Fixed Combination Calcipotriene and Betamethasone Dipropionate (Cal/BD) Foam for Beyond-Mild Psoriasis: A Possible Alternative to Systemic Medication.

Calcipotriene 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) aerosol foam is a topical agent indicated for the treatment of plaque psoriasis. While topical treatments are typically reserved for milder disease, in clinical trials with Cal/BD foam, the vast majority of patients had beyond-mild psoriasis at baseline, and multiple studies (including subgroup analyses from randomized controlled trials and other small-scale studies) have demonstrated favorable outcomes with the use of Cal/BD foam in this population. The objective of this article is to review existing data on the efficacy, safety, and cost-effectiveness of Cal/BD foam used in patients with beyond-mild psoriasis, either alone as topical monotherapy or as adjunctive therapy. Practical recommendations for managing beyond-mild psoriasis with Cal/BD foam are also provided. J Drugs Dermatol. 2020;19(8): doi:10.36849/JDD.2020.5300.

Management of Residual Psoriasis in Patients on Biologic Treatment

While biologics are highly effective, most psoriasis patients do not achieve complete skin clearance with their biologic monotherapy. How to achieve complete skin clearance in psoriasis patients who fail their biologic is not well characterized. To describe treatment approaches in psoriasis patients who fail to achieve complete clearance from their biologic, we modeled and assessed the efficacy, cost, and safety of three treatment approaches­ adding a topical agent with their biologic, escalating the biologic dose, and switching to a different biologic. Efficacy of each approach was obtained from literature identifying complete clearance defined as 100% improvement in Psoriasis Area and Severity Index and/or Physician's Global Assessment score of clear. Cost of each treatment approach was calculated using medication wholesale acquisition cost obtained from Medi-Span Price Rx. Safety was assessed by adverse event (AE) rates. Complete clearance in patients not cleared on their initial biologic was achieved when adding calcipotriene/betamethasone dipropionate (Cal/BD) foam (28%), switching to guselkumab (20%), and switching to infliximab (15.8%). Adding Cal/BD foam to the initial biologic ($3,780 per additional patient cleared) was a less costly approach compared to the lowest cost dose escalation (guselkumab; $73,370 per additional patient cleared) or switching the initial failed biologic to the lowest cost alternative biologic (infliximab; $88,250 per additional patient cleared). There were no treatment-related or serious AEs when adding Cal/BD foam. Adding a topical agent may be an efficacious, low cost, and safe approach to achieve complete clearing in psoriasis patients who previously failed to clear on their biologic. J Drugs Dermatol. 2020;19(2)188-194. doi:10.36849/JDD.2020.3989

Effectiveness comparison and incremental cost-per-responder analysis of calcipotriene 0.005%/betamethasone dipropionate 0.064% foam vs. halobetasol 0.01%/tazarotene 0.045% lotion for plaque psoriasis: a matching-adjusted indirect comparative analysis.

Background: The fixed-dose combination foam formulation of calcipotriene 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) has demonstrated efficacy and a favorable safety profile for the treatment of plaque psoriasis. Recently, a topical lotion of the combination of halobetasol 0.01% plus tazarotene 0.045% (HP/TAZ) was approved for treating adult plaque psoriasis. Currently, no head-to-head studies have compared Cal/BD foam with HP/TAZ lotion.Objective: Compare the effectiveness and drug incremental cost per responder (ICPR) of Cal/BD foam vs. HP/TAZ lotion in moderate-to-severe plaque psoriasis.Methods: An anchor-based, matching-adjusted indirect comparison was conducted for PGA treatment success (Physician's Global Assessment of "clear" or "almost clear," [PGA 0/1] with at least a 2-point improvement) using individual patient data from 3 randomized clinical studies of Cal/BD foam and published data from 2 randomized, Phase 3 clinical studies of HP/TAZ lotion. The number needed to treat and ICPR were also calculated.Results: After reweighting of patients in the Cal/BD foam studies to match summary baseline characteristics of the HP/TAZ lotion study patients and anchoring to vehicle effect, 4 weeks of Cal/BD foam produced a significantly greater rate of treatment success than 8 weeks of HP/TAZ lotion treatment (51.4 vs. 30.7%; treatment difference = 20.7%, p < .001). The number needed to treat with Cal/BD foam was also less than HP/TAZ lotion (1.9 vs. 3.3). Using US wholesale acquisition costs and equal weekly consumption rates, the incremental cost per PGA 0/1 responder relative to vehicle for Cal/BD foam was $3,988 and was 37% lower compared with HP/TAZ lotion ($6,294).Conclusions: The indirect comparison analyses showed that Cal/BD foam was associated with a greater rate of treatment success, lower ICPR, and quicker treatment response than HP/TAZ lotion in adult patients with moderate-to-severe plaque psoriasis.

