Efficacy and safety of a new combination of calcipotriol and betamethasone dipropionate (once or twice daily) compared to calcipotriol (twice daily) in the treatment of psoriasis vulgaris: a randomized, double-blind, vehicle-controlled clinical trial

Guenther, Lyn; Cambazard, F.; Kerkhof, P.C.M. van de; Snellman, Erna; Kragballe, Knud; Chu, A.C.; Tegner, E; García‐Diez, Amaro; Springborg, Jacob Bertram

doi:10.1046/j.1365-2133.2002.04967.x

Cited by 159 publications

(186 citation statements)

References 26 publications

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“…The safety profile of Cal/BD aerosol foam was similar to previous studies23, 24, 25 and was consistent with the fixed combination gel and ointment formulations 27, 28, 29. The rates of AEs and ADRs with Cal/BD aerosol foam in PSO‐ABLE cannot be compared to previous studies due to the longer observation period (12 vs. 4 weeks).…”

Section: Discussionsupporting

confidence: 83%

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

Paul

Gold

Cambazard

et al. 2016

Acad Dermatol Venereol

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167

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BackgroundFixed combination calcipotriol 50 μg/g (Cal) plus betamethasone 0.5 mg/g (BD) foam has been developed as a new treatment option for patients with psoriasis.MethodsThe randomized, parallel‐group, investigator‐blinded Phase III, 12‐week PSO‐ABLE study compared the efficacy and safety of Cal/BD foam with Cal/BD gel. Patients aged ≥18 years with mild‐to‐severe psoriasis were randomized 4:4:1:1 to once‐daily Cal/BD foam, Cal/BD gel, foam vehicle or gel vehicle (NCT02132936). The primary efficacy endpoint was the proportion of patients who were clear/almost clear with a ≥ 2 grade improvement according to the physician's global assessment of disease severity (i.e. treatment success) at week 4 for Cal/BD foam vs. week 8 for Cal/BD gel. Secondary efficacy endpoints included: proportion of patients achieving at least a 75% reduction in modified psoriasis area and severity index (mPASI75), and time to treatment success (TTTS). Safety was monitored throughout.ResultsA total of 463 patients were randomized: Cal/BD foam (n = 185), Cal/BD gel (n = 188), foam vehicle (n = 47), gel vehicle (n = 43); overall completion rate was 90%. Cal/BD foam achieved higher treatment success rates (38% vs. 22%; P < 0.001) and mPASI75 (52% vs. 35%; P < 0.001) by week 4 than Cal/BD gel by week 8. Median TTTS with Cal/BD foam was 6 weeks; this could not be determined for Cal/BD gel as 50% treatment success was not achieved (P < 0.001). Adverse drug reactions were reported in 14 (7.6%) Cal/BD aerosol foam patients and 7 (3.7%) Cal/BD gel patients; all were single events except for itch with Cal/BD aerosol foam (n = 5; 2.7%) and worsening psoriasis with Cal/BD gel (n = 3; 1.6%).ConclusionCal/BD aerosol foam showed significantly greater efficacy after 4 weeks, than 8 weeks of treatment with Cal/BD gel, with similar tolerability.

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Section: Discussionsupporting

confidence: 83%

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

Paul

Gold

Cambazard

et al. 2016

Acad Dermatol Venereol

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167

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“…Costs of topical therapies are based on reported mean quantities used in clinical trials 12,[15][16][17][18][19][20][21] converted into packs of medication available for clinical practice. Unit costs were taken from the British National Formulary.…”

Section: Topical Therapymentioning

confidence: 99%

Topical therapies for the treatment of localized plaque psoriasis in primary care: a cost-effectiveness analysis

