Betamethasone Dipropionate Foam Research Articles

Matching-adjusted Indirect Comparison of Dermatology Life Quality Index 0/1 Response in Trials of Calcipotriol Plus Betamethasone Dipropionate Foam and Cream Formulations in Patients with Psoriasis.

Abstract is missing (Short communication)

Proaktív stratégia a psoriasis helyi kezelésében – szakértői állásfoglalás

Psoriasis is a chronic, relapsing disease. Topical treatment with local corticosteroids plays a significant role in the management of psoriasis. In the current medical practice, the so called reactive treatment approach, which treats active symptoms is used. However, using this method, the relapse of the symptoms is inevitable. Relapses may affect unfavourably the quality of life of the patients, therefore reducing the frequency of the relapses is an important therapeutic target. A proactive treatment approach means that previously symptomatic areas of the skin are treated at specific times to maintain remission. Clinical studies with a high level of evidence using a fixed combination of calcipotriol and betamethasone dipropionate foam have shown that proactive treatment administered two times weekly can prolong the time until the first relapse. Furthermore, this treatment method may reduce the frequency of the relapses and may increase the number of days spent in remission without any major side effects.

Matching-Adjusted Indirect Comparison of Long-Term Efficacy and Safety Outcomes for Calcipotriol Plus Betamethasone Dipropionate Foam Versus Halobetasol Proprionate Plus Tazarotene Lotion in the Treatment of Plaque Psoriasis.

IntroductionTo date, there have been no head-to-head clinical studies comparing calcipotriol 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) aerosol foam and halobetasol propionate 0.01% plus tazarotene 0.045% (HP/Taz) lotion for the treatment of plaque psoriasis. However, the efficacy of 4 weeks of Cal/BD foam and 8 weeks of HP/Taz lotion has been compared using a matching-adjusted indirect comparison (MAIC) approach. Here, we compare the efficacy and safety of Cal/BD foam and HP/Taz lotion for up to 52 weeks.MethodsAn unanchored MAIC was conducted using individual patient data from the PSO-LONG Cal/BD foam trial and a 52-week, open-label phase 3 study of HP/Taz lotion (NCT02462083). Key outcomes of interest were Physician’s Global Assessment (PGA) success (PGA 0/1 with ≥ 2-point improvement) after 4 or 8 weeks of open-label therapy; the proportion of patients who had body surface area affected (BSA) ≤ 3 after open-label therapy who maintained BSA ≤ 3 to week 52; and adverse events (AEs).ResultsAfter matching, patients were statistically significantly more likely to have PGA success after 4 weeks of Cal/BD foam than after 8 weeks of HP/Taz lotion (84.5% versus 54.4%; p < 0.01). At week 52, 92.5% and 92.4% of patients receiving proactive and reactive Cal/BD foam, respectively, maintained BSA ≤ 3, compared with 49.3% of those treated with HP/Taz lotion (both p < 0.01). Treatment-related AEs, AEs leading to withdrawal, and AEs associated with drug application (dermatitis, application site pain, and pruritus) were significantly rarer with Cal/BD foam than with HP/Taz lotion (all p < 0.01).ConclusionsCal/BD aerosol foam demonstrated significantly greater efficacy than HP/Taz lotion, and had a more favorable safety profile, compared with HP/Taz lotion, for up to 52 weeks. Proactive Cal/BD foam maintenance therapy and reactive use of Cal/BD foam following relapse both had significant advantages over HP/Taz lotion.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13555-022-00824-9.

Matching-adjusted indirect comparison of efficacy outcomes in trials of calcipotriol plus betamethasone dipropionate foam and cream formulations for the treatment of plaque psoriasis

Background and objectives Once-daily, fixed-combination calcipotriol 50 μg/g (Cal) plus betamethasone dipropionate 0.5 mg/g (BD) is available in aerosol foam and cream formulations. As no head-to-head data are available, we use a matching-adjusted indirect comparison (MAIC) approach to compare Cal/BD foam and cream. Methods Anchored and unanchored MAIC analyses were conducted using individual patient data (IPD) from five Cal/BD foam trials and two trials of Cal/BD cream. Outcomes of interest were the proportion of patients with Physician's Global Assessment (PGA) success and the mean reduction in modified Psoriasis Area and Severity Index (mPASI). Results In the anchored MAIC, patients were more likely to achieve PGA success after 4 weeks of Cal/BD foam than after 8 weeks of Cal/BD cream and had larger mean improvements in mPASI (p < .01 in EU mPASI analysis). In unanchored analyses, 4 weeks of Cal/BD foam treatment was statistically significantly more efficacious in inducing PGA success than 8 weeks of Cal/BD cream (p < .01 in five of six comparisons). Mean reductions in mPASI were consistently statistically significantly greater with Cal/BD foam than with Cal/BD cream. Conclusions Use of Cal/BD foam consistently shows significantly greater improvements in PGA and mPASI outcomes, compared with Cal/BD cream.

