British Society For Rheumatology Research Articles

British Society for Rheumatology and British Health Professionals in Rheumatology Guideline for the Management of Gout

Gout is a common disease both in primary care and hospital practice [1]. Although drug therapy for gout has become a paradigm for the effective management and prevention of an acute and potentially chronic rheumatic disease, many of the recommendations for treatment are based on expert consensus rather than research evidence and audits of practice suggest that treatment is very variable. Evidence-based guidelines are needed at the present time:

Provisional guidelines for applying the Department of Health (England) 18-week-patient pathway to specialist rheumatology care

The Government Department of Health (England) has set a target that by 2008 patients on pathways that do or may involve medical or surgical consultant-led care should wait no longer than 18 weeks from referral to start of definitive treatment. Department of Health guidance must be interpreted and applied to patients with rheumatological problems. Provisional guidelines have been prepared in collaboration between the British Society for Rheumatology, British Pain Society, Department of Health (England) and other key stakeholders. Definitive rheumatological treatment comprises a package of care rather than a single action. The care package usually requires input from a multidisciplinary team using several modalities in parallel. Actions within the care package that must be taken before treatment can be said to have started, are definitive actions. Definitive actions should be based on evidence of cost-effectiveness, tailored to the individual patient and offered irrespective of local availability or accessibility. They should be agreed between partners in the patient's care. This requires face-to-face consultation between the patient and a health care professional with appropriate expertise and knowledge. All definitive actions specified at the outset of management within specialist care must be initiated or removed by agreement from the patient's care package before the clock can be stopped in the 18-week-patient pathway. Service redesign may be necessary in order to achieve an 18-week-patient pathway for all patients. A consistent and appropriate definition of clock-stops should ensure that patients will benefit from excellent rheumatology specialist care without unnecessary delay.

Development of a competency framework for general practitioners with a special interest in musculoskeletal/rheumatology practice

This document outlines a competency framework for general practitioners with a special interest (GPwSI) in musculoskeletal/ rheumatology practice, which has been developed by a working group, consisting of clinicians from general practice, musculoskeletal medicine and rheumatology including representatives from the Primary Care Rheumatology Society, the Royal College of General Practitioners, the British Institute for Musculoskeletal Medicine, the British Society for Rheumatology, The Royal College of Physicians and the Arthritis Research Campaign (GP Working Party of the Education Subcommittee). The objective of this working group was to bring together appropriate expertise to debate the content of a curriculum for GPwSI’s working within the musculoskeletal/rheumatology field, and to produce a framework of appropriate competencies (knowledge and skills) to inform the content of such a curriculum. The Working Party acknowledged that the confusion still exists about the definition of a GPwSI [1]. For this piece of work the following definition was agreed: A GPwSI is defined as a general practitioner who supplements their core professional role, and/or undertakes advanced procedures not normally undertaken by their peers. They will have demonstrated appropriate skills and competencies to deliver an enhanced service, be able to work independently within a defined quality framework, in a clinical area outside the normal general practice setting and be able to accept referrals from colleagues. Robust procedures for clinical governance will be developed locally to assure patients and commissioners that they operate within a coherent and quality assured clinical pathway. In approaching this work, the working group acknowledged that there were different levels of GP competence to be aware of. For example, in 2000 arc produced a Learning Guide for GPs and GP Registrars, which outlined a curriculum and competencies required to achieve a summative assessment level of competence [2]. This will subsequently be referred to as the generalist level of competence. The Royal College of General Practitioners (RCGP) has written a GP curriculum for general practice training (see RCGP website). This will come into effect from August 2007. The current piece of work concerns competencies to be achieved by all musculoskeletal/ rheumatology GPwSIs. The group acknowledged that there may also be a further level of competencies for GPwSI working within specialist areas within a musculoskeletal/rheumatology service (e.g. paediatrics, inflammatory arthritis, sports medicine). The working group did not address this latter area. Hence, the aim of this working group was to develop a specialty-specific set of competencies required by a GPwSI working within the field of musculoskeletal/rheumatology practice. Other agencies are developing the generic competencies common to all GPwSIs and are considering what mechanisms are appropriate for GPwSIs to demonstrate acquisition of appropriate competencies.

