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PubMed2005

The impact of biologics on the quality of life of psoriasis patients and the economics of psoriasis care.

Psoriasis has a tremendous impact on patients' lives, affecting them physically, psychologically, and socially. Thus, it is not merely a cosmetic concern and often warrants appropriately aggressive treatment. Traditional treatments for moderate-to-severe psoriasis include phototherapy, oral retinoids, methotrexate, and cyclosporine. Newer biologics combat the immunologic mechanism responsible for psoriasis and, to date, carry a more favorable side effect profile. We examined the impact on quality of life of biologics and assessed their total direct costs to psoriasis patients. Biologic treatments significantly improve the quality of life of psoriasis patients; however, they cost significantly more than traditional therapies. This difference calls for physicians to weigh the costs and benefits of biologic therapies and compare them to those of traditional treatments when considering care for psoriasis patients.

Biological Products↗
PubMed2005

[Validation of the Spanish version of the Psoriasis Disability Index questionnaire in assessing the quality of life of patients with moderate-severe psoriasis].

INTRODUCTION: To assess the measurement properties of the Spanish version of the Psoriasis Disability Index (PDI) quality of life questionnaire for patients with moderate or severe psoriasis in ordinary clinical practice. PATIENTS AND METHODS: A study was carried out with 294 patients with moderate or severe psoriasis who had received therapeutic treatment. Sociodemographic and clinical variables were collected and the PDI and EuroQoL-5D questionnaires were administered at the baseline visit, and at 3 and 6 months later. The feasibility (percentage of patients responding to the questionnaire), validity of the construct, internal reliability and sensitivity to change were analyzed. RESULTS: Feasibility: 98.6 % of the patients answered over 80 % of the questions on the questionnaire. Validity of the construct: the PDI scores were correlated with the scores obtained in the Psoriasis Area Disability Index (PASI) (r = 0.33) and the Visual Analogue Scale (VAS) of the EQ-5D (r = -0.41) (p < 0.01). Longitudinal validity: the PDI questionnaire score after 6 months of treatment was correlated with the changes in the PASI index and the VAS (r = 0.39 y -0.51). Reliability: the internal consistency of the dimensions was high (Cronbach's alpha = 0.89). Sensitivity to changes: the size of the effect corresponding to the changes experienced by the patients who noticed an improvement in the severity of their psoriasis during the period between visits was 0.95. CONCLUSION: The Spanish version of the PDI has proven to be reliable, valid and sensitive to changes for use with patients with psoriasis in the Spanish population, although the test-retest reliability should be analyzed for clinically stable patients.

Adult↗
PubMed2002

Cost of psoriasis: a study on the morbidity and financial effects of having psoriasis in Australia.

Eighty-three participants with psoriasis were followed over a 2-year period assessing the severity, morbidity and cost of their disease over time. At recruitment, they were examined by a dermatologist who classified them on a global basis as mild (47%), moderate (35%) or severe (18%). A Psoriasis Area and Severity Index (PASI) score was also recorded at the initial interview. Participants completed questionnaires on the morbidity related to having psoriasis using the Psoriasis Disability Index (PDI) and a self-administered PASI (SAPASI) score at the initial interview and at 3-monthly intervals over the 2-year period. During the 3-monthly follow ups, patients also collected information on the cost of treatment. Using the PDI data, two-thirds of the respondents said that, as a result of their psoriasis, they altered the way they carried out their normal daily activities; more than 50% wore different types or colours of clothing; more than 50% said their home was made more messy or untidy; and over a third had problems at the hairdresser or difficulties playing sport. The annual out-of-pocket expense for medical products was around AUD$250 per person, with costs ranging from zero to more than AUD$2,000 per individual over the 2-year period. Costs were highest for over-the-counter products purchased without a medical prescription. There were similar variations in the out-of-pocket expenses of medical consultations depending on the level of medical care required. The study revealed that the standard methods used for classification of severity of psoriasis, such as the PASI or SAPASI scores, do not take into account the treatment being used at the time the score is recorded and therefore may not accurately reflect the true severity.

