Let your patients experience Enstilar.®

Indicated for the topical treatment of psoriasis vulgaris in adults for up to 4 weeks

Demonstrated to be more effective in achieving ‘treatment success’ at 4 weeks in body psoriasis vs. calcipotriol/betamethasone dipropionate ointment2*

• ‘Treatment success’ was defined as ‘clear’ or ‘almost clear’ for subjects with at least moderate disease at baseline, ‘clear’ for subjects with mild disease at baseline, according to Physician’s Global Assessment

• At week 1, ‘treatment success’ was low across all treatment groups, with no significant differences demonstrated between active treatments (P=NS; secondary endpoint)

• Mean amount of treatment used per week for Enstilar® was 31.6 g vs. 30.6 g calcipotriol/betamethasone dipropionate ointment

* A multi-centre, comparative, randomized, investigator-blinded, 4-week study. Subjects had a range of disease severity with up to 75% moderate body psoriasis; up to 10% had severe. Treatment was limited to the trunk, arms and legs only; scalp, face, genitals and skin folds were not treated. Enstilar® (N=141), Foam vehicle (N=49), Dovobet® ointment (N=135) or ointment vehicle (N=51).

30

35

40

45

50

55

60

43.0%

11.6%mean difference; odds ratio1.7; 95% CI 1.1, 2.8

54.6%

More than half of Enstilar® patients achieved ‘treatment success’ at week 41,2

P=0.025

calcipotriol/betamethasone

dipropionateointment

Enstilar®

spray foam

% p

atie

nts

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Demonstrated powerful efficacy in body psoriasis vs. foam vehicle at week 4

• At week 1, mean mPASI score was significantly lower in patients using Enstilar® vs. vehicle (mean mPASI score, 4.5 versus 6.2; adjusted mean difference –1.3; 95% CI –1.8, –0.8; p < 0.001; multiple imputation), corresponding to mean percentage changes in mPASI from baseline of –38.2% (Enstilar®) vs. –19.6% (vehicle)

• At week 4, mean mPASI score was significantly lower for patients using Enstilar®, 2.0 vs. 5.5 for vehicle (adjusted mean difference –3.3; 95% CI –3.9, –2.7; p < 0.001; multiple imputation); mean percentage changes in mPASI from baseline of –71.9% and –25.8%, respectively

• The mean amount of Enstilar® used per week was 29.8 g vs. 32.1 g for the vehicle group

* In a randomized, double-blind, 4-week, multi-centre clinical study, in which patients with psoriasis were treated with Enstilar® spray foam (N=323) or foam vehicle (N=103). The foam vehicle is not a product available in Canada.

† Extent of disease was evaluated by percentage involvement (no involvement, <10%, 10–29%, 30–49%, 50–69%, 70–89%, 90–100%), and severity of clinical signs (redness, thickness, scaliness) was assessed using a five-point scale (0=none, 1=mild, 2=moderate, 3=severe, 4=very severe).

Δ Modified (excluding head) Psoriasis Area and Severity Index

Improvement in disease extent and severity† (mPASIΔ score) was seen as early as week 1 vs. foam vehicle (secondary endpoint)3

Enstilar® (N=323)

Aerosol foam vehicle (N=103)

BaselineWeeks

Mea

n m

PASI

sco

re (9

5% C

I)

reduction in mPASI score vs. foam vehicle 20% reduction in mPASI score

vs. foam vehicle 26%

38% 72%

p<0.001

p<0.001

MEAN CHANGE IN mPASI SCORE FROM BASELINE TO WEEK 4

In a study* of patients with ≥mild psoriasis on the body (trunk and limbs), ‘treatment success’ achieved at week 43:

Enstilar®: 53.3% vs. foam vehicle: 4.8% (95% CI 9.7, 94.3; p<0.001) (primary endpoint)

0

1

2

3

4

5

6

7

8

9

10

1 4

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Improvement in disease extent and severity† (mPASIΔ score) was seen as early as week 1 vs. foam vehicle (secondary endpoint)3

Aerosol foam vehicle(N=103)

Demonstrated favourable safety profi le

Adverse reaction rates derived from 3 randomized,

multicentre, prospective vehicle and/or active controlled trials in

1,100 patientswith psoriasis vulgaris

of which 564 subjects were treated with Enstilar® once

daily for up to 4 wks.

• No reported ADR experienced in ≥1% of subjects treated with Enstilar®1

• ADRs (<1%) were: folliculitis, hypersensitivity, hypercalcaemia, skin hypopigmentation, application site pruritus, application site irritation, application site pain and rebound eff ect1

• The mean dose of Enstilar® per week was 30.9 g (median 24.8 g)1†

Pharmacodynamic profi le

*Maximum Use (MUSE) study up to 113 g/week in patients with extensive psoriasis involving 15-30% of the body surface area, with at least 30% scalp involvement.

