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    Guideline Summary NGC-8256

    Guideline Title

    Diagnosis and management of psoriasis and psoriatic arthritis in adults. A national clinical

    guideline.

    Bibliographic Source(s)

    Scottish Intercollegiate Guidelines Network (SIGN). Diagnosis and management of psoriasis an

    psoriatic arthritis in adults. A national clinical guideline. Edinburgh (Scotland): Scottish Intercollegiat

    Guidelines Network (SIGN); 2010 Oct. 65 p. (SIGN publication; no. 121). [217 references]

    Guideline Status

    This is the current release of the guideline.

    Any amendments to the guideline in the interim period will be noted onScottish Intercollegiate

    Guidelines Network (SIGN) Web site .

    FDA Warning/Regulatory Alert

    Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which

    important revised regulatory and/or warning information has been released.

    September 7, 2011 Tumor Nec rosis Factor-alpha : The U.S. Food and Drug Administration

    (FDA) notified healthcare professionals that the Boxed Warning for the entire c lass of Tumor

    Necrosis Factor-alpha (TNF) blockers has been updated to inc lude the risk of infection from

    two bacterial pathogens, Legionella and Listeria. In addition, the Boxed Warning and Warnings

    and Precautions sections of the labels for all of the TNFblockers have been revised so that

    they contain consistent information about the risk for serious infections and the associated

    disease-causing pathogens.

    Scope

    Disease/Condition(s)

    Psoriasis

    Psoriatic arthritis (PsA)

    http://www.sign.ac.uk/new.htmlhttp://www.sign.ac.uk/new.htmlhttp://www.sign.ac.uk/new.htmlhttp://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm270977.htmhttp://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm270977.htmhttp://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm270977.htmhttp://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm270977.htmhttp://www.sign.ac.uk/new.htmlhttp://www.sign.ac.uk/new.htmlhttp://www.sign.ac.uk/new.html
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    Guideline Category

    Counseling

    Diagnosis

    Management

    Screening

    Treatment

    Clinical Specialty

    Dermatology

    Family Practice

    Internal Medicine

    Nursing

    Psychology

    Radiology

    Rheumatology

    Intended Users

    Advanced Practice Nurses

    Allied Health Personnel

    Nurses

    Occupational Therapists

    Other

    Patients

    Pharmacists

    Physicians

    Psychologists/Non-physician Behavioral Health Clinicians

    Guideline Objective(s)

    To provide recommendations based on current evidence for best practice in the diagnosis and

    management of psoriasis and psoriatic arthritis (PsA) in adults

    Target Population

    Adults with psoriasis and psoriatic arthritis (PsA)

    Note: The guideline excludes psoriasis and PsA in children. Pregnancy and pre -conception care (e.g., for patients

    on systemic therapies) are not addressed. Other inflammatory conditions sometimes associa ted with psoriasis such

    as palmoplantar pustulosis are not addressed. The management of chronic pain associated with PsA is also outside

    the scope of this guideline. A minority of patients with PsA develop inflammatory joint disease prior to the

    development of cutaneous disease. In most cases such patients will be managed as having an undifferentiated

    inflammatory arthritis and will follow the care pathway appropriate to such conditions.

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    Interventions and Practices Considered

    Diagnosis/Evaluation/Screening

    1. Rheumatology referral when psoriatic arthritis (PsA) is suspected2. Annual reassessment of arthritis symptoms in patients with psoriasis3. Use of patient-administered questionnaires4. Education of health care professionals on association between psoriasis and PsA5. Assessment for comorbid conditions (e.g., obesity, diabetes, alcohol abuse, smoking,

    cardiovascular disease, psychiatric morbidity)

    6. Monitoring disease and response to treatment using clinical assessment tools: Psoriasis Areaand Severity Index (PASI), Dermatology Life Quality Index (DLQI), Bath Ankylosing Spondylitis

    Disease Activity Index (BASDAI), PsA Response Criteria (PsARC)

    Note: Measurement of serum anticyclic citrullinated peptide antibodies to screen for psoriatic arthritis was

    considered but not recommended.

    Management/Treatment

    Treatment in Primary Care

    1. Potent topical corticosteroid or a combined potent corticosteroid plus calcipotriol ointment2. Vitamin D analogue therapy3. Moderate potency topical steroids4. Topical tacrolimus5. Emollients and other topical therapy6. Ensuring patient adherence7. Empathetic communicat ion with patients8. Referral to secondary care (rheumatology, dermatology, occupational health services)

    Treatment in Secondary Care (Rheumatology or Dermatology)

    1. Nurse-led triage clinics2. Pharmacological treatment

    Non-steroidal anti-inflammatory drugs (NSAIDS)

    Intra-articular corticosteroids (not recommended routinely)

    Disease-modifying anti-rheumatic drugs (DMARDs) (leflunomide, sulfasalazine,

    methotrexate, ciclosporin, acitretin, hydroxycarbamide, fumaric acid esters) (gold salts

    are considered but not recommended routinely)

    Biologic therapy (adalimumab, etanercept, infliximab, ustekinumab)

    Phototherapy and photochemotherapy

    3. Inpatient treatment4. Provision of information and patient education

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    Major Outcomes Considered

