Long-term outcomes of elagolix in women with endometriosis results from two extension studies

Eric Surrey, Hugh S. Taylor, Linda Giudice, Bruce A. Lessey, Mauricio S. Abrao, David F. Archer, Michael Peter Diamond, Neil P. Johnson, Nelson B. Watts, J. Chris Gallagher, James A. Simon, Bruce R. Carr, W. Paul Dmowski, Nicholas Leyland, Sukhbir S. Singh, Tomasz Rechberger, Sanjay K. Agarwal, W. Rachel Duan, Brittany Schwefel, James W. Thomas & 4 others Paul M. Peloso, Juki Ng, Ahmed M. Soliman, Kristof Chwalisz

Research output: Contribution to journalArticle

14 Citations (Scopus)

Abstract

METHODS: Elaris Endometriosis (EM)-III and-IV were extension studies that evaluated an additional 6 months of treatment after two 6-month, double-blind, placebocontrolled phase 3 trials (12 continuous treatment months) with two elagolix doses (150 mg once daily and 200 mg twice daily). Coprimary efficacy endpoints were the proportion of responders (clinically meaningful pain reduction and stable or decreased rescue analgesic use) based on average monthly dysmenorrhea and nonmenstrual pelvic pain scores. Safety assessments included adverse events, clinical laboratory tests, and endometrial and bone mineral density assessments. The power of Elaris EM-III and-IV was based on the comparison to placebo in Elaris EM-I and-II with an expected 25% dropout rate. RESULTS: Between December 28, 2012, and October 31, 2014 (Elaris EM-III), and between May 27, 2014, and January 6, 2016 (Elaris EM-IV), 569 participants were enrolled. After 12 months of treatment, Elaris EM-III responder rates for dysmenorrhea were 52.1% at 150 mg once daily (Elaris EM-IV550.8%) and 78.1% at 200 mg twice daily (Elaris EM-IV575.9%). Elaris EM-III nonmenstrual pelvic pain responder rates were 67.8% at 150 mg once daily (Elaris EM-IV566.4%) and 69.1% at 200 mg twice daily (Elaris EM-IV567.2%). After 12 months of treatment, Elaris EM-III dyspareunia responder rates were 45.2% at 150 mg once daily (Elaris EM-IV545.9%) and 60.0% at 200 mg twice daily (Elaris EM-IV558.1%). Hot flush was the most common adverse event. Decreases from baseline in bone mineral density and increases from baseline in lipids were observed after 12 months of treatment. There were no adverse endometrial findings. CONCLUSION: Long-term elagolix treatment provided sustained reductions in dysmenorrhea, nonmenstrual pelvic pain, and dyspareunia. The safety was consistent with reduced estrogen levels and no new safety concerns were associated with long-term elagolix use.

Original languageEnglish (US)
Pages (from-to)147-160
Number of pages14
JournalObstetrics and Gynecology
Volume132
Issue number1
DOIs
StatePublished - Jan 1 2018
Externally publishedYes

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Endometriosis
Dysmenorrhea
Pelvic Pain
Dyspareunia
elagolix
Safety
Bone Density
Therapeutics
Analgesics
Estrogens

ASJC Scopus subject areas

  • Obstetrics and Gynecology

Cite this

Surrey, E., Taylor, H. S., Giudice, L., Lessey, B. A., Abrao, M. S., Archer, D. F., ... Chwalisz, K. (2018). Long-term outcomes of elagolix in women with endometriosis results from two extension studies. Obstetrics and Gynecology, 132(1), 147-160. https://doi.org/10.1097/AOG.0000000000002675

Long-term outcomes of elagolix in women with endometriosis results from two extension studies. / Surrey, Eric; Taylor, Hugh S.; Giudice, Linda; Lessey, Bruce A.; Abrao, Mauricio S.; Archer, David F.; Diamond, Michael Peter; Johnson, Neil P.; Watts, Nelson B.; Chris Gallagher, J.; Simon, James A.; Carr, Bruce R.; Paul Dmowski, W.; Leyland, Nicholas; Singh, Sukhbir S.; Rechberger, Tomasz; Agarwal, Sanjay K.; Rachel Duan, W.; Schwefel, Brittany; Thomas, James W.; Peloso, Paul M.; Ng, Juki; Soliman, Ahmed M.; Chwalisz, Kristof.

In: Obstetrics and Gynecology, Vol. 132, No. 1, 01.01.2018, p. 147-160.