Antenatal corticosteroid administration in late-preterm gestations: a cost-effectiveness analysis.

Objective: To evaluate whether administration of antenatal late-preterm betamethasone is cost-effective in the immediate neonatal period.Study design: Cost-effectiveness analysis of late-preterm betamethasone administration with a time horizon of 7.5 days was conducted using a health-system perspective. Data for neonatal outcomes, including respiratory distress syndrome (RDS), transient tachypnea of the newborn (TTN), and hypoglycemia, were from the Antenatal Betamethasone for Women at Risk for Late-Preterm Delivery trial. Cost data were derived from the Healthcare Cost and Utilization Project from the Agency for Health Care Research and Quality, and utilities of neonatal outcomes were from the literature. Outcomes were total costs in 2017 United States dollars and quality-adjusted life years (QALYs) for each individual infant as well as for a theoretical cohort of the 270 000 late-preterm infants born in 2015 in the USA.Results: For an individual patient, compared to withholding betamethasone, administering betamethasone incurred a higher total cost ($6592 versus $6265) and marginally lower QALYs (0.02002 QALYS versus 0.02006 QALYs) within the studied time horizon. For the theoretical cohort of 270 000 patients, administration of betamethasone was $88 million more expensive ($1780 million versus $1692 million) with lower QALYs (5402 QALYs versus 5416 QALYs), compared to withholding betamethasone. For administration of betamethasone to be cost-effective, the rate of hypoglycemia, RDS, or TTN among late-preterm infants receiving betamethasone would need to be less than 20.0, 4.5, and 2.4%, respectively.Conclusion: Administration of betamethasone in the late-preterm period is likely not cost-effective in the short-term.

Cost-effectiveness of Antenatal Corticosteroid Therapy vs No Therapy in Women at Risk of Late Preterm Delivery: A Secondary Analysis of a Randomized Clinical Trial.

