STUDY

Development of the CLASI as a Tool to Measure

Disease Severity and Responsiveness to Therapy
in Cutaneous Lupus Erythematosus
Rachel Klein, MD; Siamak Moghadam-Kia, MD; Jonathan LoMonico, BA; Joyce Okawa, RN; Chris Coley, BA;
Lynne Taylor, PhD; Andrea B. Troxel, ScD; Victoria P. Werth, MD

Objective: To determine how to use the Cutaneous Lu-
pus Erythematosus Disease Area and Severity Index
(CLASI) to classify patients according to disease sever-
ity (mild, moderate, and severe) and to identify which
patients respond to therapy.
Design: Cohort.
Setting: The connective-tissue disease clinic at the Hos-
pital of the University of Pennsylvania, Philadelphia.
Patients: Seventy-five patients with clinical or histo-
pathologic evidence of cutaneous lupus erythematosus
or systemic lupus erythematosus were included in the
study.
Main Outcome Measures: The CLASI, Skindex-29,
and the physician’s subjective assessment of severity and
improvement were completed at every visit.
Results: Disease severity was assessed with 45 patient
visits. Mild, moderate, and severe disease corresponded
with CLASI activity score ranges of 0 to 9, 10 to 20, and
21 to 70, respectively. Improvement in disease activity
was assessed in 74 patients. A clinical improvement was
associated with a mean 3-point or 18% decrease in the
CLASI activity score. However, receiver operating char-
acteristic analysis demonstrated an increased percent-
age of patients correctly classified when a 4-point (sen-
sitivity, 39%; specificity, 93%; correctly classified, 76%)
or 20% (sensitivity, 46%; specificity, 78%; correctly clas-
sified, 67%) decrease in the CLASI activity score was used
instead to identify improvement.
Conclusion: The CLASI can be used to classify patients
into groups according to disease severity and to identify
clinically significant improvements in disease activity.
Arch Dermatol. 2011;147(2):203-208

Author Affiliations:
Department of Dermatology,
Philadelphia VA Medical
Center, Philadelphia,
Pennsylvania (Drs Klein and
Werth); Department of
Dermatology, University of
Pennsylvania School of
Medicine, Philadelphia
(Drs Klein, Moghadam-Kia, and
Werth, Mr LoMonico, and
Ms Okawa); Department of
Internal Medicine, Washington
Hospital Center, Washington,
DC (Dr Moghadam-Kia); and
Department of Biostatistics and
Epidemiology, University of
Pennsylvania, Philadelphia (Mr
Coley and Drs Taylor and
Troxel).
T
HE CUTANEOUS LUPUS ERY-
thematosus Disease Area
and Severity Index (CLASI)
is a clinical tool that quan-
tifies disease activity and
damage in cutaneous lupus erythemato-
sus (CLE). The activity score is based on
the degree of erythema, scale, mucous
membrane lesions, and nonscarring alo-
pecia.1 Unlike other outcome measures in
dermatology, CLASI scores are not based
solely on the area of involved skin; rather,
parts of the body that are most visible are
weighted more heavily than those that are
usually covered.1 The CLASI has already
been shown to have good content valid-
ity, addressing the most relevant aspects
of CLE as determined by an expert panel
of dermatorheumatologists.1 It also has
good interrater and intrarater reliability
when used by either dermatologists or
rheumatologists.1,2 Early small clinical
studies have demonstrated responsive-
ness in all subsets of CLE, including in-
dividual lesions, localized and general-
ized discoid lupus erythematosus (DLE),
as well as subacute cutaneous lupus ery-
thematosus (SCLE) and tumid lupus ery-
thematosus.3-7
In 2005, the US Food and Drug Ad-
ministration (FDA) updated their guide-
lines regarding the development of new
therapeutic agents for the treatment of sys-
temic lupus erythematosus (SLE).8 They
recommended focusing on organ-
specific therapies, which may be easier to
approve than medications that target mul-
tiple organ systems. In order to demon-
strate efficacy in 1 organ system, it is im-
portant to have an organ-specific index of
disease activity and to understand how to
use that index to characterize disease se-
verity and define improvement. There-
fore, we sought to determine how the
CLASI activity score could be used to clas-
sify patients into groups according to mild,
moderate, and severe disease, as well as the
change in the CLASI activity score that cor-
responds with a clinically significant im-
provement in disease activity.

