J. Coloproctol. (Rio J.) vol.37 número2

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w w w . j c o l . o r g . b r

Journal

of

Coloproctology

Original

Article

Postoperative

mortality

in

inflammatory

bowel

disease

patients

Renato

Vismara

Ropelato

∗

_,

_Paulo

_Gustavo

_Kotze,

_Ilário

_Froehner

_Junior,

Danieli

D. Dadan,

Eron

Fábio

Miranda

PontifíciaUniversidadeCatólicadoParaná(PUCPR),HospitalUniversitárioCajuru(SeCoHUC),UnidadedeCirurgiaColorectal,Curitiba, PR,Brazil

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Articlehistory:

Received30November2016 Accepted16January2017 Availableonline3February2017

Keywords:

Mortality Crohn’sdisease Ulcerativecolitis Surgery

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Introduction:Sincethe1960s,mortalityinCrohn’sdiseaseandUlcerativeColitispatientshad asignificantdecreaseduetoadvancesinmedicalandsurgicaltherapy.Animportant pro-portionofthesepatientsaresubmittedtosurgicalproceduresduringtheirdiseasecourse, withpostoperativemortalitybetween4and10%.

Methods:157inflammatoryboweldiseasepatientssubmittedtosurgicaltherapywere retro-spectivelyidentifiedandallocatedin2groups(Crohn’sandcolitis).Deathswereindividually discriminatedindetail.

Results:281surgicalprocedureswereperformed.Inthecolitisgroup,43operationswere performedin24patients;intheabdominalCrohn’ssubgroup,127proceduresin90patients andintheperinealCrohn’ssubgroup,115in64patients,respectively.Ninepostoperative deathswereobserved(3inthecolitisand6intheCrohn’sgroups).Overallpostoperative mortalitywas5.7%(4.5%forCrohn’s;6.6%inabdominalCrohn’sand12.5%forColitis).Most ofdeathswererelatedtoemergencyproceduresandprevioususeofcorticosteroids.The causeofdeathinallpatientswassepsis.

Conclusions:Overallpostoperativemortalityininflammatoryboweldiseasewas5.7%,andit wasattributedtotheseverityofthecasesreferred.

Mortalidade

em

portadores

de

doenc¸a

inflamatória

intestinal

submetidos

a

tratamento

cirúrgico

Palavras-chave:

Mortalidade Doenc¸adeCrohn

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e

s

u

m

o

Introdução:Apartirdadécadade60,amortalidadedosportadoresdedoençadeCrohn(DC)e aRetocoliteUlcerativaInespecífica(RCUI)tevedeclíniodevidoanovasterapêuticasclínicas ecirúrgicas.Importanteproporçãodestespacientesésubmetidaaprocedimentoscirúrgicos nodecorrerdassuasvidas,comtaxasdemortalidadevariandoentre4e10%.

∗ _{Corresponding}_author_.

E-mail:[email protected](R.V.Ropelato).

http://dx.doi.org/10.1016/j.jcol.2017.01.001

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jcoloproctol(rioj).2017;37(2):116–122

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Retocoliteulcerativa Cirurgia

Método:Foramidentificadosretrospectivamente157pacientesportadoresdedoenc¸as infla-matóriasintestinais(DII),submetidosaoperac¸õesabdominaisouperineais,divididosem doisgrupos(DCeRCUI).Oscasosdeóbitosforamdiscriminadoseavaliados individual-mente,deformadescritiva.

Resultados: 281operaçõesforamrealizadas.NogrupoRCUIforamrealizadas43operações em24pacientes,nosubgrupoDCabdominal,127operaçõesem90pacientesenosubgrupo DCperineal,115em64pacientes,respectivamente.Dototalde9óbitos,3ocorreramno grupoRCUIe6noDC.AmortalidadegeralnasDIIfoide5,7%.ParaaDC,4,5%.Nosubgrupo deoperaçõesabdominaisfoide6,6%eparaaRCUI12,5%.Amaiorpartedosóbitosestavam relacionadosaprocedimentosdeurgência/emergência,comusopréviodecorticoterapia.A

causamortisemtodosospacientesfoisepse.

Conclusões: AtaxademortalidadecirúrgicanasDIIfoide5,7%,atribuidaspelaseveridade doscasos.

