95
Views
21
CrossRef citations to date
0
Altmetric
Review

Understanding the positive benefit:risk profile of alemtuzumab in relapsing multiple sclerosis: perspectives from the Alemtuzumab Clinical Development Program

, , , &
Pages 1423-1437 | Published online: 16 Oct 2017

References

  • GiovannoniGArnoldDCohenJLong-term responders from the CARE-MS I study: no evidence of disease activity for 4 years following 2 courses of alemtuzumab and no further treatmentNeurology20168616 suppl3054
  • HauserSLBar-OrAComiCOcrelizumab versus interferon beta-1a in relapsing multiple sclerosisN Engl J Med201737622123428002679
  • ZiemssenTDe StefanoNSormaniMPVan WijmeerschBWiendlHKieseierBCOptimizing therapy early in multiple sclerosis: an evidence-based viewMult Scler Relat Disord20154546046926346796
  • University of California, San Francisco MS-EPIC TeamCreeBAGourraudPAOksenbergJRLong-term evolution of multiple sclerosis disability in the treatment eraAnn Neurol201680449951027464262
  • GiovannoniGCookCRammohanKCLARITY study groupSustained disease-activity-free status in patients with relapsing-remitting multiple sclerosis treated with cladribine tablets in the CLARITY study: a post-hoc and subgroup analysisLancet Neurol201110432933721397565
  • HavrdovaEGalettaSHutchinsonMEffect of natalizumab on clinical and radiological disease activity in multiple sclerosis: a retrospective analysis of the Natalizumab Safety and Efficacy in Relapsing-Remitting Multiple Sclerosis (AFFIRM) studyLancet Neurol20098325426019201654
  • RotsteinDLHealyBCMalikMTChitnisTWeinerHLEvaluation of no evidence of disease activity in a 7-year longitudinal multiple sclerosis cohortJAMA Neurol201572215215825531931
  • StangelMPennerIKallmannBLukasCKieseierBCTowards the implementation of ‘no evidence of disease activity’ in multiple sclerosis treatment: the multiple sclerosis decision modelTher Adv Neurol Disord20158131325584069
  • BeerSKhanFKesselringJRehabilitation interventions in multiple sclerosis: an overviewJ Neurol201225991994200822772357
  • TomassiniVMatthewsPMThompsonAJNeuroplasticity and functional recovery in multiple sclerosisNat Rev Neurol201281163564622986429
  • CohenJAColesAJArnoldDLCARE-MS I investigatorsAlemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a randomised controlled phase 3 trialLancet201238098561819182823122652
  • ColesAJTwymanCLArnoldDLCARE-MS II investigatorsAlemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trialLancet201238098561829183923122650
  • GiovannoniGGoldRKapposLDelayed-release dimethyl fumarate and disability assessed by the multiple sclerosis functional composite: integrated analysis of DEFINE and CONFIRMMult Scler J Exp Transl Clin20162 2055217316634111
  • ProsperiniLBarlettaVDe GiglioLFanelliFBorrielloGPozzilliCA five-year clinical follow-up study of patients with multiple sclerosis who started natalizumabNeurology20148210 suppl7215
  • ColesAArnoldDLCohenJAPatients with active RRMS and an inadequate response to prior therapy demonstrate durable improvements in relapse and disability following treatment with alemtuzumab: 5-year follow-up of the CARE-MS II studyNeurology20168616 suppl3022
  • GiovannoniGCohenJAColesAJCARE-MS II InvestigatorsAlemtuzumab improves preexisting disability in active relapsing-remitting MS patientsNeurology201687191985199227733571
  • Biogen IncTYSABRI (natalizumab). Prescribing InformationCambridge, MABiogen Idec2013
  • Lemtrada(alemtuzumab) Summary of Product Characteristics2016 Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003718/WC500150521.pdfAccessed March 29, 2017
  • Lemtrada(Alemtuzumab) Prescribing InformationCambridge, MAGenzyme Corporation2016
