enjoy the simple pleasures of life - ibd.as · ulcerative colitis disrupts the simple pleasures in...

Enjoy ThE simplE plEasurEs of lifE

FERRINGPHARMACEUTICALS

FOLLOW YOUR GUT FEELING

CO

R/93

9/20

14/C

H3


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%


3

ThE ThErapEuTic goals in ulcEraTivE coliTis arE:5

• inductionandmaintenanceofremissionusingwell-tolerateddrugs

• mucosalhealing

• avoidanceofsurgicalintervention

• decreasingthelikelihoodofcancer

• improvedqualityoflife.

4


corTimEnT®mmX® 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


corTimEnT®mmX® has an advErsE EvEnT profilE comparaBlE To placEBo11

• CORTIMENT®MMX®combineslocalcorticosteroidefficacywithlowsystemicexposure.6,7

Treatment-emergent adverse events (TEaEs)11

Safetypopulation(n=257)

Placebon=129

CORTIMENT®MMX®n=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

CORTIMENT®MMX®n=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


corTimEnT®mmX® sTudiEs usEd a rigorous dEfiniTion of rEmission and sTringEnT inclusion criTEria7,11,12

DEfINITIONOfREMISSION,UCDAI≤1WITH: 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


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

CORTIMENT®MMX®9mgshowsstatisticallysignificantresultsontheprimaryendpointversusplacebo.11,12

CLINICAL AND ENDOSCOPIC REMISSIONat week 8

0

5

10

15

20

Placebo (n=89)Re

miss

ion

%CORTIMENT®MMX® (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 %

CORTIMENT®MMX® (n=123)

7.4

17.9

∆ 10.4


p = 0.0013*

clinical and Endoscopic rEmission at week 8

corE ii sTudycorE i sTudy

p=0.0143*

8


corTimEnT®mmX® inducEs sympTom rEsoluTion afTEr 8 wEEks11,12

• CORTIMENT®MMX®9mginducessymptomresolutionafter8weeks.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

%

CORTIMENT®MMX ® (n=109)

11.2

23.9

∆ 12.7p = 0.0220*


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

%

CORTIMENT®MMX ® (n=123)

16.5

28.5

∆ 11.9p = 0.0258*


sympTom rEsoluTion at week 8Combindrectalbleedingandstoolfrequencyscoresof0

corE ii sTudycorE i sTudy

9


• CORTIMENT®MMX®:onesmall9mgtablet,oncedaily,forupto8weeks.7

corTimEnT®mmX® offErs sympTom rEsoluTion wiTh oncE daily convEniEncE

CORTIMENT®MMX®

o Patientsgenerallypreferalowdosefrequencyandreducedpillburden.5,8,13

o Patientspreferoralintakeoverrectaluse.8

10


corTimEnT®mmX®, Enjoy ThE simplE plEasurEs of lifE

• CORTIMENT®MMX®onesmalltablet,oncedaily,forupto8weeks

• CORTIMENT®MMX®isindicatedformild-to-moderateactiveulcerativecolitiswhere5-ASAtreatmentisnotsufficient