Long-term proactive management of psoriasis with calcipotriol and betamethasone dipropionate foam: an Italian consensus through a combined nominal group technique and Delphi approach.

Although long-term management of psoriasis is paramount, this approach is challenging in clinical practice. In the recent PSO-LONG trial, a fixed-dose combination of betamethasone dipropionate (BD) and calcipotriol (Cal) foam applied twice a week on non-consecutive days for 52 weeks (proactive treatment) reduced the risk of relapse. However, the role of Cal/BD foam in the long-term management of psoriasis needs further clarifications. The ProActive Management (PAM) program, a nationwide Italian project, aims at reaching a consensus on the role of proactive management of psoriasis. A steering committee generated some statements through the nominal group technique (NGT). The statements were voted by an expert panel in an adapted Delphi voting process. Eighteen statements were proposed, and the majority of them (14/18) reached a consensus during the Delphi voting. The need to provide long-term proactive topical treatment to reduce the risk of relapse for the treatment of challenging diseases sites or in patients where phototherapy or systemic therapies are contraindicated/ineffective was widely recognized. A consensus was reached about the possibility to associate the proactive treatment with systemic and biological therapies, without the need for dose intensification, thus favoring a prolonged remission. Moreover, the proactive treatment was recognized as more effective than weekend therapy in increasing time free from relapses. Approaches to improve adherence, on the other hand, need further investigation. The inclusion in guidelines of a proactive strategy among the effective treatment options will be a fundamental step in the evolution of a mild-moderate psoriasis therapeutic approach.

Efficacy of calcipotriol plus betamethasone dipropionate foam on psoriatic skin lesions beyond human eyes: An observational study.

Background and AimsCalcipotriol plus betamethasone dipropionate foam has been developed as a new topical therapeutic option for psoriasis, whose effect has been documented mainly on clinical basis.MethodsWe decided to evaluate its efficacy on 11 patients, not only at the clinical level (by using Psoriasis Area Severity Index [PASI], Dermatology Life Quality Index [DLQI], and Psoriasis Global Assessment [PGA] clinimetric indexes) but especially from a subclinical viewpoint (by using videocapillaroscopy and thermography).ResultsAfter 4 weeks of treatment with calcipotriol plus betamethasone dipropionate foam, there was a marked reduction in all three clinimetric indixes PASI, PGA, and DLQI (DLQI mean value decreased from 13.45 ± 3.59 to 6.82 ± 3.31 (p = 0.001), PASI from 7.909 ± 2.857 to 4.582 ± 2.422 (p = 0.001), PGA from 1.8 ± 0.6 to 0.7 ± 0.4 (p = 0.002). From thermographic survey, a significant reduction of mean value of ΔT (temperature difference [°C] between center of the lesions and their periphery [healthy skin]), from 0.28 ± 0.99 to −0.42 ± 0.39 (p = 0.058), was observed. An exceptional reduction of capillaries of psoriatic plaques was detected through videocapillaroscopy (capillary density decreased from 27.91 ± 6.70 capillaries/mm2 to 4.54 ± 2.77 capillaries/mm2 (p = 0.001), with an 83.73% reduction).ConclusionOur results demonstrate both clinical and subclinical efficacy of calcipotriol plus betamethasone dipropionate foam on psoriatic skin lesions. The subclinical improvement detected, not only demonstrates that the therapeutic effect of foam is truly due to a decrease in inflammation, but, being earlier and more effectively detectable than clinical benefit, suggests future applications of thermography and videocapillaroscopy in evaluating the in vivo effect of therapies for psoriasis, and, in general, the course of the disease “beyond human eyes.”

