Journal
of
Coloproctology
w w w . j c o l . o r g . b r
Original
article
The
epidemiological
profile
of
inflammatory
bowel
disease
patients
on
biologic
therapy
at
a
public
hospital
in
Alagoas
Petrille
André
Cavalcante
de
Barros
a,
Alberson
Maylson
Ramos
da
Silva
a,
M.Á.d.F.
Lins
Neto
b,∗aUniversidadeFederaldeAlagoas(UFAL),Maceió,AL,Brazil
bColoproctologyService,HospitalUniversitárioProfessorAlbertoAntunes(HUPAA),UniversidadeFederaldeAlagoas(UFAL),Maceió,
AL,Brazil
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Articlehistory: Received16July2013 Accepted15May2014 Availableonline17June2014
Keywords:
Inflammatoryboweldisease Epidemiologicprofile Ulcerativecolitis Crohn’sdisease Biologicdrugs
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t
Introduction:InflammatoryBowelDiseases(IBD),representedbyCrohn’sdisease(CD)and ulcerativecolitis(UC)arechronicandidiopathicinflammatoryconditionsinvolvingthe gas-trointestinaltract.Thereareseveralepidemiologicalstudiesthathaveshownanincreased incidenceofIBDworldwide.
Objective:ToanalyzetheepidemiologicalprofileofpatientswithIBDunderbiologic ther-apy,treatedinacoloproctologyoutpatientclinic,HospitalUniversitarioProfessorAlberto Antunes,Alagoas.
Methods:Retrospective observational clinical study, conducted by collecting patients’ recordsandinterviewingthematthetimeoffollow-up.
Results:40patientswereevaluated:70%female,27patients(67.5%)withCDand13(32.5%) withUC,meanageof37.8yearsandpredominanceofwhiteethnicity.Theileocolonicarea wasmorefrequentlyaffectedamongpatientswithCD(33.3%),whereastheextensivecolitis presentationpredominatedamongUCpatients(61.5%).95%ofthepatientsreceivedsome medicationbeforeusingbiologicals.70%oftherespondentsremainindeepremissionin theperiodof6–60months.
Conclusion: Thesocioeconomicprofileofpatientswassimilartothatdescribedinthe lit-erature.Crohn’sdiseasewasmorefrequentinourstudy,whileextensivecolitiswasmore commonamongUCpatients.Mostpatientsusedbiologicalsafterfailureofothertreatment options.
©2014SociedadeBrasileiradeColoproctologia.PublishedbyElsevierEditoraLtda.All rightsreserved.
∗ Correspondingauthor.
E-mail:[email protected](M.Á.d.F.LinsNeto).
http://dx.doi.org/10.1016/j.jcol.2014.05.004
Perfil
epidemiológico
dos
pacientes
portadores
de
Doenc¸a
Inflamatória
Intestinal,
que
fazem
uso
da
terapia
biológica,
atendidos
em
um
hospital
da
rede
pública
de
Alagoas
Palavras-chave:
Doenc¸aintestinalinflamatória Perfilepidemiológico
Coliteulcerativa Doenc¸adeCrohn Medicamentosbiológicos
r
e
s
u
m
o
Introduc¸ão: AsDoenc¸asInflamatóriasIntestinais(DII),representadaspelaDoenc¸adeCrohn (CD) e Retocolite Ulcerativa Inespecífica (RCUI), são condic¸ões inflamatórias crônicas, idiopáticas,queenvolvemotratogastrointestinal.Váriossãoosestudosepidemiológicos quevêmdemonstrandooaumentonaincidênciadaDIIemtodoomundo.
Objetivo: AnalisaroperfilepidemiológicodospacientesportadoresdeDII,quefazemuso daterapiabiológica,atendidosnoServic¸odeColoproctologiadoHospitalUniversitário Pro-fessorAlbertoAntunesdaUniversidadeFederaldeAlagoas.
Métodos: Estudoclínicodescritivoobservacionaltransversal,realizadoatravésdacoleta dosprontuáriosdospacienteseentrevistacomosmesmosnomomentodaconsultade acompanhamento.
Resultados: Foramavaliados40 pacientes,sendo28 dogênerofeminino e12dogênero masculino.27pacientes(67,5%)apresentavamDCe13(32,5%)apresentavamRCUI,com umamédiadeidadede37,8anoscompredominânciadaetniabranca.Aregiãoíleo-colônica foialocalizac¸ãomaisfrequenteentreospacientescomDC(33,3%),enquantoqueacolite extensivapredominouentreosportadoresdeRCUI(61,5%).95%dospacientesfizeramuso dealgummedicamentoantesdousodosbiológicos.70%dosentrevistadospermanecem comremissãoprofundanoperíodode6a60meses.
