Assessing, Managing and Monitoring Biologic Therapies for Inflammatory Arthritis - RCN Guidance for Rheumatology Practitioners Fourth edition
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Assessing, Managing
and Monitoring Biologic
Therapies for
Inflammatory Arthritis
RCN Guidance for Rheumatology Practitioners
Fourth edition
This publication is supported by the pharmaceutical industry.
Sponsors Support was received from the following pharmaceutical companies: The monies received were used in the development, publication and distribution of this guidance by the RCN. The supporting companies had no editorial control over or input into this guidance except to review the guidance for factual accuracy. The views and opinions contained in this guidance are those of the authors and not necessarily those of the sponsoring companies. To provide feedback on its contents or on your experience of using the publication, please email publications.feedback@rcn.org.uk RCN Legal Disclaimer This publication contains information, advice and guidance to help members of the RCN. It is intended for use within the UK but readers are advised that practices may vary in each country and outside the UK. The information in this publication has been compiled from professional sources, but its accuracy is not guaranteed. Whilst every effort has been made to ensure the RCN provides accurate and expert information and guidance, it is impossible to predict all the circumstances in which it may be used. Accordingly, to the extent permitted by law, the RCN shall not be liable to any person or entity with respect to any loss or damage caused or alleged to be caused directly or indirectly by what is contained in or left out of this information and guidance. Published by the Royal College of Nursing, 20 Cavendish Square, London W1G 0RN © 2017 Royal College of Nursing. All rights reserved. Other than as permitted by law no part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means electronic, mechanical, photocopying, recording or otherwise, without prior permission of the Publishers or a licence permitting restricted copying issued by the Copyright Licensing Agency, Saffron House, 6-10 Kirby Street, London EC1N 8TS. This publication may not be lent, resold, hired out or otherwise disposed of by ways of trade in any form of binding or cover other than that in which it is published, without the prior consent of the Publishers.
ROYAL COLLEGE OF NURSING
Acknowledgements
Contributors to the fourth edition (2017) External review team
This updated document has been reviewed by members Deborah Bond, Lead Biologics Specialist Nurse, Royal
of the RCN Rheumatology Nursing Forum. National Hospital for Rheumatic Diseases, Bath
We would like to thank the following individuals for Vicky Chamberlain, Trustee and Board Member,
their assistance in revising and updating the fourth Arthritis and Musculoskeletal Alliance (ARMA),
edition of this guidance. Rheumatology Nurse Specialist, Trafford Hospitals
Division, Central Manchester Universities NHS
Lead authors Foundation Trust
Diana Finney, Chair of Working Party, Consultant Chris Deighton, Consultant Rheumatologist, Royal
Rheumatology Nurse Clinical Lead, Sussex MSK Derby Hospital; Immediate and Past President, British
Partnership Society for Rheumatology (BSR); Clinical Advisor,
Lisa K Howie, Lead Adult Author, Rheumatology NICE RA Management Guidelines; Honorary Associate
Clinical Nurse Specialist, Morriston Hospital Swansea Professor, Nottingham Medical School
Karen Wynne, Lead Paediatric Author, Clinical Nurse Jill Firth, Consultant Nurse Rheumatology/Director of
Specialist Rheumatology and Vasculitis, Great Ormond Service Improvement, Pennine MSK Partnership;
Street Hospital for Children Visiting Senior Research Fellow, University of Leeds
Stewart Glaspole, Specialist Interface Pharmacist,
RCN working party (third edition) Brighton and Hove Clinical Commissioning Group;
Amanda Cheesley, Professional Lead for Long Term Senior Clinical Lecturer with Special Interest in
Conditions and End of Life Care Rheumatology, University of Brighton
Helen Smith, Rheumatology Nurse Specialist, Brighton Elizabeth McIvor, Rheumatology Nurse Specialist, NHS
and Sussex University Hospitals Greater Glasgow and Clyde NHS Foundation Trust
Louise Parker Lead Nurse inflammatory and Susan M Oliver (OBE), Nurse Consultant Rheumatology
connective tissue disease royal free London NHS and Chair of the EULAR (European League Against
foundation Trust Rheumatism) Health Professionals Standing
Polly Livermore, Matron for Rheumatology Committee
dermatology, immunology, BMT, and infectious Ruth Slack, Rheumatology Specialist Nurse, West
diseases, Advanced Nurse Practitioner, Great Ormond Suffolk NHS Foundation Trust
Street Hospital for Children Heather Savage, Associate Community Matron,
William Budd Health Centre, Bristol
The RCN working party members would also like to Nicola Price Consultant Virologist, Public Health Wales
extend their thanks to John Rowland, Patient Microbiology Cardiff, University Hospital of Wales,
Representative, for his contribution to their work. Cardiff
Fiona Smith, Adviser in Children’s and Young People’s
Nursing, Royal College Of Nursing
Elaine Wylie, Rheumatology Nurse Specialist, Southern
Health and Social Care Trust
3ASSESSING, MANAGING AND MONITORING BIOLOGIC THERAPIES FOR INFLAMMATORY ARTHRITIS
Assessing, Managing and
Monitoring Biologic Therapies for
Inflammatory Arthritis
RCN Guidance for Rheumatology Practitioners (Fourth edition)
Contents
Foreword 7 Pregnancy exposure and infant
vaccinations 27
Introduction 8
1.1.4 Patient advice 28
The guidance 8
Travel advice 29
Biologic therapies 9
1.1.5 Monitoring efficacy 29
NICE/SIGN and Innovation in Health 9 Rheumatoid arthritis 29
Biosimilars 10 Psoriatic arthritis 30
Ankylosing spondylitis 31
Patient choice and involvement 11 Other outcome measures 31
Service provision 12 1.1.6 Safety monitoring 32
PART ONE: ADULT PATIENTS 15 Infection 32
Varicella/shingles 32
Section 1: Assessment and monitoring
Varicella treatment 33
of biologic therapies 15
Measles infection 33
1.1 Before treatment starts 20 Tuberculosis (TB) 33
1.1.1 Assessment 21 Progressive multifocal
Contra-indications, special warnings leukoencephalopathy (PML) 34
and precautions 21 Blood dyscrasias 34
Pulmonary disease/interstitial
1.1.2 Pre-treatment screening 22 lung disease (ILD) 34
History of infection 22 Human anti-chimeric antibodies
Current health conditions 22 and human anti-human antibodies 34
Investigations checklist 22 Uveitis 34
