Keh514 390.397

Advance Access publication 3 February 2005 Guideline for anti-TNF-a therapy inpsoriatic arthritis S. Kyle, D. Chandler1, C. E. M. Griffiths2, P. Helliwell3,J. Lewis, I. McInnes4, S. Oliver5, D. Symmons6 and N. McHugh,on behalf of the British Society for RheumatologyStandards Guidelines Audit Working Group (SGAWG) Although PsA was once thought to be a benign condition, it isnow well recognized as a potentially destructive erosive arthrop- Psoriatic arthritis (PsA) is a chronic inflammatory arthropathy athy [3, 4, 14]. Traditional standard therapy is aimed at symptom- with a prevalence between 0.1 and 1% and an equal sex distri- atic relief with the introduction of second-line agents for more bution [1]. Psoriasis affects 1–3% of the population, with severe cases. However, most longitudinal studies of PsA have approximately a third of patients developing PsA [2]. The course shown steady progression of the condition despite use of such of PsA is variable and unpredictable ranging from a mild non- medication. Disease-modifying anti-rheumatic drugs (DMARDs) destructive disease to a severe debilitating erosive arthropathy.
used to treat RA are also used in PsA, but there is a serious deficit of Erosive and deforming arthritis occurs in 40–60% of PsA patients therapeutic trials in PsA. A Cochrane systematic review concluded (followed at hospital clinics), and is progressive from within the that only two agents had documented efficacy in PsA: sulphasa- lazine and high-dose parenteral methotrexate [15] (the latter at a The classification of PsA is an area of ongoing international dose considered too toxic by today’s standards).
discussion. The five subgroups proposed by Moll and Wright [5] Recently there has been interest in the pivotal role that TNF-, are still frequently used, although considerable overlap between a proinflammatory cytokine, plays in inflammation of skin these groups is now recognized. For the purpose of these guidelines and synovium [16] and it is a logical target for treatment in RA.
we have differentiated between peripheral joint disease in PsA and Preliminary studies and trials have shown that TNF- blockade axial disease alone. Psoriatic spondylitis is similar to ankylosing is effective in the treatment of PsA [17, 18]. In 2003 etanercept spondylitis (AS), although it is often less symptomatic, less limiting was licensed for treatment of PsA and it is expected that other and radiologically tends to be asymmetrical and less severe [6].
TNF- blockers, such as infliximab, will be licensed for the However, despite these differences, until such time as there is evidence that psoriatic spondylitis responds in a different mannerfrom AS to TNF- blockade, we recommend that AS guidelines Cost implications. TNF- blockers have the potential to for anti-TNF- treatment are used for the management of psoriatic provide symptomatic relief and help prevent disease progression in PsA. Although these drugs are relatively expensive, concerns Much like rheumatoid arthritis (RA), PsA can lead to over an increased drug budget must be balanced against the chronic joint damage, increased disability [8, 9] and increased potential long-term cost savings. At the present time there are no mortality [10, 11]. Social and financial implications are also health economic studies concerning the role of TNF- blockade important, both in terms of personal loss and the impact of in PsA. However, possible long- term benefits include: direct (e.g. medical care) and indirect (e.g. inability to work)costs to the state.
 reduced need for joint replacement surgery It is recognized that psoriasis is associated with an increased risk of non-melanoma skin cancers [12], most probably a result of  reduced demands on medical and nursing services excessive exposure to sunlight and enhanced by use of psoralen and ultraviolet A (PUVA) therapy [13]. The guidelines recognize  reduced demands on social services and carers that these risks that may be potentiated by anti-TNF- treatment and specific recommendations have been made accordingly (see sections headed Exclusion criteria and Monitoring and Toxicity).
Royal National Hospital for Rheumatic Diseases, Bath, 1Board of Trustees and Management Committee, Psoriatic Arthropathy Alliance, 2University ofManchester and Salford Royal Hospitals NHS Trust, Manchester, 3University of Leeds, Leeds, 4Centre for Rheumatic Diseases, Glasgow Royal Infirmary,Glasgow, 5RCN Rheumatology Steering Committee, and 6East Cheshire NHS Trust and ARC Epidemiology Unit, University of Manchester, Manchester,UK.
