Guidelines for the management ofpsoriasisThis document incorporates and summarises recently published Australian consensustreatment goals [1] and guidelines published by the British Association ofDermatologists [2,3], American Academy of Dermatology [4-7] and NICE [8]. It isrelevant to the treatment of psoriasis in New Zealand.

DefinitionPsoriasis is a chronic inflammatory skin disease that is characterized by disfiguring,scaling and erythematous plaques that may be itchy and/or painful. Although oncethought of as a benign dermatological condition with few serious complications,moderate-to-severe psoriasis is now considered a multisystem disease that is associatedwith, or increases, the risk of other comorbidities. Psoriasis can be both emotionally andphysically debilitating and impact on quality of life significantly.

Background In New Zealand psoriasis affects about 23% of the population. This is

comparable to worldwide figures collected by the World Psoriasis Dayconsortium.

Different rates of psoriasis are seen in certain ethnic groups; higher in NorthernEuropeans and lower in Australian aborigines. Very little data exists on theprevalence in New Zealand Mori.

Onset can occur at any age, but two peaks in incidence have been identified onein the late teens, and the other between 5060 years old.

There is a genetic predisposition with about one third of patients reporting to havean affected relative.

Approximately 80% of patients affected with psoriasis have mild to moderatedisease.

Psoriasis tends to run a chronic course, with remissions and exacerbations. Up to 40% of people with skin psoriasis have some signs of psoriatic arthritis. Metabolic syndrome, a condition involving obesity, hyperlipidaemia,

hypertension and insulin resistance is commonly found in patients with psoriasis,and significantly increases the risk of developing cardiovascular morbidity andmortality.

Severe psoriasis, particularly in younger patients, is an independent risk factor formyocardial infarction.

Psoriasis is associated with depression and substance abuse, including alcohol.

Patient assessment and diagnosis

The diagnosis and assessment of psoriasis and its extent and severity is based on:

Objective assessment of the body surface area (BSA) involvement, diseaselocation, thickness and symptoms, presence or absence of psoriatic arthritis, andany associated comorbidities.

With

Subjective assessment of the physical, psychological, social, and financial impactof the disease on the patients life.

Objective assessments

Psoriasisfeatures andsymptoms

Chronic plaque psoriasis usually presents as red, scaly patches ofskin with very well defined edges.

The scale is typically silvery white, unless psoriasis is affectingbody folds, in which case scaly patches may be smooth and shiny.

Extensor surfaces most often affected, and scalp involvement iscommon.

Fissures in the skin crease may occur in flexural psoriasis. Nail involvement shows pitting, onycholysis and subungual

hyperkeratosis. Other less common forms of psoriasis to be aware of include those

involving the palms, soles, and intertriginous areas, and pustularand erythrodermic psoriasis.

Systemic symptoms including fever and malaise may be indicativeof unstable forms of psoriasis such as erythrodermic or generalizedpustular psoriasis.

Psoriasisseverity

Severity is determined using one or more of the following assessmenttools.

PGA Physicians/Patients Global Assessment: severity isestimated by both clinician and patient using a static globalassessment score, which uses the descriptions clear, nearlyclear, mild, moderate, severe or very severe.

BSA Body Surface Area: severity is defined by how much of thebody surface area is affected.

o Mild psoriasis: 10% of BSA

(Note: 1% of BSA is approximately equal to the palm of thepatients hand, excluding fingers)

PASI Psoriasis Area and Severity Index: measure of overallseverity and extent of psoriasis by assessing BSA and intensity of

redness, thickness and scaling. A single score is calculated andranges between 0 (no disease) to 72 (maximal disease). Commonlyused in clinical trials for psoriasis treatments and bydermatologists and clinicians working in specialised treatmentcentres.

Presence ofpsoriaticarthritis

Detection of psoriatic arthritis is based on symptoms, examinationof skin and joints and compatible radiological findings.

