Quality-of-life issues in psoriasis and psoriatic ...bestpsoriasis.jaad.org/pdf/JAAD Psoriasis supplement_R82-Mease.pdf · R82 Reprinted from: J Am Acad Dermatol 2006;54:685-704

R82 Reprinted from: J Am Acad Dermatol 2006;54:685-704.

REVIEW

Quality-of-life issues in psoriasis and psoriaticarthritis: Outcome measures and therapies from

a dermatological perspective

Philip J. Mease, MD,a and M. Alan Menter, MDb

Seattle, Washington, and Dallas, Texas

Psoriasis and psoriatic arthritis are inflammatory immune-mediated skin and joint conditions with majorimpacts on patients’ health-related quality of life (HRQOL). Physical manifestations include unsightly, scaly,pruritic plaques and inflamed joints for patients with psoriatic arthritis. These symptoms can severelyimpair physical functioning and occupational capability and negatively affect psychosocial domains.Consequently, patients often experience feelings of embarrassment, helplessness, and depression. Recenttherapies, including the biologics, have been shown to improve not only the physical signs and symptomsof these conditions, but also patients’ HRQOL. To accurately assess these improvements, standardized andvalidated instruments are needed. However, there are currently a limited number of feasible and validatedtools available in dermatology for measuring HRQOL and function. Valuable insights can be acquired fromthe rheumatology field, and refinement of existing outcome measures through a cooperative andconsensus building process between dermatologists and rheumatologists will lead to standardization ofassessment tools in the years ahead. ( J Am Acad Dermatol 2006;54:685-704.)

Dermatological conditions, such as psoriasis,have traditionally been regarded as diseasesthat, in the majority of cases, are amenable

to therapy with topical agents only. Similarly thearthritis that can occur in patients with psoriasis,psoriatic arthritis (PsA), has often been considered arelatively benign, fairly uncommon condition. Overthe past several years, this view has been refuted bynumerous findings from clinical studies that havedemonstrated a significant physical, social, and

psychological burden associated with dermatosesand arthritides, especially psoriasis and PsA.1-6 Thesestudies have reported the stress and disruption in thedaily routines of patients, which, in turn, affect theirability to pursue valued life goals.

Psoriasis and its related PsA are inflammatoryimmune-mediated conditions that have been shownto have major impacts on patients’ health-related

Abbreviations used:

AIMS: Arthritis Impact Measurement ScaleDLQI: Dermatology Life Quality IndexDQOLS: Dermatology Quality of Life ScalesGHQ: General Health QuestionnaireHAQ: Health Assessment QuestionnaireHRQOL: health-related quality of lifeKMPI: Koo-Menter Psoriasis InstrumentNHP: Nottingham Health ProfileNPF: National Psoriasis FoundationOMERACT: Outcome Measures Rheumatoid

Arthritis Clinical TrialsPASI: Psoriasis Area and Severity IndexPDI: Psoriasis Disability IndexPLSI: Psoriasis Life Stress InventoryPQOL-12: psoriasis-specific HRQOL 12-item

scalePsA: psoriatic arthritisPsAQOL: Psoriatic Arthritis Quality of Life

[measure]RA: rheumatoid arthritisSF-36: Short-Form-36 Health SurveySIP: Sickness Impact ProfileSPI: Salford Psoriasis IndexTNF: tumor necrosis factor

From Seattle Rheumatology Associates,a and Psoriasis Research

Center, Baylor University Medical Center, Dallas.b

Funding sources: Supported by Amgen Inc and Wyeth.

Disclosure: Dr Mease has received research support from and is a

consultant and/or lecturer for Abbott Laboratories, Amgen Inc,

Aventis, Biogen/Idec, Centocor Inc, Genentech Inc, Merck,

Novartis, Pfizer, and Wyeth. Dr Menter has received research

support from and is a consultant and/or a lecturer for Abbott

Laboratories, Allergan Inc, Allermed, Amgen Inc, Astralis Inc,

Berlex Inc, Biogen/Idec, Centocor Inc, Collagenex Pharmaceu-

ticals, Connetics Corporation, Dermik Laboratories, Doak

Dermatologics, Dow, Ferndale Laboratories Inc, Fujisawa

Healthcare Inc, Galderma, Genentech Inc, GlaxoSmithKline,

Ligand Pharmaceuticals, Medicis, MedImmune Inc, Novartis

Pharmaceuticals, Otsuka Pharmaceuticals Inc, Serono, Synta

Pharma, Thermosurgery, 3M Pharmaceuticals, and XOMA.

Reprint requests: Philip J Mease, MD, Seattle Rheumatology

Associates, 1101 Madison St, 10th Floor, Seattle, WA 98104.

E-mail: [email protected].

0190-9622/$32.00

ª 2006 by the American Academy of Dermatology, Inc.

doi:10.1016/j.jaad.2005.10.008

685

R83reprinted from J Am Acad Dermatol

quality of life (HRQOL).1,4,6-10 Psoriasis is a chronicrelapsing skin disorder affecting 2% of the popula-tion, presenting as scaly, erythematous plaques.11,12

PsA is a spondyloarthropathy with a prevalencereported from 5% to 42% of patients with psoriasis,with potential for significant joint destruction con-tributing to pain and disability.13,14 The overt signsand symptoms of psoriasis and PsA often leavepatients with an acute and sometimes distortedperception of their self image as well as a feeling ofembarrassment about their appearance. The emo-tional burden of carrying such a stigma often leads toa significant decline in the patient’s well-being.

In this article, we discuss the impact of psoriasisand PsA on patients’ HRQOL by examining theeffects of these conditions on patients’ functionalcapabilities and on their psychosocial well-being.Wealso describe some of the currently accepted out-come measures used by dermatologists and rheu-matologists to assess quality of life and review recentclinical trials evaluating the effects of psoriatic ther-apies in the improvement of HRQOL.

IMPACT OF PSORIASIS AND PSORIATICARTHRITIS ON QUALITY OF LIFE

Measurement of disease activity and impactinvolves assessment of both physical signs as wellas subjective experience. A 75% reduction in thePsoriasis Area and Severity Index (PASI 75) is con-sidered a primary end point in clinical trials ofpsoriasis.15-17 PASI is a calculation based on theparameters of erythema, scaling, and induration in4 body areas using the rule of 9’s.18 However, a 50%improvement (PASI 50) has recently been shownto be a valid and clinically meaningful measure.19

Although the PASI measures disease severity at thetime of assessment, it does not provide any informa-tion about the patient’s psychological and mentalwell-being. In fact, for many diseases like psoriasisand PsA, two patients with similar disease manifes-tations, such as a similar PASI score, may be affectedquite differently by their disease. Therefore quality-of-life measures are as important as physiological orbiological measures in evaluating the consequencesof a disease. Measuring HRQOL provides a comple-mentary assessment of the patient’s overall well-being because it defines the functional effect of anillness and its therapy based on the patient’s ownperception. In general, HRQOL encompasses thephysical and psychosocial (psychological, social,and vocational) impairment related to the disease,as well as the therapeutic regimens associated withits treatment.20 Recognizing the tremendous impactthat psoriasis and PsA have on daily activitiesare important for understanding the significant

challenges patients have to cope with in living withthese disfiguring and disabling skin and jointdisorders.

Physical impactVisible manifestations of psoriasis take the form

of circumscribed, thickened, scaly plaques that areoften pruritic.11,12 Lesions may be localized to indi-vidual areas such as the scalp, elbows, knees, andbuttocks or involve the total body surface area as inerythrodermic psoriasis.11,12 The extent and durationof the symptoms may vary according to the severityof the skin disease, ranging from itching, irritation,and redness to physical pain, skin soreness, bleedingfrom psoriatic lesions, fatigue, and insomnia.

In addition to their skin lesions, patients with PsAalso are faced with the painful and potentiallydisabling effects of arthritis. The joint inflammationin PsA frequently involve the digits (dactylitis), thespine and back (spondylitis), and the site of insertionbetween the tendons and ligaments (enthesitis).14

Skin lesions usually precede arthritis by 5 to 10 yearsin most patients with PsA.21 Involved joints are warmand swollen, resulting in pain and discomfort andlimiting the patient’s mobility. Over time, cartilageand bone erosion in PsA can lead to significantdeformities and permanent disability.

The cumulative effects of the disease, in eitherthe skin alone or the skin and joints, all contribute todecrements in patients’ physical functioning status.Physical functioning includes the patient’s mobility,daily activities, energy/vitality, and sleeping habits.22

For many patients, activities such as walking, climb-ing stairs, and routine occupational duties (eg, typingor lifting) are significantly impaired.6,22 Rapp et al9

showed that patients with psoriasis had significantdecrements in their physical functioning capacitythat was comparable to those of patients with othermajor medical conditions, including cancer, arthritis,hypertension, heart disease, diabetes, and depres-sion. In a large survey sponsored by the NationalPsoriasis Foundation (NPF) in the United States,Krueger et al6 reported that elderly patients ($55years old) had the greatest physical impairments andwere more likely to report difficulties in daily livingactivities such as using their hands (19%) or walking(14%). Limitations in performing these activities maybe exacerbated in patients with PsA because ofmobility issues associated with the arthropathy,with more than 60% of elderly patients with PsAreporting difficulties in using their hands, standingfor long periods, and walking.6 Psoriasis may alsocompromise the patient’s ability to sleepwell, which,in turn, adversely affects their energy level and theability to perform their jobs.6,22 Although patients

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with PsA have reported higher levels of energy thanpatients with rheumatoid arthritis (RA), they never-theless experience lesser physical health comparedwith the general population.4 Furthermore, com-pared with RA patients, patients with PsA reportedmore bodily pain.