Beyond-Mild Psoriasis: A Consensus Statement on Calcipotriol and Betamethasone Dipropionate Foam for the Topical Treatment of Adult Patients

IntroductionThere are clear treatment options for mild psoriasis where topical therapies are the mainstay, and for severe psoriasis where systemic therapy (biologic or non-biologic) is necessary. However, there is less clarity in the ‘grey zone’ of patients in the moderate or so-called ‘beyond-mild’ segment. There are frequent delays to the initiation, discontinuation, switching and dose change in treatment, and many patients fail to continue treatment because of concerns about safety or lack of efficacy. Treatment with topical therapies, such as calcipotriol and betamethasone dipropionate (Cal/BD) combinations, may be suitable for these patients.MethodThese consensus recommendations on the use of topical therapies including Cal/BD foam for beyond-mild psoriasis originated from a modified Delphi process of European clinical experts. In the process, the experts iteratively refined a series of draft statements, which had to receive ≥ 80% approval to be incorporated into the consensus.ResultsThe experts identified three main themes: Cal/BD foam as monotherapy, as an add-on to non-biologic systemic therapies and as an add-on to systemic biologics. The consensus emphasises disease factors and patient preference in treatment choice, summarises the evidence base for Cal/BD foam monotherapy for flare treatment as well as long-term management, and identifies the potential for improved treatment outcomes, such as reduced time to onset of action and reduced systemic dose to minimise side effects for add-on Cal/BD therapy to non-biologic systemics. The recommendations regarding add-on Cal/BD foam to biologics are similar to those for non-biologic systemic therapies, but also include suggestions for patients on biologics who are late responders. As clinical choices of Cal/BD combination vary, we have here often used ‘Cal/BD’ without reference to any particular formulation.ConclusionsThese recommendations aim to give practical guidance to those treating patients with beyond-mild psoriasis, to support patients’ use of topical preparations and to optimise treatment outcomes.

Calcipotriene Plus Betamethasone Dipropionate Foam for Mild Psoriasis: Pooled Results from Three Randomized Trials.

Psoriasis vulgaris is not easy to manage, even when mild. Knowledge of the efficacy of most topical therapies in this population is limited. To assess the efficacy of calcipotriene 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) foam in patients with mild psoriasis. Post hoc analysis was performed on pooled data for subjects with mild psoriasis at baseline from 2 Phase 3 and 1 Phase 2 clinical trials. All subjects applied Cal/BD foam or vehicle foam once daily for at least 4 weeks. Efficacy assessments included treatment success (defined as IGA=0), mPASI, BSA, and the composite IGA&ensp;BSA score. Of the 848 subjects, 164 had mild psoriasis at baseline. Within this subpopulation of mild subjects, Cal/BD foam demonstrated significant efficacy over vehicle at week 4 in terms of the proportion of subjects achieving complete clearance of visible lesions (IGA=0). Significant improvements were also observed for mPASI, BSA, and IGA&ensp;BSA score. These post hoc analyses need to be confirmed with prospective studies. Once-daily Cal/BD foam for 4 weeks demonstrated effectiveness in treating subjects with mild psoriasis, a population in which demonstration of treatment success can be difficult, because of the requirement for complete clearance of visible disease. Clinicaltrials.gov: NCT02132936, NCT01866163, and NCT01536938 J Drugs Dermatol. 2021;20(8):822-828. doi:10.36849/JDD.5743.

Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Foam in Japanese Patients with Psoriasis Vulgaris : A Phase Ⅲ Study

Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Foam in Japanese Patients with Psoriasis Vulgaris : A Phase Ⅲ Study

17754 Treatment success in mild psoriasis patients with fixed-combination calcipotriene and betamethasone dipropionate foam: Results from the PSO-FAST trial

Background: Numerous topical and systemic therapies are available for the treatment of cutaneous psoriasis; very few have been demonstrated effective for mild psoriasis. We evaluated efficacy in a mild patient cohort with once-daily application of Cal/BD foam for 4 weeks in a post hoc analysis.

18223 Long-term proactive management of psoriasis vulgaris with fixed-dose combination of 0.005% calcipotriene and 0.064% betamethasone dipropionate foam: Results of a phase III randomized controlled trial

Patients received once-daily Cal/BD during the four-week open-label phase (NCT02899962). Patients achieving success (physician’s global assessment of disease severity [PGA] score ‘clear’/‘almost clear’ with ≥2-grade improvement from baseline) were randomized 1:1 in a double-blind fashion to twice-weekly Cal/BD or vehicle for 52 weeks. Eligibility criteria: ≥18 years; truncal and/or limb psoriasis, involving 2%-30% of body surface area; PGA ≥ ‘mild’ and modified psoriasis area and severity index score ≥2 at visit 1.

