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ASSESSING THE ASSOCIATION OF OMALIZUMAB USE AND ARTERIOTHROMBOTIC EVENTS THROUGH SPONTANEOUS ADVERSE EVENT REPORTING
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Permanent Link: http://ufdc.ufl.edu/IR00000970/00001
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Title: ASSESSING THE ASSOCIATION OF OMALIZUMAB USE AND ARTERIOTHROMBOTIC EVENTS THROUGH SPONTANEOUS ADVERSE EVENT REPORTING
Physical Description: Conference Papers
Creator: Ayad K. Ali
Conference: 17th ISPOR International Annual Meeting
Publisher: International Society for Pharmacoeconomics and Outcomes Research (ISPOR)
Place of Publication: Lawrenceville, NJ, USA
Publication Date: June 2012
 Notes
Abstract: OBJECTIVES: Omalizumab is amonoclonal antibody, indicated for the treatment of severe allergic asthma. In Europe, there have been concerns about the cardiovascular safety of omalizumab. The objective of this study is to analyze the association between omalizumab and arterial thrombotic events (ATE) in spontaneous adverse drug reaction reporting database in the United States. METHODS: Reports of ATE submitted to the US Food and Drug Administration’s Adverse Event Reporting System (AERS) between 2004 and 2011 were retrieved and analyzed by the reporting odds ratio (ROR) data mining algorithm. The ROR of ATE for omalizumab was compared to specific asthma medications and all drugs in the AERS. Values of >1 are considered significant safety signals. Medical Dictionary for Regulatory Activities (MedDRA) Preferred Terms were used to retrieve ATE (e.g. stroke, myocardial infarction). RESULTS: A total of 293,783 reports of ATE were retrieved (about 2% of all ADR reports), corresponding to 2,274 asthma drug-event pairs (omalizumab, 222; inhaled corticosteroids (ICS), 131; long-acting beta-agonists (LABA), 102; single- device combination ICS/LABA, 506; inhaled short-acting beta-agonists (SABA), 475; oral SABA, 6; inhaled antimuscarnics (AMC), 477; single-device combination AMC/SABA, 127; xanthines, 50; leukotriene modifiers, 174; and mast cell stabilizers, 4). ROR and 95%CI values for omalizumab compared to other asthma drugs and all drugs in AERS were 2.75 (2.39-316) and 1.09 (0.95-1.24), respectively. Omalizumab ranked the second after ICS in the risk of ATE; followed by AMC, AMC/SABA, and ICS/LABA. CONCLUSIONS: Omalizumab is associated with higher than expected reporting of arterial thrombotic events in asthmatic patients. This hypothesis needs further testing in robust epidemiologic studies.
Acquisition: Collected for University of Florida's Institutional Repository by the UFIR Self-Submittal tool. Submitted by Ayad K Ali.
Publication Status: Published
General Note: Suggested Citation: Ali AK. Assessing the Association of Omalizumab Use and Arteriothrombotic Events through Spontaneous Adverse Event Reporting. Value in Health.June 2012;15(4):A51 Abstract No. PRS1
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Source Institution: University of Florida Institutional Repository
Holding Location: University of Florida
Rights Management: All rights reserved by the source institution.