Available validated tools to assess adults for psoriatic arthritis (allpatient-completed questionnaires) include:

o PEST Psoriasis Epidemiology Screening Toolo ToPAS Toronto Psoriatic Arthritis Screeno PASE Psoriatic Arthritis Screening Evaluation

Presence ofco-morbidities

Identify co-morbidities by taking a complete medical history andphysical examination, including

o Blood pressure measuremento BMI calculationo Diabetic assessment (e.g. fasting glucose and lipids, retinal

screening)o Cardiovascular assessment (e.g. electrocardiogram,

validated risk estimation tools)

Subjective assessmentsAssess impact of psoriasis on physical, psychological, and social wellbeing. Questions toask include:

How does having psoriasis affect the patients daily life, at home, work or school? How is the patient coping with the condition and are they using any treatments? How does the patient feel e.g. depressed, anxious, low self-esteem, lonely? How is the condition affecting their relationship with their partner, family, friends

etc? Do they need further advice and support?

Quality of Life (QOL) measurements are important to properly assess the full effect of anillness such as psoriasis on patients. Two dermatology specific tools to assess QOLimpact of psoriasis are:

DLQI Dermatology Life Quality Index: self-reported questionnaire that consistsof 10 items covering symptoms and feelings, daily activities, leisure, work andschool, personal relationships and treatment. Each item is scored on a four pointscale, with higher scores indicating greater impairment in QOL. A final score iscalculated and ranges from 0 (no impairment of QOL) to 30 (maximumimpairment).

SKINDEX-16 Single-page survey that evaluates the most bothersome rather

than the most frequent symptoms. The self-reported survey measures cognitiveeffects, social effects, depression, fear, embarrassment, anger, physical discomfortand physical limitations.

Definition of plaque psoriasis severity

To improve patient care, both the European and Australian consensus programme havebeen established to develop specific treatment goals for psoriasis. In doing this, the needfor defining psoriasis severity was evident. A summary of the Australian consensus fordefinition of plaque psoriasis severity is shown below.

Definition of plaque psoriasis severity: An Australian consensusMild plaque psoriasis

PASI 10 and DLQI 10

Moderate to severe plaque psoriasis

PASI >10 irrespective of DLQI (i.e.: a PASI >10 is considered moderate to severedisease regardless of the DLQI)

PASI 10 and DLQI >10 presence of one or more of the following features maysignificantly impair quality of life in setting of mild psoriasis and alterclassification to moderate to severe disease

o Involvement of visible areas, major parts of the scalp, genitals, or palmsand/or soles

o Onycholysis or onychodystrophy of at least two fingernailso Pruritus leading to excoriation

Referral to specialist

Referral to a specialist is recommended in the following circumstances:

Diagnostic uncertainty Acute erythroderma or generalized pustular psoriasis (emergency referral) or

acute unstable psoriasis (urgent referral) Difficult to treat sites (e.g. face, genitalia, palms and soles) unresponsive to initial

treatment Extensive disease (more than 1020% BSA involvement) likely to require

phototherapy and/or systemic treatment Psoriasis unresponsive to topical therapies

o Failure of appropriately used topical therapy for a reasonable period (e.g.23 months)

o Unexpected adverse reactions to topical therapies

o Need for increasing amounts or potency of topical steroids Major physical and/or psychological disability associated with the disease

Management and treatmentThere is no cure for psoriasis. Successful management is very much dependent on thepatient fully understanding the chronic nature of psoriasis and the therapeutic options thatare available to them. Points to consider prior to initiating therapy include:

Reassuring the patient that psoriasis is not contagious. Determining how the patient perceives their disability as this will often dictate the

need and type of treatment. Educating patients about various treatments and how some can be difficult to use

and how some may have adverse effects. Provide general advice regarding the benefits of not smoking, avoiding excessive

alcohol and maintaining optimal weight.

Treatment must be individualized and depends on the characteristics of the psoriasis itsbody location, thickness of lesions and degree of erythema and scaling. In addition, thepatients preference or commitment to therapy must also be considered.

To enhance the availability and appropriate use of therapies and increase patientsatisfaction, psoriasis treatment goals have been developed by both European andAustralian consensus committees. The Australian treatment goals, which are inagreement with the European treatment goals, are summarized in the following table.

