Transcript Document

Biologics and the Role
of the CNS
Lucy Moorhead RGN, BA (Hons), MA,
CNS in Medical Dermatology
Guys and St Thomas’ NHS Foundation Trust
With kind thanks to janssen cilag for allowing me to use their slides re immune
system and actions of biologics
Contents
What are biologics?
 What is a clinical nurse specialist (CNS)?
 Tertiary referral psoriasis clinic
 Role of CNS in pathway
 Biologic patients pathway
 Questions

Biologics
Anti-TNF or interleukin agents
 Made from living human or animal proteins
 Block the action of certain immune cells
that play a role in psoriasis.
 Targets a type of immune cell called T
cells while others target the chemical
messengers released by activated T cells

NICE guidance 2012
Who should receive Biologics?
• Patients with severe chronic plaque psoriasis
• PASI > 10 + DLQI > 10
• Failed to respond to, contra-indication to, or
intolerance to standard systemic therapy (e.g.
methotrexate, ciclosporin, acitretin, PUVA)
Consider patients with localised involvement who
don’t meet above criteria
NICE guidance 2012

Changing to an alternative biological drug (systemic
biological therapy)

Consider changing to an alternative biological drug in
adults if:
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the psoriasis does not respond adequately to a first
biological drug as defined in NICE technology appraisals
(at 10 weeks after starting treatment for infliximab, 12
weeks for etanercept, and 16 weeks for adalimumab and
ustekinumab; primary failure)
or

the psoriasis initially responds adequately but
subsequently loses this response, (secondary failure) or
the first biological drug cannot be tolerated or becomes
Nomenclature of biologic
therapies
Suffix indicates class of biologic therapy1
 cept
= human receptor fusion protein
e.g. etanercept
 ximab = chimaeric monoclonal antibody
e.g. infliximab
 zumab = humanized monoclonal antibody
e.g. efalizumab
 umab = fully human monoclonal antibody
e.g. adalimumab, ustekinumab
1. Johnston SL. J Clin Pathol. 2007;60(1):8-17.
Biological therapies for psoriasis
and psoriatic arthritis (UK)
Cytokine
inhibitors
TNFa
blockers
generic
name
brand
name
agent
skin
ustekinumab
Stellara
IL 12 &
23
+
etanercept
Enbrel
TNF-R
+
+
infliximab
Remicade
antiTNFa
+
+
adalimumab
Humira
antiTNFa
+
+
joints
Etanercept (Enbrel)
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S/C administration
Pre filled syringe or a pen
25 mg twice weekly or 50 mg once weekly or 50
mg twice weekly initially
PASI & DLQI 10
Decision to continue treatment at 12 weeks
Infliximab (Remicade)
Administered via infusion
 Dose calculated on weight (5 mg/kg)
 After initial loading dose infusion (wks 0, 2
& 6) every 8 weeks
 PASI 20 & DLQI 18
 Decision to continue treatment at 10
weeks

Adalimumab (Humira)
S/C administration
 Week 0 – 80 mg, week 1 – 40 mg, week 3
– 40 mg and fortnightly thereafter
 PASI & DLQI 10
 Decision to continue treatment at 14
weeks

Ustekinumab (Stellara)
Fully human monoclonal binding to IL 12
and IL 23
 Week 0, 4, 16 and then every 12 weeks
 PASI 10 DLQI 10
 S/C administration
 NICE recommend hospital administration
 Decision to treat at 16 weeks
 Dose weight dependent but cost neutral

Role of the Clinical Nurse
Specialist
The history of development
1992 Scope of Professional Practice (UKCC)
1993 The Working Time Directive of the European
Union (Council Directive 93/104/EC)
1998 Nurse Consultant HSC 1998 / 161(DH)
1999 Establishing posts HSC 1999 / 217
2000 Department of Health – The NHS Plan: A
plan for investment, a plan for reform
2002 Department of Health - Liberating the
Talents: Helping Primary Care Trusts and
Nurses to Deliver the NHS Plan’
Clinical Nurse Specialists:

Job plans are varied; often dependent on
speciality

Generic definition –
 ‘The clinical nurse specialist (CNS) role
focuses on improving patient care and
developing clinical services, often within
specialist areas.’ (McArthur 2008)
Key Functions of Clinical Nurse
Specialist Role

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Clinical (67%)
Administration (21%)
Education (6%)
Research (4%)
Consultation (2%)
RCN Rheumatology Nursing Forum Clinical nurse
specialists: adding value to care. An executive
summary. 2010
RCN 2013 – Specialist Nursing in
the UK

Want govt, commissioners and healthcare
providers to commit to:
 All
patients with long term conditions or have
access to CNS
 To be allowed time accomplish vital aspects
or their role
 Increase funding combined with
understanding of wider cost implications and
health improvements (medium to long term)
Tertiary Referral Psoriasis Clinic
Patients referred in mostly from London and home
counties
 Approx 1435 patient visits a year (new and follow
ups combined)
 Over 400 patients on biologics
 Adalimumab, etanercept, infliximab and
ustekinumab
 2 x Nurse led clinics attached to psoriasis clinic
(biologics and systemics)

