NewNemluvio(nemolizumab)post-hocdatafromtheARCADIAlong-termextension(LTE)studyshowedthemajorityofWeek16respondersmaintaineddeepandlastingskinlesionanditchresponseforuptothreeyears1
    Additionallong-termdatafurtherdemonstrateNemluvio’sconsistentsafetyprofileandsustainedefficacy,includingimprovementsinskinclearance,itch,sleepandqualityoflifeinadultswithprurigonodularisupto148weeks,andpeoplewithatopicdermatitisaged12andolderupto152weeks2,3
    PhaseIIpediatricdatawillalsobepresented,withnemolizumabdrivingmeaningfulandsustainedimprovementsinchildrenaged2-11yearswithmoderate-to-severeatopicdermatitis4
    AlongsideaproducttheatreexploringhowtargetedIL-31treatmentmayimpactpatientoutcomes,thesefindingsreinforceGalderma'sleadershipinadvancingtreatmentgoalsinatopicdermatitisandprurigonodularis
    ZUG,Switzerland--(BUSINESSWIRE)--Galderma(SIX:GALD),thepure-playdermatologycategoryleader,todayannouncednewdataregardingtheuseofNemluvioforatopicdermatitisandprurigonodularistobepresentedatthe2026FallClinicalDermatologyConference,takingplacefromOctober08-11inLasVegas,UnitedStates.Thisincludesanewpost-hocanalysisfromtheARCADIALTEstudyshowingthatinadultsandadolescentsaged12andolderwhoachievedanearlyresponseatWeek16intheARCADIAtrial,Nemluvioachieveddeepandlastingskinlesionanditchresponsesforuptothreeyears.1Thedataaddtothegrowingevidencesupportingthelong-termefficacyofNemluvio,underscoringGalderma'scommitmenttoadvancingthescienceforpeoplelivingwithmoderate-to-severeatopicdermatitisandprurigonodularis.
    “Patientsandphysiciansincreasinglyexpectmorefromtreatmentthantemporarysymptomrelief.ThedatapresentedatFallClinicalreinforceourconfidenceinNemluvio'spotentialtodeliverdurablediseasecontrol,withevidencespanningdeepandsustainedresponsesonskinanditchthroughthreeyearsinadultsandadolescents,andaconsistentlong-termsafetyandefficacyprofile.Together,thesefindingsreflectGalderma'scontinuedfocusonredefiningwhatispossibleforpeoplelivingwithatopicdermatitisandprurigonodularis.”
    BILLANDRIOPOULOS,PH.D.
    HEADOFGLOBALMEDICALAFFAIRS体验AI智能工具
    GALDERMA
    MajorityofARCADIAWeek16earlyrespondersmaintaineddeepandlastingskinlesionanditchresponseswithNemluviothroughthreeyears1
    Newpost-hocdatafromtheongoingARCADIALTEstudyshowedthatadultsandadolescentsaged≥12yearswithmoderate-to-severeatopicdermatitiswhoachievedanearlyclinicalresponsewithNemluviointheARCADIAtrials,wereabletomaintaindeepandlastingimprovementsinbothskinlesionsanditchresponsethroughWeek152.1Theanalysisevaluated295patientswhoachievedaclinicalresponseatWeek16andcontinuedtreatmentduringthemaintenanceandLTEphasesofthestudy.1DeepskinclearancewasassessedbytheproportionofparticipantsachievinganIGAscoreof0or1,andthosewithamorethan90%or100%improvementfromtheinitialbaselineintheEASIscore.1
    Amongtheseearlyrespondersatoneyear(Week56),77%achievedclearskinoratleasta90%improvementindiseaseseverity.1ThiswasmaintaineduptoWeek152,where76%achievedclear(IGA0)oralmostclearskin(IGA1),and80%achievedatleasta90%improvementindiseaseseverity(EASI-90)and50%achievedcompleteskinclearance(EASI-100).1Inaddition,atWeek152,80%achievedanitch-freeornearlyitch-freestate.1
    Nemluviowaswelltolerated,withnonewsafetysignals.1ThedataareconsistentwiththepreviouslycollectedsafetyandefficacydataregardingNemluvioinadultsandadolescentswithmoderate-to-severeatopicdermatitis.5Thesefindingsfurtherstrengthenthegrowingbodyofevidencesupportingthelong-termefficacyofNemluvioanditspotentialtodeliverlastingdiseasecontrolacrosskeysymptomsofatopicdermatitis.
