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BJD

Q U A L I TA T I V E A N D O U T CO M E S R E S E A R CH British Journal of Dermatology

Severity strata for Eczema Area and Severity Index (EASI),


modified EASI, Scoring Atopic Dermatitis (SCORAD), objective
SCORAD, Atopic Dermatitis Severity Index and body surface
area in adolescents and adults with atopic dermatitis
R. Chopra,1 P.P. Vakharia,1 R. Sacotte,1 N. Patel,1 S. Immaneni,1 T. White,2 R. Kantor,1 D.Y. Hsu1
and J.I. Silverberg iD 1,2
1
Department of Dermatology, Feinberg School of Medicine at Northwestern University, Chicago, IL 60611, U.S.A.
2
Northwestern Medicine Multidisciplinary Eczema Center, Chicago, IL, U.S.A.

Linked Comment: Drucker. Br J Dermatol 2017; 177:1158–1159.

Summary

Correspondence Background Scoring systems for assessing the signs of atopic dermatitis (AD) are
Jonathan I. Silverberg. complex and difficult to interpret. Severity strata are helpful to interpret these
E-mail: JonathanISilverberg@Gmail.com assessments properly.
Objectives To confirm previously reported strata for the Eczema Area and Severity Index
Accepted for publication
27 April 2017
(EASI), Scoring Atopic Dermatitis (SCORAD) and the objective component of SCORAD
(oSCORAD), and to develop strata for the modified EASI (mEASI), Atopic Dermatitis
Funding sources Severity Index (ADSI) and body surface area (BSA) for use in adults with AD.
This publication was made possible with support Methods Skin examination was performed in 673 adolescents and adults (age
from the Agency for Healthcare Research and ≥ 13 years) with diagnosed AD, in a dermatology practice setting. Strata were selected
Quality (AHRQ), grant number K12 HS023011,
using an anchoring approach based on a four-point Investigator’s Global Assessment
and the Dermatology Foundation.
of severity (clear of active skin lesions, mild, moderate or severe disease).
Conflicts of interest Results We determined potential severity strata for EASI (0 clear, 01–59 mild, 60–
None declared. 229 moderate, 230–72 severe; j = 069), mEASI (0–09 clear, 1–89 mild, 90–
299 moderate, 300–90 severe; j = 071), oSCORAD (0–79 clear, 80–239
DOI 10.1111/bjd.15641 mild, 240–379 moderate, 380–83 severe; j = 070), SCORAD (0–99 clear,
100–289 mild, 290–489 moderate, 490–103 severe; j = 068), ADSI (0–19
clear, 2–59 mild, 60–89 moderate, 90–15 severe; j = 055) and BSA (0 clear,
01–159 mild, 160–399 moderate, 400–100 severe; j = 066). oSCORAD val-
ues > 0 were found in clear skin due to the presence of xerosis, which is scored in
oSCORAD. Similarly, SCORAD values > 0 were found in clear skin due to the scor-
ing of xerosis, pruritus and sleeplessness. Similarly, mEASI and ADSI scores > 0
occurred in patients with clear skin due to scoring of pruritus.
Conclusions We recommend using these strata for interpretation of their respective
measures in clinical trials of AD. There are important differences between the five
assessments, which profoundly impact the interpretation of their scores.

What’s already known about this topic?


• Multiple assessments have been used for the signs of atopic dermatitis. However,
scores from these instruments can be difficult to interpret.

What does this study add?


• The present study developed novel severity strata for the Eczema Area and Severity
Index (EASI), modified EASI (mEASI), Scoring Atopic Dermatitis (SCORAD), the

1316 British Journal of Dermatology (2017) 177, pp1316–1321 © 2017 British Association of Dermatologists
Severity strata for atopic dermatitis signs, R. Chopra et al. 1317

objective component of SCORAD, Atopic Dermatitis Severity Index and body sur-
face area in a cohort of adults with atopic dermatitis.

What are the clinical implications of this work?


• The strata presented for these measures can be used to improve interpretation of
clinical and research data, and have important ramifications for future clinical trials
of atopic dermatitis.