Psoriasis treatment goals for mild plaque psoriasisPASI 10 and DLQI 10

Treat with topical agents Remains mild, continue with topical agents Worsening condition, treat as for moderate/severe psoriasis

Psoriasis treatment goals for moderate to severe plaque psoriasisPASI >10 or PASI 10 and DLQI >10

Treat with non-biologic systemic therapy and/or phototherapy

Response (measured by percentage change in PASI score)*Good = PASI 75% andDLQI 5

Continue with

Partial = PASI 50% and

systemictherapy and/orphototherapy

systemic therapyand/orphototherapy

And DLQI >5,modify/changetherapy**

trialed or contraindicated, andPASI and/or DLQI remain >10, treat with biologic therapy

*% change in PASI score compares PASI score at treatment initiation to PASI score at treatment review.Appropriate time to review varies with each treatment and the range is 624 weeks.** In addition to changing treatment, modify may include adding topicals or other systemic treatments,increasing dose/frequency, or hospital admission. Patients wishes should be taken into account intreatment decisions.

The guidelines above provide a framework for initiating and monitoring psoriasistreatment, however there needs to be some flexibility in how they are used in clinicalpractice. Even though the guideline may indicate modifying or changing your patientstreatment according to their assessments, there are situations where a treatment change isnot actually necessary. Some points to consider are:

Although a high DLQI >10 and a low PASI 10 can be considered

moderate to severe disease, the high DLQI may be a result of other factors otherthan the psoriasis itself. These may include:

o Co-morbid conditions or psychiatric issueso Patient has unrealistic expectations of treatment (especially if consistently

high DLQI despite reducing PASI scores)o Significant life changing event or serious illness that may temporarily

worsen DLQI and/or PASI scores Treatment success or failure is dependent on how the patient perceives their

condition and how committed they are to their treatment regimen. It is veryimportant to incorporate patients wishes in treatment decisions. For example, apatient with satisfactory response to treatment may wish to change their treatmentfor various reasons, even though this may be contrary to the treatment guidelines.

The American Academy of Dermatology's position statement on the treatment of patientswith moderate to severe psoriasis is as follows:

Therapeutic options in the treatment of chronic plaque psoriasis should be tailored to meet individualpatients needs. Psoriasis patients with moderate-to-severe psoriasis and thus, candidates for systemictherapy, should be placed on the appropriate therapy from the beginning, i.e. phototherapy, or systemictherapy including biologic therapy. The old paradigm of stepwise-therapy, i.e. first phototherapy, thenoral systemic therapies and finally biologic therapies in ascending order is not required. The decision fortreatment should be based on efficacy, potential adverse effects, prior treatments, patient preference,duration and severity of disease, medical risk factors, co-morbidities, and potential impact on quality of life.

Pharmacological therapy in psoriasis

Topical therapy

Approximately 80% of psoriasis patients have mild to moderate disease that can betreated with topical agents. Successful treatment is highly dependent on patientacceptance of their topical regimen. It is important to match patient expectations withpractical considerations. General principles for using topical therapies include:

Choice of vehicle multiple vehicle types available to deliver the active agent.These can include ointments, creams, solutions, gels, foams, sprays, shampoos,oils and lotions. The vehicle used may have an effect on the efficacy of the activeagent but the optimal choice is usually dictated by what the patient feels mostcomfortable using.

Occlusion of some topical agents can change the effectiveness of the medication.For example, some topical corticosteroids when occluded have much greaterpenetration, thereby varying effectiveness.

Compatibility issues when using a combination of topical agents. For example,calcipotriol should not be used concurrently with agents that alter the pH of itsbase, such as topical lactic acid or salicylic acid. Patients may be advised to applyvarious topical medications at different times throughout the day.

Review patients regularly those who require continuous topical treatment shouldbe monitored and treatment adjusted so they receive the least potent agent oragent with lowest long-term risk that achieves disease control.

Topical treatments include emollients, vitamin D analogues, corticosteroids, salicylic acid,retinoids, coal tar and dithranol. The following table summarises the main topicaltreatment options.

Topical treatment Features

Emollient

Helps to lift scale and reduce fissuring. Use as a soap substitute where soap is especially irritating to

inflamed skin. Some patients dont like the greasy feel of certain products.