TB/TB screening 23 Pregnancy and conception 35
1.1.3 Vaccinations 23 1.1.7 Allergic, hypersensitivity and infusion
Live vaccines 24 reactions 35
Varicella zoster immune status/ Infusion reactions 35
vaccination 25
Measles, mumps and rubella (MMR) 1.1.8 Hepatitis B and C 36
immune status/vaccination 26 1.1.9 Malignancy 37
Inactivated vaccines 27
4ROYAL COLLEGE OF NURSING
1.1.10 Biologics and surgery 37 PART TWO: CHILDREN AND YOUNG PEOPLE 50
1.1.11 Switching between biologic therapies 39 Introduction 50
1.1.12 Reducing or stopping TNF-alpha This guidance 50
inhibitors in patients with RA 39
Section 1: Assessing and managing children
Section 2: Administration of subcutaneous and young people needing biologic therapies 51
and intravenous biologic therapies 40
1.1 The special needs of children and
2.1 Subcutaneous biologic therapies 40 young people 51
2.1.1 Home administration 40 1.2 Treating JIA with biologic therapies 51
Practitioner training and competence 41
1.3 The paediatric rheumatology clinical
Checklist for practitioners 41
nurse specialist (PRCNS) 55
Training for patients 41
Rotating injection sites 42 1.4 Shared care arrangements 55
Product changes 42 1.5 Biologics registers 55
Contra-indications for patient
self-administration 42 1.6 Special skills for working with
Continuing management 43 children and young people receiving
biologic therapies 55
2.2 Intravenous biologic therapies 43
1.7 Assessing and managing patients 56
2.2.1 Conditions for administration 43
Delivery setting 43 1.8 The use of unlicensed medicines or
Practitioner competence 44 licensed medicines for unlicensed
Vial sharing 44 applications in paediatric practice 56
Pre-infusion/injection assessment 44 1.9 Detailed assessment of patients 56
2.2.2 Treating infusion reactions 45 1.10 Vaccinations 57
2.2.3 Abatacept administration 45 Live vaccines 57
2.2.4 Infliximab administration 46 1.11 Varicella in children 57
2.2.5 Rituximab administration 47 1.12 Monitoring 58
2.2.6 Tocilizumab administration 48 1.13 Malignancy alert/warning 58
2.2.7 Belimumab administration 48 1.14 Follow-up care between treatments 58
2.2.8 Post-infusion care and advice to patients 49 1.15 Transition to adult services 58
5ASSESSING, MANAGING AND MONITORING BIOLOGIC THERAPIES FOR INFLAMMATORY ARTHRITIS
Appendices 59 References 87
Appendix 1 Core Documents 59 PART ONE Adult patients 87
Appendix 2 Specialist practitioner PART TWO Children and young people 94
competence checklist 62
Appendix 3 Diagnostic criteria 64
Appendix 4 Current live vaccines available
in the UK 66
Appendix 5 Current non-live vaccines
available in the UK 67
Appendix 6 Information for patients or
carers administering injections
of biologic therapies at home 68
Appendix 7 Safety monitoring summary 71
Appendix 8 Example of a standardised
assessment and management
template for inclusion in patient
records 74
Appendix 9 Training checklist for home
administration of subcutaneous
biologic therapy by a patient
(adult, young person or child),
carer or parent 78
Appendix 10 International League of Associations
for Rheumatology (ILAR) 2001
classification of juvenile idiopathic
arthritis (JIA), updated 2004 79
Appendix 11 BSPAR guidelines for prescribing
biologic therapies in children
and young people with JIA 80
Appendix 12 Testing for varicella antibodies
in children 82
Appendix 13 Reflection exercise for CPD
and NMC revalidation 83
Appendix 14 Websites and resources for
patients and further information 85
6ROYAL COLLEGE OF NURSING
Foreword
Welcome to this updated fourth edition of the RCN’s When updating this guidance Stop-think-best
guidance on assessing, managing and monitoring practice reflection opportunity notes have been
biologic therapies for inflammatory arthritis which added to help promote best practice, clinical excellence
provides a best practice framework for rheumatology and provision of quality care and supporting, NMC
specialist practitioners and the wider health care team (2015) Code and NMC (2016) Revalidation
involved in supporting the administration, monitoring recommendations (See appendix 14).
and delivery of care to patients in a variety of settings.
Since the third edition of this guidance was published Relevant for physicians, rheumatology specialist
in 2014, significant developments have had an impact practitioners, and health professionals who support
on this sphere of practice. These include: patients who have been prescribed biologic therapies,
this publication provides guidance for practice,
• the availability of several new licensed treatments signposts core documents and resources, and
• the development and availability of biosimilars and highlights the key issues for practitioners working in a
their impact on access to biologics variety of settings. Some sections may also be useful for
patients making decisions, alongside their health
• updated clinical guidelines and pathways to professionals, regarding their treatment.
improve the management of conditions in adults
and children issued by the National Institute for Editorial Team, RCN Rheumatology Forum
Health and Care Excellence (NICE)
• new commissioning arrangements resulting from
the enactment of the Health and Social Care Act
2012, which aims to liberate the NHS (England) by
giving patients more choice and clinicians more
control
• the expansion of the British Society of
Rheumatology Biologics Register (BSRBR) to
monitor the use and progress of patients taking
biologic therapies and biosimilar therapies and the
the long-term safety profile of for these agents
• NICE technology appraisal (see Table 1)
7 Return to contentsASSESSING, MANAGING AND MONITORING BIOLOGIC THERAPIES FOR INFLAMMATORY ARTHRITIS
Introduction PART TWO of this document covers specific issues
relating to the care of children and young people,
including transition of care to adult services.
The role of biologic therapies in the treatment and Unless otherwise specified, the guidance refers to all of
management of patients with inflammatory joint the listed biologics.
diseases has continued to evolve and is an area that has
significant implications for all practitioners. Biologic
agents are generally effective, well tolerated and safe in The guidance
most patients, however they can increase the risk of
This document should not be regarded as definitive on
complications, including infection. As the safety of
all issues related to biologic therapy, but should be read
patients is paramount, this risk can be reduced by
alongside the following key texts:
careful assessment and monitoring.