Adolescent↗
PubMed2002

Psoriasis is mediated by a cutaneous defect triggered by activated immunocytes: induction of psoriasis by cells with natural killer receptors.

This study was performed to ask whether psoriasis is a unique pathologic response of epidermis of psoriatic patients, or cells with natural killer receptors can induce psoriatic changes in skin from nonpsoriatic donors. Human nonlesional skin from five psoriatics, as well as from seven nonpsoriatics was grafted on to beige-SCID mice. Lymphocyte lines with natural killer activity, and mixed natural killer, natural killer T cell phenotype, were generated by culture of peripheral blood mononuclear cells from both psoriatic, and normal donors, in 100 U interleukin-2 per ml for 14 d. Natural killer cells were injected into the human skin grafts, and the grafts were harvested after 4 wk. Injection of natural killer cells from psoriatic donors into autologous nonlesional psoriatic skin resulted in classic psoriasis histology with a significant increase in epidermal thickness, and proliferation, as well as expression of epidermal human leukocyte antigen DR, intercellular adhesion molecule-1, CD1d, and K-16. Superantigen stimulation was not necessary. In contrast, injection of natural killer cells from normal donors into autologous normal skin did not induce the histology of psoriasis, but that of psoriasiform dermatitis. This is a nonspecific reaction pattern. These grafts also exhibited a significant increase in epidermal thickness, and proliferation. Differences from psoriasis included mild epidermal edema (spongiosis), hypergranulosis, irregular elongation of rete ridges, and lack of thinning of the suprapapillary plate. Injection of allogeneic natural killer cells into grafts also resulted in psoriasiform dermatitis, regardless of the source of natural killer cells, or skin. Psoriasis induction by cells with natural killer receptors appears to be dependent upon the source of skin. This suggests that psoriasis results from a cutaneous defect that is triggered by an autoimmune activation.

Animals↗
PubMed2006

A study examining inter- and intrarater reliability of three scales for measuring severity of psoriasis: Psoriasis Area and Severity Index, Physician's Global Assessment and Lattice System Physician's Global Assessment.

BACKGROUND: There is a lack of consensus as to the best way of monitoring psoriasis severity in clinical trials. The Psoriasis Area and Severity Index (PASI) is the most frequently used system and the Physician's Global Assessment (PGA) is also often used. However, both instruments have some drawbacks and neither has been fully evaluated in terms of 'validity' and 'reliability' as a psoriasis rating scale. The Lattice System Physician's Global Assessment (LS-PGA) scale has recently been developed to address some disadvantages of the PASI and PGA. OBJECTIVES: To evaluate the inter-rater and intrarater reliability of the PASI, PGA and LS-PGA. METHODS: On the day before the study, 14 dermatologists (raters), with varied experience of assessing psoriasis, received detailed training (2.5 h) on use of the scales. On the study day, each rater evaluated 16 adults with chronic plaque psoriasis in the morning and again in the afternoon. Raters were randomly assigned to assess subjects using the scales in a specific sequence, either PGA, LS-PGA, PASI or PGA, PASI, LS-PGA. Each rater used one sequence in the morning and the other in the afternoon. The primary endpoint was the inter-rater and intrarater reliability as determined by intraclass correlation coefficients (ICCs). RESULTS: All three scales demonstrated 'substantial' (a priori defined as ICC > 80%) intrarater reliability. The inter-rater reliability for each of the PASI and LS-PGA was also 'substantial' and for the PGA was 'moderate' (ICC 75%). CONCLUSIONS: Each one of the three scales provided reproducible psoriasis severity assessments. In terms of both intrarater and inter-rater reliability values, the three scales can be ranked from highest to lowest as follows: PASI, LS-PGA and PGA.

Adult↗
PubMed1996

Early onset (< 40 years age) psoriasis is comorbid with greater psychopathology than late onset psoriasis: a study of 137 patients.