  • BezabehSFlowersCMKortepeterCAviganMClinically significant liver injury in patients treated with natalizumabAliment Pharmacol Ther20103191028103520163378
  • LisottiAAzzaroliFBrillantiSMazzellaGSevere acute autoimmune hepatitis after natalizumab treatmentDig Liver Dis201244435635722154948
  • PolmanCHO’ConnorPWHavrdovaEAFFIRM InvestigatorsA randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosisN Engl J Med2006354989991016510744
  • SubeiAMOntanedaDRisk mitigation strategies for adverse reactions associated with the disease-modifying drugs in multiple sclerosisCNS Drugs201529975977126407624
  • FilippiMRoccaMABarkhofFAttendees of the Correlation between Pathological MRI findings in MS workshopAssociation between pathological and MRI findings in multiple sclerosisLancet Neurol201211434936022441196
  • KutzelniggALassmannHPathology of multiple sclerosis and related inflammatory demyelinating diseasesHandb Clin Neurol20141223155824507512
  • LublinFDBaierMCutterGEffect of relapses on development of residual deficit in multiple sclerosisNeurology200361111528153214663037
  • Multiple Sclerosis Therapy Consensus Group (MSTCG)WiendlHToykaKVBasic and escalating immunomodulatory treatments in multiple sclerosis: current therapeutic recommendationsJ Neurol2008255101449146319005625
  • ClericoMBarberoPContessaGFerreroCDurelliLAdherence to interferon-beta treatment and results of therapy switchingJ Neurol Sci20072591–210410817376486
  • CoxDStoneJManaging self-injection difficulties in patients with relapsing-remitting multiple sclerosisJ Neurosci Nurs200638316717116817668
  • CostelloKKennedyPScanzilloJRecognizing nonadherence in patients with multiple sclerosis and maintaining treatment adherence in the long termMedscape J Med200810922519008986
  • HavrdovaEArnoldDLCohenJACARE-MS I and CAMMS03409 InvestigatorsAlemtuzumab CARE-MS I 5-year follow-up: durable efficacy in the absence of continuous MS therapyNeurology201789111107111628835401
  • ColesAJCohenJAFoxEJCARE-MS II and CAMMS03409 InvestigatorsAlemtuzumab CARE-MS II 5-year follow-up: efficacy and safety findingsNeurology201789111117112628835403
  • ColesAJBoykoANCohenJAAlemtuzumab provides durable improvements in clinical outcomes in treatment-naive patients with active relapsing-remitting multiple sclerosis over 6 years in the absence of continuous treatment (CARE-MS I) (P213)Paper presented at: 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)September 14–17, 2016London, UK
  • FoxEJAlroughaniRBrassatDEfficacy of alemtuzumab is durable over 6 years in patients with active relapsing-remitting multiple sclerosis and an inadequate response to prior therapy in the absence of continuous treatment (CARE-MS II) (P1150)Paper presented at: 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)September 14–17, 2016London, UK
  • ZiemssenTThomasKAlemtuzumab in the long-term treatment of relapsing-remitting multiple sclerosis: an update on the clinical trial evidence and data from the real worldTher Adv Neurol Disord Prepublished August 4, 201710.1177/1756285617722706
  • CAMMS223 Trial InvestigatorsColesAJCompstonDAAlemtuzumab vs. interferon beta-1a in early multiple sclerosisN Engl J Med2008359171786180118946064
  • KovarovaIArnoldDLCohenJAAlemtuzumab pharmacokinetics and pharmacodynamics in Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis I (P341)Paper presented at: European Neurological SocietyJune 9–12, 2012Prague, Czech Republic
  • FletcherJMLalorSJSweeneyCMTubridyNMillsKHGT cells in multiple sclerosis and experimental autoimmune encephalomyelitisClin Exp Immunol2010162111120682002
  • ZhangXTaoYChopraMDifferential reconstitution of T cell subsets following immunodepleting treatment with alemtuzumab (anti-CD52 monoclonal antibody) in patients with relapsing-remitting multiple sclerosisJ Immunol2013191125867587424198283