Treating Scalp Psoriasis With Fixed-dose Combination Calcipotriene/Betamethasone Dipropionate Cutaneous Foam: Review of Phase 2 Data

Two Phase 2 studies investigated the effect of a fixed-dose combination foam containing calcipotriene monohydrate (Cal) and betamethasone dipropionate (BD) on scalp psoriasis in adult and adolescent patients. Patients had psoriasis classified as at least ‘mild’ per PGA. NCT01536938 enrolled adult patients (≥18 years) randomized 1:1:1 to once-daily (QD) Cal/BD foam (Cal 0.005%, BD 0.064%), Cal foam (0.005%) or BD foam (0.064%). NCT02387853 enrolled adolescent patients (12– <17 years) to Cal/BD foam QD (dose as previously). Treatment success was based on improvement in PGA classification at week 4. Additional efficacy endpoints included mPASI in adults and effect on extent of scalp surface area (SSA) in adolescents. Safety was also assessed. Overall, 302 adults (n=100 Cal/BD foam; n=101 Cal foam; n=101 BD foam) and 106 adolescents received treatment. Treatment success in adults was significantly higher with Cal/BD vs Cal foam (53.0% vs 35.6%, P=0.021) and numerically higher than with BD foam (47.5%, P=0.45). Mean percentage changes in mPASI were –80.0%, –57.8% and –71.2%, for Cal/BD, Cal and BD foam, respectively. In adolescents, 73.6% of patients treated with Cal/BD foam achieved treatment success and mean SSA fell from 50.6% at baseline to 12.5% at week 4. All treatment-related AEs were considered mild-to-moderate across both studies, except one severe AE (hypersensitivity reaction with urticaria) in the adult Cal/BD foam group, which led to withdrawal from the study. In these studies, treatment of scalp psoriasis with Cal/BD foam provided good efficacy for adults and adolescents and was generally well tolerated. J Drugs Dermatol. 2020;19(8): doi:10.36849/JDD.2020.5168

Safety of calcipotriene and betamethasone dipropionate foam for the treatment of psoriasis

ABSTRACTIntroduction: Psoriasis vulgaris is a chronic inflammatory skin disease characterized by well-demarcated red and scaly plaques. Most patients have mild disease that is usually controlled with topical treatment. Calcipotriene 0.05% and betamethasone dipropionate 0.064% (Cal/BD) in aerosol foam (Enstilar®) is a novel formulation, which has shown promising results in terms of efficacy and safety.Areas covered: This review evaluates the safety profile of Cal/BD aerosol foam and also the key points regarding its efficacy. A literature search was performed in PubMed in November 2019 from the start of records. Additional references were searched and retrieved manually.Expert opnion: Cal/BD aerosol foam has proven its efficacy, safety, and tolerability in several clinical trials and real clinical practice. It has also demonstrated higher efficacy than the ointment and gel formulations of the fixed combination. It has a low incidence of adverse events; nasopharyngitis and site application pain were the most frequently reported. Moreover, it is devoid of changes in calcium homeostasis and hypothalamic-pituitary-adrenal axis. As a result of its unique formulation, it is easily spread, is rapidly absorbed, and has a rapid onset of action. These features upgrade patient’s satisfaction and they may increase adherence to topical therapy.

Effect of fixed combination calcipotriene plus betamethasone dipropionate foam on lesion quality in patients with plaque psoriasis: Data from the PSO-FAST study

Effect of fixed combination calcipotriene plus betamethasone dipropionate foam on lesion quality in patients with plaque psoriasis: Data from the PSO-FAST study

Real-world experience of calcipotriene and betamethasone dipropionate foam 0.005%/0.064% in the treatment of adults with psoriasis in the United States

Background: Clinical trials have established calcipotriene 0.005%/betamethasone dipropionate 0.064% (Cal/BD) foam as a well-tolerated and efficacious topical therapy for psoriasis.Methods: A chart review of 24 US healthcare providers gathered real-world information (clinical characteristics and outcomes, safety, and resource utilization) for patients (≥18 years old) prescribed Cal/BD foam between January 1 and October 31, 2016, along with healthcare provider characteristics and perceptions of Cal/BD foam.Results: Data were reported from 105 patients and 177 active psoriatic lesions. Cal/BD foam was applied once-daily; the prescription was 4 weeks for 69/177 (39%) lesions (median 4, range 1–26 weeks). Knees (n = 41; 23%) and elbows (n = 37; 20%) were the most frequently treated areas. Among 114 lesions, severity improved from “mild”/“moderate”/“severe” to “clear”/“almost clear” in 71%, and 54% had a clinically significant improvement (two-step/greater improvement) in lesion severity from baseline. Of 128 lesions with baseline itch, 90% were not itchy at the best treatment response. Most healthcare providers reported prescribing Cal/BD foam because of its overall efficacy (n = 20/23; 87%). Adverse events were reported in 1/105 patients (1%).Conclusion: Data from real clinical practice demonstrate that Cal/BD foam improves psoriasis disease severity and associated itch in patients and further extend results of clinical trials.