Early onset (< age 40 years) psoriasis has been reported to be more readily triggered by environmental factors such as stress, in contrast to late onset (> or = age 40 years) psoriasis. We examined whether certain psychopathologic factors differentiated the psoriasis patient with early onset versus late onset disease. One hundred and thirty-seven psoriasis inpatients completed a battery of psychosocial questionnaires. Logistics regression analysis, using the psychologic measures, age and TBSA affected as independent variables, revealed that higher Anger-in (Anger Expression Scale) scores significantly (p < 0.05) increased the odds or probability of having early versus late onset psoriasis. Psoriasis with onset prior to age 40 is comorbid with greater difficulties with assertion and expression of anger, a personality trait that may adversely affect the patient's capacity to cope with stress.

Adolescent↗
PubMedDate not supplied

Psoriasis: severity assessment in clinical practice. Conclusions from workshop discussions and a prospective multicentre survey of psoriasis severity.

Psoriasis treatment is highly individualized. Although a standardized assessment of psoriasis severity for clinical practice may be theoretically advantageous for the purposes of determining treatment, the relevance of currently available research tools in clinical practice is uncertain. Our objectives were to ascertain in workshop discussions and through a prospective survey the relevance of standard severity measures in clinical practice with regard to choice of treatment. Although there was agreement on the possible structure of an algorithm for the treatment-related definition of psoriasis severity, consensus on the cut-off levels for the PASI and %BSA that would indicate a switch in treatment mode could not be reached. The lack of agreement prompted a prospective survey of 112 patients with psoriasis from 10 countries. This survey used a formal questionnaire asking for the PASI and %BSA scores, the patient's self assessment score (VAS ranging from 0 to 10), location of the psoriatic lesions and disease phase. Severity scores from 20 patients pre-selected for inclusion in a trial of a biological agent were included for comparison. Severity scores were analysed in relation to the choice of treatment (topical or systemic, which included phototherapy and combination) suggested by the treating physician.PASI scores differed significantly between the treatment groups (topical vs systemic, p=0.009); however, there was large overlap in the range of PASI scores between the groups. The same was true for VAS scores (topical vs systemic, p=0.035). %BSA scores were not significantly different between treatment groups. There was a large overlap for both the topical and systemic treatment groups with the biologicals group for the range of both the PASI and %BSA scores. A standardized protocol for the evaluation of psoriasis severity based on established severity scores (PASI, %BSA) appears to be unrealistic in day-to-day clinical practice. In clinical practice, a host of factors must be evaluated alongside possible metric measures. This requires experience and the specialized medical education of those involved in the treatment of patients with psoriasis.

Humans↗
PubMed1998

A clinical survey of psoriasis in Italy: 1st AISP report. Interdisciplinary Association for the Study of Psoriasis.

BACKGROUND: Psoriasis is present all over the world and its prevalence varies in the different populations and different geographical areas. For example, Northern European countries seem to have rates of incidence which are greater than those known for Southern Europe. However, today there is still a lack of adequate data to allow comparisons at an international level. METHODS: In Italy in 1994 the AISP (Interdisciplinary Association for the Study of Psoriasis) co-ordinated the recording of monthly case histories and clinical results relating to psoriasis in patients observed in dermatology centres homogeneously distributed throughout Italy. The results were extrapolated from the overall case series. RESULTS: A sample of nearly 8000 cases was collected, most presenting psoriasis vulgaris. This pathology, prevalent in males, first appears at an age somewhere between the teens and twenties. Numerous factors may be involved, and onset is mainly attributed to stress, viral or bacterial infections and pharmacological therapy. Over 90% of cases lost between 1 and 7 working days in the course of the year. Local anti-psoriasis treatment in monotherapy was administered more frequently than systemic therapy or combined therapy. CONCLUSIONS: The results of this first Italian epidemiological study confirm that psoriasis is homogeneously distributed throughout the country. About 50% of patients avail themselves of specialist cures, even several times in the course of the year, and use a wide range of therapies which may be more or less demanding. The internal socio-economic cost of the disease is evident, particularly in terms of working days lost and/or medical expenses.