Introduction

Crohn’sdisease(CD)andUlcerativeColitis(UC)presentanot homogeneousandincreasingglobalincidenceovertheyears. Due to the heterogeneous demographic character among countries,the incidenceofUCvaries between8–14/100,000 and120–200/100,000people;ontheotherhand,theincidence ofCDvariesbetween6–15/100,000and50–200/100,000.1

From the1960s onwards,the mortalityofpatients with thesediseases,mainlyUC,showedasignificantdeclinedue totheuseofnewclinicalandsurgicaltherapeuticmeasures.2

InthecaseofCD,thereisalowrisk,but theriskofdeath ishigherversusgeneralpopulation (consideringindividuals ofthe sameageand gender).Ameta-analysispointed toa downwardtrendinmortalityratesoverthelast30years,but withoutstatisticalsignificance.3_In_UC,_another_{meta-analysis}

showedthatthetotalmortalityofpatientsdidnotdifferfrom thegeneralpopulation,althoughinsubgroupsofpatientswith amoresevereandextensivedisease(andthatconsequently madeuseofimmunosuppressivemedication)theriskofdeath washigher.4

A significant proportion of patients with inflammatory boweldisease(IBD)willundergosurgicalprocedures through-outtheirlives.InCD,bowelsurgeryisneededinabout70–80% ofcases after 20 years of illness. Of these patients, about 30%willrequireasecondsurgeryafter10years.1_In_patients

withUC,colectomiesare requiredinapproximately20–30% ofpatientsafter25yearsofdisease.1_Considering_the_whole

rangeofoperativeprocedures,intestinalresectionsinpatients withIBDperformedonanemergencybasisareassociatedwith highermortalityrates.Inadditiontotheincreasedriskdue totheurgencyrequiredperse,atthetimeofsurgery,many patientsaremalnourished andinthe useofdrugssuchas corticosteroids,immunosuppressantsandbiologicalagents, whichmayhaveanimpactonmorbidityandmortality.5

The use of tumor necrosis factor alpha (anti-TNF␣)

inhibitorshasalteredthe naturalhistoryofthe disease.In randomizedstudies,the reductionofcomplicationsand of theneedforsurgeryhasalreadybeendemonstrated.Onthe other hand,in populationalstudies, this has notyet been documented.5

Theprimaryobjectiveofthisstudywastodeterminethe mortalityrateamongpatientswithIBDinareferralservicefor themanagementofCNandNSUCpatientsundergoing surgi-calprocedures.Thesecondaryobjectivesweretodescribethe demographiccharacteristicsofthispopulation,aswellasto makeadetailedevaluationofthecasesofdeath,relatingthem topossibleriskfactors.

Method

ThisstudywasapprovedbytheResearchEthicsCommitteeof theBioethicsNucleusofthePontifíciaUniversidadeCatólica doParaná(PUC-PR),accordingtothePresentationCertificate forEthicalAppreciation(CAAE)number58325916.6.0000.0020, providedbythePlataformaBrasilwebsite..

Thiswasaretrospective,analyticalandlongitudinalstudy ofaseriesofcases.157patientssubmittedtosurgical proce-duresrelatedtoIBDfromJanuary2004toDecember2014ina referralservicewereidentified.Thesepatientsweredivided into groups according to the diagnosis (UC and CD). The CD group wasfurtherdivided into twosubgroups: abdom-inal procedures and perineal procedures. After reviewing the patient’s medicalrecords, the followingvariables were analyzed: age,gender,indicationofsurgery,procedure per-formed,thesystemofdesignationoftheprocedure(electiveor urgent)anddeathinthepostoperativeperiod.Previous treat-ments(clinicaland surgicalones)andinparticularthe use ofcorticosteroidsandanti-TNF␣ agentswere analyzed.The

occurrenceofmalnutrition(definedasaserumalbuminvalue below 3.0mg/dL), use oftotal parenteral nutrition, anemia (definedasahemoglobinemia[Hb]<8g/dL),andtheneedfor bloodtransfusionwereequallychecked.Thetypeofsurgery performed and thepre-operativehospitalization timewere alsoanalyzed.Thecasesofdeathwereindividually discrimi-natedandevaluated.SurgicalproceduresnotrelatedtoIBDs wereexcludedfromtheanalysis.

Results

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Table1–Distributionofpatientsinrelationtogenderanddisease,withnumbersofpatientsoperatedbygroup.