BSR/BHPR guideline for disease-modifying anti-rheumatic drug (DMARD) therapy in consultation with the British Association of Dermatologists

Scope and purpose of the guideline 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.

Predictors of response to anti-TNF- therapy among patients with rheumatoid arthritis: results from the British Society for Rheumatology Biologics Register

Anti-tumour necrosis factor-alpha (TNF-alpha) therapies represent an important advancement in therapy for rheumatoid arthritis (RA). However, there remains a proportion of patients who do not improve despite therapy. These drugs are expensive and have the potential of serious toxicity. Therefore, it would be ideal to predict the patients who will respond, so that the use of these drugs can be targetted. To identify the clinical factors present at the start of anti-TNF-alpha therapy that are associated with response at 6 months in patients with RA. The British Society for Rheumatology (BSR) Biologics Register collects detailed data on all patients with a rheumatic disease receiving biologic therapy in the UK. We studied all patients with RA who had started etanercept (ETA) or infliximab (INF) and had achieved a minimum 6 months follow-up by 1 October, 2004. The disease status at the baseline and at 6 months was assessed using the Disease Activity Score (DAS28). The response was classified according to the European League against Rheumatism (EULAR) improvement criteria. The effect of baseline characteristics on response was studied using multivariate ordinal logistic regression. 2879 patients were included in this analysis (1267 ETA, 1612 INF). At the start of therapy, the mean age was 55 yrs, disease duration 14 yrs, baseline DAS28 6.7 and health assessment questionnaire (HAQ) 2.1. In all, 28% of ETA and 86% of INF patients were receiving methotrexate. After 6 months, 18% had a good EULAR response, of whom 9% were considered to be in remission and 50% had a moderate response. There was no overall difference in response rate between the two anti-TNF-alpha therapies. A higher baseline HAQ score correlated with a lower response rate while a better response was associated with the current use of NSAIDs and the use of methotrexate (MTX), although the latter only reached statistical significance with ETA [OR 1.82 (95% CI 1.38-2.40)]. There was a lower response rate among current smokers, particularly in patients receiving INF [OR 0.77 (95% CI 0.60-0.99)]. Age, disease duration, rheumatoid factor and the previous number of disease-modifying antirheumatic drugs (DMARDs) did not predict response to either drug. However, females were less likely to achieve remission. These data support an improved outcome among patients receiving MTX in combination with anti-TNF-alpha therapies. However, the most disabled patients were less likely to respond, despite concurrent MTX. The benefits of NSAIDs may reflect the relative absence of comorbidities in patients who can tolerate these drugs or the continuing presence of reversible inflammatory symptoms. The association of smoking and poor outcome with INF is a novel finding and may reflect alterations in pharmacokinetics. The inability of other baseline disease characteristics to predict the outcome suggests that other factors, including potential genetic differences in drug metabolism, may be influencing the response to anti-TNF-alpha therapies.

British Society for Rheumatology and British Health Professionals in Rheumatology Guideline for the Management of Rheumatoid Arthritis (the first two years)

British Society for Rheumatology and British Health Professionals in Rheumatology Guideline for the Management of Rheumatoid Arthritis (the first two years)

Guideline for the management of the hot swollen joint in adults with a particular focus on septic arthritis

The British Society for Rheumatology (BSR) Standards, Guidelines and Audit Working Group, in conjunction with the British Society for Antimicrobial Chemotherapy, British Orthopaedic Association, Royal College of General Practitioners and British Health Professionals in Rheumatology, has produced an evidence-based guideline for the management of the hot swollen joint with particular focus on the septic joint. The aim of the guideline is to help accurate diagnosis and appropriate treatment when a joint is hot because of sepsis, while also ensuring that other causes such as crystal arthritis are recognized and not over-treated.