  • ZozulyaALWiendlHThe role of regulatory T cells in multiple sclerosisNat Clin Pract Neurol20084738439818578001
  • CrossAHWaubantEMS and the B cell controversyBiochim Biophys Acta20111812223123820674743
  • KasperLHArnoldDLCohenJALymphocyte subset dynamics following alemtuzumab treatment in the CARE-MS II studyMult Scler20131911 supplP531
  • FoxEJAlemtuzumab in the treatment of relapsing-remitting multiple sclerosisExpert Rev Neurother201010121789179721091310
  • FreedmanMSKaplanJMMarkovic-PleseSInsights into the mechanisms of the therapeutic efficacy of alemtuzumab in multiple sclerosisJ Clin Cell Immunol201344100015224363961
  • TurnerMJLamorteMJChretienNImmune status following alemtuzumab treatment in human CD52 transgenic miceJ Neuroimmunol20132611–2293623759318
  • JonesJLAndersonJMPhuahCLImprovement in disability after alemtuzumab treatment of multiple sclerosis is associated with neuroprotective autoimmunityBrain2010133Pt 82232224720659956
  • DombrowskiYO’HaganTDittmerMRegulatory T cells promote myelin regeneration in the central nervous systemNat Neurosci201720567468028288125
  • ClarkRAWatanabeRTeagueJESkin effector memory T cells do not recirculate and provide immune protection in alemtuzumab-treated CTCL patientsSci Transl Med20124117117ra7
  • ColesAJWingMSmithSPulsed monoclonal antibody treatment and autoimmune thyroid disease in multiple sclerosisLancet199935491911691169510568572
  • HuYTurnerMJShieldsJInvestigation of the mechanism of action of alemtuzumab in a human CD52 transgenic mouse modelImmunology2009128226027019740383
  • MargolinDKieseierBPalmerJZiemssenTAlemtuzumab has similar efficacy and safety in active relapsing-remitting multiple sclerosis (RRMS) patients who were treatment-naive or who relapsed on prior therapy (P2.209)Neurology20148210 suppl2209
  • ArnoldDLTraboulseeACohenJAAlemtuzumab demonstrates durable reduction of MRI activity over 5 years in CARE-MS I with the majority of patients treatment-free for 4 years (P1100)Paper presented at: 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)October 7–10, 2015Barcelona, Spain
  • BarkhofFCohenJAColesAJAlemtuzumab slows brain volume loss over 5 years in patients with active relapsing-remitting multiple sclerosis with most patients not receiving treatment for 4 years: CARE-MS I and II extension studyPaper presented at: 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)October 7–10, 2015Barcelona, Spain
  • FoxEJArnoldDLCohenJADurable efficacy of alemtuzumab on clinical outcomes over 5 years in CARE-MS II with most patients free from treatment for 4 years (P1102)Paper presented at: 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)October 7–10, 2015Barcelona, Spain
  • HavrdovaEArnoldDLCohenJADurable efficacy of alemtuzumab on clinical outcomes over 5 years in treatment-naive patients with active relapsing-remitting multiple sclerosis with most patients not receiving treatment for 4 years: CARE-MS I extension study (P152)Paper presented at: 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)October 7–10, 2015Barcelona, Spain
  • TraboulseeACohenJAColesAJAlemtuzumab demonstrates durable reduction of MRI activity over 5 years in CARE-MS I with the majority of patients treatment-free for 4 years (P1103)Paper presented at: 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)2015Barcelona, Spain
  • LimmrothVGiovannoniGArnoldDLTreatment-naive patients with active RRMS demonstrate durable improvements in relapse and disability following treatment with alemtuzumab: 5-year follow-up of the CARE-MS I StudyNeurology20168616 supplS51.004
  • FoxEJArnoldDLCohenJADurable efficacy in RRMS patients receiving two annual courses of alemtuzumab and no additional treatment for 4 years: pooled analysis of CARE-MS I and IINeurology20168616 supplS51.005
