Managing an Managing an Alemtuzumab ServiceAlemtuzumab Service

Gail ClaytonGail ClaytonLead MS Clinical Nurse Specialist Lead MS Clinical Nurse Specialist

& & Jacki SmeeJacki Smee

MS Clinical Nurse SpecialistMS Clinical Nurse Specialist

Cardiff and Vale University Health BoardCardiff and Vale University Health Board

AimsAims

Background on setting up Alemtuzumab Background on setting up Alemtuzumab serviceservice

Patient selectionPatient selection Infusion related and long-term side-effectsInfusion related and long-term side-effects Ongoing monitoring requirementsOngoing monitoring requirements Potential challengesPotential challenges Case studiesCase studies

Historical perspectiveHistorical perspective Consultant with special interest Consultant with special interest

appointed appointed

A number of patients with highly A number of patients with highly active / aggressive MSactive / aggressive MS

2001 – Helen Durham2001 – Helen Durham

Cambridge trialCambridge trial

2002 – 12002 – 1stst patient treated in patient treated in CardiffCardiff

Risk Sharing Scheme – Risk Sharing Scheme – negotiated funding with WAG to negotiated funding with WAG to include all disease modifying include all disease modifying therapies therapies

Setting up the serviceSetting up the service

Ad hoc Limited staff knowledge No patient information MS nurse working 12 hour

days - competence? No follow up and

monitoring

Keen to learn and develop a protocol

Protocol Protocol DevelopmentDevelopment

Training and educationTraining and education Interpreting blood resultsInterpreting blood results

Pre-treatment screening Pre-treatment screening

Managing the infusionManaging the infusion

Ongoing management and Ongoing management and follow-upfollow-up

MDT review of the protocolMDT review of the protocol

A Team ApproachA Team Approach

Patient SelectionPatient Selection

MRIMRI Disease onsetDisease onset Clinical relapsesClinical relapses Cognition Cognition Family plans Family plans Risks / benefits / Risks / benefits /

informed consentinformed consent AlternativesAlternatives

Pre treatment screening and counsellingPre treatment screening and counselling

BloodsBloods PregnancyPregnancy Cervical ScreeningCervical Screening ShinglesShingles Commitment to monitoringCommitment to monitoring Side effectsSide effects Irradiated blood productsIrradiated blood products ConsentConsent

Managing Expectations Managing Expectations

So what do we do?So what do we do?1.1. Identify patients Identify patients 2.2. Discuss at MDTDiscuss at MDT3.3. Admit to Neurology Day UnitAdmit to Neurology Day Unit4.4. Patient information folderPatient information folder5.5. Buddy systemBuddy system6.6. In-patient prescriptionIn-patient prescription7.7. Take home medicationsTake home medications

In-patient prescriptionIn-patient prescription

Infusion related side-effectsInfusion related side-effects

Cytokine release syndromeCytokine release syndrome

• Rash Rash

• Headache Headache

• Transient worsening of Transient worsening of neurological deficit neurological deficit

• Chest tightness Chest tightness

Information following Information following infusioninfusion

Self-management-patient information Self-management-patient information folderfolder

Dietary advice leafletDietary advice leaflet Time off workTime off work FatigueFatigue VaccinationsVaccinations Monitoring requirementsMonitoring requirements Irradiated blood productsIrradiated blood products

Irradiated Blood ProductsIrradiated Blood Products

Longer term side effectsLonger term side effects

Autoimmune diseases:Autoimmune diseases:• Thyroid DiseaseThyroid Disease• ITPITP• HaematologyHaematology• RheumatologyRheumatology• DermatologyDermatology• Good PasturesGood Pastures• VaricellaVaricella

Thyroid DiseaseThyroid Disease

What to look forWhat to look for

ITP ITP

RashRash

Easy bleedingEasy bleeding

BruisingBruising

Platelet countPlatelet count↓↓

Other HaematologyOther Haematology

Haemolytic anaemiaHaemolytic anaemia

NeutrophiliaNeutrophilia

PancytopeniaPancytopenia

DermatologyDermatology

Anti-GBM (Goodpasture’s Anti-GBM (Goodpasture’s Syndrome)Syndrome)

OtherOther

Opportunistic Opportunistic infectionsinfections

CancersCancers

Human Papilloma Human Papilloma VirusVirus

Herpes Simplex Type Herpes Simplex Type 1 and 21 and 2

Challenges!Challenges! Cancelled appointmentsCancelled appointments MRIMRI Accessing blood resultsAccessing blood results DNADNA Monitoring to month 60Monitoring to month 60 Responsive serviceResponsive service DatabaseDatabase Emails for patientsEmails for patients CostCost Where to go next Where to go next Motivating patients to continue Motivating patients to continue

follow upfollow up Longer term……….Longer term……….

