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ORIGINAL ARTICLE

Long-term follow-up reveals a low

persistence rate of abobotulinumtoxinA

injections for idiopathic overactive bladder

Efficacité et tolérance à long terme des injections d’abobotulinumtoxinA dans le traitement de l’hyperactivité vésicale idiopathique

M. Baron

a,∗

, A. Aublé

a

, F. Paret

b

, C. Pfister

a

, J.-N. Cornu

a

aUrologyDepartment,RouenUniversityHospital,1,ruedeGermont,76031Rouencedex1, France

bUrologyDepartment,NantesUniversityHospital,1,placeAlexis-Ricordeau,44000Nantes, France

Received29March2020;accepted28July2020 Availableonline2September2020

KEYWORDS

OnabotulinumtoxinA;

AbobotulinumtoxinA;

Idiopathicoveractive bladder;

Urinaryincontinence;

Detrusoroveractivity

Summary

Introduction.—Littleisknownaboutlong-termefficacyandtoleranceofintra-detrusorinjec- tionsofabobotulinumtoxinAformanagementofidiopathicoveractivebladder(OAB).Wereport long-termefficacyandcomplianceofabobotulinumtoxinAinpatientstreatedforOAB.

Methods.—AllpatientstreatedwithabotulinumtoxinAforOABinatertiaryreferencecentre between2005and2012wereincludedinaretrospectiveanalysis.Patientsreceived150,250 or500UofabotulinumtoxinAasfirstinjection.Theprimaryendpointwasthediscontinuation rateat5years.Otheroutcomesofinterestwere:rateoffailure,reasonsfordiscontinuation andsubsequenttreatmentelectedinthosewhodidnotpersistwithabobotulinumtoxinA.

Results.—Fifty-ninepatients(50womenand9men)wereincluded.Forty-onepatients(69.4%) received250UofabobotulinumtoxinAasfirstinjection.Thirteenpatients(22%)received500U and5(8.4%)received150UofBoNT-A.Medianfollow-upwas83.6months[0.3—183.6].Median numberofinjectionsperpatientwas2[1—15]andmedianreinjectionintervalwas10.7[3—86.4]

months.Theestimated5-yeardiscontinuation-freesurvivalratewas23.4%.Fourteenpatients (23.7%)experiencedpersistentimprovementofsymptomsand12patients(20.3%)stoppedthe injectionsbecauseoftolerability issues.Maincause ofdiscontinuationwas primaryfailure, whichoccurredin21patients(35.5%).

Correspondingauthorat:UrologyDepartment,RouenUniversityHospital,1,ruedeGermont,76031Rouencedex1,France.

E-mailaddress:maximilienbaron@hotmail.com(M.Baron).

https://doi.org/10.1016/j.purol.2020.07.242

1166-7087/©2020ElsevierMassonSAS.Allrightsreserved.

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Conclusion.—Overall, 59.3% ofpatients were successfully treatedwith first abobotulinum- toxinA injection. Although the estimated 5-year discontinuation-free survival rate is low, abobotulinumtoxinAcouldbeconsideredasanalternativeoff-labelledinpatientsnotrespon- derstoonabotulinumtoxinAafterfailureofotherconservativemeasures.

Levelofproof.—3.

©2020ElsevierMassonSAS.Allrightsreserved.

MOTSCLÉS

OnabotulinumtoxinA; AbobotulinumtoxinA; Hyperactivité vésicale idiopathique; Incontinenceurinaire

Résumé

Introduction.—Il existe peu de données sur la tolérance et l’efficacité à long terme de l’abobotulinumtoxinA(DysportTM)dansletraitementdel’hyperactivitévésicaleidiopathique (HAVi).Nousrapportonsnotreexpériencedel’utilisationdecettetoxine.

Matérielsetméthodes.—L’ensemble des patients traités par injection d’abotulinumtoxinA pourHAVientre2005et2012auseindenotrecentreontétéinclusrétrospectivement.Les patientsrec¸urent150,250ou500Ud’abobotulinumtoxinAlorsdeleurpremièreinjection.Le critèredejugementprincipalétaitletauxd’arrêtdutraitementà5ans.Étaientégalement évalués: letaux d’échec,lesraisons d’arrêt dutraitementet la nécessitéd’untraitement ultérieur.