    Sensitivity, specificity, and reliability of diagnostic and assessment tools

    Risk for comorbid conditions

    Efficacy and tolerability of treatment

    Patient adherence to t reatment

    Dermatology Life Quality Index (DLQI)

    Psoriasis Area and Severity Index (PASI) 75

    Psoriasis clearance

    American College of Radiology (ACR) 20, 50, 70 response to treatment

    Radiologic progression of disease

    Number of tender or swollen joints

    Quality of life

    Methodology

    Methods Used to Collect/Select the Evidence

    Hand-searches of Published Literature (Primary Sources)

    Hand-searches of Published Literature (Secondary Sources)

    Searches of Electronic Databases

    Description of Methods Used to Collect/Select the Evidence

    Systematic Literature Review

    The evidence base for this guideline was synthesised in accordance with Scottish Intercollegiate

    Guidelines Network (SIGN) methodology. A systematic review of the literature was carried out using an

    explicit search strategy devised by a SIGN Information Officer. Databases searched include Medline,

    Embase, CINAHL, PsycINFO and the Cochrane Library. Full details of the searches, including date

    ranges and search strategies, are available on the SIGN website. Internet searches were carried out on

    various websites including the US National Guideline Clearinghouse and Guidelines International

    Network. The main searches were supplemented by material identified by individual members of the

    development group. Each of the selected papers was critically appraised by two members of the group

    using standard SIGN methodological checklists before conclusions were considered as evidence.

    Literature Search for Patient Issues

    At the start of the guideline development process, a SIGN Information Officer conducted a literature

    search for qualitative and quantitative studies that addressed patient issues of relevance. Databases

    searched include Medline, Embase, CINAHL and PsycINFO. The results were summarised and

    presented to the guideline development group. A copy of the Medline version of the patient search

    strategy is available on the SIGN website.

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    Number of Source Documents

    19,447

    Methods Used to Assess the Quality and Strength of the Evidence

    Weighting According to a Rating Scheme (Scheme Given)

    Rating Scheme for the Strength of the Evidence

    Levels of Evidence

    1++: High quality meta-analyses, systematic reviews of randomised controlled trials (RCTs), or RCTs

    with a very low risk of bias

    1+: Well-conducted meta-analyses, systematic reviews, or RCTs with a low risk of bias

    1-: Meta-analyses, systematic reviews, or RCTs with a high risk of bias

    2++: High quality systematic reviews of case control or cohort studies

    High quality case control or cohort studies with a very low risk of confounding or bias and a high

    probability that the relationship is causal

    2+: Well-conducted case control or cohort studies with a low risk of confounding or bias and a

    moderate probability that the relationship is causal

    2-: Case control or cohort studies with a high risk of confounding or bias and a significant risk that the

    relationship is not causal

    3: Non-analytic studies (e.g., case reports, case series)

    4: Expert opinion

    Methods Used to Analyze the Evidence

    Review of Published Meta-Analyses

    Systematic Review with Evidence Tables

    Description of the Methods Used to Analyze the Evidence

    Once papers have been selected as potential sources of evidence, the methodology used in each study

    is assessed to ensure its validity. The result of this assessment will affect the level of evidence

    allocated to the paper, which will in turn influence the grade of recommendat ion that it supports.

    The methodological assessment is based on a number of key questions that focus on those aspects of

    the study design that research has shown to have a significant influence on the validity of the results

    reported and conclusions drawn. These key questions differ between study types, and a range of

    checklists is used to bring a degree of consistency to the assessment process. The Scottish

    Intercollegiate Guidelines Network (SIGN) has based its assessments on the MERGE (Method for

    Evaluating Research and Guideline Evidence) checklists developed by the New South Wales

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    Department of Health, which have been subjected to wide consultation and evaluation. These

    checklists were subjected to detailed evaluation and adaptation to meet SIGN's requirements for a

    balance between methodological rigour and practicality of use.

    The assessment process inevitably involves a degree of subjective judgment. The extent to which a

    study meets a particular criterione.g., an acceptable level of loss to follow upand, more

    importantly, the likely impact of this on the reported results from the study will depend on the clinical

    context. To minimise any potential bias resulting from this, each study must be evaluated

    independently by at least two group members. Any differences in assessment should then be discussed

    by the full group. Where differences cannot be resolved, an independent reviewer or an experienced

    member of SIGN Executive staff will arbitrate to reach an agreed quality assessment.

    Evidence Tables

    Evidence tables are compiled by SIGN Executive staff based on the quality assessments of individual

    studies provided by guideline development group members. The tables summarise all the validatedstudies identified from the systematic literature review relating to each key question. They are

    presented in a standard format to make it easier to compare results across studies, and will present

    separately the evidence for each outcome measure used in the published studies. These evidence

    tables form an essential part of the guideline development record and ensure that the basis of the

    guideline development group's recommendat ions is transparent.

    Additional details can be found in the companion document titled "SIGN 50: A Guideline Developers'

    Handbook." (Edinburgh [UK]: Scottish Intercollegiate Guidelines Network. [SIGN publication; no. 50]),

    available from theSIGN Web site .