• the British Society of Rheumatology and British
This guidance has been developed to support
Health Professionals in Rheumatology (BSR and
practitioners in the safe and effective assessment,
BHPR) resources and guidelines
screening and management of patients when biologic
therapies are being considered. It provides practitioners • guidelines issued by the British Society for
with practical information to help them care for Paediatric and Adolescent Rheumatology (BSPAR)
patients with different forms of inflammatory arthritis,
in all care settings. • National Institute for Health and Care Excellence
(NICE) technology appraisals and clinical
Note: the term practitioner is used throughout this guidelines
document and relates to nurses or allied practitioners
who have been trained in assessing, managing and • National Patient Safety Agency (NPSA) publications
monitoring biologic therapies for inflammatory guidelines
arthritis. • the Scottish Intercollegiate Guidelines Network
The aim of this document is to provide practitioners (SIGN) guidelines relevant to those working in
with an outline of current biologic therapies, both Scotland
licensed and unlicensed, and refers the reader to • Nursing and Midwifery Council (NMC) professional
additional key documents and resources that will regulations or similar bodies for those practitioners
support practitioners in the UK to develop a where nursing is not their primary professional
standardised approach to caring for patients receiving registration
biologic therapies.
• the summary of product characteristics (SPC) for
PART ONE of this document deals with the all relevant drugs, including drugs prescribed
management of biologic therapy in adults, focusing alongside biologics – found in the Electronic
on three main treatment indications covered by Medicines Compendium (eMC) which contains
NICE/SIGN: up-to-date and easily accessible SPCs for all
• rheumatoid arthritis (RA) medicines licensed for use in the UK (see
www.medicines.org.uk)
• psoriatic arthritis (PsA)
• local protocols, policies and guidelines for
• ankylosing spondylitis (and non radiographic infusions, including sharps (RCN, 2013; HSE/EU,
Spondyloarthropathy) (AS). 2014)
Return to contents 8ROYAL COLLEGE OF NURSING
• local governance arrangements, including home medicines and treatments recommended by NICE’s
care delivery services policies. technology appraisals. The technology appraisals
outlined in this guidance define the criteria for
A full and comprehensive listing of these and additional treatment with biologic therapy for specific conditions.
advisory documents, alongside core documents In addition, there are a number of NICE publications,
produced by national regulatory bodies, can be found such as the Quality Standards (QS33, NICE 2013) for
at Appendix 1. rheumatoid arthritis, which provide a framework for
the measurement of service provision. QS33, for
example, requires that patients with RA are offered
Biologic therapies monthly treatment escalation to an agreed low disease
activity score.
The term `biologic’ describes treatments developed and
produced in live cell systems (biologically active In the current economic climate there is a strong drive
systems). There are a number of biologic therapies for to improve outcomes and quality of life for patients
different indications used in the field of rheumatology. through innovation. Innovation Health and Wealth
Those currently licensed target the pro-inflammatory (IHW) is a Department of Health initiative (DH, 2012;
cytokines tumour necrosis factor alpha (anti-TNF alpha DH, 2013) which aims to drive the adoption and
agents), interleukin 1 (IL-1receptor antagonist agents), diffusion of innovation at pace and scale within the
interleukin 6 (anti-IL-6 receptor antibody agents), or NHS, including ensuring the effective implementation
are B cell depleting, or T cell co-stimulant inhibitors. of NICE technology appraisals.
See section below outlining the key issues regarding
newer biosimilar therapies. There is an expectation for clinical commissioning
groups (CCGs) and the NHS England to promote
innovation and a direct link between innovation and
financial incentives to support Commissioning for
NICE/SIGN and Innovation in
Quality and Innovation (CQUIN) has been established.
Health
In essence IHW fosters a view that if a medicine – such
NICE/SIGN technology appraisals are as a biologic drug – is approved by NICE as part of a
recommendations on the use of new and existing technology appraisal, then it should be automatically
medicines and treatments within the NHS, and are added to local formularies and be available for those
based on a review of: who need it, within 90 days of the publication.
• clinical evidence – how well the medicine or Innovation in treatment regimens are progressing, not
treatment works, and only in relation to the way biologic therapies are
utilised. For example, the early use of conventional
• health economic evidence – how well the medicine
non-biologic disease modifying drugs (DMARDs) as a
or treatment works and how much it costs the NHS.
first-line treatment for patients with rheumatoid
In other words, does it represent value for money?
arthritis, ideally within three months of the onset of
Health care professionals are expected to take the above persistent symptoms, has been recommended to reduce
fully into account when exercising their clinical disease progression and long-term disability in relation
judgement. However, this guidance does not override to the condition. There is good evidence that this early
the individual responsibility of health care treatment and support can reduce joint damage and
professionals to make decisions appropriate to the enable people with arthritis to live as active a life as
circumstances of the individual patient, in consultation possible, and reduce the need for biologic therapies
with the patient and/or guardian or carer. (NICE CG79). These innovations benefit both the
patient and the health economy.
NICE/SIGN aim to standardise access to health care
and the NHS is legally obliged to fund and resource the
9 Return to contentsASSESSING, MANAGING AND MONITORING BIOLOGIC THERAPIES FOR INFLAMMATORY ARTHRITIS
Biosimilars and the resulting guidance, to relevant licensed
biosimilar products which subsequently appear on the
A similar biological or ‘biosimilar’ medicine is a market. In other circumstances, where a review of the
biological medicine that is similar to another biological evidence for a biosimilar medicine is considered
medicine that has already been authorised for use in necessary, NICE will consider producing an evidence
the European Community. The active substance of a summary.
biosimilar is a known biological active substance and
Biosimilar versions of several biologic drugs have been
similar to the one of the reference medicinal product.
available for some time. As for all medicines, the safety
The biosimilar sponsor is to “generate evidence
of biosimilar medicines is continuously monitored after
substantiating the similar nature, in terms of quality,
authorisation. Recently, biosimilar versions of
safety and efficacy”. In the development of a biosimilar,
infliximab (Inflectra and Remsima) and etanercept
there is no requirement to demonstrate clinical benefit
(Benepali) have been launched in the UK, and further
to patients per se as this has been shown for the
biosimilar versions of adalimumab, flixabi, rituximab
reference medicine. Instead, biosimilars undergo a
and truxima are expected to be available in the near
comprehensive totality of evidence approach which
future.
demands extensive comparability studies that
demonstrate similarity to the reference medicine. The Because biosimilar and reference biological medicines
benefits and risks are then inferred from the similarity that have the same international non-proprietary name
of the biosimilar medicine to the reference medicine. (INN) are not presumed to be identical in the same way
Biosimilars are regulated in the same way by the as generic non-biological medicines, brand name
European Medicines Agency (EMA). Therefore, from a prescribing is recommend (MHRA February 2008
scientific and regulatory point of view, the active edition of Drug Safety Update). This ensures that the
substance of a biosimilar medicine has been shown to intended product is received by the patient. Products
have no clinically meaningful differences compared to cannot be automatically substituted at the point of
the active substance of the originator. dispensing and the choice of whether a patient receives
a biosimilar or originator biological medicine is
For more details see the NHS publication, Answers to
decided between the clinician and the patient.