Dermatitis Severity Index (ADSI) has also been used to assess


Introduction
the signs and symptoms of AD in clinical trials.9 Despite not
Atopic dermatitis (AD) can present with heterogeneous mani- being a preferred assessment selected by the HOME consensus
festations and varying degrees of severity. There is currently group, ADSI was recently used in a randomized controlled
no gold standard for evaluating the severity and extent of trial of a novel topical agent for AD.10,11 However, severity
AD.1 Severity assessment for AD is based on an assessment of strata have not been formally established for BSA and ADSI.
lesional severity and extent, and/or disease-related symptoms. We sought to confirm previously proposed strata for EASI,
A recent systematic review by Harmonizing Outcome Mea- oSCORAD and SCORAD. Moreover, we sought to develop inter-
sures in Eczema (HOME), an international consensus group pretable severity strata for the mEASI, ADSI and BSA scales.
aimed at standardizing outcomes in clinical trials for AD, iden-
tified 56 different named and unnamed objective measure-
Materials and methods
ments of disease severity.2 The recommended outcomes
assessments for the signs of AD were the Eczema Area and
Study design
Severity Index (EASI) followed by Scoring Atopic Dermatitis
(SCORAD), based on factors including demonstration of valid- We performed a prospective dermatology practice-based study of
ity and good intra- and inter-rater reliability.1 adolescents and adults (age ≥ 13 years) with AD as defined by the
However, these assessments have complicated scoring sys- Hanifin and Rajka diagnostic criteria.12 Patients underwent full-
tems, with scores that can be difficult to interpret. EASI body skin examination by a dermatologist (J.I.S.) and were
assesses only active acute or chronic AD lesions, whereas assessed with Investigator’s Global Assessment (IGA) (a gestalt
SCORAD also assesses xerosis, pruritus and sleeplessness. These physician’s assessment of clear of active acute or chronic AD
differences may result in differences of scores that can pro- lesions, or mild, moderate or severe overall disease), EASI (four
foundly impact the interpretation. Furthermore, modifications signs – erythema, excoriation, swelling and lichenification – on
of these scores have also been used in clinical trials. For exam- four body sites; range 0–72),13 mEASI (four signs – erythema,
ple, a modified version of EASI (mEASI) has been used, which excoriation, swelling and lichenification – on four body sites, and
also includes patient report of pruritus. A modified version of pruritus; range 0–90),14 SCORAD (six signs – erythema, excoria-
SCORAD including only the objective component (oSCORAD) tion, swelling, oozing/crusting, lichenification and dryness – on
has been used in some trials. This may further confuse the eight body sites, and pruritus and sleeplessness; range 0–103),15
interpretation of these scores. oSCORAD (six signs – erythema, excoriation, swelling, oozing/
Severity strata have been used to improve the interpretation crusting, lichenification and dryness – on eight body sites, and no
of patient-reported outcomes in dermatology3–6 and have symptoms; range 0–83),15 ADSI (four signs – erythema, excoria-
recently been developed for EASI in AD.7 The proposed sever- tion, exudation and lichenification – and pruritus; range 0–15)9
ity strata for oSCORAD (mild 0–14, moderate 15–39, severe and BSA (0–100%) affected with active lesions.
40–83) were developed by expert opinion without any formal Patients were enrolled at different stages of disease activity,
testing.8 The source for the commonly used SCORAD strata and disease severity ranged from clear to severe. Patients
(mild 0–25, moderate 26–50, severe 51–103) is unclear, but found to be clear upon assessment were previously confirmed
appears to be a modification of the proposed oSCORAD strata. to have AD based on history and physical exam. The patients
Body surface area (BSA) of lesional involvement in itself is were evaluated between January 2014 and June 2016. The
an important aspect of AD severity. However, BSA as a mea- study was approved by the institutional review boards of
sure of disease extent alone does not fully characterize AD, as Northwestern University and informed consent was waived.
it does not account for lesional severity. Nevertheless, it has
been widely used as an inclusion criterion in AD trials with
Data processing and statistical methods
variable definitions of severity, and also as a secondary efficacy
outcome measure in AD trials. Thus, proper interpretation of An anchor-based approach was used, where the severity
BSA and its relation to AD severity is important. The Atopic assessments are compared, or anchored, to a global assessment

© 2017 British Association of Dermatologists British Journal of Dermatology (2017) 177, pp1316–1321
1318 Severity strata for atopic dermatitis signs, R. Chopra et al.