• CORTIMENT®MMX®isdesignedforlocaldeliveryofapotentcorticosteroid

• CORTIMENT®MMX®hasanadverseeventprofilecomparabletoplacebo

• CORTIMENT®MMX®combinescorticosteroidefficacywithlowsystemicexposure

Enjoy ThE simplE plEasurEs of lifE

1.DignassA,EliakimR,Magrofetal.SecondEuropeanevidence-basedconsensusonthediagnosisandmanagementofulcerativecolitispart1:definitionsanddiagnosis.JCrohnsColitis.2012;6:965-990.2.IMPACT2010-2011Crohn’sandUlcerativeColitisPatientlifeImpactSurvey.Presentationavailableat:http://efcca-solutions.net/european.php.lastaccessed:february2014.3.GhoshS,MitchellR.Impactofinflammatoryboweldiseaseonqualityoflife:ResultsoftheEuropeanfederationofCrohn’sandUlcerativeColitisAssociations(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.Cortiment®MMX®9mgSmPC.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-dailybudesonideMMX®extended-releasetabletsinduceremissioninpatientswithmildtomoderateulcerativecolitis:resultsfromtheCOREIstudy.Gastroenterology.2012;143:1218-26.e1.13.DignassAU,BokemeyerB,AdamekHetal.Mesalamineoncedailyismoreeffectivethantwicedailyinpatientswithquiescentulcerativecolitis.ClinGastroenterolHepatol.2009;7:762-769.

Cortiment®mmX® 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,HIVproteaseinhibitorsandgrapefruitjuice,canthereforeincreasesystemicexposuretobudesonideseveraltimes(seesection4.4).Sincethereisnodatatosupportadosagerecommendation,thecombinationshouldbeavoided.Ifthisisnotpossible,theperiodbetweentreatmentsshouldbeaslongaspossibleandareductionofthebudesonidedosecouldalsobeconsidered.BudesonideisunlikelytoinhibitotherdrugsmetabolizedviaCYP3A4,sincebudesonidehaslowaffinitytotheenzyme.Corticosteroidinteractionsthatmaypresentasignificanthazardtoselectedpatientsarethosewithheartglycosidesanddiuretics.Fertility, pregnancy and lactation:Dataonuseofinhaledbudesonideinaverylargenumberofexposedpregnanciesindicatenoadverseeffects.Althoughtherearenodataofoutcomesofpregnanciesafteroraladministration,thebioavailabilityafteroraladministrationislow.Inanimalexperiments,athighexposures,corticosteroidsprovedtobeharmful.CORTIMENTshouldonlybeusedduringpregnancyifthepotentialbenefitjustifiesthepotentialrisktothefetus.Budesonideisexcretedinsmallamountsinbreastmilk.Duetotherapidbudesonideclearancefromtheblood,ontheoreticalgrounds,theexposuretothesucklingchildisexpectedtobelow.However,therearenodata.Adecisionmustbemadewhethertodiscontinuebreast-feedingortodiscontinue/abstainfrombudesonidetherapytakingintoaccountthebenefitofbreast-feedingforthechildandthebenefitoftherapyforthewoman. Undesirable effects:Occasionally,sideeffectstypicalofsystemicglucocorticosteroidsmayoccur.Thesesideeffectsdependonthedosage,durationoftreatment,concomitantorprevioustreatmentwithotherglucocorticosteroidsandindividualsensitivity.Steroidsclasssideeffectsincludefollowingdisorders:Skinandsubcutaneoustissue,Musculoskeletal,connectivetissueandbone,Eye,Psychiatric,Gastrointestinal,MetabolismandNutrition,Vascular,Immunesystem.overdose:Intheeventofacuteoverdosage,nospecificantidoteisavailable.Treatmentconsistsofsupportiveandsymptomatictherapy.Pharmacodynamic properties: Budesonideisreleasedintotheintestinaltractatacontrolledratethroughoutthecolon.–Clinicalefficacy:5-ASAistheStandardofCarefortreatmentofmildtomoderatedisease.ResultsofaheadtoheadcomparisonwithCORTIMENTand5-ASAarenotavailable.Therefore,theplaceinthetherapeuticwork-upremainstobeestablished.SomepatientsmaybenefitfromtreatmentinitiallywithCORTIMENT.PleasecheckwithyourlocalferringrepresentativeforlocalprescribinginformationandSmPC.Cortiment®mmX® 9 mg: Ferring Pharmaceuticals, Switzerland.


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prEscriBing informaTion

CORTIMENTisaregisteredtrademarkofferringB.V.MMXisaregisteredtrademarkofCosmoTechnologieslimited.

enjoy the simple pleasures of life - ibd.as · ulcerative colitis disrupts the simple pleasures in...

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