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 METHODS
PATIENT SELECTION
Patients were recruited from our connective tissue disease clinic
at the Hospital of the University of Pennsylvania, Philadel-
phia. Inclusion criteria included a diagnosis of CLE based on
the modified Gilliam criteria.9 All patients were 18 years or older.
The study was approved by our institutional review board (IRB),
and all patients were enrolled with IRB-approved informed con-
sent and Health Insurance Portability and Accountability Act
forms.
OUTCOME MEASURES
Procedures
Several questionnaires were completed at each visit; the prin-
cipal investigator (V.P.W.) completed the Physician’s Subjec-
tive Assessment of Severity, the Physician’s Subjective Assess-
ment of Improvement, and the CLASI. The study participant
completed the Skindex-29. These questionnaires are de-
scribed in detail in the following subsections.
Physician’s Subjective Assessment of Severity
Patients were classified as having mild, moderate, or severe dis-
ease by the principle investigator, based on her subjective as-
sessment of disease activity (Physician’s Subjective Assess-
ment of Severity [PSAS]).
Skindex-29
Skin-specific quality of life (QOL) was measured with the pre-
viously validated Skindex-29.10 This questionnaire consists of
29 items, which are used to calculate 3 subscales: symptoms,
emotions, and functioning. The symptoms scale measures the
physical burden of the disease, such as pain, itch, burning, or
sensitivity. The emotions scale measures the psychiatric ef-
fects of the disease, such as depression, anxiety, embarrass-
ment, or anger. The functioning subscale focuses on the changes
to daily life, such as work, sleep, and relationships with oth-
ers. Each question ranges from 0 to 100 points, with higher
scores indicating worse QOL. Subscale scores were calculated
based on the mean scores of the individual questions that com-
prise the subscale.
Physician’s Subjective Assessment of Improvement
At clinic visits, the principle investigator categorized disease
activity in each patient as improved, unchanged, or worse since
the last visit. These assignments were based on the physician’s
subjective assessment of the patient’s skin disease.
CLASI ACTIVITY SCORE
Disease activity was measured using the CLASI activity score.
This score ranges from 0 to 70, with higher scores indicating
more severe skin disease (Figure 1).
SEVERITY ANALYSIS
Study patients seen from November 2008 through April
2009 were classified by the principle investigator as having
mild, moderate, or severe disease based on the degree of dis-
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ease activity, as described herein. Corresponding CLASI
activity scores were also calculated. The optimal CLASI
activity score ranges that corresponded with each severity
group were determined by inspection of the CLASI score by
PSAS crosstab row percentages and receiver operating char-
acteristic (ROC) analysis. Using the crosstab row percent-
ages, it was determined how frequently a particular CLASI
score was associated with each severity group. The CLASI
cutoff score for each severity group was determined when 3
consecutive CLASI scores were associated most frequently
with the same severity group. Two ROC analyses were used
to assess the merits of the CLASI cut points suggested by the
crosstab, 1 for mild disease (mild vs moderate and severe)
and 1 for severe disease (severe vs moderate and mild). The
CLASI scores that fell between the upper limit of mild and
the lower limit of severe were designated as indicating mod-
erate disease.
QOL ANALYSIS
Study patients seen between January 2007 and June 2009
were included in the QOL analysis. Quality of life, as indi-
cated by Skindex-29 scores, was then compared between pa-
tients in each CLASI severity range using trend analysis,
Spearman correlations, and general linear model (GLM)
analysis of variance. Quality of life was assessed in terms of
mean Skindex-29 scores and the linear relationship between
CLASI severity levels and QOL.
RESPONSIVENESS ANALYSIS
In study patients seen between August 2008 and October
2009, disease activity was classified by the principle investi-
gator as improved, unchanged, or worse compared with the
previous visit, as described the subsection titled “Physician’s
Subjective Assessment of Improvement” (in this section).
Those with disease classified as having improved were con-
sidered responders, and those with disease classified as
unchanged or worse were considered nonresponders. The
CLASI activity score associated with a clinical improvement
was estimated by calculating the mean signed change and
percentage change in CLASI activity scores for each group.
When the baseline CLASI activity score was zero, 0.5 points
were added to each score to allow the percentage change to
be calculated. In addition, all outlier percentage change
scores, defined as more than ±500% in magnitude, were
excluded from the analysis. If a patient had more than 1 set
of consecutive visits in either the responder or nonresponder
group, the mean change in the CLASI activity scores was cal-
culated such that the patient was included only once per cat-
egory in the final analysis.
An ROC analysis was performed to determine the sensi-
tivity (the likelihood that a patient has a given ⌬ CLASI
given that he or she is a true responder), specificity (the
likelihood that a patient does not have a given ⌬ CLASI
given that he or she is not a true responder), and percentage
of patients correctly classified for each signed change
and percentage change in the CLASI activity scores. The
final signed change and percentage change CLASI scores
associated with a clinical improvement were chosen based
on the average signed change and percentage change in
CLASI scores derived by responders and then confirmed by
assessing the ROC operating characteristics at and around
that cutoff, focusing primarily on the classification rate. All
analyses were conducted using Stata MP (version 11.0; Stata-
Corp, College Station, Texas) and SAS (version 9.2; SAS
Institute Inc, Cary, North Carolina) statistical software.
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 Cutaneous LE Disease Area and Severity Index (CLASI)©
Select the score in each anatomical location that describes the most severely affected cutaneous lupus-associated lesion

