Clinics in Dermatology (2010) 28, 6772

Scoring and monitoring the severity of psoriasis. What is

the preferred method? What is the ideal method?
Is PASI pass? facts and controversies
Luigi Naldi, MD
Centro Studi Gruppo Italiano Studi Epidemiologici in Dermatologia and Department of Dermatology, Ospedali Riuniti,
Largo Barozzi 1, 24100 Bergamo, Italy

Abstract Instruments to measure and to monitor the severity of psoriasis over time are needed for
research and for optimal patient care. Scoring psoriasis has moved from an earlier time when clinical
categories were adopted without concern about their reliability; for example, from clearance to more
recent semi-quantitative scores, such as the Psoriasis Area and Severity Index (PASI), that carry the
allure of being objective and quantitative hard data but actually translate a subjective judgement into a
number. The PASI score has never been standardized, and data on interrater and intrarater reliability are
limited. Better clinimetrics of disease severity are needed. The next generation of instruments should
reflect the major concern of patients and treating physicians relative to safe and effective long-term
disease control for a lifelong condition.
2010 Elsevier Inc. All rights reserved.

Psoriasis is a chronic relapsing skin disease. As for other

long-lasting cutaneous disorders, limiting psoriasis to a
problem on the skin is a rather restrictive approach. Psoriasis
deeply affects well-being and has emotional and relational
consequences that go far beyond the skin. 1 Several
comorbidities have also been linked with psoriasis that
need to be properly recognized and managed accordingly.2
The main aim of the treatment is to reduce the burden of
the disease over time by controlling symptoms, helping
patient to cope with the chronic nature of the disease,
mitigating psychologic and relational consequences, and
preventing systemic complications and comorbidities. The
presentation and clinical course of psoriasis vary widely.
Instruments to measure severity and monitor it over time are
Tel.: +39 0352278719; fax: +39 0352278676.
E-mail address: luigi.naldi@gised.it.
URL: http://www.centrostudigised.it.
0738-081X/$ see front matter 2010 Elsevier Inc. All rights reserved.
doi:10.1016/j.clindermatol.2009.03.001

needed for optimal patient care and for comparisons of

outcome data between patients and studies. This review will
summarize the available instruments and make some
suggestions for the future.

Measuring clinical judgment

A clinical scoring system is a system translating a
clinical judgement into a scale.3 Clinical judgement is
needed to make predictions and interventions to modify the
expected outcome of disease. Scales imply measurements,
such as rules for assigning a value (numeric or nominal) to
objects or events so that it represents quantities, qualities, or
categories of an attribute.
The term clinimetrics was introduced by Alvar Feinstein
more than 30 years ago to describe the need for a systematic
approach to scale development in the clinical setting,

68
distinguishing between hard and soft data.4 Hard data
refers to objective measurements, preferably done by machines, that are expressed in numbers or standardized dimensional scales. These data are perceived as trustworthy and
have the advantage of being mathematically tractable; that is,
they can can be added, multiplied, or summarized as means.
On the other hand, many of the most important clinical
events are intrinsically human reactions and sensations, such
as pain and discomfort, that cannot be measured (if not
arbitrarily) in numeric terms but are better captured by
ordinal scales such as none, mild, moderate, or severe, or by
semi-quantitative scales such as visual analog scales. These
soft data are usually considered to be scientifically or
statistically unappealing.
Severity assessment implies an understanding of the
many influences of the disease on the patient's life,
including the most ominous one, death, and other less
extreme consequences such as disease-associated discomfort or level of disability.5 Proficient clinical judgement for
severity usually considers such things as patterns of
symptoms, effects of comorbid conditions, rate of progression, and functional capacity to demarcate major prognostic
and therapeutic differences among groups of patients who
otherwise seem deceptively similar because they have
received the same diagnosis.
According to a general definition, outcome refers to all
the possible results that stem from exposure to a causal
factor, or from preventive or therapeutic interventions.6
Outcome in health care evaluation is now recognized as
consisting of several dimensions, such as disability,
discomfort, cost, and death, that can be separated into their
measurable components. Each measure used to assess the
result of a treatment achieves its value only to the extent that
it serves as a proxy for an outcome component. For example,
if the Psoriasis Area and Severity Index (PASI) score
accurately quantitates disability or discomfort, then it may be
of value as a surrogate outcome measure for psoriasis. What
is a relevant outcome variable is a matter of judgement
derived from the knowledge of the disease, patient requirements, and values of society (outcome measures are, to some
extent, culture-dependent).
The problems implied in the development of severity
criteria and those implied in outcome measures are
analogous7 in that they both consist of measures that must
have the properties of validity and reliability. In addition,
outcome measures must be responsive to change; that is, they
must have the ability to identify what may be small but
nevertheless clinically important changes, whereas severity
criteria should be able to discriminate between individuals.
The distinction between the aims of severity assessment and
outcome evaluation is frequently blurred when measurement
systems for skin disorders are developed. If an instrument is
useful to discriminate among the severity levels of psoriasis,
it does not necessarily mean that it will be able to detect
changes that are important as a result of treatment within
these categories.