Crohn’sdisease(CD) Ulcerativecolitis(UC) Total

Male Female Male Female

Patients(n) 75 58 15 9 157

Surgicalprocedures(n) 135 104 27 16 281

Meanage 34.2(12–65) 41.5(15–82) 37.7(19–76) 40.6(14–64) 36.2(12–82)

CD)wereanalyzed.Themeanagewas36.2years.Thesedata aredetailedinTable1.

In the UC group, 43 operations were performed in 24 patients.Themeannumberofsurgicalproceduresperpatient was1.79(1–4).Thetypesofoperationsandtheirindications arelistedinTable2.Asobserved,amongtheprocedures,17 wereperformedonanemergencybasis.Theelectivesurgical indicationswere:refractorydisease,intestinaltransit recon-struction, dysplasia-associated lesion or mass (DALM),and stenosis. The surgical indications of emergency were: dis-easerefractorytomedicaltreatment,abdominalabscessor collection,toxicmegacolon,intestinalobstruction,and evis-ceration. The mostcommon surgical indication– both for electivesurgeryandforemergencysurgery–was refractori-nesstomedicaltreatment.Inthisgroup,3deathsoccurred. Still,inthisgroup,themortalityrateoftotalcolectomywith endileostomyintheemergencyroomreached30%.

InthegroupofpatientswithCD,238operationswere car-riedoutin133patients(meanageof35.6years;Table3).In 7cases,abdominalandperinealprocedureswereperformed duringthesamesurgicaltime.Themeannumberof surger-iesperpatientwas1.4(1–5).IntheabdominalCDsubgroup, 32operationswerecarriedoutonanemergencybasis. Sur-gical indications in patients with CD were, among others: localizedileocolicdisease,stenoses,fistulas,refractorinessto medicaltreatment, perineal disease,intestinal obstruction, anabdominalcollectionoranastomoticdehiscence, intesti-nal perforation, evisceration, stoma necrosis, hemorrhage, abdominalwall/peristomalabscess,andbladderfistula.The mostcommon indicationinelectiveprocedureswas steno-sis;ontheotherhand,intheemergencysurgeries,themost common indication was abdominal collection/anastomotic

dehiscence (Table 3). There were 6 related deaths in the abdominalCDsubgroup.

InthegroupofpatientsoperatedonforCD,115perineal operations wereperformedin64patients(perinealCD sub-group): 39 men(mean age36 years) and 25women (mean age31.9years).Themeannumberofproceduresperpatient was1.79(1–8proceduresperpatient).101fistulotomiesand 19 other procedures (drainage of abscess, anal dilatation, debridement,andfissurectomy)werecarriedout.Therewere nodeathsinthissubgroup.

Amongthepatientsanalyzed,9deathswereidentified,3 (1maleand 2female)intheUCgroupand6(4maleand2 females)intheCDgroup.Themeanageofthecasesofdeath was 37.3(14–77) years.Theoverall mortalityratewas5.7% (9/157patients).FortheCDgroup,themortalityratewas4.5% (6/133patients);inthesubgroupofabdominaloperationsthe mortalityratewas6.6%(6/90patientsoperated),andintheUC group,12.5%(3/24patientsoperated).Thesedataaredetailed inTable4.

The9patientswhodiedhadundergone27operations(1–6 procedures).Inonlytwocases,onlyoneoperationwas per-formedduringhospitalization.Amongthesesurgeries,asa mainprocedure6colectomies(withorwithoutenterectomy), threeenterectomies,threeperinealprocedures,and15 proce-duresofothertypeswereperformed(Table5).

In the 3 UC-related deaths, the disease had a pancoli-tispresentation.Allofthesepatientsunderwentintravenous (IV)corticosteroidtherapy,oneofthemhadbeentakingoral mesalazineforlessthanaweek,anotherhadused azathio-prine,andthethirdhadundergoneasingle-doseinfusionof infliximab twodays beforesurgery. Noneof thesepatients hadanyprevioussurgeryrelatedtoIBD.Allweresubmitted

Table2–ProceduresperformedandregimenofsurgicalindicationinpatientswithUC.