performed at the same time.3 The score is then stratified using IGA of 18. EASI scores ≥ 7 all showed median and mode IGA
thresholds into severity strata comparable with the global scores of 2 and mean IGA ≥ 16. Therefore, an EASI score of
score. EASI, mEASI, oSCORAD, SCORAD, ADSI and BSA were 6 was selected as the proposed threshold for moderate AD. In
stratified against the IGA (three point and four point), which addition, we tested an EASI score of 7 as a threshold for mod-
was used as the severity anchor. IGA was used as a gestalt erate AD based on previously proposed severity strata.7 A
assessment of overall AD severity at that encounter, irrespec- median and mode IGA score of 3 (severe) first occurred at an
tively of prior disease history. EASI score of 17, with a mean IGA of 26. Therefore, an EASI
All data analyses and statistical processes were performed score of 17 was considered as a threshold for severe AD.
using SAS version 9.4 (SAS Institute Inc., Cary, NC, U.S.A.). However, EASI scores of 18–22 were associated with median
Spearman rank correlation was performed to compare IGA and mode IGA scores of 2 and mean IGA scores < 25. An
with EASI, mEASI, oSCORAD, SCORAD, ADSI and BSA scores. EASI of 23 was the next score to be associated with a median
The frequency, mean, median and mode of clear skin and and mode IGA of 3, and a mean IGA of 28. Therefore, an
mild, moderate and severe disease were determined for each EASI of 23 was also considered as a potential threshold for
integer value of the EASI, mEASI, oSCORAD, SCORAD, ADSI severe AD.
and BSA scales. Potential strata were selected based on these Four different strata were tested based on the combinations
summary statistics. Different values for each assessment that of thresholds identified for moderate and severe disease. The
were associated with a one-grade increase in mean, median set of strata with the highest j-coefficient compared with a
and/or mode IGA were considered possible threshold values four-point IGA (clear, mild, moderate, severe) was EASI of 0
for severity strata. Potential strata were then constructed using clear, 1–59 mild, 60–229 moderate and 230–72 severe
combinations of these different threshold values. Weighted (j = 069) (Table 1). A collapsed version of these strata (0–
j-coefficients were determined for concordance between the 59 clear–mild, 60–229 moderate, 230–72 severe) also had
potential severity strata and IGA. In addition, we tested any the highest j-coefficient when compared against a three-point
strata that were previously reported for the above-mentioned IGA (clear-mild, moderate, severe) (j = 076). Previously
scales. Subgroup analyses were performed to determine how reported strata of 0–70, 71–210 and 211–727 had the low-
many patients had IGA scores that were outside the final est j-value of all strata tested in this cohort of adults with AD
severity strata for each measure. (j = 073).
Only seven patients (11%) had an IGA score > 1 point out-
side of that predicted by the final EASI severity strata. There
Results
were 82 patients (126%) whose IGA score was 1 point
higher and 27 (41%) whose IGA score was 1 point lower
Patient characteristics
than the final EASI strata predicted. Patients falling outside the
Overall, 673 adolescents and adults (aged 13–93 years) were possible strata had a similar distribution of sex, age and race/
included in the study, including 401 female (596%) and 403 ethnicity to the overall study cohort.
white patients (599%). The mean age at enrolment was
434  196 years, and the mean age of self-reported AD
Modified Eczema Area and Severity Index
onset was 352  359 years. In total, 111 patients (16.5%)
were clear of active acute or chronic lesions on skin exam. Four different strata were selected for testing. The set of strata
Xerosis was observed in 36 (38%) and pruritus was reported with the highest j-coefficient when compared against a four-
in 69 (72%) of those who were otherwise clear. Furthermore, point IGA was mEASI of 0 clear, 1–89 mild, 90–299 mod-
320 (490%) had mild, 215 (329%) moderate and 118 erate and 300–90 severe (j = 071). Similarly, a collapsed
(181%) severe disease. version of these strata (0–89 clear–mild, 90–299 moderate,
The distribution, mean, median and mode of AD severity 300–90 severe) had the highest j-value compared against a
for each scale are presented in Tables S1–6 (see Supporting three-point IGA (j = 076).
Information). There were strong correlations of EASI (Spear- Only seven patients (11%) had an IGA score > 1 point out-
man correlation, q = 085), mEASI (q = 085), oSCORAD side of that predicted by the final mEASI severity strata. There
(q = 084), SCORAD (q = 083), ADSI (q = 072) and BSA were 101 patients (156%) whose IGA score was 1 point
(q = 083) with both the three- and four-point IGA higher and 62 (96%) whose IGA score was 1 point lower
(P < 0001 for all). than the final mEASI strata predicted. Patients falling outside
the possible strata had a similar distribution of sex, age and
race/ethnicity to the overall study cohort.
Eczema Area and Severity Index
To illustrate the anchor-based approach, selection of potential
Objective Scoring Atopic Dermatitis
thresholds for moderate and severe AD will be elaborated. A
median and mode IGA score of 1 (mild) first occurred at an Five different strata were selected for testing. The set with the
EASI score of 1, whereas a median and mode IGA score of 2 highest j-coefficient compared against a four-point IGA was
(moderate) first occurred at an EASI score of 6, with a mean oSCORAD of 0–79 clear, 80–239 mild, 240–379 moderate

