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In adult patients†1:
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60% of adult ELIDEL patients reported improved pruritus at 1 week, vs 18% of placebo cream patients. |
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48 hours into treatment, 45% of ELIDEL patients reported improved pruritus, vs 17% of placebo cream patients.
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The ELIDEL results were maintained through the 6-month study |
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In pediatric patients§1:
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Throughout the study, significantly more ELIDEL patients vs placebo cream patients reported mild or no itch (P<0.001)
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ELIDEL significantly decreased the itch associated with eczema in conjunction with disease signs.ll
In pediatric patients, ELIDEL significantly improved the pruritus that caused sleep disturbance by first visit (Day 8), and through study endpoint ( P<0.001)§¶
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About 75% of patients in these pediatric studies had
head and neck involvement |
Long-term Safety of Topical Calcineurin Inhibitors Has Not Been Established.
Continuous long-term use of ELIDEL Cream in any age group should be avoided. Application should be limited to areas of involvement with atopic dermatitis.
*ELIDEL (pimecrolimus) Cream 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in
non-immunocompromised people ages 2 and older who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. ELIDEL Cream is not indicated for use in children under 2 years of age.
The most common adverse events seen in clinical studies included application-site burning, headache, pharyngitis, nasopharyngitis, cough, influenza, pyrexia, and viral infection. In clinical studies, skin papilloma or warts were observed in 1% of ELIDEL patients. The efficacy and safety of ELIDEL have not been studied beyond 1 year.
† 6-month, randomized, double-blind, parallel-group, multicenter study investigating the efficacy and safety of ELIDEL in the long-term management of
adults with moderate atopic dermatitis (AD) (N=130).
‡ Improvement defined as improvement in severity of at least 1 point on a scale of 0 to 3.
§ Data from the 6-week, double-blind phases of two, 26-week, multicenter trials comparing ELIDEL to placebo cream in pediatric patients with mild to moderate eczema aged 2 to 17 years (N=403).
ll Through 6-week study endpoint.
¶ Pruritus was assessed on a 4-point scale as 0 (none), 1 (occasional/slight itching), 2 (constant or intermittent itching which does not disturb sleep), and 3 (bothersome itching which disturbs sleep).
# Based on Eczema Area and Severity Index (EASI), a composite score of area and severity of erythema, infiltration/papulation, excoriation, and lichenification.2
References:
- Data on file, Novartis Pharmaceuticals Corporation.
- Hanifin JM, Thurston M, Omoto M, et al. The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. Exp Dermatol. 2001;10:11-18.
Please see complete Prescribing Information.
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