patientslikeme epilepsy community: factors affecting quality of...
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Symptoms
• Symptomsmostfrequentlyrecordedasmoderateorseverewerememoryproblems,problemsconcentrating,fatigue,andsomnolence(Figure1)
Figure 1. Severity of Symptoms at First Evaluation (n=2,135)
SideEffects
• Themostfrequentlyrecordedsideeffectsperceivedbythepatientsasassociatedwiththeirtreatmentweresomnolence,fatigue,andmemoryimpairment(Table3)
Table 3. Side Effects Perceived to be Associated with Any Treatment (Recorded by ≥5% Patients; n=639)
Side effect (MedDRApreferredterm)
Patients n (%)
Somnolence 148(23.2)
Fatigue 110(17.2)
Memoryimpairment 88(13.8)
Dizziness 74(11.6)
Abnormalweightgain 67(10.5)
Depression 48(7.5)
Insomnia 39(6.1)
Nausea 36(5.6)
Headache 35(5.5)
Balancedisorder 32(5.0)
MedDRA,MedicalDictionaryforRegulatoryActivitiesSideeffectsduetomedicationandemergingsymptomsofdiseaseareoftendifficulttodistinguishandthereforemustbecarefullyevaluatedAsinglepatientmayhavereportedmorethanoneperceivedsideeffect
ResultsDemographicandEpilepsyCharacteristics• 3,073registeredpatientsrecordedadiagnosisofepilepsyandhadmultipleseizures(Table2):
– 69.5%completedthepresetsymptomschecklist
– 36.2%completedapatient-reportedoutcomes(PROs)assessment
– 20.8%patientsreported≥1sideeffecttheyperceivedasbeingtreatment-related
Table 2. Patient Demographic and Epilepsy Characteristics
Parametera Epilepsy population
N=3,073
Symptoms population
n=2,135
PRO and symptoms population
n=1,113
Gender,n 2,929 2,107 1,113
Female,% 71.5 73.2 72.3
Age,n 2,909 2,095 1,112
Mean(SD),years 37.8(12.7) 37.6(12.6) 37.8(12.3)
Ageclass,%
0–20years 7.3 7.1 6.2
21–50years 76.3 76.8 77.6
>50years 16.4 16.2 16.2
Timesincediagnosis,n 3,044 2,130 1,113
Mean(SD),years 17.7(14.1) 17.4(13.8) 17.7(13.6)
Ageatfirstseizure,n 2,906 2,095 1,112
Mean(SD),years 17.2(13.5) 17.1(13.3) 16.5(13.0)
Seizuretypeb,n 3,073 2,135 1,113
Generalized,% 23.7 28.3 30.7
Partial,% 23.7 29.1 33.6
Mixed,% 28.0 33.4 35.0
Unknown,% 24.7 9.2 0.6
AEDtreatmentc,d,n 1,773 1,593 1,009
Monotherapy,% 51.4 50.3 47.7
Polytherapy,% 48.6 49.7 52.3
NewerAEDsonly,% 56.4 56.4 56.3
OlderAEDsonly,% 19.8 19.4 17.9
CombinationofnewerandolderAEDs,% 23.8 24.2 25.8
Co-morbiditiese,n 2,271 1,769 986
Patientswith≥1co-morbidcondition,% 53.9 54.8 55.7
Migraine,% 28.1 28.6 28.4
Anxietydisorder,% 17.6 17.9 18.1
Majordepressivedisorder,% 13.9 14.6 15.4
Hypertension,% 10.5 10.7 11.4
AED,antiepilepticdrug;PRO,patient-reportedoutcome;SD,standarddeviationaNotallparameterswerecompletedbyallpatientsbSeizuretypeinlifetimecPatientsthatreported≥1AEDdMembersofthePatientsLikeMeEpilepsyCommunitywhodonotself-reportAEDtreatmentmaytakenoAED(s)ormayhavenotreportedtheirtreatmenteCo-morbiditiesrecordedby≥10%ofthepatientsfromapresetco-morbiditychecklist
Introduction• PatientsLikeMe,whichhostsafreeonlinecommunityforpatientswithepilepsy,wasdevelopedinpartnershipwithUCBandlaunchedinJanuary2010
• Previousdataanalyses(March20101,September20102,andMay20113,4)providedinsightsintothecharacteristicsandexperiencesofuserswithepilepsy
MethodsStudyPopulation•CommunitymemberswhologgedinbetweenJanuary2010–November2011andreporteddiagnosisofepilepsyandmultipleseizures
DataCollected• Demographics,epilepsycharacteristics,symptoms(presetsymptomschecklist;Table1;Figure1),andsideeffectspatientsperceivedtoberelatedtotheirtreatment
Patient-Reported Outcomes
•QOLIE-31/P(QualityofLife[QoL]inEpilepsy)totalscore5:Epilepsy-specificqualityoflifeinstrument(scorerange=0–100;100representsbesthealthstatus)