Research output: Contribution to journalArticle

Surrey, E, Taylor, HS, Giudice, L, Lessey, BA, Abrao, MS, Archer, DF, Diamond, MP, Johnson, NP, Watts, NB, Chris Gallagher, J, Simon, JA, Carr, BR, Paul Dmowski, W, Leyland, N, Singh, SS, Rechberger, T, Agarwal, SK, Rachel Duan, W, Schwefel, B, Thomas, JW, Peloso, PM, Ng, J, Soliman, AM & Chwalisz, K 2018, 'Long-term outcomes of elagolix in women with endometriosis results from two extension studies', Obstetrics and Gynecology, vol. 132, no. 1, pp. 147-160. https://doi.org/10.1097/AOG.0000000000002675
Surrey, Eric ; Taylor, Hugh S. ; Giudice, Linda ; Lessey, Bruce A. ; Abrao, Mauricio S. ; Archer, David F. ; Diamond, Michael Peter ; Johnson, Neil P. ; Watts, Nelson B. ; Chris Gallagher, J. ; Simon, James A. ; Carr, Bruce R. ; Paul Dmowski, W. ; Leyland, Nicholas ; Singh, Sukhbir S. ; Rechberger, Tomasz ; Agarwal, Sanjay K. ; Rachel Duan, W. ; Schwefel, Brittany ; Thomas, James W. ; Peloso, Paul M. ; Ng, Juki ; Soliman, Ahmed M. ; Chwalisz, Kristof. / Long-term outcomes of elagolix in women with endometriosis results from two extension studies. In: Obstetrics and Gynecology. 2018 ; Vol. 132, No. 1. pp. 147-160.
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title = "Long-term outcomes of elagolix in women with endometriosis results from two extension studies",
abstract = "METHODS: Elaris Endometriosis (EM)-III and-IV were extension studies that evaluated an additional 6 months of treatment after two 6-month, double-blind, placebocontrolled phase 3 trials (12 continuous treatment months) with two elagolix doses (150 mg once daily and 200 mg twice daily). Coprimary efficacy endpoints were the proportion of responders (clinically meaningful pain reduction and stable or decreased rescue analgesic use) based on average monthly dysmenorrhea and nonmenstrual pelvic pain scores. Safety assessments included adverse events, clinical laboratory tests, and endometrial and bone mineral density assessments. The power of Elaris EM-III and-IV was based on the comparison to placebo in Elaris EM-I and-II with an expected 25{\%} dropout rate. RESULTS: Between December 28, 2012, and October 31, 2014 (Elaris EM-III), and between May 27, 2014, and January 6, 2016 (Elaris EM-IV), 569 participants were enrolled. After 12 months of treatment, Elaris EM-III responder rates for dysmenorrhea were 52.1{\%} at 150 mg once daily (Elaris EM-IV550.8{\%}) and 78.1{\%} at 200 mg twice daily (Elaris EM-IV575.9{\%}). Elaris EM-III nonmenstrual pelvic pain responder rates were 67.8{\%} at 150 mg once daily (Elaris EM-IV566.4{\%}) and 69.1{\%} at 200 mg twice daily (Elaris EM-IV567.2{\%}). After 12 months of treatment, Elaris EM-III dyspareunia responder rates were 45.2{\%} at 150 mg once daily (Elaris EM-IV545.9{\%}) and 60.0{\%} at 200 mg twice daily (Elaris EM-IV558.1{\%}). Hot flush was the most common adverse event. Decreases from baseline in bone mineral density and increases from baseline in lipids were observed after 12 months of treatment. There were no adverse endometrial findings. CONCLUSION: Long-term elagolix treatment provided sustained reductions in dysmenorrhea, nonmenstrual pelvic pain, and dyspareunia. The safety was consistent with reduced estrogen levels and no new safety concerns were associated with long-term elagolix use.",
author = "Eric Surrey and Taylor, {Hugh S.} and Linda Giudice and Lessey, {Bruce A.} and Abrao, {Mauricio S.} and Archer, {David F.} and Diamond, {Michael Peter} and Johnson, {Neil P.} and Watts, {Nelson B.} and {Chris Gallagher}, J. and Simon, {James A.} and Carr, {Bruce R.} and {Paul Dmowski}, W. and Nicholas Leyland and Singh, {Sukhbir S.} and Tomasz Rechberger and Agarwal, {Sanjay K.} and {Rachel Duan}, W. and Brittany Schwefel and Thomas, {James W.} and Peloso, {Paul M.} and Juki Ng and Soliman, {Ahmed M.} and Kristof Chwalisz",
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TY - JOUR

T1 - Long-term outcomes of elagolix in women with endometriosis results from two extension studies

AU - Surrey, Eric

AU - Taylor, Hugh S.

AU - Giudice, Linda

AU - Lessey, Bruce A.

AU - Abrao, Mauricio S.

AU - Archer, David F.

