Rheumatology 2008; 1 of 16 doi:10.1093/rheumatology/kel216b Guidelines BSR/BHPR guideline for disease-modifying anti-rheumatic drug (DMARD) therapy in consultation with the British Association of Dermatologists K. Chakravarty, H. McDonald1, T. Pullar2, A. Taggart3, R. Chalmers4, S. Oliver5,6, J. Mooney7, M. Somerville8, A. Bosworth9, T. Kennedy10 on behalf of the British Society for Rheumatology, British Health Professionals in Rheumatology Standards, Guidelines and Audit Working Group in consultation with the British Association of Dermatologists KEY WORDS: DMARD, Guideline, Multidisciplinary, Multi professional. Scope and purpose effects can be significant in some patients. Most specialists recommend regular safety monitoring of these drugs based on Background to disease/the drug therapy clinical experience and the data from published literature, such as Inflammatory arthritis, and especially rheumatoid arthritis (RA), Product Specific Characteristics, the British National Formulary is common and affects over 1% of the population. Even in the (BNF) and publications from various clinical trials in the specialty 21st century, the prognosis of RA remains uncertain. It runs a literature [3–6]. The adverse effects of DMARDs as reported in variable and unpredictable course. Several longitudinal studies research trials have limitations, as the patient characteristics are have demonstrated the progressive course of the disease, leading likely to be different from those in daily clinical practice. It is to joint destruction and deformity and, ultimately, to loss of desirable if not necessary, to have some form of guideline which is functional independence and to residual disability. Research has multidisciplinary with patient participation, using evidence base, shown that early intervention with disease specific anti-rheumatic peer reviewed, well researched and supported by some study/audit drugs, also called second line drugs or disease-modifying anti- of national practice. In 2000 the British Society for Rheumatology rheumatic drugs (DMARDs) is the cornerstone of treatment and, (BSR) produced its second edition of DMARD monitoring in the early stages may be able to curb or arrest the progressive guidelines for rheumatologists but this was considered by the synovitis and joint destruction and thereby limit disability [1]. committee for evaluation of guidelines of the Royal College of This guideline is intended to help clinicians and allied health Physicians to be more appropriate as a ‘practical tool’ than professionals, both in primary and secondary care, to make guideline. The need for a review of the guideline is, therefore, not decisions about DMARD therapy, with particular reference to only timely but also of paramount importance as the approach their toxicity profile. These drugs are used in a number of to therapy of many rheumatological and dermatological diseases conditions, including RA, psoriasis and psoriatic arthritis, as well has changed in the recent years, with greater accumulation of as the connective tissue diseases and vasculitis. It is essential that evidence since the last publication. Moreover, the current DMARDs are used in appropriate doses to achieve an optimal DMARD guideline has been developed in collaboration with balance between benefit and risk [2]. the British Association of Dermatologists (BAD), as there is a common interest to prevent and limit toxicity associated with the use of these drugs in these two specialties. Need for guideline The use of DMARDs in rheumatology and dermatology requires the use of guidelines for drug toxicity monitoring, as adverse Objective of the guideline This guideline provides a list of licensed and unlicensed indica- Harold Wood Hospital, BHR Trust, Romford, 1Gubbins Lane Surgery, Harold tions for the use of DMARDs in rheumatology and dermatology. Wood, 2Ninewells Hospital, Dundee, 3Musgrave Park Hospital, Belfast, It provides an evidence-based approach with appropriate refer- 4Manchester Royal Infirmary, Manchester, 5Royal College of Nursing ences to all recommendations in terms of predicting, assessing and Rheumatology Forum, London, 6Litchdon Health Centre, Barnstaple, 7Norfolk & counteracting any toxic effects related to the use of the DMARDs Norwich University Hospital and University of East Anglia, 8Norfolk & Norwich in these two specialties. University Hospital, Norwich, 9National Rheumatoid Arthritis Society, Maidenhead The main objective of this guideline is to provide clear 10 and Royal Liverpool and Broadgreen University Hospital Trust, Liverpool, UK. information that the responsible clinician can use to ensure Submitted 19 February 2006; revised version accepted 11 March 2008. DMARDs may be safely prescribed and monitored. Correspondence to: K. Chakravarty, Harold Wood Hospital, BHR NHS Trust, It is expected that the guidelines should be viewed with Romford, Essex, RM7 OBE, UK. E-mail: [email protected] individual drug SPC’s (Summary of Product Characteristics) 1of16 ß The Author 2008. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: [email protected] 2of16 K. Chakravarty et al. and together will provide sufficient up-to-date knowledge about Dr Harry McDonald Royal College of General the DMARDs. This guideline also addresses many unresolved and General Practitioner Practitioners evolving issues that can be considered as part of a research or Gubbins Lane Surgery audit, locally or nationally. Havering PCT It is essential that clinicians remember to report (yellow card Essex system) any serious adverse events (SAE) related to the use of DMARDs. Dr Tom Kennedy BSR–Consultant Royal Liverpool and Broadgreen Rheumatologist University Hospital Trust Target audience Prescott Road This document is targeted at the following: Liverpool (1) Health care professionals in primary and secondary care. Mrs Janice Mooney Specialist Nurse (2) Health service managers. Lecturer/Practitioner (Rheumatology Forum) (3) Patients receiving these drugs and patient organizations, Norfolk & Norwich such as Arthritis Care, and national patient support groups, University Hospital such as the National Rheumatoid Arthritis Society (NRAS). Norwich (4) Other national societies, such as the BAD. Mrs Susan Oliver Royal College of Nursing Nurse Consultant & Chairperson, The areas the guideline does not cover Rheumatology Forum Royal College of Nursing (1) The management of DMARD therapy in children with London inflammatory arthritis. The British Society for Paediatric and Adolescent Rheumatology (BSPAR) has produced Dr Tom Pullar BSR–Consultant guidelines [7]. Consultant Rheumatologist Rheumatologist (2) The management of the underlying disease for which the Ninewells Hospital DMARD is prescribed. Dundee (3) The management of RA with immunotherapies, such as anti-TNF, anti-IL-1 and anti-B-cell therapy [8]. Ms Margaret Somerville BHPR (British Health (4) This guideline does not advise specific monitoring profile for Clinical Research Manager Professionals in patients receiving ‘combination’ therapy. Where the mon- Norfolk & Norwich Rheumatology) itoring schedule is different between the drugs used in University Hospital combination, it is advised to adopt a more stringent Norwich monitoring schedule based on clinical judgement. (5) This guideline does not advise on the management of Dr Allister Taggart BSR–Consultant patients on cyclophosphamide, as this drug is more Consultant Rheumatologist Rheumatologist commonly used in the treatment of vasculitis and will be Musgrave Park Hospital discussed in the guideline for the management of adults with Belfast vasculitis [9]. (6) Immunization: It is beyond the scope of this guideline to Names and affiliations of users on the working group give detailed advice on immunization in patients treated Mrs Ailsa Bosworth with DMARDs, as there is insufficient evidence about the Chief Executive, NRAS degree of immunosuppression induced by the drugs. National Rheumatoid Arthritis Society (NRAS) However, some general principles have been mentioned. Unit B4, Westcott Business Centre The advice on immunization, particularly against encapsu- Westcott Way, Little Wick Green lated organism, such as pneumovax, has been mentioned Maidenhead, SL6 3RT on the website of the Health Protection Agency. As guidelines are evolving, in difficult cases it is advisable to discuss with the Health Protection Agency, or check their Involvement of other people or organizations including user website, for further advice (Prof. Liz Miller, Centre for representative organizations and pharmaceutical companies Infectious Disease and Immunisation, Colindale, London, in the development of the guideline personal communication). This guideline was developed in collaboration with the NRAS. Patient surveys related to DMARD treatments and the patients’ Stakeholder involvements perspectives have been included [10]. No representatives of phar- maceutical companies were involved in guideline development. Names and roles of members of multidisciplinary team Names Representing Rigour of development Prof. Kuntal Chakravarty BSR–Chairman Statement of scope of literature search and strategy Consultant Rheumatologist employed BHR Trust Hospitals Harold Wood Hospital A comprehensive literature search was undertaken prior to the Romford, Essex development of this guideline. Searches were conducted using MEDLINE, CINAHL, Cochrane, PUBMED, EMBASE, AMED Dr Robert Chalmers British