Psoriatic patients frequently have to alter their dailyroutines and generally avoid social activities. In theNPFsurvey, 26%claimed that theirdisease forced themto alter or stop their normal daily activities and 40%reported difficultieswith their choice of clothing.6,23 Ina large European survey conducted by the EuropeanFederation of Psoriasis Patients Organisations, a sig-nificant proportion of patients also reported havingdifficulties choosing their clothes (46%), washing andchanging their clothes (38%), bathing (37%), andengaging in sport activities (26%). *,y

Psoriasis also adversely affects patients’ occupa-tional capability, which can lead to significant finan-cial difficulty.6 Patients have reported discriminationat work and job disruptions because of the timeneeded for medical attention or because of physicallimitations imposed by their disease. In one study, asmany as 59% of patients required time off from workduring the preceding year.1 Those with severe formsof PsA may also find that they can no longerphysically perform their usual duties, such as liftingboxes or filing documents as part of their dailyroutines, and are either forced into early retirementor unemployment. The financial burden is oftensubstantial and includes the cost of care, the timeneeded for medical care, lost wages from time off,and unemployment due to disability.24 The impact ofpsoriasis on financial quality of life is even greater forpatients with lower family income.6 Overall, 31% ofpatients in the NPF survey reported suffering finan-cial difficulty. Among those earning less than $30,000a year, 42% faced financial difficulties and lived infear of losing their jobs.6

Psychosocial impactThe burden of coping with the physical problems

associated with psoriasis and PsA inevitably affects

psychosocial domains. Pruritus, in particular, isassociated with distressing symptoms and depres-sion.25 Because psoriasis usually begins early in life(60% before the age of 30 and 14% before the ageof 10),26 changes of physical appearance and anyaccompanying psychosocial effects are an enduringhardship.

The impacts of dermatological diseases onpatients’ lives are substantial and have been con-sistently underestimated. Psoriasis and PsA are asso-ciated with significant psychosocial morbidity and areduction in HRQOL. Of the patients who respondedto the extensive 2001 NPF survey, 79% believedpsoriasis had a negative impact on their lives.6 Thisfinding was almost identical to a more recent NPFsurvey, which found that 77% of patients consideredpsoriasis to be a moderate to-large problem in theirlives.23 Similar responses were found amongEuropeans in the European Federation of PsoriasisPatients Organisations survey, in which 60% ofpatients reported that their psoriasis was a problemor a significant problem.*,y As discussed previously,patients experience feelings of embarrassment, help-lessness, and frustration about their disease.27

Unresolved emotional problems can often deterio-rate into more intense feelings of anger, anxiety, anddepression that may lead to increased alcohol useand other behavioral changes. A majority of patients(54%) in the 2001 NPF survey reported feelingdepressed and experiencing significant life disrup-tions and social withdrawal as a result of theirdisease.6 Additionally, Gupta and Gupta28 foundthat many patients had a death wish (9.7%) andsuicidal ideation (5.5%), especially prevalent inyounger people and a considerable increase overthat found in the nonpsoriatic population.

In addition, patients with psoriasis generally havelow self-esteem. Thus 81% have reported feelingembarrassment and shame, whereas 75% reportedfeeling physically unattractive and/or sexually un-desirable.6,22 Afflicted patients are conscious aboutthe clothes they wear and the social events theyattend. Many report limitations with skin exposingsocial activities, such as communal swimming, sportsactivities, and sunbathing.6,22 These limitations maynot necessarily be of the patient’s making, consider-ing that 40% have reported experiencing problemswith receiving equal service or treatment in variousservice establishments,6 and 19% have reportedexperiencing instances of gross social rejection,such as being asked to leave a place because of theirdisease.29 Social contacts and intimate relationshipsare also negatively affected, with a significant de-crease of sexual functioning observed for manypatients.6,22

*Salonen SH on behalf of the EUROPSO Patient Survey Study

Group. Large-scale European Survey of Quality of Life in

Patients with Psoriasis: Second-phase results on quality of life

and treatment reported by 7,575 members of European pso-

riasis patient associations. The EUROPSO Psoriasis Patient

Study. Presented at the 10th International Psoriasis Symposium,

June 10-13, 2004, Toronto, Canada.ySalonen SH on behalf of the EUROPSOPatient Survey Study Group.

The EUROPSO psoriasis patient study: Treatment history and

satisfaction reported by 17,990 members of European psoriasis

patient associations. The EUROPSO Psoriasis Patient Study.

Presented at the 1st European Academy of Dermatology and

Venereology Spring Symposium, Feb 27-March 1, 2003, Malta.

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Patients with psoriasis and PsA rarely experiencedeath directly because of their disease or its treat-ment. Even in reported cases of death of patientsdue to psoriasis, the primary cause of mortality is re-lated predominantly to its therapy (eg, methotrexate[MTX] and methoxypsoralen plus ultraviolet A ther-apy).30,31 Although deaths directly related to PsA arerare, in one center patients with PsA had prematuremortality compared with the general public.32,33

Wong et al33 observed that of the 428 patients froman outpatient clinic, 53 died of causes ranging fromdiseases of circulatory or respiratory systems, malig-nant neoplasms, and fatal injuries and/or poisoning.This was considered to be 67% higher than thebackground mortality rate in that region. Althoughthese deaths were not directly linked to PsA, thehigher incidence raises the possibility of comorbiditythat could be affected by more effective and timelytreatment.

HRQOL is a relatively new area of research focusin psoriasis because of a growing awareness amongdermatologists that physical manifestations such asredness, scaling, and induration represent only aportion of the impairment and the potential dramatic

impact of therapy on HRQOL. There are currently alimited number of feasible and validated tools avail-able to measure HRQOL and function. Based on therelatively large body of literature on HRQOL andassessment tools that have been developed forrheumatic diseases over the years, the rheumatologyfield is able to provide some valuable insights.

LESSONS LEARNED FROMRHEUMATOLOGY

Several rheumatology studies have shown thatthe mechanisms underlying the pathogenesis of pso-riasis and other rheumatic diseases, including adultand juvenile RA, PsA, and ankylosing spondylitis aremediated by a similar network of proinflammatorycytokines (eg, tumor necrosis factor-a [TNF-a] andinterleukin 1) and cellular components (eg, T cells,fibroblasts, and macrophages).34,35 In many cases,therapeutic approaches that are successful in treatingRA and other musculoskeletal diseases have beendemonstrated to be equally effective in alleviatingthe signs and symptoms of psoriasis and PsA, as wellas in improving patients’ HRQOL.16,17,36-40

As a result of these therapeutic advances, mea-surements of physiological and psychosocial factorsin rheumatic diseases have been continuously re-fined over the years to provide more accurate andreliable tools. The development and validation ofthese instruments have been facilitated by the con-certed efforts of rheumatologists to standardize out-come measures that truly reflect specific areas ofa patient’s health that are being evaluated. Theseefforts are focused inOMERACT (OutcomeMeasuresin Rheumatoid Arthritis Clinical Trials), an interna-tional initiative that strives to improve outcomemeasurement through a data-driven, iterative con-sensus process, based on the collaboration of inves-tors, industry, and Food and Drug Administrationrepresentatives.41 The biostatistical quality of out-comemeasures used in trials is critically assessed andjudged by the standard of the OMERACT filter,42 thatis, truth (does the instrument have face, content,construct, and criterion validity?), discrimination (isthemeasure reliable and sensitive enough to discrim-inate between situations that are of interest?), andfeasibility (can the measure be applied easily, givenconstraints of time, money, and interpretability?).

Measuring quality of life in rheumatic diseasesoften requires multiple instruments, depending onthe specific domains that are being assessed (Table I).Many measures have been developed for functionaldisability. Themost common andwidely used instru-ment in RA is the Health Assessment Questionnaire(HAQ), a 20-item instrument that focuses on twodimensions of health, physical disability (8 subscales)

Table I. Commonly used quality-of-life measuresin rheumatology

Psychosocial

dimensions Instruments References

Depression Beck DepressionInventory

Beck et al59 (1961)

GHQ Chandarana et al60 (1987)SF-36 Ware, Snow, and

Kosinski50 (2000)AIMS-2 Husted et al45 (1996)

Functionaldisability

HAQ Fries et al43 (1980)

Modified HAQ Blackmore et al76 (1995)AIMS and AIMS-2 Husted et al46 (1996);

Husted et al45 (1996)Pain VAS Fries et al52 (1982)

Likert Scale Fries et al52 (1982)Fatigue FACIT Cella et al54 (2002)

FSS Krupp et al55 (1989)MAF Belza56 (1995)MFI Smets et al57 (1995)NHP McEwen58 (1993)

Anxiety GHQ Chandarana et al60 (1987)AIMS-2 Husted et al45 (1996)

AIMS, Arthritis Impact Measurement Scale; FACIT, Functional

Assessment of Chronic Illness Therapy; FSS, Fatigue Severity Scale;

GHQ, General Health Questionnaire; HAQ, Health Assessment

Questionnaire; MAF, Multidimensional Assessment Fatigue Scale;

MFI, Multidimensional Fatigue Inventory; NHP, Nottingham Health

Profile; SF-36, Medical Outcomes Study Short Form-36; VAS, Visual

Analogue Scale.