• HADS(HospitalAnxietyandDepressionScale):Anxietyanddepressioninstrument6(scorerange=0–21;0representsbestanxietyordepressionstatus)
• EQ-5D(Euro-QoL5dimensions)utilityscore7:Generichealthstatusinstrument(scorerange=0–1;1representsbesthealthstatus)
LogisticRegressionAnalysis•MultivariatelogisticregressionanalysistoidentifyvariablesassociatedwithpoorHRQoL(<Quartile1[Q1]ofQOLIE-31/PtotalscoreorEQ-5Dutilityscore;Table1)
Table 1. Variables Included in Multivariate Logistic Regression Analysis
Variable Levels (vs reference level)
SociodemographicAge >25–50,>50yearsvs0–25 yearsGender FemalevsMaleBodymassindex 0–18.5,>25vs>18.5–25Epilepsy-relatedDurationsincediagnosis 0–1,>1–10yearsvs>10 yearsTypeofepilepsysyndrome Focal,UnidentifiedvsGeneralized
SeizuresOccurrenceofseizuresin4weeksprecedingPROassessment
TC,Non-TC,MissingvsNone
SymptomsSeverityofeachsymptomfromthesymptomchecklist(anxiety,depression,fatigue,headache,insomnia,memoryproblems,pain,problemsconcentrating,andsomnolence)
Moderate&severevsNone & mild
AED treatmentTypeofcurrentAEDs Combinationofoldera&newerb,
Newermonotherapy,Newerpolytherapy,Oldermonotherapy,MissingvsOlder polytherapy
Side effectsModerateandseveresideeffectsin4weeksprecedingPROassessment
YesvsNo
Co-morbiditiesNumberofco-morbidities 1,2+,Missingvs0
AED,antiepilepticdrug;PRO,patient-reportedoutcome;TC,tonic-clonicaOlderAEDs:acetazolamide,benzodiazepines,carbamazepine,ethosuximide,methsuximide,phenobarbital,phenytoin,sultiame,valproicacidbNewerAEDs:felbamate,gabapentin,lacosamide,levetiracetam,lamotrigine,oxcarbazepine,pregabalin,rufinamide,retigabine,tiagabine,topiramate,vigabatrin,zonisamide
EQ-5D
• 263/1,113(23.6%)patientsincludedinthemultivariatelogisticregressionanalysiswereclassifiedashavingpoorHRQoL(EQ-5DUtilityScore<Q1)(Figure4)
Figure 4. Predictors of Low EQ-5D Utility Score (<Q1)a
CorrelationBetweenQOLIE-31/PTotalScoreandHADSSubscores
•QOLIE-31/PtotalscorewashighlycorrelatedtoHADSAnxiety(R=0.6214)andDepression(R=0.6919)scores(Figure2)
Figure 2. Correlation Between QOLIE-31/P Total Score and HADS Anxiety and Depression Scores (n=1,113)
PredictorsofPoorHealth-RelatedQualityofLife
QOLIE/31P
• 279/1,113(25.1%)patientsincludedinthemultivariatelogisticregressionanalysiswereclassifiedashavingpoorHRQoL(QOLIE-31/Ptotalscore<Q1)(Figure3)
Figure 3. Predictors of Low QOLIE-31/P Total Score (<Q1)a
PatientsLikeMe® Epilepsy Community: Factors Affecting Quality of LifeSimonBorghs1,ChristinedelaLoge1;SvetlanaDimova1;TracyDurgin2;GeorgePhillips3;KnutMueller4;CandiceLafosse5;PaulWicks6
1UCBPharma,Brussels,Belgium;2UCBPharma,Smyrna,GA,USA;3UCBPharma,Raleigh,NC,USA;4UCBPharma,Monheim,Germany;5KeyrusBiopharma,Levallois-Perret,France;6PatientsLikeMeInc,Cambridge,MA,USA
AcknowledgementsTheauthorswouldliketothankallthepatientswhohavecontributedtothisworkbysharingtheirdataSallyCotterill,PhD(QXVCommunications)assistedwithposterdevelopment,whichwasfundedbyUCBPharmaArtworkwassupportedbyQXVCommunications,partoftheInforMedgroup
DisclosureSupportedbyUCBPharmaSimonBorghs,SvetlanaDimova,TracyDurgin,GeorgePhillipsandKnutMuellerareemployeesofUCBPharmaSvetlanaDimovaownsstock/stockoptionsinthecompanyChristinedelaLogewasanemployeeofUCBPharmaatthetimethatthestudywascarriedoutCandiceLafosseisanemployeeofKeyrusBiopharma,Levallois-Perret,FrancePaulWicksisanemployeeofPatientsLikeMeandownsstockoptionsinthecompany.ThePatientsLikeMeR&DteamhasreceivedresearchsupportfromAbbott,Acorda,Avanir,Biogen,Johnson&Johnson,Merck,Novartis,SanofiandUCB