Importance: Administration of corticosteroids to women at high risk for delivery in the late preterm period (34-36 weeks' gestation) improves short-term neonatal outcomes. The cost implications of this intervention are not known. Objective: To compare the cost-effectiveness of treatment with antenatal corticosteroids with no treatment for women at risk for late preterm delivery. Design, Setting, and Participants: This secondary analysis of the Antenatal Late Preterm Steroids trial, a multicenter randomized clinical trial of antenatal corticosteroids vs placebo in women at risk for late preterm delivery conducted from October 30, 2010, to February 27, 2015. took a third-party payer perspective. Maternal costs were based on Medicaid rates and included those of betamethasone, as well as the outpatient visits or inpatient stay required to administer betamethasone. All direct medical costs for newborn care were included. For infants admitted to the neonatal intensive care unit, comprehensive daily costs were stratified by the acuity of respiratory illness. For infants admitted to the regular newborn nursery, nationally representative cost estimates from the literature were used. Effectiveness was measured as the proportion of infants without the primary outcome of the study: a composite of treatment in the first 72 hours of continuous positive airway pressure or high-flow nasal cannula for 2 hours or more, supplemental oxygen with a fraction of inspired oxygen of 30% or more for 4 hours or more, and extracorporeal membrane oxygenation or mechanical ventilation. This secondary analysis was initially started in June 2016 and revision of the analysis began in May 2017. Exposures: Betamethasone treatment. Main Outcomes and Measures: Incremental cost-effectiveness ratio. Results: Costs were determined for 1426 mother-infant pairs in the betamethasone group (mean [SD] maternal age, 28.6 [6.3] years; 827 [58.0%] white) and 1395 mother-infant pairs in the placebo group (mean [SD] maternal age, 27.9 [6.2] years; 794 [56.9%] white). Treatment with betamethasone was associated with a total mean (SD) woman-infant-pair cost of $4681 ($5798), which was significantly less than the mean (SD) amount of $5379 ($8422) for women and infants in the placebo group (difference, $698; 95% CI, $186-$1257; P = .02). The Antenatal Late Preterm Steroids trial determined that betamethasone use is effective: respiratory morbidity decreased by 2.9% (95% CI, -0.5% to -5.4%). Thus, the cost-effectiveness ratio was -$23 986 per case of respiratory morbidity averted. Inspection of the bootstrap replications confirmed that treatment was the dominant strategy in 5000 samples (98.8%). Sensitivity analyses showed that these results held under most assumptions. Conclusions and Relevance: The findings suggest that antenatal betamethasone treatment is associated with a statistically significant decrease in health care costs and with improved outcomes; thus, this treatment may be an economically desirable strategy.

A Cost-utility Analysis of Calcipotriol/Betamethasone Dipropionate Aerosol Foam versus Ointment for the Topical Treatment of Psoriasis Vulgaris in Sweden.

Psoriasis is a chronic inflammatory disorder that imposes a substantial economic burden. We conducted a cost-utility analysis from a Swedish healthcare payers perspective using a decision-tree model with a 12-week time horizon. Patients with psoriasis vulgaris could have two 4-week cycles of topical treatment with calcipotriol 50 µg/g and betamethasone 0.5 mg/g as dipropionate (Cal/BD) foam or Cal/BD ointment before progressing to phototherapy/methotrexate. In the base-case analysis, Cal/BD foam dominated over Cal/BD ointment. The increased efficacy of Cal/BD foam resulted in fewer consultations and a decreased risk of progressing to phototherapy/methotrexate. Although Cal/BD foam costs more than Cal/BD ointment, this was offset by lower costs for phototherapy/methotrexate or consultation visits. Sensitivity analyses revealed that the base-case net monetary benefit was robust to plausible variations in key parameters. In conclusion, Cal/BD foam was predicted to be more cost-effective than Cal/BD ointment in the treatment of psoriasis vulgaris.

Efficacy, safety, and cost-effectiveness of all-trans retinoic acid/Clobetasol Propionate Compound Ointment in the treatment of mild to moderate psoriasis vulgaris: A randomized, single-blind, multicenter clinical trial.

To assess the efficacy, safety, and cost-effectiveness of all-trans retinoic acid/Clobetasol Propionate Compound Ointment and calcipotriol/betamethasone dipropionate ointment in the treatment of mild-to-moderate patients with psoriasis vulgaris. This was a randomized, single-blind, multicenter clinical trial. A total of 240 patients were randomized to receive twice-daily all-trans retinoic acid/Clobetasol Propionate Compound Ointment (treatment group) or once-daily calcipotriol/betamethasone dipropionate ointment (control group) for 4 weeks. The efficacy, safety, and cost-effectiveness were assessed at Weeks 2 and 4. After 4 weeks, both groups showed a significant clinical improvement compared to baseline (88.33% vs. 89.83%, respectively, p = .7112). But PASI 75 response in the treatment group was superior to the control group (44.12% vs. 28.57%, respectively, p = .0200), at Week 4. SSRI improvement rate in the treatment group was also superior to control group (67.11% vs. 59.43%, respectively, p = .0119) at Week 4. All-trans retinoic acid/Clobetasol Propionate Compound Ointment showed a significant clinical improvement in erythema, infiltration, and scales of skin lesions and PASI score compared to baseline. 1.67% of patients (treatment group) reported adverse reactions compared to 2.50% (control group) with no statistical significance. In addition, the cost-effectiveness assessment showed a higher cost-effectiveness of the treatment group compared to the control group in 4 weeks (199.25 vs. 801.51). All-trans retinoic acid/Clobetasol Propionate Compound Ointment was effective and safe in the treatment of psoriasis vulgaris with similar efficacy as calcipotriol/betamethasone dipropionate ointment and lower treatment costs.