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and pain.43 A modification of the HAQ, called theHAQ-S, has been developed for spondyloarthropa-thies and tested in patients with PsA.44 Although theHAQ-S measures physical disability, it only incorpo-rates aspects of disability associated with the joints,but not the skin. In addition, the HAQ-S does notconfer any advantage over the original HAQ whentested in patients with PsA, which may limit itsusefulness. Other measures of disability include theArthritis Impact Measurement Scale (AIMS) andAIMS-2 for the assessment of PsA,45,46 and the BathAnkylosing Spondylitis Functional Index and theBath Ankylosing Spondylitis Disease Activity Indexfor the assessment of ankylosing spondylitis.47,48

Generic instruments, such as the Medical OutcomeStudy Short Form-36 (SF-36) and the EUROQOL (EQ-5D), are also valuable tools for evaluating physicaldisability and can be utilized in studies of all rheu-matic and dermatologic diseases.49-51

In addition to disability, physical parameterssuch as pain and fatigue are also measurable featuresof RA and spondyloarthropathies. Pain is commonlyassessed using a visual analogue scale or the Likertscale, both of which are included as subscales inmany instruments, including the HAQ and the SF-36.52,53 Disease-related fatigue can be evaluated byusing a variety of instruments including the follow-ing: the Functional Assessment of Chronic IllnessTherapy,54 the Krupp Fatigue Severity Scale,55

the Multidimensional Assessment Fatigue scale,56

the Multidimensional Fatigue Inventory,57 or theNottingham Health Profile (NHP).58

Assessing psychosocial well-being in rheumaticand dermatologic conditions is an especially impor-tant dimension to measure because of their impacton emotional and psychological well-being. Inclinical trials, much of the emphasis has been ondepression and anxiety. Measures like the BeckDepression Inventory59 or more generic instruments,such as theGeneral HealthQuestionnaire (GHQ) andthe SF-36, are self-administered questionnaires thatinclude depression and/or anxiety subscales.50,60

Other psychosocial variables include social support,coping skills, health cognition, spirituality, and pos-itive mood, all of which require specialized instru-ments for measurement.53,61 The World HealthOrganization and OMERACT recently introducedthe concept of ‘‘participation in life’’ as another im-portant facet of HRQOL.62 ‘‘Participation’’ is definedas a patient’s social functioning status or real-lifeperformance and involvement in community andrecreational activities. It can also be described as thepatient’s willingness and enthusiasm to pursue val-ued life goals despite the limitations imposed by thedisease and other social and environmental factors.

Although there are currently no measures for ass-essing ‘‘participation,’’ these instruments are indevelopment.

The large number of outcome measures utilizedin the study of rheumatic diseases underscores thecomplexity involved in the assessment of HRQOL.Generally, it has been recommended that clinicaltrials include one generic measure of health status(eg, SF-36) and one instrument specific either to adisease (eg, PsA or RA), to a problem (eg, pain), or toa patient population (eg, child vs adult).63,64 Disease-specific instruments such as the Rheumatoid ArthritisQuality of Life measure, the Ankylosing Spondy-litis Quality of Life measure, and the Psoriatic Arthri-tis Quality of Life measure have all purported toassess very specific aspects of quality of life unique totheir respective disease.65-67 In addition to specific-ity, disease-specific instruments have been shown tohave increased sensitivity and responsiveness tosmall but clinically important changes, comparedwith generic instruments.20,68 However, one of theadvantages of generic instruments is that they pro-vide additional information about comorbid condi-tions or treatment side-effects that are not easilycaptured by specific instruments. Thus generic andspecific instruments are complementary measuresthat, when combined, provide a comprehensiveassessment of the patient’s overall well-being.

In dermatology, evaluating quality of life inpatients with psoriasis and PsA requires similarlyvalidated and standardized instruments. Forums thatare modeled after OMERACT would provide anappropriate setting for academic and practicing der-matologists to engage in thoughtful discussions andcritiques of the kinds of outcome measures thatwould be most valuable to the dermatology world.An example of such a forum is the Group forResearch and Assessment of Psoriasis and PsoriaticArthritis. Formed in 2003, this international consor-tium of rheumatologists and dermatologists is fo-cused on a variety of tasks, ranging from establishingclinical registries to development of treatment guide-lines to standardization and validation of outcomemeasures for clinical trials in psoriasis and PsA. Thisincludes evaluation and refinement of measures ofquality of life, function and participation, which willin turn be further ratified by OMERACT. A newlyformed international psoriasis consortium, the Inter-national Psoriasis Council, will be a similar forumspecifically focused on psoriasis issues. Ideally, anyinstruments that are adopted should achieve testretest reliability, internal consistency, and face andconstruct validity, comparable to the OMERACTfilter. As with RA and other rheumatic diseases,utilization of multiple instruments may be warranted

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in psoriasis to capture the various dimensions ofHRQOL. For PsA, the choice of instruments will alsodepend on which areas—skin or joints—the patientconsiders of higher importance. For instance, pa-tients experiencing severe joint damage due to PsAmay be less concerned about their appearance if theyare faced with the possibility of being permanentlyhandicapped. Age is another factor, with youngerpatients more likely to be concerned about theirappearance (skin-focused), whereas elderly patientsare more likely to worry about physical disability(joint-focused).6 Dermatologists and rheumatolo-gists frequently have different views that are inevi-tably biased toward their areas of expertise. Toreconcile these differences, efforts are under wayto develop HRQOL tools that have dual purposes forassessing the impact of both psoriasis and arthritis inPsA patients.66,69

MEASURES OF QUALITY OF LIFE INPSORIASIS AND PSORIATIC ARTHRITIS

Over the past few years, assessments of HRQOLin patients with skin conditions have become morecommon in clinical trials. The increased attention toHRQOL is a consequence of a greater understandingwithin the dermatology community that more com-prehensive outcome measures can lead to bettertreatment strategies by providing valuable informa-tion that assists clinicians and patients. To accuratelyassess HRQOL, precise and reliable psychometricinstruments are needed. Currently, there is no con-sensus as to which measures provide the mostbenefit to dermatologists. In the following sections,we describe some of the widely used generic, der-matology-specific, and psoriasis-specific instrumentsand discuss their merits.

Generic instrumentsIn the past several years, several researchers have

applied existing patient-reported instruments, suchas the HAQ and the SF-36, to clinical trials of psoriasisand PsA.39,70-75,*,y Although these tools have beensomewhat successful in capturing the functionalimpairment associated with joint damage in PsA,

their clinical utility in skin-based assessments ofpsoriatic patients is limited.

The HAQ43 has been used extensively formeasuring disability in patients with RA, ankylosingspondylitis, and PsA (Table II). A modified HAQ forspondyloarthropathies (HAQ-S), and a psoriasis-specific HAQ (HAQ-SK), were developed to increasespecificity and sensitivity, but these instruments didnot enhance the health assessment capabilities of theoriginal HAQ.44,76,77 Both the HAQ and the HAQ-Sscores were shown to correlate with several clinicalmeasures of functional disability in patients withPsA.76 However, these scores correlated poorly withall measures of disease severity (eg, PASI scores) anddisease activity.76 The HAQ-SK, despite includingmore skin-focused questions, also did not correlatewell with the PASI score and was not very responsiveto articular changes.77 These findings suggest that theHAQ and its derivatives may not be appropriate forthemajority of psoriasis patients because it places toomuch weight on physical symptoms (impairment)and/or functioning (activity or disability). Althoughthe HAQ may be applicable to studying joint-relatedimpairments in PsA, it does not provide adequateassessments of skin-related discomfort or psychoso-cial problems. This problem is most obvious amongpatients with psoriasis who continue to experiencelow quality of life despite the absence of any skinlesions and physical disability during remission.

The SF-36, a generic health assessment question-naire, has been used in many clinical trials to studythe impact of several different types of chronicdiseases, including several rheumatic disorders. Itassesses 8 domains of health status: physical func-tioning, pain, vitality, social functioning, psycholog-ical functioning, general health perceptions, and rolelimitations due to physical and emotional problems(Table II).50 As a measure of both the physical andmental impact of a disease, the SF-36 has the abilityto assess a broad spectrum of dimensions in HRQOLand can be used in comparative analyses of variouspatient groups across multiple studies.

Several clinical trials of PsA have utilized the SF-36as an outcome measure for HRQOL.72,74,75,y Hustedet al77 demonstrated that the SF-36 was equally ormore responsive to short-term changes in perceivedhealth and inflammatory disease activity than eitherthe HAQ or the AIMS-2. However, the SF-36 corre-lates only moderately with clinical indicators offunction, pain, and arthritis activity in patients withPsA.78 One of the limitations of the SF-36 is that itemphasizes impairment and physical disability anddoes not give equal weight to important issuesrelevant to psoriasis such as stigmatization andembarrassment.79 Clinical trials of patients with

*Krueger G, Woolley JM, Zitnik R. The effects of etanercept therapy

on patient-reported outcomes for patients with moderate to

severe psoriasis. Presented at the 62nd Annual Meeting of the

American Academy of Dermatology; Feb 6-11, 2004, Washing-

ton, DC.yWanke LA, Gottlieb AB, Mease PJ, Kivitz AJ, Cohen SB, Burge DJ.

Etanercept (Enbrel�) improves health-related quality of life in

patients with psoriatic arthritis. Presented at the 66th Annual

Scientific Meeting of the American Academy of Rheumatology;

October 25-29, 2002; New Orleans, La.

