Ruxolitinib cream monotherapy demonstrates rapid improvement in the extent and signs of mild to moderate atopic dermatitis across head and neck and other anatomic regions in adolescents and adults: pooled results from 2 phase 3 studies

Figures & data

Table 1. Patient demographics and baseline clinical characteristics among patients with head and neck involvement and the overall population.^a

	Population with head and neck involvement		Overall population
Characteristic	Vehicle (n = 141)	RUX cream^b (n = 555)	Vehicle (n = 250)	RUX cream^b (n = 999)
Age, median (range), y	33.0 (12–77)	29.0 (12–77)	34.0 (12–82)	32.0 (12–85)
Female, n (%)	96 (68.1)	349 (62.9)	159 (63.6)	612 (61.3)
Race, n (%)
White	100 (70.9)	408 (73.5)	170 (68.0)	702 (70.3)
Black	31 (22.0)	106 (19.1)	61 (24.4)	231 (23.1)
Asian	7 (5.0)	23 (4.1)	10 (4.0)	36 (3.6)
Other	3 (2.1)	18 (3.2)	9 (3.6)	30 (3.0)
Affected BSA, mean (SD), %	11.0 (5.6)	11.0 (5.5)	9.6 (5.5)	9.8 (5.3)
Overall EASI score,^c mean (SD)	9.3 (5.2)	9.0 (5.1)	7.8 (4.8)	8.0 (4.8)
Head and neck subscore^d	1.2 (0.9)	1.1 (0.9)	0.7 (0.9)	0.6 (0.9)
Upper limbs subscore^e	3.0 (1.9)	2.8 (1.8)	2.6 (1.9)	2.5 (1.8)
Trunk subscore^f	1.9 (2.0)	2.2 (2.0)	1.6 (2.0)	1.7 (2.0)
Lower limbs subscore^g	3.2 (3.1)	2.9 (3.1)	3.0 (3.0)	3.1 (3.1)
IGA, n (%)
2	33 (23.4)	103 (18.6)	64 (25.6)	248 (24.8)
3	108 (76.6)	452 (81.4)	186 (74.4)	751 (75.2)
Itch NRS score,^h mean (SD)	5.1 (2.5)	5.3 (2.4)	5.1 (2.4)	5.1 (2.4)
DLQI score, mean (SD)	10.1 (6.1)	10.7 (6.6)	9.4 (6.3)	9.8 (6.5)
CDLQI score, mean (SD)	8.3 (6.1)	8.8 (6.3)	7.8 (5.7)	7.8 (6.2)
Disease duration, median (range), y	20.1 (1.9–78.9)	16.2 (0.1–68.8)	16.5 (0.8–79.1)	15.5 (0–69.2)
Number of flares in prior 12 mo, mean (SD)	8.7 (33.4)	5.4 (6.8)	7.3 (25.7)	5.6 (13.3)

Note: BSA: body surface area; CDLQI: Children’s Dermatology Life Quality Index; DLQI: Dermatology Life Quality Index; EASI: Eczema Area and Severity Index; IGA: Investigator’s Global Assessment; NRS: numerical rating scale; RUX: ruxolitinib; VC: vehicle controlled.

^aIncludes all patients who received ≥1 dose of study drug during the VC period.

^b Data were pooled from patients who applied 0.75% or 1.5% RUX cream; patient demographics and baseline clinical characteristics were consistent across both strengths of RUX cream.

^c Range for overall score, 0–72.

^d Range for head and neck subscore, 0–7.2.

^e Range for upper limbs subscore, 0–14.4.

^f Range for trunk subscore, 0–21.6.

^gRange for lower limbs subscore, 0–28.8.

^h Baseline itch data missing from 34 patients in the population with head and neck involvement (vehicle, n = 8; RUX cream, n = 26) and from a total of 69 patients in the overall population (vehicle, n = 15; RUX cream, n = 54).

Figure 1. LSM percentage improvements from baseline in total EASI anatomic region subscores for head/neck (A), trunk (B), upper limbs (C), and lower limbs (D) in patients applying 0.75% or 1.5% RUX cream versus vehicle. EASI: Eczema Area and Severity Index; LSM: least squares mean; RUX: ruxolitinib. ****p < .0001 vs vehicle.

