Enjoy ThE simplE plEasurEs of lifE - ibd.as ?· ulcEraTivE coliTis disrupTs ThE simplE plEasurEs in…

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  • Enjoy ThE simplE plEasurEs of lifE

    FERRINGPHARMACEUTICALS

    FOLLOW YOUR GUT FEELING

    CO

    R/93

    9/20

    14/C

    H3

  • FERRINGPHARMACEUTICALS

    2

    ulcEraTivE coliTis disrupTs ThE simplE plEasurEs in lifE

    Patientswithulcerativecolitismaylivewithaconsiderablesymptomburdendespitemedicaltreatment.1,2

    Ulcerativecolitiscanhavesubstantialpsychosocialimplicationswithconsequentimpactonqualityoflife.3

    Theuseofconventionalcorticosteroidsforinflammatorydiseasesisassociatedwithgreatersideeffectsthantopical

    steroids.4ASurveyinEuropeontheimpactofinflammatoryboweldiseasesonpatientslives(N=4995)showedthat2:

    42%ofthepatientsexperiencesideeffectsfromtakingcorticosteroids.

    49%ofthepatientsareworriedabouttheimpactofcorticosteroidsontheirlong-termhealth.

    symptoms experienced at least once a day2 (n=4995)

    Duringaflare Betweenflares

    Bleeding 61% 28%

    Abdominalcrampingpain 87% 62%

    Tired,weakorwornout 96% 83%

    Urgentbowelmovements 89% 66%

    Diarrhoea 93% 61%

  • FERRINGPHARMACEUTICALS

    3

    ThE ThErapEuTic goals in ulcEraTivE coliTis arE:5

    inductionandmaintenanceofremissionusingwell-tolerateddrugs

    mucosalhealing

    avoidanceofsurgicalintervention

    decreasingthelikelihoodofcancer

    improvedqualityoflife.

  • 4

    FERRINGPHARMACEUTICALS

    corTimEnTmmX is dEsignEd for local dElivEry of a poTEnT corTicosTEroid for paTiEnTs wiTh ulcEraTivE coliTis7

    POTENT ANTI-INFLAMMATORY ACTIVITY

    >3 times RRA* versus prednisolone and hydrocortisone10 (in vitro data) *RRA = Relative Receptor Affinity, an indirect measure of corticosteroid activity.

    ORAL ADMINISTRATIONONE DOSE DAILY

    PATIENT CONVENIENCE one small tablet once a day

    FIRST-PASS LIVER METABOLISM

    Metabolites with limited activity Low systemic exposure: about 10%9

    = side effect profile similar to placebo11,12

    COLONIC RELEASE SYSTEM

    Targeted release for topical effect at the site of inflammation = TOPICAL ACTIVITY7

  • 5

    FERRINGPHARMACEUTICALS

    corTimEnTmmX has an advErsE EvEnT profilE comparaBlE To placEBo11

    CORTIMENTMMXcombineslocalcorticosteroidefficacywithlowsystemicexposure.6,7

    Treatment-emergent adverse events (TEaEs)11

    Safetypopulation(n=257)

    Placebon=129

    CORTIMENTMMXn=128

    RelatedTEAEs 24.0% 25.8%

    SeriousTEAEs 3.9% 3.1%

    Potentialcorticosteroideffectsoccurredinfrequently.

    Mostadverseeventswereofmild-to-moderateintensityandofanon-seriouscharacter.

    most common potential corticosteroid effects at final visit 11

    Safetypopulation(n=257)

    Placebon=129

    CORTIMENTMMXn=128

    Moodchanges 5.4% 1.6%

    Sleepchanges 3.1% 2.3%

    Insomnia 1.6% 0.8%

    Acne 1.6% 0.8%

    Moonface 3.1% 1.6%

    TablesshowsafetydatafromstudyCOREII.11COREIsafetydataaresimilar.12

  • 6

    FERRINGPHARMACEUTICALS

    corTimEnTmmX sTudiEs usEd a rigorous dEfiniTion of rEmission and sTringEnT inclusion criTEria7,11,12