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Table II. Instruments for measuring quality of life in psoriasis and/or psoriatic arthritis

Instrument Description

Generic*HAQ and variants d The full HAQ is based on 5 dimensions: disability, pain and discomfort, adverse treatment

effects, dollar costs of treatment, and deathd The abbreviated form focuses on 2 dimensions of health status: physical disability(20 questions in 8 subscales scored on a scale of 0-3) and pain (1 question scored on ahorizontal visual analogue scale of 0-100)

SF-36 d 36-item generic measure that consists of 8 scales of health status: physical function, rolelimitations due to physical problems, body pain, vitality/energy, social functioning, generalhealth, mental health, and role limitations due to emotional problems

d Can be aggregated into 2 summary scores: Physical Component Summary and MentalComponent Summary

d Scoring is on a 100-point scale, with a change of 5 points considered clinically significant

Dermatology-specificDLQI d 10-item instrument measures symptoms (1 item), feelings (1 item), daily activities (2 items),

leisure (2 items), work/school (1 item), relationship (2 items), and treatment (1 item), witheach item graded on a Likert scale of 0-3 for a maximum score of 30

d Patients answer questions with regard to previous 7 daysDQOLS d 41 items consisting of psychosocial subscales (embarrassment [5 items], despair [5 items],

irritableness [3 items], distress [4 items]), physical activities subscales (everyday [6 items],summer [3 items], social [2 items], sexual [1 item]), and symptoms (12 items)

d Each item rated on a Likert scale of 0-4 for a maximum score of 100

Psoriasis-specificKMPI d 12-item instrument derived from the 41-item Psoriasis QOL questionnaire, and graded on a

scale of 0-10 for a maximum score of 120d Based on assessment of previous monthd Total score of 50 or higher indicative of patients who should be considered for systemictherapy

d The information characterizes disease status in terms of its impact on quality of life, bodysurface area affected, the presence of joint involvement, and certain severe forms of psoriasis,and whether phototherapy is an option.

PDI d 15-item version derived from a 10-item instrument designed to quantify functional lifestyledisability 4 weeks before and 4 weeks after treatment

d Covers 5 areas: daily activities (5 items), work or school (3 items), personal relationships(2 items), leisure (4 items), and treatment (1 item)

d Scored on a visual analogue scale of 1-7 with a maximum score of 105, or a graded 4-pointtick-box system

PLSI d 15-item instrument based on an original 41-item questionnaire designed to provide an indexof psoriasis-related stress

d Covers stress associated with cosmetic disfigurement/social stigma (11 items) and stressassociated with symptoms of the disease and/or inconvenience of treatment (4 items)

d Each item graded on a scale of 0-3, for a maximum score of 45, based on assessment ofprevious month

SPI d Derived from combining a score of current severity of psoriasis based on the PASI (signs),a score indicating psychological disability, and a score based on historical information(interventions)

d The SPI transforms the PASI into a number from 0-10, assigns a score of 0-10 to psychologicaldisability based on the visual analogue scale, and a score of 1-5 for historical information.

DLQI, Dermatology Life Quality Index; DQOLS, Dermatology Quality of Life Scales; HAQ, Health Assessment Questionnaire; KMPI, Koo-Menter

Psoriasis Instrument; QOL, quality of life; PASI, Psoriasis Area and Severity Index; PDI, Psoriasis Disability Index; PLSI, Psoriasis Life Stress

Inventory; SF-36, Short-Form 36; SPI, Salford Psoriasis Index.

*Other widely used generic questionnaires: General Health Questionnaire; Nottingham Health Profile, Sickness Impact Profile, Satisfaction

with Life Scale.

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psoriasis have found that the SF-36 does not have thediscriminative capacity to distinguish between treat-ment groups and placebo.70,71

Despite these limitations, nonedisease-specificinstruments are valuable because they provide sup-plementary assessments that would not otherwise beavailable to dermatologists, particularly during eval-uations of patients with PsA. In addition to the HAQand the SF-36, other general outcome measures thathave been tested in psoriasis studies include theAIMS,45,46 the NHP,80 the GHQ,81 and the SicknessImpact Profile (SIP).82 Further studies are needed toascertain which of these instruments are best suitedfor assessments of skin-based HRQOL in thesediseases.

Dermatology-specific instrumentsThe Dermatology Life Quality Index. The

Dermatology Life Quality Index (DLQI) is a 10-iteminstrument that was developed as a measure ofdisability based on the responses of 120 dermatologyoutpatients.83 It is used in a wide range of dermato-logical conditions and across a wide range of diseaseseverity as a quality of life instrument. The 10 itemsof the questionnaire focus on a variety of healthdimensions, including symptoms, feelings, dailyactivities, leisure, work/school, relationships, andtreatment (Table II). Patients answer questions on a0-3 Likert scale based on their experience during theprevious 7 days. The scores are then tabulated andexpressed as a number from 0 to 30 or, alternatively,as a percentage of the maximum score, with highervalues indicative of poorer outcomes.

TheDLQI has been themost utilized and validatedinstrument of HRQOL in psoriasis. It is short, practi-cal, and applicable tomanydermatological disorders.Finlay and Khan83 showed that DLQI scores forpatients with psoriasis, atopic eczema, generalizedpruritus, viral warts, and acne were all significantlyhigher than those for control patients, thus demon-strating discriminant and construct validity. TheDLQI

was found to have high reliability and internalconsistency.83,84 Additionally, several studies haveshown that the DLQI is sensitive and responsive toclinical changes in quality of life following varioustherapies (Table III).16,37,70,71,73,85-88,*,y,z,§ A strongcorrelation between the DLQI and the PsoriasisDisability Index (PDI) has also been demonstrated.89

However, the correlation was much lower whencompared with measures of disease severity, espe-cially among those with mild tomoderate psoriasis.83

The Dermatology Quality of Life Scale. TheDermatology Quality of Life Scale (DQOLS) is a41-item instrument that focuses primarily on areas ofpsychosocial well-being and was designed to com-plement theDLQI.80 It was derived from a study of 50dermatology outpatients and includes subscales onpsychosocial health, physical activities, and symp-toms (Table II). Each item is rated on a 0-4 Likertscale based on the previous 4 weeks. The scores arethen standardized to a 100 scale, with the maximumscore representing the worst outcome.

The validity of the DQOLS has been tested againstthe NHP in a group of dermatology patients in theUnited Kingdom, where it was shown to have highersensitivity to detect differences betweenpatientswithpsoriasis versus thosewith acne.80 Sensitivity has alsobeen demonstrated in a few clinical trials, with theDQOLS responsive to improvement in HRQOLafter psoriatic treatments (Table III).70,71,73,z

This instrument has high internal consistency and test-retest reliability.80 However, one of the main criticismsof the DQOLS is that it is too long and unwieldy to bepractical for use in routine clinical practice andcould benefit by eliminating redundant questions.Furthermore, it may not adequately capture theimpact of PsA.

Psoriasis-specific instrumentsThe Koo-Menter Psoriasis Instrument. The

Koo-Menter Psoriasis Instrument (KMPI) was origi-nally designed to offer dermatologists a simple andpractical assessment tool for quickly and easilyidentifying patients with psoriasis who may be can-didates for systemic therapy (Table II).90,91,k It is

*Feldman SR, Bala M, Menter A, Gordon KB. The quality of life of

patients with severe psoriasis treated with infliximab. Presented

at the 62nd Annual Meeting of the American Academy of

Dermatology; Feb 6-11, 2004, Washington, DC.yKrueger GG, Lebwohl M, Wang A, Zitnik R. Continuance on

etanercept after early incomplete response in patients with

psoriasis. Presented at the 62nd Annual Meeting of the


ton, DC.zMenter A, Gottlieb AB, Griffiths C, Mordin M. Health-related

quality of life impact of weekly intravenous or intramuscular

alefacept in patients with psoriasis: results from two random-

ized, placebo-controlled phase III trials. Presented at the 60th

Annual Meeting of the American Academy of Dermatology, Feb

22-27, 2002, New Orleans, La.

§Menter A, Hamilton T, Caro I, Chen-Rundle A. Impact of

efalizumab on patient-reported outcomes in patients with

moderate to severe plaque psoriasis: pooled results from three

randomized phase III trials. Results from two randomized,

placebo-controlled phase III trials. Presented at the 62nd

Annual Meeting of the American Academy of Dermatology,

Feb 6-11, 2004, Washington, DC.kKoo J, Menter A. The Koo-Menter instrument for identification of

psoriasis patients requiring systemic therapy. Presented at the

9th International Psoriasis Symposium; June 17-22, 2003, New

York, NY.

