Significant skin clearance
in 3 pivotal trials1
1 year (secondary endpoint)2,3,a-c
CHRONOS: Concomitant
Therapy
With TCS
Definitive conclusions cannot be made at Week 2, as this was a post hoc analysis.
Data were not multiplicity controlled and
P value
was nominal.
Significant improvement in lesion extent and severity was also demonstrated with DUPIXENT in monotherapy trials1,4
endpoint) vs 15% with placebo at Week 16 in SOLO 1 (n=224; P<0.001)
endpoint) vs 12% with placebo at Week 16 in SOLO 2 (n=236; P<0.001)
EASI results across body regions at 1 year
18+ years
CHRONOS: Concomitant
Therapy
With TCS
Results at Week 16 (LSM change in EASI score from baseline; post hoc analysis)2
Head and neck:
72% for DUPIXENT + TCS
(n=104);
35% for placebo
+ TCS (n=304)
Upper extremities:
74% for DUPIXENT + TCS
(n=104);
40% for placebo
+ TCS (n=304)
Trunk:
79% for DUPIXENT + TCS
(n=104);
44% for placebo +
TCS (n=304)
Lower extremities:
77% for DUPIXENT +
TCS
(n=104);
41% for
placebo + TCS
(n=304)
Definitive conclusions cannot be made for these
results at Week 16 and Week 52, as this was a post hoc analysis. Data were
not
multiplicity controlled
and P values were nominal.5
Skin clearance and flare data at 1 year
18+ years
(post hoc analysis)3,a-c
CHRONOS: Concomitant Therapy With TCS
Definitive conclusions cannot be made for EASI-90 at Week 52, as this was a post hoc analysis in which data were not multiplicity controlled.
Flare data through Week 52 in adult patients who experienced flares prior to enrollment6
- In the 12 months prior to study enrollment, 84% of patients randomized to DUPIXENT + TCS (89 of 106) and 77% of patients randomized to placebo + TCS (243 of 315) experienced flares (based on self-reporting by patients)
- Flare was defined as a worsening of signs and symptoms requiring escalation/intensification of treatment
Limitations of analysis:
There is potential for recall bias in patients’ self-reported number of flares prior to treatment. Results cannot be directly compared with other reports of flare prevention due to differing definitions of flare, duration of treatment, and patient baseline disease severity.
Definitive conclusions cannot be made for these results up to 1 year, as this was a post hoc analysis in which data were not multiplicity controlled and P values were nominal.
aIn the primary analyses of the efficacy endpoints, subjects who received rescue treatment or with missing data were considered nonresponders.1
bFull Analysis Set includes all subjects randomized.1
cIn CHRONOS, as needed, subjects received topical calcineurin inhibitors for problem areas only, such as the face, neck, and intertriginous and genital areas.1
dWeek 52 data were limited to patients completing 52 weeks as of the cutoff date.1
Measuring the extent and severity of lesional signs of atopic dermatitis
EASI combines the severity of the signs of eczema and the extent of skin involvement.7
The severity of each of
4 eczema signs is
assessed on a scale of
0 to 37
The extent of lesions in each body region is evaluated based on the percentage of involvement and is given a value between 0 and 6. Each body region value is then weighted by a corresponding multiplier; lower extremities are weighted more while head and neck are weighted the least.7
Each region gets a total region score:
Severity Score x Area Score x Multiplier = Region Score
The final EASI score is the sum of all 4 region scores. The composite score, on a scale from 0 to 72, determines the severity of the signs of eczema and the extent to which the patient is affected.7,e
An improvement of at least 75% in lesion extent and severity (EASI-75) from baseline is a clinically meaningful change.1
eIn patients <8 years of age, the multipliers for the head and neck are 0.2, the trunk is 0.3, the upper extremities are 0.2, and the lower extremities are 0.3.
In patients ≥8 years of age, the multipliers for the head and neck are 0.1, the trunk is 0.3, the upper extremities are 0.2, and the lower extremities are 0.4.7
Dosage and
administration
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