Published on the British Society for Rheumatology website in July 2004.
Submitted 20 August 2004; revised version accepted 9 November 2004.
Correspondence to: Dr. Neil McHugh, Royal National Hospital for Rheumatic Diseases, Upper Borough Wells, Bath, BA1 IRL. E-mail: Rheumatology Vol. 44 No. 3 ß British Society for Rheumatology 2005; all rights reserved Guideline for anti-TNF- therapy in psoriatic arthritis In order to achieve maximum benefit to patients with PsA  Grade B: Controlled trial or quasi-experimental study or within a limited health resource, there is a need for evidence- based guidelines in the prescribing of TNF- blockers for this The Working Party acknowledges that there is a lack of high- Objectives. These guidelines offer systematic and reviewed quality evidence on which to base the recommendations.
recommendations for the prescribing of licensed anti-TNF- These guidelines cover a rapidly evolving area of therapeutic therapies in adult PsA patients with peripheral joint involvement.
The guidelines provide a stepwise management plan giving clearinclusion/exclusion and response criteria. The guidelines also set becomes available and more anti-TNF- therapies are licensed,the guidelines will have to be updated. The Working Target audience. The guidelines have been developed to give Party recommends that the evidence is reviewed annually and assistance to rheumatologists and involved prescribing clinicians.
updates are posted on the BSR website: www.rheumatology.
They will also assist nurses in the application, assessment and The guidelines have been drawn from the evidence base available, and in areas of insufficient evidence consensus opinion Guidelines for anti-TNF-a therapy in adults with has been sought and is clearly documented.
The remit of these guidelines does not include:  anti-TNF- therapy for PsA axial-only disease [refer to British Treatment algorithm for psoriatic arthritis (Fig. 1) Society for Rheumatology (BSR) guideline for prescribing Standard therapy. Management of PsA is aimed at suppres- TNF- blockers in adults with ankylosing spondylitis] [7] sing joint, tendon and entheseal inflammation. NSAIDs and  newer anti-TNF- therapies (e.g. adalimumab), although the corticosteroid injections remain an important initial intervention Working Party acknowledges that the guidelines will have to be but current practice is aimed at early diagnosis and early use reviewed and amended regularly as evidence becomes available.
of potential DMARDs to suppress persistent inflammation.
Sulphasalazine or methotrexate is widely used in clinical practice  anti-TNF- therapies for juvenile idiopathic arthritis (JIA) as DMARD therapy. Efficacy has been proven for sulphasalazine, (please refer to British Paediatric Rheumatology Group and methotrexate is being further evaluated in a current multi- (BPRG) protocol for prescribing biologic therapies in children centre UK randomized controlled trial. Patients with a poor clinical response are changed to an alternative DMARD or are  the use of anti-TNF- therapies for psoriasis (current NICE  The Working Party acknowledges the lack of evidence but proposes the use of sulphasalazine (A) [15]; methotrexate (B) [15]; ciclosporin (B) [19] or leflunomide (A) [20, 21] as DMARDtherapies in PsA either individually or in combination.
The guidelines have been developed by a multidisciplinaryWorking Party set up by the BSR. Any conflicts of interest Failure to respond to therapy. In order to fail standard among the Working Party were fully declared.
therapy patients should have active disease and have had adequate The guidelines were presented for comment at the 20th BSR therapeutic trials of at least two of the above standard DMARDs Annual Meeting (20–23 April 2004) prior to submission for individually or in combination. An adequate therapeutic trial is  Treatment for at least 6 months, of which at least 2 months is at standard target dose (unless significant intolerance or toxicity  Treatment for <6 months, where treatment is withdrawn The evidence in these guidelines was compiled from a comprehen- sive literature search, including electronic bibliographic databases  When treatment is withdrawn because of intolerance or toxicity (Medline, Embase) and systematic review databases (Cochrane) after >2 months therapy, at least 2 months should have been at back to 1990. Key words were the following: psoriasis; arthritis; anti-TNF-; biologics; etanercept; infliximab; trials.