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Table III. Quality-of-life outcomes in recent clinical trials involving patients with either psoriasisor psoriatic arthritis

Study Agents Patient population QOL instrument Treatment outcomes

Koo et al*(2004)

Oraltazarotene

690 pts withmoderateto severepsoriasis

KMPI(also knownas PQOL-12)

d At baseline, mean PQOL-12 scores for patientson tazarotene and placebo were 5.39 and 5.43,respectively

d At wk 12, mean changes in PQOL-12 score forthe tazarotene and placebo groups were �1.63and �0.84, respectively (P\ .0001)

Kaltwasseret al98

(2004)

Leflunomide 190 pts withPsA andpsoriasis

DLQI, HAQ d Mean baseline DLQI scores were 9.1 for placebocontrol and 8.8 for the leflunomide group

d At 24 wk, mean change in DLQI scores weresignificantly higher in leflunomide group (�1.9)compared with placebo (�0.2) (P\ .0173)

d Mean baseline HAQ scores were 1.14 forplacebo control and 1.08 for leflunomide group

d At 24 wk, mean change in HAQ scores weresignificantly greater in leflunomide group(�0.19) compared with placebo (�0.05)(P\ .0267)

Feldman et al71

(2004)Alefacept 549 pts with

chronicplaquepsoriasis

DLQI, DQOLS,SF-36

d Mean baseline DLQI for the alefacept groupwas 11.58 compared with 10.75 for the placebogroup.

d Continuous treatment with alefacept 7.5 mg IVonce weekly significantly reduced mean DLQIscores compared with placebo (�4.4 vs �1.8points, respectively) at 2 wk after last dose(P\ .001).

At 12 weeks after the last dose:d Mean DLQI reduction for alefacept treatmentwas �3.4 compared with �1.4 for placebo(P\ .001)

d Mean change in DQOLS Symptoms scale wassignificantly greater in patients receivingalefacept compared with placebo(�18.2 vs �11.1, respectively).

d Mean changes in SF-36 scores were notsignificant between the treatment groups.

Menter et al86,y

(2004) andStone et alz

(2004)

Efalizumab 1242 pts withmoderateto severepsoriasis

DLQI d Efalizumab-treated (1 mg/kg/wk) pts hadsignificantly greater mean improvement frombaseline in DLQI score than placebo-treated pts(5.6 vs 1.9 points; P\ .001) at wk 12

d 51%-61% of efalizumab-treated pts werecategorized as ‘‘better’’ on each DLQI scale,compared with 23%-29% of placebo-treated pts

d Mean percent improvement from baseline inDLQI score was 46% in the efalizumab groupand 15% in the placebo group at wk 12

Feldman et al§

(2004) andKrueger et alk

(2004)

Etanercept 652 pts withmoderateto severepsoriasis

DLQI d Mean baseline DLQI scores were 11.3, 12.7, 12.2,and 12.8 for 50-mg BIW etanercept, 25-mg BIWetanercept, the 25-mg QW etanercept, andplacebo groups

d At wk 12, DLQI response rates were 71% for50-mg BIW, 64% for 25-mg BIW, and 55% for25-mg QW groups; all statistically significantly(P\ .001) superior to placebo (30%)

Continued

J AM ACAD DERMATOL



Table III. Cont’d


d Using more stringent ‘‘not at all affected bytheir psoriasis’’ responder definition, pts on allbut the 25-mg QW dose had clinicallymeaningful DLQI response (24% for 50-mg BIW,12% for 25-mg BIW, 6% for 25-mg QW, and2% for placebo groups)

d In open-label phase (etanercept 25 mg BIW),mean percent improvements in DLQI were 39%at wk 24, 51% at wk 36, 53% at wk 48, and54% at wk 60

Krueger et al{

(2004)Etanercept 583 pts

with stable,moderateto severepsoriasis

DLQI, SF-36 d Mean baseline DLQI scores were 11.43, 11.49,and 12.15 for the 50-mg BIW etanercept group,25-mg BIW etanercept group, and placebogroup, respectively

d At wk 2, relative to patients on placebo,patients on etanercept had achieved statisticallysignificantly (P\ .001) greater improvement inDLQI total score

d Scores increased at each assessment; by wk 12,mean percent improvement in DLQI was 70%for 50-mg etanercept BIW, 65% for 25-mg BIWetanercept, and 6% for placebo groups(P\ .002)

d Improvements in both physical and mentalsummary scores of the SF-36 were alsosignificantly higher (P\ .01) for the etanerceptgroups at wk 12

Mease et al75

(2004),Mease et al74

(2003), andWanke et al#

(2002)

Etanercept 205 ptswith PsA

HAQ, SF-36,EuroQoLFeelingThermometer

d Mean baseline HAQ was 1.1 for both etanerceptand placebo groups

d Mean improvement in HAQ score was 0.6 unit(54%) at wk 24 in the 25-mg BIW etanerceptgroup and 0.1 unit (6%) in the placebo group(P\ .0001)

d At wk 24, a 0.5-unit improvement in HAQ wasseen in 50% of etanercept pts compared with14% of placebo pts (P\ .0001)

d Mean baseline SF-36 Physical ComponentSummary scores were 36 units for both groups

d Improvement in SF-36 Physical ComponentSummary score was 9.3 units at 24 wk in theetanercept group and 0.7 unit in the placebogroup (P\ .0001); improvement was sustainedfor 72 wk

d Mean change in Vitality SF-36 scores frombaseline was 14.6 at wk 24 and 59.5 at wk 72

d Mean improvement in Feeling Thermometerscores from baseline was 14.3 units in theetanercept group and 2.1 units in the placebogroup at wk 24 (P\ .0001)

Leonardi et al16

(2004)Etanercept 672 pts

with stable,moderateto severepsoriasis

DLQI d Mean baseline DLQI scores were 11.3, 12.7, and12.2 for the 50-mg BIW, 25-mg BIW, and 25-mgQW etanercept groups, respectively, comparedwith 12.8 for placebo

J AM ACAD DERMATOL



Table III. Cont’d


d Mean percentage improvements from baselinein DLQI scores were significantly greater in alletanercept groups compared with placebo atwk 12: 61% for 50-mg BIW group, 51% for25-mg BIW group, 47% for 25-mg QW group,and 11% for placebo group (P\ .001)

d Mean percentage improvements from baselinein DLQI scores were significantly greater in allthe etanercept groups compared with placeboat wk 24: 74% for 50-mg BIW group, 59% for25-mg BIW group, 54% for 25-mg QW group,and 11% for placebo group

Feldman et al**(2004)

Infliximab 249 pts withextensiveor severepsoriasis

DLQI d Mean baseline DLQI scores were 12, 11, and14 for the 5-mg/kg infliximab group, 3-mg/kginfliximab group, and placebo group,respectively

d Median percent change from baseline inDLQI at wk 10 was 84%, 91%, and 0% for the3-mg/kg infliximab group, 5-mg/kg infliximabgroup, and placebo group, respectively(P\ .001)

d Median change from baseline in DLQI at wk 10was �8.0, �10.0, and 0.0 for the 3-mg/kginfliximab group, 5-mg/kg infliximab group,and placebo group, respectively (P\ .001)

d 33% of pts in the 3-mg/kg group and 40% ofpatients in the 5-mg/kg group had a DLQIscore of 0 at wk 10, compared with 0% in theplacebo group (P\ .001)

Feletar et al72

(2004)Infliximab 16 pts

with PsAHAQ, SF-36 d The domains evaluating quality of life, including

the HAQ, the SF-36, Fatigue Severity Scale,patient visual analogue scale for skin severity,stiffness, and pain did not show statisticallysignificant improvement at wks 14, 30, or 54

Wallace et alyy

(2004)Adalimumab 148 pts with

moderateto severeplaquepsoriasis

DLQI d Pts receiving 40 mg adalimumab EOW and40 mg adalimumab QW had significantly bettermean DLQI scores at wk 12 than placebo-treated patients (2.8 EOW and 2.0 weekly vs10.7 for placebo; P\ .001)

d Mean DLQI change from baseline to week 12was also significant (e10.8 EOW, e11.5 weeklyvs e1.3 placebo; P\ .001)

Heydendaelet al39 (2003)

MTX or CsA 88 pts withmoderateto severepsoriasis

SF-36 d No significant differences observed in QOLbetween patients treated with MTX (15 mg/wk)or those treated with CsA (3 mg/kg/d)

d Mean physical and mental component scoreswere comparable for the MTX group (52 and51, respectively) and for the CsA group (53and 51, respectively) after 16 wk of treatment

Ellis et al70


moderateto severechronicplaquepsoriasis

SF-36, DLQI,DQOLS

d SF-36 at baseline generally did not indicateimpairment in any group, and there werelittle observed changes in SF-36 scoresduring therapy

Continued

J AM ACAD DERMATOL



Table III. Cont’d


d Mean baseline DLQI scores were 9.0, 8.6, and9.8 for the 0.075-mg/kg alefacept, 0.025-mg/kgalefacept, and placebo groups

At 12 wk after the last dose:d Mean change in DLQI Overall scale[% improvement] were significantly greater inpatients receiving 0.025- and 0.075-mg/kgalefacept compared with placebo (�4.0[47%], �4.4 [49%], and �1.7 [17%],respectively; P = .04)

d Mean baseline DQOLS Symptoms scales were43.4, 44.5, and 50.9 for the 0.075-mg/kgalefacept, 0.025-mg/kg alefacept, and placebogroups

d Mean change in DQOLS Symptoms scale[% improvement] were significantly greater inpatients receiving 0.025- and 0.075-mg/kgalefacept compared with placebo (�21.1[47%], �19.4 [45%], and �8.2 [16%],respectively; P = .01)

Finlay et al73


chronic plaquepsoriasis

DLQI, DQOLS,SF-36, GHQ

d Mean DLQI was 11.9 for alefacept 15-mg groupcompared with 10.9 for the placebo group

d Mean reductions from baseline in DLQI scoreswere significantly greater in the alefacept 15-mggroup than in the placebo group 2 wk after lastdose (�4.9 vs �2.7 points; P = .012)

d Similar observations were made for DQOLS andSF-36 scores in favor of alefacept 2 wk and12 wk after last dose

