The Impact and Treatment of Psoriasis in Manitoba Dermatology Clinics: The Case for Calcipotriol-Betamethasone Dipropionate Foam Formulation

Shane Silver MD FRCPC¹; Danielle Roy MD CCFP²; Victoria Taraska MD FRCPC³; Marni Wiseman MD FRCPC^2
1Academy Skin Centre, Winnipeg, MB, Canada
²Skinwise Dermatology, Winnipeg, MB, Canada
³The Derm Centre, Winnipeg, MB, Canada

Introduction

Psoriasis vulgaris (PsO) is a common immune-directed disorder that affects approximately 1 million Canadians.¹ Spontaneous, durable remission is rare, and patients and physicians should expect PsO to persist throughout life, with unpredictable periods of improvement or flares/exacerbations.²

Psoriasis can be difficult to manage; daily treatment application may be challenging despite the proven efficacy and safety of topical formulations. Randomized clinical trials have demonstrated that topical aerosol foam therapy offers patients a combination of higher efficacy and better patient acceptability, with easier application to enhance patient adherence. In a small real-world patient case review study, dermatologists tested the efficacy, safety and patient preference of Enstilar^®, a calcipotriol-betamethasone dipropionate (Cal/BD) aerosol foam, in patients with moderate-to-severe scalp PsO or mild-to-severe plaque PsO on the body, who had previously used Cal/BD gel and/or ointment formulations with sub-optimal response. Cases included in this article were selected prospectively from patients presenting at Winnipeg, Manitoba area dermatology practices.

Background

• Plaque PsO is distinguished by the presence of red, erythematous plaques, usually covered with silver, flaking scales, with a tendency to be itchy or painful; depending on their extent and location.²
• Overall, the prevalence of PsO has been estimated to be about 2%;^3–5 In 2015, an Ontario study identified a PsO prevalence of 2.5% for individuals aged ≥20 years of age.⁶
• PsO is a chronic inflammatory skin disease that requires ongoing, lifelong care,⁷ with a burden of disease that extends far beyond the physical dermatological symptoms. Indeed, PsO has an impact on physical and mental function as well as health-related quality of life (HRQoL) similar to that of cancer, arthritis, hypertension, heart disease, diabetes, and depression.^8–13
• Clinical trial and real-world evidence indicate that psoriatic patients have high rates of depression and anxiety, challenges at work, and difficulties with interpersonal relationships and intimacy.^14,15
• PsO is associated with a large socioeconomic burden including loss of productivity,^5,16–18 and cost of treatment may be significant. Treatments are broadly categorized into three main types: topical treatments, phototherapy, and systemic medications.^1,25 For patients with more severe PsO, the treatment costs associated with biologic agents are considerably higher than costs associated with topical therapies.^5,16,19
• A reliable assessment of PsO requires the use of several independent simultaneous evaluations to minimize the subjective perceptions of physicians.²⁰ Two assessments for severity (Psoriasis Area and Severity Index [PASI] and Body Surface Area [BSA]), and one for impact on quality of life (Dermatology Life Quality Index [DLQI]) were used during the collection of cases as presented here. PASI is evaluated on a scale of 0 (no disease) to 72 (very severe disease) and examines extent of disease and severity by three measures (redness, induration, scaling).^21,22 BSA ranges from 0-100% with less than 3% being considered mild, 3-10% being moderate, and greater than 10% considered severe.²³ DLQI is a short, 10 question survey that covers impact on quality of life and ranges from 0 (no impact) to 30 (extremely large impact).²⁴
• Data supports that about 75% of patients with moderate-to-severe plaque psoriasis manage their disease with topical therapies, either alone or in combination with other modalities,²⁶ which may lead to quicker treatment fatigue as a daily topical treatment regimen can be cumbersome and time consuming.³ There is considerable evidence from clinical trials that dermatology patients commonly self-undertreat, while inflating their reported use of the assigned treatment.^27,28
• Evidence suggests that changes in drug formulation may make patients more willing to use the treatment as instructed, leading to a sudden dramatic increase in treatment effectiveness.²
• Cal/BD aerosol foam (Enstilar^®) is indicated for the topical treatment of psoriasis vulgaris in adults for up to 4 weeks. This fixed dose Cal/BD combination is formulated as a pressurized aerosol foam, comprised of an emollient vehicle base and the active ingredients dissolved in a mixture of volatile propellants. The propellants evaporate rapidly after spray application, creating a stable solution of active ingredients on the skin; this formulation leads to greater skin penetration of the active ingredients.²⁹

Patient Case Review

Cases included in this review were selected prospectively from patients presenting at Winnipeg, Manitoba area dermatology practices. Patients reviewed presented with moderate-to-severe scalp PsO or mild-to-severe plaque PsO on the body and all had previously tried and did not obtain optimal results using the Cal/BD gel and/or ointment formulations. Following baseline assessment, patients were prescribed Cal/BD aerosol foam and then returned in four weeks for follow-up assessment.

Case 1

A 41-year old female had scalp, body and face PsO for 12 years, with significant impact on HRQoL.

Patient treatment history included very potent topical steroids, coal tar (for 5 or more years), fluocinolone acetonide (5 years of therapy), Cal/BD gel/ointment (5 years of treatment). At the time of the baseline visit the patient had been using Cal/BD gel with limited success.