The benefits and costs of biologic registers

The era of biological therapy has arrived, and we would do well to learn the lessons of the ‘steroid era’, in which too many years passed before the side effects of these new ‘wonder drugs’ were fully appreciated. Will biological agents be as good as we hope, will they have complications we have not anticipated, and will they be affordable? Pharmacovigilance is the name of the game. Furthermore, it is clear from the Vioxx ® (Merck & Co., Inc., New Jersey, NY) experience that the normal 6–12 months of pharmacovigilance carried out by pharmaceutical companies could be too short a time to make any balanced judgements. In order to circumvent these problems, several countries—Sweden, Germany and the United Kingdom, for example—have established biological registers to determine the long-term outcome of treating patients with tumor-necrosis-factor (TNF) blockers, principally in patients with rheumatoid arthritis. The largest register established to date is the British Society for Rheumatology (BSR)’s Biologics

British Society for Rheumatology and British Health Professionals in Rheumatology Guideline for the Management of Rheumatoid Arthritis (The first 2 years)

British Society for Rheumatology and British Health Professionals in Rheumatology Guideline for the Management of Rheumatoid Arthritis (The first 2 years)

Experience of six years of a regional peer review scheme in rheumatology

Following discussions on peer review by the British Society for Rheumatology, the West Midlands Rheumatology Service and Training Committee established a peer review scheme for the West Midlands in 1998. We report our initial 6 yr of experience, during which all 14 units have been visited. A rotating programme of visits was organized. Following this first cycle of peer review, questionnaires were sent to all consultants and senior allied health professionals in each visited unit and to all members of each visiting team to evaluate the process. There was clear consensus amongst staff from both visited units and visiting teams that a peer review visit is worthwhile and constructive. It is a good opportunity for education and exchange of ideas between staff and to promote the multidisciplinary team in rheumatology. Most recommendations from the reports were considered necessary. The most frequent recommendations were for an increase in consultants and therapy staff. Appointing further consultants has been successful. Opinion was only divided on whether the reports were viewed seriously by Trusts, whether peer review should be regional or national, and how to accurately assess the quality, as well as the quantity, of care provided. Staff would support further cycles of peer review visits. This has been a successful initiative and a positive learning experience for all staff involved. Specifically, it helped to obtain more staff and secure facilities. We recommend developing this scheme and promoting it to other regions.

The world of biologics

In March 2002 the National Institute for Health and Clinical Excellence (NICE) published guidelines for the use of anti-TNF therapy for patients with rheumatoid arthritis (RA). The guidelines recommended that all RA patients treated with these drugs should be enrolled on a national register which had been established by the British Society for Rheumatology (the BSRBR). A comparison cohort of RA patients treated with traditional disease modifying drugs (DMARDs) is also being recruited. The main role of the BSRBR is to study the long-term safety of biologic drugs. Up to the end of March 2005, 9508 patients with RA had been enrolled on the BSRBR. Four thousand, three-hundred and six had been treated with etanercept, 3561 with infliximab, 1500 with adalimumab and 141 with anakinra. With regards to anti-TNF drugs, 79% remained on their original drug at six months, 65% of whom could be classified as responders. Co-prescription with methotrexate was associated with a 70% response rate. Patients with a high baseline level of disability were less likely to respond. Overall the rates of serious infection were not increased in the anti-TNF versus the comparison cohort. However the rates of skin and soft tissue infection and of intracellular infections (eg, salmonella, listeria, legionella) were increased. There were 11 cases of tuberculosis (seven extra-pulmonary). There was concern about the high mortality rates among patients with baseline pulmonary fibrosis treated with anti-TNF therapy. It is unclear whether this is related to the drug or to the underlying disease. The rates of malignancy and mortality were not increased compared to the DMARD treated group in the short term. Further follow-up is needed to determine the long term safety of these drugs.