activity damage

Scale/ Scarring/
Anatomical Location Erythema Hypertrophy Dyspigmentation Atrophy/ Anatomical Location
Pannicullitis
0- absent
1- pink; faint erythema 0- absent 0- absent
0- absent 1- scarring
2- red; 1- scale
1- dyspigmentation 2- severely
3- dark red; 2- verrucous/
purple/violaceous/ atrophic scarring
hypertrophic or panniculitis
crusted/hemorrhagic
Scalp See below Scalp
Ears Ears
Nose (incl. malar area) Nose (incl. malar area)
Rest of the face Rest of the face
V-area neck (frontal) V-area neck (frontal)
Post. Neck &/or shoulders Post. Neck &/or shoulders
Chest Chest
Abdomen Abdomen
Back, buttocks Back, buttocks
Arms Arms
Hands Hands
Legs Legs
Feet Feet Figure 1. The Cutaneous Lupus
Erythematosus Disease Area and
Mucous membrane Dyspigmentation Severity Index. Reprinted by
Report duration of dyspigmentation after active lesions have resolved
permission from the University of
Mucous membrane lesions (examine if patient confirms involvement) (verbal report by patient – tick appropriate box) Pennsylvania, copyright 2009.
Dsypigmentation usually lasts less than 12 months (dyspigmentation
0-absent; score above remains)
1-lesion or ulceration Dsypigmentation usually lasts at least 12 months (dyspigmentation
score is doubled)

Alopecia

Recent Hair loss

(within the last 30 days/as reported by patient) NB: if scarring and non-scarring aspects seem
1-Yes
0-No
to coexist in one lesion, please score both
Divide the scalp into four quadrants as shown. The dividing line between right and left is the midline. The dividing line between frontal and
occipital is the line connecting the highest points of the ear lobe. A quadrant is considered affected if there is a lesion within the quadrant.

Alopecia (clinically not obviously scarred) Scarring of the scalp (judged clinically)

0- absent 0- absent
1- diffuse; noninflammatory 3- in one quadrant
2- focal or patchy in one quadrant 4- two quadrants
3- focal or patchy in more than one quadrant 5- three quadrants
6- affects the whole skull

Total Activity Score Total Damage Score

(For the activity score please add up the scores (For the damage score, please add up the
of the left side; i.e. for Erythema, Scale/Hypertrophy, scores of the right side, i.e. for
Mucous membrane involvement and Alopecia) Dyspigmentation, Scarring/Atrophy/
Panniculitis and Scarring of the Scalp)