    Methods Used to Formulate the Recommendations

    Expert Consensus

    Description of Methods Used to Formulate the Recommendations

    Synthesising the Evidence

    Guideline recommendat ions are graded to differentiate between those based on strong evidence and

    those based on weak evidence. This judgement is made on the basis of an (objective) assessment of

    the design and quality of each study and a (perhaps more subjective) judgement on the consistency,

    clinical relevance and external validity of the whole body of evidence. The aim is to produce a

    recommendat ion that is evidence-based, but which is relevant to the way in which health care is

    delivered in Scotland and is therefore implementable.

    It is important to emphasise that the grading does not relate to the importance of the

    recommendat ion, but to the strength of the supporting evidence and, in particular, to the predictive

    power of the study designs from which that data was obtained. Thus, the grading assigned to a

    recommendat ion indicates to users the likelihood that, if that recommendation is implemented, the

    predicted outcome will be achieved.

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    Considered Judgement

    It is rare for the evidence to show clearly and unambiguously what course of action should be

    recommended for any given question. Consequently, it is not always clear to those who were not

    involved in the decision making process how guideline developers were able to arrive at their

    recommendat ions, given the evidence they had to base them on. In order to address this problem,

    SIGN has introduced the concept of considered judgement.

    Under the heading of considered judgement, guideline development groups summarise their view of

    the total body of evidence covered by each evidence table. This summary view is expected to cover the

    following aspects:

    Quantity, quality, and consistency of evidence

    External validity (generalisability) of study findings

    Directness of application to the target population for the guideline

    Any evidence of potential harms associated with implementation of a recommendat ion

    Clinical impact (i.e., the extent of the impact on the target patient population, and the

    resources needed to treat them in accordance with the recommendation)

    Whether, and to what extent, any equality groups may be particularly advantaged or

    disadvantaged by the recommendations mad

    Implementability (i.e., how practical it would be for the NHS in Scotland to implement the

    recommendation.)

    The group are finally asked to summarise its view on all of these issues, both the quality of the

    evidence and its potential impact, before making a graded recommendation. This summary should be

    succinct, and taken together with its views of the level of evidence represent the first draft of the text

    that will appear in the guideline immediately before a graded recommendation.

    Additional detail about SIGN's process for formulating guideline recommendations is provided in

    Section 6 of the companion document titled "SIGN 50: A Guideline Developers' Handbook." (Edinburgh

    [UK]: Scottish Intercollegiate Guidelines Network. [SIGN publication; no. 50], available from theSIGN

    Web site .

    Rating Scheme for the Strength of the Recommendations

    Grades of Recommendation

    Note: The grade of recommendation relates to the strength of the evidence on which the

    recommendat ion is based. It does not reflect the clinical importance of the recommendation.

    A: At least one meta-analysis, systematic review, or randomised controlled trial (RCT) rated as 1++,

    and directly applicable to the target population; or

    A body of evidence consisting principally of studies rated as 1+, directly applicable to the target

    population, and demonstrating overall consistency of results

    B: A body of evidence including studies rated as 2++, directly applicable to the target population, and

    http://www.sign.ac.uk/guidelines/fulltext/50/index.htmlhttp://www.sign.ac.uk/guidelines/fulltext/50/index.htmlhttp://www.sign.ac.uk/guidelines/fulltext/50/index.htmlhttp://www.sign.ac.uk/guidelines/fulltext/50/index.htmlhttp://www.sign.ac.uk/guidelines/fulltext/50/index.htmlhttp://www.sign.ac.uk/guidelines/fulltext/50/index.html
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    demonstrating overall consistency of results; or

    Extrapolated evidence from studies rated as 1++ or 1+

    C: A body of evidence including studies rated as 2+, directly applicable to the target population and

    demonstrating overall consistency of results; or

    Extrapolated evidence from studies rated as 2++

    D: Evidence level 3 or 4; or

    Extrapolated evidence from studies rated as 2+

    Good Practice Points: Recommended best practice based on the clinical experience of the guideline

    development group

    Cost Analysis

    A formal cost analysis was not performed and published cost analyses were not reviewed.

    Method of Guideline Validation

    External Peer Review

    Internal Peer Review

    Description of Method of Guideline Validation

    National Open Meeting

    A national open meet ing is the main consultative phase of Scottish Intercollegiate Guidelines Network

    (SIGN) guideline development, at which the guideline development group presents its draft

    recommendat ions for the first time. The national open meeting for this guideline was held on 1 October

    2009 and was attended by 157 representatives of all the key specialties relevant to the guideline and

    members of the public.

    The draft guideline was also available on the SIGN website for a limited period at this stage to allow

    those unable to attend the meeting to contribute to the development of the guideline.

    Specialist Review

    This guideline was also reviewed in draft form by independent expert referees, who were asked to

    comment primarily on the comprehensiveness and accuracy of interpretation of the evidence base

    supporting the recommendations in the guideline. The guideline group addresses every comment made

    by an external reviewer, and must justify any disagreement with the reviewers' comments (see

    Section 11 of the original guideline document for a listing of the independent reviewers).

    SIGN Editorial Group

    As a final quality control check, the guideline is reviewed by an editorial group comprising the relevant

    specialty representatives on SIGN Council to ensure that the specialist reviewers' comments have been

    addressed adequately and that any risk of bias in the guideline development proc ess as a whole has

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    Recommendations

    Major Recommendations

    Note from the Scottish Intercollegiate Guidelines Network (SIGN) and National Guideline

    Clearinghouse (NGC): In addition to these evidence-based recommendations, the guideline

    development group also identifies points of best clinical practice in the full-text guideline document.