Real-world efficacy and safety of calcipotriene and betamethasone dipropionate foam 0.005%/0.064% (Cal/BD foam) in the treatment of adult psoriasis in the United States

Real-world efficacy and safety of calcipotriene and betamethasone dipropionate foam 0.005%/0.064% (Cal/BD foam) in the treatment of adult psoriasis in the United States

PSS2 - Real World Experience with Calcipotriene and Betamethasone Dipropionate Foam 0.005%/0.064% (Cal/BD Foam) in the Treatment of Adult Psoriasis Including Psoriasis Itch from Retrospective Chart Review

Despite itch being a bothersome symptom in plaque psoriasis, real-world data on the impact of topical medications on itch is not widely reported. Cal/BD foam is a topical treatment for chronic adult plaque psoriasis with established efficacy and safety. We assessed the clinical characteristics, treatment patterns, and other physician and patient characteristics, and adverse events in patients using Cal/BD foam for plaque psoriasis. At 24 US clinical sites, a retrospective chart review was performed for patients ≥18 years of age with a diagnosis of psoriasis and who were initiating therapy with Cal/BD foam between 1/1/2016 and 10/31/2016. Patients had to have a baseline visit, at least three months of available data after treatment initiation, and no history of psoriatic arthritis. 105 patients were enrolled with mean psoriasis body surface area (body and scalp) at baseline of 5%. At baseline, 55.2% of patients complained of itch and itch affected the quality of life of 60.4% of the patients who experienced itch. Most patients were prescribed Cal/BD foam to use once-daily (n=124/177 treated plaques; 70.1%) for 4 weeks (n=69/177 treated plaques; 39.0%). Following treatment with Cal/BD foam, 70.6% of plaques classified as mild/moderate/severe at baseline were “clear” or “almost clear”. Of the plaques treated with Cal/BD foam with presence of itch recorded at baseline and time of best response, 50% of treated areas had itch at baseline and 50% did not. Following Cal/BD foam treatment, 90.1% of treated areas with itch at baseline did not have itch at time of best response. In clinical practice, adult patients treated with Cal/BD foam for up to 4 weeks realized significant improvements in treatment response with corresponding reductions of itch. Adverse events were rare and mild. These data extend results reported from clinical trials with Cal/BD foam.

Calcipotriol Plus Betamethasone Dipropionate Foam is Effective in Patients with Moderate-to-Severe Psoriasis: Post-Hoc Analysis of the PSO-ABLE Study

Abstract not available. Disclosures: Study sponsored by LEO Pharma. Copyright 2018 SKIN

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

Abstract not available. Disclosures: Study sponsored by LEO Pharma. Copyright 2018 SKIN

Budget impact model in moderate-to-severe psoriasis vulgaris assessing effects of calcipotriene and betamethasone dipropionate foam on per-patient standard of care costs

Aims: To develop a budget impact model (BIM) for estimating the financial impact of formulary adoption and uptake of calcipotriene and betamethasone dipropionate (C/BD) foam (0.005%/0.064%) on the costs of biologics for treating moderate-to-severe psoriasis vulgaris in a hypothetical US healthcare plan with 1 million members.Methods: This BIM incorporated epidemiologic data, market uptake assumptions, and drug utilization costs, simulating the treatment mix for patients who are candidates for biologics before (Scenario #1) and after (Scenario #2) the introduction of C/BD foam. Predicted outcomes were expressed in terms of the annual cost of treatment (COT) and the COT per member per month (PMPM).Results: At year 1, C/BD foam had the lowest per-patient cost ($9,913) necessary to achieve a Psoriasis Area and Severity Index (PASI)-75 response compared with etanercept ($73,773), adalimumab ($92,871), infliximab ($34,048), ustekinumab ($83,975), secukinumab ($113,858), apremilast ($47,960), and ixekizumab ($62,707). Following addition of C/BD foam to the formulary, the annual COT for moderate-to-severe psoriasis would decrease by $36,112,572 (17.91%, from $201,621,219 to $165,508,647). The COT PMPM is expected to decrease by $3.00 (17.86%, from $16.80 to $13.80).Limitations: Drug costs were based on Medi-Span reference pricing (January 21, 2016); differences in treatment costs for drug administration, laboratory monitoring, or adverse events were not accounted for. Potentially confounding were the definition of “moderate-to-severe” and the heterogeneous efficacy data. The per-patient cost for PASI-75 response at year 1 was estimated from short-term efficacy data for C/BD foam and apremilast only.Conclusions: The introduction of C/BD foam is expected to decrease the annual COT for moderate-to-severe psoriasis treatable with biologics by $36,112,572 for a hypothetical US healthcare plan with 1 million plan members, and to lower the COT PMPM by $3.00.