Health-related quality of life improvements in patients with endometriosis treated with elagolix
Open accessAbstract
OBJECTIVE: To evaluate the effects of elagolix on clinically meaningful improvements in health-related quality of life (HRQOL) measured by the EHP-30 (Endometriosis Health Profile-30). METHODS: Data from two phase III trials of elagolix for moderate to severe pain associated with endometriosis were pooled and analyzed as three groups: placebo, elagolix 150 mg once daily, or elagolix 200 mg twice daily. Patients were administered the EHP-30 questionnaire at baseline, and at months 1, 3, and 6 of treatment. Previously established responder definitions were applied to determine percentages of patients with clinically meaningful EHP-30 improvements. The probability of meeting EHP-30 responder definitions with elagolix compared with placebo at months 3 and 6 was determined by Poisson regression analysis, controlling for baseline scores. RESULTS: At month 6, the probabilities of meeting EHP-30 subscale responder definitions for pain, control and powerlessness, self-image, social support, emotional well-being, and sexual intercourse were 169% (adjusted relative risk [aRR]: 2.69, 95% CI 2.26-3.21), 129% (aRR 2.29, 95% CI 1.96-2.67), 80% (aRR 1.80, 95% CI 1.54-2.11), 70% (aRR 1.70, 95% CI 1.47-1.97), 67% (aRR 1.67, 95% CI 1.45-1.92), and 62% (aRR 1.62, 95% CI 1.36-1.92) greater, respectively (all P<.001), in the 200-mg group than in the placebo group. Although lower in magnitude than the 200-mg group, the 150-mg group also had greater probabilities of meeting responder definitions than the placebo group for all subscales except sexual intercourse. The probabilities of meeting responder definitions for pain, control and powerlessness, self-image, social support, and emotional well-being were 75% (aRR 1.75, 95% CI 1.44-2.14), 50% (aRR 1.50, 95% CI 1.25-1.80), 22% (aRR 1.22, 95% CI 1.01-1.47), 30% (aRR 1.30, 95% CI 1.09-1.53), and 35% (aRR 1.35, 95% CI 1.16-1.57) greater, respectively (all P<.05), in the 150-mg group than in the placebo group. CONCLUSION: Patients with moderate to severe pain associated with endometriosis and were treated with elagolix experienced clinically meaningful HRQOL improvements. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT01620528 and NCT01931670. FUNDING SOURCE: AbbVie Inc.
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Achieving a clinically meaningful response to endometriosis-related pain with elagolix was found to be associated with improvements in health-related quality of life and work productivity.
“Achieving a clinically meaningful response to endometriosis-related pain with elagolix was found to be associated with improvements in health-related quality of life and work productivity [111,112].”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [112]
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Cites
ESHRE guideline: management of women with endometriosis
Dunselman, G. A. J., Vermeulen, N., Becker, C., Calhaz-Jorge, C., D'Hooghe, T., De Bie, B., Heikinheimo, O., Horne, A. W., Kiesel, L., Nap, A., et al. (2014) · Human Reproduction · doi:10.1093/humrep/det457 · Cited by 2,211 · see citing works
Nnoaham, K. E., Hummelshoj, L., Webster, P., d’Hooghe, T., de Cicco Nardone, F., de Cicco Nardone, C., Jenkinson, C., Kennedy, S. H., & Zondervan, K. T. (2011) · Fertility and Sterility · doi:10.1016/j.fertnstert.2011.05.090 · Cited by 1,584 · see citing works
ESHRE guideline for the diagnosis and treatment of endometriosis
Kennedy, S., Bergqvist, A., Chapron, C., D’Hooghe, T., Dunselman, G., Greb, R., Hummelshoj, L., Prentice, A., & Saridogan, E. (2005) · Human Reproduction · doi:10.1093/humrep/dei135 · Cited by 1,584 · see citing works