Conclusão: Operfilsocioeconômicodospacientesfoisemelhanteaodescritonaliteratura. Doenc¸adeCrohnfoimaisfreqüenteemnossoestudo,enquantoquecoliteextensivafoi aformamaiscomumentreosportadoresdeRCUI.Amaioriadospacientesfezusodos biológicosapósfalhadasoutrasopc¸õesdetratamentoclínico.
©2014SociedadeBrasileiradeColoproctologia.PublicadoporElsevierEditoraLtda. Todososdireitosreservados.
Introduction
Inflammatory Bowel Disease (IBD), represented by Crohn’s disease (CD) and Ulcerative Colitis (UC), are chronic, idio-pathicinflammatoryconditions, whichprobablyinvolve an immunereactionofthebodyagainstits own gastrointesti-naltract.1,2Consideringthatthesearechronicconditionsthat affectpreferablyyoungpeopleintheproductivephaseand contributetolong-termmorbidity,thuscausingchanges in the social,psychological and professional realms, IBDsare gainingimportance,constitutingapublichealthproblemin manycountries,withalargefinancialimpactonthe health-caresystem.3–6
There are several epidemiological studies showing an increased incidence of IBD in the world.1–8 A recent epi-demiologicalresearchestimatesthatabout4millionpeople worldwidehaveeither UC or CD,with 1.4millionof these casesoccurringintheUnitedStates.9Themale/femaleratio issimilarforbothUCandCD,withwomenshowingaslightly higher incidence. Both diseases are more commonly diag-nosedinyoungadults.Thevastmajorityofnewdiagnoses are detectedinthe age rangingbetween15–40 years,with thepeakincidenceoccurringearlyinthesecond decadeof life.2
BrazilisstillconsideredanareaoflowprevalenceofIBD, despite the significant increase in the incidence of these
diseases in reports of the national literature. In our envi-ronment, thesediseases are not considered ofcompulsory notification,which leadsustothinkthat perhapsIBDsare beingunderdiagnosed.4
ThemanagementofIBDwilldependonitsseverityandof the extentandanatomicalregioninvolved.Alargenumber ofdrugshavebeenused,achievingremission,butnotacure forthedisease.Amongtheclassesusedinconventional ther-apy, aminosalicylates, glucocorticoids, immunomodulators andantibioticsarementioned.10,11However,theconventional therapeuticoptionsforIBDarelimited,bothbytheinability tomaintainclinicalremission,andbytheirsideeffects.10In thiscontext,anewtherapeuticapproachemergesbasedon theuseofantagonistsoftumornecrosisfactor␣ (TNF-␣):the so-calledbiologicaltherapy.
treatmentofthesediseases,corroboratestherelevanceofthis study.
Objective
Toanalyzetheepidemiologicalprofileofpatientswith inflam-matory bowel disease using biological therapy treated at theColoproctology Service,Hospital UniversitárioProfessor AlbertoAntunes,withcharacterizationofpatientsaccording tosocial,clinicalanddisease-relatedaspects.
Method
Thisisanobservationalcross-sectionaldescriptivestudythat wasconductedfromMarch2012toMarch2013inthe colo-proctologyoutpatientclinic,HospitalUniversitárioProfessor AlbertoAntunes(HUPAA),areferenceserviceincolorectal dis-eases’care.
Thestudy population involvedall patients with inflam-matoryboweldisease(IBD):Crohn’sdisease,ulcerativecolitis orindeterminatecolitis,seen,registeredandfollowedupin thecoloproctologyoutpatientclinic,HUPAA,withatotalof 44patients. Thesample consistedofforty (40)patients, in viewofthewithdrawalorexclusionofsomeindividuals in thepopulation.
Patientsofbothgenders,regardlessofage,diagnosedwith IBD, seen atthe coloproctology outpatient clinic,HUPAA – UFAL,andcurrentlyinbiologicaltherapywere enrolled.On theotherhand,patientswho,forsomereason,hadtostop theirbiologictherapy,inadditiontopatientsusingbiologicals fordifferentpathologiesofIBD,wereexcludedfromthestudy. Themedicalrecordsofthesubjectswereacquiredby con-sultationofHUPAA–UFALfiles,underauthorizationbythe institutionproposingthestudy,withassuranceofcomplete confidentialityinrelationtopersonaldataandclinical infor-mation,accordingtothestandardsproposedbytheResolution CNS/MS196/96.