British Journal of Dermatology (2017) 177, pp1316–1321 © 2017 British Association of Dermatologists
Severity strata for atopic dermatitis signs, R. Chopra et al. 1319

Table 1 Concordance of proposed severity strata for EASI, mEASI, oSCORAD, SCORAD and BSA with IGA

IGA (four point) IGA (three point)


Clear Mild Moderate Severe j-coefficient Clear–mild Moderate Severe j-coefficient
Possible EASI strata
0 01–59 60–169 17–72 069 0–59 60–169 170–72 075
0 01–59 60–229 23–72 069 0–59 60–229 230–72 076
0 01–69 70–169 17–72 068 0–69 70–169 17–72 073
0 01–69 70–229 23–72 068 0–69 70–229 23–72 074
0–707 71–210 211–72 073
Possible mEASI strata
0–09 1–89 90–299 300–90 071 0–89 90–299 300–90 076
0–09 1–89 90–309 310–90 071 0–89 90–309 310–90 076
0–09 1–99 100–299 300–90 070 0–99 100–299 300–90 075
0–09 1–99 100–309 310–90 070 0–99 100–309 310–90 074
Possible oSCORAD strata
0–39 4–239 240–379 380–83 069
0–39 4–239 240–399 400–83 068
0–79 8–239 240–379 380–83 070 0–239 240–379 380–83 075
0–79 8–239 240–399 400–83 069 0–239 240–399 400–83 075
0–1498 150–409 410–83 057
Possible SCORAD strata
0–19 2–289 290–459 460–103 064
0–19 2–289 290–489 490–103 064
0–59 6–289 290–459 460–103 066
0–59 6–289 290–489 490–103 067
0–99 10–289 290–459 460–103 068 0–289 290–459 460–103 072
0–99 10–289 290–489 490–103 068 0–289 290–489 490–103 073
0–25916 260–509 510–103 070
Possible ADSI strata
0–1 2–5 6–8 9–15 055 0–5 6–8 9–15 058
0–1 2–6 7–8 9–15 051 0–6 7–8 9–15 052
0–1 2–5 6–9 10–15 054 0–5 6–9 10–15 057
0–1 2–6 7–9 10–15 049 0–6 7–9 10–15 050
0–2 3–5 6–8 9–15 054
0–2 3–6 7–8 9–15 050
0–2 3–5 6–9 10–15 053
0–2 3–6 7–9 10–15 049
Possible BSA strata
0 01–149 150–399 400–100 065 0–149 150–399 400–100 070
0 01–149 150–419 420–100 065 0–149 150–419 420–100 070
0 01–149 150–459 460–100 065 0–149 150–459 460–100 070
0 01–159 160–399 400–100 066 0–159 160–399 400–100 071
0 01–159 160–419 420–100 066 0–159 160–419 420–100 071
0 01–159 160–459 460–100 066 0–159 160–459 460–100 071
0 01–169 170–399 400–100 066 0–169 170–399 400–100 071
0 01–169 170–419 420–100 065 0–169 170–419 420–100 071
0 01–169 170–459 460–100 066 0–169 170–459 460–100 071

EASI, Eczema Area and Severity Index; mEASI, modified EASI; SCORAD, Scoring Atopic Dermatitis; oSCORAD, objective SCORAD; ADSI, Ato-
pic Dermatitis Severity Index; BSA, body surface area; IGA, Investigator’s Global Assessment. The strata with the highest j-coefficients are
highlighted in green. Selected literature values are given for comparison.