A cost-effectiveness analysis of calcipotriol plus betamethasone dipropionate aerosol foam versus gel for the topical treatment of plaque psoriasis.

BACKGROUND: Calcipotriol 50 µg/g and betamethasone 0.5 mg/g dipropionate (Cal/BD) aerosol foam formulation provides greater effectiveness and improved patient preference compared with traditional Cal/BD formulations for the topical treatment of plaque psoriasis. OBJECTIVE: To determine the cost-effectiveness of Cal/BD foam compared with Cal/BD gel from the Australian perspective. METHODS: A Markov model was developed to evaluate the cost-effectiveness of topical Cal/BD foam and gel for the treatment of people with plaque psoriasis. Treatment effectiveness, safety, and utilities were based on a randomized control trial, resource use was informed by expert opinion, and unit costs were obtained from public sources. Outcomes were reported in terms of 1-year costs, quality-adjusted life years, and incremental cost-effectiveness ratios. All costs were reported in 2017 Australian Dollars. RESULTS: The model showed that patients using Cal/BD foam had more QALYs and higher costs over 1 year compared with patients using Cal/BD gel, resulting in a cost of $13,609 per QALY gained at 4-weeks. When 4 weeks of Cal/BD foam was compared with 8 weeks of Cal/BD gel treatment, Cal/BD foam was $8 less expensive and resulted in 0.006 more QALYs gained. Sensitivity analyses showed that, compared with Cal/BD ointment, Cal/BD foam was associated with an incremental cost of $15,091 per QALY gained. CONCLUSION: Cal/BD foam is the most cost-effective Cal/BD formulation for the topical treatment of patients with plaque psoriasis.

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.

Economic burden of psoriatic patients in Japan: Analysis from a single outpatient clinic.

Topical and systemic agents have dramatically improved the treatment efficacy of psoriasis. Few reports, however, exist describing the economic burden in Japanese psoriatic patients. The aim of the study was to evaluate the total costs as well as cost versus efficacy of topical and systemic treatments of psoriatic patients under the Japanese health insurance system. The retrospective study was performed from the database of our clinic, which is located in Hokkaido Prefecture. Cost and effectiveness of psoriatic patients were evaluated during the 12-month period from April 2015 to March 2016. Data were collected and calculated for the total cost per year, treatment efficacy and cost versus efficacy. The mean total cost of topical corticosteroid treatment was ¥18 184/year and was lowest among the treatments. The systemic treatment with biologics was most expensive and the costs were over ¥400 000/year. Among the topical treatments, calcipotriol/betamethasone dipropionate was most expensive (¥34 693/year). However, cost versus efficacy was not significantly different from that of topical corticosteroid treatments. The cost of secukinumab was highest among all the treatments (¥631 600/year). However, treatment day per cost was lowest of all the psoriasis treatments. Biologics showed the highest cost than topical or systemic treatments. However, they showed most marked efficacy in terms of improving the psoriatic skin lesions.

First-Line Fixed-Combination Psoriasis Treatment Is Associated With Lower Healthcare Costs.