In cases where information from medical records was insufficientforimplementationoftheResearchProtocolfor IBD,patientswereapproachedduringroutineconsultations, toconductaninterviewaimedatcomplementingthis proto-col.
After collecting the clinical records, the social aspects, medicalhistoryandcurrenthistoryofthediseasewere ana-lyzed,inordertoadaptthesedatatotheresearchobjectives (by inclusionand exclusion criteria)and to implementthe Research Protocol for Inflammatory Bowel Disease. In the eventthattheinformationcontainedinmedicalrecordswas insufficient,theProtocolwascomplementedwithinterviews withthepatientitself.
After data collection, the material was scanned into a databaseandprocessed.
The following project was approved by the Ethics and ResearchCommittee,Centrode EnsinoSuperiorde Maceió (CESMAC),andregisteredunderprotocolnumber1419/12.All patientsinterviewedwereinformedaboutthestudyobjectives andsignedtwo(2)copiesofaFreeandInformedConsentTerm
Table1–DiseaselocationaccordingtotheMontreal classificationbetweenMarch2012andMarch2013, Alagoas.
Location Numberof
patients
Percentage(%)
Colon 9 33.3
Ileumandcolon 9 33.3
Terminalileum 7 25.9
Uppergastrointestinaltract 2 7.5
–FICT.Forthosecasesinwhichtheanalysisofmedicalrecords wasdone,FICTexemptionwasrequested.
Results
After conducting all methodological steps, with interviews andmedicalrecords’analysis,afinalnumberof40patients wasreached;ofthose,12(30%)weremaleand28(70%)were female patients.Thepatients’agerangedfromsevento67 years,withameanof37.8years(formalepatients,themean was35.6yearsandforfemalepatients,38.8years).Regarding ethnicity:22(55%)werewhite,16(40%)mixedraceand2(5%) wereblack.
Regardingthepatients’diagnosis,itwasobservedthat27 (67.5%)patientshadCD,while13(32.5%)hadUC.This diagno-siswasdefinedbeforeage40in32patients(80%)(2patients >16yearsand30patients>20years).Eight(20%)patients,of morethan40yearsofagehadtheirdiagnosisconfirmed.
Inourstudy,27patients(67.5%)didnotundergoany surgi-calprocedurerelatedtotheircondition,but13(32.5%)patients hadbeensubmittedtosometypeofsurgery.
Amongthepatientsevaluated,itwasfoundthat38(95%) alreadyhadundergonesometypeofdrugtherapypriortothe useofbiologicals,whereastwo(5%)wereonbiologicaltherapy asfirstchoiceoftreatmentforIBD.Amongthecommonlyused alternative therapies (aminosalicylates, antibiotics, cortico-steroidsandimmunosuppressiveagents),13patients(34.2%) hadmadeuseofthemall,followedby10individuals(26.3%) whohadusedthreeofthesedrugsandnine(23.7%)whoused onlytwoofthem.Four(10.5%)patientswereonmonotherapy withimmunosuppressiveagents,whiletwo(5.3%)hadused onlyaminosalicylatesbeforethebiologicals.
Regardingthesocialandfamilyhistory,22(55%)patients reportednosmokinghabitthroughoutlife,whileeight(20%) hadbeensmokersand10(25%)didnotanswer.Familial recur-rence was present in four (10%) patients, compared to 25 (62.5%)individualswhodidnothaveanyrelativewitha diag-nosisforIBDand11(27.5%)patientswhocouldnotinform abouttheoccurrenceofthesediseasesintheirfamilies.
Thelocationofthediseasewasdiagnosedandestablished bymeansofuppergastrointestinal endoscopy,colonoscopy andCT(enterography)(Table1).
Crohn’sdiseasemanifesteditselfina non-stenosing/non-penetrating inflammatory presentation in 15 (55.5%), in a stenoticpresentationinnine(33.3%)andinapenetrating pre-sentationinthree(11.1%)subjects.
sample,nocasesofulcerativeproctitisorproctosigmoiditis werefound.
Extra-intestinalmanifestationswere present in28 (70%) patients.Itwasnotedthatthesemanifestationsweremore frequentlyfoundinpatientswithUC(76.9%)whencompared withpatientswithCD(66.7%).
Withrespectto medication duration ofuse, 23patients (57.5%)usebiologicalagentsbetween2and 5yearsand17 (42.5%)forlessthantwoyears.Thirty-threepatients(82.5%) showed no adverse effects during the biological therapy, whereasseven(17.5%)subjectshadsometypeofreactionwith theuseofthismedication(erythema,painattheinfusionsite, tuberculosisintwopatients,herpessimplex,acne).