and 380–83 severe (j = 070). Similarly, a collapsed version Only seven patients (11%) had an IGA score > 1 point
of these strata (0–239 clear–mild, 240–379 moderate, outside of that predicted by the final oSCORAD severity
380–83 severe) had the highest j-value compared against a strata. There were 70 patients (107%) whose IGA score
three-point IGA (j = 075). The previously reported strata for was 1 point higher and 42 (64%) whose IGA score was 1
oSCORAD8 of 0–149 mild, 150–409 moderate and 41–83 point lower than the final oSCORAD strata predicted.
severe had a considerably lower j-coefficient than the above- Patients falling outside the possible strata had a similar dis-
mentioned strata when compared against a three-point IGA tribution of sex, age and race/ethnicity to the overall study
(j = 057). cohort.

© 2017 British Association of Dermatologists British Journal of Dermatology (2017) 177, pp1316–1321
1320 Severity strata for atopic dermatitis signs, R. Chopra et al.

and ≥ 400 were potential thresholds for defining mild and


Scoring Atopic Dermatitis
severe disease, respectively. However, moderate disease was
Six different strata were selected for testing. The set of strata associated with a higher threshold for oSCORAD (240–379
with the highest j-coefficient when compared against a four- vs. 15–40) and SCORAD (16–39 vs. 26–50), with narrower
point IGA was SCORAD of 0–99 clear, 100–289 mild, ranges of values. Interestingly, the potential severity band for
290–489 moderate and 490–103 severe (j = 068). Simi- clear skin of active acute or chronic AD lesions on oSCORAD
larly, a collapsed version of these strata (0–289 clear–mild, was 0–79. This was due to the presence of xerosis, which is
290–489 moderate, 490–103 severe) had the highest included in oSCORAD and can be present even in the absence
j-value compared against a four-point IGA (j = 073). The of active lesions. Similarly, the potential severity band for clear
previously reported strata for SCORAD16 of 0–259 mild, skin on SCORAD was 0–99, secondary to the presence of
260–509 moderate and 510–103 severe had a lower j-coef- xerosis, pruritus and sleeplessness.
ficient than the above-mentioned strata when compared Furthermore, the potential severity band for clear skin on
against a three-point IGA (j = 070). mEASI was 0–09 and for ADSI 0–1, secondary to the presence
Only two patients (03%) had an IGA score > 1 point out- of pruritus. While severity strata were not previously estab-
side of that predicted by the final SCORAD severity strata. lished for ADSI, the original study of ADSI9 used 6 as a cut-
There were 56 patients (84%) whose IGA score was 1 point off for moderate disease, which is consistent with the range
higher and 79 (111%) whose IGA score was 1 point lower of moderate disease observed in this study (range 6–8). ADSI
than the final SCORAD strata predicted. Patients falling outside was not a preferred outcome measure for AD and its use was
the possible strata had a similar distribution of sex, age and not encouraged by the HOME consensus group.1 Nevertheless,
race/ethnicity to the overall study cohort. it has been recently used in a randomized controlled trial for
AD,10,11 and potential severity strata would be useful for
interpretation of those results. These are important for the
Atopic Dermatitis Severity Index
interpretation of oSCORAD, SCORAD, mEASI and ADSI scores,
Eight different ADSI strata were selected for testing. The set of because there may be clinical clearance of active AD lesions
strata with the highest j-coefficient when compared against a without scores of zero for these scales.
four-point IGA was ADSI of 0–19 clear, 20–59 mild, 60– The potential severity strata observed in this study have
89 moderate and 90–15 severe (j = 055). Similarly, a important ramifications for study inclusion criteria. We found
collapsed version of these strata (0–59 clear–mild, 60–89 that moderate disease includes up to 40% BSA. Yet some trials
moderate, 90–15 severe) had the highest j-value compared of mild-to-moderate AD have used BSA < 20% as an inclusion
against a three-point IGA (j = 058). or exclusion criterion, which may bias the study population
towards only mild disease. Furthermore, some trials of moder-
ate-to-severe AD have used EASI scores > 12 or > 16 as an
Body surface area
inclusion or exclusion criterion, which likely biases the study
Nine different strata were selected for testing. The set of strata population towards more severe disease. There are also ramifi-
with the highest j-coefficient compared against a four-point cations on interpretation of studies that examine the absolute
IGA was BSA of 0 clear, 01–159 mild, 160–399 moderate or percentage change of oSCORAD, SCORAD, mEASI and ADSI
and 400–100 severe (j = 066). Similarly, a collapsed ver- as efficacy end points. These measures may hit a relative floor,
sion of these strata (0–159 clear–mild, 160–399 moderate, owing to the persistence of xerosis and symptoms. As EASI
400–83 severe) had the highest j-value compared against a scores only active acute or chronic lesions, it may be a more
three-point IGA (j = 071). responsive end point, particularly when trying to demonstrate
Only eight patients (12%) had an IGA score > 1 point out- skin clearance.
side of that predicted by the final BSA severity strata. There There are a number of advantages of applying these strata
were 58 patients (89%) whose IGA score was 1 point higher for the interpretation of their respective instruments. They can
and 87 (133%) whose IGA score was 1 point lower than the be used to assess more accurately clinically meaningful
final BSA strata predicted. Patients falling outside the possible improvement in clinical trials. This is particularly important in
strata had a similar distribution of sex, age and race/ethnicity very large trials that are overpowered to detect differences of
to the overall study cohort. continuous mean scores. A better approach in that scenario
might be to assess the proportion of persons who improve
from severe at baseline to mild or moderate at follow-up.
Discussion
Another approach that has been developed is to determine the
The present study determined potential severity strata for EASI, proportion of patients achieving a prespecified percentage
mEASI, oSCORAD, SCORAD, ADSI and BSA in AD. The severity improvement from baseline. For example, EASI 50 and EASI
strata for EASI and SCORAD were similar to previously 75 represent the proportion of patients achieving ≥ 50% or
reported strata overall.7,16 However, we found that moderate ≥ 75% improvement from baseline EASI scores, respectively.
disease was associated with even lower EASI scores and a There were strong correlations between all of the examined
broader range of values (60–220 vs. 71–210). BSA ≤ 15 outcome measures and global AD severity. EASI had the