Adolescent↗
PubMed2003

[The role of biologics into the management of psoriasis: a consensus paper by the Psoriasis Study Group, Arbeitsgemeinschaft Dermatologische Forschung].

About 20% of all psoriasis patients require photo- and/or systemic therapy because of the severity of their disease. Side effects, contraindications, insufficient clinical responses, and lack of long-term efficacy underline the need for novel and improved anti-psoriatic therapies. In recent years, the technology has been established to generate therapeutic molecules from living cells capable of inhibiting disease-relevant mediators or cell-cell interactions. Several of these so-called biologics interfering with key steps in the immunopathogenesis of psoriasis have the potential to meet this need with regard to treating moderate to severe psoriasis. Here, the Psoriasis Study Group of the Arbeitsgemeinschaft Dermatologische Forschung (ADF) analyses the established anti-psoriatic treatment modalities. With the shortcomings of these options in mind, biologics with an immediate relevance for clinical application in the treatment of psoriasis are discussed. The focus is on their potential medical advantages along with safety aspects. Moreover, legal and economical aspects with an impact on the use of biologics are addressed.

Arthritis, Psoriatic↗
PubMed2003

Animal models of psoriasis and pustular psoriasis.

Investigation of psoriasis and pustular psoriasis is presently hampered by the lack of appropriate animal models. So far, more than ten models have been developed in mice by spontaneous gene mutations and by gene manipulation. However, none of them has satisfactorily reproduced the clinicopathological and immunopathological phenotypes of these diseases. Xenotransplantation techniques have been used for designing models of psoriasis vulgaris, in which CD4(+) T cells have been shown to play an important role. An ideal model for pustular psoriasis should have an immunological background and fulfill the diagnostic criteria of psoriasis.

Animals↗
PubMed2004

A 50% reduction in the Psoriasis Area and Severity Index (PASI 50) is a clinically significant endpoint in the assessment of psoriasis.

A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis. Many consider this endpoint to be too stringent as it places potentially useful therapies at risk of failing to demonstrate efficacy. We hypothesized that a 50% reduction in the PASI score (PASI 50) represents a meaningful change in a person's life and thus is a better primary endpoint. To test this hypothesis, we analyzed PASI scores, quality of life (QoL) data, and desired re-treatment scores from a number of clinical trials in addition to studying individual elements that make up the PASI. This analysis shows (1). the PASI score is not linearly reflective of psoriasis severity (eg, a reduction in area of 95% without a change in redness, scaliness, and induration translates to only a 66% reduction in PASI); conversely, a drop in erythema, scale, and induration from an average of 3 to 1 would not lead to a 75% reduction in PASI; (2). treatment with methotrexate, an effective psoriasis therapy, more frequently reaches PASI 50 than PASI 75 as evidenced by a recent open trial in which 63% of patients achieved PASI 50 versus 26% achieving PASI 75; (3). improvement in QoL exists at PASI 50, using the Dermatology Quality of Life Index, as documented in several recently completed large clinical trials; (4). patients achieving PASI 75 frequently defer therapy until they are well below PASI 50; a clinical trial where retreatment was patient initiated showed patients did not re-treat until their PASI dropped to an average of 20% improvement from baseline; and (5). effective, meaningful therapies are consistently differentiated from placebo at PASI 50 as evidenced by histologic and photographic parameters of clinical trials of alefacept, efalizumab, and etanercept. We conclude that PASI 50 equates to a clinically meaningful improvement in psoriasis and represents a discerning primary endpoint.

Humans↗
PubMed1983

Etretinate in severe psoriasis. Results of double-blind study and maintenance therapy in pustular psoriasis.