    The grades of recommendations (AD) and levels of evidence (1++, 1+, 1-, 2++, 2+, 2-, 3, 4) are

    defined at the end of the "Major Recommendations" field.

    Diagnosis, Assessment and Monitoring

    Diagnosis

    Early Diagnosis

    B- All patients suspected as having psoriatic arthritis should be assessed by a rheumatologist so that

    an early diagnosis can be made and joint damage can be reduced.

    B- Patients with inflammatory joint disease should be classified as having psoriatic arthritis based on

    ClASsification criteria for Psoriatic ARthritis (CASPAR) criteria.

    Screening for Psoriatic Arthritis

    D- Healthcare professionals who treat patients with psoriasis should be aware of the association

    between psoriasis and psoriatic arthritis.

    C- The use of patient-administered screening questionnaires such as the Psoriasis Epidemiology

    Screening Tool (PEST) should be considered for early detection of psoriatic arthritis in primary care and

    dermatology clinics.

    B- The measurement of serum anticyclic citrullinated peptide antibodies in patients with psoriasis

    should not be used to screen for psoriatic arthritis.

    Comorbidities

    D- Healthcare professionals should be aware of the need to consider comorbid condit ions in patients

    with psoriasis and psoriatic arthritis. Where necessary, detailed assessment should be carried out to

    accurately identify and manage comorbid conditions.

    Cardiovascular Risk

    D- Evaluation of patients with severe psoriasis or psoriatic arthritis should include annual body mass

    index (BMI), diabetes mellitus (DM) screening, blood pressure measurement, and lipid profile.

    D- Consider advising patients with severe psoriasis or psoriatic arthritis that they may be at increased

    risk of cardiovascular disease and diabetes.

    Alcohol Consumption

    D- All patients with psoriasis or psoriatic arthritis should be encouraged to adopt a healthy lifestyle,

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    including:

    Regular exercise

    Weight management, aiming for BMI 18.5-24.9

    Moderation of alcohol consumption

    Cessation of smoking

    Impact on Psychological Well-being

    D- Assessment of patients with psoriasis or psoriatic arthritis should include psychosocial measures,

    with referral to mental health services as appropriate.

    Monitoring Disease Activity and Response to Treatment

    Assessment Tools for Psoriasis

    D- Healthcare professionals should be aware that the Psoriasis Area and Severity Index (PASI) and

    Dermatology Life Quality Index (DLQI) are part of the eligibility criteria for biologic therapy in psoriasisand must be used to assess the efficacy of these agents over t ime.

    D- The DLQI should be measured as part of the global assessment of patients with psoriasis.

    Assessment Tools for Psoriatic Arthritis

    D- Psoriatic Arthritis Response Criteria (PsARC) should be used to monitor response to biologic agents

    in patients with peripheral psoriatic arthritis.

    D- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and spinal pain visual analogue score

    should be used to monitor response to biologic agents in patients with axial disease.

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    Treatment in Primary Care

    Topical Therapy

    A- Short term intermittent use of a potent topical corticosteroid or a combined potent corticosteroid

    plus calcipotriol ointment is recommended to gain rapid improvement in plaque psoriasis.

    D- Potent to very potent topical corticosteroids are not recommended for regular use over prolongedperiods because of concern over long term adverse effects.

    A- For long term topical treatment of plaque psoriasis a vitamin D analogue is recommended.

    B- If a vitamin D analogue is ineffective or not tolerated then short contact dithranol, coal tar solution,

    cream or lotion or tazarotene gel should be considered in appropriate patients.

    Scalp, Nail, Facial, and Flexural Psoriasis

    Scalp

    B- Short term intermittent use of potent topical corticosteroids or a combination of a potent

    corticosteroid and a vitamin D analogue is recommended in scalp psoriasis.

    Face and Flexures

    B- Moderate potency topical corticosteroids are recommended for short term use in facial and flexural

    psoriasis.

    B- If moderate potency topical corticosteroids are ineffective in facial and flexural psoriasis, then

    vitamin D analogues or tacrolimus ointment are recommended for intermittent use.

    Concordance-Related Issues

    D- Patients should be offered a follow-up appointment within six weeks of initiating or changing

    topical therapy to assess treatment efficacy and acceptability.

    D- To improve adherence, the number of treatments per day should be kept to a minimum.

    Communication with Patients

    D- Healthcare professionals should express empathy, acknowledge day to day difficulties, and

    recognise and manage psychosocial needs related to having psoriasis.

    D- Treatment options, risks and benefits should be discussed with the patient, allowing them to be

    involved in decision making.

    Referral to Secondary Care

    Referral to Dermatology

    D- Referral to a consultant dermatologist should be considered if any of the following apply:

    Diagnost ic uncertainty

    Extensive disease

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    Occupational disability or excessive time lost from work or schoolInvolvement of sites which are difficult to treat, e.g., the face, palms or genitalia

    Failure of appropriate topical treatment after two or three months' use

    Adverse reactions to topical treatment

    Severe or recalcitrant disease

    D- Patients with erythrodermic or generalised pustular psoriasis must receive emergency referral to

    dermatology.

