The negative impact of psoriasis on a patient's quality of life (QoL) is well documented in the literature. Patients often suffer poor self-esteem, difficulties in social interactions, and significant psychological distress. It is, therefore, critically important that a clinician evaluate the extent to which the disease impacts a patient's QoL. This chapter reviews several validated and reliable generic, dermatology-specific, and disease-specific QoL instruments useful in measuring the impact of psoriasis on patient's QoL. These QoL instruments can be especially helpful in identifying those patients who would most benefit from systemic or biologic therapy.
"Environmental and genetic factors, as well as super antigens and toxins from Candida species, may play various roles in the exacerbation and persistence of psoriasis (Taheri et al., 2014; Leung et al., 1993). Most psoriasis patients have a diminished quality of life in comparison with healthy individuals, particularly with reference to sexual dysfunction, anxiety, depression, selfesteem , and nutritional condition (Heller et al., 2012). In the present study, the presence of Candida albicans and other species of Candida were evaluated in the saliva and skin of fifty (50) psoriatic patients and were compared to a control group of fifty (50) healthy people. "
"In general, psoriasis is usually classified as mild, moderate or severe, depending on the surface area affected, redness, and the thickness and desquamation of the plaques. A number of instruments have been devised to define the severity of the disease and compare scores over time for the same patient and between patients . "
[Show abstract][Hide abstract] ABSTRACT: Biologic therapies are considered to be cost effective by leading Health Technology Assessment (HTA) agencies and, therefore, eligible for reimbursement by public health services. However, biologic therapies entail sizable incremental costs and, besides, have a considerable financial impact that in Italy amounts to 13.7 % of the national health service's pharmaceutical expenditure. In the reimbursability decision process, an important role is played by both the drug efficacy data observed in pre-licensing RCTs and the economic modelling assumptions, as they give evidence on cost effectiveness. The administration of therapies in real practice settings is likely to produce a significant deviation from the results predicted by the models, theoretically outweighing the assumption on which the decision process is founded. This is a matter of concern for public health services and, consequently, an interesting topic to investigate.
To overcome the lack of knowledge concerning the actual cost effectiveness of biologic therapies for the treatment of plaque psoriasis in the clinical practice setting in Italy, an observational study was conducted in 12 specialist centres on patients switching to biologic therapy within a 6-month enrolment window.
The study confirms in clinical practice the efficacy of the switch to biologic therapies, analysed using a number of clinical [Psoriasis Area and Severity Index (PASI), pain visual analogue scale (VAS) and itching VAS] and quality-of-life parameters. A general health-related quality of life (HR-QOL) improvement, with a 0.23 quality-adjusted life-year (QALY) mean gain per patient, has been reported in the 6-month observation period. The direct medical costs to treat plaque psoriasis with biologic therapies amount to 15,073.7 per year (prior to their enrolment, the same patients cost 2,166.2 on an annual basis). After the switch to biologic agents, the cost per QALY during the first year of treatment amounts to 28,656.3.
At least in the short-term, the clinical practice of the specialised Italian centres taking part in the study confirms that switching patients to a biologic drug produces an incremental cost-effectiveness ratio comparable with the values predicted by the HTA bodies.
[Show abstract][Hide abstract] ABSTRACT: Limited data exist on transitioning psoriasis patients from conventional systemic agents to biologics.
The TRANSIT study aimed to assess the efficacy and safety of two methotrexate-to-ustekinumab transition strategies.
Patients with moderate-to-severe psoriasis and inadequate methotrexate response were randomized 1:1 to initiate ustekinumab with immediate (arm 1) or 4-week gradual (arm 2) methotrexate withdrawal. Patients weighing ≤100 kg or >100 kg received 45 mg or 90 mg ustekinumab, respectively. The primary endpoint was the frequency of adverse events (AEs) at week 12. Secondary endpoints included additional safety, efficacy and patient-reported outcomes. We report the 12-week efficacy and safety results.
Overall, 244 patients in arm 1 and 245 in arm 2 were randomized and received ustekinumab. Four patients per arm discontinued the trial by week 12. At week 12 in arms 1 and 2, respectively, 61% and 65% of patients experienced an AE, 2.9% and 2.4% had a serious AE, and 1.2% and 0.4% had an AE leading to ustekinumab discontinuation. In arms 1 and 2, respectively: median psoriasis area and severity index (PASI) decreased from 15.2 and 15.4 at baseline to 2.9 and 2.8 at week 12; 58% and 62% of patients had PASI 75 at week 12; median baseline dermatology life quality index fell from 8 and 9 at baseline to 1 (both groups) at week 16.
Ustekinumab was well tolerated and effective in patients inadequately responsive to methotrexate. Both transition strategies resulted in similar week 12 safety and efficacy outcomes. This article is protected by copyright. All rights reserved.
British Journal of Dermatology 09/2013; 170(2). DOI:10.1111/bjd.12646 · 4.28 Impact Factor
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