 Standard target and therapeutic doses of DMARDs are given No related guidelines were found in other guideline databases in Appendix 1 that may be viewed at Rheumatology online.
 These guidelines do not provide a specific treatment response DMARDs in PsA patients. The Working Party agreed that this should be a combined patient and physician decision The literature was reviewed and quality of evidence was graded by the Working Party according to the Royal College of Physicians’  Patients who fail to respond to standard therapy and ‘Concise Guidance to Good Practice’. Grading of recommendation meet the required criteria but satisfy none of the exclusion criteria should be considered for licensed anti-TNF-therapy.
 Grade A: Meta-analysis of randomized controlled trials or  The Working Party emphasizes that patient choice is very important and that anti-TNF- therapy is not mandatory.
AXIAL PsA
PERIPHERAL PsA
A/B/C=Grade of Recommendation
Adequate therapeutic trial of 2 standard DMARDs individually or in
combination
From: Sulphasalazine [A]/Methotrexate [B] Systemic Corticosteroid use could be considered with appropriate precautions.
Possibility of considerable overlap between joint and skin pathologies therefore WP recommend combined care
where appropriate and possible
ACTIVE JOINT DISEASE
ACTIVE SKIN DISEASE
(NICE guidelines for anti-TNFα
3 tender joints & ≥3 swollen joints
use are currently being
On 2 separate occasions 1 month apart. commissioned)
Dactylitis to count as 1 Joint [C]
Resistant large joint mono/oligoarthritis to be reviewed on individual basis. Etanercept (A)
NB: Measure baseline patient & physician global assessments (Likert scale 0-5), tender & swollen joint scores & PASI at
initiation of therapy.
Primary Joint Response PSARC at
Defined as: Improvement in 2 factors (with at least one being a joint score) with worsening in none of the Patient and Physician global assessments (improvement defined as decrease by ≥ 1 unit; worsening defined as If still fail consider other Biologics.
Tender and swollen joint scores (improvement defined as decrease by ≥ 30%, worsening defined as increase ≥ 30%) Primary Skin Response PASI 75
NB: If indicated reason for therapy fails but other tissue
responds adequately (PsARC or PASI 75) the decision to
continue anti TNF therapy lies with the appropriate specialist.
FIG. 1. Treatment algorithm for PsA patients.
Figure 2 shows an algorithm highlighting patient choices and NICE is currently undertaking a technology appraisal of Exclusion criteria. Exclusion criteria have been adapted from Licensed anti-TNF- therapy. At present only one com- those used for anti-TNF- treatment in RA and are shown in pound is licensed for use in active PsA in the UK. Etanercept Appendix 2 (may be viewed at Rheumatology Online).
(Enbrel; Wyeth) is a recombinant human TNF receptor:Fc The Working Party recommends specific caution in: fusion protein consisting of a dimer of the extracellular portionof two p75 receptors fused to the Fc portion of human IgG1.
 Patients with active psoriasis who have received >1000 joules Etanercept is administered subcutaneously at a dose of 25 mg cumulative dosage of PUVA; particularly those patients who have subsequently been treated with ciclosporin for at least 1 yr.
