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SIGN Scottish Intercollegiate Guidelines Network Part of NHS Quality Improvement Scotland 123 Management of early rheumatoid arthritis A national clinical guideline February 2011 KEY TO EVIDENCE STATEMENTS AND GRADES OF RECOMMENDATIONS LEVELS OF EVIDENCE 1++ High quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias 1+ Well conducted meta-analyses, systematic reviews, or RCTs with a low risk of bias 1- Meta-analyses, systematic reviews, or RCTs with a high risk of bias High quality systematic reviews of case control or cohort studies 2++ High  quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal 2+ Well conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal 2- Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal 3 Non-analytic studies, eg case reports, case series 4 Expert opinion GRADES OF RECOMMENDATION Note: The grade of recommendation relates to the strength of the evidence on which the recommendation is based. It does not reflect the clinical importance of the recommendation. A B  t least one meta-analysis, systematic review, or RCT rated as 1++, A and directly applicable to the target population; or  body of evidence consisting principally of studies rated as 1+, A directly applicable to the target population, and demonstrating overall consistency of results A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 1++ or 1+ C A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 2++ D Evidence level 3 or 4; or Extrapolated evidence from studies rated as 2+ GOOD PRACTICE POINTS  Recommended best practice based on the clinical experience of the guideline development group NHS Evidence has accredited the process used by Scottish Intercollegiate Guidelines Network to produce guidelines. Accreditation is valid for three years from 2009 and is applicable to guidance produced using the processes described in SIGN 50: a guideline developer’s handbook, 2008 edition (www.sign.ac.uk/guidelines/ fulltext/50/index.html). More information on accreditation can be viewed at www.evidence.nhs.uk NHS Quality Improvement Scotland (NHS QIS) is committed to equality and diversity and assesses all its publications for likely impact on the six equality groups defined by age, disability, gender, race, religion/belief and sexual orientation. SIGN guidelines are produced using a standard methodology that has been equality impact assessed to ensure that these equality aims are addressed in every guideline. This methodology is set out in the current version of SIGN 50, our guideline manual, which can be found at www.sign.ac.uk/guidelines/fulltext/50/index.html. The EQIA assessment of the manual can be seen at www.sign. ac.uk/pdf/sign50eqia.pdf. The full report in paper form and/or alternative format is available on request from the NHS QIS Equality and Diversity Officer. Every care is taken to ensure that this publication is correct in every detail at the time of publication. However, in the event of errors or omissions corrections will be published in the web version of this document, which is the definitive version at all times. This version can be found on our web site www.sign.ac.uk. This document is produced from elemental chlorine-free material and is sourced from sustainable forests. Scottish Intercollegiate Guidelines Network Management of early rheumatoid arthritis A national clinical guideline February 2011 MANAGEMENT OF EARLY RHEUMATOID ARTHRITIS ISBN 978 1 905813 70 4 Published February 2011 Citation text Scottish Intercollegiate Guidelines Network (SIGN). Management of early rheumatoid arthritis. Edinburgh: SIGN; 2011. (SIGN publication no. 123). [cited February 2011]. Available from URL: http://www.sign.ac.uk SIGN consents to the photocopying of this guideline for the purpose of implementation in NHSScotland Scottish Intercollegiate Guidelines Network Elliott House, 8 -10 Hillside Crescent Edinburgh EH7 5EA www.sign.ac.uk CONTENTS Contents 1 Introduction................................................................................................................. 1 1.1 The need for a guideline............................................................................................... 1 1.2 Remit of the guideline................................................................................................... 1 1.3 Definitions.................................................................................................................... 1 1.4 Statement of intent........................................................................................................ 2 2 Key messages................................................................................................................ 3 2.1 Principles of management............................................................................................. 3 2.2 Disease modifying anti-rheumatic drugs........................................................................ 3 2.3 Biologic response modifiers.......................................................................................... 3 3 Diagnosis of early rheumatoid arthritis........................................................................ 4 3.1 Clinical indicators......................................................................................................... 4 4 Principles of management............................................................................................ 5 4.1 Patient education.......................................................................................................... 5 4.2 Multidisciplinary team.................................................................................................. 5 4.3 Early treatment.............................................................................................................. 5 4.4 Assessing disease activity.............................................................................................. 5 4.5 Treat-to -target strategies................................................................................................ 6 5 Analgesics and non-steroidal anti-inflammatory drugs................................................. 7 5.1 Analgesics..................................................................................................................... 7 5.2 Non-steroidal anti-inflammatory drugs........................................................................... 7 6 Disease modifying drugs............................................................................................... 9 6.1 Systemic corticosteroids – oral and parenteral............................................................... 