Table 2.

CLASI Disease Activity and Damage Group Means Stratified by Each Validation Measures’ Subgroups (a Clinically Meaningful Change vs No Change)

Variable	Patients, No.	Patient-Specific Baseline Scores	Day 56 Scores	Baseline vs Day 56 Difference, Median (Range)a	Wilcoxon Signed Rank Test, Z score	P Valueb
CLASI Activity Scale
Physician’s global skin rating (0-10), changec
0-1	3	21, 19, 8	19, 14, 9	2.0 (−1 to 5)	1.07	.25
≥2	4	49, 28, 23, 17	20, 12, 7, 0	16.5 (16 to 29)	1.84	.06
Patient’s skin rating, changec
0-2	3	21, 19, 8	19, 14, 9	2.0 (−1 to 5)	1.07	.25
≥3	5	49, 28, 23, 17, 17	20, 12, 7, 0, 0	17.0 (16 to 29)	2.04	.03
Patient’s itch rating, changed
0-1	3	28, 21, 8	12, 19, 9	2.0 (−1 to 16)	1.07	.25
≥2	4	49, 23, 19, 17	20, 7, 14, 0	16.5 (5 to 29)	1.83	.06
Patient’s pain rating, changed
0-1	2	21, 8	19, 9	0.5 (−1 to 2)	0.45	.50
≥2	3	49, 23, 19	20, 7 ,14	16.0 (5 to 29)	1.60	.13
CLASI Damage Scale
Physician’s global skin rating, changec
0-1	3	35, 17, 15	38, 33, 17	−3.0 (−16 to −2)	−1.60	.13
≥2	4	44, 25, 10, 0	44, 35, 9, 0	0.0 (−10 to 1)	−0.45	.50
Patient’s skin rating, changec
0-2	3	35, 17, 15	38, 33, 17	−3.0 (−16 to −2)	−1.60	.13
≥3	5	44, 25, 10, 2, 0	44, 35, 9, 4, 0	0.0 (−10 to 1)	−1.07	.25
Patient’s itch rating, changed
0-1	3	25, 17, 15	35, 33, 17	−10.0 (−16 to −2)	−1.60	.13
≥2	4	44, 35, 10, 0	44, 38, 9, 0	0.0 (−3 to 1)	−0.45	.50
Patient’s pain rating, changed
0-1	2	17, 15	33, 17	−9.0 (−16 to −2)	−1.34	.25
≥2	3	44, 35, 10	44, 38, 9	0.0 (−3 to 1)	−0.45	.50

Abbreviation: CLASI, Cutaneous Lupus Erythematosus Disease Area and Severity Index.

^aDifferences are calculated so that a negative difference indicates worst and a positive difference indicates improvement.

^bOne-sided.

^cDirection of scales: The scores are 0 to 10; the higher the score, the better the skin condition.

^dThe higher the score, the worse the skin condition.