Résultats.—Cinquante-neufpatientsontétéinclus(50femmeset9hommes).Quarante-et-un patients(69.4%)rec¸urent250Ud’abobotulinumtoxinAenpremièreinjection.Lesuivimédian était de83.6 mois[0.3—183.6].Le nombre médiand’injections était de2[1—15]. Le taux d’arrêtdelatoxineà5ansétaitde23.4%.Laprincipalecaused’interruptionétaitl’échecpri- maire(n=21,35.5%).Parmilesautrescauses,14patients(23.7%)ressentirentuneamélioration persistantedessymptômesaprèsuneinjectionet12(20.3%)n’ontpastolérélesinjections.

Conclusion.—Au total, 59,3 % des patients ont été améliorés par une première injection d’abobotulinumtoxinA. Bien que le taux de patients toujours traités à 5 ans soit faible, l’abobotulinumtoxinA pourrait êtreconsidérée comme unealternative, horsAMM, chez les patientsnonrépondeursàl’onabotulinumtoxinAaprèséchecdesautrestraitementsconserva- teurs.

Niveaudepreuve.— 3.

©2020ElsevierMassonSAS.Tousdroitsr´eserv´es.

Introduction

Overactive bladder (OAB) is defined as the presence of urinaryurgencyusuallyassociatedwithfrequencyandnoc- turia, with or without urgency urinary incontinence [1].

Idiopathicoveractivebladder(iOAB)ishighlyprevalentand greatlyimpactshealth relatedqualityoflife(HRQOL) and workproductivity[2—4].Whenconservativemeasures and medicaltreatmenthavefailed,intra-detrusorinjectionsof botulinumtoxinA(BoNT-A)canbeproposedasasecondline treatment[5].

Two different molecules are currently available in France for intra-detrusor injections: onabotulinumtoxinA and abobotulinumtoxinA marketed underthe brand name BotoxTM (Allergan Pharmaceuticals, Irvine, Ca, USA) and DysportTM (Ipsen Biopharm Ltd., Wrexham, UK), respec- tively.InFrance,onabotulinumtoxinAwasauthorisedin2012 forneurogenicOAB(nOAB)andin2014foriOABassociated withurinaryincontinence[6].Beforethat,bothtoxinswere usedoff-labelledin tertiaryreferencecentres[5].Abobo- tulinumtoxinAhasshown goodshort-termresultsfor iOAB management[7,8]withimprovementinqualityoflifeand symptomsscore.Nonetheless,duetothelackofrandomised

controlledtrials,abobotulinumtoxinAwasnotlabelledand wasthereforenotproposedfornewpatientsafter2012.

AbobotulinumtoxinAhasbeenrecentlybroughttolightby recentstudiesthatsuggestedanefficacyofabobotulinum- toxinA in case of failure of onabotulinumtoxinA in nOAB [9,10]. Recentreports showthatafter5 years,twothirds ofpatientstreatedwithonabotulinumtoxinAinjectionsfor iOABstoptheirtreatmentbecauseofalackofefficacy(20%) or due to side effects (43%) [11]. In this era of renewed interest for abobotulinumtoxinA, it occurs that long-term dataafterrepeatedabobotulinumtoxinAinjectionsremain scarce.

Our aim was to assess the long-term compliance with repeated abobotulinumtoxinA injections in patients with iOAB with or without detrusoroveractivity (DO). We also reportreasonsfordiscontinuationandlong-termefficacy.

Patients and methods Study design

Allpatientswhohadfailedconservativemeasures (includ- ingatleasttwooralantimuscarinics)andweretreatedwith

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abobotulinumtoxinAforiOABinatertiaryreferencecentre between 2005 and 2012 were included in a retrospective analysis.Patients were identifiedthrough a chartreview, usingthenationalcodingsystemforsurgicalacts.Patients withinterstitialcystitis,bladderpainsyndrome,chronicuri- naryretentionornOABwereexcluded.

After failure of conservative measures, patients were proposed for BoNT-A injection or sacral neuromodulation (SNM),according topatient’s preference, becauseoffail- ure or adverse events of conservative measures. Before BoNT-Atreatment, anurodynamic studywasperformedin most cases. Patients were systematically trained to per- formcleanintermittentself-catheterisation(CISC)priorto surgery.Allpatients weregiven oraland writteninforma- tion about BoNT-A injections including expected efficacy andside effects. They were asked tostop their antimus- carinic medication prior to the injection. The work was conductedinaccordancewiththeprinciplesoftheDeclara- tionofHelsinkiandwasapprovedbylocalEthicscommittee (protocolEH2020-08).

