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Plain Language Summary of Publication
27 June 2024

Changes in symptom burden and quality of life among women with uterine fibroids receiving relugolix combination therapy: a plain language summary

Authors: Elizabeth A Stewart, Andrea S Lukes, Roberta Venturella, Yulan Li, Elke Hunsche, Rachel B Wagman, and Ayman Al-HendyAuthor Info & Affiliations
Volume 13, Number 8
https://doi.org/10.57264/cer-2023-0194
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Abstract

What is this summary about?

This is a summary of findings from two research studies (known as clinical trials). The studies looked at how well a medicine called relugolix combination therapy worked in women with heavy menstrual bleeding (heavy bleeding during a period) with uterine fibroids (noncancerous or benign growths in the uterus). In this analysis of the studies, researchers looked at how patients self-reported their uterine fibroid symptoms before and after taking relugolix combination therapy. Researchers also looked at how patients self-reported the impact of uterine fibroids on their health-related quality of life before and after taking relugolix combination therapy.

What were the results?

Women took either relugolix combination therapy or placebo (a pill that contains no medicine) by mouth once daily for 24 weeks. Women completed the Uterine Fibroid Symptom and Quality of Life questionnaire (where “quality of life” refers to the women's health-related quality of life related to uterine fibroids) before, during, and after treatment. The questionnaire let researchers see if the women felt that relugolix combination therapy decreased the burden of uterine fibroid symptoms and improved the women's health-related quality of life related to uterine fibroids. More women said that they felt less distress due to their uterine fibroid symptoms and that their health-related quality of life related to uterine fibroids was better after taking relugolix combination therapy compared with women who took placebo.

What do the results mean?

Relugolix combination therapy may lessen distress associated with uterine fibroid symptoms and improve health-related quality of life related to uterine fibroids.
This is an abstract of the Plain Language Summary of Publication article.
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Acknowledgments

Sumitomo Pharma Switzerland GmbH and the authors thank all of the women who took part in these studies and their families, as well as the treating physicians, research nurses, study coordinators, and operations staff.

Financial disclosure

Elizabeth A Stewart has provided consulting services to Myovant, (now known as Sumitomo Pharma America, Inc.) (Steering Committee member for LIBERTY Phase 3 trials), Bayer, AbbVie, and ObsEva. She has received royalties for development of educational content from UpToDate, payment for development of educational content from Med Learning Group, Med-IQ, Medscape, Peer View, and PER, and honoraria for written content from the American College of Obstetricians and Gynecologists and Massachusetts Medical Society. In addition, she holds a patent for Methods and Compounds for Treatment of Abnormal Uterine Bleeding (US Pat. No. 6440445) for which there is no commercial activity. Andrea S Lukes has provided consulting services to Sumitomo Pharma America, Inc. and AbbVie, and is Principal Investigator for Sumitomo Pharma America, Inc., AbbVie, Bayer, Merck & Co., Inc., Gynesonics, and ObsEva. Roberta Venturella has provided consulting services to Sumitomo Pharma America, Inc. Yulan Li and Rachel B Wagman are employed at Sumitomo Pharma America, Inc. Elke Hunsche is employed at Sumitomo Pharma Switzerland GmbH. Ayman Al-Hendy has provided consulting services to AbbVie, Bayer, Myovant, MD Stem Cells, ObsEva, and Novartis, and is grant funded by the National Institute of Health for leiomyoma-related research (R01 ES 028615-01, R01 HD 087417, R01 HD 094378, R01 HD 094380, 5U54 MD 007602-32, R01 HD 100367). In addition, he holds a patent for Methods for novel diagnostics and therapeutics for uterine sarcoma (US Pat No. 9,790,562 B2). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Competing interests disclosure

The authors have no competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Writing disclosure

Writing support for this summary was provided by Anna Stern, PhD, and Kandyss Najjar, PhD, of ICON (Blue Bell, PA) and was funded by Sumitomo Pharma Switzerland GmbH in partnership with Pfizer Inc.

Open access

This work is licensed under the Creative Commons Attribution 4.0 License. To view a copy of this license, visit https://creativecommons.org/licenses/by/4.0/
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