    “Asprogressinthishigh-burdendiseaseareaaccelerates,wearechallengedtoaimhigherinatopicdermatitiscare.Thesenewthree-yearresultsareencouragingforNemluvio,addingtoitsgrowingbodyofevidenceandhighlightingitspotentialtohelppatientsachievemeaningfullong-termoutcomesinatopicdermatitis.”
    SARINAELMARIAH,M.D.
    DERMATOLOGISTANDITCHSPECIALIST
    UNIVERSITYOFCALIFORNIA
    SANFRANCISCO,UNITEDSTATES
    Separatethree-yearinterimanalysisfromtheARCADIALTEreinforcesthelong-termbenefitofNemluvio2
    Aseparatepre-specifiedinterimanalysisoftheoverallARCADIALTEpopulationassessedthelong-termsafetyandefficacyofNemluvioin1,903adultsandadolescentsaged≥12yearswithmoderate-to-severeatopicdermatitis.2AtWeek152,Nemluviowaswell-toleratedandassociatedwithsustainedefficacy,includingimprovementsinskinlesions,itch,sleepdisturbanceandqualityoflife.2Basedonobservedcaseanalyses:
    Upto91%ofpatientsachievedatleast75%improvementineczemaseverity(EASI-75),andupto75%achievedatleast90%improvementineczemaseverity(EASI-90)2
    Upto67%ofpatientsachievedclearoralmostclearskin(IGA0/1)2
    Upto88%ofpatientsachievedclinicallymeaningfulitchreliefandupto73%achievedanitch-freeornearlyitch-freestate2
    Upto92%ofpatientsachievedclinicallymeaningfulimprovementsindermatology-relatedqualityoflife2
    ThesafetyprofileofNemluvioremainedconsistentwithpreviousfindingsthroughthreeyearsoftreatment,withnonewsafetysignalsidentifiedcomparedtopreviouslong-termextensionstudyinterimanalyses2,5
    Pediatricdatasupportnemolizumab’spotentialacrosspatientpopulations4
    GaldermawillalsopresentclinicalresultsfromaphaseIIstudydesignedtoassessthepharmacokinetics,safety,andefficacyofnemolizumabinchildren(aged2to11years)withmoderate-to-severeatopicdermatitis.4Resultsshowedthatnemolizumabpediatricdoseswereassociatedwithsimilarpharmacokineticexposurecomparedtoadultsandadolescents,andwerewelltoleratedandeffectiveinchildren,withclinicallymeaningfulreductionsinskinlesionsanditchthroughWeek16andsustaineduptoWeek52.4
    Long-termdatareinforcesustainedimprovementsinprurigonodularisburden3
    AseparatedescriptiveanalysisfromtheOLYMPIALTEstudyshowedthatNemluvioalsodeliveredsustainedandclinicallymeaningfulimprovementsacrossmultipledimensionsofprurigonodulariburdenthroughWeek148,includingitch,pain,sleepdisturbance,qualityoflifeandoverallhealthstatus.3AtWeek48,outof508enrolledpatients:
    Morethan85%ofpatientsachievedclinicallymeaningfulitchimprovement,withaboutthree-quartersofpatientsachievinganitch-freeornearlyitch-freestate3
    60%reportednoprurigonodularis-associatedpain3
    85%achievedclinicallymeaningfulimprovementsinsleepdisturbance3
    91%experiencedclinicallymeaningfulimprovementsinqualityoflife3
    ThesafetyprofileofNemluvioremainedconsistentwithpreviousfindingsthroughthreeyearsoftreatment,withnonewsafetysignalsidentifiedcomparedtopreviouslong-termextensionstudyinterimanalyses3
    Thesefindingsreinforcethatlong-termtreatmentwithNemluviomaysupportnotonlysymptomrelief,butalsomeaningfulimprovementsinpatients'dailyfunctioningandwellbeing.