Treatment of psoriasis is associated with significant healthcare-related costs. A retrospective, observational study was conducted to investigate whether first-line treatment with calcipotriene/betamethasone dipropionate (CBD) fixed-combination topical products would lower the cost impact of psoriasis compared with using the fixed-combination product later in the course of treatment. Patients were classified as being initially treated with CBD combination products (cohort A, n=7307) or other topical psoriasis medications (cohort B, n=9670). We included only patients who, at some point after diagnosis, were prescribed a CBD fixed-combination product. During the 1-year followup, the mean±standard deviation values and number of total office visits and psoriasis-related office visits were significantly lower in cohort A (13.36±14.39; 2.79±7.60) than in cohort B (16.08±16.68; 4.25±10.23) (both P<.0001). Mean total healthcare costs were also significantly lower for cohort A ($7785.80±$15,255.60; median, $3411.30) than for cohort B ($11,757.20±$19,747.60; median, $5595.80) (P<.0001). Compared with other topical psoriasis medications, first-line treatment with CBD fixed-combination topical products was associated with fewer office visits and lower total healthcare costs.

Using a single product (calcipotriene/betamethasone topical suspension) vs multiple products to manage body and scalp psoriasis: comparisons in resource utilization and costs.

OBJECTIVES: To compare resource utilization and costs among patients who used calcipotriene/betamethasone dipropionate topical suspension (Taclonex Scalp Topical Suspension, Leo Pharma A/S) vs those who used multiple body and scalp formulations for psoriasis. RESEARCH DESIGN AND METHODS: A retrospective study using Truven Health MarketScan Commercial Database from 2006-2011 was performed to identify patients with psoriasis (ICD code 696.1x). Two study cohorts analyzed were cohort A (used body-only formulations for psoriasis and switched on the index date to using calcipotriene/betamethasone dipropionate topical suspension alone) and cohort B (used multiple body and scalp formulations for psoriasis). Patients were required to be continuously enrolled during 180-days pre- and post-index periods. Multiple regression analyses adjusting for baseline demographic and clinical covariates were performed. MAIN OUTCOMES MEASURES: Number of psoriasis-related outpatient visits, total healthcare costs, psoriasis-related costs, and use of systemic agents during post-index period. RESULTS: A total of 1923 patients were identified with at least one prescription for calcipotriene/betamethasone dipropionate scalp topical suspension (cohort A = 367, cohort B = 1556). Patients using multiple medications (cohort B) were associated with 48% higher number of outpatient visits as compared with those who used a single formulation (cohort A) after controlling for baseline covariates (p < 0.001). A generalized linear model adjusting for baseline covariates showed significantly higher post-index total and psoriasis-related healthcare costs for cohort B as compared with cohort A (both p < 0.001). Patients in Cohort B also had twice the odds of using systemic agents as compared to patients in Cohort A (p < 0.001). CONCLUSIONS: Patients with body and scalp psoriasis using a single product had significantly lower overall and psoriasis-related healthcare costs, needed fewer psoriasis-related outpatient visits, and used less systemic agents during the post-index period. A lack of robust clinical measures to define the disease severity may have limited the interpretations from this study.

Cost effectiveness of the two-compound formulation calcipotriol and betamethasone dipropionate gel in the treatment of scalp psoriasis in Scotland.

