Calcipotriol plus betamethasone dipropionate aerosol foam provides superior efficacy vs. gel in patients with psoriasis vulgaris: randomized, controlled PSO‐ABLE study

Paul, C.; Gold, Linda Stein; Cambazard, F.; Kalb, Robert E.; Lowson, David; Bang, Bo; Griffiths, C.E.M.

doi:10.1111/jdv.13859

Cited by 102 publications

(177 citation statements)

References 28 publications

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“…The efficacy and safety of fixed combination calcipotriol 50 μg/g (Cal) and betamethasone 0.5 mg/g as dipropionate (BD) have been confirmed in a number of studies 14, 15, 16, 17, 18, 19, 20, 21. The ointment and gel formulations of this fixed combination are established first‐line treatments for psoriasis 22.…”

Section: Introductionmentioning

confidence: 96%

“…The ointment and gel formulations of this fixed combination are established first‐line treatments for psoriasis 22. An aerosol foam formulation, which was developed to enhance adherence and increase the therapeutic options available to patients, has been shown to be effective and well tolerated 17, 23. The Phase IIIb PSO‐INSIGHTFUL study was designed to assess the patient‐reported factors that influence preference following once‐daily topical treatment with Cal/BD foam and gel, whilst minimizing the impact of efficacy.…”

Section: Introductionmentioning

confidence: 99%

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Patients with psoriasis have different preferences for topical therapy, highlighting the importance of individualized treatment approaches: randomized phase IIIb PSO‐INSIGHTFUL study

Papp

et al. 2017

Acad Dermatol Venereol

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BackgroundPoor adherence to topical therapy in psoriasis remains an issue; it is associated with poor clinical outcomes, reduced quality of life and increased costs. Treatment‐related factors leading to poor adherence include lack of efficacy, excessive time applying medication and poor cosmetic characteristics (e.g. slow absorption, greasiness).ObjectiveTo assess the topical treatment attributes that influence patient preference for fixed combination calcipotriol 50 μg/g (Cal) and betamethasone 0.5 mg/g as dipropionate (BD) foam vs. gel, as well as in comparison with the latest topical treatment (LTT) a patient received.Methods PSO‐INSIGHTFUL was a Phase IIIb, prospective, multicentre (Canada/Germany), open‐label, randomized, two‐arm crossover study in patients aged ≥18 years with mild‐to‐severe psoriasis (NCT02310646). Following a washout period of up to 4 weeks, patients were randomized 1 : 1 to once‐daily Cal/BD foam for 1 week, followed by Cal/BD gel for 1 week, or vice versa. Patients completed six questionnaires evaluating patient preferences.ResultsA total of 213 patients were randomized; 118 had received a topical treatment in the previous 3 months. Based on the Subject's Preference Assessment, 50% of patients preferred Cal/BD foam and 50% preferred Cal/BD gel. Based on the Topical Product Usability Questionnaire (TPUQ), overall mean scores were high for both Cal/BD foam and gel, and were often significantly in favour of both products compared with LTT. Greater differences between Cal/BD foam and gel vs. LTT occurred when the previous treatment was an ointment or cream. Cal/BD foam was generally preferred by younger patients (aged 18–39 years), whereas Cal/BD gel tended to be preferred by older patients (aged ≥40 years). Results from other questionnaires were aligned with the TPUQ.ConclusionsPatients with psoriasis have diverse needs and different preferences for topical treatment. This knowledge may help prescribers to choose the right formulation for the right patient, potentially leading to improved adherence and better treatment outcomes.

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Section: Introductionmentioning

confidence: 96%

Section: Introductionmentioning

confidence: 99%

Patients with psoriasis have different preferences for topical therapy, highlighting the importance of individualized treatment approaches: randomized phase IIIb PSO‐INSIGHTFUL study

Papp

et al. 2017

Acad Dermatol Venereol

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“…A number of studies have demonstrated the superior efficacy of Cal/BD aerosol foam compared with traditional formulations such as ointments, gels, and lotions (Table 2) 15,[22][23][24] The increased efficacy of Cal/BD aerosol foam is also associated with a similar safety profile, as demonstrated in a pooled safety analysis comparing fixed-dose combination Cal/BD aerosol foam with BD foam, Cal foam, Cal/BD ointment, and vehicles (foam and ointment) 25 …”