RESULTS 48 years. A number of different CLE subtypes was rep-

resented, the most common including generalized dis-
coid lupus erythematosus (DLE) (23%), localized DLE
PATIENT CHARACTERISTICS
(24%), and subacute cutaneous lupus erythematosus
(SCLE) (31%) (Table 1).
A total of 187 patients were enrolled in the study; of these,
74 had at least 2 visits recorded and completed the ap-
propriate questionnaires and were included in the re- SEVERITY ANALYSIS
sponsiveness analysis. A subset of these patients (n=37)
was assessed with the PSAS and was included in the se- Thirty-seven patients were classified by the principal in-
verity analysis. Of these, 1 patient did not have consecu- vestigator as having mild, moderate, or severe disease,
tive visits recorded and was excluded from the respon- and corresponding CLASI activity scores were calcu-
siveness analysis. Another subset of these patients (n=65) lated. The number of visits ranged from 1 to 3, for a total
completed the Skindex-29 and was included in the QOL of 45 different assessments. Overall, 60% of the patient-
analysis. In all, 75 patients were included in this analy- visits were mild disease, 29% were moderate disease, and
sis. The population was composed mostly of women 11% were severe disease. The crosstabs suggested a maxi-
(89%) and white individuals (64%), with a mean age of mum CLASI activity score of 9 points for mild disease

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 Table 1. Patient Characteristics a 90
Severe Moderate Mild
80
Characteristic No. (%)
70
Sex

Skindex-29 Scores
Male 8 (11) 60
Female 67 (89) 50
Race/ethnicity
African American 22 (29) 40
White 48 (64) 30
Asian 4 (5)
Hispanic/Latino 1 (⬍1) 20
Age, mean, y 48 10
Diagnosis
Discoid, generalized 17 (23) 0
Symptoms Emotions Functioning
Discoid, localized 18 (24)
Tumid 8 (11)
Panniculitis 5 (7) Figure 3. Quality of life and disease (QOL) severity Skindex-29 scores were
SCLE 23 (31) calculated for each patient at the initial visit. Patients were divided into
ACLE 12 (16) severity groups based on Cutaneous Lupus Erythematosus Disease Area and
Other 9 (12) Severity Index (CLASI) scores. Skindex-29 subscores increased with
worsening disease severity, indicating moderate convergent validity between
the CLASI severity classifications and QOL measures.
Abbreviations: ACLE, acute cutaneous lupus erythematosus; SCLE,
subacute cutaneous lupus erythematosus.
a A total of 75 patients were included in the analysis. Of these, 1 patient did
not have consecutive visits recorded and was therefore included in the
P⬍ .008; GLM F test=1.95, P =.15; mild vs severe emo-
severity analysis but not the responsiveness analysis. Patients diagnosed as tions: rS =0.35, P ⬍.005; GLM F test=4.73, P =.04; mild
having more than 1 lupus subtype were counted more than once under vs severe functioning: rS =0.35, P⬍.005; GLM F test=1.95,
“diagnosis.” P = .15), indicating moderate convergent validity be-
tween the CLASI severity classifications and QOL mea-
sure (Figure 3).
120
Severe Moderate Mild
RESPONSIVENESS ANALYSIS
100

A total of 74 patients were included in the responsive-

80
ness analysis. Of these, there were 59 instances of non-
Patients, %

responsiveness and 28 instances of responsiveness, for

60
40
20
0 change in the CLASI activity score was 50% sensitive and
0-4 5-9 10-14 15-20 21+
CLASI Scores
Figure 2. Cutaneous Lupus Erythematosus Disease Area and Severity Index
(CLASI) scores according to disease severity. For a given range of CLASI
scores, the percentage of patients within each category of disease severity
was calculated.
(sensitivity, 93%; specificity, 78%; 87% correctly classi-
fied) and 20 points for moderate disease (sensitivity, 80%;
specificity, 95%; 93% correctly classified) (data not
shown). Among the patients with CLASI activity scores
of 0 to 9, 86% of had mild disease, 14% had moderate
disease and none had severe disease. For scores of 10 to
20, 20% of patients had mild disease, 70% had moderate
disease, and 10% had severe disease. For scores of 21 and
70, no patients had mild disease, 33% had moderate dis-
ease, and 67% had severe disease (Figure 2).
Mean Skindex-29 scores were calculated for patients
in each severity group, as defined by CLASI activity scores.
Quality of life became statistically significantly more im-
paired as disease severity increased (mild vs severe symp-
toms: Spearman rank correlation coefficient [rS]=0.33,
a total of 87 assessments. Overall, the prevalence of a clini-
cally significant improvement was 32%.
The mean decreases in the CLASI activity score for re-
sponders and nonresponders were 3.2 and −0.3 points,
respectively. An ROC analysis indicated that a 3-point
83% specific for improvement, resulting in 72% of pa-
tients being correctly classified as responders or nonre-
sponders. However, a 4-point change in the CLASI ac-
tivity score had better specificity (93%), resulting in 76%
of patients being correctly classified as having improved
or not improved (Table 2).
Similarly, the adjusted mean percentage decrease in
the CLASI activity score for responders and nonre-
sponders was 18% and −12%, respectively. An ROC analy-
sis indicated that the percentage of patients correctly clas-
sified was optimized when using a 20% decrease in the
CLASI activity score to detect improvement, which has
46% sensitivity, 78% specificity, and 67% correct classi-
fication (Table 2).
COMMENT
These results indicate that the CLASI can be used to cat-
egorize patients into severity groups, with activity scores
of 0 to 9 indicating mild disease, scores of 10 to 20 in-
dicating moderate disease, and scores of 21 of 70 indi-
cating severe disease. It is also a useful tool in determin-