References1. delaLogeetal.AES2010,Abstract1.305,www.aes.org2. delaLogeetal.AES2011,Abstract2.271,www.aes.org3. Dimovaetal.AbstractP01.062,AAN2012,Neurology2012;78(Suppl.1);www.neurology.org4. delaLogeetal.ValueHealth2012;15:A147–A1485. CramerJA,etal.Epilepsia1998;39:81–86. ZigmondAS,SnaithRP.ActaPsychiatrScand.1993;67:361–707. TheEuroQolGroup.HealthPolicy1990;16:199–208
Conclusions • BasedonreportsbyusersofthePatientsLikeMeEpilepsyCommunity,memoryproblems,fatigueandsomnolencewerethemostfrequentlyoccurringsymptomsandperceivedtreatment-relatedsideeffects
• ThemostpredictivefactorsforpoorHRQoL(oddsratio>2;p<0.05)differedaccordingtotheinstrumentused:
– QOLIE-31/P:moderate/severeproblemsconcentrating,depression,memoryproblems,andsideeffects;occurrenceofgeneralizedtonic-clonicseizuresandepilepsyduration≤1year
– EQ-5D:pain,depressionandco-morbidities
• VariationsinthepredictorshighlightdifferencesinthecontentofQOLIE-31/PandEQ-5D–eachcoversdifferentdimensionsofpatienthealthandusesdifferentweightingtoderivetheirsummaryscore
• Theseresultssuggestthataholisticapproachnotlimitedtoseizurecontrolshouldbeconsideredwhentreatingpeoplewithepilepsy
P03.122
Per
cent
of p
atie
nts
None (1) Mild (2) Moderate (3) Severe (4) Mean
Mea
n se
verit
y
0
10
20
30
40
50
60
70
80
90
100
AnxietyFatigue PainProblemsconcentrating
HeadachesDepressionMemoryproblems
Somnolence Insomnia
42.4
26.1
14.9
30.132.9
16.1
50.0
18.3
31.8
25.2
32.5
24.9
33.4 30.4
30.1
23.5
31.8
34.7
20.3
28.3
37.7
27.7 25.0
37.1
19.0
35.9
25.2
12.013.0
22.6
8.711.8
16.7
7.514.1
8.3
1
4
3
2
100
90
80
70
60
50
40
30
20
10
0
0 105 15 5 15
HADS Anxiety score
R2 = 0.3861 R2 = 0.4787
QO
LIE
-31/
P T
otal
sco
re
QO
LIE
-31/
P T
otal
sco
re
HADS Depression score
20
100
90
80
70
60
50
40
30
20
10
0
0 10 20
Variable Patients (n)
Duration since diagnosis 0–1 years 104
>1–10 years 349
>10 years 660
Anxiety None/mild 742
Moderate/severe 371
Moderate and severe side effectsduring last 4 weeks
No 1019Yes 94
Depression
aMedian (Q1–Q3) QOLIE-31/P total score: 51.0 (37.3–65.6)Wald Chi-Square of complete logisitic regression model: 235.41 (p<0.0001)p-values: *<0.05; **<0.01; ***<0.001AED, antiepileptic drug; PRO, patient-reported outcome
None/mild 718
Moderate/severe 395
Level(reference level)
Fatigue None/mild
Moderate/severe
None/mild
Moderate/severe
Memory problems
560
553
485
628
Odds ratio (95% confidence interval)
Problems concentrating None/mild
Moderate/severe
547
566
Type of AEDs Older polytherapy
Combination of older and newer
38
268
No AED
Newer monotherapy
63
Missing 26
340
Newer polytherapy
Older monotherapy
236
142
No seizuresOccurence of seizures in 4 weeks preceding PRO assessment
458
124
Missing
****
**
*
***
***
*
*
**
*
***
****
104
≥1 tonic-clonic seizure
≥1 seizure (not tonic-clonic) 427
0 2 4 6
Variable Patients (n)
Epilepsy syndrome Generalized epilepsy 392
Focal epilepsy 465
256
Number of co-morbidities 0 433
1 274
2+ 275
Missing 131
Anxiety None/mild 742
Moderate/severe 371
Depression None/mild 718
Moderate/severe 395
Unclassified
Level(reference level)
Pain None/mild
Moderate/severe
840
273
Insomnia None/mild
Moderate/severe
768
345
Problems concentrating None/mild
Moderate/severe
547
566
Odds ratio (95% confidence interval)
*
**
***
***
*
***
***
*
*
aMedian (Q1–Q3) EQ-5D utility score: 0.8 (0.7–0.8)Wald Chi-Square of complete logisitic regression model: 234.48 (p<0.0001)p-values: *<0.05; **<0.01; ***<0.001
6420 8
Posterpresentedatthe65thAmericanAcademyofNeurologyAnnualMeeting,SanDiego,CA,USA,16–23March2013
Objective• ToassesstheimpactofepilepsyonthequalityoflifeofmembersofthePatientsLikeMeEpilepsycommunity