The British Society for Rheumatology Biologics Register

The British Society for Rheumatology (BSR) established a nationwide register for patients with rheumatological disorders treated with biologic agents. The register is designed as a national prospective study whose primary...

The updated BSR guidelines for anti‐TNF in adults with RA: What has changed and why?

In 2001 the British Society for Rheumatology (BSR) published guidelines for prescribing TNF-alphablockers in adults with rheumatoid arthritis (RA). In an unusual move, the National Institute of Clinical Excellence (NICE) accepted the BSR guidelines and published them unchanged and included them in their own Technology Appraisal (National Institute of Clinical Excellence, 2002). The field of anti-TNF in RA is rapidly changing, and the BSR Standards, Guidelines and Audit Working Group decided in 2004 to update the guidelines. These were published in February 2005 (Ledingham and Deighton, 2005). This article summarizes the key changes, and attempts to justify them, using further data that has emerged since the updated guidelines were produced, and audit data from the Derby Rheumatology department.

Is it time for more rheumatologists to embrace osteoarthritis?

There has been a degree of apathy or even antipathy towards osteoarthritis (OA) by UK rheumatologists, the origin of which is hard to elucidate. Clinical research in OA has historically not been regarded as the highest priority by UK funding bodies [1]. The paucity of evidence-based therapy, particularly diseasemodifying OA drugs (DMOADs), may have led to OA patients being a source of frustration for clinicians whose clinics are already bulging in addressing the challenges of inflammatory arthritis. The previous attempts of enthusiasts to nurture interest in OA have fallen by the wayside; for example, a previous incarnation of an OA Special Interest Group at the British Society for Rheumatology (BSR) Annual General Meeting was characterized by a small number of devotees and tumbleweed whistling through an otherwise deserted room. What, if anything, has changed? There are a number of answers to this question. Firstly, the Arthritis Research Campaign (arc) is taking a more progressive approach to clinical research, including OA: as much is now being directed towards projects for weight loss, exercise or rehabilitation, and vitamin D therapy for knee pain and hand OA as previously supported molecular studies [2]. Similarly, there are major initiatives in the USA, including the National Institutes for Health-funded Glucosamine/chondroitin Arthritis Intervention Trial (GAIT) [3] and the $8.9 million Osteoarthritis Initiative, a 7-yr project to recruit 5000 people at risk of OA of the knee, examining predictors including biomarkers [4]. The controversy surrounding the two industry-sponsored trials suggesting glucosamine sulphate may be a DMOAD [5, 6] has certainly raised awareness among rheumatologists of the problem. The EULAR recommendations for the management of knee [7] and hip [8] OA and the MOVE consensus for the role of exercise in the management of OA of the hip or knee [9] have made the task of managing OA less daunting. Patients are also better informed, using resources like Arthritis Care’s OA Nation report [10] to understand the impact of their problems and the interventions available through conventional and complementary medicine. It is against this background that a group of OA enthusiasts met under the auspices of the BSR in Edinburgh 2004, including some who remembered the previous OA Special Interest Group, but came anyway. The event was notable not just for the eminence of the speakers and quality of the debate: rather it was the popularity of the session that overwhelmed. An equal number of putative attendees were turned away as were able to fit into a room of admittedly modest dimensions. The proceedings are reported elsewhere, but the initiative has been distilled by due democratic process into a discrete set of objectives for the OA Special Interest Group, to:

Update on the British Society for Rheumatology guidelines for prescribing TNF blockers in adults with rheumatoid arthritis (update of previous guidelines of April 2001)