Simoens, S., Dunselman, G., Dirksen, C., Hummelshoj, L., Bokor, A., Brandes, I., Brodszky, V., Canis, M., Colombo, G. L., DeLeire, T., et al. (2012) · Human Reproduction · doi:10.1093/humrep/des073 · Cited by 1,070 · see citing works
The social and psychological impact of endometriosis on women's lives: a critical narrative review
Culley, L. A., Law, C., Hudson, N., Denny, E., Mitchell, H., Baumgarten, M. N., & Raine‐Fenning, N. (2013) · Human Reproduction Update · doi:10.1093/humupd/dmt027 · Cited by 689 · see citing works
Consensus on current management of endometriosis
Johnson, N. P., Hummelshoj, L., for the World Endometriosis Society Montpellier Consortium, Abrao, M. S., Adamson, G. D., Allaire, C., Amelung, V., Andersson, E., Becker, C., Birna Árdal, K. B., et al. (2013) · Human Reproduction · doi:10.1093/humrep/det050 · Cited by 558 · see citing works
Impact of endometriosis on women’s lives: a qualitative study
Moradi, M., Parker, M. A., Sneddon, A., López, V., & Ellwood, D. A. (2014) · BMC Women s Health · doi:10.1186/1472-6874-14-123 · Cited by 525 · see citing works
Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist
Taylor, H. S., Giudice, L. C., Lessey, B. A., Abrao, M. S., Kotarski, J., Archer, D. F., Diamond, M. P., Surrey, E., Johnson, N. P., Watts, N. B., et al. (2017) · New England Journal of Medicine · doi:10.1056/nejmoa1700089 · Cited by 511 · see citing works
Self-citationDe Graaff, A. A., D'Hooghe, T. M., Dunselman, G. A. J., Dirksen, C. D., Hummelshoj, L., WERF EndoCost Consortium, Simoens, S., Bokor, A., Brandes, I., Brodszky, V., et al. (2013) · Human Reproduction · doi:10.1093/humrep/det284 · Cited by 473 · see citing works
Development of an endometriosis quality-of-life instrument: The Endometriosis Health Profile-30
Jones, G. (2001) · Obstetrics & Gynecology · doi:10.1016/s0029-7844(01)01433-8 · Cited by 334 · see citing works
Interpreting patient-reported outcome results: US FDA guidance and emerging methods
McLeod, L., Coon, C. D., Martin, S. A., Fehnel, S. E., & Hays, R. D. (2011) · Expert Review of Pharmacoeconomics & Outcomes Research · doi:10.1586/erp.11.12 · Cited by 318 · see citing works
Fourquet, J., Báez, L., Figueroa, M., Iriarte, R. I., & Flores, I. (2011) · Fertility and Sterility · doi:10.1016/j.fertnstert.2011.04.095 · Cited by 262 · see citing works
Patients’ report on how endometriosis affects health, work, and daily life
Fourquet, J., Gao, X., Zavala, D., Orengo, J. C., Abac, S., Ruiz, A., Laboy, J., & Flores, I. (2010) · Fertility and Sterility · doi:10.1016/j.fertnstert.2009.09.017 · Cited by 252 · see citing works
The Effect of Endometriosis Symptoms on Absenteeism and Presenteeism in the Workplace and at Home
Soliman, A. M., Coyne, K. S., Gries, K. S., Castelli‐Haley, J., Snabes, M. C., & Surrey, E. S. (2017) · Journal of Managed Care & Specialty Pharmacy · doi:10.18553/jmcp.2017.23.7.745 · Cited by 160 · see citing works
Self-citationEvaluating the responsiveness of the endometriosis health profile questionnaire: The EHP-30
Jones, G., Jenkinson, C., & Kennedy, S. (2004) · Quality of Life Research · doi:10.1023/b:qure.0000021316.79349.af · Cited by 158 · see citing works
Minimally important difference estimates and methods: a protocol
Johnston, B. C., Ebrahim, S., Carrasco‐Labra, A., Furukawa, T. A., Patrick, D. L., Crawford, M. W., Hemmelgarn, B. R., Schünemann, H. J., Guyatt, G. H., & NESRALLAH, G. E. (2015) · BMJ Open · doi:10.1136/bmjopen-2015-007953 · Cited by 148 · see citing works
Systematic review of quality of life measures in patients with endometriosis
Bourdel, N., Chauvet, P., Billone, V., Douridas, G., Fauconnier, A., Gerbaud, L., & Canis, M. J. (2019) · PLoS ONE · doi:10.1371/journal.pone.0208464 · Cited by 139 · see citing works
