual Clinical and Scientific Meeting regarding the oral gonadotropin-releasing hormone (GnRH) antagonist called elagolix. The presentations 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’s a stigma associated with women’s health conditions. Period pain can be viewed as normal, or 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.
Tell me more about the data itself? What did it show and why are these findings important for providers? How can they apply these findings to clinical practice?
One study aimed to conduct a systematic literature review and meta-analysis of quality of life (QoL) outcomes of elagolix plus add-back and hysterectomy for the treatment of symptomatic uterine fibroids. Results showed both elagolix plus add-back, and hysterectomy, lead to significant improvement in quality of life of uterine fibroids patients, with no statistical difference between the two treatments. These results were found in the analysis of both therapies even though 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 (SSS) and overall health related quality of life (HRQoL) measurement.
The findings of this study suggest that consideration of elagolix plus add-back for uterine fibroid patients that do not want or are not an ideal candidate 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 US.
Additionally, findings from a three-month interim analysis of the real-world effectiveness of elagolix in US patients from the longitudinal outcomes (LOTUS) prospective cohort study were presented for the first time at the ACOG meeting. The analysis included data from the monthly assessments of dysmenorrhea (painful periods), non-menstrual pelvic pain (NMPP) and dyspareunia (painful sex) among 155 volunteer pre-menopausal women, aged 18-49 years with a self-reported endometriosis diagnosis. Results from this analysis found that patients receiving elagolix self-reported significant reductions in their endometriosis-associated pain, across all three types of pain at three months, with improvements that were consistent with data reported in the ELARIS EM-I and ELARIS EM-II 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 for 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 US, assessing the impact of elagolix on endometriosis-associated pain in the real-world from physicians’ perspectives were presented. 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 than 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, and this study demonstrates physician preference in the real-world setting of elagolix over other currently available endometriosis treatments given patient and physician satisfaction with the results for endometriosis-associated pain.
Is there anything else you’d like to add?
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 fibroid in a safe and efficacious way and we’re 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 alike.
About Dr Owens
Dr Charlotte Owens is a board-certified obstetrician and gynecologist and the former Therapeutic Area Lead for Women's Health in US Medical Affairs at AbbVie. She oversees the scientific communications, field medical science liaison team, educational efforts, and publications for Women’s Health efforts at AbbVie. She also serves and practices as an adjunct clinical assistant professor at the Morehouse School of Medicine.
References:
- Surrey E et al. Real-World Effectiveness of Elagolix in Reducing Endometriosis-Associated Pain: Interim Results From the Elagolix Longitudinal Outcomes (LOTUS) Prospective Cohort Study. ACOG Virtual Annual Clinical and Scientific Meeting. April-May 2021 (presentation # 326).
- Taylor H et al. Physician-reported Satisfaction with Treatment and Pain Reduction in Endometriosis Patients Receiving Elagolix Compared with Other Prescribed Treatments. ACOG Virtual Annual Clinical and Scientific Meeting. April-May 2021 (presentation # 302).
- Aggarwal S et al. Meta-Analysis of Quality of Life Outcomes for Treatment with Elagolix+AB and Hysterectomy for Symptomatic Uterine Fibroids. ACOG Virtual Annual Clinical and Scientific Meeting. April-May 2021 (presentation # 214).