Surgicalproceduresperformed Elective Emergency Total

Totalcolectomywithterminalileostomy 2 9 11

Totalproctocolectomywithilealpouch 6 0 6

Totalproctocolectomywithendileostomy 4 0 4

Proctectomy 3 0 3

Rightcolectomy 2 0 2

Totalcolectomywithileorectalanastomosis 1 0 1

Enteroanastomosis 8 0 8

Laparotomyforabdominalcollectiondrainage 0 3 3

Laparotomyforlysisofadhesions 0 2 2

Abscessdrainagebyperinealroute 0 1 1

Peristomalabscessdrainage 0 1 1

Abdominalwallreconstruction 0 1 1

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Table3–ProceduresperformedandregimenofsurgicalindicationforsurgeriesinpatientswithCD(abdominal subgroup).

Surgeriesperformed Elective Emergency Total

Enterectomyand/orstenoplasty 39 3 42

RightIleocolectomy 32 2 34

RightIleocolectomywithEnterectomy 22 0 22

Leftcolectomy 5 0 5

Totalcolectomywithendileostomy 3 2 5

Totalproctocolectomywithendileostomy 3 0 3

Proctectomy 2 0 2

Enteroanastomosis 6 0 6

Ileostomy 4 4 8

Loopcolostomy 0 2 2

Colorraphy 4 0 4

Exploratorylaparotomy 0 11 11

Urologicalprocedures 3 3 6

Reconstructionoftheabdominalwall 0 3 3

Peritoniostomy 0 3 3

Incisionalherniorraphy 1 0 1

Oophorectomy 1 0 1

Total 126 32 158

Table4–Mortalityrateinrelationtothenumberofpatientsandoperationsperformedinthedifferentgroups.

Patients Operations Deaths Mortality(%)

Patients Operations

General 157 281 9 5.7 3.2

Crohn’s(abdominalsubgroup) 90 127 6 6.6 4.7

Crohn’s(perinealsubgroup) 64 115 0 0 0

UC 24 43 3 12.5 6.9

toanemergencysurgery.Thethreecaseshadasanindication oftheprocedureatoxicmegacolon,andinonecasecolonic perforationwaspresent.

BetweenCD-relateddeaths,thedisease waslocalizedto thesmallintestineintwocases(oneofwhichhadan asso-ciated perineal disease); two other patients suffered from colonicandperinealdisease;inoneofthecases,thedisease waslocatedinthesmallbowel,colon,andperineum;andin thelattercaseonlyanileocolicdiseasewasdiagnosed.Only onepatientwasnotoperatedonanemergencybasis.Onlytwo patientswerenotinuseofpreoperativecorticosteroids.

Onepatienthad beentreatedwithintravenous corticos-teroidtherapy and underwent aperianal abscessdrainage procedure under diagnostic suspicionof CD onlyfivedays beforea totalcolectomy with emergency ileostomydue to colonic perforation and a low digestive hemorrhage. Only one patient was in use of biological drugs before surgery: adalimumab,alreadyinlong-termuse,associatedwith aza-thioprineandoralcorticosteroidtherapy,alsoforalongtime. Inthispatient,theindicationforsurgerywasdueto multi-pleenterocutaneous(peri-ileostomic)fistulas,inanelective procedure.

Inallthedeathsabloodtransfusion wasindicated(one patientunderwenttransfusionreaction,withthesuspension ofthetransfusion),withthepresenceofmalnutritionatsome timeofthehospitalization.Inonlyonecasethepatientdid notreceivetotalparenteralnutrition.

Inallpatients,thecauseofdeathwassepsis,fourof pul-monaryorigin andtwocasesofcentralvenouscatheter, in

additiontooneofabdominalfocus,fungalsystemic, anda progressionofFournier’ssyndrome,respectively(Table5).

Discussion

Among patients with CD, intestinal surgery is required in about 70–80%ofcasesafter20 years ofillness.In patients withUC,colectomiesarerequiredinapproximately20–30% ofpatientsafter25yearsofdisease.1_Frolkis_et_al.,_in_a

meta-analysisofpopulationstudies,haveidentifiedthat therisk ofsurgeryat1,5,and10yearsafterthediagnosisofCDand between1and10yearsafterthediagnosisofUChasdecreased significantlyoverthelastsixdecades.6

A Danish study observed increased mortality in cases ofUC in patientsolder than 50 years,duringthe first two yearsafterdiagnosis,andinpatientswithanextensive col-itis.Suchdeathsusuallyoccurintheperioperativeperiodin patientswithseveredisease.7_Kaplan_et_al._assessed_the

post-colectomymortalityinpatientswithUC,andalsoidentified theoccurrenceofhighermortalityinpatientsover60yearsof age.8_In_the_present_study,_all_deaths_related_to_UC_had_a_recent

diagnosisofdisease(<2years)andsufferedfrompancolitis. OnlyoneofthedeathsrelatedtoUCoccurredamongpatients agedover60,but proportionatelythisincreaseinmortality wasalsoidentified.