Injection technique

Injectionswereperformedbythesamesurgeon,underlocal anaesthesia or general anaesthesia depending on patient preference in an outpatientprocedure. Abobotulinumtox- inAwaspreviouslyreconstitutedwith0.9%normalsalineto adosageof 25U,50Uor 15Upermillilitres.Firstinjec- tionswereperformedwith500Uaccordingtodosageusedin firstpublications[12,13].Afterpublicationofdatasuggest- ing100UasthestandarddoseofonabotulinumtoxinAand the conversion ratio of 1/3 between onabotulinumtoxinA andabobotulinumtoxinAof3/1in2008[14],250Udosage wasusedforfirstinjection.Ifpatientsdidnotwanttoper- formCISC,an injectionof125 Uwasproposed.The toxin wasthen injected supra-trigonally intothe detrusormus- cle in 20 injection points of 1mL each. After 2012, only labelledonabotulinumtoxinAwasusedforfirstinjectionin ourcentre.

Outcomes evaluation

Preoperativedatawerecollectedinelectronicrecordsand included medical history, 3-day bladder diary, andurody- namicresults.Dataaboutinterventionwereretrievedfrom electronic chart including date, type of anaesthesia and doseoftoxin.

Afterfirstinjectionorafterswitchtoahigherdosageof BoNT-A,allpatientswerescheduledforapostoperativevisit atday10forevaluationofurinaryflowrate,andpost-void residualestimation.Ifpost-voidresidualvolumewashigher than200mL,patientswereaskedtoperformCISC.Efficacy wasestimatedat 6weeksbasedona3-day bladderdiary.

Incase offailure,arepeatinjectionof thesametoxin at ahigherdosage(500Uafter250Uand750Uafter500U) wasproposedatleastthreemonthsafterthefirstinjection.

After2012and2014,patientswereproposedtogoonwith thesametoxinortoswitchtoonabotulinumtoxinA.Patients werethenseenannually.Theyalsohadtheopportunityto contactanurseforearlierevaluationincaseofrecurrence ofOABsymptomsinordertoperformanotherinjection.

Table1 Baselinepatients’characteristics.

n=59(%) Men

Women

9(15.2) 50(84.8) Age,mean(years,SD) 60.4±14.3 Dosageoffirstinjectionof

AbobotulinumtoxinA 150U

250U 500U

5(8.5) 41(69.5) 13(22) Urodynamicparameters

Meanmaximumcystometric capacity(mL)

Meancompliance (mL/cmH20)

Meanvolumeoffirstdesireto void(mL)

Meanmaximumdetrusor pressure(cmH20)

329.3±173 55.8±40.1 163.3±107 54.7±28.9

Detrusoroveractivity No

Yes Unknown

11(18.6) 27(45.7) 20(33.8) Medianfollow-up,months 78[0.3—156.6]

U:Units;SD=Standarddeviation.

Theprimaryendpointwastheestimateddiscontinuation- free rate at 5 years of management with intra-detrusor abotulinumtoxinA.Otheroutcomesofinterestwere:rateof failure,reasons for discontinuation andsubsequent treat- ment elected in those who did not persist with BoNT-A.

SuccessofBoNT-Awasdefinedas50%improvementinurge UI,urgencyorfrequencyasassessedatthe6-weekevalua- tion.Primaryfailurewasdefinedaslackofefficacyofany injectionfromthefirstone.Secondaryfailurewasdefinedas lackofefficacyofatleasttwoconsecutiveinjectionsafter successfulinitialinjection.Causesofdiscontinuationwere carefullyassessedandrecorded.

Statistical analysis

Time todiscontinuationand failure were calculatedfrom the momentofthe firstbotulinuminjectionuntil thelast injection plus 6 months.Discontinuation-free and failure- freesurvivalswereestimatedusingKaplan—Meieranalyses.

StatisticalanalysiswasperformedusingMcNemar’stestand Khi2testforallqualitativevariablesandWilcoxontestfor pairedvaluesofquantitativedata.AP-value<0.05wascon- sideredsignificant.Statisticalanalysiswasperformedusing GraphPadPrism5software.

Results

Patient characteristics

Fifty-nine patients (50 women and 9 men)were included (Table1).Meanagewas61years[17.2—85.4].Fiftypatients

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(84.7%) had urinary incontinence. Twenty-seven patients (45.7%)haddetrusoroveractivityonurodynamicstudyand median maximum cystomanometric capacity was 300mL [30—740]. Forty-three patients (72.8%) received 250 U of abobotulinumtoxinA as first injection. Twelve patients (20.3%)received500Uand4(6.7%)whowereworriedabout performingCISCreceived150UofBoNT-A.