Sawyer¹,

Samarasekera

Wonderling

et al. 2013

Br J Dermatol

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SummaryBackground Topical therapies are a mainstay of psoriasis treatment, but they vary substantially in terms of cost. Objectives To determine the cost-effectiveness and optimal treatment sequence for psoriasis of the trunk, limbs and scalp. Methods Probabilities of response from a network meta-analysis were used to determine the short-term efficacy of topical therapies. Longer-term outcomes, including relapse, were informed by published evidence and clinical opinion. Benefits of treatment were measured as quality-adjusted life years (QALYs). Direct costs included topical agents, primary and secondary care visits and second-line therapies for treatment failures. Results For the trunk and limbs, initial treatment with a two-compound formulation (TCF) product containing vitamin D and potent corticosteroid provided the most QALYs, followed by separate morning and evening application of vitamin D and potent corticosteroid [two-compound application, TCA (am/pm)], and then twice-daily potent corticosteroids. The use of twice-daily potent corticosteroids was the most cost-effective first-line strategy (incremental cost-effectiveness ratio £20 000 per QALY), followed by TCA (am/pm) (£22 658 per QALY) and TCF product (£179 439 per QALY). For scalp psoriasis, initial treatment with very potent corticosteroids generated the most QALYs, followed by TCF product and then potent corticosteroids. Very potent corticosteroids were the most costeffective treatment but, if too aggressive, potent corticosteroids were optimal followed by TCF product (£219 846 per QALY). The cost-effectiveness of second-and third-line topical agents varied with the assumptions made. Conclusions Potent corticosteroids, used alone or in combination with vitamin D, are the most cost-effective treatment for patients with psoriasis of the trunk and limbs. Potent or very potent corticosteroids are the most cost-effective treatment for patients with scalp psoriasis.

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“…[10][11][12][13][14][15] The two-compound ointment appears to have an improved tolerability profile vs. either compound alone; this may be due to the vitamin D analogue and steroid components each neutralizing the side-effects of the other agent (e.g. atrophy and tachyphylaxis ⁄ rebound effect may be reduced by the presence of the vitamin D analogue, and irritation may be reduced by the presence of the steroid).…”

Section: Combination Therapy Provides Enhanced Efficacymentioning

confidence: 99%

What is new in topical therapy for psoriasis?

Reich

Bewley

2011

Acad Dermatol Venereol

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This article describes a recent development in topical therapies for psoriasis and is based on a presentation given by the authors at a satellite symposium convened during the 19th Congress of the European Academy of Dermatology and Venereology, 6-10 October 2010, in Gothenburg, Sweden. Topical therapies are the mainstay of treatment for psoriasis; however, for optimal outcomes to be achieved, medications need to be used as prescribed. Patients with psoriasis often report low treatment adherence rates; the reasons for this are multifactorial, but can include specific aspects of the treatments themselves. For example, physical properties, ease of use and the vehicle in which the active ingredients are dissolved can all play a role in an individual patient's adherence to treatment. Of the available topical therapies, corticosteroids and vitamin D analogues are the treatment of choice, with combined efficacy that is superior to monotherapy with either agent. To permit simultaneous once-daily dosing, an ointment was formulated that allowed calcipotriol and betamethasone dipropionate to be delivered together; this twocompound ointment had an improved efficacy and tolerability profile vs. either compound alone. To provide an alternative for patients who may dislike ointments, but still want to benefit from the high efficacy of combination therapy, a two-compound (calcipotriol ⁄ betamethasone dipropionate) gel has recently been developed; data from phase 2 and phase 3 studies show that it is more effective than the comparators it was tested against, with fewer adverse events, and a rapid onset of action. In a series of one-to-one interviews recently conducted with 150 patients with psoriasis, gel and cream formulations were preferred for ease of use and cosmetic acceptability compared with ointment. The availability of this new gel thus increases patient choice. Ultimately, treatment should always be tailored to match individual patients' needs.

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Efficacy and safety of a new combination of calcipotriol and betamethasone dipropionate (once or twice daily) compared to calcipotriol (twice daily) in the treatment of psoriasis vulgaris: a randomized, double-blind, vehicle-controlled clinical trial

Abstract: No statistically significant nor clinically relevant difference in efficacy was seen between the combined formulation used once daily and twice daily. When compared to vehicle ointment or calcipotriol ointment alone, the combined formulation was shown to be clearly more efficacious.

Cited by 159 publications

References 26 publications

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

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

Topical therapies for the treatment of localized plaque psoriasis in primary care: a cost-effectiveness analysis

What is new in topical therapy for psoriasis?

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