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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, Multicenter, Three-arm, Phase 2 Study.

ABSTRACT: OBJECTIVE:To evaluate the efficacy of fixed combination aerosol foam calcipotriene 0.005% (Cal) plus betamethasone dipropionate 0.064% (BD). DESIGN:Patients were randomized (100:101:101) to receive Cal/BD foam, Cal foam, or BD foam once daily for four weeks. SETTING:Twenty-eight United States centers. PARTICIPANTS:302 patients (?18 years) with Psoriasis vulgaris (plaque Psoriasis; ?mild disease severity by physicians global assessment). MEASUREMENTS:Treatment success of the body ("clear"/"almost clear" from baseline moderate/severe disease; "clear" from baseline mild disease). Involved scalp treatment success was an additional endpoint. RESULTS:Most patients (76%) had moderate Psoriasis of the body (66% for scalp). At Week 4, 45 percent of Cal/BD foam patients achieved treatment success, significantly more than Cal foam (14.9%; OR 4.34 [95%CI 2.16,8.72] P<0.001) or BD foam (30.7%; 1.81 [1.00,3.26] P=0.047). Fifty-three percent of Cal/BD foam patients achieved treatment success of the scalp, significantly greater than Cal foam (35.6%; 1.91 [1.09,3.35] P=0.021), but not BD foam (47.5%; 1.24 [0.71,2.16] P=0.45). Mean modified Psoriasis area and severity index (population baseline 7.6) improved in all groups, with statistically significant differences in Week 4 Cal/BD foam score (2.37) versus Cal foam (4.39; mean difference -2.03 [-2.63][-1.43] P<0.001) and BD foam (3.37; -1.19 [-1.80][-0.59] P<0.001). Four (Cal/BD), 10 (Cal), and 8 (BD) adverse drug reactions were reported. CONCLUSION:Cal/BD foam was significantly more effective than Cal foam and BD foam in providing treatment success at Week 4 and effective on involved scalp. TRIAL REGISTRATION:NCT01536938.

SUBMITTER: Lebwohl M

PROVIDER: S-EPMC4771388 | biostudies-literature | 2016 Feb

REPOSITORIES: biostudies-literature

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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, Multicenter, Three-arm, Phase 2 Study.

Lebwohl Mark M Tyring Stephen S Bukhalo Michael M Alonso-Llamazares Javier J Olesen Martin M Lowson David D Yamauchi Paul P

The Journal of clinical and aesthetic dermatology 20160201 2

<h4>Objective</h4>To evaluate the efficacy of fixed combination aerosol foam calcipotriene 0.005% (Cal) plus betamethasone dipropionate 0.064% (BD).<h4>Design</h4>Patients were randomized (100:101:101) to receive Cal/BD foam, Cal foam, or BD foam once daily for four weeks.<h4>Setting</h4>Twenty-eight United States centers.<h4>Participants</h4>302 patients (≥18 years) with Psoriasis vulgaris (plaque Psoriasis; ≥mild disease severity by physicians global assessment).<h4>Measurements</h4>Treatment ...[more]

PMID: 27313822

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Project description:Treatment non-adherence is a complex problem encountered in all therapy areas, particularly in chronic diseases such as psoriasis vulgaris. To address adherence issues, focus is turning towards developing interventions tailored to individual patient needs. Topical therapies remain the mainstay of psoriasis treatment; however, these are associated with additional challenges where preparations may be perceived as messy, inconvenient and time-consuming. Once-daily fixed-combination calcipotriene 0.005% (Cal) and betamethasone dipropionate 0.064% (BD) topical suspension is a convenient and effective first-line topical psoriasis therapy. To improve the patient experience with this treatment, we undertook a program-in collaboration with patients and healthcare professionals-to develop a topical treatment delivery system that further caters to the unmet needs of psoriasis patients. The finalized Applicator comprises: an easy to operate pump-action lever providing consistently accurate dose delivery (0.05 g of Cal/BD topical suspension/pump); a single-tip nozzle allowing for targeted, precise application to body and scalp psoriasis plaques; two spreading surfaces designed to disperse treatment evenly across both large and small affected skin areas; and a protective cover. Patients listed the following as key Applicator attributes: ease of use, 'less messy' treatment, precise application, consistent accurate dosing, 'no touch' treatment, reduction of wasted treatment and extended length of reach for awkward areas. Although these attributes were well received by most patients and healthcare professionals, some patients did not perceive them all as improvements over their current treatment; this highlights the need to tailor treatment for each individual patient's requirements. For patients who prefer using the Applicator, it has the potential to provide greater control over their daily psoriasis management by providing a simple, convenient treatment option, with minimal impact on their lives. The Applicator may represent a more acceptable treatment delivery system for some patients with psoriasis vulgaris and may, therefore, promote long-term treatment adherence.FundingLEO Pharma.