commonly asked questions about biosimilar versions of
infliximab and NHS England’s ‘What is a biosimilar Pharmacovigilance is important for biosimilar
medicine?’ medicines and every biosimilar authorised by the EMA
will have a risk management plan in place (details of
The continuing development of biological medicines,
which will be in the European Public Assessment
including biosimilar medicines, creates increased
Report). Safe introduction and ongoing safe use of
choice for patients and clinicians, increased
biosimilars requires practitioner, patient and
commercial competition and enhanced value
manufacturer engagement with these processes.
propositions for individual medicines. Biosimilars have
been available for some time and to date we haven’t The NICE adoption resource introducing biosimilar
seen the use of biosimilars result in additional patients versions of infliximab: Inflectra and Remsima®, has
being treated with other biologics. been produced to help manage the introduction of
biosimilar medicines into care pathways safely and
The NICE position statement on evaluating biosimilars
effectively. Local organisations will need to assess the
was published in January 2015. This states that
applicability of the learning from the examples
biosimilars notified to the NICE topic selection process
provided of current practice, taking into consideration
for referral to the technology appraisal programme will
the time, resources and costs of an implementation
be considered in the context of a multiple technology
programme.
appraisal, in parallel with their reference products.
This enables NICE to decide to apply the same remit,
Return to contents 10ROYAL COLLEGE OF NURSING
Tips for managing the introduction of Patient choice and involvement
biosimilar medicines
1. Identify clinical and pharmacy champions to take The Government’s ambition is to achieve health care
the lead in introducing biosimilars. outcomes that are amongst the best in the world and in
its white paper Equity and excellence: Liberating the
2. Educate all stakeholders (including patients) to NHS (DH, 2010) it sets out its vision of an NHS that puts
provide them with information on what a biosimilar patients and the public first, giving everyone more say
is, how it differs from a generic, the biosimilar over their care and treatment.
regulatory process, the manufacturing process,
indication extrapolation, to allow them to make an Making the concept of ‘no decision about me, without
informed decision on their introduction. me’ a reality for everyone along the patient pathway
– in primary care, before a diagnosis, at referral and
3. Identify the potential cost-saving and re-investment after a diagnosis – means involving patients fully in
opportunities. their own care, with decisions being made in
4. Seek formal approval at the local formulary partnership with clinicians rather than by clinicians
committee once there is clinical consensus to alone. The widespread adoption of shared decision-
include biosimilars on the formulary. making is central to empowering and involving
patients fully in their own care and treatment.
5. Collect baseline data and agree metrics to be
collected during and after the introduction of The Shared Decision Making Programme, part of the
biosimilars. Quality, Innovation, Productivity and Prevention
(QIPP) Right Care Programme which ended on 31
6. Submit data to national audits and registries. For March 2013, has now become the responsibility of NHS
further information refer to NICE’s Biosimilar England which has stated its objective to embed shared
medicines key therapeutic topic (NICE, 2016). decision-making in NHS care.
Available at: nice.org.uk/guidance/ktt15
The shared decision-making process makes it possible
Technology appraisal guidance (NICE, 2016). Available for patients reaching a decision crossroads in their
at: www.nice.org.uk health care to explore all the treatment options
available to them, work through any questions they
Stop-think-best practice reflection may have and select a treatment route which best suits
opportunity their needs and preferences – all in consultation with
Full patient monitoring at the time of switch should their health care professional.
occur whether the patient is stable or whether the This approach requires the development of new
patient is being switched for medical reasons such therapeutic relationships between patients, carers and
as loss of efficacy. Pre-switch screening should take clinicians in which everyone works together, in equal
place. BSR guidance states: partnership, to make decisions and agree a care plan.
“the decision to switch patients currently receiving The shared decision-making approach is also being
a reference product to a biosimilar should be on a embedded at the strategic and commissioning level,
case-by-case basis until further data are available and as a result patients are increasingly involved in the
to support safe switching” co-design, co-commissioning and co-production of
health care.
11 Return to contentsASSESSING, MANAGING AND MONITORING BIOLOGIC THERAPIES FOR INFLAMMATORY ARTHRITIS
The key messages for patients and those Patient and shared decision-making
who support them are: resources
• shared decision-making allows you, the patient, to Patient decision aids for biologic therapy are available
be an equal partner in your health care, working at: www.musculoskeletal.cochrane.org/decision-aids
with your doctor, nurse or other health professional
Shared decision making resources can be found at:
to make an informed decision about your treatment
http://personcentredcare.health.org.uk
• whilst clinicians may be treatment experts, you, as
Measuring shared decision making (sure score):
the patient, are ‘an expert in yourself’
www.england.nhs.uk/rightcare
• always remember to ‘ask three questions’:
Improving patient experience – ‘ask three questions’
1. what are my options? available at the e-learning resource for shared decision
making: Advancing Quality Alliance
2. what are the pros and cons of each option for me? www.aquanw.nhs.uk
3. h ow do I get support to help me make a decision Quality statements from the NICE clinical guidelines
that is right for me? on patient experience in adult NHS services (NICE
CG138) specify that patients should be:
Key messages for provider organisations and
the voluntary sector: • actively involved in shared decision-making and
supported by practitioners to make fully informed
• there is enormous potential to be realised when
choices about investigations, treatment and care
patients are joint decision-makers in their own
that reflect what is important to them
treatment options
• supported by practitioners to understand relevant
• patients are more likely to be satisfied with their
treatment options, including benefits, risks and
health care experience
potential consequences.
• patients are more likely to adhere to their chosen
Ultimately, the decision about whether to prescribe a
treatment
NICE approved medicine should be arrived at between
• clinical outcomes and safety are improved the prescriber and the patient.
