Powerful Efficacy in Plaque Psoriasis

Enstilar® is indicated for the topical treatment of psoriasis vulgaris in adults for up to 4 weeks.

Topical Spray Foam Delivery

Enstilar® is the first and only psoriasis topical corticosteroid + Vitamin D analogue combination in an aerosol spray foam2,3*

*Comparative clinical significance is unknown.

Enstilar® efficacy studies

The efficacy of Enstilar® in treating plaque psoriasis was studied in 1,104 adult patients (Enstilar® n=564) presenting with mild, moderate, or severe disease at baseline according to the PGA:2

75 percent icon

Approx. 75% had
moderate plaque psoriasis

10 percent icon

Up to 10% had
severe plaque psoriasis

2-30 percent icon

2-30% of Body Surface Area
(BSA) affected

Icon of white hand palm with blue outline

Estimating BSA: 1% BSA is roughly
1 palm-sized area (patient’s flat hand,
thumb/fingers included)4

PGA= Physician’s Global Assessment

Demonstrated efficacy vs. monotherapy with calcipotriol or betamethasone in foam vehicle alone

Enstilar® was statistically significantly more effective in achieving ‘treatment success’ at week 4 vs. betamethasone (BD) in foam vehicle and calcipotriol (Cal) in foam vehicle.2

How was ‘treatment success’ defined in Enstilar® efficacy studies?
In clinical studies of Enstilar®, treatment success was defined as achieving ‘clear’ or ‘almost clear’ skin for subjects with at least moderate disease at baseline, and ‘clear’ for subjects with mild disease at baseline according to the Physician’s Global Assessment (PGA) at Week 4. The PGA is a 5-point scale measuring the average psoriatic lesion from ‘clear’ to ‘severe’.2

Study details1
Based on a multi-centre, randomized, double-blind, 4-week study comparing the efficacy of Enstilar® spray foam (n=100), betamethasone dipropionate (foam vehicle; n=101), and calcipotriol (foam vehicle; n=101) in adults with plaque psoriasis. Treatment was limited to the trunk, limbs and scalp only. Note betamethasone dipropionate and calcipotriol in foam vehicles are not products available in Canada.

Bar graph showing Enstilar treatment success at week 4, comparing calcipotriol (14.9%), betamethasone dipropionate (30.7%) and Enstilar spray foam (45.0%)

Demonstrated efficacy vs. combination Cal/BD therapy in ointment formulation

Bar graph showing Enstilar treatment success at week 4, comparing calcipotriol/ betamethasone dipropionate (43.0%) and Enstilar spray foam (54.6%)

Enstilar® was statistically significantly more effective in achieving ‘treatment success’ at week 4 in body psoriasis vs. calcipotriol/betamethasone dipropionate ointment.2

Study details1
Based on a multi-centre, randomized, investigator-blinded, 4-week study comparing the efficacy of Enstilar® (n=141), calcipotriol/betamethasone dipropionate ointment (n=135), and their respective vehicles (foam [n=49], ointment [n=51]) in adults with plaque psoriasis. Treatment was limited to the trunk and limbs only.

See Clinical Trial Images

Swipe to reveal lesion images from separate patients in a phase III clinical trial using Enstilar® once daily. Please note these are real patient images; however, the photographs are not intended to be predictive of results in the general population. Individual results may vary.

In a study of patients with ≥mild body psoriasis on their trunk and limbs, 53.3% using Enstilar® (n=323) achieved ‘treatment success’ at week 4 vs. 4.8% using foam vehicle (n=103; OR: 30.3; 95% CI: 9.7 to 94.3; p<0.001).2,7†

• In a secondary endpoint analysis, Enstilar® significantly lowered mean mPASI score from baseline at week 1 (Enstilar® 4.5 vs. 6.2; p<0.001) and week 4 (2.0 vs. 5.5; p<0.001).7‡

‡Baseline mPASI score for Enstilar® and foam vehicle were 7.4 and 7.9, respectively.