Project description:IntroductionThe phase 3 PSO LONG study (NCT02899962) demonstrated superior efficacy of proactive (PM) versus reactive management (RM) using calcipotriene 0.005%/betamethasone dipropionate 0.064% (Cal/BD) foam in adults with psoriasis. Here, we evaluated whether certain baseline parameters had an effect on time to first relapse (TTFR), number of relapses, and assessed interactions between treatment effect.MethodsPSO LONG included an initial 4-week open-label phase (once-daily Cal/BD foam) and a 52-week maintenance phase where patients were randomized to twice-weekly Cal/BD (PM) or vehicle foam (RM), with a 4-week once-daily Cal/BD foam rescue treatment for relapse. Baseline parameters analyzed using a stepwise variable selection procedure included body surface area, modified Psoriasis Area Severity Index (mPASI), Physician Global Assessment (PGA), body mass index, age, sex, Dermatology Life Quality Index, and duration of psoriasis. Continuous variables were divided into groups based on standard criteria.ResultsOverall, the effect of treatment on TTFR did not vary across any baseline parameters. Variables with a statistically significant effect on TTFR were: treatment group (PM vs. RM hazard ratio [HR]: 0.56; p < 0.001); PGA (moderate vs. mild HR: 1.42; severe vs. mild HR: 2.32; overall p = 0.009); mPASI (moderate vs. mild HR: 1.19; severe vs. mild HR: 1.77; overall p = 0.009); and sex (women vs. men HR: 1.26; p = 0.030). Variables with a significant effect on the number of relapses were: treatment group (PM vs. RM, rate ratio [RR] 0.52; p < 0.001); PGA at baseline (moderate vs. mild, RR 1.38; severe vs. mild, RR 2.22; overall p < 0.001); and mPASI (moderate vs. mild, RR 1.25; severe vs. mild, HR 1.70; overall p = 0.002).ConclusionAll patients benefitted from long-term PM versus RM with Cal/BD foam regardless of baseline characteristics, and the benefit of treatment increased with greater disease severity.Trial registrationClinicalTrials.gov identifier, NCT02899962.

Project description:IntroductionGood treatment adherence is important in the effective management of psoriasis and is related to both the frequency of applications and the amount of product used versus the recommended dose. The efficacy and safety of fixed combination calcipotriol 50 µg/g (Cal) and betamethasone 0.5 mg/g as dipropionate (BD) in the treatment of psoriasis is well established; an aerosol foam formulation has been developed to enhance adherence. This subanalysis from the Phase III PSO-FAST study evaluates the amount of Cal/BD foam used during treatment and the association between the extent and severity of baseline disease.MethodsPatients (≥18 years) with mild-to-severe body psoriasis were randomized 3:1 to once-daily Cal/BD foam or vehicle. The amount of Cal/BD foam and vehicle used over the 4-week study period was evaluated according to three baseline disease assessments: extent of body surface area (BSA) affected by psoriasis, physician's global assessment of disease severity (PGA) and modified psoriasis area and severity index (mPASI). Treatment success and mPASI75 rates were assessed according to body mass index (BMI) and body weight.Results323 patients were randomized to Cal/BD foam and 103 to vehicle. At week 4, the mean total amount of Cal/BD foam used was 120.8 g (n = 293), which was similar to the amount of vehicle used (128.9 g; n = 98). The total amount of Cal/BD foam used at week 4 was greater with increasing BSA and increasing severity of baseline PGA and mPASI. Throughout the study, 93.1% of patients in the Cal/BD foam group and 99.0% of patients in the vehicle group missed ≤10% of treatment applications. Treatment success and mPASI75 rates were generally similar when stratified according to BMI and body weight.ConclusionsThis subanalysis demonstrates that Cal/BD aerosol foam is used appropriately and is effective for the treatment of psoriasis, independent of BMI and the extent or severity of disease.Clinical trials numberNCT01866163.FundingLEO Pharma A/S.