• shared decision-making helps to break down the
Stop-think-best practice reflection
barriers of jargon, experience and the perceived
opportunity
hierarchical relationship between patients and their
health care advisors. Also reflect on your approach to shared decision
making. What information do you need to know in
The Health Foundation, in conjunction with Cardiff order to advise your patients about biologics and
and Newcastle Universities, has been working with biosimilars?
frontline health professionals to embed best practice
and support the culture shift from a traditional ‘passive
patient’ and ‘expert health professional’ care model Service provision
towards a more equal partnership. Its training
programme – MAGIC (making good decisions in The rheumatology service’s primary responsibility for
collaboration) – supports clinical teams to embed patients receiving biologic therapies is to deliver safe
shared decision making with patients into everyday and effective care using a robust management pathways
practice. that assure the safe administration and monitoring of
Return to contents 12ROYAL COLLEGE OF NURSING
biologic therapies, and that all eligible patients have • locally agreed pathways must ensure that diagnostic
access to timely and cost-effective treatment. and eligibility criteria have been addressed and
adhered to as outlined by NICE/BSR/SIGN guidance
Other rheumatology service responsibilities include:
• ensuring the shared decision-making process is
• reporting and acting on any adverse effects, errors tailored to the patient, carer or family’s needs and
or near misses to the Yellow Card Scheme (see wishes, taking into account any capacity issues
www.mhra.gov.uk/yellowcard) and the BSRBR which should be clearly recorded and audited
(yellow card reporting is a requirement under the (Mental Capacity Act, 2007)
Black Triangle medicines pharmacovigilence
scheme, which indicates the requirement for • record evidence that shared decision-making has
intensive monitoring through the use of an inverted been utilised in the provision and delivery of
black triangle symbol after the trade name of a biologic therapies in line with commissioning
British medicine or vaccine). For biosimilars it is requirements, for example using the Sure Score to
important to report by the product name not the support shared decision-making (Legare, 2010)
substance e.g Remsima not inlfiximab (MHRA
• provide appropriate training and educational
2008)and also the batch number (MHRA 2012)
resources to support patients with the self-
• support for on-going monitoring and management administration of subcutaneous injections
• providing a high quality multidisciplinary patient- • undertake integrated working with community
centred approach where all members of the health service providers such as home care companies and
care team, including patients, are valued and have a primary shared care providers
voice (Francis Inquiry Report, 2013)
• exception reporting processes should be in place
• managing risk is an essential part of running a safe where patients are considered to be likely to benefit
service; practitioners should consult their own local but do not fit locally agreed criteria; processes may
policies and ensure that all potential risk areas have differ locally, but in essence the reasons for
been addressed exceptional consideration should be clearly
documented and supporting evidence provided
• promoting best practice in prescribing is essential.
Repeat prescription management is often organised For guidance on specifying a service for people who
by rheumatology nurse and team administrators. In need biologic drugs for the treatment of
this setting it is essential that non medical inflammatory disease in rheumatology,
prescribing roles are clearly defined. The NMC dermatology and gastroenterology see
recommend separation of prescribing and www.nice.org.uk
administration roles as this poses a significant risk
• time should be allowed for consent and
and formal policies need to be in place. (NMC 2011)
observational data collection documentation for
Transcribing of a prescription by a registered nurse BSRBR studies. Funding is available to support
who is not a prescriber should only happen in teams if needed, the registers continue to grow and
exceptional circumstances and should not be provide essential information used to support safe
routine practice. The transcriber is responsible for and effective treatment for patients
any action resulting from their transcription. This
The BSRBR-RA study team can be contacted at:
must be covered by a medicines management policy
biologics.register@manchester.ac.uk
and a robust agreed transcribing protocol.
The BSRBR-AS study team can be contacted at:
• any untoward incidents and near misses should be
bsrbr-as@abdn.ac.uk
reported following local policy and guidelines
13 Return to contentsASSESSING, MANAGING AND MONITORING BIOLOGIC THERAPIES FOR INFLAMMATORY ARTHRITIS
• undertake the collection of data and reporting to Stop-think-best practice reflection
support effective local commissioning and the opportunity
management of patients on biologic therapies. Consider all the information required before a
repeat prescription for a biologic is completed.
For further information see the NICE ‘into practice’
online guidance, Specifying a service for people who What information do you need to know about that
need biologic drugs for the treatment of inflammatory patient and what assessments are required?
disease in rheumatology, dermatology and
gastroenterology, available at www.nice.org.uk
Francis report summary • the fit and proper person test for directors should
Published in February 2013, the final report of the be subject to a new test, which should include a
Francis Inquiry into failures of care at Mid requirement to comply with a prescribed code of
Staffordshire NHS Foundation Trust has profound conduct for directors
implications for the whole of the NHS. Its key
• complaints should be published on hospital
recommendations are summarised here:
websites, alongside the trust’s response
• a ‘duty of candour’ requires all NHS staff to be
• GPs need to undertake a monitoring role on behalf
honest, open and truthful in all their dealings with
of patients who receive acute hospital and other
patients and the public
specialist services
• a single regulator for financial and care quality,
• local authorities should be required to pass over the
with patient safety and quality standards for all
centrally provided funds allocated to its local
trusts
Healthwatch, while requiring the latter to account
• powers to suspend or prosecute boards and to it for its stewardship of the money.
individuals with criminal liability, where serious
Also see: The Andrews report ‘Trusted to care’ (2014),
harm or death has resulted to a patient due to a
the independent review into the care of older patients
breach of standards
at the Princess of Wales and Neath Talbot Hospitals
• banning gagging clauses in relation to public in Wales, which contains highly specific
interest issues of patient safety and care recommendations regarding aspects of care and
of frail older people and patients with dementia
• only registered people should provide direct care which is of particular relevance when shared treatment
for patients in a hospital or care home setting; a decisions are being made.
registration system should be created
• reinstatement of lead clinician identification so that
patients and their supporters are clear who is in
overall charge of a patient’s care
Return to contents 14ROYAL COLLEGE OF NURSING
PART ONE: ADULT PATIENTS
Section 1: Ankylosing Spondylitis (AS) is a multisystem disease
characterised by inflammatory back pain which can
also have non-skeletal manifestations (including iritis
Assessment and and inflammatory bowel disease) that can be severe.
The condition is a type of spondyloarthropathy with
monitoring of prevalence estimate of 0.05%-0.23% of the UK
population. Peak onset is between 15-25 years of age;
the male: female ratio is 3:1. Women tend to have
biologic therapies milder or subclinical disease. Many patients with mild
disease may remain undiagnosed (NICE TA383, 2016).