Gordon et al85

(2003)Efalizumab 556 pts

with stable,moderate tosevere plaquepsoriasis

DLQI d Mean baseline DLQI was 12 for both efalizumaband placebo groups

d Efalizumab-treated (1 mg/kg/wk) patientsexhibited significantly greater mean percentageimprovement from baseline in DLQI overallscore than placebo-treated patients (47% vs14%; P\ .001) at week 12

Gottlieb et al37

(2003)Etanercept 112 pts with

moderate tosevere plaquepsoriasis

DLQI d Mean percent improvement in DLQI score was64% in 25-mg twice-weekly SC etanerceptgroup compared with 7% for placebo control(P\ .001)

Chan andGebauer88

(2003)

Infliximab 7 pts with chronicplaque psoriasis

DLQI d A single dose of infliximab (5 mg/kg IV)induced 61% improvement in DLQI scoresat wk 2

d Four of 7 pts were seen at 10 wk after infusionand sustained improvement in DLQI (79%)

Menteret alzz

(2002)

Alefacept [1000 pts withpsoriasis fromtwo phase IIIclinical trials

DLQI, DQOLS d Pts receiving 7.5 mg IV or 15 mg IM alefaceptreported mean improvements in DLQI of 4.4and 4.9 points vs mean placebo improvementsof 1.8 points (P\ .0001) and 2.7 points(P\ .001), respectively

J AM ACAD DERMATOL



Table III. Cont’d


d Patients receiving 7.5 mg IV alefacept reportedsignificant mean improvements in DQOLSscores vs placebo as assessed by thePsychosocial (10.8 vs 6.1; P = .005), Activities(10.4 vs 4.9; P\ .0001), and Symptoms(19.9 vs 9.2; P\ .0001) scales

d Patients receiving 15 mg IM alefacept alsoreported significant mean improvements inDQOLS for the Psychosocial (10.6 vs 5.4;P = .004), Activities (9.5 vs 3.5; P\ .001), andSymptoms (17.5 vs 8.4; P\ .001) scales

d Changes in QOL scores were not significantlydifferent between patients receiving alefacept10 mg IM and placebo

Touw et al87

(2001)CsA 255 pts with

chronic plaquepsoriasis

DLQI d Median DLQI scores improved from 36.67% ofmaximum score at baseline to 3.33% at end ofthe 12-wk therapy, for a mean change of e9.58(P\ .001)

d Median DLQI scores improved from 26.67% ofmaximum score to 3.33% for pts who relapsedafter treatment withdrawal and received anadditional 12-wk CsA therapy, for a meanchange of e6.73 (P\ .001)

Gupta et al94

(1999)NarrowbandUVB

100 consecutivepts withchronic plaque,small plaque, orguttate psoriasis

PDI d Median baseline PDI score of 42 reduced(improved) to 30 at 3 mo (P\ .001)

BIW, Twice weekly; CsA, cyclosporine; DLQI, Dermatology Life Quality Index; DQOLS, Dermatology Quality of Life Scales; EOW, every other

week; GHQ, General Health Questionnaire; HAQ, Health Assessment Questionnaire; IM, intramuscular; IV, intravenous; KMPI, Koo-Menter

Psoriasis Instrument; MTX, methotrexate; PDI, Psoriasis Disability Index; PQOL-12, psoriasis-specific health-related quality of life 12-item scale;

PsA,psoriatic arthritis; pts, patients; QOL, quality of life; QW, once weekly; SC, subcutaneous; SF-36, Short-Form-36 Health Survey; UVB,

ultraviolet B.

*Koo JY, Kowalski J, Guenther L, Walker P. Quality of life effect of oral tazarotene in patients with moderate to severe psoriasis as measured

by the 12-item psoriasis quality of life questionnaire (PQOL-12). Presented at the 62nd Annual Meeting of the American Academy of

Dermatology; Feb 6-11, 2004, Washington DC.yMenter A, Hamilton T, Caro I, Chen-Rundle A. Impact of efalizumab on patient-reported outcomes in patients with moderate to severe

plaque psoriasis: pooled results from three randomized phase III trials. Results from two randomized, placebo-controlled phase III trials.

Presented at the 62nd Annual Meeting of the American Academy of Dermatology, Feb 6-11, 2004, Washington, DC.zStone S, Papp K, Caro I. Interpretation of positive patient response to efalizumab for the treatment of moderate to severe plaque psoriasis.

Presented at the 62nd Annual Meeting of the American Academy of Dermatology, Feb 6-11, 2004, Washington, DC.§Feldman SR, Kimball A, Woolley JM, Zitnik R. Clinically meaningful improvements in health-related quality of life from etanercept therapy for

patients with moderate to severe psoriasis. Presented at the 62nd Annual Meeting of the American Academy of Dermatology, Feb 6-11,

2004, Washington, DC.kKrueger GG, Lebwohl M, Wang A, Zitnik R. Continuance on etanercept after early incomplete response in patients with psoriasis. Presented

at the 62nd Annual Meeting of the American Academy of Dermatology; Feb 6-11, 2004, Washington, DC.{Krueger G, Woolley JM, Zitnik R. The effects of etanercept therapy on patient reported outcomes for patients with moderate to severe

psoriasis. Presented at the 62nd Annual Meeting of the American Academy of Dermatology; Feb 6-11, 2004, Washington DC.#Wanke LA, Gottlieb AB, Mease PJ, Kivitz AJ, Cohen SB, Burge DJ. Etanercept (Enbrel�) improves health-related quality of life in patients with

psoriatic arthritis. Presented at the 66th Annual Scientific Meeting of the American Academy of Rheumatology, Oct 25-29, 2002, New

Orleans, La.

**Feldman SR, Bala M, Menter A, Gordon KB. The quality of life of patients with severe psoriasis treated with infliximab. Presented at the

62nd Annual Meeting of the American Academy of Dermatology; Feb 6-11, 2004, Washington, DC.yyWallace K, Hamlin R, Langley R, Chen DM. Results of the Dermatology Life Quality Index in moderate to severe plaque psoriasis patients

receiving 12 weeks of adalimumab therapy. Presented at the 10th International Psoriasis Symposium, June 10-13, 2004; Toronto, Canada.zzMenter A, Gottlieb AB, Griffiths C, Mordin M. Health-related quality of life impact of weekly intravenous or intramuscular alefacept in

patients with psoriasis: results from two randomized, placebo-controlled phase III trials. Presented at the 60th Annual Meeting of the

American Academy of Dermatology, Feb 22-27, 2002, New Orleans, La.

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a questionnaire on two sides of one page thatcomprises a patient-reported assessment on oneside and a physician-reported evaluation on theother. Patients are asked to assess psoriasis-specificHRQOL (PQOL-12), location and extent of the dis-ease, and the presence of and degree of arthritissymptoms, based on their experience in the previousmonth. The PQOL-12 is a 12-item scale derived froma 41-item psoriasis quality of life questionnaire andwas chosen as the quality of life measure for theKMPI because of its brevity, broad applicability, therigor of its development and psychometric valida-tion, and its psoriasis-specific focus.27,* Each item inthe PQOL-12 is rated on a 0 to 10 scale for a max-imum score of 120, with higher scores indicative ofworse quality of life and a score of 50 representingsignificant negative HRQOL because of psoriasis.

In a study of 474 psoriatic patients, the KMPIwas determined to be a valid and reliable instrumentfor assessing the impact of psoriasis across a wideranging spectrum of disease severity.27,* It is respon-sive and sensitive to changes in disease after treat-ment, as recently demonstrated in a trial oftazarotene therapy (Table III).y The KMPI is ideallysuited for clinical practice because it only takesapproximately 5 minutes for patients and physiciansalike to complete the questions. However, longerexperience with this instrument and additional val-idation against well-established measures is stillneeded to determine its clinical usefulness.

PDI. The PDI was one of the first instrumentsdeveloped specifically for quantifying HRQOL inpatients with psoriasis.92 This 15-item questionnairewas derived from an original 10-item version amongdermatological patients in the United Kingdom(Table II). It measures dimensions in daily activities,work/school, relationships, leisure, and treatmenteffects based on the previous month. Each item israted on a 1 to 7 visual analog scale for a maximumscore of 105, or on a graded 4-point tick-box (0-3)scoring system for a maximum score of 45.1,82 Forboth scoring systems, the higher scores representlower quality of life.

To demonstrate its validity, the PDI was comparedto 5 other measures, namely the PASI, the GHQ, the

SIP, the SF-36, and the DLQI.81,82,93 The PDI wasshown to have moderate correlation with the PASI,the SIP, and the SF-36; and high correlation with theDLQI and the GHQ. PDI scores declined after ultra-violet phototherapy, which shows its sensitivity andresponsiveness to the treatment (Table III).92,94

However, a major limitation of the PDI is its subop-timal sensitivity to changes in patients with mild tomoderate disease.

The Psoriasis Life Stress Inventory. ThePsoriasis Life Stress Inventory (PLSI) is a 15-item in-strument designed tomeasure psoriasis-related stressassociated with cosmetic disfigurement and socialstigma, symptoms of disease, and treatment effects(Table II).95 It is derived from a 41-itemquestionnairebased on a study of 50 psoriatic patients. Each item israted on a 0 to 3 scale for a maximum score of 45,based on their experience in the previous month.Higher scores indicate poorer quality of life.