Jones, G., Jenkinson, C., Taylor, N., Mills, A., & Kennedy, S. (2006) · Human Reproduction · doi:10.1093/humrep/del231 · Cited by 138 · see citing works
Gerlinger, C., Schumacher, U., Faustmann, T. A., Colligs, A., Schmitz, H., & Seitz, C. (2010) · Health and Quality of Life Outcomes · doi:10.1186/1477-7525-8-138 · Cited by 135 · see citing works
Ng, J., Chwalisz, K., Carter, D. C., & Klein, C. E. (2017) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2016-3845 · Cited by 110 · see citing works
Bernuit, D., Ebert, A. D., Halis, G., Strothmann, A., Gerlinger, C., Geppert, K., & Faustmann, T. (2011) · Journal of Endometriosis · doi:10.5301/je.2011.8525 · Cited by 83 · see citing works
Schuring, M., Robroek, S. J., & Burdorf, A. (2017) · Scandinavian Journal of Work Environment & Health · doi:10.5271/sjweh.3675 · Cited by 56 · see citing works
Wickström, K., & Edelstam, G. A. B. (2017) · Sexual & Reproductive Healthcare · doi:10.1016/j.srhc.2017.05.004 · Cited by 37 · see citing works
Surrey, E. S., Soliman, A. M., Agarwal, S. K., Snabes, M. C., & Diamond, M. P. (2019) · Fertility and Sterility · doi:10.1016/j.fertnstert.2019.02.031 · Cited by 32 · see citing works
Self-citationResponsiveness of the Dutch Endometriosis Health Profile-30 (EHP-30) questionnaire
van de Burgt, T. J. M., Kluivers, K. B., & Hendriks, J. C. M. (2013) · European Journal of Obstetrics & Gynecology and Reproductive Biology · doi:10.1016/j.ejogrb.2012.12.037 · Cited by 23 · see citing works
ACOG Updates Guideline on Diagnosis and Treatment of Endometriosis
Armstrong, C. (2011) · American family physician · Cited by 19 · see citing works
Pokrzywinski, R. M., Soliman, A. M., Chen, J., Snabes, M. C., Taylor, H. S., & Coyne, K. S. (2019) · Journal of Women s Health · doi:10.1089/jwh.2019.7788 · Cited by 15 · see citing works
Self-citationLeyland, N. A., Taylor, H. S., Archer, D. F., Peloso, P. M. J., Soliman, A. M., Palac, H., Martínez, M., & Abrão, M. S. (2019) · Journal of Endometriosis and Pelvic Pain Disorders · doi:10.1177/2284026519872401 · Cited by 5 · see citing works
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Donnez, J., & Dolmans, M.-M. (2021) · Journal of Clinical Medicine · doi:10.3390/jcm10051085 · Cited by 182 · see citing works
- Authors
- Taylor, H. S., Soliman, A. M., Johns, B., Pokrzywinski, R. M., Snabes, M., & Coyne, K. S.
- Affiliations
- AbbVie (United States) (US)
- Corresponding author
- Taylor, Hugh S.
- Venue
- Obstetrics & Gynecology
- Published
- 2020-08-05
- Volume
- 136
- Issue
- 3
- Pages
- 501-509
- ISSN
- 0029-7844 (ISSN-L)
- PMC
- PMC7431150
- OpenAlex
- W3048062679
- Cited by
- 25
- References
- 28
- Citations by year
- 2026: 5 · 2024: 4 · 2023: 4 · 2022: 5 · 2021: 6 · 2020: 1
- FWCI
- 3.53
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Obstetrics and Gynecology (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Funders
- National Institutes of Health (UL1TR001863)
- National Center for Advancing Translational Sciences
- Topics
- Health Sciences › Medicine › Reproductive Medicine › Endometriosis Research and Treatment
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Menstrual Health and Disorders
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ectopic Pregnancy Diagnosis and Management
- Keywords
- endometriosis, elagolix, health-related quality of life, Endometriosis Health Profile-30, dysmenorrhea, dyspareunia, pain, self-image, social support, emotional well-being, sexual intercourse, aromatase inhibitors, responder definition, dose comparison, placebo comparison, chronic pelvic pain
- MeSH terms
- Adult, Endometriosis, Female, Humans, Hydrocarbons, Fluorinated, Pyrimidines, Quality of Life, Treatment Outcome, Clinical Trials, Phase III as Topic
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