Juvenile idiopathic arthritis (JIA) is a relatively rare
NICE guidance continues to stipulate the eligibility
disease. Management of this condition is currently
criteria for biologic therapies. To support a patient
commissioned as a specialised service by NHSE.
starting biologic therapy, practitioners need to
Available data suggest that the number of children aged
understand NICE eligibility criteria as well as the main
4-17 years with JIA eligible for and receiving treatment
diagnostic criteria, safety, monitoring and management
with biologic therapies is 0.015%, or 15 per 100,000
issues for each condition. The content of this section
children per year. Older individuals over the age of 16
should be read in conjunction with the section on
years, who continue to experience JIA as adults, are
Biosimilars on page 10 of this document.
treated with the same options used for children and
Rheumatoid arthritis (RA) is a chronic and young people but individual funding may need to be
progressive disabling condition characterised by requested. For more information, see PART TWO:
inflammation of the synovial tissue of the joints. It may CHILDREN AND YOUNG PEOPLE of this document.
cause tenderness, swelling and stiffness of joints and
Systemic Lupus erythematosus (SLE) and systemic
their progressive destruction, and symptoms including
Vasculitis (SV) are rarer musculoskeletal conditions,
pain and fatigue. Rheumatoid arthritis affects three
such as systemic lupus erythematous (SLE) and systemic
times as many women as men and has a peak age of
vasculitis (SV), are treated with biologic drug therapies
onset of 40–70 years. It is estimated that 580,000 people
– some of which are as yet not licensed. In England,
in England and Wales, approximately 1% of the
specialised commissioning has produced approved
population, have rheumatoid arthritis. Of these,
protocols for access to rituximab for SLE and SV. There is
approximately 15% have severe disease making them
increasing evidence for the benefit of B-cell depleting
eligible for biologic therapy (NICE TA195, 2010)
drugs such as rituximab rather than the anti-TNFα
Psoriatic arthritis (PsA) is an inflammatory arthritis drugs. There are also on-going clinical trials exploring
affecting bone, tendon and joints and is associated with the therapeutic potential of costimulatory blockage, such
psoriasis of the skin or nails. The prevalence of psoriasis as abatacept, in the management of SLE. Belimumab is
in the general population has been estimated between licensed as an adjunctive therapy for SLE high disease
2% and 3%. The estimated number of those diagnosed activity, and is now NICE approved (NICE TA397, 2013).
with PsA and eligible for biologic therapies has been
Other long term conditions treated with biologic
calculated by NICE in a costing template as 2.4% (NICE
therapies include skin conditions such as psoriasis, and
TA199, 2010).
inflammatory bowel conditions such as Crohn’s disease
(CD) and ulcerative colitis (UC).
15 Return to contentsASSESSING, MANAGING AND MONITORING BIOLOGIC THERAPIES FOR INFLAMMATORY ARTHRITIS
Table 1 outlines the current biologic and biosimilar
therapy options licensed and available for adults with
RA, PsA and AS, along with related information on
mode of action, current NICE approval, and
administration method.
Return to contents 16ROYAL COLLEGE OF NURSING
Table 1: Biologic therapy (including Biosimilar therapy) options for adults*
International Manufacturer Mode of action Current Licence Administration
Non- NICE
proprietary approval (by
name (INN) condition)
and (brand
name)
Adalimumab Abbvie Anti TNFα RA TA195/ RA, PsA 40mg every other week
(Humira®) Human TA375 Severe active AS by subcutaneous
monoclonal PsA TA199 or severe non- injection
antibody AS TA383 radiographic axial Prefilled pen or syringe
spondyloarthritis
ie signs of
inflammation
(elevated CRP
and/or MRI) ;
after trying
steroidal anti
inflammatory
drugs (NSAIDs),
which have not
worked.
JIA Also: Psoriasis
Crohn’s Disease
Ulcerative colitis
Psoriatic arthritis
Certolizumab UCB Pharma Anti TNFα RA TA375 RA 400mg at weeks 0, 2 and
pegol PEGylated Fab’ AS TA383 AS (as above) 4 (given as two
(Cimzia®) fragment of a PsA injections of 200mg),
humanised and then 200mg every
monoclonal other week thereafter by
antibody subcutaneous injection
Prefilled syringe
Etanercept Pfizer Anti TNFα RA RA 25mg twice a week, or
(Enbrel®) (formerly Human TNF TA195 / PsA 50mg weekly by
Wyeth) receptor fusion TA375 AS (as above) subcutaneous injection
protein and PsA TA199 JIA Prefilled syringe or
dimer of a AS TA383 Also: Psoriasis MyClic pen (50mg dose
chimeric protein JIA TA373 only) or vial and diluent
Etanercept Biogen Anti-TNFα As above RA Pre-filled syringe 50mg
(Benepali®) Human TNF (except JIA) PsA once weekly & pre-filled
BIOSIMILAR receptor fusion AS (as above) pen 50mg once weekly
protein is a JIA (please see Benepali is currently
dimer of Benepali) only available as a 50mg
chimeric protein Also : Psoriasis pre-filled syringe or a
50mg pre-filled pen
which are unsuitable for
use in children and
adolescents
17 Return to contentsASSESSING, MANAGING AND MONITORING BIOLOGIC THERAPIES FOR INFLAMMATORY ARTHRITIS
Table 1: Biologic therapy (including Biosimilar therapy) options for adults* continued
Infliximab MSD Anti TNFα RA RA (with MTX) 3mg (RA) & 5mg (PsA,
(Remicade®) (formerly Chimeric TA195/ PsA AS) per kg of body
Schering human-murine TA375 AS (as above) weight. Intravenous
Plough) IgG1monoclonal PsA TA199 Also: Psoriasis infusion repeated 2
antibody AS TA383 Crohn’s Disease weeks and 6 weeks after
Ulcerative colitis the first infusion, then
every 8 weeks (can be
6-weekly in AS)
Infliximab Hospira As above As above As above As above
(Inflectra®)
BIOSIMILAR
Infliximab Celltrion/ As above As above As above As above
(Remsima®) Napp
BIOSIMILAR
Golimumab Schering Anti TNFα RA RA (with MTX) 50mg monthly by
(Simponi®) Plough (MSD) Human TA375 PsA subcutaneous injection
monoclonal (partially AS (as above) (100mg can be
antibody updated Also: ulcerative considered if over 100kg
TA225) colitis and no response after
PsA TA445 3-4 injections)
ASTA383 Prefilled pen and syringe
Caution: as this
treatment comes in two
strengths – care should
be taken to provide the
right strength to ensure
that patients are not
under or overdosed
Abatacept Bristol-Myers T-Cell RA TA375 RA (with MTX) 500mg, 750mg or
(Orencia®) Squibb co-stimulation JIA 1000mg (depending on
inhibitor weight) at week 0, 2, 4
Fusion protein then monthly by
intravenous infusion eg
weightROYAL COLLEGE OF NURSING
Table 1: Biologic therapy (including Biosimilar therapy) options for adults* continued
Tocilizumab Roche/Chugai IL-6 receptor RA RA 8mg per kilogram of
(RoActemra®) Products Ltd Humanised TA347 sJIA body weight once every
monoclonal (partially pJIA 4 weeks – by intravenous
antibody updated infusion (maximum
TA247) dose 800mg)
OR
162mg weekly
subcutaneously prefilled
syringe
Ustekinumab Jansen Human PsA TA340 PsA 90mg dose for people
(Stelera®) monoclonal who weigh more than
antibody 100kg at the same cost
as the 45mg dose, as
agreed in the patient
access scheme
Initial dose 45mg
followed by a dose 4/52s
later and further dose
every 12/52s thereafter.