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Table5–Detailedanalysisofcasesofdeath.

Previoustreatments

Gender Age AZA MSZ CTC Anti-TNF-␣ Surgeries Malnutrition/ TPN

Anemia/ Transfusion

Surgeryperformed (initial)

Indication Emergency POHT (days)

Surgeries (n)

Causamortis

CD

1 M 38 Yes No No No Enterectomy Yes/Yes Yes/Yes Enterorraphiesand ileostomy

Enterocutaneous fistulas

Yes 11 4 Abdominalsepsis

2 M 31 Yes No Yes No No Yes/Yes Yes/No Debridement Fournier’sSd. Yes 0 6 Fournier’sSd.

3 F 77 Yes Yes No No No Yes/Yes Yes/Yes Rightileocolectomy andenterectomy

Yes 4 2 Pulmonarysepsis

4 M 44 Yes No Yes No Right

ileocolectomy

Yes/Yes Yes/Yes Rightileocolectomy Intestinal occlusion

5 M 18 No No Yes No Perianalabscess drainage

Yes/Yes Yes/Yes Totalcolectomywith endileostomy

Colon

perforation+LDH

Yes 0 6 Centralvenous cathetersepsis 6 F 20 Yes No Yes Yes(ADA) Two-stagetotal

colectomyand fistulotomy

Yes/Yes Yes/Yes Two-stageenterectomy andfistulotomy

Yes 2 3 Centralvenous cathetersepsis

NSUC

7 F 18 Yes Yes Yes No No Yes/Yes Yes/Yes Totalcolectomywith endileostomy

Intractability– hemorrhage

Yes 17 1 Fungalsepsis

8 F 14 Yes Yes Yes Yes(IFX) No Yes/Yes Yes/Yes Totalcolectomywith endileostomy

Intractability– perforation

9 M 76 No No Yes No No Yes/No Yes/Yes Totalcolectomywith

endileostomy

Intractability– toxicmegacolon

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colectomywithendileostomyandtheclosure oftherectal stump,respectively).8_In_the_present_study,_we_identified_in_the

UCgroupageneralmortalityof12.5%,butthatreached30% inthosepatientssubmittedtothissameprocedurealsoonan emergencybasis.Still,accordingtothesameauthors,ahigher mortalityratewasalsoobservedinpatientsoperatedafter6 daysofhospitaladmission.8_These_data_were_also_registered

inanotherCanadianstudy,wheretheauthorsnotedthatthe complicationrateandmortalitywerehigherinpatients sub-mittedtoemergencycolectomies,incaseswherethesurgery wasperformed14daysafterhospitalization(incomparison topatientswiththeirsurgeryperformedbetween3and14 days).9

Another factor to consider is the number of colec-tomies/year for UC treatment, considered as of small (<4 colectomies/year), medium (4–11) and large (>11 colec-tomies/year)volume.Mortalitywashigherinhospitalswith asmall volumeofsurgeries.8 _Our _study _presented_a_small

volume(1.4)ofannualcolectomiesintheinitialstudyperiod (2004–2010),butthatreachedamediumvolume(4)initsfinal period(2011–2014). Therefore, the UC management experi-ence isdirectly linkedtocomplications and deathsinthis difficultpatientpopulation.

UndertakingacolectomyinisolationinpatientswithUC isnotausualtreatment.However,inthepresentstudy,this scenariooccurred ontwo occasions: ina caseofapatient alreadysubmittedtoaleftcolectomy,withatransversecolon stomaandclosureofrectalstumpinanemergencybasisdue tohemorrhage,andinanotherpatienttowhomthesurgical indicationwasduetoadysplasticlesionintherightcolon, withtherefusalofthepatienttoperformawidercolectomy.