OBJECTIVES: To compare the cost effectiveness of the two-compound formulation (TCF) calcipotriol plus betamethasone dipropionate gel used first-, second- or third-line to standard topical treatments for moderately severe scalp psoriasis from a Scottish NHS perspective. RESEARCH DESIGN AND METHODS: Treatment pathways for scalp psoriasis patients in primary care were defined by Scottish prescribing statistics, an interview programme and published sources. The extensive 1-year Markov model included 12 different topical treatment pathways, each simulating three lines of therapy. Seven pathways contained the TCF gel in first-, second- or third-line. The remaining five pathways were included as comparators, reflecting the heterogeneity across clinical practice. The cost effectiveness of TCF gel was compared to the average of five non-TCF gel pathways. The clinical effectiveness measure was the ability of topical treatments to control disease at 4 weeks. Response rates were derived from indirect comparisons of ten randomised controlled trials. Utilities were elicited from SF-36 (v2) scores in one TCF gel trial. The main outcome was the incremental cost per quality-adjusted life-year (QALY). Extensive sensitivity analyses were performed to assess the robustness of the results. RESULTS: TCF gel used first-, second- or third-line was projected to increase QALYs (around 0.0025) with cost savings per patient (£20-30) over 1 year. The study analysis acknowledged a number of limitations including lack of quality comparator data, the need to make assumptions in the absence of evidence and lack of model validation. However the results showed that TCF gel was the dominant treatment strategy across a broad range of credible scenarios. CONCLUSIONS: Scalp psoriasis is difficult to treat. Many different topical preparations can be used but several factors such as greasiness, irritation, time needed to apply, and lack of efficacy often result in reduced adherence to treatment regimens. Where cosmetic properties are important for patient acceptability and compliance is a major issue contributing to treatment failure, the once-daily TCF gel offers patients with scalp psoriasis an attractive, cost-saving treatment option.

The two-compound formulation of calcipotriol and betamethasone dipropionate for treatment of moderately severe body and scalp psoriasis - an introduction.

Psoriasis is a common chronic inflammatory skin disease and many patients require lifelong treatment. Characteristic scaly, itchy, unsightly psoriatic lesions affect many body areas and most patients commonly experience scalp involvement. The cosmetic embarrassment of visible body lesions, inaccessibility of scalp skin to application of therapies and proximity of sensitive facial skin add to the challenges of most patients managing their psoriasis long term. Psoriasis can severely impact patients' quality of life. This can impact significantly on the patient. In economic terms patients may incur increased out-of-pocket expenditure or extended time away from work as a direct consequence of psoriasis, particularly in severe cases; In many countries, specialist review of patients provides pressures on hard-pressed services and the costs of psoriasis care are substantial, particularly in patients with severe recalcitrant psoriasis which may require lengthy inpatient admission. Around 80% of patients with psoriasis have mild to moderately severe disease and the majority are treated with topical medicines by their physician in primary care. Despite the availability of a wide range of treatment options, regimens have been unsatisfactory, associated with patient dissatisfaction, poor compliance and often safety concerns with long-term use. Evidence-based clinical guidelines aim to improve healthcare of patients and while there are such guidelines for psoriasis, to date the challenges of (and recommendations for) managing scalp psoriasis are often limited or missing from these treatment guidelines. In the following in-journal supplement, a connected suite of five papers focus on the use of topical therapies for the treatment of the person afflicted with psoriasis. This work harnesses robust evidence from randomised clinical trials (RCTs) of topical therapies commonly used in psoriasis patients and translates this into recommendations for the most appropriate treatment of patients with body or scalp psoriasis, from an efficacy, safety and cost-effectiveness perspective. Based upon systematic review and harnessing 'state of the art' evidence assessment methodologies, the modelling work suggests that the use of a two-compound formulation (TCF) product of calcipotriol and betamethasone dipropionate is the most appropriate treatment option for both body and scalp psoriasis. This Editorial acknowledges the results of any modelling exercise have limitations; indeed such limitations are acknowledged in each modelling contribution in this issue. With these caveats in mind, this introductory paper considers the implications of this research and distillation of the evidence. This work should guide cost-effective treatment choices for body and scalp psoriasis, assist in recommendations for management of scalp psoriasis in future iterations of psoriasis clinical guidelines and help primary care physicians striving to attain best outcomes in the care of the person with psoriasis.

Cost-effectiveness model of topical treatment of mild to moderate psoriasis vulgaris in Germany. A comparison of calcipotriol/betamethasone (Daivobet/Dovobet/Taclonex) once daily and a morning/evening non-fix combination of calcipotriol and betamethasone.