AU - Diamond, Michael Peter

AU - Johnson, Neil P.

AU - Watts, Nelson B.

AU - Chris Gallagher, J.

AU - Simon, James A.

AU - Carr, Bruce R.

AU - Paul Dmowski, W.

AU - Leyland, Nicholas

AU - Singh, Sukhbir S.

AU - Rechberger, Tomasz

AU - Agarwal, Sanjay K.

AU - Rachel Duan, W.

AU - Schwefel, Brittany

AU - Thomas, James W.

AU - Peloso, Paul M.

AU - Ng, Juki

AU - Soliman, Ahmed M.

AU - Chwalisz, Kristof

PY - 2018/1/1

Y1 - 2018/1/1

N2 - METHODS: Elaris Endometriosis (EM)-III and-IV were extension studies that evaluated an additional 6 months of treatment after two 6-month, double-blind, placebocontrolled phase 3 trials (12 continuous treatment months) with two elagolix doses (150 mg once daily and 200 mg twice daily). Coprimary efficacy endpoints were the proportion of responders (clinically meaningful pain reduction and stable or decreased rescue analgesic use) based on average monthly dysmenorrhea and nonmenstrual pelvic pain scores. Safety assessments included adverse events, clinical laboratory tests, and endometrial and bone mineral density assessments. The power of Elaris EM-III and-IV was based on the comparison to placebo in Elaris EM-I and-II with an expected 25% dropout rate. RESULTS: Between December 28, 2012, and October 31, 2014 (Elaris EM-III), and between May 27, 2014, and January 6, 2016 (Elaris EM-IV), 569 participants were enrolled. After 12 months of treatment, Elaris EM-III responder rates for dysmenorrhea were 52.1% at 150 mg once daily (Elaris EM-IV550.8%) and 78.1% at 200 mg twice daily (Elaris EM-IV575.9%). Elaris EM-III nonmenstrual pelvic pain responder rates were 67.8% at 150 mg once daily (Elaris EM-IV566.4%) and 69.1% at 200 mg twice daily (Elaris EM-IV567.2%). After 12 months of treatment, Elaris EM-III dyspareunia responder rates were 45.2% at 150 mg once daily (Elaris EM-IV545.9%) and 60.0% at 200 mg twice daily (Elaris EM-IV558.1%). Hot flush was the most common adverse event. Decreases from baseline in bone mineral density and increases from baseline in lipids were observed after 12 months of treatment. There were no adverse endometrial findings. CONCLUSION: Long-term elagolix treatment provided sustained reductions in dysmenorrhea, nonmenstrual pelvic pain, and dyspareunia. The safety was consistent with reduced estrogen levels and no new safety concerns were associated with long-term elagolix use.

AB - METHODS: Elaris Endometriosis (EM)-III and-IV were extension studies that evaluated an additional 6 months of treatment after two 6-month, double-blind, placebocontrolled phase 3 trials (12 continuous treatment months) with two elagolix doses (150 mg once daily and 200 mg twice daily). Coprimary efficacy endpoints were the proportion of responders (clinically meaningful pain reduction and stable or decreased rescue analgesic use) based on average monthly dysmenorrhea and nonmenstrual pelvic pain scores. Safety assessments included adverse events, clinical laboratory tests, and endometrial and bone mineral density assessments. The power of Elaris EM-III and-IV was based on the comparison to placebo in Elaris EM-I and-II with an expected 25% dropout rate. RESULTS: Between December 28, 2012, and October 31, 2014 (Elaris EM-III), and between May 27, 2014, and January 6, 2016 (Elaris EM-IV), 569 participants were enrolled. After 12 months of treatment, Elaris EM-III responder rates for dysmenorrhea were 52.1% at 150 mg once daily (Elaris EM-IV550.8%) and 78.1% at 200 mg twice daily (Elaris EM-IV575.9%). Elaris EM-III nonmenstrual pelvic pain responder rates were 67.8% at 150 mg once daily (Elaris EM-IV566.4%) and 69.1% at 200 mg twice daily (Elaris EM-IV567.2%). After 12 months of treatment, Elaris EM-III dyspareunia responder rates were 45.2% at 150 mg once daily (Elaris EM-IV545.9%) and 60.0% at 200 mg twice daily (Elaris EM-IV558.1%). Hot flush was the most common adverse event. Decreases from baseline in bone mineral density and increases from baseline in lipids were observed after 12 months of treatment. There were no adverse endometrial findings. CONCLUSION: Long-term elagolix treatment provided sustained reductions in dysmenorrhea, nonmenstrual pelvic pain, and dyspareunia. The safety was consistent with reduced estrogen levels and no new safety concerns were associated with long-term elagolix use.

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