Success of first injection

Overall,35patients(59.3%)weresuccessfullytreatedwith firstinjection,including16whohadpriorDO(16/27,59.2%).

The 4 patients who received 150 U as first injection did nothaveanyimprovementinurinarysymptomsat6weeks.

One refused any other injection and was managed with antimuscarinicmedicationalone.Threeunderwentanother injectionatahigherdosage(250U).

Of43patientsinjectedwith250U,23(53.4%)received asecondinjection.Thirteen(30.3%)wereinjectedwiththe samedosage,7(16.2%)receivedhigherdosageand3(6.9%) wereswitchedtoonabotulinumtoxinA.

Of 12 patients whowere injected with500 U, 3 (25%) receivedasecondinjectionincludingone(8.3%)atahigher dosage(750U).

Eighteen patients (30.5%) required CISC after first or repeatedinjectionatahigherdosage.

Fouroutof20patientswhoreceived500U(20%)and1out of2patients(50%)whoreceived750Urequiredpersistent CISC.

Discontinuation and failures of BT therapy

Median follow-up was 83.6 months [0.3—182.6]. Median numberofinjectionsperpatientwas2[1—15]withamedian reinjectionintervalof10.7[3—86.4]months.Mostpatients stoppedinjections afterthefirst(n=30,50.8%)or second injection(n=12,20.3%).

The estimated5-year discontinuation-freesurvival rate was23.4%[13.6—34.8]withamediansurvivalof9.1months (Fig. 1a). At last follow-up, 52 patients (88.1%) had dis- continuedBoNT-A injections including20 patients (20/27, 74.1%)whohadpriorDO.

Theestimated5-yearfailure-freesurvivalratewas64.8%

[50.9—75.7](Fig.1b).Failure-freemediansurvivalwasnot achieved.

Causes of discontinuation

Fourteenpatients(14/59,23.7%)including3whohadprior DO,experiencedpersistentimprovementofsymptomsafter amediannumberofinjectionsof2[1—5]anddidnotrequire anyreinjections.Ofthem,8received250U,5hadahigher dosage(500U)andonewasswitchedtoonabotulinumtoxinA 100Uafterfirstinjection.

Maincauseofdiscontinuationwasprimaryfailure,which occurredin21patients(21/59,35.5%)including8whohad priorDO.Allpatientswithprimaryfailuredidnothavepost- voidresidualvolume.Secondaryfailureoccurredin1patient withpriorDO(1/59,1.6%)after5injectionsand82.5months afterfirstinjection.

Twelve patients (12/59, 20.3%) stopped the injections because of tolerability issues including 6 with prior DO.

EightpatientsdidnottolerateCISC,2hadmultipleurinary tractinfections despite adequate prophylactic antibiotics andCISC, 1 experienced nightmares and headaches after first injection attributed to the toxin by the patient and 1 under anticoagulant therapy had persistent haematuria aftereachinjection.Fourpatients(4/59,6.7%)including2 withpriorDO,foundreinjectionstoorestrictiveanddecided tostop.

Subsequent treatment

Sixpatients(6/59,10.1%)refusedtohaveanothertreatment afterBoNT-Adiscontinuation.Twenty-threepatients(23/59, 38.9%) underwent subsequent treatment. Six patients (10.1%)switched backto anticholinergicsat their request andtwo(3.3%)weretreatedwithmirabegron.Twopatients (3.3%) with primary inefficiency had a successful switch ofabobotulinumtoxinAtoonabotulinumtoxinA.Four(6.7%), with prior DO, underwent cystoplasty, which relieved all OABsymptoms.Seven patients (11.8%)were treated with SNM.Of them,3 weresatisfiedwithnourgency,1under- wentcystoplastyand3experiencedpersistentleakage.Of thosethreewhoremainunsatisfiedafterSNM,cystoplasty or cystectomy wasproposedand refused bythe patients.

Four(6.7%)weretreatedwithtranscutaneous tibialnerve stimulationwithout efficiency.Two underwent SNMand 2 refusedanyothertreatment.Onepatient(1.6%)withmixed UIunderwent mid-urethralsling implantation.Subsequent treatment was not documented for 16 patients (16/59, 38.1%).