Role of the CNS in psoriasis clinic
First point of contact
 Initiation and early monitoring of
treatments
 IP for topicals/treatment at home plans –
to be extended to include systemics and
biologics
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Biologic Initiation 
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Decision made and screening started within
psoriasis clinic
Patient for referred to NLC to complete
screening and initiation
Electronic prescription for all
Reviewed in NLC at week 4 of treatment
Reviewed in psoriasis clinic at NICE time point
Review every 3 months plus after 2 years 6
monthly reviews considered
Decision in clinic to start patient on ustekinumab
Start screening
Determine washout/cross over
Give appropriate patient information (BAD info sheet and pack) and contact details
Book appointments
Refer to research
If patients fails
screening to follow
applicable pathway
Patient attends NLC:
Complete screening and
Refer for discussion to MDM
Refer to research
Patient discussed in MDM by referring doctor
Prescription signed by doctor
Added to database
Screened by pharmacist
Sent to BUPA
Week 0
Injection administered by BUPA team
Week 4
Biologics monitoring visit (as per protocol)
Confirm/ensure week 4 visit with BUPA
Week 13 (or one week prior to next planned dose)
Review in the psoriasis clinic
NICE compliance ascertained
Patient to discontinue therapy
Follow applicable pathway
Patient to receive week 16 dose (or appropriate dose)
•BUPA prescription to be completed in clinic and given to PPM for screening by
pharmacy
Appt for next review in severe psoriasis service to be arranged (11 weeks)
mdCNS to check bloods next day and follow protocol for any abnormal values.
To inform patient by telephone that drug can be administered
Refer to research
Week 16
BUPA nurse to email mdCNS to confirm injection administered
Spreadsheet to be updated
Patient Information
•Research shows that up to 50% of
patients are taking drugs incorrectly!
•Recognise that patients prefer information to
be given in different ways
•Recognise that it can be daunting to
regularly administer/receive a sub-cutaneous
injection or infusion
•Recognise that we often ‘overload’ patients
with information in clinic settings
Patient Information
Patients are given BAD patient information
AND industry sponsored information often
including a CD
 Patients are given card with contact details
for our service
 Information briefly introduced in the severe
psoriasis clinic and reviewed at depth in
nurse led clinic

British Association of Dermatologists - PIS
Biologics Initiation and Monitoring
Clinic
Nurse consultant: Karina Jackson
 In operation for over 5 years
 Once weekly clinic – Tuesday morning
 7 patient slots a week
 30 minute appointments
 Often overbooked!
 Patients booked for initiation and for one
month reviews
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Biologics Initiation and Monitoring
Clinic
Scope of clinic:
 To ensure all patients under consideration for biologic
therapies used in the treatment of psoriasis have fulfilled
all recommended clinical assessments and
investigations prior to treatment initiation and to ensure
the patient fully understands the risks and benefits of
therapy
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To initiate patients on biologic therapies used in the
treatment of psoriasis
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To review the patient at one month post initiation of
applicable sub cutaneous biologic therapy
NLC - Initiation of Biologic
Check all screening
 Review patient information
 Baseline PASI/DLQI if required
 Crossover/washout
 Confirm timings
 Confirm appointments
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Psoriasis MDM
Prior to all psoriasis clinic
 Attended by all dermatology consultants,
registrars, CNS’ and research nurses
 All patients screened for biologics
 Referred to MDM prior to initiation appt
 Presented by Dermatology Registrar
 Outcome documented on EPR

NLC - 1 month review
NOT included in BAD guidelines
 BUT important:

 Confirm
correct administration & schedule
 Patient motivation
 Side effects
 FBC, U&E’s & LFT’s
 Confirm next psoriasis clinic appt (NICE)
 Topicals and other concomitant medication
Administration related to biologics
Letters to GP/Consultant
 Healthcare at Home/BUPA Paperwork
 Liaising with pharmacy/H@H/BUPA
 Confirm contact details
 Ensuring patient has correct follow up
appointments
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Recent issues occurring within
biologics clinic
Live vaccinations
 Wrong dosing schedule
 Low literacy level in patient on s/c mtx and
etanercept
 Planned surgery/dental treatments
 Fathering of a child whilst on MTX
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Nurse Preceptorship’s
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Commenced in July 2010
2 days experience in St John’s Institute of
dermatology
1 nurse attends every 2 months
Preceptorships aimed at dermatology nurses
either working within biologics or planning to
Tailored to each individual
Funded by unrestricted educational grant
(Abbvie)
‘The specialist nurse is a key member of the
multidisciplinary team delivering biological
therapy, and acts to facilitate all aspects of
the patient pathway’
(BAD - Guidelines for Biological Interventions for Psoriasis - 2009)
Thank

you for listening!
[email protected]