• Trend for decreased cortisol response to ACTH with increased dose was identifi ed, but no clinically meaningful adrenal suppression was observed

• There was no evidence of change of calcium metabolism

†The maximum daily dose of Enstilar® is 15 g. The maximum weekly dose should not exceed 100 g. The total weekly dose of all calcipotriol containing medical products, including Enstilar®, should not exceed 100 g. The total body surface area treated, including scalp should not exceed 30%.1

Eff ects on the HPA axis and calcium metabolism were evaluated in a maximum use (up to 113 g/wk) trial in adult subjects (N=35) with extensive psoriasis, treated with Enstilar® once daily for 4 weeks.1*

EnstilarMiniDA_EN_11.17.17.indd 3 2017-12-19 7:42 PM

The fi rst and only psoriasis topical corticosteroid + Vitamin D analogue combination in an aerosol spray foam*

• White to off -white, fl at, non-expanding foam forms after spraying

• Alcohol-free

• Odourless

• Available in a 60 g can

Clinical Use

The use in pediatrics (<18 years of age) is not recommended as safety and effi cacy have not been established in this population.

Contraindications

• Disorders of calcium metabolism

• Viral skin lesions; fungal, bacterial, parasitic skin infections; skin manifestations related to tuberculosis

• Perioral dermatitis

• Striae atrophicae

• Skin atrophy

• Fragility of skin veins

• Ichthyosis

• Acne vulgaris, acne rosacea or rosacea

• Ulcers and wounds

• Erythrodermic and pustular psoriasis

Relevant Warnings & Precautions

• No experience with use in guttate psoriasis

• Prolonged use of corticosteroids may increase risk of local and systemic ADRs. Treatment should be discontinued if ADRs develop

• Calcipotriol when used in combination with ultraviolet radiation (UVR) may enhance the known skin carcinogenic eff ect of UVR. Prolonged exposure to natural or artifi cial sunlight should be avoided

• AE risks with systemic absorption or upon withdrawal of topical corticosteroids: reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticoid insuffi ciency.

• Application on large areas of damaged skin, on mucous membranes, in skin folds, or under occlusive dressings should be avoided

• AE risks with systemic absorption of topical corticosteroids: manifestations of Cushing’s syndrome, eff ects on the metabolic control of diabetes mellitus and unmasking of latent diabetes mellitus

• Concurrent treatment with other corticosteroids on the same treatment area should be avoided

• Risk of hypothalamic-pituitary-adrenal (HPA) axis suppression

• Monitoring recommendation for HPA axis suppression related to the systemic absorption of topical corticosteroids

• Hypercalcaemia and hypercalciuria have been observed with the use of Enstilar®. If hypercalcaemia or hypercalciuria develop, treatment should be discontinued until parameters of calcium metabolism have normalized. Incidence of hypercalcaemia and hypercalciuria following Enstilar® treatment for more than 4 weeks has not been evaluated.

• Monitoring recommendation for serum calcium levels at baseline and at other suitable intervals

• Should not be used in the eyes. May cause eye irritation

• Should not be used on the face, axillae, fl exures, groin or genitals

• Avoid contact with the mouth, mucous membranes or eyes

• Patients with severe hepatic impairment

• Patients with severe renal impairment

• Periodic interruption recommended

related to risk of generalised pustular psoriasis or rebound psoriasis upon therapy discontinuation following prolonged topical use of corticosteroid-containing products

• Should be used for the shortest possible duration, in the smallest needed amounts when used in pregnant women

• Caution should be exercised when used in nursing women. Should not be applied to breast when breastfeeding.

• Use of corticosteroid-containing products in elderly patients

• Concomitant skin infections should be treated with an appropriate antimicrobial agent

Recommended Dosing

• The maximum daily dose of Enstilar® is 15 g. One 60 g can should last for at least 4 days. The maximum weekly dose should not exceed 100 g. The total weekly dose of all calcipotriol containing medical products, including Enstilar®, should not exceed 100 g. The total body surface area treated, including scalp should not exceed 30%.

For More Information

Please consult the product monograph at www.leo-pharma.ca/enstilar_pm for important information relating to adverse reactions, drug interactions, and dosing information which have not been discussed in this piece.

The product monograph is also available by contacting LEO Pharma Medical Information

at 1-800-263-4218.

POWERFUL EFFICACY IN PSORIASIS

www.leo-pharma.ca

1. Enstilar® spray foam product monograph. LEO Pharma Inc. Sept 8, 2016.2. Koo J. et al. Superior effi cacy of calcipotriene and betamethasone dipropionate aerosol foam

versus ointment in patients with psoriasis vulgaris. J Dermatolog Treat. 2016 Mar;27(2):120-7. 3. Leonardi et al, Effi cacy and Safety of Calcipotriene Plus Betamethasone Dipropionate Aerosol

Foam in Patients With Psoriasis Vulgaris. J Drugs Dermatol.2015;14(12):1468-1477.

*Comparative clinical significance unknown

Enstilar® od dispense2 x 60 g

®Registered trademark of LEO Pharma A/S used under license and distributed by LEO Pharma Inc., 123 Commerce Valley Dr. E., Suite 400, Thornhill, Ontario L3T 7W8.

ENS-057-17E

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