Infliximab (Remicade; Schering-Plough) is a chimeric human– Such patients are at high risk (six-fold increase) of non- murine monoclonal antibody usually administered by slow melanoma skin cancer [12, 13]. It is recommended that annual intravenous infusion at weeks 0, 2 and 6 and 8-weekly thereafter skin checks be performed by a consultant dermatologist for at a dose of 5 mg/kg in combination with methotrexate. Despite a psoriasis patients receiving anti-TNF therapy (C).
supporting body of evidence [22–26], infliximab is not currently  HIV-positive/AIDS patients. There is an increased incidence of PsA in HIV and AIDS patients [27]. Until data become Guideline for anti-TNF- therapy in psoriatic arthritis Starting Point
Your disease is poorly controlled on current You are being given the opportunity to discuss the new anti-TNFα therapy because you have failed to get sufficient benefit from your current You will need to be seen by a practitioner who will explain the new therapy including the possible risks and benefits of this treatment If you wish to consider this treatment you will need to be assessed to ensure that it is safe for you to have the treatment and that your disease is active will be reviewed andmay be eligible or have FIG. 2. Algorithm of patient’s considerations and choices.
available on the effect of TNF- blockers under these condi- Table 1 shows the eligibility criteria for entry into clinical trials and the median or mean scores for baseline tender and swollenjoints.
All clinical trials show a far higher mean or median tender prescribing TNF- blockers in adults with RA [28], caution is and swollen joint count than the required inclusion criteria.
However, setting a high threshold for involved joint count as aninclusion criterion for anti-TNF- treatment would exclude a large  Congestive cardiac failure (CCF)/cardiovascular disease [29].
number of patients with PsA from effective treatment, including Etanercept should only be used with extreme caution in patients those patients with resistant oligoarthritis. At present there is no with New York Heart Association (NYHA) grade 3/4CCF [30].
evidence to differentiate between treatment options for mono/ As other anti-TNF- therapies become licensed, please refer to oligo-arthritis or polyarthritis in PsA patients.
 The Working Party elected to use three or more tender joints and three or more swollen joints on two separate occasions atleast 1 month apart as a marker of active joint disease, based on a 78-tender and 76-swollen joint count (A) [17, 18] (Appendix 3;may be viewed at Rheumatology Online).
Active disease. The most widely used method for assessing  The Working Party accepts there will be patients with severe peripheral joint disease activity in PsA is the American College symptoms and disability who do not fulfil the guideline criteria.
of Rheumatology (ACR) joint count, which in some studies has These patients will have to be put forward for anti-TNF- been modified for PsA [17, 18]. There has been some validation of treatment on a named basis until further evidence becomes the ACR joint count when applied to patients with PsA [31]. The DAS 28 is an instrument used for assessing the severity of RA butmay not be appropriate for PsA as it does not include some of the Two specific clinical features of PsA, dactylitis and enthesitis, joints that are frequently involved (e.g. distal interphalangeal proved an area of debate. How could these entities be included in a joints). Published evidence has used tender and swollen joint PsA activity score? At present there is no validated measure for counts as a marker of disease activity.
clinical assessment of dactylitis. Although scoring indices exist for TABLE 1. Eligibility criteria for entry into PsA trials and the median or mean baseline tender and swollen joint scores TABLE 2. Clinical responses in anti-TNF- trials enthesitis [32, 33] none have been proven for PsA. The Working Party came to the following consensus opinions:  swollen joint score (improvement defined as decrease of at least 30%; worsening defined as an increase of at least 30%).
 Dactylitis, where present, should be counted as one active Although a large placebo response is often seen in trials of  Enthesitis should be treated as a separate entity (not covered by therapies for PsA, trials of anti-TNF- treatment have shown a these guidelines). Until such time as further trial data become statistically significant difference in the numbers achieving the available, anti-TNF- therapy in PsA entheseal disease will be PsARC and ACR 20 compared with placebo (Table 2).
 The Working Party elected to use the PsARC as the pri-  Until such time as more validated instruments are available for assessing PsA, the Working Party proposes that a maximum mary joint response to anti-TNF- therapy until a validated amount of peripheral joints are assessed in order that a data set responder index becomes available (A) [17, 18, 35].
is derived to facilitate further studies.
 Although the PsARC will be the primary joint response, the Working Party advocate some extra data collection. An ESRor CRP, a patient pain assessment (visual analogue score Joint response. Two main instruments have been used for Assessment Questionnaire, HAQ) will enable an ACR20 and measuring clinical response in PsA, the PsARC and the ACR20 a DAS28 to be calculated. These data can then be used for The PsARC is a response criterion adapted from the Veterans Skin response. From the patient’s perspective, PsA and psoriasis Affairs Cooperative Study of sulphasalazine [34].
are seen as different manifestations of the same condition.