British Journal of Dermatology (2017) 177, pp1316–1321 © 2017 British Association of Dermatologists
Severity strata for atopic dermatitis signs, R. Chopra et al. 1321

strongest correlation, but mEASI, oSCORAD and SCORAD had suggesting severity strata derived using anchor-based methods. Br J
nearly identical correlation coefficients. These data provide Dermatol 2013; 169:1326–32.
further support for the HOME consensus group’s selection of 4 Reich A, Heisig M, Phan NQ et al. Visual analogue scale: evaluation
of the instrument for the assessment of pruritus. Acta Derm Venereol
EASI as the preferred outcome measure for the clinical signs
2012; 92:497–501.
of AD,1 although SCORAD was close behind. ADSI had the 5 Rogers A, DeLong LK, Chen SC. Clinical meaning in skin-specific
weakest correlation with AD severity, suggesting that lesional quality of life instruments: a comparison of the Dermatology Life
severity alone is inadequate to describe AD severity fully. Quality Index and Skindex banding systems. Dermatol Clin 2012;
In contrast, BSA had virtually the same strength of corre- 30:333–42.
lation with global AD severity as EASI and SCORAD, sug- 6 Love EM, Marrazzo GA, Kini S et al. ItchyQoL bands: pilot clinical
gesting that lesional extent may be a more important interpretation of scores. Acta Derm Venereol 2015; 95:114–15.
7 Leshem YA, Hajar T, Hanifin JM et al. What the Eczema Area and
construct. That is, outcome measures that include lesional
Severity Index score tells us about the severity of atopic dermatitis:
extent appear to correlate better with overall AD severity. an interpretability study. Br J Dermatol 2015; 172:1353–7.
Furthermore, BSA by itself may be a reasonable AD out- 8 Kunz B, Oranje AP, Labreze L et al. Clinical validation and guideli-
come measure in this respect. Nevertheless, it may be that nes for the SCORAD index: consensus report of the European Task
interpretation of AD severity using BSA alone is inadequate. Force on Atopic Dermatitis. Dermatology 1997; 195:10–19.
Importantly, none of the outcome measures correlated per- 9 Van Leent EJ, Graber M, Thurston M et al. Effectiveness of the
fectly with overall AD severity, suggesting that no one mea- ascomycin macrolactam SDZ ASM 981 in the topical treatment of
atopic dermatitis. Arch Dermatol 1998; 134:805–9.
sure is perfect at characterizing the severity of AD signs.
10 Stein Gold LF, Spelman L, Spellman MC et al. A phase 2, random-
EASI is recommended by the HOME group as the assess- ized, controlled, dose-ranging study evaluating crisaborole topical
ment of AD signs to be included in AD trials. Even so, ointment, 0.5% and 2% in adolescents with mild to moderate ato-
additional inclusion of other validated assessments of AD pic dermatitis. J Drugs Dermatol 2015; 14:1394–9.
signs might add value in describing AD severity in clinical 11 Murrell DF, Gebauer K, Spelman L et al. Crisaborole topical
trials and research. ointment, 2% in adults with atopic dermatitis: a phase 2a, vehicle-
This study has several strengths, including the large sample controlled, proof-of-concept study. J Drugs Dermatol 2015; 14:
1108–12.
size and good representation across sex, race/ethnicity and AD
12 Hanifin J, Rajka G. Diagnostic features of atopic eczema. Acta Derm
severity. However, there are some limitations. The study Venereol 1980; 92:44–7.