    D- Patients in primary care who do not respond to topical therapy and who score 6 or above on the

    DLQI should be offered referral to dermatology.

    D- Referral to a dermatology nurse specialist or nurse-led clinic should be considered in patients in

    whom a diagnosis of psoriasis has previously been established in secondary care if any of the following

    apply:

    Relapse following topical therapy

    Refractory scalp psoriasis

    Request for further counselling and/or education, including demonstration of topical treatment

    Topical therapy/phototherapy according to protocols, nurse competencies and local

    arrangements

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    Treatment of Psoriatic Arthritis in Secondary Care

    Organisation of Care

    D- Nurse-led triage clinics should be considered for psoriatic arthritis.

    Pharmacological Treatment

    C- Non-steroidal anti-inflammatory drugs (NSAIDs) are recommended for short term symptom relief

    in patients with psoriatic arthritis where not contraindicated.

    Disease-Modifying Anti-rheumatic Drugs

    A- Leflunomide is recommended for the treatment of active peripheral psoriatic arthritis.

    C- Sulfasalazine may be considered as an alternative in the treatment of peripheral psoriatic arthritis.

    C- Methotrexate may be considered in the treatment of psoriatic arthritis.

    D- The addition of ciclosporin to methotrexate in the treatment of psoriatic arthritis is not

    recommended for routine therapy.

    B- The use of intramuscular or oral gold in the treatment of psoriatic arthritis is not recommended

    where less toxic treatments are an option.

    Biologic Therapy

    A- Adalimumab, etanercept or infliximab are recommended for treatment of active psoriatic arthritis in

    patients who have failed to respond to, are intolerant of, or have had contraindications to at least tw o

    disease-modifying therapies.

    Treatment of Psoriasis in Secondary Care

    Organisation of Care

    D- Patients with erythrodermic or generalised pustular psoriasis must receive emergency referral to

    dermatology.

    Inpatient Care

    D- Inpatient t reatment on a dermatology ward should be available for patients with severe psoriasis.

    Nurse-Led Clinics

    C- Nurse-led clinics for psoriasis should be considered for delivery of services such as follow up of

    specialist caseload, re-access for patients with recurrent disease, and monitoring of systemic therapies.

    Phototherapy and Photochemotherapy

    A- Broad band ultraviolet B phototherapy (BBUVB) is not recommended.

    B- Patients with psoriasis who do not respond to topical therapy should be offered narrow band

    ultraviolet B phototherapy (NBUVB).

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    B- Psoralen ultraviolet A photochemotherapy (PUVA) should be considered for those patients who do

    not respond to NBUVB.

    D- All patients who have received >200 whole-body PUVA treatments and/or >500 whole-body

    ultraviolet B (UVB) treatments should be invited for annual skin cancer screening review.

    B- Three times weekly NBUVB phototherapy is recommended where practicable.

    B- Home NBUVB phototherapy under controlled supervision should be considered where practicable

    for patients who are unable to attend hospital.

    Pharmacological Treatment

    Systemic Therapy

    B- Patients with severe or refractory psoriasis should be considered for systemic therapy with

    ciclosporin, methotrexate or acitretin, following discussion of benefits and risks.

    B- Methotrexate is recommended for longer term use and where there is concomitant psoriatic

    arthritis.

    A- Ciclosporin is recommended for short term intermittent use.

    B- Acitretin can be considered as an alternative.

    B- Fumaric acid esters can be considered as an alternative maintenance therapy for patients who are

    not suitable for other systemic therapies or have failed other therapies.

    C- Hydroxycarbamide can be considered as an alternative maintenance therapy for patients who are

    not suitable for other systemic therapies or have failed other therapies.

    Biologic Therapy

    A- Patients with severe psoriasis who fail to respond to, have a contraindication to, or are intolerant of

    phototherapy and systemic therapies including ciclosporin and methotrexate should be offered biologic

    therapy unless they have contraindications or are at increased risk of hazards from these therapies.

    A- Adalimumab loading regimen followed by 40 mg every other week is recommended in the

    treatment of severe psoriasis.

    A- Etanercept 25 mg twice weekly or 50 mg weekly is recommended in the treatment of severe

    psoriasis.

    A- Infliximab 5 mg/kg at weeks 0, 2, 6 and repeated as maintenance treatment every two months is

    recommended in the treatment of severe psoriasis, especially when rapid disease control is required.

    A- Ustekinumab 45 mg for patients weighing under 100 kg and 90 mg for patients weighing over 100

    kg given at weeks 0 and 4 then every 12 weeks as maintenance is recommended in the treatment of

    severe psoriasis.

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    Provision of Information

    Provision of Information and Patient Education

    D- Active involvement of patients in managing their care should be encouraged.

    D- Patients should receive information about their diagnosis, treatment options, and the correct

    application of topical treatments.

    Definitions:

    Levels of Evidence

    1++: High quality meta-analyses, systematic reviews of randomised controlled trials (RCTs), or RCTs

    with a very low risk of bias

    1+: Well-conducted meta-analyses, systematic reviews, or RCTs with a low risk of bias

    1-: Meta-analyses, systematic reviews, or RCTs with a high risk of bias

    2++: High quality systematic reviews of case control or cohort studies

    High quality case control or cohort studies with a very low risk of confounding or bias and a high

    probability that the relationship is causal

    2+: Well-conducted case control or cohort studies with a low risk of confounding or bias and a

    moderate probability that the relationship is causal

    2-: Case control or cohort studies with a high risk of confounding or bias and a significant risk that the

    relationship is not causal

    3: Non-analytic studies (e.g., case reports, case series)

    4: Expert opinion

    Grades of Recommendations

    Note: The grade of recommendation relates to the strength of the evidence on which the

    recommendat ion is based. It does not reflect the clinical importance of the recommendation.