BACKGROUND: Psoriasis vulgaris requires lifelong treatment associated with considerable health cost. Studies showed that a combination of a steroid and a vitamin D(3) analogue is more effective than both compounds in monotherapy. OBJECTIVE: To determine the cost-effectiveness of a fix calcipotriol/betamethasone combination (Daivobet/Dovobet/Taclonex) compared to a morning/evening non-fix calcipotriol/betamethasone combination in psoriasis treatment. METHODS: A Markov model (discrete-time stochastic process based on transitions between health states) with 2 treatment arms (Daivobet/Dovobet/Taclonex vs. non-fix calcipotriol/betamethasone) over a 48-week time period was developed. The effectiveness criterion was the number of days with clearance or marked improvement. Clinical and health resource utilisation data were derived from randomised studies. RESULTS: Treatment with Daivobet/Dovobet/Taclonex showed a higher cost-effectiveness compared to the non-fix combination, even when assuming a maximum compliance for the twice daily non-fix combination and varying the effectiveness of Daivobet/Dovobet/Taclonex by 10%. CONCLUSION: Psoriasis treatment with a fix calcipotriol/betamethasone combination is more cost-effective than a non-fix morning/evening combination.

Calcipotriol/betamethasone dipropionate for the treatment of psoriasis.

The two-compound product calcipotriol/betamethasone dipropionate is arising as a first-line treatment for mild-to-moderate plaque psoriasis. Its beneficial action is attributed to the synergistic effect of its components on keratinocyte proliferation and differentiation, and on inflammation. The good tolerability of the two-compound product is thought to be due to the anti-inflammatory effect of betamethasone. Evidence from short-term (4-12 weeks) and long-term use (> 1 year) has shown a good safety profile. Areas such as the face or skin folds, which are sensitive to the components of the combination, should be avoided. Finally, it is unsuitable for use in unstable psoriasis, in which potent steroids may lead to an increased inflammatory response.

Corticosteroid compared with hyaluronic acid injections for the treatment of osteoarthritis of the knee. A prospective, randomized trial.

BACKGROUND: Although both corticosteroid and hyaluronic acid injections are widely used to palliate the symptoms of knee osteoarthritis, little research involving a comparison of the two interventions has been done. We tested the hypothesis that there are no significant differences between Hylan G-F 20 (Synvisc) and the corticosteroid betamethasone sodium phosphate-betamethasone acetate (Celestone Soluspan) in terms of pain relief or improvement in function, as determined by validated scoring instruments. METHODS: One hundred patients with knee osteoarthritis were randomized to receive intra-articular injection of either Hylan G-F 20 or the corticosteroid, and they were followed for six months. The patients treated with Hylan G-F 20 received one course of three weekly injections. The patients treated with the corticosteroid received one injection at the time of enrollment in the study, and they could request one more injection any time during the study. An independent, blinded evaluator assessed the patients with the Western Ontario and McMaster University Osteoarthritis Index (WOMAC), a modification of the Knee Society rating system, and the visual analog pain scale. RESULTS: Both the group treated with the corticosteroid and the group treated with Hylan G-F 20 demonstrated improvements from baseline WOMAC scores (a median decrease from 55 to 40 points and from 54 to 44 points, respectively; p < 0.01 for both). The scores according to the Knee Society system did not significantly improve for the patients who received the corticosteroid (median, 58 to 70 points; p = 0.06) or for those who received Hylan G-F 20 (median, 58 to 68 points; p = 0.15). The scores on the visual analog scale improved for patients receiving Hylan G-F 20 (median, 70 to 52 mm; p < 0.01) but not for the patients who received the corticosteroid (median, 64 to 52 mm; p = 0.28). However, no significant differences between the two treatment groups were found with respect to the WOMAC, Knee Society system, or visual analog scale results. Women demonstrated a significant improvement in only one of the six possible outcome-treatment combinations (the WOMAC scale), whereas men demonstrated significant improvements in five of the six outcomes (all measures except the Knee Society rating system). CONCLUSIONS: No differences were detected between patients treated with intra-articular injections of Hylan G-F 20 and those treated with the corticosteroid with respect to pain relief or function at six months of follow-up. Women demonstrated significantly less response to treatment than men did for both treatments on all three outcome scales. Such significant gender-related differences warrant further investigation.