Regardingthecourseoftheclinicalpicture,itwasobserved that28(70%)patientsachievedcompleteremission,while12 (30%)remainedwithsymptoms.
Discussion
Wedemonstrated inthis study a predominance offemale gender(70%)amongpatients withIBD,consistentwiththe national and international literature.1,2,4,14,15 Regarding the age of our patients, a distribution pattern similar to that describedintheliteraturewasobserved,withaminimumof sevenandamaximumof67yearsold,withameanage cor-respondingtothepeakincidenceamongyoungadults(mean age,37.8years).1–5,7,10,14,15Regardingethnicity,therewas pre-dominanceofwhitesubjects(55%)whencomparedtoother races,afactthatagreeswiththeepidemiologyofIBD.1,2,7
OtherfactorsassociatedwiththeetiologyofIBDare famil-ial recurrence and smoking.2,7,16 The hereditary character waspresent infour patients(10%). However,it is notewor-thythat11patients(27.5%)werenotcertainaboutrelatives possiblyaffected,whichmayhavecontributedtoan under-estimationofthisvariable.Regardingsmoking,eightpatients (20%)reportedthatweresmokersatsomepointintheirlife. However,10patients(25%)declinedtoanswerthisquestion, underestimating,again,thestatisticalresultsofthisvariable. Accordingtostudiesrecentlypublished,4–6,8,10,15UCisthe most prevalent disease among IBDs – a finding that goes againstthestatistics ofour study,where67.5%ofthe par-ticipants were CD patients. Most patients were diagnosed between17and39years,agreeingwiththeliterature,most likely because the peak incidence of IBD covers this age group.1,2
Withregard tothe location ofthedisease,we observed thatinpatientswithCD,themostaffectedareainthe diges-tive tract (ileocolonic area) corresponds to that found in theliterature.2,4,5,10,15Asforitsbehavior, non-stenosing/non-penetratingCDwasthemoreprevalentpresentationamong thepatientsstudied(55.5%),whichisconsistentwithSouza etal.4findings.
On the other hand,these studies reveal that ulcerative proctitisis the most common clinical presentation among patients with UC. This goes against our study findings of extensive colitis as the more prevalent presentation and localization.2,4,5,10,15
Accordingtosomestudies,6,12 theextra-intestinal mani-festationsarehighlyprevalentamongpatientswithIBD.Inour
study,weobservedaprevalenceof70%,occurringmoreoften inpatientswithUC(76.9%)comparedwithpatientswithCD (66.7%).Thislatterfindingisatoddswithourfindings,which showthatsucheventsaremorecommoninpatientswithCD. Pharmacological treatment has been extensively researched, aiming to decrease the symptoms and inflammation.3,5,7,10,11 The early use of biologic therapy was notyetadopted;this optionisreserved onlyforcases of moderate or severe bowel disease in patientsrefractory toconventionaltreatment.13 Inthepresentstudy wefound that95% ofthepatientsusedanothertypeofdrugtherapy beforestartingtheuseofbiologicals,whichspeaksinfavorof thereferencedstudies.Ofthesepatients,34.2%usedalldrug classes prescribed inthetreatment ofIBD, without clinical improvement.
Regarding surgical treatment, 32.5% of the patients requiredsomeformofsurgicalinterventionduringthecourse ofthedisease,allofthembeingpatientswithCD,whichis sim-ilartoresultsintheliteraturethatshowahigherprevalence ofsurgicalproceduresamongCDpatientswhencomparedto UC.4,5
Withrespecttotheuseofbiologicaltherapy,mostpatients evaluated(57.5%)madeuseofthismedicationformorethan two years. The remission of the disease was obtained in mostcases(70%),whichisconsistentwithrecentlypublished studies.10,14
Conclusion
Patientcharacteristicsweresimilartothosefoundinthe lit-erature,withapredominanceofwomen(70%),youngadults (meanage,37.8years)andpresenceofCD(67.5%).Inrelation tothiscondition,theileocolonicmanifestationwasthemost frequentpresentation(33.3%),whileextensivecolitisor pan-colitis wasmorecommonamongpatientswithUC(61.5%). Thevastmajorityofpatients(95%)madeuseofbiologicals aslatetherapyand70% progressedwithremissionoftheir symptoms.
Conflicts
of
interest
Theauthorsdeclarenoconflictsofinterest.
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