Week 0 (baseline) / Week 4

Arm

Close up of arm with plaque psoriasis at week 0Close up of arm with reduced plaque psoriasis at week 4

Leg

Close up of leg with plaque psoriasis at week 0Close up of leg with reduced plaque psoriasis at week 4

Knee

Close up of knee with plaque psoriasis at week 0Close up of knee with reduced plaque psoriasis at week 4

Hip

Close up of knee with plaque psoriasis at week 0Close up of hip with reduced plaque psoriasis at week 4

Torso

Close up of torso with plaque psoriasis at week 0Close up of torso with reduced plaque psoriasis at week 4

Above lesion images are from separate patients in a phase 3 clinical trial using Enstilar® once daily. The photographs are not intended to be predictive of results in the general population. Individual results may vary. Adapted from Leonardi C, et al., 2015.7†

Scalp (case study)§

In a study of the effect of Enstilar® (n=100) on scalp psoriasis that assessed the percentage of subjects who achieved ‘treatment success’ according to the PGA of the scalp at week 4:

• Enstilar® was statistically significantly more effective than calcipotriol (n=101) and associated with a higher rate of treatment success than BD (n=101), but this comparison did not reach statistical significance (Enstilar®: 53.0%; BD: 47.5%; Cal: 35.6%)2,5

Week 0 (baseline) / Week 4

Close up of a female's scalp with plaque psoriasis at week 0Close up of a female's scalp with reduced plaque psoriasis at week 4

The photographs above are not intended to be predictive of results in the general population. Individual results may vary. Photos courtesy of Dr. Marian Anderko.

†A multicentre, comparative, randomized, double-blind, vehicle-controlled 4-week study. Patients were randomized (3:1) to Cal/BD aerosol or aerosol foam vehicle once daily for up to 4 weeks. The primary efficacy endpoint was the proportion of patients at week 4 who achieved treatment success, defined as ‘clear’ or ‘almost clear’ (for patients with ≥moderate disease at baseline) or ‘clear’ (for patients with mild disease at baseline), according to PGA. All physician and patient assessments were performed at each visit (baseline and weeks 1, 2, and 4). Severity of psoriasis was evaluated according to physician’s global assessment (PGA), using a five-point scale (clear, almost clear, mild, moderate, severe). Extent and severity of clinical signs were assessed to determine an mPASI score; each area (arms, trunk, and legs) was assessed separately. 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). A target lesion, selected at baseline by the investigator, was used to evaluate the change from baseline in severity of clinical signs at week 4.

In a 4-week, vehicle-controlled study of Enstilar® (n=323) vs. foam vehicle (n=103):

Statistically significant improvement in quality of life as measured by DLQI was observed from Week 1 and throughout treatment period in patients treated with Enstilar® vs. foam vehicle (secondary endpoint).

Significant improvement in EQ-5D-5L was observed at Week 4 in patients receiving Enstilar® vs. foam vehicle (secondary endpoint).

53.3% of Enstilar®-treated patients achieved ‘treatment success’ vs. 4.8% with foam vehicle (primary endpoint).2

DLQI=Dermatology Life Quality Index, a 10-question patient-reported outcome measure of patients’ perception of the impact of skin disease on different aspects of their health-related quality of life over the past week. For more information, please click here

EQ-5D-5L=EuroQol 5-Dimensions 5-Levels

§Based on a multi-centre, randomized, investigator-blinded, 4-week study comparing the efficacy of Enstilar® (n=323) and foam vehicle (n=103) in adults with plaque psoriasis. Treatment was limited to the trunk and limbs only.

Dual MOA to act on both aspects of psoriasis:
Inflammation and keratinocyte growth2

While the clinical significance is unknown, the combination of calcipotriol and betamethasone
dipropionate has greater anti-inflammatory and anti-proliferative effects than either component alone.2

Consider the properties of each below:

Blue bubble showing Calcipotriol info

Dark blue bubble showing Betamethasone dipropionate info

Need a refresher?