Getting it rightGetting it right

Diagnosed Aug 2006Diagnosed Aug 2006 2007 x22007 x2 2008 Apr Oct2008 Apr Oct Rebif Nov 2008Rebif Nov 2008 2009 x22009 x2 2010 x42010 x4 Scanned 2010 new and Scanned 2010 new and

enhancing lesionsenhancing lesions Treated Oct 2010 & 2011Treated Oct 2010 & 2011 Currently building houses Currently building houses

in Nepal for a charityin Nepal for a charity

When all else fails When all else fails Diagnosed Nov 2008Diagnosed Nov 2008 Relapses 2009 x2Relapses 2009 x2 Rebif Oct 2009Rebif Oct 2009 2010 x32010 x3 2011 x12011 x1 Natalizumab Dec 2011Natalizumab Dec 2011 2012 x42012 x4 NABs +NABs + Liaison with CambridgeLiaison with Cambridge 6 month washout6 month washout Alemtuzumab Nov 2012Alemtuzumab Nov 2012 Re-scan next weekRe-scan next week

Complications!Complications!

Relapse at onset 2007Relapse at onset 2007 Diagnosed Oct 2008Diagnosed Oct 2008 Relapses 2008 x3Relapses 2008 x3 Alemtuzumab April Alemtuzumab April

2009, 2010, 20112009, 2010, 2011

Thyrotoxicosis 2010Thyrotoxicosis 2010 Herpes zoster 2011Herpes zoster 2011 Vitiligo 2011Vitiligo 2011 Athritis 2011Athritis 2011 Psoriasis 2011Psoriasis 2011

Patient comments!Patient comments! After my MS Campath treatment it felt like i had hit rock bottom, feeling useless, After my MS Campath treatment it felt like i had hit rock bottom, feeling useless,

drained and fatigued in a big way. Then a few months later i felt like Superman, felt drained and fatigued in a big way. Then a few months later i felt like Superman, felt like i had been cloned. NOTHING CAN STOP ME, NOT EVEN MS !like i had been cloned. NOTHING CAN STOP ME, NOT EVEN MS !

Campath has given me my life back. Before my first infusion, life was steadily closing Campath has given me my life back. Before my first infusion, life was steadily closing in. I had no room to breathe between relapses, each one leaving me weaker than in. I had no room to breathe between relapses, each one leaving me weaker than before. Campath stopped MS in its tracks. I may still have the same symptoms as before. Campath stopped MS in its tracks. I may still have the same symptoms as pre-Campath, but there has been absolutely no disease progression since last pre-Campath, but there has been absolutely no disease progression since last summer. A miracle? It certainly feels that way. I still get bad days, but they are more summer. A miracle? It certainly feels that way. I still get bad days, but they are more than outweighed by the good. My son is no longer frightened at the decline in my than outweighed by the good. My son is no longer frightened at the decline in my health. I am able to be fully-engaged in his life once more, a precious, priceless gift.health. I am able to be fully-engaged in his life once more, a precious, priceless gift.

I received my first dose of Campath in November 2012. At this time I was confined to I received my first dose of Campath in November 2012. At this time I was confined to a wheelchair because I was having relapse after relapse and was unable to walk. a wheelchair because I was having relapse after relapse and was unable to walk. Before recovering from one relapse I was going into another. I now work 4 days a Before recovering from one relapse I was going into another. I now work 4 days a week in a school. I am so grateful to have been able to have this treatment, it has week in a school. I am so grateful to have been able to have this treatment, it has made such a difference giving me back quality of life. I feel myself again! made such a difference giving me back quality of life. I feel myself again!

ConclusionsConclusions

Alemtuzumab is highly effective Alemtuzumab is highly effective at reducing relapses at reducing relapses

Significant side-effect profileSignificant side-effect profile Restrict use to Restrict use to

more aggressive disease more aggressive disease conventional treatments failuresconventional treatments failures

Absolute need to ensure robust Absolute need to ensure robust long-term monitoring and long-term monitoring and follow-up follow-up

Preceptorship Preceptorship -4000 -3500 -3000 -2500 -2000 -1500 -1000 -500 0 500 1000

Time (Days Pre and Post Campath)

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RelapsesPatient 1

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Graph showing relapses pre and post Campath treatment