System ID: IR00000970:00001

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core-setwerealsoobtainedbothatbaselineand4weekapart.Theseincludedtenderjointcount(outof28),swollenjointcount(outof28),physician'sandpa-tient'sglobalassessmentofdiseaseactivity,painscoreandWestergrenerythro-cytesedimentationrate(ESR).DiseaseactivitywasmeasuredusingtheDAS28score,whichwasobtainedatbaselineandattheendofthestudyforeachpatient.RESULTS: Themedianageofthe60studypatientswas48yr 6 9.5SDandthe mediandurationofsymptomswas17months 6 5.5SD.Thirtyofthesereceivedthe EnglishversionoftheHAQandtheother30receivedtheHindiversion.BaselineHAQvaluesforEnglishandHindigroupswere1.84 6 0.48and1.91 6 0.49,respectively.Aftertreatment,theHAQvalueschangedto0.71 6 0.42and0.62 6 0.51,respectively,demonstratingaverygoodsensitivitytochange(Student'sunpairedt-test: p 0.05).ConstructvaliditywasassessedusingPearson'scorrelationcoefcientbetweenthecorrespondingvaluesofHAQandDAS28,bothatbaseline(r 5 0.47, p 0.05)andafterintervention(r 5 0.60, p 0.01). CONCLUSIONS: Theseresultssupportthevalidity,andreliabilityoftheIND-HAQasameasurethatcapturestheimpactofRAonpatients'health-relatedqualityoflife.PMS93PAPERANDWEBEQUIVALENCEOFTHEENSEMBLEMDS-ATOOLUSEDTOCOLLECTPHENOTYPICINFORMATIONPRIORTOTREATMENTBushnellDM1,MccarrierKP2,MartinML2,PaczkowskiR3,ShenW3,BueschingD3 1HealthResearchAssociates,Inc.,MountlakeTerrace,WA,USA,2HealthResearchAssociates, Inc.,Seattle,WA,USA,3EliLillyandCompany,Inc.,Indianapolis,IN,USAOBJECTIVES: TheENSEMBLEMDSisabatteryofphenotypicgenericpatient-reportedinstrumentsdesignedforuseinclinicalstudiesorcomparativeeffective-nessresearch.Thecomponentinstrumentsassessbaselinepatientcharacteristicsthatarebelievedtobeeitherpredictors(healthstatus,illnessburden,depression,anxiety,andperceivedstress)oreffect-modifyingfactors(perceivedsocialstatus,objectivesocialstatus,perceivedsocialsupport,income)ofclinicaloutcomesand/ortreatmentresponse.WesoughttoevaluatetheequivalenceoftheMDSacrosstwodifferentmodesofadministrationpaperandweb. METHODS: This studywasadatacollectioneffortthatusedarandomizedcross-overdesignintheUnitedStates(English)andSingapore(SimpliedChinese).Participantswereout-patientswithaclinicaldiagnosisofoneofvetargetedhealthconditions:depres-sion,type2diabetes,psoriasis,rheumatoidarthritisandchronickidneydisease.ThoseenrolledwererandomizedtoinitiallycompletetheMDSonpaperorwebformat,andreturned24hourslatertocompletethealternateformat.Equivalencewasevaluatedbytheintraclasscorrelationcoefcient(ICC)withequivalencyde-nedatorabovetheminimalacceptablelevelof0.70.Theseanalyseswereper-formedindividuallyforeachofthenineMDScomponentmeasures. RESULTS: A totalof314participants(258inUS,56inSingapore)wereanalyzed.IntheUS,meanagewas49 6 13years,61%werefemale;inSingaporemeanagewas57 6 12,59% female.TheICCsbetweenpaperandwebadministrationofthedifferentcompo-nentsoftheENSEMBLEMDSrangedbetween0.74and0.98intheUS,andbetween0.75and0.97inSingapore. CONCLUSIONS: EquivalencebetweenpaperandwebbasedadministrationoftheENSEMBLEMDSwasdemonstratedstatisticallyfortheUS-EnglishVersionandtheChineseversionforSingapore,indicatingstabilityofsubjectcomprehensionandresponsepatternsacrosstwomodesofadministrationintwodifferentlanguagesandcultures.PMS94INTEGRATINGPATIENT-REPORTEDOUTCOMES(PRO)ANDMEDICALRECORDDATA(MR)INOBSERVATIONALSTUDYDESIGNS:RESULTSFROMADIRECT-TO-PATIENTPILOTSTUDYINGOUTCascadeE1,MarrP2,WinslowM3,TuttleD2 