Review pathophysiology here

Enstilar®
demonstrated
a favourable
safety profile

The rates of adverse reactions (ADRs) were derived from 3 randomized, multi-centre, prospective vehicle and/or active controlled trials in 1,100 patients with psoriasis vulgaris, of which 564 patients were treated with Enstilar® once daily for up to 4 weeks.2

Less common ADRs (<1%) were: folliculitis, hypersensitivity, hypercalcaemia, skin hypopigmentation, application site pruritus, application site irritation, application site pain, and rebound effect.2

Visual with blue bubbles around showing No ADRs info

Enstilar® is applied to affected areas once daily for up to 4 weeks2

Grey calendar icon highlighting the first day of the month

Maximum
daily dose:
15 g

Grey calendar icon highlighting the first week of the month

Maximum weekly
dose: should not
exceed ≤100 g

Icon of person highlighting the bottom portion with blue

Total BSA treated
including scalp:
Do not exceed 30%

Maximum
daily dose:
15 g

Maximum weekly
dose: should not
exceed 100 g

Total BSA treated
including scalp:
Do not exceed 30%

Total weekly dose of all calcipotriol containing medical products including Enstilar®: Do not exceed 100 g.

In clinical trials, patients treated with Enstilar® used a mean of 30.9 g per week (24.8 g/week median). Thus, approximately
2×60 g canisters of Enstilar® were required to complete the 4-week treatment on average.2

Grey icon of a ventilator with blue wavy arrows pointing to the right

Enstilar® should be used in a well-ventilated area

Grey icon of the silhouette of a person inhalating spray in a crossed circle

Inhalation should be avoided

Grey icon of a hand under a water drop coming out of the tap

Wash hands after using Enstilar® (unless it is used to treat the hands) to avoid accidentally spreading to other parts of the body

Enstilar® should be used in a well-ventilated area

Inhalation should
be avoided

Wash hands after using Enstilar® (unless it is used to treat the hands) to avoid accidentally spreading to other parts of the body

Enstilar can icon

Select administration note: Enstilar® may feel cool when applied to the skin due to the evaporation of propellants2

Please see Product Monograph section 3.2 for complete administration details

Enstilar® Safety Information

Indication and Clinical Use:
Enstilar® is indicated for the topical treatment of psoriasis vulgaris in adults for up to 4 weeks.
The use in pediatrics (<18 years of age) is not recommended as safety and efficacy 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, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers and wounds
● Erythrodermic and pustular psoriasis

Relevant warnings and precautions:
● Long-term or concomitant corticosteroid use
● Use with ultraviolet radiation
● Avoid use on broken skin, on mucous membranes, in skin folds, or under occlusive dressing
● Hypercalcemia and hypercalciuria
● Hepatic or renal impairment
● Avoid ophthalmic use
● Avoid use on face, axillae, flexures, groin, or genitals
● Use caution in pregnant patients
● Avoid use on breast if breastfeeding
● Use in children <18 years of age or the elderly ≥65 years of age

For more information:
Please consult the Product Monograph at https://health-products.canada.ca/dpd-bdpp/index-eng.jsp 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 calling LEO Pharma Medical Information at 1-800-263-4218.

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© 2020 LEO Pharma Inc. All rights reserved.
® Registered trademark of LEO Pharma A/S used under license
and distributed by LEO Pharma Inc.
www.leo-pharma.ca

References:

  1. IQVIA GPM TRX Audit. April 2020.
  2. Current Enstilar® spray foam Product Monograph, LEO Pharma Inc.
  3. Data on File. LEO Pharma Inc. Oct 15, 2019.
  4. Canadian Psoriasis Guidelines Committee. Canadian guidelines for the management of plaque psoriasis. 2009:1-109.
  5. Lebwohl M, Tyring S, Bukhalo M, et al. Fixed Combination Aerosol Foam Calcipotriene 0.005% (Cal) Plus Betamethasone Dipropionate 0.064% (BD) is More Efficacious than Cal or BD Aerosol Foam Alone for Psoriasis Vulgaris: A Randomized, Double-blind, Multi-centre, Three-arm, Phase 2 Study. J Clin Aesthet Dermatol 2016;9(2):34-41.
  6. Koo J, Tyring S, Werschler W, et al. Superior efficacy of calcipotriene and betamethasone dipropionate aerosol foam versus ointment in patients with psoriasis vulgaris—A randomized phase II study. J Dermatolog Treat 2016;27(2):120-127.
  7. Leonardi C, Bagel J, Yamauchi P, et al. Efficacy and Safety of Calcipotriene Plus Betamethasone Dipropionate Aerosol Foam in Patients With Psoriasis Vulgaris—a Randomized Phase III Study (PSO-FAST). J Drugs Dermatol 2015;14(12):1468-1477.