Physical examination revealed psoriasis on both elbows and on the face and scalp around both left and right ears (Figure 1) and on both elbows (Figure 2). The estimated body surface area (BSA) was 5 to 9.9%, with PASI score of 8.8. The Dermatology Life Quality index (DLQI) score was 14, suggesting a significant impact on quality of life (QoL) for this patient.

Although the patient was eligible for treatment using systemic therapy, she preferred topical therapy due to personal preferences and financial considerations. The patient was prescribed 1 can (60 g) of Cal/BD aerosol foam to apply to arms, face/neck and scalp, continuing to use the product until the plaques were clear.

Following 4-weeks of treatment, the patient had used less than 1 can of product. BSA was reduced to <5%, and PASI decreased to 1.4. The DLQI was markedly improved with a 10-point reduction to 4 (a small impact on the patient’s HRQoL). The patient expressed high satisfaction with the treatment, reporting improvement in itch and overall disease. She described the treatment as cool and moisturizing, and felt the product was superior to all other topicals she had previously tried.

Case 2

A 31-year old woman had PsO affecting the scalp, knees and elbows for 3 years. She had been treated with various topical treatments including Cal/BD gel, very potent topical corticosteroids, as well as liberal and longstanding use of moisturizing gels.

Physical examination identified psoriatic lesions on both left and right elbows (Figure 3) and both left and right knees (Figure 4). PASI was calculated as 4, with a BSA estimated to be less than 5%. The DLQI score was 8, indicating moderate impact on QoL. The patient was prescribed Cal/BD aerosol foam (1 can of 60 g) and instructed to use the product for 4 weeks or until the plaques were visually clear.

At the 4-week follow-up assessment, the patient reported using the foam product only intermittently, with lapses when she forgot to apply the product as directed. Despite these lapses, she experienced marked improvement including resolution of her psoriasis, with only post-inflammatory changes remaining in some areas. PASI was reduced to 1.2 and DLQI score was reduced by 5 to a final score of 3. The patient expressed high satisfaction with Cal/BD aerosol foam, reporting both improved disease and improved itch.

Discussion

• These cases provide real-world clinical data supporting the benefits of Cal/BD aerosol foam for patients with either long- or short-duration disease, who were unable to gain satisfactory response with other topical treatment. Improvements were noted for both the objective disease measures (i.e., PASI and BSA) as well as the more subjective measures (i.e., DLQI and symptom impact).
• Robust clinical evidence has demonstrated that the Cal/BD aerosol foam is an effective treatment for patients with PsO, with many healthcare providers prescribing the aerosol foam due to its clinical efficacy versus other formulations.³⁰ This efficacy has been demonstrated in several randomized phase II and III clinical trials, including a 4 week, head-to-head comparison of the aerosol foam and ointment in 376 patients, which demonstrated significantly improved treatment success (54.6% vs 43% (p < 0.05)).³¹ A phase III study in 463 patients demonstrated significantly higher treatment success rates following 4 weeks of treatment, with 38% of patients achieving treatment success when using the Cal/BD aerosol foam formulation compared with only 22% using the gel formulation at 8 weeks (p < 0.001).³²
• A pooled analysis of randomized phase II and III clinical trials demonstrated that Cal/BD aerosol foam has a positive benefit-risk profile for the treatment of psoriasis vulgaris; importantly, the superior efficacy versus Cal/BD ointment or the individual active ingredients, is not associated with poorer tolerability.³³
• Patient preference and acceptance of treatment is a strong indicator of adherence to the prescribed treatment regimen. Patient adherence to topical PsO therapy is generally low.³⁵ The high burden of treatment and the substantial effort required to maintain ongoing therapy often leads to treatment fatigue.³⁶ A recent survey of Canadian patients identifying attitudes towards PsO and their views regarding topical therapies found that patients were generally more satisfied with an aerosol foam formulation and more likely to use the product, which could lead to improved treatment outcomes.^37,38 Clinical data supports that the aerosol foam formulation is an appropriate topical therapy option for patients with PsO of any severity.³⁹ Aerosol foam vehicles were developed to address several needs beyond the effective delivery of active ingredients: ease of application over large areas; gentle application, and cosmetic factors (no greasy film on the skin, no greasy feeling).³⁶ Patients are typically more satisfied with the aerosol foam formulation than other formulations and vehicles used.⁴⁰ Both patients described in this clinical review expressed very high satisfaction with the treatment.
• There remains an inequity in the accessibility to the Cal/BD aerosol foam formulation between Canadian provinces. It has been added to formulary in most provinces, including Quebec, Ontario, Newfoundland and Labrador, Saskatchewan, Alberta, New Brunswick, and Nova Scotia, and Manitoba, as well as federally. British Columbia does not yet list the product in their formulary.

Conclusion

This patient case review provides real-world clinical practice data supporting the benefits of calcipotriol-betamethasone aerosol foam formulation.

Patients reported that the aerosol foam formulation was the preferred treatment they had used and they were very satisfied with their treatment outcomes. This demonstrates that there is a clear need for alternative topical formulations in patients with PsO.