Compared with the PDI, the PLSI provides a bettermeasurement of HRQOL in patients with mild tomoderate psoriasis because of its greater emphasison psychosocial stressors. It has been validatedagainst the SF-36 and the PDI.79 In the study,Fortune et al79 demonstrated that patients withhigher stress levels had lower mental health (mea-sured by the SF-36) and experienced more disability(measured by the PDI) than patients with less stress.However, the sensitivity of the PLSI to changes inHRQOL after treatment has not been assessed. Theinstrument only has modest correlation with globalpatient self-ratings, but no correlation with the PASI.

The Salford Psoriasis Index. The SalfordPsoriasis Index (SPI) is one of the more recentlydeveloped tools in psoriasis that assesses 3 aspects ofthe disease: signs of psoriasis based on the currentPASI score, psychosocial disability, and historicalseverity of psoriasis as judged by the need forintervention (Table II).96 The PASI score is convertedinto a number from 0 to 10, reflecting the extent ofthe disease. Psychosocial disability is measuredusing a visual analogue scale from 0 to 10, andhistorical severity is graded by assigning points (0 to5) to patients who had previous systemic treatment,who were hospitalized, and who experienced eryth-roderma as a result of their disease. The SPI is thenexpressed as 3 independent values. For example, a1:1:0 score would indicate minimal signs, psychoso-cial impact, and historical severity, whereas a 10:10:5score represents serious impairment in HRQOL.

In a study assessing 150 consecutive patients withpsoriasis, the individual components of the SPI werevalidated against each other and against the PASI andthe PDI.96 A modest correlation was found amongall 3 components. The Psychosocial Impact Score

*Koo J, Kozma CM, Menter A, Lebwohl M. Development of a

disease-specific quality of life questionnaire: the 12-item pso-

riasis quality of life questionnaire (PQOL-12). Presented at the

61st Annual Meeting of the American Academy of Dermatol-

ogy; March 21-26, 2003, San Francisco, Calif.yKoo JY, Kowalski J, Guenther L, Walker P. Quality of life effect of oral

tazarotene in patients with moderate to severe psoriasis as

measured by the 12-item psoriasis quality of life questionnaire

(PQOL-12). Presented at the 62nd Annual Meeting of the Amer-

ican Academy of Dermatology; Feb 6-11, 2004, Washington, DC.

J AM ACAD DERMATOL



correlated strongly with the PDI, but not withthe PASI. To demonstrate reliability and sensitivity,the SPI was assessed in two separate cohorts. TheSPI showed high reproducibility and was highly re-sponsive to changes in HRQOL after treatment forpsoriasis. These findings were corroborated in asubsequent trial of 101 patients with psoriasis.97

Other quality-of-life instruments currentlyin development. As described earlier, the PsAQOLmeasure, a 20-item questionnaire, has recently beendeveloped by McKenna et al66 specifically for mea-suring HRQOL in patients with PsA. It was designedto provide a convenient and practical tool that allowsarthritic and dermatological impacts to be summa-rized in a single outcome measure. A 25-item mea-sure specific to psoriasis (PSORIQoL) has also beendeveloped using the same needs-based quality-of-life model adopted for the PsAQOL.69 The premisefor the needs-based quality-of-life model is thatdisease-related disability can influence the patient’sability to meet his or her needs. Both instrumentshave been shown to have good internal consistency,test-retest reliability, and validity.66,69 However, theyhave not yet been tested in clinical trials to assesstheir responsiveness to changes in HRQOL associ-ated with treatments.

IMPROVING QUALITY OF LIFE:TREATMENT OF PSORIASIS ANDPSORIATIC ARTHRITIS

It is important to understand that HRQOL instru-ments provide not only assessments of the impact ofa disease but also its treatment. Studies demonstrat-ing significant improvements in HRQOL have beenvery limited for older therapies, such as photother-apy and traditional systemic therapy. This is primar-ily because until now these treatments have onlybeen modestly used as monotherapy, especially inpatients with moderate to severe disease, and manyhave not been satisfactory with respect to eithersafety or efficacy.6,23,*,y In addition, many of theseagents were available well before the treatment

paradigm placed a greater emphasis on quality oflife. The advent of the biologics has substantiallyimproved treatment options and coincided with thisshift toward a more global approach in evaluatingtreatment efficacy. Improvements in HRQOL haverecently been demonstrated with various agents,ranging from traditional phototherapy and systemictreatments to biologic therapies (Table III). In all ofthese studies, patients experienced a concomitantimprovement in PASI scores.

Significant improvements in HRQOL have alsobeen observed with nonbiologic therapies (TableIII). A 12-week course of oral tazarotene, a novelreceptor-selective retinoid, resulted in a significantimprovement in PQOL-12 scores compared withplacebo (1.63 vs e0.84).z Narrowband ultravioletphototherapy was also effective in improvingHRQOL, with significant reductions in PDI scoresobserved after 3 months of treatment (from a base-line score of 42 to 30 at 3 months).94 Treatment withleflunomide, a pyrimidine-inhibiting agent, was as-sociated with significantly greater improvement inDLQI scores (�1.9 units) compared with placebo(�0.2 units).98 In addition, the leflunomide-treatedpatients demonstrated significant improvement inHAQ scores, with a mean change of 0.19 unitobserved at week 24, compared with only 0.05 unitfor the placebo control.98 Intermittent short coursesof cyclosporine monotherapy produced an evengreater decline in DLQI scores after 12 weeks(mean change, �9.58)87 and was shown to haveefficacy comparable to that of methotrexate in im-proving SF-36 scores among patients with moderateto severe psoriasis.39 Despite significant improve-ments in both disease severity and quality of life, themajority of older therapies are characterized bycumulative toxicity (methotrexate, cyclosporine),brief duration of posttreatment remission (topicalmedications, methotrexate and cyclosporine treat-ment), and inconvenient administration modalities(ultraviolet phototherapy) that limit their potentialfor long-term maintenance therapy.

Alefacept, efalizumab, and etanercept are 3 bio-logic drugs that have recently been approved in theUnited States for the treatment of psoriasis and are indifferent stages of development for approval in therest of the world. Alefacept (Amevive) is a recombi-nant dimeric fusion protein consisting of the

*Salonen SH on behalf of the EUROPSO Patient Survey Study

Group. Large-scale European Survey of Quality of Life in

Patients with Psoriasis: Second-phase results on quality of life

and treatment reported by 7,575 members of European pso-

riasis patient associations. The EUROPSO Psoriasis Patient

Study. Presented at the 10th International Psoriasis Symposium,

June 10-13, 2004, Toronto, Canada.ySalonen SH on behalf of the EUROPSO Patient Survey Study

Group. The EUROPSO psoriasis patient study: Treatment history

and satisfaction reported by 17,990 members of European

psoriasis patient associations. The EUROPSO Psoriasis Patient

Study. Presented at the 1st European Academy of Dermatology

and Venereology Spring Symposium, Feb 27-March 1, 2003,

Malta.

zKoo JY, Kowalski J, Guenther L, Walker P. Quality of life effect of

oral tazarotene in patients with moderate to severe psoriasis

as measured by the 12-item psoriasis quality of life question-

naire (PQOL-12). Presented at the 62nd Annual Meeting of the


ton, DC.

J AM ACAD DERMATOL



CD2-binding portion of the human leukocyte func-tion antigen-3 protein linked to the Fc region ofhuman immunoglobulin G1 (IgG1).99 In 3 indepen-dent trials of patients with chronic plaque psoriasis,alefacept provided a modest, but consistent im-provement in HRQOL, as measured by the DLQIand the DQOLS (Table III).70,71,73,* Mean changes inDLQI scores were significantly greater in the alefa-cept group (ranging from �3.4 to �4.9) at 12 weeksafter the last dose, compared with placebo (rangingfrom �1.4 to �2.7). In these studies, reductions inDQOLS scores were similarly higher in the alefacepttreatment group compared with the placebo group,indicating improvement in quality of life. Patientsreceiving either weekly intravenous or intramuscularadministration of alefacept reported similar improve-ments, with positive effects observed as early as2 weeks.73 However, alefacept therapy currentlyrequires 12 weekly physician visits for routine mon-itoring of lymphocyte counts (CD4) and intramus-cular injections of the drug, thus requiring time offfrom work.99

Efalizumab treatment was slightly superior toalefacept in reducing DLQI scores (Table III).Efalizumab (Raptiva) is a recombinant humanizedIgG1 k isotype monoclonal antibody that bindsspecifically to human CD11a.100 After 12 weeks oftreatment with subcutaneous efalizumab at a dosageof 1 mg/kg per week, mean reduction in DLQI scorewas �5.6 units, compared with �1.9 units for theplacebo control.86,y,z When expressed as a percent-age, mean improvement in DLQI was 46% versus15% for the placebo group. Almost identical rateswere observed in another study, in which meanDLQI improvement of 47% was reported for efalizu-mab-treated patients, compared with only 14% forplacebo-treated patients.85 Efalizumab therapy re-quires infrequent monitoring of platelet counts

because of rare instances of drug-induced throm-bocytopenia.85,100

TNF antagonists are another class of biologicsthat have been successfully used in treating rheu-matic diseases, and have subsequently been shownto be effective in treating both psoriasis andPsA.16,37,74,75,85,88,§,k,{ with better safety profilesthan traditional agents. Currently, there are 3 TNF-neutralizing agents, a soluble TNF-receptor antago-nist (etanercept)101 and two monoclonal antibodies(infliximab and adalimumab).102,103 Of these 3,etanercept has thus far been approved for use inthe treatment of both psoriasis and PsA.