Factors associated with discontinuation

Meanageofpatientswhodiscontinuedtreatmentwassig- nificantlyhigherthanthosewhowerestillunderinjections atlastfollow-up(63.3vs.53.2years,P=0.016,Table2).

Therewasnodifferenceofdiscontinuationbetweendif- ferentdosagesusedatfirstinjection(P=0.05).

Malegenderwassignificantlyassociatedwithdiscontin- uation.Mediandurationoftreatment formenandwomen were6and17.6monthsrespectively(P=0.02).

Discussion

Toourknowledge,ourstudyreportsthelongestfollow-upto dateabouttheuseofabobotulinumtoxinAinpatientswith idiopathicOAB.

Initialsuccessoffirstinjectionwashighwithanimprove- mentofmorethan50%ofsymptomson3-daybladderdiary in59.3%ofcases.ThisisinaccordancewithCraciunetal., whorecentlyreportedimprovementinOABsymptomscore in55%ofcases[8].

However,theestimated5-yeardiscontinuation-freesur- vival rate was 23.4%. Those results are comparable to long-term results after injection of onabotulinumtoxinA.

Indeed,Moheeetal.reporteda66.3%discontinuationrate at 3 yearsin 137 patients treated withonabotulinumtox- inA(200 U)for OAB[15].These data were inaccordance withthose recently published by Marcelissen et al. [11], whofounda70%discontinuationrateafterameanfollow- up of 97 months in a cohort of patients treated with

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Figure1. Discontinuationfreesurvival.

onabotulinumtoxin.Nittietal.havereportedlong-termdis- continuationof onabotulinumtoxinA fromtwo randomised controlledstudies[16].At3.5years,52%ofpatientswere stillunderinjections. However,patients whodidnot suc- ceedtheinitialtrial[17]werenotincludedinthislong-term analysis,which,therefore,doesnotreflectclinicalpractice.

Given the well-known negative impact of OAB on patient’s HRQOL [18], treatment discontinuation is often justifiedbyalackofefficacy,orsignificantadverseevents.

Indeed, in our study, main cause of discontinuation was primary lack of efficacy, which explained 50% of failures (n=21). Although secondary failuremay occur, it seemed tobelimitedtoveryfewcases inourstudy(n=1).Those resultsarelowerthanthosereportedbyMoheeetal.,who found a 11.7% (n=14) rate of secondary inefficiency with onabotulinumtoxinA[15]at3years.

Inour study,20.3% of patients discontinuedtreatment because of tolerability issues including 8 who did not tolerateCISC.Marcelissenetal.foundhigherratesofdis- continuationduetotolerabilityissues(43%)[11],buthigher rates of CISCwere seen afterfirstinjection (23%).Mohee et al., in a mixed population of idiopathic and neuro- genicOAB,alsofoundhigherrateofdiscontinuationtherapy related to tolerability issues (34.3%) [15]. This can be explainedbythehigherdosageofBoNT-Ausedinthesestud- ies.Furthermore,fourpatients(9.5%)foundreinjectionstoo restrictive. Some ofthese patients decidedtogo backto oralmedicationeveniftheywerenotfullysatisfiedwithit.

Althoughtreatmentalgorithmforthirdlinetherapyfocuson eithertochoosebetweenSNM,posteriortibialnervestim- ulationorBoNT-A[19,20],failureofthirdlinetherapydoes notnecessarilyimplygoingtotherapeuticescalation.It is

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Table2 Predictivefactorsforfailure.

Cohort Patientswho

discontinuedtreatment becauseoffailureor tolerabilityissues

Patientsstilltreatedor withpersistentlong termimprovement

P

n(%) 59 38(64.4) 21(35.6%)

Gender Women Men

50 9

29 9

21

0 0.02

Age,range 60.4 64.9[30.6—85.4] 58.7[17.2—79] 0.03

MCC,mL 345.7 360 300 0.892

Dosageatfirstinjection 250U

500U

43 12

13 9

18 3

0.05 MCC:Maximumcystometriccapacity.

alsoanalternativetochooseatreatmentwithlessefficacy butbettertolerance.Thisshowstheimportanceofpatient’s choice andthe role of thepractitioner asa counsellorin orderforthepatienttofindhisownbalance.

