Treating Atopic Dermatitis in sensitive skin areas such as the face or eyelids^1,2

Elidel^®: Similar efficacy as low to medium potency topical corticosteroids (low potency: e.g., hydrocortisone 1%, or medium potency: e.g., hydrocortisone butyrate 0.1%). n=2,418.³

Elidel^® is better accepted by patients compared to preceding topical corticosteroid retrospective therapy. n=3200.⁴

Elidel^® does not cause epidermal atrophy when applied to normal skin for 4 weeks, contrary to topical corticosteroids (betamethasone valerate 0.1% and triamcinolone acetonide 0.1%). n=16, p <0.001.^5-7

Elidel^® improved skin atrophy induced by topical corticosteroids (including hydrocortisone 1%, betamethasone valerate 0.1% and triamcinolone acetonide 0.1%) in 46.5% of patients. n=200, p=0.02.⁸

PBS Information: Authority required (STREAMLINED). Refer to PBS Schedule for full authority information.

Before prescribing, please review approved product information available here.

Elidel^® does not cause epidermal atrophy when applied to normal skin for 4 weeks, contrary to TCS^1-3*

TCS*: Topical Corticosteroids including hydrocortisone 1%, betamethasone-17-valerate 0.1% and triamcinolone acetonide 0.1%

Elidel^® improved skin atrophy induced by TCS* in 46.5% of patients¹

Study design:
A 12-week study in 200 patients aged 12 years or over with mild-to-moderate head and neck atopic dermatitis, intolerant of or dependent on TCS; comprising of a 6-week, double-blind, randomised, vehicle-controlled phase, followed by a 6-week, open-label phase. The primary efficacy criterion was the facial investigator’s global assessment score at 6 weeks. Secondary efficacy criteria were head and neck Eczema Area and Severity Index (EASI), pruritus score and eyelid dermatitis. Facial skin atrophy and telangiectasia were assessed with dermatoscopy.

TCS*: Topical Corticosteroids including hydrocortisone 1%, betamethasone-17-valerate 0.1% and triamcinolone acetonide 0.1%

Elidel^® is better accepted by patients compared to preceding TCS retrospective therapy¹

Graphic adapted from figure 1 in Gollnick H et al. 2008.¹
Satisfaction of patients with the therapy (including values of agree and strongly agree) N: 3200 patients.

Study design:
A 4-month multicenter observational study in 3200 patients with atopic dermatitis who were previously with TCS, recruited by physicians in Germany. At baseline and at the end of the study, patients were asked to assess relief of symptoms, number of flares, quality of life and their overall skin condition for the past 2 months. Patients used a 5-point scale (1 = complete agreement; 5 = complete disagreement).

TCS: Topical Corticosteroids

Elidel^®: Similar efficacy as low to medium potency TCS¹

Long-term efficacy: by study end, >95% patients in both groups¹

Study design:
A 5-year multicenter, open-label, randomised, parallel group study of 2418 infants. The primary objective was to compare the safety of pimecrolimus 1% cream to TCS (low potency, eg, hydrocortisone 1%; or medium potency, eg, hydrocortisone butyrate 0.1%); the secondary objective was to document long-term efficacy. Treatment success was defined as an Investigator’s Global Assessment score of 0 (clear) or 1 (almost clear).

IGA: Investigator Global Assessment; TCS: Topical Corticosteroids

Management of atopic dermatitis in adults

A Consensus Statement endorsed by the Australasian College of Dermatologists recommends Topical Calcineurin Inhibitors (such as Elidel^®) or Topical Corticosteroids in the management of atopic dermatitis in adults.¹

Adapted from Figure 1 Management flow chart for adult atopic dermatitis patients in Australia, reproducing the flowchart boxes for patients with mild disease.¹

*Treatment failure, despite appropriate dose, duration and adherence = inadequate clinical improvement OR failure to achieve stable long-term disease control OR presence of ongoing impairment while on treatment or unacceptable adverse events OR poor tolerability.

AD: Atopic Dermatitis, TCI: Topical Calcineurin Inhibitor, TCS: Topical Corticostreoids.

Elidel is indicated for short term treatment of signs and symptoms atopic dermatitis or the intermittent long-term treatment of emerging and resolving lesions in atopic dermatitis.

Indications
Indicated for patients 3 months of age and older with atopic dermatitis (eczema) for:

• short term treatment of signs and symptoms;
• intermittent long-term treatment of emerging and resolving lesions in atopic dermatitis where the use of a topical corticosteroid is not yet warranted, no longer needed, or is inadvisable (according to the usage restrictions in the respective topical corticosteroid Product Information).¹

How to Use:

• Apply а thin layer to the affected skin only, twice daily, rub in gently and completely.
• Мау bе used on all affected skin areas, including head, face, neck and intertriginous areas.
• lnitiate at the first sign of itching (pruritus), persistent redness, or thickening of skin to prevent progression to flares.¹

Elidel^® is available in 15g and 30g tubes.

Elidel is PBS listed (15g Tube)¹
PBS Information: Authority Required (STREAMLINED). For the treatment of atopic dermatitis.
PBS Code 8802G
Max qty: 1 x 15g pack
No. of repeats: 1

Authority Required (STREAMLINED) 5482

• Patient must be at least 3 months of age.
• The condition must be on the patient’s face OR eyelid, AND,
• Patient must have 1 or more of the following contraindications to topical corticosteroids: (i) perioral dermatitis; (ii) periorbital dermatitis; (iii) rosacea; (iv) epidermal atrophy; (v) dermal atrophy; (vi) allergy to topical corticosteroids; (vii) cataracts; (viii) glaucoma; (ix) raised intraocular pressure.

Authority Required (STREAMLINED) 5472. Short-term (up to 3 weeks) intermittent treatment

• Patient must be at least 3 months of age.
• The condition must be on the patient’s face OR eyelid, AND,
• Patient must have failed to achieve satisfactory disease control with intermittent topical corticosteroid therapy, AND, the condition must have been initially diagnosed more than three months prior to this treatment

Note: Patients must not receive more than two 15g packs of PBS-subsidised pimecrolimus per 6-month period.

Refer to PBS Schedule for full information, listing accessible from: https://www.pbs.gov.au/medicine/item/8802G

PBS: Pharmaceutical Benefits Scheme.