1MediGuard.org,Rockville,MD,USA,2OutcomesHealthInformationSolutions,Marietta,GA, USA,3QuintilesGlobalConsulting,Durham,NC,USAOBJECTIVES: Thegrowthinpatientempowermentandincreaseinon-linepatient poolshasgivenrisetonewdirect-to-patientresearchmethods(i.e.,directrecruit-mentofpatients,withoutphysiciansites).Onekeyconcern,however,istheab-senceofphysician-reporteddatatovalidatediagnosisandprovideotherstudydata.Theobjectiveofthisstudywastoemployadirect-to-patientapproachtocollectpatient-reportedoutcomes(PRO)andmedicalrecord(MR)information.METHODS: InJuly2011,arandomsampleofUSMediGuard.orgmembersage18to 80wereinvitedtoparticipateviaemailbasedonagouttreatmentordiagnosisintheirprole.Interestedmembersclickedonanemaillinktoaccessstudyinforma-tionandscreenbasedonself-reporteddiagnosisandwillingnesstoreleasemedicalrecords.Therst50consentingparticipantscontinuedontocompleteanonlinesurveyandelectronicandpapermedicalreleaseforms.CompletedformswereprovidedtoOutcomesHealthInformationSolutionstocontactphysiciansandobtainparticipantcharts. RESULTS: Atotalof120membersclickedon1250emails sent(9.6%).5members(4%)explicitlydeclinedtoparticipateduetothemedicalrecordrequirement,althoughthiscouldbeashighas38%ifallindividualsclosingthebrowserareincluded.Ofthe50participantscompletingtheon-linesurveyandelectronicrelease,42(84%)returnedthepaperform.Withtheseforms,weobtained38of50charts(76%):28of38(74%)withelectronicand10of38(26%)withpaper;35chartshadagoutdiagnosisandanadditional2hadagoutmedication;only1chartwasmissinganymentionofgout. CONCLUSIONS: PatientscanberecruiteddirectlyforobservationalstudydesignsthatincludePROandMRdatawithover75%datacompleteness.Althoughconcernexistsregardingvalidityofself-reporteddi-agnosis,inthisPRO 1 MRpilot,nearlyall(37of38)chartsconrmedpatient-reporteddata. RESPIRATORY-RELATEDDISORDERSClinicalOutcomesStudies PRS1ASSESSINGTHEASSOCIATIONOFOMALIZUMABUSEANDARTERIOTHROMBOTICEVENTSTHROUGHSPONTANEOUSADVERSEEVENTREPORTINGAliAK UniversityofFlorida,Gainesville,FL,USAOBJECTIVES: Omalizumabisamonoclonalantibody,indicatedforthetreatmentof severeallergicasthma.InEurope,therehavebeenconcernsaboutthecardiovas-cularsafetyofomalizumab.Theobjectiveofthisstudyistoanalyzetheassociationbetweenomalizumabandarterialthromboticevents(ATE)inspontaneousadversedrugreactionreportingdatabaseintheUnitedStates. METHODS: ReportsofATE submittedtotheUSFoodandDrugAdministration'sAdverseEventReportingSystem(AERS)between2004and2011wereretrievedandanalyzedbythereportingoddsratio(ROR)dataminingalgorithm.TheRORofATEforomalizumabwascomparedtospecicasthmamedicationsandalldrugsintheAERS.Valuesof 1 areconsideredsignicantsafetysignals.MedicalDictionaryforRegulatoryActivi-ties(MedDRA)PreferredTermswereusedtoretrieveATE(e.g.stroke,myocardialinfarction). RESULTS: Atotalof293,783reportsofATEwereretrieved(about2%of allADRreports),correspondingto2,274asthmadrug-eventpairs(omalizumab,222;inhaledcorticosteroids(ICS),131;long-actingbeta-agonists(LABA),102;sin-gle-devicecombinationICS/LABA,506;inhaledshort-actingbeta-agonists(SABA),475;oralSABA,6;inhaledantimuscarnics(AMC),477;single-devicecombinationAMC/SABA,127;xanthines,50;leukotrienemodiers,174;andmastcellstabilizers,4).RORand95%CIvaluesforomalizumabcomparedtootherasthmadrugsandalldrugsinAERSwere2.75(2.39-316)and1.09(0.95-1.24),respectively.OmalizumabrankedthesecondafterICSintheriskofATE;followedbyAMC,AMC/SABA,andICS/LABA. CONCLUSIONS: Omalizumabisassociatedwithhigherthanexpected reportingofarterialthromboticeventsinasthmaticpatients.Thishypothesisneedsfurthertestinginrobustepidemiologicstudies.PRS2EVALUATINGTHEINCIDENCEOFSIDEEFFECTSINNEWLYDIAGNOSEDTUBERCULOSISPATIENTSOFKHYBERPAKHTOONKHUWASairaAzharDSA,AroojSahirAS,RabeehaKhanRK,MairaFaizullahShahMFS, IzharHussainIHCOMSATAbbottabad,Abbottabad,KPK,PakistanOBJECTIVES: Toevaluatetheincidenceofvarioussideeffectsinnewlydiagnosed tuberculosispatientsofKhyberPakhtoonKhuwa. METHODS: Quantitativestudy wasconductedtoevaluatetheincidenceofsideeffectsintuberculosispatients.DatawascollectedfromMedicine,Infectiousdiseases,andchestandgastroenter-ologyunitoftheAyubTeachingHospitalandT.BcenteratDHQHospitalofKPK.Atotalof125randomnewlydiagnosedpatientswereincludedinthestudieswhichweregiven1stlineATTwhichincludeRifampicin,Pyrazinamide,IsoniazidandEthambutol.This4drugregimenwasgiventoinitiatethetherapy.Aformalcon-sentwastakenfromthepatientortheattendant.Thepatientswereexaminedforsignsofpreviousliverorkidneydiseasebyphysicalexamination.LiverfunctiontestsandurineRE,aswellasbloodCPandhematologicalinvestigations. RESULTS: Patientsweregiven4drugregimei.e.,isoniazid(INH),rifampicin,pyrazinamideandethambutol.Atotalof31.97%patientsexperiencednausea;25.4%patientsexperiencedanorexia;13%patientsexperiencedvomiting;and11.4%patientsex-perienceddiarrhea.Hypersensitivityreactionwerealsonoticed,12.3%peoplesuf-feredfromfever.Skinrasheswereexperiencedby16(13.11%)patients.Hepatotox-icitywasseenin9.01%patients;(0.82%)patientssufferedfromthrombocytopeniawhowasafemale;1.64%patientsexperiencedrenalfailure;1(50%)wasamaleand1(50%)wasafemale;and99.18%patientsexperiencedurinarydiscolourationoutofwhich81(66.94%)weremalesand34(28.1%)werefemales.Twopatients(1.64%)experiencedacne,bothweremales. CONCLUSIONS: VariousadverseeffectsofAnti TuberclosisTherapyhavebeenobservedinthepatientsrangingfromtheminorsymptomslikeskinrashesandGIdisturbancestoseriouseffectslikerenalfailure,hepatotoxicity,thrombocytopenia,hyperuricemiawhichmaybefatal.Thereisaneedofoptimalpatientcareduringtheperiodoftherapy.Manyofthesesideeffectscanbeavoidedbyalteringtheregimenandpropercounseling.PRS3INHALEDANTICHOLINERGICSANDRISKOFALL-CAUSEMORTALITYINPATIENTSWITHCHRONICOBSTRUCTIVEPULMONARYDISEASE:ASYSTEMATICREVIEWANDMETAANALYSISOFRANDOMIZEDCONTROLLEDTRIALSAjmeraMR,RanePB,KelleyG,SambamoorthiU WestVirginiaUniversity,Morgantown,WV,USAOBJECTIVES: Inhaledanticholinergicsareimportantpharmacologicinterventions inthemanagementofChronicObstructivePulmonaryDisease(COPD)withtiotro-piumbromidebeingthemostprescribedCOPDmedication.Concernsregardingitsassociationwithcardiovascularadverseeventshavebeenraised.Theobjectiveofthisstudywastoassesstheriskofall-causemortalityassociatedwithinhaledanticholinergicsamongCOPDpatientsusingsystematic-reviewwithmeta-analy-sistechniques. METHODS: Asystematicliteraturesearchwasconductedusingsix electronicdatabases(PubMed,Scopus,Web-of-Science,Web-ofKnowledge,Co-chraneCentralRegisterofControlledTrialsandProquest)andcross-referencing.Studiesmeetingthefollowingeligibilitycriteriawereselected:1)randomizedcon-trolledtrials(RCTs)withmortalitydata;2)adultsagedgreater 35yearswithCOPD ofanyseverity;3)inhaledanticholinergics(ipratropiumbromideortiotropiumbromide)withaminimumfollow-upof4weeks;and4)placebooractivecontrolgroup.Studiesincludingasthmapatientswereexcluded.Dataextractionwasper-A51 VALUEINHEALTH15(2012)A1A256