Infliximab for the Treatment of Adults with Psoriasis. [TA134]

Southampton Health Technology Assessments Centre, Wessex Institute for Health Research and Development, University of Southampton, UK.
Health technology assessment (Winchester, England) 06/2009; 13 Suppl 1(Suppl 1):55-60. DOI: 10.3310/hta13suppl1/09
Source: PubMed


This paper presents a summary of the evidence review group (ERG) report into the clinical and cost-effectiveness of infliximab for the treatment of moderate to severe plaque psoriasis, in accordance with the licensed indication, based on the evidence submission from Schering-Plough to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal (STA) process. The outcomes stated in the manufacturer's definition of the decision problem were severity [Psoriasis Area and Severity Index (PASI) score], remission rates, relapse rates and health-related quality of life. The main evidence in the submission comes from four randomised controlled trials (RCT) comparing infliximab with placebo and eight RCTs comparing either etanercept or efalizumab with placebo. At week 10, patients on infliximab had a significantly higher likelihood of attaining a reduction in PASI score than placebo patients. There were also statistically significant differences between infliximab and placebo in the secondary outcomes. In the comparator trials both the efalizumab and etanercept arms included a significantly higher proportion of patients who achieved a reduction in PASI score at week 12 than the placebo arms. No head-to-head studies were identified directly comparing infliximab with etanercept or efalizumab. The manufacturer carried out an indirect comparison, but the ERG had reservations about the comparison because of the lack of information presented and areas of uncertainty in relation to the included data. The economic model presented by the manufacturer was appropriate for the disease area and given the available data. The cost-effectiveness analysis estimates the mean length of time that an individual would respond to infliximab compared with continuous etanercept and the utility gains associated with this response. The base-case incremental cost-effectiveness ratio (ICER) for infliximab compared with continuous etanercept for patients with severe psoriasis was 26,095 pounds per quality-adjusted life-year. A one-way sensitivity analysis, a scenario analysis and a probabilistic sensitivity analysis were undertaken by the ERG. The ICER is highly sensitive to assumptions about the costs and frequency of inpatient stays for non-responders of infliximab. The guidance issued by NICE in August 2007 as a result of the STA states that infliximab within its licensed indication is recommended for the treatment of adults with very severe plaque psoriasis, or with psoriasis that has failed to respond to standard systematic therapies. Infliximab treatment should be continued beyond 10 weeks in people whose psoriasis has shown an adequate response to treatment within 10 weeks. In addition, when using the Dermatology Life Quality Index (DLQI), care should be taken to take into account the patient's disabilities, to ensure DLQI continues to be an accurate measure.

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    • "We therefore propose that proSPI–s scores of o9, 9–18, and 418 and saSPI–s scores of o10, 10–20, and 420 can be used as equivalents for EMA-defined mild, moderate, and severe psoriasis, respectively. As less stringent PASI criteria for defining psoriasis severity have been widely advocated (van de Kerkhof et al., 2006; Loveman et al. 2009), the proSPI-s and saSPI-s equivalents of alternative PASI cutoff points (o5, 415, and 418) are shown in Tables 4 and 5. "
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    ABSTRACT: The Simplified Psoriasis Index (SPI) is a summary measure of psoriasis with separate components for current severity (weighted for functionally or psychosocially important sites), psychosocial impact and past behaviour. The professionally-assessed (proSPI-s) and patient self-assessed (saSPI-s) severity components of each have been shown to be valid and reliable. Their responsiveness to change and equivalence to the current standard (Psoriasis Area and Severity Index: PASI) were investigated. Responsiveness and minimum clinically important differences (MCIDs) were derived from PASI changes from baseline at weeks four (n=100) and 10 (n=65) in patients commencing therapy for psoriasis. Receiver operating characteristic (ROC) analysis confirmed that both measures detected responsiveness well (area under the curve [AUC]=0.72-0.96). On ROC and PASI-based anchor analysis, MCIDs equated to mean absolute and percentage changes of 5 and 60% (proSPI-s), and 7 and 70% (saSPI-s). Satisfactory response as defined by 75% reduction in PASI equated to 85 and 95% reductions in proSPI-s and saSPI-s respectively. PASI-equivalent cut-off scores for mild (PASI<10) and severe (PASI>20) psoriasis were <9 and >18 for proSPI-s (n=300) and <10 and >20 for saSPI-s (n=200) (AUC=0.86-0.96). These studies further support the validity of SPI for use in routine clinical practice.Journal of Investigative Dermatology accepted article preview online, 29 July 2013. doi:10.1038/jid.2013.318.
    Full-text · Article · Jul 2013 · Journal of Investigative Dermatology
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    • "Systemic therapies are frequently required and the economic burden for patients and health service alike is considerable. United Kingdom estimates of cost of treatment for moderate to severe disease vary from £45.5 to £80 million (Van de Kerkhof 2003) Costs for individual patients are considerable and may include difficulties with employment (NICE 2006; Scottish Medicines Consortium 2007). "
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    ABSTRACT: Psoriasis is a chronic, immune mediated inflammatory disease characterized by increased cell signalling via cytokines and chemokines on a background of up-regulated gene expression. There is substantial evidence that psoriasis should be regarded as more than a cutaneous disease; major psychological morbidity and increased mortality from cardiovascular disease and cancer are increasingly recognized. Improved understanding of the genetic and immunological mechanisms underpinning psoriasis has occurred concurrently with the development of targeted biological therapies including infliximab. These newer therapeutic approaches can be very effective but their long term safety profile is not yet fully determined.
    Preview · Article · Jan 2009 · Therapeutics and Clinical Risk Management
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    ABSTRACT: Psoriasis is commonly associated with a co-existent arthritis known as psoriatic arthritis (PsA). Although there is some treatment overlap for psoriasis and psoriatic arthritis, it is possible that dermatologists may not diagnose or treat appropriately patients who are developing psoriatic arthritis at an early stage of the disease process when joint damage may be preventable. In this article we review the criteria for diagnosis of this sero-negative arthritis, look at the clinical indications for referral to a rheumatologist and discuss evolving treatment options relevant to both conditions.
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