L. Naldi
The following steps have been delineated in the
development of a measurement instrument:
1. item selection: definition of the areas related to health
status and its changes;
2. item reduction: retain frequent and important items;
3. reproducibility: assessment of variations between
replicate measurements;
4. validity: the degree to which a measurement measures
what it purports to measure; and,
5. limited to outcome measures: sensitivity to changes
(or responsiveness), ability of the test to detect changes
over time.
Most of the influences on severity and outcome, with the
remarkable exception of death, are better expressed as a
continuum rather than as a yes or no phenomenon. There are
practical advantages, nonetheless, in trying to translate the
continuum into a limited number of workable categories. The
main advantage is a better compliance with the discrete
nature of most clinical decisions where thresholds are usually
required for implementing interventions. Examples of
categoric classifications of a severity continuum are tumor
staging and arterial hypertension definition. One difficulty
with psoriasis is that, at variance with many chronic
disorders, it does not appear to progress steadily toward a
definite outcome,8 and hence, it is difficult to split the disease
into stages by natural history.

Severity assessment and outcome measures for

psoriasis: a brief historical perspective
In earlier trials of psoriasis up to the 1970s; for example,
trials of psoralen plus ultraviolet light (PUVA) therapy,9
severity of psoriasis was mainly identified by clinical pattern,
with inclusion of simple entities such as generalized
plaque, erythrodermic, or generalized pustular psoriasis.
Clearance and complete clinical remission were categories used to define outcome. Once clearance was achieved,
maintenance and relapse were used to establish treatment success over time.
It is with the introduction of less effective interventions
compared with PUVA or the shortening of trial duration, or
both, that the need for a more detailed analysis of the effect of
interventions arose. In 1978 to assess outcome in a trial of
acitretin, Fredriksson and Pettersson10 introduced PASI, an
empirically developed instrument that was to gain large
popularity in subsequent randomized trials of psoriasis. It
represented the prototype for families of similar activity
indexes adopted in dermatology during the last 20 years
(Table 1).11-16 These indexes mainly assess severity by
considering the skin area involved at a point in time and by
adding scores for selected clinical features such as the degree
of scaling and infiltration.

Scoring psoriasis
Table 1

69

Selected quantitative indexes for scoring psoriasis

Index

Description

PASI-derived indexes
Psoriasis Area and Severity
Index (PASI)