    DEfINITIONOfREMISSION,UCDAI1WITH: INClUSIONCRITERIA

    o normalstoolfrequencyo absenceofbleedingo presenceofnormalmucosawithoutfriabilityo endoscopicimprovementconfirmedbyfull

    colonoscopy

    o adultpatients(18-75years)o ulcerativecolitisduringatleastsixmonthso mildormoderateactivedisease(UCDAI4-10)o abnormalhistologyinatleastoneofthreebiopsiesfrom

    coloniclesions

    Thisrigorousdefinitionofremissionhasanimpactontheobservedremissionratesforactiveandplacebotreatmentarms.7,11,12

    UCDAI:Ulcerativecolitisdiseaseactivityindex

  • 7

    FERRINGPHARMACEUTICALS

    corTimEnTmmX 9mg shows 2,4 - 3,9 TimEs highEr rEmission raTEs comparEd To placEBo11,12

    CORTIMENTMMX9mgshowsstatisticallysignificantresultsontheprimaryendpointversusplacebo.11,12

    CLINICAL AND ENDOSCOPIC REMISSIONat week 8

    0

    5

    10

    15

    20

    Placebo (n=89)Re

    miss

    ion

    %CORTIMENTMMX (n=109)

    4.5

    17.4

    12.9

    *Statistically significant versus placebo

    p = 0.0047*

    CLINICAL AND ENDOSCOPIC REMISSIONat week 8

    0

    5

    10

    15

    20

    Placebo (n=121)

    Rem

    issio

    n %

    CORTIMENTMMX (n=123)

    7.4

    17.9

    10.4

    *Statistically significant versus placebo

    p = 0.0013*

    clinical and Endoscopic rEmission at week 8

    corE ii sTudycorE i sTudy

    p=0.0143*

  • 8

    FERRINGPHARMACEUTICALS

    corTimEnTmmX inducEs sympTom rEsoluTion afTEr 8 wEEks11,12

    CORTIMENTMMX9mginducessymptomresolutionafter8weeks.11,12

    SYMPTOM RESOLUTION AT WEEK 8Combined rectal bleeding and stool frequency scores of 0

    0

    5

    10

    15

    20

    25

    30

    Placebo (n=89)

    Sym

    ptom

    Res

    olut

    ion

    %

    CORTIMENTMMX (n=109)

    11.2

    23.9

    12.7p = 0.0220*

    *Statistically significant versus placebo

    SYMPTOM RESOLUTION AT WEEK 8Combined rectal bleeding and stool frequency scores of 0

    0

    5

    10

    15

    20

    25

    30

    Placebo (n=121)

    Sym

    ptom

    Res

    olut

    ion

    %

    CORTIMENTMMX (n=123)

    16.5

    28.5

    11.9p = 0.0258*

    *Statistically significant versus placebo

    sympTom rEsoluTion at week 8Combindrectalbleedingandstoolfrequencyscoresof0

    corE ii sTudycorE i sTudy

  • 9

    FERRINGPHARMACEUTICALS

    CORTIMENTMMX:onesmall9mgtablet,oncedaily,forupto8weeks.7

    corTimEnTmmX offErs sympTom rEsoluTion wiTh oncE daily convEniEncE

    CORTIMENTMMX

    o Patientsgenerallypreferalowdosefrequencyandreducedpillburden.5,8,13

    o Patientspreferoralintakeoverrectaluse.8

  • 10

    FERRINGPHARMACEUTICALS

    corTimEnTmmX, Enjoy ThE simplE plEasurEs of lifE

    CORTIMENTMMXonesmalltablet,oncedaily,forupto8weeks

    CORTIMENTMMXisindicatedformild-to-moderateactiveulcerativecolitiswhere5-ASAtreatmentisnotsufficient