Figure 2. LSM percentage improvements from baseline in EASI anatomic region subscores for induration/papulation/edema (a), erythema (B), excoriations (C), and lichenification (D) in patients applying 0.75% RUX cream versus vehicle. EASI: Eczema Area and Severity Index; LSM: least squares mean; RUX: ruxolitinib. Data are shown for head/neck, trunk, upper limbs, and lower limbs regions. ***p < .001 vs vehicle; ****p < .0001 vs vehicle.

Figure 3. LSM percentage improvements from baseline in EASI anatomic region subscores for induration/papulation/edema (a), erythema (B), excoriations (C), and lichenification (D) in patients applying 1.5% RUX cream versus vehicle. EASI: Eczema Area and Severity Index; LSM: least squares mean; RUX: ruxolitinib. Data are shown for head/neck, trunk, upper limbs, and lower limbs regions. ****p < .0001 vs vehicle.

Figure 4. EASI-50 (a), EASI-75 (B), and EASI-90 (C) based on head and neck region subscore in patients with head and neck involvement and composite score in the overall population. EASI-50: ≥50% improvement in Eczema Area and Severity Index score from baseline; EASI-75: ≥75% improvement in Eczema Area and Severity Index score from baseline; EASI-90: ≥90% improvement in Eczema Area and Severity Index score from baseline; RUX: ruxolitinib. ****p < .0001 vs vehicle. ^†Includes patients with an EASI head and neck region score >0 at baseline; patients with missing postbaseline values were imputed as nonresponders at Weeks 2, 4, and 8. ^‡Includes all patients who were evaluable for efficacy; patients with missing postbaseline values were imputed as nonresponders at Weeks 2, 4, and 8.

Figure 5. IGA-TS in patients with head and neck involvement and the overall population. IGA-TS: Investigator’s Global Assessment treatment success; RUX: ruxolitinib. ****p < .0001 vs vehicle. ^†Defined as patients achieving an IGA score of 0 or 1 with an improvement of ≥2 points from baseline. Patients with missing postbaseline values were imputed as nonresponders at Weeks 2, 4, and 8.

Figure 6. Representative clinical photographs of AD lesions in the head and neck region. AD: atopic dermatitis; RUX: ruxolitinib.

Figure 7. LSM improvements from baseline in DLQI (A) and CDLQI (B) in patients with head and neck involvement and the overall population. CDLQI: children’s Dermatology Life Quality Index; DLQI: Dermatology Life Quality Index; LSM: least squares mean; RUX: ruxolitinib. *p < .05 vs vehicle; **p < .01 vs vehicle; ***p < .001 vs vehicle; ****p < .0001 vs vehicle. ^†Includes patients with an EASI head and neck region score >0 at baseline.

Table 2. Application site reactions in the population with head and neck involvement and overall populations up to Week 8.

	Population with head and neck involvement		Overall population
Patients with an AE, n (%)	Vehicle (n = 141)	RUX cream^a (n = 555)	Vehicle (n = 250)	RUX cream^a (n = 999)
Application site reactions^b	13 (9.2)	14 (2.5)	19 (7.6)	19 (1.9)
Pain^c	8 (5.7)	5 (0.9)	13 (5.2)	7 (0.7)
Pruritus	5 (3.5)	4 (0.7)	7 (2.8)	6 (0.6)
Irritation	2 (1.4)	2 (0.4)	2 (0.8)	2 (0.2)
Erythema	2 (1.4)	0	2 (0.8)	1 (0.1)
Dryness	0	1 (0.2)	0	1 (0.1)
Folliculitis	0	1 (0.2)	0	2 (0.2)
Exfoliation	0	1 (0.2)	0	1 (0.1)
Papules	0	1 (0.2)	0	1 (0.1)
Swelling	0	0	1 (0.4)	0

Note: AE: adverse event; RUX: ruxolitinib.

^aData were pooled from patients who applied 0.75% or 1.5% RUX cream.

^bPatients may have reported >1 type of application site reaction.

^c Reported lowest-level terms include application site burning, application site stinging, and pain after application.

Data availability statement

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