A dose of 90mg may be
used in people with a
body weight over 100kg
Secukinumab Novartis Monoclonal PsA TA445 PsA 150mg once weekly
(Cosentyx®) antihuman AS (TA407) Active AS & given by subcutaneous
antibody of the non-radiographic injection at weeks 0, 1, 2
IgG1/kappa after treatment and 3; followed by a
isotype that with NSAIDs or maintenance dose once
targets TNF-alpha a month starting at
interleukin‑17A inhibitors week 4
The company has agreed
a patient access scheme
with the Department of
Health
Belimumab GlaxoSmith Human SLE Add on therapy in 10mg/kg on days 0, 14,
(Benlysta®) Kline monoclonal (TA397) adults with active 28, and at 4 week
antibody that Auto autoantibody intervals thereafter
inhibits the antibody positive systemic
activity of positive lupus
B-lymphocyte
stimulator
(BLyS)
*Accurate as of October 2016
19 Return to contentsASSESSING, MANAGING AND MONITORING BIOLOGIC THERAPIES FOR INFLAMMATORY ARTHRITIS
Assessment, management and monitoring of biologic 1.1 Before treatment starts
therapies may be provided in secondary care settings,
or community settings including in patients’ homes. Practitioners should ensure that patients fulfil the
eligibility criteria for biologic therapy as defined by
The role of rheumatology practitioners is to support
NICE/SIGN, and have made a choice of treatment
and guide the person considering biologic therapy and
options available based on a discussion about the risks
their family through diagnosis and treatment options,
and benefits of each option.
and provide on-going access to support and
information, safe monitoring and follow up. Patients should be assessed and diagnosed according to
validated diagnostic criteria RA, PsA and AS; these are
Specialist rheumatology practitioners summarised in Appendix 3.
should:
Severity of disease is a key component for defining
• have specialist skills and knowledge in the eligibility. Outcome measures specified in NICE
management of rheumatological conditions technology appraisals are:
• be able to use the principles of shared decision- • DAS (Disease Activity Score) 28 for RA
making in patient education and support, ensuring
patients have enough information to make an • PsARC (Psoriatic Arthritis Response Criteria) for
informed choice, including the route of drug psoriatic arthritis
administration
• BASDAI (Bath Ankylosing Spondylitis Disease
• utilise specialist knowledge of current NICE Activity Index) and spinal pain VAS (Visual
eligibility criteria, assessment requirements and use Analogue Scale) for AS.
of outcome measures in daily practice.
When using outcome measures practitioners should
• be competent in the management and take into account any physical, sensory or learning
administration of biologic therapies by infusion or disabilities, or communication difficulties that could
subcutaneous route, and in the treatment of adverse affect a person’s responses and make any adjustments
reactions including knowledge of cautions and they consider appropriate to suit the patient’s
contra-indications of biologic therapies and use of circumstances and secure equality of access to
current reference resources where needed, such as treatments.
SPCs
As well as diagnosis, disease severity and the duration
• be competent in the education and training of of the DMARD trial, you should also consider:
patients in the self-administration of subcutaneous
• methotrexate (MTX) tolerance – to support plan for
injections and equipment disposal (this training
co-prescription if needed (see the HACA section
may need to be supported by a local protocol or
below for more information)
guideline).
• suitability for self-injection
A competency example can be found at Appendix 2.
• patient choice
• other health conditions including pregnancy
• extra-articular manifestations of disease (for
example, ocular/skin involvement.
If the patient declines treatment, or does not fulfil
eligibility criteria, you should provide guidance on
Return to contents 20ROYAL COLLEGE OF NURSING
their treatment options and act as the patient’s • significant haematological abnormalities, for
advocate. example, reduced WBC, neutrophil or platelet count
Biologic therapy should normally be started with the • an absolute neutrophil count (ANC) below 2 x 109/l
most cost-effective medicine (taking into account drug (tocilizumab and infliximab)
administration costs, required dose and product-price-
• a clear history of multiple sclerosis (MS)
per-dose). This may need to be varied for individual
patients because of differences in the method of • lupus diagnosis/symptoms/strongly positive ANA
administration and treatment schedules. Always refer (antinuclear antibodies) and positive double-
to local protocol/policy. stranded DNA (anti-ds DNA) as +ANA and anti-ds
DNA antibodies development may occur with
etanercept, adalimumab, certolizumab pegol and
1.1.1 Assessment infliximab – is also listed in the SPC as an adverse
drug reaction for golimumab
Practitioners frequently have to assess patients for
biologic therapy, and a full history is essential to ensure • moderate/severe congestive cardiac failure (CCF)
safe prescribing. Check lists are a useful tool to ensure (New York Heart Association class/grade III/IV)
nothing is missed. (NYHA) or severe, uncontrolled cardiac disease –
all anti-TNFα agents list moderate/severe CCF as a
The NICE and SIGN guidance algorithms for RA, PSA special warning/contraindication
and AS can be found at www.rheumatology.
oxfordjournals.org and www.medicines.org.uk. See • history of having received a recent live vaccine; it is
also the BSR guideline (2011) for rituximab and the recommended that a period of at least four weeks is
BSR guidelines (2014) for tocilizumab. allowed, prior to commencement of any biologic
therapy, following the administration of a live
The following sections contain check lists based upon vaccine (Butler, 2008; updated 2012)
recommendations in RA safety guidelines for anti-
TNFα therapies BSR/BHPR (2010) and the SPCs of • hereditary problems of fructose intolerance
current biologic therapies, and apply to all drugs, (golimumab)
unless stated otherwise.