Response is defined as improvement in two factors (with at least Therefore, the impact of any treatment for PsA should include one being a joint score) with worsening of none of the following a skin assessment. The psoriasis area and severity index (PASI) is a scoring system to evaluate baseline and response to therapy  patient global assessment (on a 0–5 Likert scale) in psoriasis (Appendix 4; may be viewed at Rheumatology  physician global assessment (as above) (improvement defined as Online). In the clinical trials of biologic therapies in PsA it decrease by at least 1 unit; worsening defined as increase by at has been proved to be a reliable measure of improvement in Guideline for anti-TNF- therapy in psoriatic arthritis  The Working Party recommend using PASI at baseline and a TABLE 3. Required data collection at baseline, 3 months, 6 months and PASI 75 for primary response of psoriasis (A) [17, 36, 37].
 Due to the complexity of the PASI scoring system, adequate teaching must be given to those performing the scores, with active collaboration of a dermatologist.
 Where possible the PASI scores should be performed by the same health professional to prevent inter-observer bias.
Patient global health (0–5)Physician global health (0–5)  Due to the significant overlap of benefit to both skin and joints, the Working Party recommend combined care (rheumatologist and dermatologist) of patients with PsA who have concomitant psoriasis whenever appropriate and possible (C).
 The Working Party proposes that a nail score should be ESR or CRP (can be used to calculate ACR20 and DAS28) obtained where possible. Suggested nail scores include the Nail Psoriasis Severity Index (NAPSI) [38] or the Bath Nail Score [39]. The Working Party acknowledges this will complicate and Patient disability (in accordance with BSR Biologics Register) lengthen assessments but long-term benefits for data collection Quality of life. The Working Party felt further information Patient pain assessment (optional for calculating ACR20) on quality of life should be obtained using the SF-36 GeneralHealth Survey. These data can be adjusted to Quality-Adjusted Life Years, a useful outcome for the required health economic Radiological outcome. Despite evidence that radiographic pro- gression was inhibited by etanercept at 12 months in patients with PsA (A) [18], the Working Party believes that the measures forassessing radiographic progression in PsA need further validation and are beyond the scope of these guidelines and should be Accumulative PUVA dose (joules)*Previous ciclosporin/psoralen use Withdrawal of therapy. As for the anti-TNF- for RA guidelines treatment will be withdrawn in the event of adverse *Data collection required at baseline only unless clinical symptoms  malignancy severe drug related toxicity pregnancy (temporary withdrawal)  Patients with skin involvement should be assessed by a practi-  severe intercurrent infection (temporary withdrawal) tioner competent in the assessment of skin disorders. Psoriasis  temporary withdrawal for surgical procedures in accordance severity should be recorded using the PASI system.
with updated BSR guidelines for TNF- blockers in adultswith RA.
Monitoring and toxicity. Table 3 shows a full list of required  inefficacy: patients who fail to achieve the PsARC response data collection at baseline, 3 months, 3 months and thereafter at 3-monthly intervals. After the first 6 months monitoring data canbe collected simultaneously with that required for a register.
Assessment. Assessment of PsA patients for anti-TNF- Table 4 shows the currently required data collection for the BSR treatment will be based on those used for RA and should include a full musculoskeletal history and examination, a clinicalassessment of cardiopulmonary status and further investigations if required, as well as the following salient points (specific  A full review of treatment benefit should be undertaken initially recommendations for PsA patients are in italics).
at 3 months then at 3 months and thereafter at 3-monthly  Fulfils BSR eligibility criteria for PsA (Moll and Wright: inflammatory arthritis documented by a physician in the presence of psoriasis and, usually, negative rheumatoid factor). For  skin assessment (PASI) and response (PASI75).
patients who have been selected for treatment and do not fulfil the BSR criteria, documentary evidence should be provided toidentify clinical indications for treatment.