Plaques are graded based on three criteria: redness (R), thickness (T), and scaliness (S). Severity is rated for
each index on a 0-4 scale (0 for no involvement; 4 for severe involvement). The body is divided into
4 regions: head (h), upper extremities (u), trunk (t), and lower extremities. In each of these areas, the fraction
of total surface area affected is graded on a 0 to 6 scale (0, no involvement; up to 6 for N90 % involvement).
The various body regions are weighted to reflect their respective proportion of body surface area. The
composite PASI score can then be calculated: PASI = 0.1(Rh + Th + Sh)Ah + 0.2(Ru + Tu + Su )Au + 0.3(Rt +
Tt + St )At + 0.4(Rl + Tl + Sl )Al
Psoriasis Log-based Area and To overcome the problem of improper weighting of area scores in PASI (eg, when patients reach b 10%
Severity Index (PLASI)
skin involvement in any body area, the PASI scale for this parameter loses its sensitivity) the area scale is
divided logarithmically into 6 equal groups and the group upper limits (ie, 100, 46, 21, etc) are used for the
area score.
Psoriasis Exact Area and
To overcome the problem of improper weighting of area scores in PASI (see above), this index uses actual
Severity Index (PEASI)
proportion of body area involvement instead of an area score for each body area.
Self-administered PASI
Adopts visual analog scales (VAS) to describe the color, thickness, and scaling of an average psoriatic
(SAPASI)
lesion. The SAPASI is calculated from the equation: SAPASI = [(0.1 AH) + (0.2 AU) + (0.3 AT) +
(0.4 AL)][0.0333 (VASE + VASI + VASS)], where AH is head area score; AU is upper extremity area
score; AT is trunk area score; AL is lower extremity area score; VASE is VAS erythema score; VASI is VAS
induration score; VASS is VAS scale score.
Simplified PASI (SPASI)
Involves estimating the mean redness, thickness, and scaliness of psoriasis for the whole body using the
same scores as PASI and multiplying this by the whole body area of involvement.
Other severity indexes
Body surface
Actual clinician-estimated percentage of body surface involved by psoriatic lesions; ranges from 0%
area involved
to 100%
Physician Global
A static and a dynamic scale can both be used. Usually used as a 7-point score. Static scale: 0 = clear; scores
Assessment (PGA)
1 to 6 = increasing severity.
Lattice System PGA
The percentage of body surface area involved is measured in categories of 0%, 1%3%, 4%9%, 10%
20%, 21%29%, 30%50%, and 51%100%. By combining these areas of involvement with the character
of the plaques, in terms of elevation (ie, induration or thickness), erythema, and scaliness, each scored on a
none-to-mild or moderate-marked scale, the psoriasis can be categorized into 1 of 8 categories from clear to
very severe.
Salford Psoriasis Index (SPI) This holistic index incorporates the current clinical extent of psoriasis based on PASI, a score indicating
psychosocial disability, and past severity based on treatment history. The resultant 3-figure SPI (signs,
psychosocial disability, interventions) is a similar paradigm to the TNM classification used for cancer
staging. The first figure transforms the PASI into a number from 0 to 10 reflecting extent of psoriasis. The
second assesses the psychosocial effect of psoriasis on each patient using a 0 to 10 VAS. The third figure
reflects historical severity of disease as judged by the need for systemic treatment, admission to hospital,
and number of episodes of erythroderma.

The measures derived from assessments like PASI are

used to assess severity and define treatment response. When
the index is used as a severity index, thresholds are
established that allow movement from one severity level to
another.17 When the index is used as an outcome measure,
changes in score values are taken into account. By
considering patients as body areas, these indexes do not
provide any direct information on the disease in terms of
psychologic or social consequences. These indexes, moreover, do not show differences between different pattern
distributions or clinical subgroups and are poorly suited to
assess disease varieties other than chronic plaque psoriasis.18
In more recent years, quality of life instruments have
complemented objective measures of clinical involvement.
Quality of life, which is better termed health-related quality
of life, refers to quantitative estimates of the overall effect of

a disease on the physical, social, and psychologic well-being

of a patient.19,20 The estimates are obtained through
standardized questionnaires exploring the relevant dimensions of the patient's life that the disease may be affecting.
Among the quality of life instruments designed for
specifically assessing psoriasis are the Psoriasis Disability
Index (PSI),21 and the Psoriasis Life Stress Inventory
(PLSI).22 Quality of life measures have had the merit of
pointing to the multidimensional nature of disease assessment and outcome, which should include evaluation of
disease-associated discomfort, level of disability, and social
disruption. One difficulty is their validation against a gold
standard and the definition of severity thresholds.
A useful distinction should be made between severe
psoriasis and psoriasis that severely affects quality of life. As
pointed out recently, such a distinction has relevant

