Four-Week Daily Calcipotriene/Betamethasone Dipropionate Foam Is Highly Efficacious in Patients With Psoriasis (PSO-LONG Lead-in Phase)

Warren, Richard B.; Gold, M.; Gooderham, Melinda; Kircik, Leon; Lacour, Jean‐Philippe; Laws, Philip; Liljedahl, Monika; Lynde, Charles; Mørch, Marie Holst; Sondermann, Wiebke; Thaçi, Diamant

doi:10.36849/jdd.5728

Cited by 6 publications

(6 citation statements)

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“…PSO‐LONG trial design (as published in Warren et al . 2021) 53 . a Patients with treatment success at end of open‐label lead‐in phase [PGA score ‘clear’/‘almost clear’ (PGA <2) with ≥2‐grade improvement from baseline] were randomized 1:1 in the maintenance phase; b Following 4 weeks of once‐daily rescue treatment, patients who regained PGA<2 (‘clear’/‘almost clear’) re‐started the twice‐weekly maintenance treatment according to the original randomization scheme; c Patients who did not regain a PGA score <2 (‘clear’/‘almost clear’) following 4 weeks of once‐daily rescue treatment were withdrawn from the trial.…”

Section: Methodsmentioning

confidence: 99%

Impact of fixed‐dose combination Cal/BD foam on the work productivity of patients with psoriasis: results from the 52‐week randomized, double‐blind, PSO‐LONG trial

Guenther

Takhar²,

Megna

et al. 2022

Acad Dermatol Venereol

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Background Psoriasis contributes to unemployment, work impairment, missed workdays and substantial indirect costs due to lost productivity. Combination Cal/BD foam is the only topical that is approved for long-term maintenance treatment of plaque psoriasis for 52 weeks. This is the first known investigation of the effect of topical psoriasis therapy on productivity. Objective To examine the change in work productivity and activity impairment after 4 weeks of treatment with fixeddose combination calcipotriol 50 µg/g/betamethasone dipropionate 0.5 mg/g (Cal/BD) foam and observe long-term changes after 52 weeks of long-term management (proactive or reactive treatment).Methods This is a post-hoc analysis of the PSO-LONG triala phase 3, randomized, double-blind, vehicle-controlled, parallel group, international multi-centre trial of treatment with combination Cal/BD foam. Work and activity impairment due to psoriasis were assessed by the Dermatology Life Quality Index (DLQI) and the Work Productivity and Activity Impairment Psoriasis (WPAI:PSO) questionnaire at baseline, week 4, week 28 and week 56. The improvement in hours of work productivity was translated into monthly and annual indirect cost savings estimates for patients in Italy, Sweden, United Kingdom, Canada and Germany.Results Using fixed-dose combination Cal/BD foam for four weeks significantly reduced psoriasis-related work presenteeism, total work productivity impairment (TWPI) and total activity impairment (TAI) over 56 weeks, with significant improvements observed as early as 4 weeks after the baseline visit. The proportion of patients reporting impact on work productivity (as measured by presenteeism and TWPI) and activity impairment (as measured by both DLQI-Q7b and TAI) also decreased.Conclusion Fixed-dose combination Cal/BD foam used for long-term management of psoriasis significantly reduces psoriasis-related work productivity and activity impairment which may result in substantial indirect cost savings.

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Section: Methodsmentioning

confidence: 99%

Impact of fixed‐dose combination Cal/BD foam on the work productivity of patients with psoriasis: results from the 52‐week randomized, double‐blind, PSO‐LONG trial

Guenther

Takhar²,

Megna

et al. 2022

Acad Dermatol Venereol

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“…Recently, high doses of vitamin D were found to be efficient in eradication of psoriatic plaques [ 150 ]. In addition, the efficiency of co-treatment of psoriatic patients with vitamin D and glucocorticoids was recently supported by several clinical studies in combination with calcipotriol and betamethasone dipropionate [ 151 , 152 ]. There is ongoing debate about whether vitamin D levels also influence mood, behavior, learning, and other brain functions.…”

Section: Sunlight Deficiency Influences Psoriasis and Depressionmentioning

confidence: 99%

The Brain–Skin Axis in Psoriasis—Psychological, Psychiatric, Hormonal, and Dermatological Aspects

Marek-Józefowicz

Czajkowski

Borkowska

et al. 2022

IJMS

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Psoriasis is a chronic inflammatory skin disease with systemic manifestation, in which psychological factors play an important role. The etiology of psoriasis is complex and multifactorial, including genetic background and environmental factors such as emotional or physical stress. Psychological stress may also play a role in exacerbation of psoriasis, by dysregulation of the hypothalamic–pituitary–adrenal (HPA) axis, sympathetic–adrenal–medullary axis, peripheral nervous system, and immune system. Skin cells also express various neuropeptides and hormones in response to stress, including the fully functional analog of the HPA axis. The deterioration of psoriatic lesions is accompanied by increased production of inflammatory mediators, which could contribute to the imbalance of neurotransmitters and the development of symptoms of depression and anxiety. Therefore, deregulation of the crosstalk between endocrine, paracrine, and autocrine stress signaling pathways contributes to clinical manifestations of psoriasis, which requires multidisciplinary approaches.