Coal tar

Used for over 100 years to treat psoriasis and is safe andeffective.

Limited use because of poor patient acceptance due tocosmetic issues such as smell, staining of skin and clothes,messy to apply and potential to cause folliculitis.

Dithranol

Effective on large, thick plaques as short-contact therapywhere it is applied then rinsed off with water after a shortperiod of time (10 to 30 minutes).

Often irritant to surrounding normal skin and may stain skinand clothing.

Salicylic acid Effective keratolytic agent that reduces scaling to allow other

topical treatments to penetrate.

Vitamin D analogue(calcipotriol)

Effective on most chronic plaque psoriasis. Initially usetwice daily and reduce to once daily as condition improves.

Ointment base is better absorbed than cream base. Can cause irritation, especially on the face and in flexures. Rarely causes elevated serum calcium. To avoid risk of

hypercalcaemia, do not use with calcium or vitamin Dsupplements.

Total dose should not exceed 5 mg/week (i.e. 100 g of 50mcg/g ointment or cream).

Often used in combination with corticosteroid agent as it hasa corticosteroid-sparing effect.

Use in combination with salicylic acid can reduce efficacy ofcalcipotriol.

Corticosteroid

Cornerstone of treatment for most patients, especially thosewith limited disease. Easy to use and causes no irritation.

Use mild to moderate potency corticosteroid once or twicedaily on the face, intertriginous areas, areas with thin skin,and in infants (for a maximum of 2 weeks). If responseunsatisfactory consider using a topical calcineurin inhibitor.

Initial therapy with moderate to high potency corticosteroidscan be used in other areas of the body (trunk, limbs andscalp). Apply once daily for up to 4 weeks. Considercombining with other topical agents, UV light, and systemicagents if response unsatisfactory.

Thick chronic plaques and plaques on hands and feet mayrequire very high potency agents (class I steroids) for 2-4weeks. Do not exceed 50 g/week.

Potential side effects that limit use include local effects suchas skin atrophy, telangiectasia, striae, acne, and folliculitis.Systemic effects include adrenal suppression, increasedintraocular pressure, glaucoma, and cataracts.

Tachyphylaxis may occur with long-term use and results indecreased efficacy, and sometimes an acute flare-up whentreatment is stopped.

Minimise side effects and tachyphylaxis by gradualreduction in frequency, or change to less potent formulationfollowing clinical response. Another strategy is to havecorticosteroid-free times, for example, take a minimum breakof 4 weeks before reusing high potency topicalcorticosteroids.

Calcineurin Initiated by dermatologist or doctor with expertise in treating

inhibitor(tacrolimus,pimecrolimus)

psoriasis. Effective in facial and intertriginous psoriasis and may be

preferable to long-term potent topical steroids in these sites. Apply twice daily for up to 4 weeks, then review treatment. Most common side effect is burning and itching that

generally reduces with ongoing usage. Tacrolimus is not availablle in New Zealand (2014).

Retinoid(tazarotene)

Best used in combination with topical corticosteroids.Applied once daily.

Most common side effect is skin irritation in lesional andperilesional skin.

Potentially photosensitizing so use with caution whencombining with phototherapy.

Tazarotene is not available in New Zealand.

Phototherapy

Traditional broadband ultraviolet B (BB-UVB) phototherapy has been used totreat psoriasis for more than 75 years. In the last 20 years, narrowband UVBlamps have improved phototherapy for psoriasis with increased efficacy andreduced toxicity.

Photochemotherapy (PUVA) was introduced to New Zealand in the 1980s but isnow rarely used.

Phototherapy can be given either as monotherapy or in combination with topicalor systemic agents.

Initial dosage of UVB is based according to Fitzpatrick skin type or the minimalerythema dose (MED), with subsequent dosages adjusted accordingly.

Phototherapy is administered in hospital or some private dermatological practices.It requires treatments 2-3 times per week for up to 2 months or longer.

Risks of phototherapy include erythema and burning, premature aging of the skin,and presumed increase in skin cancer. Accurate records of the dosage and numberof treatments along with any side effects must be recorded for every patient.