9 6.2 Disease modifying anti-rheumatic drugs........................................................................ 10 6.3 Biologic response modifiers.......................................................................................... 11 7 The role of the multidisciplinary team.......................................................................... 13 7.1 Occupational therapy.................................................................................................... 13 7.2 Physiotherapy............................................................................................................... 13 7.3 Podiatry........................................................................................................................ 14 7.4 Dietetics........................................................................................................................ 15 7.5 Complementary and alternative therapies...................................................................... 15 8 Provision of information............................................................................................... 16 8.1 Sources of further information....................................................................................... 16 8.2 Checklist for provision of information........................................................................... 17 MANAGEMENT OF EARLY RHEUMATOID ARTHRITIS 9 Implementing the guideline.......................................................................................... 18 9.1 Implementation............................................................................................................. 18 9.2 Resource implications of key recommendations............................................................ 18 9.3 Auditing current practice............................................................................................... 18 9.4 Advice to NHSScotland from NHS Quality Improvement Scotland and the Scottish Medicines Consortium..................................................................................... 18 10 The evidence base........................................................................................................ 19 10.1 Systematic literature review........................................................................................... 19 10.2 Recommendations for research..................................................................................... 19 10.3 Review and updating.................................................................................................... 19 11 Development of the guideline...................................................................................... 20 11.1 Introduction.................................................................................................................. 20 11.2 The guideline development group................................................................................. 20 11.3 Consultation and peer review........................................................................................ 21 Abbreviations............................................................................................................................... 23 Annex 1 ..................................................................................................................................... 24 References................................................................................................................................... 25 1 INTRODUCTION 1 Introduction 1.1 THE NEED FOR A GUIDELINE Rheumatoid arthritis (RA) is an inflammatory disease which, though systemic, typically involves the small joints of the hands and feet, often symmetrically. It affects approximately 1% of the population and is more common in women. The course of RA is variable and unpredictable but for a significant number of patients it is a severe disease resulting in persistent pain and stiffness, progressive joint destruction, functional decline and premature mortality.1-3 There is also the potential loss of social and financial independence4 and the burden of care on direct (eg medical care) and indirect costs (eg effects on the individual’s ability to work).5, 6 The goal of early treatment for rheumatoid arthritis is to achieve clinical and radiological remission and reduce functional limitations and permanent joint damage. 1.1.1 UPDATING THE EVIDENCE This guideline updates SIGN 48 to reflect the most recent evidence. Where no new evidence was identified to support an update, text and recommendations are reproduced verbatim from SIGN 48. The original supporting evidence was not re-appraised by the current guideline development group. 1.2 REMIT OF THE GUIDELINE 1.2.1 OVERALL OBJECTIVES This guideline addresses the diagnosis of early RA, its pharmacological treatment including symptom relief and disease modification, and the role of the multidisciplinary team in improving the care of patients with RA. The guideline does not address the treatment of comorbidities (eg anaemia, osteoporosis), complications of drug therapy and their management, or treatment of extra-articular disease (eg vasculitis, ocular complications, amyloid). 1.2.2 TARGET USERS OF THE GUIDELINE This guideline will be of particular interest to rheumatologists, general practitioners (GPs), rheumatology nurse specialists, physiotherapists, occupational therapists, dietitians, podiatrists and pharmacists. 1.2.3 1.3 SUMMARY OF UPDATES TO GUIDELINE BY SECTION 2 Key messages New 3 Diagnosis Major update 4 Principles of treatment Partial update 5 Analgesics and non-steroidal anti-inflammatory drugs 6 Disease modifying drugs Major update 7 The role of the multidisciplinary team Partial update Partial update DEFINITIONS At present there is no formal definition of ‘early RA’. It is defined in this guideline as disease duration of ≤5 years from onset of symptoms. The guideline development group recognises that the interval between seeking advice and initiation of disease modifying anti-rheumatic drugs (DMARD) treatment has continued to narrow and patients should be advised to seek treatment as early as possible to reduce disease progression. 