    AlsoattheFallClinical2026congress,Dr.RajChovatiyaandDr.ShawnKwatrawillpresenttohealthcareprofessionalsattendingthecongressataGalderma-sponsoredproducttheatretitled“TargetingtheIL-31NeuroimmunePathway:ACase-BasedApproach.”TakingplaceonFriday,October9,from12:30-1:00PMintheCastillonroom,thesessionwillexploretheroleofneuroimmuneinteractionsinprurigonodularisandatopicdermatitis,discussingreal-worldcasesandthepotentialimpactoftargetingtheIL-31pathwayonpatientoutcomes.
    Mediacanfindmoreinformationandresourcesonatopicdermatitisandprurigonodularisinthistoolkit.
    Aboutnemolizumab
    NemolizumabisthefirstapprovedmonoclonalantibodythatspecificallytargetsandinhibitsthesignalingofIL-31–aneuroimmunecytokinethatdrivesitchandisinvolvedininflammation,epidermaldysregulationandfibrosisinbothatopicdermatitisandprurigonodularis.6-9
    NemolizumabwasinitiallydevelopedbyChugaiPharmaceuticalCo.,Ltd.In2016,Galdermaobtainedexclusiverightstothedevelopmentandmarketingofnemolizumabworldwide,exceptinJapan.InJapan,nemolizumabismarketedasMitchga®andisapprovedforthetreatmentofprurigonodularisinadultsandchildrenaged13yearsandolder,aswellaspruritusassociatedwithatopicdermatitisinadultsandchildrenbetweentheagesof6and12.10,11
    Nemolizumab(underthenameNemluvio®)wasapprovedbytheUnitedStatesFoodandDrugAdministrationforthetreatmentofadultswithprurigonodularis,andpatients12yearsandolderwithmoderate-to-severeatopicdermatitis,incombinationwithtopicalcorticosteroidsand/orcalcineurininhibitorswhenthediseaseisnotadequatelycontrolledwithtopicalprescriptiontherapies.7Todate,nemolizumabisapprovedforbothadolescentsandadultswithmoderate-to-severeatopicdermatitisandadultswithprurigonodularisinmorethan40countriesaroundtheworld.Additionalregulatorysubmissionsandreviewsareongoing.
    NemluvioImportantSafetyInformation
    INDICATIONS:NEMLUVIO®(nemolizumab-ilto)isaninterleukin-31receptoralphaantagonistindicatedfor:
    thetreatmentofadultsandpediatricpatients12yearsofageandolderwithmoderate-to-severeatopicdermatitisincombinationwithtopicalcorticosteroidsand/orcalcineurininhibitorswhenthediseaseisnotadequatelycontrolledwithtopicalprescriptiontherapies.
    thetreatmentofadultswithprurigonodularis.
    CONTRAINDICATION:NEMLUVIOiscontraindicatedinpatientswithknownhypersensitivitytonemolizumab-iltoortoanyoftheexcipientsinNEMLUVIO.体验AI智能工具
    WARNINGSANDPRECAUTIONS:HypersensitivityreactionshavebeenreportedwithNEMLUVIOuse.Ifclinicallysignificanthypersensitivityreactionoccurs,immediatelyinstituteappropriatetherapy,anddiscontinueNEMLUVIO.AvoiduseoflivevaccinesduringtreatmentwithNEMLUVIO.
    ADVERSEREACTIONS:Mostcommonadversereactions(incidence≥1%)are:
    AtopicDermatitis:headache(includingmigraine),arthralgia,urticaria,andmyalgia.
    PrurigoNodularis:headache,dermatitisatopic,eczema,andeczemanummular.
    USEINSPECIFICPOPULATIONS:
    Pregnancy:Therearenoadequateandwell-controlledstudiesonNEMLUVIOinpregnantwomen.ThelimitedavailableinformationonNEMLUVIOuseduringpregnancyisnotsufficienttoinformadrug-associatedriskofmajorbirthdefectsormiscarriageinhumans.HumanIgGantibodiesareknowntocrosstheplacentalbarrier;therefore,NEMLUVIOmaybetransmittedfromthemothertothedevelopingfetus.
    Lactation:TherearenodataonthepresenceortransferofNEMLUVIOinhumanmilk,theeffectsonthebreastfedinfant,ortheeffectsonmilkproduction.HumanIgGisknowntobepresentinhumanmilk.TheeffectsoflocalgastrointestinalandlimitedsystemicexposuretoNEMLUVIOonthebreastfedinfantareunknown.NEMLUVIOhasnotbeenadministeredtonursing/lactatingwomen.Thedevelopmentalandhealthbenefitsofbreastfeedingshouldbeconsideredalongwiththemother’sclinicalneedforNEMLUVIOandanypotentialadverseeffectsonthebreastfedchildfromNEMLUVIOorfromtheunderlyingmaternalcondition.