 Although no specific monitoring is required, the Working Party recommend that patients prescribed a TNF- blocker  Alcohol intake units/week; if co-prescribed methotrexate reduces without a DMARD should have blood monitoring. The alcohol consumption according to BSR monitoring guidelines monitoring includes full blood count, urea and electrolytes and liver function tests at baseline, 3 months and 6 months  Tuberculosis screening (refer to BSR recommendations for and thereafter at 6-monthly intervals in accordance with good assessing risk and for managing M. tuberculosis infection and disease in adult patients due to start anti-TNF- treatment).
 If a DMARD is co-prescribed with anti-TNF-, monitoring  Symptoms that might indicate demyelinating disease.
should adhere to BSR guidelines for the relevant DMARD.
 History of malignancies should be reviewed prior to consid-  If the patient develops lupus-like symptoms, repeat blood eration of treatment. Previous cumulative PUVA treatment tests for ANA and DNA binding before considering further should not exceed 1000 joules. Previous/current psoralen or treatment. Treatment should be stopped if the patient develops any ‘lupus like’ symptoms.
TABLE 4. Data collection required for register health professionals may find useful include:  RCN guidelines on assessing, managing and monitoring biologic therapies for inflammatory arthritis  vaccinations in the immunocompromised person—guidelines for the patient taking immunosuppressants, steroids and the Details of PsA duration and severityGeneral medical history/co-morbidity The Working Party was set up independently of any input or funding from the manufacturers of the new biologic therapies.
Members of the Working Party were asked to clarify their relationships with the manufacturers of biologic therapies for PsA.
Members were asked to declare if they, as individuals, had been sponsored to attend scientific or other meetings in the past 24months or if they had a direct financial stake in the manufacturing The Working Party propose the following amendments for PsA patients companies. They were also asked if their units had received funding from the manufacturers to take part in clinical trials of the biologic Previous PUVA dose in joules be documented therapies for psoriatic arthritis. Organizations were asked todeclare if they had received sponsorship from manufacturers of the biologic therapies for activities related to the new therapies (either educational or promotional) or for activities not related to The following replies were received.
The units in which the following Working Party members work have received funding from one or more of the manufacturers of therapies for psoriatic arthritis: N. McHugh, S. Kyle, S. Oliver,D. Symmons, J. Lewis, C. Griffiths.
Six-monthly returns would continue for 3 yr after treatment starts,  The following Working Party members have received funding regardless of whether or not it is continued. Thereafter returns will be from pharmaceutical companies involved in producing biologic therapies to attend scientific meetings in the past 24 months:C. Griffiths, I. McInnes, D. Symmons, S. Oliver, P. Helliwell.
 BSR has established a register which is funded by the manufacturers of biologic therapies for RA; training for  Maintain a high index of suspicion of infection and screen rheumatologists in data collection has also been funded bythese manufacturers.
Central Biologics Register. There is evidence that the background risk of patients with PsA with respect to mortality [10, 11], honoraria: I. McInnes, C. Griffiths.
malignancy [12, 13] and cardiovascular disease is not the same  No Working Party members declared a direct financial stake, as that of patients with RA. The spectrum of adverse events on such as personal shareholding, in companies manufacturing the biologic therapy may also differ between the two diseases.
A biologics register for patients being prescribed anti-TNF  The other authors have declared no conflicts of interest.
therapies for PsA does not currently exist. However, the workinggroup recommends that such a register is set up for these patients,and the BSR is currently pursuing this. In the meantime, the BSR currently recommends that data collection, including updateddosage, outcome and toxicity information, is conducted at a local Supplementary data are available at Rheumatology level. Adverse incidents/serious side-effects arising whilst on anti- TNF therapy should be notified immediately via the yellow cardsystem.
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Source: http://reumadoktor.dk/pdf/guidelines/BSRPsa.pdf