These guidelines have been developed for use by prescribing secondary-care rheumatologists. They are intended to indicate which adult patients with rheumatoid arthritis (RA) may benefit from the anti-tumour necrosis factor (anti-TNF) therapies, precautions that need to be taken in their use and to highlight potential side-effects from these therapies. The previous guidelines applied to the then available anti-TNF therapies (etanercept and infliximab) [1]. These current guidelines would apply to these two products together with adalimumab, which is a newly licensed anti-TNF therapy for RA. This is a rapidly changing field with new data emerging each month, so that it is vital that clinicians keep up to date with this area of practice. These guidelines can only incorporate information that was available to the authors at the time of their completion. The guidelines have been drawn up by the above working party and have been approved by the British Society for Rheumatology (BSR) Standards, Guidelines and Audit Working Group (SGAWG). National Institute of Clinical Excellence (NICE) guidelines, Medline literature searches for published data on the anti-TNF drugs and data from the pharmaceutical companies producing anti-TNF agents have been used to draw together the updated guidelines. The guidelines were subject to a consultation process at the BSR Annual Meeting 2004 and feedback was received from BSR members, allied health professionals, patient representatives and members of the pharmaceutical industry. The BSR SGAWG will be responsible for initiating a further update of these guidelines in the future and for auditing their use. The anti-TNF therapies are not necessarily the only treatment option available to patients who are eligible for treatment according to these guidelines—the potential risks versus the benefits need to be considered for each individual case. There will be circumstances in which rheumatologists will feel that there are other drugs that may be equally likely to produce a good clinical response. In the UK all patients commenced on the following anti-TNF therapies need to be registered on the BSR biologics register (BSRBR): etanercept, infliximab, adalimumbab and anakinra. It is currently intended that data be collected on 4000 patients per antiTNF therapy. Thereafter the BSR would recommend continued data collection, in the same format as for the BSRBR, at a local level. These guidelines will be updated as other anti-TNF treatments are included in the register. For further clarification before registration, please contact Dr Kath Watson, BSRBR Study Co-ordinator, arc Epidemiology Unit, Stopford Building, The University of Manchester, Oxford Road, Manchester M13 9PT, UK (Tel: 0161 275 1613, E-mail: biologics.register@ man.ac.uk). Adverse incidents/serious side-effects arising whilst on antiTNF therapy should be notified immediately via the yellow card system, but also to the BSRBR via the 6-monthly review sheets. Rheumatologists have responsibility for supplying updated information to the BSRBR as required and as requested. Written consent will be sought from patients for their participation in this study via the BSRBR.

British Society for Rheumatology Biologics Register

The British Society for Rheumatology (BSR) established a register of patients newly treated with biological agents, the BSR Biologics Register (BSRBR), which became active in January 2002. The goal is...

The prevalence of patients with rheumatoid arthritis in the West Midlands fulfilling the BSR criteria for anti-tumour necrosis factor therapy: an out-patient study.

There are currently two anti-tumour necrosis factor (anti-TNF) therapies licensed for treatment of rheumatoid arthritis (RA). A British Society for Rheumatology (BSR) working party defined criteria for patients that would be suitable for such treatment. The aim of this study was to determine the prevalence of these patients attending rheumatology out-patient departments across the West Midlands. Data were collected over a 2-week period in adult out-patient departments of 12 centres. A questionnaire was completed at each patient review. Disease activity scores (DAS-28) were recorded for those who had failed methotrexate treatment and at least one other disease-modifying anti-rheumatic drug (DMARD) in the absence of contraindications to anti-TNF therapy. Information was also collected on the number of DMARDs failed and the use of steroid therapy. A total of 1441 patients with RA were assessed; 177 (12.3%) patients had failed methotrexate and at least one other DMARD. Of these, 19 had contraindications to the use of anti-TNF therapy. In the remaining 158 patients (11%), 80 (5.6%) had a DAS-28 score of >5.1, thus fulfilling BSR criteria for use of anti-TNF therapy. Those with a DAS-28 score of < or = 5.1 were significantly more likely to have been taking steroids compared with those with a DAS-28 score >5.1 (68.2 and 49.3%, respectively, P=0.024). Of patients with RA attending adult rheumatology out-patient clinics in the West Midlands, 5.6% would meet BSR criteria for use of anti-TNF therapy. Eligibility may be affected by steroid use.