Phototherapy is contraindicated in patients with known lupus erythematosus orxeroderma pigmentosum.

Traditional (non-biologic) systemic therapy

Most commonly used traditional systemic agents include methotrexate,ciclosporin, and acitretin. Their oral route of administration and low cost(compared with biologics) makes them important treatment options.

Methotrexate given as a single weekly oral dose (range 10 to 30mg) is effectivefor at least 60% of psoriasis patients. It is contraindicated in pregnancy andlactation, in patients with cirrhosis, and in patients with significant anaemia,

leucopenia or thrombocytopenia. Patients require ongoing monitoring to reducethe risk of haematological toxicity and hepatotoxicity.

Ciclosporin is highly effective as it produces a rapid response. Useful in crisismanagement when rapid or short-term disease control is required, e.g. psoriasisflare. Patients must be monitored for nephrotoxicity and hypertension.

Acitretin, an oral retinoid agent, is particularly useful for erythrodermic andpustular forms of psoriasis. It is considered the treatment of choice in HIV-positive patients with severe psoriasis as it does not cause significantimmunosuppression. It is highly teratogenic, so is contraindicated in pregnancyand its use is severely limited in women of childbearing age (strict contraceptionfor 2 years after stopping treatment).

Other systemic agents include azathioprine, fumaric acid esters, hydroxyurea,leflunomide, mycophenolate mofetil, sulfasalazine, tacrolimus, and 6-thioguanine.These agents may be considered in treatment-resistant disease or where multipleadverse events prevent or limit the use of methotrexate, ciclosporin and acitretin.

Biologic systemic therapy

In the last decade biologic response modifiers in the treatment of psoriasis have beenshowing promising results, treatment is well tolerated and often very effective inmoderate to severe disease. While they are often more efficacious than traditionalsystemic therapies, the long term risks are still largely unknown. In addition, biologicsystemic therapy is expensive, hence their use in clinical practice remains limited.

In most countries where biologic response modifiers are being used to treat severechronic plaque psoriasis or psoriatic arthritis, fully funded access to these agents iscontrolled by exclusion and inclusion criteria set by government medical agencies.PHARMAC, the governing agency in New Zealand, require patients to meet thefollowing criteria to receive fully funded systemic therapy with adalimumab, etanercept,and infliximab.

PHARMAC Initial application to use adalimumab, etanercept, and infliximab.Patient must meet all of the following criteria..

1. Either:a. Patient has "whole body" severe chronic plaque psoriasis with a Psoriasis

Area and Severity Index (PASI) score of greater than 15, where lesionshave been present for at least 6 months from the time of initial diagnosis;OR

b. Patient has severe chronic plaque psoriasis of the face, or palm of a handor sole of a foot, where the plaque or plaques have been present for at least6 months from the time of initial diagnosis; AND

2. Patient has tried, but had an inadequate response (see Note) to, or has experiencedintolerable side effects from, at least three of the following (at maximum tolerateddoses unless contraindicated): phototherapy, methotrexate, cyclosporin, oracitretin; AND

3. A PASI assessment has been completed for at least the most recent priortreatment course (but preferably all prior treatment courses), preferably while stillon treatment but no longer than 1 month following cessation of each priortreatment course; AND

4. The most recent PASI assessment is no more than 1 month old at the time ofapplication.

Note: Inadequate response is defined as: for whole body severe chronic plaquepsoriasis, a PASI score of greater than 15, as assessed preferably while still on treatmentbut no longer than 1 month following cessation of the most recent prior treatment; forsevere chronic plaque psoriasis of the face, hand or foot, at least 2 of the 3 PASIsymptom subscores for erythema, thickness and scaling are rated as severe or verysevere, and the skin affected is 30% or more of the face, palm of a hand or sole of a foot,as assessed preferably while still on treatment but no longer than 1 month followingcessation of the most recent prior treatment.

Guidelines for the management of psoriasisDefinitionBackgroundPatient assessment and diagnosisDefinition of plaque psoriasis severityReferral to specialistManagement and treatmentPharmacological therapy in psoriasisTopical therapyPhototherapyTraditional (non-biologic) systemic therapyBiologic systemic therapy