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“…Corticosteroids are well known for their immunosuppressive effects in reducing T‐cell‐driven cutaneous inflammation, and vitamin D for its inhibition of hyperproliferation of keratinocytes in the skin of psoriasis patients 3 . Recent studies suggest that topical treatment of Betamethasone dipropionate with vitamin D analogue (Calcipotriol) had better clinical efficacy (improvement in PASI score, Psoriasis Area Severity Index) than Betamethasone or Calcipotriol alone and is associated with few side effects and better long‐term management of the disease 4–6 . When given in aerosol foam, combined treatment increases skin absorption, has a rapid onset of action, reduces number of relapses and improves patients quality of life (QoL) 7–9 …”

Section: Introductionmentioning

confidence: 99%

“…3 Recent studies suggest that topical treatment of Betamethasone dipropionate with vitamin D analogue (Calcipotriol) had better clinical efficacy (improvement in PASI score, Psoriasis Area Severity Index) than Betamethasone or Calcipotriol alone and is associated with few side effects and better long-term management of the disease. [4][5][6] When given in aerosol foam, combined treatment increases skin absorption, has a rapid onset of action, reduces number of relapses and improves patients quality of life (QoL). [7][8][9] The cellular mechanisms involved in the effectiveness of this approach are not fully understood.…”

Section: Introductionmentioning

confidence: 99%

Impact of topical emollient, steroids alone or combined with calcipotriol, on the immune infiltrate and clinical outcome in psoriasis

Heim

Irondelle

Cardot‐Leccia

et al. 2022

Experimental Dermatology

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Psoriasis is a chronic inflammatory disease whereby long‐term disease control remains a challenge for the patients. Latest evidence suggests that combined topical treatment with steroids and vitamin D analogue foam (Calcipotriol/Betamethasone) is efficient in long‐term management of the disease and reducing the number of relapses. Its effects on cellular inflammation and cytokine production remain to be explored. We set out to examine the effect of topical therapies on cellular infiltrate and cytokine profile in the lesional skin of psoriasis patients. This was a monocentric, double‐blind, randomized trial with 30 patients. Patients were treated with the combined Calcipotriol/Betamethasone foam, Betamethasone foam alone, Clobetasol Propionate ointment or placebo. 4 mm skin biopsies from lesional and non‐lesional sites were taken before and 4 weeks after treatment. Cellular infiltrate, IFNγ and IL‐17 were studied by immunofluorescence. Each patient was their own control. Evolution in skin inflammation was studied in parallel with changes in patient's epidermal thickness and their tPASI clinical score. Lesional skin was characterized by increased epidermal thickness, increased number of IL‐17 and IFNγ producing CD8+ T cells, NK cells and neutrophils. All treatment reduced epidermal thickness and improved patients tPASI scores. Only the combined Calcipotriol/Betamethasone foam completely abolished epidermal and dermal influx of CD8+ T cells, reduced number of CD8 + IFNγ+ cells (but not CD8 + IL‐17+ cells) and significantly reduced the number of MPO+ neutrophils which were predominantly IL‐17+. None of the treatments had effect on NK cells. We have shown the combined topical treatment with Calcipotriol/Betamethasone foam to be effective in reducing cellular influx into lesional skin of psoriasis patients and this effect to be superior to emollient or Betamethasone alone. Its previously described efficacy in the clinic may be attributed to its unique and rapid ability to inhibit both adaptive CD8+ T cell and innate immune neutrophilia influx into the skin, which was not observed for the other treatments.

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Four-Week Daily Calcipotriene/Betamethasone Dipropionate Foam Is Highly Efficacious in Patients With Psoriasis (PSO-LONG Lead-in Phase)

Cited by 6 publications

References 0 publications

Impact of fixed‐dose combination Cal/BD foam on the work productivity of patients with psoriasis: results from the 52‐week randomized, double‐blind, PSO‐LONG trial

Impact of fixed‐dose combination Cal/BD foam on the work productivity of patients with psoriasis: results from the 52‐week randomized, double‐blind, PSO‐LONG trial

The Brain–Skin Axis in Psoriasis—Psychological, Psychiatric, Hormonal, and Dermatological Aspects

Impact of topical emollient, steroids alone or combined with calcipotriol, on the immune infiltrate and clinical outcome in psoriasis

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