70

L. Naldi

consequences in terms of disease management.23 Patients

with mild psoriasis on an objective scale who experience a
disproportionate effect on quality of life may benefit from
psychologic support and by learning coping strategies rather
than systemic drugs to suppress disease activity.
Criteria were developed recently by the European
Medicines Agency (EMEA) to establish disease severity,
mainly for the purpose of standardizing assessment in
randomized clinical trials. The system focuses on critical
features of psoriasis that may involve a change in disease
management moving from no treatment to topical and to
systemic modalities. A modified version of this system is
presented in Table 2.24 The definition takes into account the
extent of skin involvement and the patient's judgement. Such
a definition, focusing on the action to be taken, may be
referred to as an operational one.
Table 2

Working definitions of disease severity in psoriasis a

Psoriasis severity

Definition

In remission, minimal

Stable remission with no

psoriatic lesions
Signs of borderline psoriasis
(eg, nail pitting, severe dandruff)
A few isolated lesions negligible
to the patient
Mild
Psoriasis involving b 10% of body
surface area (or PASI b 10)
Good control of lesions with
topical therapy
Moderate
Skin involvement N 10% of the
body surface area but topical
therapy still possible
Moderate to severe
Skin involvement N 10% of
body surface area and topical
therapy fails to control disease.
Skin involvement b 10%
but lesions in difficult
areas (such as
involvement of the face,
hands or feet) with
distressing or
disabling effects
Severe
Skin involvement N 20%
(or PASI N 20) with a justified
need for systemic treatment.
Skin involvement N 10% but
b 20% with lesions in difficult
areas with distressing/disabling
effects, or unstable
(rapidly extending) psoriasis
Psoriatic arthritis
Associated with a guarded Generalized pustular psoriasis
prognosis (skin failure) (von Zumbusch type)
Psoriatic erythroderma
PASI, Psoriasis Area and Severity Index.
a
Table from European Medicines Agency (EMEA) 2002,
modified.24

A critique of existing measures

The situation of severity and outcome evaluation in psoriasis in recent decades can be briefly summarized as follows:
Considerably more attention has been given to
dermatologists' views on severity and treatment effects
than to patients' views.25
Most of the interest has been concentrated on skin
involvement; only recently have psychologic and
social factors relevant to outcome been appraised.
Assessment of involved areas by objective quantitative indexes has been preferred to hazarding definition
of synthetic relevant clinical outcome (eg, clearing).
Scoring systems have been adopted without any formal
methodologic refinement. Even a simple measure such as the
approximate percentage of area involved is prone to wide
interobserver and intraobserver variations if the evaluation
methods are not clearly specified.18
The PASI score has never been standardized, and testing
for interrater and intrarater reliability is limited. Moreover,
it has never been demonstrated that the weights arbitrarily
attributed to each item in the PASI score actually reflect the
clinical severity of lesions. A conceptual difficulty when
changes in the PASI score are used to assess clinical
response arises in specifying what a clinically important
change a given variation in the PASI score represents. The
adoption of a 75% change, as in PASI-75, is as arbitrary as
any other degree of change in the lack of formal validation.
Such a validation would involve assessment of a relation
between changes in PASI and specific important dimensions of outcomes.
To overcome the problems arising from subjective
judgement, more objective measures have been repeatedly
advocated, such as the use of ultrasound imaging to evaluate
the thickness of psoriasis plaques.26 Any measurement,
however, is fully justified only when it represents a good
surrogate for clinically important outcomes, such as the
patient's disability and discomfort.5
Some additional points could be made about the usual
presentation of score data over time.27 It is common practice
to build up a curve from the mean score values of the
treatment and control groups. The means may not represent a
good descriptor of a typical curve for an individual, and
separate analyses of different time points do not convey
information on how individuals respond over time. This
practice also can be criticized on statistical grounds because
of multiple potentially data-driven statistical tests, and
because the values over time are not independent and one
time point is likely to influence successive time points.28
Scoring systems available for psoriasis seem to fit best
with the clearance issue. Clearing the disease in the shortterm is different from maintaining clearance over time, and
long-term results are not simply predictable from short-term
outcomes (Figure 1). Conversely, it is not easy to define what

Scoring psoriasis

Fig. 1 Clinical prediction of effective and safe disease control in

psoriasis. Is that possible from short term data?