A randomized double-blind study was performed in forty patients with severe psoriasis. Etretinate, in contrast to placebo, clearly reduced the psoriatic area and severity index score, and this difference was statistically significant from week 2. The results in psoriasis vulgaris were satisfactory in only three of ten patients; however moderate improvement was noticed in four of ten patients. In pustular psoriasis of von Zumbusch type, the drug produced moderate improvement to complete clearing in all four of the treated patients and was regarded as the first-choice therapy in all of them. In erythrodermic psoriasis satisfactory results were obtained in four of six patients. In three of the five patients with psoriatic arthropathy there was a marked improvement of arthralgia. Laboratory investigations did not show significant abnormalities with the exception of an increase of alanine transaminase (ALT; SGPT) in about 20% of the patients. Ten patients with pustular psoriasis (four of them included in the double-blind trial) on long-term, i.e., maintenance, therapy remained free of lesions up to this writing for 3 years. Triglyceride levels were not elevated.

Clinical Trials as Topic↗
PubMed1988

A novel approach for the evaluation and treatment of psoriasis. Oral or topical use of 1,25-dihydroxyvitamin D3 can be a safe and effective therapy for psoriasis.

We investigated the effects of 1,25-dihydroxyvitamin D3 (1,25-(OH)2-D3) on cultured fibroblasts and keratinocytes from patients with psoriasis and treated 17 patients with psoriasis with orally or topically administered 1,25-(OH)2-D3. Cultured fibroblasts from three of five patients showed a normal response to the antiproliferative activity of a physiologic dose of 1,25-(OH)2-D3, whereas fibroblasts from the other two had a partial resistance to the drug. Cultured keratinocytes from two patients with psoriasis possessed nuclear receptors for 1,25-(OH)2-D3 and the drug caused a dose-dependent inhibition of proliferation and induction of terminal differentiation of these cells similar to effects in normal cultured keratinocytes. Ten of 14 patients with moderate to severe psoriasis who received oral 1,25-(OH)2-D3 showed significant clearing of their hyperkeratotic plaques. Three patients had complete clearing that was sustained with maintenance therapy, but four patients received little or no benefit from the therapy. By the administration of 1,25-(OH)2-D3 as a single oral dose at bedtime, larger doses of the drug could be tolerated without evidence of hypercalciuria or hypercalcemia. Three patients who received topical 1,25-(OH)2-D3 showed a rapid response with complete clearing after 6 weeks of therapy. Therefore, these preliminary findings suggest that orally or topically administered 1,25-(OH)2-D3 may be a safe and effective alternative therapy for the treatment of psoriasis.

Administration, Cutaneous↗
PubMed1988

Psoriasis and drugs: influence of tetracyclines on the course of psoriasis.

Patients with psoriasis vulgaris (462) were studied by questionnaire to find the effect on psoriasis of drug therapy for intercurrent diseases or focal infections. Of 462 patients with psoriasis, in 76 (16.45%) the disease became more severe during drug therapy. Of these, 19 worsened after administration of tetracyclines, and in five psoriasis was precipitated after therapy with drugs of the tetracycline family. We suggest that tetracyclines should be avoided in patients with psoriasis and in healthy persons with a genetic predisposition (positive family history, human leukocyte antigens B13, B17, B27).

Ampicillin↗
PubMed1997

Terbinafine therapy may be associated with the development of psoriasis de novo or its exacerbation: four case reports and a review of drug-induced psoriasis.

Adverse effects may occur in 10.4% of patients receiving terbinafine therapy, with cutaneous reactions in 2.7%. We describe the development of psoriasis in four patients who took oral terbinafine. Two patients had plaque-type psoriasis that flared 12 and 17 days, respectively, after starting terbinafine. Another patient developed pustular-type psoriasis de novo after 27 days of terbinafine therapy. The fourth patient was a psoriatic with stable plaque disease who experienced a pustular flare after taking terbinafine for 21 days. We are aware of only one report in the literature in which a patient developed pustular psoriasis de novo after 5 days of terbinafine therapy. In all patients the psoriasis cleared or lessened after discontinuation of terbinafine and institution of antipsoriatic therapy.