  • Arroyo GonzalezRKitaMCraytonHCARE-MS I and II InvestigatorsAlemtuzumab improves quality-of-life outcomes compared with subcutaneous interferon beta-1a in patients with active relapsing-remitting multiple sclerosisMult Scler201723101367137627885061
  • Arroyo GonzálezRMoreauTHartungHPSustained reduction in disability with alemtuzumab is associated with durable quality-of-life improvement on SF-36 over 4 years in CARE-MS II patients with RRMS though most were treatment-free after year 1 (P1152)Paper presented at: 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)October 7–10, 2015Barcelona, Spain
  • KitaMCohenJMoreauTTImprovement in disability with alemtuzumab is associated with quality of life improvement over 3 years in patients who relapsed on prior therapyNeurology20158414 suppl3260
  • MayerLFoxEJLaGankeCIncidence of infusion-associated reactions decreases with subsequent courses of alemtuzumab: 5-year data from the CARE-MS extension study (DX44)Paper presented at: 30th Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC)June 1–4, 2016National Harbor, MD, USA
  • BreslinSCytokine-release syndrome: overview and nursing implicationsClin J Oncol Nurs2007111 Suppl374217471824
  • MaggiEVultaggioAMatucciAAcute infusion reactions induced by monoclonal antibody therapyExpert Rev Clin Immunol201171556321162650
  • McEwanLCaonCChieffeCMayerLSaldana-KingTMillerCEBest practices in alemtuzumab administration: practical recommendations for infusion patients with multple sclerosisJ Infus Nurs20163929310426295502
  • CaonCNameyMMeyerCPrevention and management of infusion-associated reactions in the comparison of Alemtuzumab and Rebif ® Efficacy in Multiple Sclerosis (CARE-MS) ProgramInt J MS Care201517419119826300705
  • WraySBoykoANBraleyTAdministration of alemtuzumab on nonconsecutive days does not impact infusion-associated reactions, efficacy, or lymphocyte depletionNeurology20158414 suppl7277
  • Jung HensonLArnoldDCohenJIncidence of infection decreases over time in alemtuzumab-treated patients with relapsing-remitting multiple sclerosis: 4-year follow-up of the CARE-MS StudiesNeurology20158414 suppl7265
  • SelmajKWHabekMBassAEfficacy and safety of alemtuzumab in patients with RRMS is durable over 10 years: follow-up from the CAMMS223 studyNeurology20178816 suppl5338
  • HolmøyTvon der LippeHLeegaardTMListeria monocytogenes infection associated with alemtuzumab a case for better preventive strategiesBMC Neurol20171716528376817
  • DécardBFThöneJHaghikiaAListeria rhombencephalitis mimicking a demyelinating event in an immunocompetent young patientMult Scler201723112312527430683
  • Hernandez-MilianAPayeras-CifreAWhat is new in listeriosis?Biomed Res Int2014201435805124822197
  • ClericoMDe MercantiSArtusiCADurelliLNaismithRTActive CMV infection in two patients with multiple sclerosis treated with alemtuzumabMult Scler201723687487628290755
  • PfeufferSBeukerCRuckTAcute cholecystitis during treatment with alemtuzumab in 3 patients with RRMSNeurology201687222380238127794114
  • Sheikh-TahaMCormanLCPulmonary Nocardia beijingensis infection associated with the use of alemtuzumab in a patient with multiple sclerosisMult Scler201723687287428290754
  • SeniorPAArnoldDLCohenJAIncidence and timing of thyroid adverse events in patients with RRMS treated with alemtuzumab through 5 years of the CARE-MS StudiesNeurology20168616 suppl2086
  • CukerAArnoldDLCohenJADetection and management of immune thrombocytopenia in alemtuzumab-treated patients in the Multiple Sclerosis Clinical Development Program (P590)Paper presented at: 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)October 7–10, 2015Barcelona, Spain
