Long-Term Outcomes of Elagolix in Women With Endometriosis

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dc.contributorSistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSP
dc.contributor.authorSURREY, Eric
dc.contributor.authorTAYLOR, Hugh S.
dc.contributor.authorGIUDICE, Linda
dc.contributor.authorLESSEY, Bruce A.
dc.contributor.authorABRAO, Mauricio S.
dc.contributor.authorARCHER, David F.
dc.contributor.authorDIAMOND, Michael P.
dc.contributor.authorJOHNSON, Neil P.
dc.contributor.authorWATTS, Nelson B.
dc.contributor.authorGALLAGHER, J. Chris
dc.contributor.authorSIMON, James A.
dc.contributor.authorCARR, Bruce R.
dc.contributor.authorDMOWSKI, W. Paul
dc.contributor.authorLEYLAND, Nicholas
dc.contributor.authorSINGH, Sukhbir S.
dc.contributor.authorRECHBERGER, Tomasz
dc.contributor.authorAGARWAL, Sanjay K.
dc.contributor.authorDUAN, W. Rachel
dc.contributor.authorSCHWEFEL, Brittany
dc.contributor.authorTHOMAS, James W.
dc.contributor.authorPELOSO, Paul M.
dc.contributor.authorNG, Juki
dc.contributor.authorSOLIMAN, Ahmed M.
dc.contributor.authorCHWALISZ, Kristof
dc.date.accessioned2019-01-17T13:34:47Z
dc.date.available2019-01-17T13:34:47Z
dc.date.issued2018
dc.description.abstractOBJECTIVE: To evaluate the efficacy and safety of elagolix, an oral, nonpeptide gonadotropin-releasing hormone antagonist, over 12 months in women with endometriosis-associated pain. METHODS: Elaris Endometriosis (EM)-III and -IV were extension studies that evaluated an additional 6 months of treatment after two 6-month, double-blind, placebo-controlled 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-IV=50.8%) and 78.1% at 200 mg twice daily (Elaris EM-IV=75.9%). Elaris EM-III nonmenstrual pelvic pain responder rates were 67.8% at 150 mg once daily (Elaris EM-IV=66.4%) and 69.1% at 200 mg twice daily (Elaris EM-IV=67.2%). After 12 months of treatment, Elaris EM-III dyspareunia responder rates were 45.2% at 150 mg once daily (Elaris EM-IV=45.9%) and 60.0% at 200 mg twice daily (Elaris EM-IV=58.1%). 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.eng
dc.description.conferencedateOCT 28-NOV 01, 2017
dc.description.conferencelocalSan Antonio, TX
dc.description.conferencename73rd Scientific Congress and Expo of the American-Society-for-Reproductive-Medicine (ASRM)
dc.description.indexMEDLINEeng
dc.description.sponsorshipOvaScience
dc.description.sponsorshipPfizer
dc.description.sponsorshipBayer Healthcare
dc.description.sponsorshipAbbVie
dc.description.sponsorshipTherapeuticsMD
dc.description.sponsorshipEndoceutics
dc.description.sponsorshipGlenmark
dc.description.sponsorshipShionogi
dc.description.sponsorshipSymbio
dc.description.sponsorshipRadius
dc.description.sponsorshipShire
dc.description.sponsorshipActavis
dc.description.sponsorshipAgile Therapeutics
dc.description.sponsorshipNew England Research Institute
dc.description.sponsorshipNovo Nordisk
dc.description.sponsorshipPalatin Technologies
dc.description.sponsorshipSymbio Research
dc.description.sponsorshipBayer
dc.description.sponsorshipAllergan
dc.description.sponsorshipAstellas
dc.identifier.citationOBSTETRICS AND GYNECOLOGY, v.132, n.1, p.147-160, 2018
dc.identifier.doi10.1097/AOG.0000000000002675
dc.identifier.issn0029-7844
dc.identifier.urihttps://observatorio.fm.usp.br/handle/OPI/29984
dc.language.isoeng
dc.publisherLIPPINCOTT WILLIAMS & WILKINSeng
dc.relation.ispartofObstetrics and Gynecology
dc.rightsrestrictedAccesseng
dc.rights.holderCopyright LIPPINCOTT WILLIAMS & WILKINSeng
dc.subject.otherdepot medroxyprogesterone acetateeng
dc.subject.otheroral gnrh antagonisteng
dc.subject.otherquality-of-lifeeng
dc.subject.otherpaineng
dc.subject.otherburdeneng
dc.subject.othercostseng
dc.subject.wosObstetrics & Gynecologyeng
dc.titleLong-Term Outcomes of Elagolix in Women With Endometriosiseng
dc.typearticleeng
dc.type.categoryarticle; proceedings papereng
dc.type.versionpublishedVersioneng
dspace.entity.typePublication
hcfmusp.affiliation.countryEstados Unidos
hcfmusp.affiliation.countryisous
hcfmusp.author.externalSURREY, Eric:Colorado Ctr Reprod Med, 10290 Ridgegate Circle, Lone Tree, CO 80124 USA
hcfmusp.citation.scopus91
hcfmusp.contributor.author-fmusphcMAURICIO SIMOES ABRAO
hcfmusp.description.beginpage147
hcfmusp.description.endpage160
hcfmusp.description.issue1
hcfmusp.description.volume132
hcfmusp.origemWOS
hcfmusp.origem.pubmed29889764
hcfmusp.origem.scopus2-s2.0-85054503558
hcfmusp.origem.wosWOS:000442475500026
hcfmusp.publisher.cityPHILADELPHIAeng
hcfmusp.publisher.countryUSAeng
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