    PediatricUse:ThesafetyandeffectivenessofNEMLUVIOhavenotbeenestablishedinpediatricpatientsyoungerthan12yearsofageforthetreatmentofmoderate-to-severeatopicdermatitisorpediatricpatientsyoungerthan18yearsofageforthetreatmentofprurigonodularis.
    PleaseseefullPrescribingInformationincludingPatientInformation.
    AboutGalderma
    Galderma(SIX:GALD)isthepure-playdermatologycategoryleader,presentinapproximately90countries.Wedeliveraninnovative,science-basedportfolioofpremiumflagshipbrandsandservicesthatspanthefullspectrumofthefast-growingdermatologymarketthroughInjectableAesthetics,DermatologicalSkincareandTherapeuticDermatology.Sinceourfoundationin1981,wehavededicatedourfocusandpassiontothehumanbody’slargestorgan–theskin–meetingindividualconsumerandpatientneedswithsuperioroutcomesinpartnershipwithhealthcareprofessionals.Becauseweunderstandthattheskinweareinshapesourlives,weareadvancingdermatologyforeveryskinstory.Formoreinformation:www.galderma.com.
    References
    1.Elmariah,etal.Nemolizumabtreatmentisassociatedwithdeepandlastingskinlesionanditchresponses:ResultsfromtheARCADIAlong-term-extension(LTE)studyuptoweek152.PresentedatFallClinicalDermatologyConference2026;October8-11,2026;LasVegas.
    2.Silverberg,etal.Long-termsafetyandefficacy(upto152weeks)ofnemolizumabinARCADIAopen-labellong-termextensionstudyinadultsandadolescentswithmoderate-to-severeatopicdermatitis.PresentedatFallClinicalDermatologyConference2026;October8-11,2026;LasVegas.
    3.Stander,etal.Evolutionofclinicalresponsewithlong-termnemolizumabtherapyinprurigonodularis:Fromsymptomrelieftoimprovementsinsleepandqualityoflife(AS-4212).PresentedatFallClinicalDermatologyConference2026;October8-11,2026;LasVegas.
    4.Eichenfield,etal.Pharmacokinetics,safety,andefficacyofnemolizumabinchildren(aged2-11years)withmoderate-to-severeatopicdermatitis.PresentedatAAD2026;March27-31,2026.
    5.Silverberg,etal.Nemolizumabwithconcomitanttopicaltherapyinadolescentsandadultswithmoderate-to-severeatopicdermatitis(ARCADIA1&2):resultsfromtworeplicatedouble-blinded,randomisedcontrolledphase3trials.Lancet.2024;404(10451):445-460.doi:10.1016/S0140-6736(24)01203-0.
    6.SilverbergJI,etal.Phase2Brandomizedstudyofnemolizumabinadultswithmoderate-to-severeatopicdermatitisandseverepruritus.JAllergyClinImmunol.2020;145(1):173-182.doi:10.1016/j.jaci.2019.08.013
    7.NemluvioU.S.PrescribingInformation.Availableonline.AccessedMarch2025
    8.NemluvioEuropeanMedicinesAgency.SummaryofProductCharacteristics.Availableonline.AccessedMarch2025
    9.BewleyA,etal.PrurigoNodularis:AReviewofIL-31RABlockadeandOtherPotentialTreatments.DermatolTher(Heidelb).2022;12(9):2039–2048.doi:10.1007/s13555-022-00782-2
    10.ChugaiPharmaceuticalCo.,Ltd.MaruhoObtainedRegulatoryApprovalforMitchga,theFirstAntibodyTargetingIL-31forItchingAssociatedwithAtopicDermatitis.Availableonline.AccessedMarch2025.
    11.ChugaiPharmaceuticalCo.,Ltd.MitchgaApprovedforItchinginPediatricAtopicDermatitisandPrurigoNodularis,foritsSubcutaneousInjection30mgVials.Availableonline.AccessedMarch2025.

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