Rheumatology Advance Access originally published online on August 28, 2006
Rheumatology 2008 47(6):924-925; doi:10.1093/rheumatology/kel216a
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BSR/BHPR guideline for disease-modifying anti-rheumatic drug (DMARD) therapy in consultation with the British Association of Dermatologists
Harold Wood Hospital, BHR Trust, Romford, 1Gubbins Lane Surgery, Harold Wood, 2Ninewells Hospital, Dundee, 3Musgrave Park Hospital, Belfast, 4Manchester Royal Infirmary, Manchester, 5Royal College of Nursing Rheumatology Forum, London, 6Litchdon Health Centre, Barnstaple, 7Norfolk & Norwich University Hospital and University of East Anglia, 8Norfolk & Norwich University Hospital, Norwich, 9National Rheumatoid Arthritis Society, Maidenhead and 10Royal Liverpool and Broadgreen University Hospital Trust, Liverpool, UK.
Correspondence to: K. Chakravarty, Harold Wood Hospital, BHR NHS Trust, Romford, Essex RM7 OBE, UK. E-mail: Kuntal.Chakravarty{at}bhrhospitals.nhs.uk
KEY WORDS: DMARD, Guideline, Multidisciplinary, Multi professional
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Scope and purpose of the guideline |
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 Top Scope and purpose of... Guideline eligibility and...Monitoring of treatmentAudit proformasAcknowledgements |
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Inflammatory arthritis and especially rheumatoid arthritis (RA) is common and affects 1% of the population. The prognosis of RA remains uncertain as it runs a variable and unpredictable course. Several longitudinal studies have demonstrated the progressive course of RA and new research has emphasized the need for early intervention with disease-modifying anti-rheumatic drugs (DMARDs) to prevent long-term disability.
The development of Clinical Guidelines is the first step towards earlier diagnosis and treatment. This multidisciplinary and multiprofesssional guideline on DMARDs is timely for two major reasons: first, it was necessary to update the guideline produced by the British Society for Rheumatology (BSR) 5 yrs ago; and second, it was necessary to produce a unified approach to monitoring patients on some of the DMARDs particularly methotrexate due to recent developments with the national patient safety agency. Therefore, this guideline is somewhat unique, as BSR has taken a collaborative approach with the British Association of Dermatologists (BAD) to develop this document. This comprehensive evidence-based guideline on individual DMARDs gives a framework for monitoring the effects of these drugs that will help all health-care professionals across the primary and secondary care.
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Guideline eligibility and exclusion criteria |
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TopScope and purpose of...Guideline eligibility and...Monitoring of treatmentAudit proformasAcknowledgements |
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This guideline is to be taken in conjunction with the guideline on the management of RA (Rheumatology 2006;45:1167–9). It is generally believed that specific therapy with DMARD should commence once the diagnosis of RA is confirmed, usually within 3 months.
This document will address issues related to 10 major DMARDs that are used in day-to-day clinical practice for adults with RA. This document will not address drugs such as biologics, as the guideline on these drugs have already been published. This guideline is not for use in children, and British Society for Paediatrics and Adolescent Rheumatology (BSPAR) has produced a similar guideline for children requiring the use of similar drugs for RA. This guideline is essentially for patients on monotherapy and extra caution should be taken for patients on combination therapy.
The best DMARDs are those that provide the greatest efficacy with the least toxicity over the long term. It is therefore important to assess the progress of the disease and response to treatment on a regular basis. ‘Annual review’ may be an ideal way of assessing such clinical progress. Some patients require withdrawal of therapy and the two common reasons for such withdrawal are inefficacy and adverse effects. However, patients’ choice does also play a role in some cases when they prefer to withdraw therapy after being in long-term remission. Temporary withdrawal is also advised in some clinical circumstances, i.e. if patients develop an untoward side effect or in some physiological conditions, i.e. pregnancy/lactation.
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Monitoring of treatment |
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TopScope and purpose of...Guideline eligibility and...Monitoring of treatmentAudit proformasAcknowledgements |
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This is one of the major remits of this document and each drug has been described fully, as it should be used in rheumatology with appropriate recommendations from BAD where there are common indications for use between specialties.
The key statements when monitoring a DMARD are:
- It is important to note that in addition to absolute values for any haematological or biochemical indices, a rapid unusual fall or rise or a consistent downward or upward trend in any value should prompt caution and extra vigilance.