cohort included adolescents and adults recruited from a single 13 Hanifin JM, Thurston M, Omoto M et al. The Eczema Area and
academic centre, which may limit generalizability. In particu- Severity Index (EASI): assessment of reliability in atopic dermatitis.
lar, an assessor’s notion of disease severity may reflect their EASI Evaluator Group. Exp Dermatol 2001; 10:11–18.
experience and may not match others’ experience and inter- 14 Remitz A, Harper J, Rustin M et al. Long-term safety and efficacy
pretations. However, we do not believe this to be a major of tacrolimus ointment for the treatment of atopic dermatitis in
children. Acta Derm Venereol 2007; 87:54–61.
issue given that the potential strata for EASI and SCORAD are
15 Stalder JF, Atherton DJ, Bieber T et al. Severity scoring of atopic
similar to those in previous reports. This suggests that the dermatitis: the SCORAD index. Consensus report of the European
results from our cohort are generalizable to the broader popu- Task Force on Atopic Dermatitis. Dermatology 1993; 186:23–31.
lation of adult patients with AD. Nevertheless, the proposed 16 Wollenberg A, Oranje A, Deleuran M et al. ETFAD/EADV Eczema
potential severity strata are not the final word and may not be Task Force 2015 position paper on diagnosis and treatment of ato-
optimal for all settings. Future, even larger multicentre studies pic dermatitis in adult and paediatric patients. J Eur Acad Dermatol
are needed to confirm these findings. Additional studies are Venereol 2016; 30:729–47.
also needed to confirm the potential severity strata to apply to
younger children. Supporting Information
In conclusion, the present study identified potential severity
strata for EASI, mEASI, oSCORAD, SCORAD, ADSI and BSA in Additional Supporting Information may be found in the online
AD. These strata can be used to improve interpretation of clin- version of this article at the publisher’s website:
ical and research data using these instruments, and have Table S1 Distribution of atopic dermatitis severity across
important ramifications for future clinical trials of AD. different Eczema Area and Severity Index scores.
Table S2 Distribution of atopic dermatitis severity across
different modified Eczema Area and Severity Index scores.
References Table S3 Distribution of atopic dermatitis severity across
1 Schmitt J, Langan S, Williams HC et al. What are the best outcome different objective Scoring Atopic Dermatitis scores.
measurements for atopic eczema? A systematic review. J Allergy Clin Table S4 Distribution of atopic dermatitis severity across
Immunol 2007; 120:1389–98. different Scoring Atopic Dermatitis scores.
2 Charman C, Chambers C, Williams H. Measuring atopic dermatitis Table S5 Distribution of atopic dermatitis severity across
severity in randomized controlled clinical trials: what exactly are different Atopic Dermatitis Severity Index scores.
we measuring? J Invest Dermatol 2003; 120:932–41.
Table S6 Distribution of atopic dermatitis severity across
3 Charman CR, Venn AJ, Ravenscroft JC et al. Translating patient-
oriented eczema measure (POEM) scores into clinical practice by different body surface areas.

© 2017 British Association of Dermatologists British Journal of Dermatology (2017) 177, pp1316–1321

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