Most patients (79.4%, n=31) discontinued treatment after first or second injection. This is consistent with Marcelissen et al.’s results, which showed that among patientswhodiscontinuedtreatment,67%decidedtostop after first injection. After two injections, we observed a plateauingeffect.TheseresultsarealsoinlinewithVeerat- terapillay,whoreportedfewdiscontinuationafterefficacy offirstBoNT-Ainjection[21].Interestingly,thishighdiscon- tinuation rate is also seen in the neurological population [22],wheremorethan50%ofpatientsdiscontinuedtreat- ment at 10 years.It seems that botulinumtoxinA is not a lifetimetreatmentbutisusedtopostponefurtherinvasive surgeryinneurologicalpopulation.

Interestingly, discontinuation of botulinum toxin was not always associated with failure or tolerability issues.

In our study, discontinuation was due to persistent long- term improvement of symptoms in 23.7% of cases. This is higher than Khan et al.’s study [23], which reported a rate of 10% of patients whoconsidered themselves cured after injection of 200 U of onabotulinumtoxinA and 14 months of follow-up. More recently, Craciun et al. [8]

showed a significantly prolonged interval between injec- tionsofabobotulinumtoxinA(21.2months)suggesting that some patients may have sustained long-term efficacy. As previouslydebated[11],firstbotulinuminjectioncouldbe perceived as a test injection in order to select patients responder orpatients fit forreinjection. We donotadvo- cate for abobotulinumtoxinA tobe seen asan alternative for patients whofailed antimuscarinicas thereis already onabotulinumtoxinAthatshowedgoodshort-andlong-term results.However,althoughonabotulinumtoxinAistheonly toxin recommended in France, abobotulinumtoxinA could beseenasanalternativeinpatientsinitiallyrespondersto onabotulinumtoxinAwhoexperiencedsecondary failureor tolerabilityissues.Thiswouldbeinaccordancewithstudies inneurologicalpopulationthatshowedabenefitinswitch- ingbetweenonabotulinumtoxinAandabobotulinumtoxinAin thosecases[9].

Weacknowledgeseverallimitations. Theuseof abobo- tulinumtoxinAiscontroversialasonabotulinumtoxinAisthe onlytoxinrecommendedinFrancebytheHASsince2014[6].

However,allinjectionswereperformedbefore2014whenno botulinumtoxinAwaslabelled.Furthermore,abobotulinum- toxinAforOABhasshowngoodresultsinshort-termstudies [16,17].Heterogeneityof gender and dosage madeit dif- ficult to assess the efficacy of the toxin. Post-injection urodynamicdatawereinsufficienttoperformvaluableanal- ysis,notably becausethesetests arenotroutine practice in case of successful outcomes. Due to lack of phase III study,mostefficient dosage of abobotulinumtoxinAis not known.Therefore,dosage is chosen mostly onconversion ratios(1/3)withonabotulinumtoxinA[14].Basedonphase IIIstudies[17,24],theuseof100UofonabotulinumtoxinA forfirstinjectionwasapprovedbyFDAin2014.Therefore, wedecidetochoose250UofabotulinumtoxinAasfirstinjec- tion.In France, 50 Uis the dosage recommendedin first intention[6],explainingwhywechoose125Uforfewinitial cases.

However,ourstudygivesaclinicalpracticeoverviewof abobotulinumtoxinAadherenceinthelongterm.

Conclusion

Overall, 59.3% of patients were successfully treated with first abobotulinumtoxinA injection. Although the esti- mated 5-year discontinuation-free survival rate is low, abobotulinumtoxinAcouldbeconsideredasan alternative off-labelledinpatientsnon-responderstoonabotulinumtox- inAafterfailureofotherconservativemeasures.

Ethical considerations

Allproceduresperformedinstudiesinvolvinghumanparti- cipantswereinaccordancewiththeethicalstandardsofthe institutionaland/ornationalresearchcommitteeandwith the1964Helsinki Declarationanditslateramendmentsor comparableethicalstandards.The studywasapprovedby

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the ethic committee of Rouen University Hospital (Ethics boardapprovalnumber:E2020-08).

Authors’ contribution

M.G. Baron contributed to the protocol/project devel- opment, data collection or management, data analysis, andmanuscript writing/editing; A.Aublé and F.Paret, to data collectionor management; C. Pfister, tomanuscript writing/editing; and J.-N. Cornu to the protocol/project developmentandmanuscriptwriting/editing.

Acknowledgement

Theresearchreportedinthemanuscriptdidnotreceiveany fundingfromcommercialsponsors.

Disclosure of interest

Theauthorsdeclarethattheyhavenocompetinginterest.

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