InCD,thesurgicalmortalityreportedinsomeseriesranges from0.5%to5%,10,11_a_number_similar_to_our_4.5%_found_in_the

groupofCrohn’spatientsoperatedoninoursample. Duetoitspotentialimmunosuppressiveeffect,theuseof biologicaldrugshasalwaysbeenmuchquestionedregarding theincreaseofpostoperativecomplications,especiallythose oftheinfectioustype.Inthissense,severalpublicationsdealt withthetheme.Inameta-analysisandsystematicreview,a slightincreaseinpostoperativecomplicationsassociatedwith theirusewasobserved,particularlyinCDpatients.12_On_the

otherhand,anotherDanishstudyfoundthattheuseof inflix-imabinthe preoperativeperioddidnotincrease morbidity andmortalityrates,13_which_was_also_confirmed_in_two_other

relevantprospectivestudies.14,15_In_the_present_series,_only₂

patientswhodiedhadbeenmedicatedwithbiologicalagents inthepreoperativeperiod(1inCDand1inUC),bothwiththe associateduseofcorticosteroids.

Corticosteroidtherapyhasalsobeenextensivelystudied. Despiteitsundeniablebeneficialeffectsinthetreatmentof IBDs,especiallyinthe acutephase,itspostoperative reper-cussionisnegative.TREAT15_and_ENCORE16_studies_identified

apotentialriskforinfectiouspostoperativecomplicationsand deathsinassociationwithcorticosteroiduse. Anotherlarge Canadianstudyalsofoundthisassociation,withanincrease inpostoperativecomplicationsbutnotinmortality.17_In_this

series,weidentifiedthisriskfactorinallUC-relateddeaths andin2/3ofCD-relateddeaths.

Anemiawasalsoanimportantfactoridentifiedincases ofdeath.AllpatientshadlevelsofHb<8g/dLatsometime

duringhospitalization.AKoreanstudycitesahematocrit(HT) <30%asariskfactorforearlypostoperativecomplications.18

Inaretrospectivestudyonpost-bowelresectionmorbidityin CDcases,Brueweretal.foundthatpatientswithHb<10g/dL showed a significant association with postoperative septic complications,comparedwithpatientswithHb>10g/dL,in aproportionof20%versus6%,respectively(p<0.05).19

Anotherdeterminantriskfactorforpostoperative morbid-ity andmortalityisthe nutritionalstatusofthe patient.In a series comparing anastomosis withmanual or mechani-calsuture,Smedhetal.observedthatthecomplicationrates were lower inthegrouppreviouslytreatedwithan enteral diet before the procedures.20 _In _addition, _a _Korean _study

foundthatserumalbuminlevelsbelow3g/dLarepredictorsof increasesincomplicationsandthatitspreoperativecorrection decreasesmorbidityrates.18_Yamamoto_et_al._also_identified

hypoalbuminemia(<3g/dL)asariskfactorforpostoperative abdominalsepticcomplicationsincasesofCD.11_This_risk

fac-torwasdetectedevenmoreseverely(albumin<2mg/dL)inall deathsstudiedinthisseries.

Ourstudypresentssignificantlimitations,whichmustbe takenintoaccountintheanalysisoftheresults.Firstly,thisisa seriesofretrospective,descriptivecases,withoutcomparison amonggroupsandwithoutstatisticalanalysis,andwhichhad thesimpleobjectiveofservingasanalertfortheseriousness ofthesurgicaltreatmentofIBDinourcountry.Inaddition,the highnumberofmortalitycasesdemonstratestheclearbiasof areferralcenterinthemanagementofthesediseases,which receivesevere,oftenlate,cases–whichincreases complica-tions.Despiteitslimitations,itshouldbenotedthatthisis thefirstdescriptiveanalysisonmortalityinIBDcasesinour country.

Insummary,theoverallmortalityratefoundinthepresent studywas5.7%ofthepatients.Thepresenceofseveralrisk factors acting simultaneously and in a complex way con-tributedtothepostoperativemortalityincasesofIBDinthe groupofdeathsevaluatedhere.Amongthemainriskfactors found,thereistheemergencyandurgencyregimen,multiple operations,malnutrition,anemia,andpreviouscorticosteroid therapy.Studieswithagreaternumberofpatientsareneeded, inorder toobtainadeeper understandingofpostoperative mortalityinthemanagementofIBDsinourscenario.

Conflicts

of

interest

PGK:Abbvie,Ferring,Janssen,Pfizer,andTakeda;EFM:Abbvie andJanssen.Theotherauthorsdeclarenoconflictsofinterest.

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