Adult↗
PubMed2003

Attentional bias for psoriasis-specific and psychosocial threat in patients with psoriasis.

Information processing biases relate to the manner in which people attend to particular types of information more readily than others. This bias, which is central to cognitive models of disorder, has not been explored in patients with psoriasis. The purpose of this study was to examine whether patients with psoriasis show an automatic attentional bias to classes of information relative to controls. Sixty patients and 60 age- and sex-matched controls completed a computer-based attentional interference task (the modified Stroop task). Patients with psoriasis showed significant interference for disease-specific, self-referent, and others' behavior stimuli relative to controls. In terms of information processing biases, the relationship between subject status (psoriasis patient vs. control) and color-naming interference was significantly stronger than that between anxiety, depression and worry, and interference. Recall bias was limited to disease-specific stimuli only. The observed bias to threat is more appropriately accounted for by participant's status (i.e., psoriasis patient or control) than by psychological distress.

Adult↗
PubMed2006

Observations of psoriasis in the absence of therapeutic intervention identifies two unappreciated morphologic variants, thin-plaque and thick-plaque psoriasis, and their associated phenotypes.

Psoriatic plaque thickness is a clinical measure of psoriasis severity. We have observed that patients tend to revert to a baseline thickness of psoriatic plaques when in an untreated state, and hypothesized that other features of psoriasis could associate with this trait. Data prospectively collected on 500 participants in the Utah Psoriasis Initiative were used for the study. In response to a question assessing plaque thickness when disease was at its worst, 144 (28.8%) reported thick plaques, 123 (24.6%) reported thin plaques, and 233 (46.6%) reported intermediate thickness. For patients with "worst-ever" disease at enrollment (n=122), there was significant correlation of thickness between assessment by the patient and the physician (r=0.448, P-value 0.01). Thick plaques associated with male gender, increased body mass index, nail disease, psoriatic arthritis, larger plaques, more body sites, and greater total body surface area affected. Thin plaques associated with eczema, guttate psoriasis, and skin cancer. We suggest that this is preliminary evidence that plaque thickness is an easily measured trait that associates with other clinical features of psoriasis, and that stratification on this phenotype may be useful in further defining the genetic basis of this disease.

Adult↗
PubMed2003

Psoriasis patients who are homozygous for the HLA-Cw*0602 allele have a 2.5-fold increased risk of developing psoriasis compared with Cw6 heterozygotes.

BACKGROUND: Psoriasis is strongly associated with certain human leucocyte-associated antigens, especially HLA-Cw*0602. Patients who are HLA-Cw*0602 positive have been reported to have more active disease and a younger age at disease onset than HLA-Cw6-negative patients. OBJECTIVES: To ascertain whether there are differences in the clinical features and relative risk between HLA-Cw*0602 homozygous and heterozygous psoriasis patients. METHODS: One thousand and six patients with chronic plaque psoriasis were evaluated clinically and HLA-C typed. In addition, 512 unrelated controls were typed for HLA-C. RESULTS: Of the patients 646 (64.2%) were HLA-Cw*0602 positive, and 68 (6.8%) were homozygous for this allele. Heterozygosity was associated with a relative risk of developing psoriasis of 8.9 compared with 23.1 for the Cw6 homozygous patients. The homozygous patients also had an earlier disease onset (mean 15.0 vs. 17.8 years, P = 0.04). However, the Cw6 homozygotes did not differ from the heterozygotes with respect to disease severity, guttate onset, distribution of plaques, nail changes or any other clinical parameter recorded. CONCLUSIONS: Homozygosity for the gene in the major histocompatibility complex region has a major additive impact on the risk of developing psoriasis and predisposes to an earlier disease onset, but does not have any marked influence on the phenotype or the severity of the disease.

Adolescent↗