  • CukerAColesAJSullivanHA distinctive form of immune thrombocytopenia in a phase 2 study of alemtuzumab for the treatment of relapsing-remitting multiple sclerosisBlood2011118246299630521960587
  • GhodasaraRSRarickMBMosleyMCAlemtuzumab causes significant, transient, post-infusion thrombocytopenia and other non autoimmune cytopenias following initial and subsequent coursesPaper presented at: Consortium of Multiple Sclerosis Centers Annual MeetingJune 1–4 2016National Harbor, MD, USA
  • RanganathanUKaunznerUFosterSVartanianTPerumalJSImmediate transient thrombocytopenia at the time of alemtuzumab infusion in multiple sclerosisMultiple Scler Epub201731
  • RodeghieroFStasiRGernsheimerTStandardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working groupBlood2009113112386239319005182
  • WynnDArnoldDLCohenJADetection, incidence, and management of glomerulonephritis in the alemtuzumab clinical development program (P597)Paper presented at: 29th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)October 2–5, 2013Copenhagen, Denmark
  • HaghikiaADendrouCASchneiderRSevere B-cell-mediated CNS disease secondary to alemtuzumab therapyLancet Neurol2017163104106
  • BakerDHerrodSSAlvarez-GonzalezCGiovannoniGSchmiererKInterpreting lymphocyte reconstitution data from the pivotal phase 3 trials of alemtuzumabJAMA Neurol201774896196928604916
  • ChenFDaySLMetcalfeRACharacteristics of autoimmune thyroid disease occurring as a late complication of immune reconstitution in patients with advanced human immunodeficiency virus (HIV) diseaseMedicine (Baltimore)20058429810615758839
  • DaikelerTTyndallAAutoimmunity following haematopoietic stem-cell transplantationBest Pract Res Clin Haematol200720234936017448966
  • JubaultVPenfornisASchilloFSequential occurrence of thyroid autoantibodies and Graves’ disease after immune restoration in severely immunocompromised human immunodeficiency virus-1-infected patientsJ Clin Endocrinol Metab200085114254425711095463
  • TingSSZieglerJBVowelsMRAcquired autoimmune thrombocytopenia post-bone marrow transplantation for severe combined immunodeficiencyBone Marrow Transplant19982188418439603413
  • MillerTHabekMColesAJAnalysis of data from RRMS alemtuzumab-treated patients in the clinical program to evaluate incidence rates of malignancyPaper presented at: Joint Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) – European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) MeetingSeptember 10–13, 2014Boston, MA, USA
  • LecumberriBArnoldDLCohenJADetection of thyroid malignancies in alemtuzumab-treated patients in the multiple sclerosis clinical development programMult Scler201521S11P1117
  • OhJAchironAChambersCPregnancy outcomes in patients with RRMS who received alemtuzumab in the Clinical Development Program (S24.008)Neurology20168616 SupplS24.008
  • HassounLEiseleJThomasKZiemssenTHands on alemtuzumab experience from clinical practice: whom and how to treatMulti Scler Demyelinating Disorders2016110114
  • RogDSefertaNDanielDLEMTRADA® (Alemtuzumab) Pregnancy Exposure Registry: study design and enrolment procedures for pregnant women with multiple sclerosis exposed to alemtuzumabMS Trust 2015 ConferenceNovember 8–10, 2015Windsor, UK
  • JohnsonFRVan HoutvenGOzdemirSMultiple sclerosis patients’ benefit-risk preferences: serious adverse event risks versus treatment efficacyJ Neurol2009256455456219444531
  • MayerLCasadyLClaytonGManagement of infusion-associated reactions in alemtuzumab-treated relapsing-remitting multiple sclerosis patients (P880)Paper presented at: Joint Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) – European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) MeetingSeptember 10–13, 2014Boston, MA, USA