Section: An Innovative Drug Delivery Formulation Results In Improved mentioning

confidence: 99%

Innovation in Topical Therapy for Psoriasis with Corticostereoid and Vitamin D Analogue Commbination

Segaert¹,

Shear²,

Chiricozzi³

et al. 2017

J of Skin

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Plaque psoriasis is a chronic, inflammatory, immune-mediated skin disorder that negatively impacts a patient's quality of life, both physically and psychologically 1,2 In individuals with a genetic predisposition, environmental factors (eg physical and psychological stress) may trigger the initiation of psoriasis, beginning with the activation of dendritic cells (Figure 1) 1,3 Topical treatments containing corticosteroids and vitamin D analogues target key steps in psoriasis pathogenesis and are essential, well-established first-line treatments for patients with mild-to-moderate psoriasis 4,5 Here we discuss recent data showing the anti-inflammatory and immunomodulatory mechanisms underlying the efficacy of fixed-dose combination therapy versus topical steroidal monotherapy, and explore developments in topical drug delivery and the clinical relevance of these data Corticosteroid and vitamin D analogue combination treatment addresses therapeutic goals, resulting in increased effectiveness versus monotherapyThe treatment goal is to clear the psoriatic plaques by inhibiting the underlying inflammation via immunomodulation (rather than immunosuppression), thereby normalizing skin homeostasis, keratinocyte proliferation and differentiation Both corticosteroids and vitamin D analogues inhibit pro-inflammatory mediator release ( Figure 1) from dendritic cells, Type 1 and 17 (cytotoxic and helper) T-cells, and keratinocytes. [6][7][8][9] Vitamin D analogues exert normalizing effects on the hyperproliferation and abnormal differentiation of keratinocytes and also have immunomodulatory effects 6,10 Recent preclinical data show that fixed-dose combination treatment provides significantly increased inhibition of pro-inflammatory cytokines compared with monotherapies ( Figure 2) 11 The effect of fixed-dose combination therapy on cellular targets in psoriasis pathophysiology is summarized in Figure 3a-d Corticosteroid and vitamin D analogue combination topical treatment may provide long-term management of psoriasisUpon clearance of psoriatic plaques and normalization of skin homeostasis, the therapeutic objective shifts to the maintenance of a relapse-free state as psoriatic inflammation tends to recur in previously affected skin locations 12,13 -This may be caused by the expression of inflammatory cytokines upon reactivation of immune cells present in the apparently normalized, plaque-free skin after treatment 12,13 New data indicate that combination treatment is able to induce regulatory T-cells, as well as counteract the activation and differentiation of cytotoxic T-cells, more effectively than corticosteroids alone ( Figure 3e Attenuates reduced skin flexibility/ elasticity observed in topical steroidal monotherapy Downward arrow indicates down-regulation, upward arrow indicates up-regulation, equal sign indicates no effect. The data presented here are based on non-inflamed skin. AMP, antimicrobial peptide; KC, keratinocyte Challenges of drug delivery in topical formulationsPoor penetration of active ingredients int...

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“…[2][3][4][5]  We assessed the clinical characteristics, treatment patterns, and other physician and patient characteristics, adverse events, and resource utilizations in patients using Cal/BD foam to treat plaque psoriasis.…”

Section: Disclosuresmentioning

confidence: 99%

Real World Experience with Calicpotriene and Betamethasone Dipropionate Foam 0.005%/0.064% (Cal/BD Foam) in the Treatment of Adult Psoriasis Itch from Retrospective Chart Review

Wu¹,

Veverka²,

Lu³

et al. 2018

J of Skin

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Calcipotriol plus betamethasone dipropionate aerosol foam provides superior efficacy vs. gel in patients with psoriasis vulgaris: randomized, controlled PSO‐ABLE study

Cited by 102 publications

References 28 publications

Patients with psoriasis have different preferences for topical therapy, highlighting the importance of individualized treatment approaches: randomized phase IIIb PSO‐INSIGHTFUL study

Patients with psoriasis have different preferences for topical therapy, highlighting the importance of individualized treatment approaches: randomized phase IIIb PSO‐INSIGHTFUL study

Innovation in Topical Therapy for Psoriasis with Corticostereoid and Vitamin D Analogue Commbination

Real World Experience with Calicpotriene and Betamethasone Dipropionate Foam 0.005%/0.064% (Cal/BD Foam) in the Treatment of Adult Psoriasis Itch from Retrospective Chart Review

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