1 MANAGEMENT OF EARLY RHEUMATOID ARTHRITIS 1.4 STATEMENT OF INTENT This guideline is not intended to be construed or to serve as a standard of care. Standards of care are determined on the basis of all clinical data available for an individual case and are subject to change as scientific knowledge and technology advance and patterns of care evolve. Adherence to guideline recommendations will not ensure a successful outcome in every case, nor should they be construed as including all proper methods of care or excluding other acceptable methods of care aimed at the same results. The ultimate judgement must be made by the appropriate healthcare professional(s) responsible for clinical decisions regarding a particular clinical procedure or treatment plan. This judgement should only be arrived at following discussion of the options with the patient, covering the diagnostic and treatment choices available. It is advised, however, that significant departures from the national guideline or any local guidelines derived from it should be fully documented in the patient’s case notes at the time the relevant decision is taken. 1.4.1 PRESCRIBING OF LICENSED MEDICINES OUTWITH THEIR MARKETING AUTHORISATION Recommendations within this guideline are based on the best clinical evidence. Some recommendations may be for medicines prescribed outwith the marketing authorisation (product licence). This is known as ‘off label’ use. It is not unusual for medicines to be prescribed outwith their product licence and this can be necessary for a variety of reasons. Generally the unlicensed use of medicines becomes necessary if the clinical need cannot be met by licensed medicines; such use should be supported by appropriate evidence and experience.7 Medicines may be prescribed outwith their product licence in the following circumstances: ƒƒ for an indication not specified within the marketing authorisation ƒƒ for administration via a different route ƒƒ for administration of a different dose. “Prescribing medicines outside the recommendations of their marketing authorisation alters (and probably increases) the prescribers’ professional responsibility and potential liability. The prescriber should be able to justify and feel competent in using such medicines.”7 Any practitioner following a SIGN recommendation and prescribing a licensed medicine outwith the product licence needs to be aware that they are responsible for this decision, and in the event of adverse outcomes, may be required to justify the actions that they have taken. Prior to prescribing, the licensing status of a medication should be checked in the current version of the British National Formulary (BNF).7 1.4.2 ADDITIONAL ADVICE TO NHSSCOTLAND FROM NHS QUALITY IMPROVEMENT SCOTLAND AND THE SCOTTISH MEDICINES CONSORTIUM NHS QIS processes multiple technology appraisals (MTAs) for NHSScotland that have been produced by the National Institute for Health and Clinical Excellence (NICE) in England and Wales. The Scottish Medicines Consortium (SMC) provides advice to NHS Boards and their Area Drug and Therapeutics Committees about the status of all newly licensed medicines and any major new indications for established products. SMC advice and NHS QIS validated NICE MTAs relevant to this guideline are summarised in section 9.4. 2 2 KEY MESSAGES 2 Key messages The following recommendations were highlighted by the guideline development group as the key clinical recommendations that should be prioritised for implementation. The grade of recommendation relates to the strength of the supporting evidence on which the recommendation is based. It does not reflect the clinical importance of the recommendation. 2.1 PRINCIPLES OF MANAGEMENT ;;  ll patients with suspected inflammatory joint disease should be referred to a specialist A as soon as possible to confirm the diagnosis and evaluate disease activity. ;;  he multidisciplinary team has been shown to be effective in optimising management of T patients with RA. All patients should have access to such a range of professionals including general practitioner, rheumatologist, nurse specialist, physiotherapist, occupational therapist, dietitian, podiatrist, pharmacist and social worker. B Early initiation of treatment with DMARDs is recommended to control the symptoms and signs of RA as well as limiting radiological damage. B 2.2 Patients with moderate to severe disease activity should: ƒƒ be assessed for disease activity using a standardised scoring system such as DAS/ DAS28 ƒƒ be reviewed monthly until remission or a low disease activity score is achieved ƒƒ receive treatment with DMARDs, adjusted with the aim of achieving remission or a low DAS/DAS28 score. DISEASE MODIFYING ANTI-RHEUMATIC DRUGS A  Methotrexate and sulfasalazine are the DMARDs of choice due to their more favourable efficacy and toxicity profiles.  B  DMARD therapy should be sustained in patients with early RA to control the signs and symptoms of disease. A A combination DMARD strategy, rather than sequential monotherapy, should be considered in patients with an inadequate response to initial DMARD therapy. 2.3 BIOLOGIC RESPONSE MODIFIERS Use of the TNF-α inhibitors for the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate or other DMARDs is not recommended. 3 MANAGEMENT OF EARLY RHEUMATOID ARTHRITIS 3 Diagnosis of early rheumatoid arthritis The diagnosis of early RA relies heavily on the accurate interpretation of medical history and clinical examination, and is informed by clinical investigations. The American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) 2010 criteria for the classification of RA illustrates this.8 The evidence reviewed within this guideline uses the 1987 ACR criteria, as the studies predate the publication of the 2010 criteria.9 3.1 CLINICAL INDICATORS 3.1.1 ANTI-CYCLIC CITRULLINATED PEPTIDE ANTIBODIES Two meta-analyses concluded that in patients with a high clinical probability of RA, anti-cyclic citrullinated peptide antibodies (anti-CCP) may identify those with a higher probability of developing radiological damage.10,11 Few studies included patients with early RA and neither review provided an estimate of the sensitivity and specificity of anti-CCP in early disease. 2++ A systematic review concluded that anti-CCP2 is useful in early RA diagnosis because of its greater specificity but it has similar sensitivity to rheumatoid factor (RF).12 Of the eight cohort studies included, IgM RF had a specificity of 86% (95% CI 78 to 92) and anti-CCP2 had a specificity of 96% (95% CI 93 to 97). This review was limited by poor quality studies. 2++ No evidence was identified on the use of anti-CCP in guiding the management of patients with early RA. B Anti-CCP2 antibody may be used as part of the assessment of a patient suspected of an early inflammatory polyarthritis such as RA. 3.1.2 IMAGING The evidence for additional imaging at diagnosis to assess disease activity in early RA is limited and methodologically poor.13,14 The evidence suggests that power Doppler ultrasound may be useful in assessing disease activity and may have predictive value on radiological outcome.15 4 2-