71
Multistage outcome models. We generally expect
people to change quickly in a dichotomous way.
Particularly in the area of disability, we may be interested
in slowly moving changes. A multistate outcome model
could be more realistic for long-term evaluation.30
Drop-outs. Participants who drop out of a study have a
special importance in a situation such as psoriasis, with
no hard end point, because they may strongly reflect
dissatisfaction with treatment.31 Patients who do not
provide a PASI score, disability score, or quality of life
score could be different from those who do, and simply
ignoring them could provide unreliable results. This
consideration reinforces the need for selecting simple
outcome measures and incorporating dropping out as
an outcome in the study.

Final considerations
represents a clinically significant long-term change in
psoriasis status, because at variance with other health
conditions such as cancer or ischemic heart diseases where
mortality or major hard clinical end points (eg, myocardial
infarction) are of particular interest, psoriasis does not
progress to any definite outcome. In the long-term, the way
the disease is controlled and the treatment side effects are
vitally important.

What for the future?

Psoriasis is a chronic disorder that waxes and wanes over
time. Withdrawal of treatments usually is accompanied by a
relapse of skin manifestations. Long-term concerns should
inform both the development of instruments to capture
disease activity and the design of clinical trials. Response to
treatment and stability of clinical manifestations over time
should be considered for severity assessment. Safety issues
should represent a major concern when projecting treatment
long-term, and they should be incorporated into outcome
measures. Safe and effective long-term disease control
should be considered as a primary outcome that may be
summarized by simple outcome measures such as safe
remission duration or a flare-up that needs a change in
treatment or withdrawal from a trial.
The design of a study obviously influences outcome
evaluation. A few points are worth further consideration:
Patients' preferences. In most studies of psoriasis,
patients seem to have developed the disease in a
vacuum, and their preferences for a treatment are only
considered as a matter of informed consent.29
Motivations of volunteers could be different from
those of nonvolunteers. Besides contributing to
generalizability, assessment of motivations at the
start of the study would allow a better understanding
of patients' preferences as the end result of treatment.

Despite advancements in understanding pathogenesis and

treatment options, psoriasis still remains a rather elusive and
even enigmatic disease. Better clinimetrics of disease
severity are needed that take into account the many
influences of the disease on the patient's life. Once
developed, measures should be applied in long-term
prognostic and interventional studies.
A consensus on the relevant outcome measures should be
reached. Ideally, an internationally coordinated approach
should be adopted. There are examples of such international
collaboration in other difficult areas of medicine like psychiatry32 and, particularly, rheumatology with the Outcome
Measures in Rheumatology (OMERACT) initiative.33,34

References
1. Jobling R, Naldi L. Assessing the impact of psoriasis and the relevance
of qualitative research. J Invest Dermatol 2006;126:1438-40.
2. Christophers E. Comorbidities in psoriasis. Clin Dermatol
2007;25:529-34.
3. Feinstein AR. Clinical judgement revisited: the distraction of
quantitative models. Ann Intern Med 1994;120:799-805.
4. Feinstein AR. An additional basic science for clinical medicine: IV. The
development of clinimetrics. Ann Intern Med 1983;99:843-8.
5. Fries JF. Toward an understanding of patient outcome measurement.
Arthritis Rheum 1983;26:697-704.
6. Last JM. A dictionary of epidemiology. New York: Oxford University
Press; 1988.
7. Guyatt GH, Kirshner B, Jaeschke R. Measuring health status: what are
the necessary measurement properties? J Clin Epidemiol 1992;45:
1341-5.
8. Farber EM, Nall L. The natural history of psoriasis in 5,600 patients.
Dermatologica 1974;148:1-18.
9. Henseler T, Wolff K, Hnigsmann H, Christophers E. Oral 8methoxypsoralen photochemotherapy of psoriasis. The European
PUVA study: a cooperative study among 18 European centres. Lancet
1981;1:853-7.
10. Fredriksson T, Pettersson U. Severe psoriasis: oral therapy with a new
retinoid. Dermatologica 1978;157:238-44.