    A: At least one meta-analysis, systematic review, or RCT rated as 1++, and directly applicable to the

    target population; or

    A body of evidence consisting principally of studies rated as 1+, directly applicable to the target

    population, and demonstrating overall consistency of results

    B: A body of evidence including studies rated as 2++, directly applicable to the target population, and

    demonstrating overall consistency of results; or

    Extrapolated evidence from studies rated as 1++ or 1+

    C: A body of evidence including studies rated as 2+, directly applicable to the target population and

    demonstrating overall consistency of results; or

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    Extrapolated evidence from studies rate as 2++

    D: Evidence level 3 or 4;or

    Extrapolated evidence from studies rated as 2+

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    Clinical Algorithm(s)

    A care pathway for psoriasis and psoriatic arthritis in primary and secondary care is provided in the

    original guideline document.

    Evidence Supporting the Recommendations

    Type of Evidence Supporting the Recommendations

    The type of supporting evidence is identified and graded for each recommendat ion (see "Major

    Recommendations").

    Benefits/Harms of Implementing the Guideline Recommendations

    Potential Benefits

    Appropriate diagnosis and treatment of psoriasis and psoriatic arthritis, including patient involvement

    in care, results to greater patient satisfaction with care, reduction in pain and joint damage, and

    improved quality of life

    Potential Harms

    Adverse Effects of Topical Treatments for Psoriasis

    These adverse effects include development of striae, skin fragility and easy bruising; rebound,

    persistent or unstable psoriasis; and systemic adverse effects. These adverse effects were

    uncommon in the reported studies, but most studies were short term (none involving topical

    corticosteroid use for more than one year). Because monitoring in studies is close, participants

    will be less likely to continue to more serious side effects than in standard treatment outwith a

    study. Rare but serious (sometimes fatal) side effects such as systemic hypothalamic-pituitary

    axis suppression and generalised pustular psoriasis need to be considered.

    Potent to very potent topical corticosteroids are not recommended for regular use over

    prolonged periods because of concern over long term adverse effects.

    Ultraviolet Radiation Risks

    Exposure to ultraviolet (UV) radiation is a recognised risk factor for squamous cell carcinoma (SCC),

    basal cell carcinoma (BCC) and malignant melanoma (MM).

    Toxicity of Systemic Therapy

    Methotrexate potentially causes hepatotoxicity and is less effective than ciclosporin.

    Ciclosporin is potentially nephrotoxic and causes hypertension.

    Hydroxycarbamide is teratogenic and can cause bone marrow suppression.

    Acitretin is teratogenic.Nonsteroidal anti-inflammatory drugs (NSAIDs) are potentially cardiotoxic.

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    product licence and this can be necessary for a variety of reasons.

    Generally the unlicensed use of medicines becomes necessary if the clinical need cannot be met by

    licensed medicines; such use should be supported by appropriate evidence and experience.

    Medicines may be prescribed outwith their product licence in the following circumstances:

    For an indication not specified within the marketing authorisation

    For administration via a different route

    For administration of a different dose

    Prescribing medicines outside the recommendations of their marketing authorisation alters (and

    probably increases) the prescribers' professional responsibility and potential liability. The prescriber

    should be able to justify and feel competent in using such medicines.

    Any practitioner following a Scottish Intercollegiate Guidelines Network (SIGN) recommendation and

    prescribing a licensed medicine outwith the product licence needs to be aware that they are

    responsible for this decision, and in the event of adverse outcomes, may be required to justify the

    actions that they have taken. Prior to prescribing, the licensing status of a medication should be

    checked in the current version of the British National Formulary (BNF).

    Implementation of the Guideline

    Description of Implementation Strategy

    Implementation of national clinical guidelines is the responsibility of each National Health Service

    (NHS) Board and is an essential part of clinical governance. Mechanisms should be in place to review

    care provided against the guideline recommendations. The reasons for any differences should be

    assessed and addressed where appropriate. Local arrangements should then be made to implement

    the national guideline in individual hospitals, units and practices.

    Resource implications of key recommendations and key points to audit are available in section 9 of the

    original guideline document.

    Implementation of this guideline will be encouraged and supported by the Scottish Intercollegiate

    Guidelines Network (SIGN), NHS Quality Improvement Scotland (QIS) and other stakeholder

    organisations. The implementation strategy for this guideline encompasses dissemination, provision of

    tools such as PowerPoint slide sets, education and awareness-raising activities. The detailed strategy is

    available fromwww.sign.ac.uk .

    Implementation Tools

    Audit Criteria/Indicators

    Chart Documentation/Checklists/Forms

    Clinical Algorithm

    Patient Resources

    Quick Reference Guides/Physician Guides

    http://www.sign.ac.uk/http://www.sign.ac.uk/http://www.sign.ac.uk/http://www.sign.ac.uk/
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    For information about availability, see theAvailability of Companion Documents and Patient Resourcesfields below.