- Extra caution is required before advising patients about immunizations, as live vaccines are not recommended when patients are on certain immuno modulators.
- Drug interactions are important and should always be weighed against the clinical need.
- Pregnancy and related issues such as breast-feeding must be addressed when patients are receiving a DMARD. It is necessary to be absolutely certain about the effect of the DMARD on the fetus as well as on lactation.
- All monitoring activity for early detection of toxicity should also be documented in case notes and the patient should be informed as well.
- Although side effects are not mentioned with each individual DMARD, users of this document are requested to also consult the British National Formulary (BNF) and individual drug summary of product characteristics (SPC) wherever needed.
- ALL patients should be provided with a patient-held booklet of their DMARD monitoring records with clear mention of all current results where appropriate.
- Patients should be encouraged to take part in a self-management programme to monitor their own therapy as studies have shown that patients like to be involved in their continuing care rather than just informed about the therapy.
- All patients should ideally be made go through a regular educational programme before prescribing the DMARD.
- It is desirable that some form of outcome assessment is undertaken and all contacts between the health professional and the patient for the purpose of monitoring should be taken as an opportunity for teaching and training about the role of the DMARD in RA or other similar diseases.
- Although the current guideline has been developed on the basis of available evidence, it still has a significant weakness, as not much of the evidence exists about the exact time at which some of the adverse events occurred after starting a specific DMARD.
The recommendations are based predominantly on clinical experience and less on clinical evidence and research.
This guideline describes 10 DMARDs such as auranofin (oral gold), azathioprine, ciclosporin, D-penicillamine, hydroxychloroquine, leflunomide, methotrexate, mycophenolate mofetil (MMF), sodium aurothiomalate and sulphasalazine. Cyclophosphamide will not be discussed in this document, as this drug will be covered at length in the guideline document of management of systemic vasculitis, which is currently in preparation (see full guidelines at Rheumatology online).
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Audit proformas |
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TopScope and purpose of...Guideline eligibility and...Monitoring of treatmentAudit proformasAcknowledgements |
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This guideline on individual DMARDs provides a framework on which to base the day-to-day clinical care of patients between primary and secondary care particularly as the general practitioners (GPs) are now encouraged to undertake ‘near patient testing’. ‘Practical tools’ for management of these drugs are also published by the BSR. There are a number of unresolved issues and lack of evidence associated with almost all the drugs used as DMARDs and regular audit and research should be undertaken to gather evidence that may help in planning the best practice for the future. These audits can be undertaken locally, regionally or nationally depending on the feasibility and should be done before and after the implementation of the guideline. It would be hugely beneficial to both patients and professionals if assessment of impact of these guidelines on the clinical outcome is undertaken by means of randomized clinical trial. There is no algorithm to follow in this guideline, as the drugs are used variably at different stages of the disease depending on the clinical need.
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Acknowledgements |
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TopScope and purpose of...Guideline eligibility and...Monitoring of treatmentAudit proformasAcknowledgements |
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The working party on DMARDs would like to thank the BSR secretariat including Mooka Barker, Debbie Smith, Karishma Chandaria and Lizzie Bloom for their kind support. The authors would also like to extend their special thanks to Mike Shipley and colleagues in the SAGWG for their kind reviewing and advising on the paper.
Disclosure statement: K.C. has received honoraria for lecturing at GP meetings from Servier, Aventis and MSD, and is a member of the Advising Panel. S.O. has carried out consultancy work for National Patient Satefy Agency (Methotrexate) and a number of educational/advisory roles for Medac UK, Wyeth, Abbott, Schering, Plough, Pfizer and Roche. A.B. has received unrestrictive educational grants for Abbott, Schering Plough, Roche and Wyeth in the last 12 months. H.M. is a shareholder in GlaxoSmithKline and Astra Zeneca. A.T. has acted as a medical advisor to Abbott Laboratories, Merck Sharp and Dohme Ltd, Roche Pharmaceuticals, Schering Plough and Wyeth. T.P. is in receipt of a research grant from Wyeth and his unit has a nurse specialist jointly funded by Abbott and Wyeth. All other authors have declared no conflicts of interest.
Submitted 19 February 2006;
revised version accepted 11 March 2008.
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