72
11. Jacobson CC, Kimball AB. Rethinking the Psoriasis Area and Severity
Index: the impact of area should be increased. Br J Dermatol
2004;151:381-7.
12. Fleischer Jr AB, Feldman SR, Dekle CL. The SAPASI is valid and
responsive to psoriasis disease severity changes in a multi-center
clinical trial. J Dermatol 1999;26:210-5.
13. Louden BA, Pearce DJ, Lang W, Feldman SR. A Simplified Psoriasis
Area Severity Index (SPASI) for rating psoriasis severity in clinic
patients. Dermatol Online J 2004;10:7.
14. Langley RG, Ellis CN. Evaluating psoriasis with Psoriasis Area and
Severity Index, Psoriasis Global Assessment, and Lattice System
Physician's Global Assessment. J Am Acad Dermatol 2004;51:563-9.
15. Henseler T, Schmitt-Rau KA, comparison between BSA. PASI, PLASI
and SAPASI as measures of disease severity and improvement by
therapy in patients with psoriasis. Int J Dermatol 2008;47:1019-23.
16. Kirby B, Fortune DG, Bhushan M, Chalmers RJ, Griffiths CE. The
Salford Psoriasis Index: an holistic measure of psoriasis severity. Br J
Dermatol 2000;142:728-32.
17. Feldman SR. A quantitative definition of severe psoriasis for use in
clinical trials. J Dermatolog Treat 2004;15:27-9.
18. Ashcroft DM, Wan Po AL, Williams HC, Griffiths CE. Clinical
measures of disease severity and outcome in psoriasis: a critical
appraisal of their quality. Br J Dermatol 1999;141:185-91.
19. Katz S. The science of quality of life. J Chron Dis 1987;40:459-63.
20. Wilson IB, Cleary PD. Linking clinical variables with health-related
quality of life. A conceptual model of patient outcomes. JAMA
1995;273:59-65.
21. Finlay AY. Quality of life measurement in dermatology: a practical
guide. Br J Dermatol 1997;136:305-14.
22. Gupta MA, Gupta AK. The Psoriasis Life Stress Inventory: a preliminary
index of psoriasis-related stress. Acta Derm Venereol 1995;75:240-3.

L. Naldi
23. Schmitt J, Wozel G. The psoriasis area and severity index is the
adequate criterion to define severity in chronic plaque-type psoriasis.
Dermatology 2005;210:194-9.
24. European Medicines Agency (EMEA) Committee for Proprietary
Medicinal Products. Note for guidance on clinical investigation of
medical products indicated for the treatment of psoriasis. CPMP/EWP
2454/02. http://www.emea.europa.eu/pdfs/human/ewp/245402en.pdf.
25. McHenry PM, Doherty VR. Psoriasis: an audit of patients' views on the
disease and its treatment. Br J Dermatol 1992;127:13-7.
26. Marks R, Barton SP, Shuttleworth D, Finlay AY. Assessment of disease
progress in psoriasis. Arch Dermatol 1989;125:235-40.
27. Naldi L. Dermatology. In: Day S, Green SB, Machin D, editors.
Textbook of clinical trials. New York: John Wiley & Sons; 2004.
28. Matthews JNS, Altman DG, Campbell MJ, Royston P. Analysis of
serial measurements in medical research. BMJ 1990;300:230-5.
29. Brewin CR, Bradley C. Patient preferences and randomized trials. Br
Med J 1989;299:313-5.
30. Nijsten T, Looman CW, Stern RS. Clinical severity of psoriasis in last
20 years of PUVA study. Arch Dermatol 2007;143:1113-21.
31. Newell DJ. Intention-to-treat analysis: implications for quantitative and
qualitative research. Int J Epidemiol 1992;21:837-41.
32. Kendler KS. Toward a scientific psychiatric nosology: strengths and
limitations. Arch Gen Psychiatry 1990;47:969-73.
33. Arnett FC, Edworthy SM, Bloch DA, McShane DJ, Fries JF, Cooper
NS. The American Rheumatism Association 1987 revised criteria for
the classification of rheumatoid arthritis. Arthritis Rheum 1988;31:
315-24.
34. Stucki G, Boonen A, Tugwell P, Cieza A, Boers M. The World Health
Organisation International Classification of Functioning, Disability and
Health: a conceptual model and interface for the OMERACT process.
J Rheumatol 2007;34:600-6.