Mixed treatment comparison of a two-compound formulation (TCF) product containing calcipotriol and betamethasone dipropionate with other topical treatments in psoriasis vulgaris.

OBJECTIVE: The efficacy of the two-compound formulation (TCF) product containing calcipotriol and betamethasone dipropionate applied once daily in psoriasis has been demonstrated in phase III trials but no randomised clinical trial comparing all commonly used topical treatments exists. The aim of the study was to compare the efficacy of once-daily use of the TCF product relative to other commonly used topical agents in plaque psoriasis. RESEARCH DESIGN AND METHODS: Data on change in Psoriasis Area and Severity Index (PASI) score from baseline and PASI 75 (percentage of patients achieving a 75% reduction in PASI score), after 4 weeks of treatment were obtained by means of a systematic literature review of randomised controlled trials and synthesised with a Bayesian mixed treatment comparison meta-analysis. RESULTS: Relative to all active interventions, except for the unlicensed twice-daily application of the TCF product, the TCF once daily showed a greater efficacy based on PASI 75 response (relative risk ranging from 1.22 to 3.18) and improvement in PASI score from baseline (difference in % CFB PASI between TCF once daily and other active interventions ranged from 4.01 to 49.68). CONCLUSION: Among topical therapies evaluated, TCF once daily can be considered the most efficacious treatment for plaque psoriasis.

A psoriasis-specific model to support decision making in practice - UK experience.

OBJECTIVES: The balance of service provision for people with psoriasis across community and hospital sectors is inappropriate in many localities. Disease-specific models are being used by policy makers to inform public health decision making and guide their long-term budgets. The aim of the present study was to develop an interactive psoriasis model to compare the 2-year outcomes of topical treatment strategies in patients with moderately severe psoriasis in real-world settings. RESEARCH DESIGN AND METHODS: A previously published 1-year economic analysis of the two-compound formulation (TCF) calcipotriol plus betamethasone dipropionate and other commonly used topical agents in plaque psoriasis was adapted. Literature review and an interview programme identified additional relevant data to inform model assumptions. The model estimated local psoriasis costs and resources in accord with decision makers' priorities. A key element of the model was the facility for all default input data to be adapted to reflect local circumstance. Model validation was not undertaken. The UK experience is described. RESULTS: Topical treatment with high-efficacy first-line therapies is a cost-effective treatment strategy in moderate plaque psoriasis. The model predicts potential savings in psoriasis care for a UK population of £126 million over 2 years if all psoriasis patients received the TCF in a community setting. A frequently used feature of the model was to identify ways of reducing inappropriate referrals to hospital, and so enabling secondary care resources to be focussed on the most resilient psoriasis cases. CONCLUSIONS: The present study psoriasis disease model could facilitate collaboration between healthcare professionals to optimise healthcare in the UK. Psoriasis management strategies in primary care can be compared in a variety of realistic clinical settings, allowing the identification of optimal treatment regimens. This model is adaptable to tailor inputs to reflect local situations, providing an attractive tool to GP commissioners. Country-specific adaptations are being researched in other European countries.

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 effectiveness of two-compound formulation calcipotriol and betamethasone dipropionate gel in the treatment of moderately severe scalp psoriasis: a systematic review of direct and indirect evidence.

OBJECTIVES: To evaluate the two-compound formulation (TCF) calcipotriol and betamethasone dipropionate (BDP) gel versus other topical therapies for scalp psoriasis in adults using direct and indirect comparisons. METHODS: A systematic review identified 10 randomised controlled trials (RCTs) of topical treatments used in clinical practice for moderately severe scalp psoriasis. A meta-analysis was undertaken to obtain estimates of clinical effectiveness using recommended efficacy and safety outcome measures. We determined the proportion of responding patients using two definitions: i) 'controlled disease' using the Investigator Global Assessment (IGA) rating scale and ii) a score of 0 or 1 on the Total Sign Score (TSS). Tolerability was extracted in terms of percentages of patients experiencing all adverse events (AEs), skin AEs and withdrawals due to AEs. Direct comparisons were performed where head-to-head data were available. For other comparators where TCF gel was compared indirectly, 'pairs' of trials were compared on the basis of a common comparator using meta-regression in order to derive an indirect comparison estimate, while preserving randomisation within trials. Assumptions of comparability were considered regarding study homogeneity (data can be pooled in a meta-analysis), similarity of trials (clinical and methodological) and consistency of findings from direct and indirect evidence. RESULTS: The meta-analysis showed that TCF gel was statistically significantly more effective than other topical treatments in terms of achieving a response defined according to both IGA and TSS criteria. TCF gel was generally associated with a statistically significant lower risk of AEs, skin AEs or patients withdrawing from RCTs due to AEs. CONCLUSIONS: Although direct and indirect evidence in this analysis is sparse, this indirect comparison suggests that the TCF gel has significant benefits over other topical therapies considered in the routine management of patients with moderately severe scalp psoriasis. Despite other analysis limitations in terms of study heterogeneity inevitable across an evidence base spanning decades, these results were consistent, using a number of efficacy and tolerability outcome measures.