    Institute of Medicine (IOM) National Healthcare Quality Report Categories

    IOM Care Need

    Getting Better

    Living with Illness

    IOM Domain

    Effectiveness

    Patient-centeredness

    Identifying Information and Availability

    Bibliographic Source(s)

    Scottish Intercollegiate Guidelines Network (SIGN). Diagnosis and management of psoriasis and

    psoriatic arthritis in adults. A national clinical guideline. Edinburgh (Scotland): Scottish Intercollegiate

    Guidelines Network (SIGN); 2010 Oct. 65 p. (SIGN publication; no. 121). [217 references]

    Adaptation

    Not applicable: The guideline was not adapted from another source.

    Date Released

    2010 Oct

    Guideline Developer(s)

    Scottish Intercollegiate Guidelines Network - National Government Agency [Non-U.S.]

    Source(s) of Funding

    Scottish Executive Health Department

    Guideline Committee

    Guideline Development Group

    Composition of Group That Authored the Guideline

    Guideline Development Group: Dr David Burden (Chair), Consultant Dermatologist, The Alan Lyell

    Centre for Dermatology, Western Infirmary, Glasgow; Mrs Rosemary Beaton, Patient Representative,

    Glasgow; Dr David Bilsland, Consultant Dermatologist, Southern General Hospital, Glasgow; Mr

    Stewart Campbell, Patient Representative, Psoriasis Association; Dr Robert Dawe, Consultant

    Dermatologist, Ninewells Hospital, Dundee; Dr Diane Dixon, Senior Lecturer, School of Psychological

    Sciences and Health, University of Strathclyde; Dr Linda Grimmond, Consultant Occupational Physician,

    Occupational Health and Safety Advisory Services, Dundee; Mrs Sandra Hanlon, Dermatology Liaison

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    Sister, Inverclyde Royal Hospital, Greenock; Dr Iain Henderson, General Practitioner, Kingsway Medical

    Practice, Glasgow; Ms Michele Hilton Boon, Programme Manager, SIGN; Mrs Janice Johnson, Patient

    Representative; Director, PSALV - Psoriasis Scotland, Arthritis Link Volunteers, Edinburgh; Dr Alan

    Jones, General Practitioner, Newton Stewart; Dr Danny Kemmett, Consultant Dermatologist, Royal

    Infirmary of Edinburgh; Dr Joyce Leman, Consultant Dermatologist, Western Infirmary, Glasgow; Dr

    Ayyakkannu Manivannan, Laser Protect ion Advisor and Clinical Sc ientist, NHS Grampian and University

    of Aberdeen; Dr Lorna McHattie, Lecturer, School of Pharmacy and Life Sciences, Robert Gordon

    University, Aberdeen; Dr David McKay, Consultant Dermatologist, Royal Infirmary of Edinburgh;

    Professor Harry Moseley, Consultant Clinical Scientist, Photobiology Unit, Ninewells Hospital and

    Medical School, Dundee; Dr Tony Ormerod, Reader in Dermatology, Department of Applied Medicine,

    University of Aberdeen and Honorary Consultant Dermatologist, Aberdeen Royal Infirmary; Dr Gozde

    Ozakinci, Lecturer in Health Psychology, University of St Andrews; Dr Ruth Richmond, Consultant

    Rheumatologist, Borders General Hospital, Melrose; Mrs Lynne Smith, Information Officer, SIGN; Dr

    Derek Stewart, Reader in Pharmacy Practice, Robert Gordon University, Aberdeen; Anne Thorrat,

    Psoriasis/Research Nurse, Western Infirmary, Glasgow; Dr Hilary Wilson, Consultant Rheumatologist,

    Stobhill Hospital, Glasgow

    Financial Disclosures/Conflicts of Interest

    Declarations of interests were made by all members of the guideline development group. Further

    details are available from the Scottish Intercollegiate Guidelines Network (SIGN) Executive.

    Guideline Status

    This is the current release of the guideline.

    Any amendments to the guideline in the interim period will be noted onScottish Intercollegiate

    Guidelines Network (SIGN) Web site .

    Guideline Availability

    Electronic copies: Available in Portable Document Format (PDF) from theScottish Intercollegiate

    Guidelines Network (SIGN) Web site .

    Availability of Companion Documents

    The following are available:

    Quick reference guide: Diagnosis and management of psoriasis and psoriatic arthritis in adults.

    A national clinical guideline. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network;

    2010. 72 p. Available in Portable Document Format (PDF) from theScottish Intercollegiate

    Guidelines Network (SIGN) Web site .

    Summary of recommendations: Diagnosis and management of psoriasis and psoriatic arthritis

    in adults. A national clinical guideline. Edinburgh (Scotland): Scottish Intercollegiate Guidelines

    Network; 2010. Available from theSIGN Web site .