Etanercept (Enbrel) is a fully human solubleTNF-receptor IgG1 fusion protein that inactivatesthe biological activity of endogenous TNF by com-petitively inhibiting its interaction with cell-surfacereceptors.101 Mean percent improvement in DLQIscores was highly significant and dose-dependentafter etanercept therapy in patients with moderate tosevere psoriasis (Table III). In one study, subcuta-neous etanercept, 25 mg given twice weekly, in-duced an impressive 64% mean improvement inDLQI score compared with only 7% for the placebogroup.37 Gradual improvement in DLQI was ob-served over a 60-week period in another study, from39% at week 24 to 51% at week 36, and 54% at week60.£,** Krueger et al** showed that statistically signif-icant improvements in DLQI scores were apparent asearly as 2 weeks and increased with time and dosageof etanercept. At week 12, mean improvement inDLQI was 70% for 50 mg twice-weekly etanercept,

*Menter A, Gottlieb AB, Griffiths C, Mordin M. Health-related

quality of life impact of weekly intravenous or intramuscular

alefacept in patients with psoriasis: results from two random-

ized, placebo-controlled phase III trials. Presented at the 60th

Annual Meeting of the American Academy of Dermatology, Feb

22-27, 2002, New Orleans, La.yMenter A, Hamilton T, Caro I, Chen-Rundle A. Impact of

efalizumab on patient-reported outcomes in patients with

moderate to severe plaque psoriasis: pooled results from three

randomized phase III trials. Results from two randomized,

placebo-controlled phase III trials. Presented at the 62nd

Annual Meeting of the American Academy of Dermatology,

Feb 6-11, 2004, Washington, DC.zStone S, Papp K, Caro I. Interpretation of positive patient

response to efalizumab for the treatment of moderate to

severe plaque psoriasis. Presented at the 62nd Annual Meeting

of the American Academy of Dermatology, Feb 6-11, 2004,

Washington, DC.

§Wanke LA, Gottlieb AB, Mease PJ, Kivitz AJ, Cohen SB, Burge DJ.



Scientific Meeting of the American Academy of Rheumatology,

Oct 25-29, 2002, New Orleans, La.kFeldman SR, Kimball A, Woolley JM, Zitnik R. Clinically meaningful

improvements in health-related quality of life from etanercept

therapy for patients with moderate to severe psoriasis. Pre-

sented at the 62nd Annual Meeting of the American Academy

of Dermatology, Feb 6-11, 2004, Washington, DC.{Wallace K, Hamlin R, Langley R, Chen DM. Results of the

Dermatology Life Quality Index in moderate to severe plaque

psoriasis patients receiving 12 weeks of adalimumab therapy.

Presented at the 10th International Psoriasis Symposium, June

10-13, 2004, Toronto, Canada.£Krueger GG, Lebwohl M, Wang A, Zitnik R. Continuance on

etanercept after early incomplete response in patients with

psoriasis. Presented at the 62nd Annual Meeting of the

American Academy of Dermatology, Feb 6-11, 2004, Washing-

ton, DC.**Krueger G, Woolley JM, Zitnik R. The effects of etanercept

therapy on patient reported outcomes for patients with mod-

erate to severe psoriasis. Presented at the 62 Annual Meeting of

the American Academy of Dermatology, Feb 6-11, 2004,

Washington, DC.

J AM ACAD DERMATOL



65% for 25 mg twice-weekly etanercept, and 6% forplacebo. Reductions in DLQI scores corresponded tosimilar improvements in SF-36 scales. Comparableimprovements were reported in a pivotal trial ofetanercept, in which mean improvement in DLQIwas 74% for the 50-mg twice-weekly etanerceptgroup, 59% for the 25 mg twice-weekly etanerceptgroup, and 54% for the 25 mg once-weekly etaner-cept group, compared with only 11% in the placebogroup.16

Infliximab and adalimumab are monoclonalanti-TNF antibodies that are currently in phase IIIclinical trials for the treatment of psoriasis (Table III).Infliximab (Remicade) is a chimeric monoclonalantibody to TNF that combines the variable regionof a mouse antibody with the constant region of ahuman IgG1 antibody.102 In a case study report of7 patients with chronic plaque psoriasis, a singledose (5 mg/kg) of intravenous infliximab induced a61% improvement in DLQI scores at 2 weeks.88

Improvement was sustained for up to 10 weeks(79% improvement in DLQI). In a trial of 249 patientswith extensive to severe plaque psoriasis, a medianimprovement of 91% (�10.0 units from baseline) and84% (�8.0 units from baseline) was observed atweek 10 for the 5- and 3-mg/kg infliximab groups,respectively, compared with 0% (0.0 units from base-line) for the placebo group.* Adalimumab (Humira)is a recombinant human IgG1 monoclonal antibodyto TNF.103 In a large phase II trial of adalimumab,patients with psoriasis were recently reported toshow significantly greater mean change inDLQI afterreceiving either 40 mg adalimumab every otherweek (�10.8 units) or 40 mg adalimumab weekly(�11.5 units), compared with placebo (�1.3 units).y

Among patients with refractory PsA, a significantimprovement in the HAQ was demonstrated inpatients treated with etanercept at week 24.74,75,z

A mean change of 0.6 unit in the HAQ (54%) wasfound in patients receiving twice-weekly 25-mgetanercept, compared with only 0.1 unit (6%) for

the placebo group.74,75,z In addition, 50% of patientsin the etanercept group compared with 14% in theplacebo group achieved a 0.5 unit improvement,which represents a clinically meaningful change.These improvements were corroborated by othermeasures, including the SF-36 and the EUROQOLFeeling Thermometer (Table III). In a 12-monthobservational study, infliximab therapy led to amarked improvement in psoriasis (as measured bythe PASI), but did not show statistically significantimprovement in either the HAQ or the SF-36.72

However, this study was based on a small samplesize of only 16 PsA patients. HRQOL results fromlarger completed clinical trials of infliximab andadalimumab therapies in patients with PsA areexpected to be published soon.

CONCLUSIONSA review of the literature on psoriasis and PsA

demonstrates the significant adverse effects thatthe diseases have on quality of life. New therapiesare emerging that have greatly improved patients’quality of life, as well as the ability to control skin andjoint disease, which therefore behooves us to moreaccuratelymeasure this domain aswell as other moreclinical disease domains. On the basis of our surveyof the literature, it is quite apparent that there iscurrently a lack of uniformity in how HRQOL is mea-sured in patients with psoriasis and PsA. Individualdifferences in the various instruments, and even inthe way improvements are represented (either as aunit or a percentage), prevent true cross-study com-parisons that allow patients and physicians to deter-mine which therapies provide the greatest benefit.Although treatment efficacy is usually measured bychanges in the PASI and other physician-reportedinstruments, they do not always provide a completepicture of the patient’s health status. As treatmentshave become increasingly more effective in treatingskin conditions, optimal therapy that leads to long-lasting remission can only be achieved by addressingboth the physical and psychosocial ill effects of thesedisorders. Several drug therapies reduce the severityof skin lesions, but may not necessarily improve thepatient’s psychosocial well-being. In fact, treatmentsthat have significant adverse effects (eg, requiringregular physician and laboratory visits) and highcosts can improve a patient’s physical appearance,but may lead to occupational and financial distress.Traditional medications such as methotrexate mayalso cause gastrointestinal side effects and a feelingof malaise for 24 to 48 hours after each weekly dose.Biologic therapies represent more effective treat-ments for many psoriasis patients because they candramatically improve multiple facets of a patient’s

*Feldman SR, Bala M, Menter A, Gordon KB. The quality of life of

patients with severe psoriasis treated with infliximab. Presented

at the 62nd Annual Meeting of the American Academy of

Dermatology, Feb 6-11, 2004, Washington, DC.yWallace K, Hamlin R, Langley R, Chen DM. Results of the

Dermatology Life Quality Index in moderate to severe plaque

psoriasis patients receiving 12 weeks of adalimumab therapy.

Presented at the 10th International Psoriasis Symposium, June

10-13, 2004, Toronto, Canada.zWanke LA, Gottlieb AB, Mease PJ, Kivitz AJ, Cohen SB, Burge DJ.



Scientific Meeting of the American Academy of Rheumatology,

Oct 25-29, 2002, New Orleans, La.

J AM ACAD DERMATOL



life, including the physical, psychological, social,and occupational domains of HRQOL. The TNFinhibitors particularly are of benefit because of theireffectiveness in both skin and joint aspects ofpsoriasis.

Measures of quality of life often claim to be able tocapture all psychosocial dimensions associated withspecific illnesses. However, there is currently no‘‘gold standard’’ measure in dermatology. This willrequire refinement of existing instruments and aconsensus-building process similar to OMERACT, withthe goal being the standardization of assessmenttools. The initial work of the Group for Research andAssessment of Psoriasis and Psoriatic Arthritis andthe International Psoriasis Council is encouraging inthis regard, and standardization is likely to be accom-plished in the years aheadwith the close cooperationof dermatologists and rheumatologists.

We thank Ting Chang, PhD, for editorial support.

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Quality-of-life issues in psoriasis and psoriatic ...bestpsoriasis.jaad.org/pdf/JAAD Psoriasis supplement_R82-Mease.pdf · R82 Reprinted from: J Am Acad Dermatol 2006;54:685-704