    CORTIMENTMMXisdesignedforlocaldeliveryofapotentcorticosteroid

    CORTIMENTMMXhasanadverseeventprofilecomparabletoplacebo

    CORTIMENTMMXcombinescorticosteroidefficacywithlowsystemicexposure

  • Enjoy ThE simplE plEasurEs of lifE

  • 1.DignassA,EliakimR,Magrofetal.SecondEuropeanevidence-basedconsensusonthediagnosisandmanagementofulcerativecolitispart1:definitionsanddiagnosis.JCrohnsColitis.2012;6:965-990.2.IMPACT2010-2011CrohnsandUlcerativeColitisPatientlifeImpactSurvey.Presentationavailableat:http://efcca-solutions.net/european.php.lastaccessed:february2014.3.GhoshS,MitchellR.Impactofinflammatoryboweldiseaseonqualityoflife:ResultsoftheEuropeanfederationofCrohnsandUlcerativeColitisAssociations(EfCCA)patientsurvey.JCrohnsColitis.2007;1:10-20.4.DignassA,lindsayJO,SturmAetal.SecondEuropeanevidence-basedconsensusonthediagnosisandmanagementofulcerativecolitispart2:currentmanagement.JCrohnsColitis.2012;6:991-1030.5.SiewN,KammMA.Therapeuticstrategiesforthemanagementofulcerativecolitis.InflammBowelDis.2009;15:935-950.6.farkasK,MolnarT.Novelextendedreleasebudesonideformulationfortreatmentofulcerativecolitis.ExpertOpinPharmacother.2014;15:131-137.7.ferringPharmaceuticals.CortimentMMX9mgSmPC.DateofRevisionText:October2014.8.KaneSV.Systematicreview:adherenceissuesinthetreatmentofulcerativecolitis.AlimentPharmacolTher.2006;23:577-585.9.RyrfeldtA,AnderssonP,EdsbackerSetal.Pharmacokineticsandmetabolismofbudesonide,aselectiveglucocorticoid.EurJRespirDisSuppl.1982;122:86-95.10.MagerDE,MoledinaN,JuskoWJ.Relativeimmunosuppressivepotencyoftherapeuticcorticosteroidsmeasuredbywholebloodlymphocyteproliferation.JPharmSci.2003;92:1521-1525.11.TravisSP,DaneseS,Kupcinskasletal.Once-dailybudesonideMMXinactive,mild-to-moderateulcerativecolitis:resultsfromtherandomisedCOREIIstudy.Gut.2014;63:433-441.12.SandbornWJ,TravisS,Moroletal.Once-dailybudesonideMMXextended-releasetabletsinduceremissioninpatientswithmildtomoderateulcerativecolitis:resultsfromtheCOREIstudy.Gastroenterology.2012;143:1218-26.e1.13.DignassAU,BokemeyerB,AdamekHetal.Mesalamineoncedailyismoreeffectivethantwicedailyinpatientswithquiescentulcerativecolitis.ClinGastroenterolHepatol.2009;7:762-769.

    CortimentmmX 9 mg,BudesonideProlongedreleasetablets. indications:CORTIMENTisindicatedinadultsforinductionofremissioninpatientswithmildtomoderateactiveulcerativecolitis(UC)where5-ASAtreatmentisnotsufficient.Dosing:Therecommendeddailydoseforinductionofremissionisone9mgtabletinthemorning,withorwithoutfood,forupto8weeks.Contraindications: Hypersensitivitytotheactivesubstance,soyaoil,peanutoilortoanyoftheexcipients.Warnings and precautions:CORTIMENTtabletsshouldbeusedwithcautioninpatientswithinfections,hypertension,diabetesmellitus,osteoporosis,pepticulcer,glaucomaorcataractsorwithafamilyhistoryofdiabetesorglaucomaorwithanyotherconditionwheretheuseofglucocorticoidsmayhaveunwantedeffects.Reducedliverfunctionmayaffecttheeliminationofglucocorticoidsincludingbudesonide,causinghighersystemicexposure.Beawareofpossiblesystemicsideeffects.Whentreatmentistobediscontinued,itmaybeusefultograduallyreducethedoseatthediscretionofthetreatingphysician.TreatmentwithCORTIMENTtabletsresultsinlowersystemicsteroidlevelsthanconventionaloralglucocorticoidtherapy.Transferfromothersteroidtherapymayresultinsymptomsrelatingtothechangeinsystemicsteroidlevels.Somepatientsmayfeelunwellduringthewithdrawalphase.Ascorticosteroidsareknowntohaveimmunologicaleffectstheco-administrationofCORTIMENTtabletsislikelytoreducetheimmuneresponsetovaccines.CORTIMENTcontainslecithin(derivedfromsoya)andlactose.interactions:NointeractionstudieshavebeenperformedBudesonideisprimarilymetabolizedbycytochromeP4503A4(CYP3A4).Inhibitorsofthisenzyme,e.g.ketoconazole,itraconazole,HIVproteaseinhibitorsandgrapefruitjui