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 ing whether patients responded to treatment, because
patients who improved clinically had a mean 3-point or
18% decrease in their CLASI activity scores. However,
the ROC analysis suggests that the percentage of pa-
tients correctly classified can be optimized by using a
4-point or 20% decrease in the CLASI activity score to
identify improvement.
An earlier study3 suggested that the CLASI is respon-
sive to changes in disease activity; members of our group
followed 8 patients with CLE (7 DLE, 1 SCLE) for 56 days
following the initiation of a new therapy and found that
decreases in the CLASI activity score correlated well with
improvements in the physician’s global skin assessment,
the patient’s global skin assessment, and the pain score. Simi-
larly, Kreuter et al5 have demonstrated that CLASI activity
scores decrease significantly in patients with tumid lupus
following 3 months of therapy with an antimalarial medi-
cation. They have also shown that CLASI activity scores
decrease significantly in patients with refractory SCLE af-
ter therapy with mycophenolate sodium, which corre-
lates with objective signs of improvement on ultrasonog-
raphy and colorimetry.6 Finally, Erceg et al4 illustrated a
significant decrease in CLASI activity scores in patients with
DLE following pulsed dye laser therapy. While these stud-
ies imply that the CLASI is sensitive to improvement, to
our knowledge this is the first study to systematically de-
termine the minimal change in the CLASI that corre-
sponds to a meaningful clinical improvement.
For both the signed change and percentage change
analyses, there was a clear difference in the mean CLASI
scores of the responders and nonresponders, indicating
that the CLASI is sensitive to improvement. The mean
change in the CLASI score for the nonresponders, par-
ticularly with respect to percentage change, was nega-
tive; this is likely due to the fact that the nonresponder
group included patients with both stable and worsening
disease activity.
In the responsiveness analysis, the sensitivity was lower
than the specificity; sensitivity could have been maxi-
mized by using lower CLASI scores, but this would have
caused the specificity to decrease. For the purposes of a
clinical trial, we felt that it was more important for the
CLASI to be specific than sensitive. With high specific-
ity, the degree of false-positive responses decreases,
thereby minimizing the inclusion of patients who have
not experienced a true clinical improvement.
In addition, the change in the CLASI score that cor-
responds to a clinical improvement was selected primar-
ily based on the percentage of patients correctly classi-
fied rather than by optimizing sensitivity and specificity.
This was done because the latter suggested a change in
the CLASI activity score of merely 1 point, which is only
69% specific for improvement. As discussed herein, we
felt that it was important to have high specificity and there-
fore based the analysis on the percentage of patients cor-
rectly classified instead.
These applications are critical in clinical trials be-
cause they provide a standardized technique for quanti-
fying and describing disease activity. Previously, inves-
tigators relied on their own individualized, often
subjective, methods for describing disease severity and
response to treatment in CLE. As such, it can be diffi-
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Table 2. Responsiveness
CLASI Change % Correctly
Score a Sensitivity, % Specificity, % Classified
⌬
2 57.14 79.66 72.41
3 50.00 83.05 72.41
4 39.29 93.22 75.86
%⌬
10 50.00 70.69 63.95
17 50.00 72.41 65.12
20 46.43 77.59 67.44
Abbreviation: CLASI, Cutaneous Lupus Erythematosus Disease Area and
Severity Index.
a For each CLASI change score (⌬ CLASI) and percentage change score
(% ⌬ CLASI) the sensitivity, specificity, and percentage of patients correctly
classified were calculated. The numbers shown are based on the calculated
mean ⌬ CLASI and % ⌬ CLASI that corresponded with a clinical
improvement, as well as the adjacent scores. Within the % ⌬ CLASI group,
there were no patients with an 18- or 19-point change; therefore 10, 17, and
20 are shown instead.
cult to know exactly what is meant when a patient is de-
scribed as having “moderate disease” or as experiencing
a “clinical improvement.” It is also difficult to directly
compare the results of various trials when different meth-
ods are used to determine efficacy of a particular drug.
The CLASI addresses these issues by providing a simple,
quantitative clinical tool that standardizes the way dis-
ease activity is described and provides guidelines for iden-
tifying a clinical change.
There are, however, some limitations to this study that
should be addressed in the future. First, owing to the small
sample size, patients with mild, moderate, and severe dis-
ease were analyzed as 1 group. However, it is likely that
the patient’s baseline CLASI score influences the mag-
nitude of change seen in a clinical improvement; thus, a
patient with mild disease may have a significant improve-
ment even with a small change in the CLASI activity score
(ⱕ4 points), whereas a patient with severe disease may
require a larger change in the CLASI activity score to de-
tect a significant improvement (⬎4 points). Follow-up
studies should therefore be performed in which pa-
tients are classified according to disease severity, with sepa-
rate analyses performed in each group.
Second, also owing to the small sample size, patients with
every type of CLE were analyzed as 1 group, including those
with localized and generalized disease. The patients with
localized disease, by definition, will always have relatively
low CLASI scores, even if they have severe disease. It will
therefore be more difficult for such patients to demon-
strate the changes in CLASI scores that have been associ-
ated with a clinical improvement. In these cases, investi-
gators may choose to look at the percentage change in the
CLASI activity score rather than signed change. Fol-
low-up studies should include a separate analysis of pa-
tients with localized disease to determine how to define the
severity groups and how to identify a clinical improve-
ment using signed changes in the CLASI activity score.
The aim of this study was to evaluate responsiveness;
the CLASI, however, has other practical applications, such
as identifying flares, which will be examined in future
studies. Overall, this study provides the framework for
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 using the CLASI to characterize disease severity and to
identify a clinical improvement. While more studies must
be done to address specific patient populations, this analy-
sis provides a foundation for the practical use of the CLASI
in clinical trials.
tion, Office of Research and Development, Biomedical
Laboratory Research and Development.
REFERENCES

