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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 . Psoriasis affects 1–3% of the population, with
severe cases. However, most longitudinal studies of PsA have
approximately a third of patients developing PsA . 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  (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 
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  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 .
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 , 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 . 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] 
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) ; methotrexate (B)
; ciclosporin (B)  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.
=Grade of Recommendation
Adequate therapeutic trial of 2 standard DMARDs individually or in
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-TNF
3 tender joints &
≥3 swollen joints
use are currently being
On 2 separate occasions 1 month apart.
Dactylitis to count as 1 Joint [C]
Resistant large joint mono/oligoarthritis
to be reviewed on individual basis.
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 . Until data become
Guideline for anti-TNF- therapy in psoriatic arthritis
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 , 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 .
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 .
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 . 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 .
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)  or the Bath Nail Score
. 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) , 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.
The information required for PsA patients on the Register
will be the same as for RA patients on the BSR Biologics Register,the Working Party suggesting the following amendments:
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“Vitamin D is like a Religious Revival; either you're a believer or Adam Thornton discusses vitamin D with Dr Michael Holick There is no doubt that the current ‘vitamin du jour’ in both the scientific literature and the lay media is vitamin D. Vitamin D is rightly in the spotlight because of the enormous amount of scientific research that has been conducted in recent years that sheds light