Project description:An aerosol foam formulation of fixed combination calcipotriol 50 ?g/g (Cal) and betamethasone 0.5 mg/g (as dipropionate; BD) has been developed for psoriasis vulgaris treatment.To compare Cal/BD aerosol foam pharmacodynamic activity with Cal/BD ointment and with other topical corticosteroids of different potencies by assessing vasoconstrictor potential.A Phase I, single-centre, investigator-blinded, vehicle-controlled, intra-individual comparison vasoconstriction study. Healthy volunteers received a single application on selected sites of: Cal/BD aerosol foam, clobetasol propionate 0.5 mg/g cream (CP; very potent), Cal/BD ointment (potent), fluocinolone acetonide 0.25 mg/g ointment (FA; moderately potent), BD aerosol foam and aerosol foam vehicle. A seventh untreated site acted as a negative control. Skin blanching was assessed by visual (primary response criterion) and colorimetric a* and L* measurements (secondary criteria), and was analysed over time (6-32 h post-application).Thirty-five healthy volunteers were included. All active treatments led to significantly greater skin blanching than control. By visual assessment, skin blanching with Cal/BD aerosol foam was significantly less compared with CP cream [mean AUC0-32 2560 vs. 3831; mean difference = -1272; 95% confidence interval (CI): -1598, -945; P < 0.001], similar to BD aerosol foam (mean AUC0-32 2560 vs. 2595; mean difference = -35; 95% CI: -362, 292; P = 0.83) and significantly greater than Cal/BD ointment (mean AUC0-32 2560 vs. 2008; mean difference = 552; 95% CI: 225, 878; P = 0.001) and FA ointment (mean AUC0-32 2560 vs. 1981; mean difference = 578; 95% CI: 251, 905; P < 0.001). Colorimetric assessments a* and L* also indicated significantly reduced skin blanching with Cal/BD aerosol foam compared with CP cream. No adverse events (AEs) were reported.Cal/BD aerosol foam can be considered a more potent formulation than Cal/BD ointment and the moderately potent FA ointment, but less potent than the very potent corticosteroid, CP cream.

Project description:BackgroundPlaque psoriasis has significant impact on patients' quality of life. Topical therapy is considered the treatment mainstay for mild-to-moderate disease according to guidelines. Calcipotriol/betamethasone dipropionate (Cal/BD) [0.005%/0.05%] aerosol foam is indicated for psoriasis vulgaris treatment in adults. Cal/BD foam trials demonstrated improved efficacy and similar safety in this population. Psoriasis treatment is complicated by the broad range of disease presentation, variability and therapeutic options; particularly decisions on transition from topical to non-biologic systemic treatment are difficult. Assessing comparative effectiveness of treatment options provides meaningful value to treatment decisions.ObjectiveTo compare efficacy of Cal/BD foam individual patient data from pooled trials with efficacy of non-biologic systemic treatments based on aggregated patient characteristics and treatment outcomes.MethodsIndividual data from four Cal/BD foam trials in 749 psoriasis patients were pooled to conduct matching-adjusted indirect comparisons. Literature review identified non-biologic systemic treatment trials where methods, populations and outcomes align with Cal/BD foam trials. Of 3090 screened publications, four studies of apremilast, methotrexate, acitretin or fumaric acid esters (FAE) were included.ResultsAfter baseline matching, patients treated with 4 weeks of Cal/BD foam had greater Physician's Global Assessment 0/1 response compared to those treated with 16 weeks of apremilast (52.7% vs. 30.4%; P < 0.001). Patients treated with Cal/BD foam had significantly greater Psoriasis Area and Severity Index (PASI) 75 response at Week 4 compared to 16 weeks of apremilast treatment (51.1% vs. 21.6%; P < 0.001). Cal/BD foam patients demonstrated significantly greater PASI 75 response improvements at Week 4 vs. 12 weeks of methotrexate (50.8% vs. 33.5%; P < 0.001) or acitretin (50.9% vs. 31.7%; P = 0.009), and comparable response to FAE (42.4% vs. 47.0%; P = 0.451).ConclusionsDespite recent treatment advances, unmet needs for psoriasis patients remain. Cal/BD foam offers improved efficacy in baseline matched psoriasis patients compared to apremilast, methotrexate or acitretin, and comparable efficacy to FAE.

Dataset Information

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, Multicenter, Three-arm, Phase 2 Study.

Publications

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, Multicenter, Three-arm, Phase 2 Study.

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