Accepted for Publication: September 16, 2010.
Correspondence: Victoria P. Werth, MD, Department of
Dermatology, Hospital of the University of Pennsylva-
nia, PCAM Suite 1-330S, 3400 Civic Center Blvd, Phila-
delphia, PA 19104 (werth@mail.med.upenn.edu).
Author Contributions: Dr Werth had full access to all
of the data in the study and takes responsibility for the
integrity of the data and the accuracy of the data
analysis. Study concept and design: Klein, Moghadam-
Kia, Okawa, and Werth. Acquisition of data: Klein,
Moghadam-Kia, LoMonico, and Werth. Analysis and
interpretation of data: Klein, LoMonico, Coley, Taylor,
Troxel, and Werth. Drafting of the manuscript: Klein
and LoMonico. Critical revision of the manuscript for
important intellectual content: Moghadam-Kia, Okawa,
Coley, Taylor, Troxel, and Werth. Statistical analysis:
Coley, Taylor, and Troxel. Obtained funding: Klein and
Werth. Administrative, technical, and material support:
LoMonico, Okawa, and Werth. Study supervision:
Moghadam-Kia and Werth.
Financial Disclosure: None reported.
Funding/Support: This study is based on work sup-
ported by the National Institutes of Health, including NIH
K24-AR 02207 (Dr Werth) and training grant NIH T32-
AR007465-25 (Dr Klein). This work was also partially
supported by a Merit Review Grant from the Depart-
ment of Veterans Affairs Veterans Health Administra-
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