• severe central nervous system Lupus, renal lupus,
major organ or stem cell transplantation
Contra-indications, special warnings and (Belimumab)
precautions
Biologic therapy should not be considered for patients • all patients but in particular patients over 60 yrs of
with: age patients with a medical history of prolonged
immunosuppressant therapy or those with a history
• infection (including skin), sepsis or risk of of PUVA treatment should be monitored for the
sepsis, serious active infection – for example, TB, appeabce of non-melanoma skin cancer
hepatitis, HIV (ustekinumab)
• hypersensitivity to the active substances or to any of • both ustekinumab and secukinumab latex
the excipients, severely immunocompromised state, sensitivity – be aware that the needle cover of the
for example, hypogammaglobulinaemia or where prefilled syringe is manufactured from a derivative
levels of CD4 or CD8 are very low (rituximab) of latex.
• hepatic impairment and where baseline ALT or AST
is > 5 x ULN (upper limit of normal) (tocilizumab
and infliximab)
21 Return to contentsASSESSING, MANAGING AND MONITORING BIOLOGIC THERAPIES FOR INFLAMMATORY ARTHRITIS
1.1.2 P
re-treatment screening • any planned surgery
• current or planned pregnancy/ breastfeeding/
History of infection contraception plans
There is an increased risk of infection for all patients • diverticulitis and hyperlipidaema (tocilizumab).
receiving biologic therapy with or without MTX,
particularly in the first six months of therapy with In addition you should check for:
anti-TNFα. Therefore patients should be asked:
• any allergies including latex
• if they have any infection (including skin infections
• risks of malignancy such as ulcerative colitis,
such as cellulitis) or history of recurrent infection.
history of smoking, Barrett’s oesophagus, cervical
• any TB contact or exposure or a family or personal dysplasia and/or large bowel polyps or family
history (check BCG scar)( BTS, 2005) – also ask history of malignancy
about work history particularly in rural areas as
• for anti-TNFα agents: a medical history of psoriasis,
anecdotally there is an increased risk of latent TB
prolonged PUVA or immunosuppressive therapy
for individuals working with cattle or pigs, or
needs to be considered, as a significant number of
individuals involved in the slaughter of these
reports of psoriasis developing in patients treated
animals.
with these agents specifically have emerged
• you should also check the patient’s hepatitis and (Collamer et al., 2008; Harrison et al., 2009 –
varicella history, and any HIV risk factors. BSRBR; Ko et al., 2009)
(BSR/BHPR, 2010; BSR and BHPR, 2011; BSR & BHPR, • MS family history
2012; EASL, 2016).
• vaccination history – such as flu and pneumonia
and chicken pox and shingles, measles, mumps and
Current health conditions rubella (MMR), as per local guidelines, and
Patients should also be asked about any current BCG scar
conditions, in particular:
• anti-coagulation treatment (certolizumab pegol
• auto immune conditions such as lupus may cause erroneously elevated activated partial
thromboplastin time – aPPT)
• diabetes
• sodium controlled diet as tocilizumab (IV only),
• neurological disorders such as MS
abatacept and infliximab all contain sodium
• malignancies (including skin)
• exercise caution with patients with Crohn’s
• cardiac disorders such as heart failure (CCF), prescribed secukinumab as activation of this
hypertension/hyperlipidaemia, ischaemic heart condition has been observed.
disease, arrhythmias
Investigations checklist
• haematological disease, disorders – such as
neutropenia, thrombocytopenia, leucopenia, Your investigations checklist should include:
pancytopenia and/or, aplastic anaemia • IgG and (before rituximab cycles, as can become
• hepatic impairment, disease such as hepatitis depleted and increase infection risk)
• pulmonary/lung disease – such as interstitial lung • if indicated exclude possible infection, such as
disease, COPD swabs, MSU, sputum
• uveitis • pre-treatment chest X ray
Return to contents 22ROYAL COLLEGE OF NURSING
• for all biologic indications screen for hepatitis B However, even though only some biologics have been
surface antigen (HBsAg), Hepatitis B total core identified to increase both the risk of and reactivation
antibody (HBcAb), Hepatitis C antibody, HIV Ag/ of TB, it is recommended (all SPCs; BTS, 2005; BSR/
Ab test (4th generation assay) BHPR, 2010) that all patients are screened for TB prior
to the commencement of biologic therapy.
• liver enzyme parameters – ALT and AST (and in
particular for tocilizumab and infliximab) when TB screening should include:
administered concomitantly with MTX; treatment
• the establishment of a patient’s TB history/contact/
to be initiated and continued in caution if ALT or
previous treatment
AST >1.5 x ULN
• clinical examination and a chest x-ray and if
• FBC – neutrophil, leucocyte and platelet count
appropriate
• ANA – if positive, suggest repeat test and order
• TB testing (for example, Quantiferon or T-spot) in
extractable nuclear antigen (ENA) and double
all patients (local recommendations may apply)
stranded DNA (ds-DNA) to help exclude lupus, as
some patients have developed positive ANA and • results should be recorded in the patient’s medical
anti-ds DNA antibodies following treatment with record and alert card.
some biologic therapies, hence the reason for
pre-treatment positive ANA testing Prescribers are reminded of the risk of false negative
tuberculin skin and interferon-gamma TB blood test
• MMR screening (as per local policy) results, especially in patients who are severely ill or
immune compromised.
• varicella zoster serology (varicella IgG levels) –
see separate section for further information Any patient with an abnormal chest x-ray or previous
history of TB should be referred for assessment by a
• lipids before tocilizumab and Cimzia® as can cause
specialist with an interest in TB, as any patient with
hyperlipidaemia
evidence of active or potential latent TB or at high risk
• check current APPT status if on heparin anti- of TB should be treated with standard anti-
coagulants and ensure this is recorded mycobacterial therapy (supervised by an appropriate
specialist) before biologic therapy is initiated. (BTS,
• pre-treatment blood pressure check is advised 2005; Butler, 2008 – updated 2012; NICE (CG117) 2011;
• suspected malignancy should be investigated RCN, 2012).
• check for hypogammaglobulinaemia before starting
belimumab. 1.1.3 Vaccinations
TB/TB screening The following section is designed as a resource to
There is evidence from the BSRBR (Dixon et al., support the practitioner in providing vaccination
2010a&b) to suggest that the rate of TB in patients with advice to the patient or carer – or a health professional
RA treated with anti-TNFα therapy was three-to-four providing vaccination (such as the practice nurse). It is
fold higher in patients receiving infliximab and not intended to support the provision of vaccination
adalimumab than those receiving etanercept. A study itself, as this is outside the remit of rheumatology
by Burmester et al., (2012) has found that the use of services.
appropriate pre-treatment screening and prophylaxis Practitioners should identify the patient’s immune
for latent TB resulted in a significant reduction in the status whilst planning their care pathway. This will
risk of active TB in adalimumab clinical trials. mean patients are adequately prepared before starting
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