Elidel®
Overview
Treating Atopic Dermatitis in sensitive skin areas such as the face or eyelids1,2
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
References:
- Therapeutic Guidelines [March 2020 edition]. eTG complete, Dermatology, Dermatitis, Atopic dermatitis. Accessed 26-Oct-2021. Available from: www.tg.org.au.
- Department of Health, Pharmaceutical Benefits Scheme, pimecrolimus listing. Accessed 26 Oct 2021. Available from: www.pbs.gov.au/medicine/item/8802G.
- Sigurgeirsson B, Boznanski A, Todd G, Vertruyen A, Schuttelaar ML, Zhu X, et al. Safety and efficacy of pimecrolimus in atopic dermatitis; a 5-year randomized trial. Pediatrics. 2015; 135(4):597-606.
- Gollnick H, Luger T, Freytag S, Bräutigam M. StabiEL: stabilization of skin condition with Elidel—a patient’s satisfaction observational study addressing the treatment, with pimecrolimus cream, of atopic dermatitis pretreated with topical corticosteroid. J Eur Acad Dermatol Venereol. 2008; 22(11):1319-25.
- Aschoff R, Schmitt J, Knuschke P, Koch E, Bräutigam M, Meurer M. Evaluation of the atrophogenic potential of hydrocortisone 1% cream and pimecrolimus 1% cream in uninvolved forehead skin of patients with atopic dermatitis using optical coherence tomography. Exp Dermatol. 2011;20(10):832-6.
- Queille-Roussel C, Paul C, Duteil L, Lefebvre MC, Rapatz G, Zagula M, Ortonne J-P. The new topical ascomycin derivative SDZ ASM 981 does not induce skin atrophy when applied to normal skin for 4 weeks: a randomized, double-blind controlled study. Br J Dermatol. 2001; 144(3):507-13.
- Jensen JM, Pfeiffer S, Witt M, Bräutigam M, Neumann C, Weichenthal M et al. Different effects of pimecrolimus and betamethasone on the skin barrier in patients with atopic dermatitis. J Allergy Clin Immunol. 2009; 123(5):1124-33.
- Murrell DF, Calvieri S, Ortonne JP, Ho VC, Weise-Riccardi S, Barbier N et al. A randomized controlled trial of pimecrolimus cream 1% in adolescents and adults with head and neck atopic dermatitis and intolerant of, or dependent on, topical corticosteroids. Br J Dermatol. 2007; 157(5):954-9.
PI & PBS Information
PBS Information: Authority required (STREAMLINED). Refer to PBS Schedule for full authority information.
Before prescribing, please review approved product information available here.
Dermal Atrophy
Elidel® does not cause epidermal atrophy when applied to normal skin for 4 weeks, contrary to TCS1-3*
TCS*: Topical Corticosteroids including hydrocortisone 1%, betamethasone-17-valerate 0.1% and triamcinolone acetonide 0.1%
References:
- Aschoff R, Schmitt J, Knuschke P, Koch E, Br utigam M, Meurer M. Evaluation of the atrophogenic potential of hydrocortisone 1% cream and pimecrolimus 1% cream in uninvolved forehead skin of patients with atopic dermatitis using optical coherence tomography. Exp Dermatol. 2011;20(10):832-6.
- Queille-Roussel C, Paul C, Duteil L, Lefebvre MC, Rapatz G, Zagula M, Ortonne J-P. The new topical ascomycin derivative SDZ ASM 981 does not induce skin atrophy when applied to normal skin for 4 weeks: a randomized, double-blind controlled study. Br J Dermatol. 2001; 144(3):507-13.
- Jensen JM, Pfeiffer S, Witt M, Br utigam M, Neumann C, Weichenthal M et al. Different effects of pimecrolimus and betamethasone on the skin barrier in patients with atopic dermatitis. J Allergy Clin Immunol. 2009; 123(5):1124-33.
Improved Skin Atrophy
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%
Reference:
- Murrell DF, Calvieri S, Ortonne JP, Ho VC, Weise-Riccardi S, Barbier N et al. A randomized controlled trial of pimecrolimus cream 1% in adolescents and adults with head and neck atopic dermatitis and intolerant of, or dependent on, topical corticosteroids. Br J Dermatol. 2007; 157(5):954-9.
Patient Acceptance
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
Reference:
- Gollnick H, Luger T, Freytag S, Bräutigam M. StabiEL: stabilization of skin condition with Elidel—a patient’s satisfaction observational study addressing the treatment, with pimecrolimus cream, of atopic dermatitis pretreated with topical corticosteroid. J Eur Acad Dermatol Venereol. 2008; 22(11):1319-25.
Efficacy
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
Reference:
- Sigurgeirsson B, Boznanski A, Todd G, Vertruyen A, Schuttelaar ML, Zhu X, et al. Safety and efficacy of pimecrolimus in atropic dermatitis; a 5-year randomized trial. Pediatrics. 2015; 135(4):597-606.
Atopic Dermatitis Management
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.
Reference:
- Smith S, Marshman G, McMeniman E, Ross T, Sladden M. Consensus statement: Management of atopic dermatitis in adults. Endorsed by The Australasian College of Dermatologist 9 March 2021.
How to Use
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
- 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.
Reference:
- Elidel® Approved Product Information (PI). Date of revision: 11 May 2018.
PBS Criteria
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
- 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.
- 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.
Reference:
- Department of Health, Pharmaceutical Benefits Scheme, pimecrolimus listing. Accessed 26 Oct 2021. Available from: www.pbs.gov.au/medicine/item/8802G.