Prevention of vascular damage in scleroderma with angiotensin-converting enzyme (ACE) inhibition.

Great strides have been made in identifying and managing the organ-based complications of systemic sclerosis (SSc). There is no room for the nihilism towards treating this disease that used to be so prevalent. However, there is still relatively little hard evidence on which to base treatment decisions. Previous trials have been constrained by the low disease prevalence and the difficulty in recruiting sufficient patients especially with disease of recent onset. The results of past trials have often been confounded by the failure to recognize the marked heterogeneity of SSc and the inclusion of patient subsets with widely varying disease expression, course and outcome. It is recognized that progress will only be made in this area with coordinated multicentre studies. As a result, national and international networks of clinicians with expertise in the management of SSc have been formed. In the UK, the Systemic Sclerosis Study Group has established a national scleroderma register and, together with the Scleroderma Special Interest Group of the British Society for Rheumatology (BSR), a multicentre base for therapeutic studies. As a result of developments in our understanding of the pathogenesis of scleroderma and our ability to subset patients more effectively, a number of rather more rational approaches to treating the disease and its complications are being tested. In parallel with this, considerable progress is being made in developing universally agreed measures of disease activity and severity and in identifying surrogate laboratory markers of disease activity that are relevant to therapeutic studies. These multicentre trials need substantial funding and often do not attract support from the pharmaceutical industry. It was because of the difficulty in financing long-term, multicentre studies in uncommon conditions that the ARC/BSR Clinical Trials Programme was established. The QUINS trial, which is funded by this Programme, is described here as an example of one of several therapeutic protocols being developed by the UK Systemic Sclerosis Study Group that are currently being tested in multicentre trials. Contact details are provided in the appendix for clinicians who are interested in registering patients on the UK Scleroderma Register or participating in this or in the other therapeutic studies.

Aceclofenac may offer advantages in arthritis management

Although non-steroidal anti-inflammatory drugs (NSAIDs) effectively relieve the pain and inflammation of osteoarthritis (OA), there remain suspicions that some, at least, may hinder the organised regrowth of cartilage. Recent in vivo research reviewed at the 15th Annual Meeting of the British Society for Rheumatology [ Brighton, UK; April 1998 ] during a symposium entitled ‘Current concepts in arthritis: reviewing the evidence’, suggests that not all NSAIDs are equivalent in this respect. * Aceclofenac has recently been shown to increase cartilage synthesis in chondrocytes cultured from patients with OA and rheumatoid arthritis (RA), but not in those from controls. Some NSAIDs exert an inhibitory effect on cartilage synthesis which can be associated with clinical deterioration, while others are neutral with respect to cartilage formation. The balance between efficacy and tolerability has always been problematic for NSAIDs, particularly as many patients who take these drugs for OA are elderly. The results of a meta-analysis focusing on patient compliance, which were also shown to delegates at the congress, revealed a clear and significant advantage for aceclofenac in terms of compliance and tolerability in patients with OA and RA.

Latest drug research in rheumatology

Rheumatologists are focusing on both new and established drugs in attempts to improve the treatment of rheumatoid arthritis (RA). In particular, the selectivity of meloxicam for cyclo-oxygenase type 2 (COX-2), and a possible novel mechanism of action for sulfasalazine in reducing levels of cell adhesion molecules (CAMs), are attracting interest. Additionally, pulsed cyclophosphamide therapy is effective in systemic vasculitis, and intramuscular methylprednisolone may be an effective way of reducing corticosteroid dosages in polymyalgia rheumatica. These findings were presented at the 12th Annual General Meeting of the British Society for Rheumatology [Glasgow, UK; April, 1995].