Clotrimazole/betamethasone diproprionate: a review of costs and complications in the treatment of common cutaneous fungal infections.

The use of antifungal/corticosteroid combinations as topical therapy for dermatophytoses has been criticized as being less effective, more expensive, and the cause of more adverse cutaneous reactions than antifungal monotherapy. The combination of clotrimazole and betamethasone diproprionate (Lotrisone) is a mix of an azole antifungal and a high-potency corticosteroid, and is one of the most widely prescribed of these combinations. Our objective was to describe the beneficial and deleterious effects of Lotrisone in the treatment of common cutaneous fungal infections and its relative cost-effectiveness. We did a literature review documenting clinical trial data and adverse reactions to Lotrisone and collected a cost analysis of topical antifungal prescribing data over a 2-month period from a large midwestern staff-model health maintenance organization (HMO). Lotrisone is approved by the U.S. Food and Drug Administration (FDA) for the treatment of tinea pedis, tinea cruris, and tinea corporis in adults and children more than 12 years of age. Treatment is limited to 2 weeks in the groin area and 4 weeks on the feet. The most concerning adverse effects of Lotrisone were reported in children and included treatment failure, striae distensae, hirsuitism, and growth retardation. This combination was also reported to have decreased efficacy in clearing candidal and Trichophyton infections as compared to single-agent antifungals. Lotrisone was considerably more expensive than clotrimazole alone and was found to account for more than 50% of topical antifungal expenditures as prescribed by primary care physicians, but only 7% of topical antifungals prescribed by dermatologists. We found that Lotrisone was shown to have the potential to induce many steroid-related side effects and to be less cost effective than antifungal monotherapy. This combination should be used judiciously in the treatment of cutaneous fungal infections and may not be appropriate for use in children.

[Value of prenatal corticotherapy in the prevention of hyaline membrane disease in premature infants. Randomized prospective study]. / Apport de la corticothérapie anténatale dans la prévention de la maladie des membranes hyalines chez le prematuré. Etude prospective randomisée.

OBJECTIVE: The aim of the study was to determine the feasibility, the cost and the effects of antenatal maternal corticosteroid treatment on preventing respiratory distress syndrome in premature neonates of our population. SUBJECTS AND METHODS: Between January, 1, 1998 and June, 31, 1999, 118 pregnant women at 26-34 weeks' gestation and at a high risk of premature delivery, were prospectively randomized in 2 groups: group 1 received intramusculary 24 mg of betamethasone (12 mg every 24 hours), group 2 didn't receive antenatal corticosteroids. At birth, premature neonates were systematically examined by a neonatologist. RESULTS: 131 premature neonates were born (63 from group 1, 68 from group 2). The incidence and the degree of severity of respiratory distress syndrome, appeared substancially reduced (4.8% vs 27.9%) by the use of antenatal corticosteroids. Moreover, neonatal mortality due to respiratory distress syndrome was statistically less in group 1 than in group 2 (22.9% vs 57%). There was no significant difference in the occurrence of maternal or neonatal corticosteroid complications such as infection between treated group and control subjects. We estimated a potential annual savings of 21 thousands tunisian dinars, when the cost implications for antenatal corticosteroid therapy were estimated to 2 thousands tunisian dinars. CONCLUSION: Maternal administration of corticosteroids before preterm delivery results in a decrease in the incidence and severity of respiratory distress syndrome and a decrease in neonatal mortality rate among premature neonates born to treated versus untreated mothers at 26-34 weeks' gestation; added to an annual savings estimated to 21 thousands tunisian dinars.