    SIGN 50: A guideline developer's handbook. Edinburgh (Scotland): Scottish Intercollegiate

    http://www.sign.ac.uk/new.htmlhttp://www.sign.ac.uk/new.htmlhttp://www.sign.ac.uk/new.htmlhttp://sign.ac.uk/guidelines/fulltext/121/index.htmlhttp://sign.ac.uk/guidelines/fulltext/121/index.htmlhttp://sign.ac.uk/guidelines/fulltext/121/index.htmlhttp://www.sign.ac.uk/pdf/qrg121.pdfhttp://www.sign.ac.uk/pdf/qrg121.pdfhttp://www.sign.ac.uk/pdf/qrg121.pdfhttp://www.sign.ac.uk/guidelines/fulltext/121/recommendations.htmlhttp://www.sign.ac.uk/guidelines/fulltext/121/recommendations.htmlhttp://www.sign.ac.uk/guidelines/fulltext/121/recommendations.htmlhttp://www.sign.ac.uk/pdf/qrg121.pdfhttp://www.sign.ac.uk/pdf/qrg121.pdfhttp://www.sign.ac.uk/pdf/qrg121.pdfhttp://sign.ac.uk/guidelines/fulltext/121/index.htmlhttp://sign.ac.uk/guidelines/fulltext/121/index.htmlhttp://sign.ac.uk/guidelines/fulltext/121/index.htmlhttp://www.sign.ac.uk/new.htmlhttp://www.sign.ac.uk/new.htmlhttp://www.sign.ac.uk/new.html
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    Guidelines Network. (SIGN publication; no. 50). Available in PDF from theSIGN Web site .

    Appraising the quality of clinical guidelines. The SIGN guide to the AGREE (Appraisal of

    Guidelines Research & Evaluation) guideline appraisal instrument. Edinburgh (Scotland):

    Scottish Intercollegiate Guidelines Network; 2001. Available in PDF from theSIGN Web site .

    Implementation strategy: Diagnosis and management of psoriasis and psoriatic arthritis.

    Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network; 2010. 1 p. Available in PDF

    from theSIGN Web site .

    Search narrative: Guideline topic: Management of psoriasis and psoriatic arthritis. Edinburgh

    (Scotland): Scottish Intercollegiate Guidelines Network; 2010. 1 p. Available in PDF from the

    SIGN Web site .

    In addition, the annexes of the original guideline document include a number of screening and

    assessment tools for psoriasis and psoriatic arthritis. Section 9 of the original guideline document also

    contains key points to audit.

    Patient Resources

    The following is available:

    Treating psoriasis and psoriatic arthritis. A booklet for patients and carers. Edinburgh (UK):

    Scottish Intercollegiate Guidelines Network, 2011. 33 p. Available in Portable Document

    Format (PDF) from theScottish Intercollegiate Guidelines Network (SIGN) Web site .

    Please note: This patient information is intended to provide health professionals with information to share with

    their patients to help them better understand their health and their diagnosed disorders. By providing access to

    this patient information, it is not the inten tion of NGC to provide specific medical advice for particular patients.

    Rather we urge patients and their representatives to review this material and then to consult with a licensed health

    professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their

    personal medical questions. This patient information has been derived and prepared from a guideline for health

    care professionals included on NGC by the authors or publishers of that original guideline. The pa tient information

    is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

    NGC Status

    This summary was completed by ECRI Institute on February 22, 2011. The information was verified by

    the guideline developer on March 4, 2011. This summary was updated by ECRI Institute on October12, 2011 following the U.S. Food and Drug Administrat ion (FDA) advisory on Tumor Necrosis Factor-

    alpha (TNF) Blockers.

    Copyright Statement

    Scottish Intercollegiate Guidelines Network (SIGN) guidelines are subject to copyright; however, SIGN

    encourages the downloading and use of its guidelines for the purposes of implementation, education,

    and audit.

    Users wishing to use, reproduce, or republish SIGN material for commercial purposes must seek prior

    approval for reproduction in any medium. To do this, please [email protected] .

    Additional copyright information is available on theSIGN Web site .

    http://www.sign.ac.uk/guidelines/fulltext/50/index.htmlhttp://www.sign.ac.uk/guidelines/fulltext/50/index.htmlhttp://www.sign.ac.uk/methodology/agreeguide/index.htmlhttp://www.sign.ac.uk/methodology/agreeguide/index.htmlhttp://www.sign.ac.uk/pdf/SIGN121_implementation_strategy.pdfhttp://www.sign.ac.uk/pdf/SIGN121_implementation_strategy.pdfhttp://www.sign.ac.uk/pdf/SIGN121_implementation_strategy.pdfhttp://www.sign.ac.uk/pdf/sign121_search_narrative.pdfhttp://www.sign.ac.uk/pdf/sign121_search_narrative.pdfhttp://www.sign.ac.uk/pdf/pat121.pdfhttp://www.sign.ac.uk/pdf/pat121.pdfmailto:[email protected]:[email protected]://www.sign.ac.uk/guidelines/published/copyright.htmlhttp://www.sign.ac.uk/guidelines/published/copyright.htmlhttp://www.sign.ac.uk/guidelines/published/copyright.htmlhttp://www.sign.ac.uk/guidelines/published/copyright.htmlmailto:[email protected]://www.sign.ac.uk/pdf/pat121.pdfhttp://www.sign.ac.uk/pdf/sign121_search_narrative.pdfhttp://www.sign.ac.uk/pdf/SIGN121_implementation_strategy.pdfhttp://www.sign.ac.uk/methodology/agreeguide/index.htmlhttp://www.sign.ac.uk/guidelines/fulltext/50/index.html
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