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Abstracts

Life Extension Magazine September 2009
Reports

DermaWhey

The impact of psoriasis on health care costs and patient work loss.

BACKGROUND: There are few comprehensive estimates of the cost of psoriasis in the United States. OBJECTIVE: We sought to quantify the incremental direct medical and indirect work loss costs associated with psoriasis. METHODS: A de-identified claims database from 31 self-insured employers during the period 1998 to 2005 was used. Patients with at least two psoriasis diagnosis claims (N = 12,280) were compared with 3 control subjects (matched on year of birth and sex) without psoriasis. Multivariate two-part regression analysis was used to isolate the incremental cost of psoriasis by controlling for comorbidities and other confounding factors. RESULTS: After multivariate adjustment, the incremental direct and indirect costs of psoriasis were approximately $900 and $600 (P < .001) per patient per year, respectively. LIMITATIONS: The database used in this study does not contain information on patient out-of-pocket costs or loss of productivity costs at work. CONCLUSION: The incremental cost of psoriasis is approximately $1500 per patient per year, with work loss costs accounting for 40% of the cost burden.

J Am Acad Dermatol. 2008 Nov;59(5):772-80

Cardiovascular disease and risk factors among psoriasis patients in two US healthcare databases, 2001-2002.

BACKGROUND: Cardiovascular diseases or risk factors (CVDR) seem to be more common in psoriasis patients than in the general population. OBJECTIVE: We assessed the relationship of psoriasis with CVDR by analysis of healthcare claims data using a cross-sectional, prevalence-based study design. PATIENTS AND MeTHODS: The IMS Health and MarketScan claims databases were used to identify adults with psoriasis diagnostic codes. Non-psoriasis controls were matched 3:1 based on age, gender, census region and previous medical insurance coverage. Odds ratios evaluated the relative prevalence of CVDR, and Mantel-Haenszel confidence intervals were estimated. RESULTS: CVDR prevalence was generally higher in psoriasis patients than controls in both datasets. Odds ratios for atherosclerosis, congestive heart failure, type 2 diabetes, and peripheral vascular disease were >or=1.20 for psoriasis patients. Elevated disease severity was associated with a higher rate of CVDR, but varied somewhat by dataset and condition. Conclusions: Elevated CVDR rates were found in psoriasis patients compared with controls. This pattern merits further examination.

Dermatology. 2008;217(1):27-37

Psoriasis and the risk of diabetes and hypertension: a prospective study of US female nurses.

OBJECTIVE: To evaluate the independent association between psoriasis and risk of diabetes and hypertension. DESIGN: A prospective study of female nurses who were followed up from 1991 to 2005. SETTING: Nurses’ Health Study II, a cohort of 116,671 US women aged 27 to 44 years in 1991. PARTICIPANTS: The study included 78,061 women who responded to a question about a lifetime history of physician-diagnosed psoriasis in 2005. Women who reported a diagnosis of diabetes or hypertension at baseline were excluded. Main Outcome Measure: New diagnosis of diabetes or hypertension, obtained from biennial questionnaires. RESULTS: Of the 78,061 women, 1,813 (2.3%) reported a diagnosis of psoriasis. During the 14 years of follow-up, a total of 1560 incident cases (2%) of diabetes and 15,724 incident cases (20%) of hypertension were documented. The multivariate-adjusted relative risk of diabetes in women with psoriasis compared with women without psoriasis was 1.63 (95% confidence interval, 1.25-2.12). Women with psoriasis were also at an increased risk for the development of hypertension (multivariate relative risk, 1.17; 95% confidence interval, 1.06-1.30). Age, body mass index, and smoking status did not significantly modify the association between psoriasis and risk of diabetes or hypertension (P values for interaction, > or =.07). CONCLUSIONS: In this prospective analysis, psoriasis was independently associated with an increased risk of diabetes and hypertension. Future studies are needed to find out whether psoriasis treatment will reduce the risk of diabetes and hypertension.

Arch Dermatol. 2009 Apr;145(4):379-82

Genome-wide scan reveals association of psoriasis with IL-23 and NF-kappaB pathways.

Psoriasis is a common immune-mediated disorder that affects the skin, nails and joints. To identify psoriasis susceptibility loci, we genotyped 438,670 SNPs in 1,409 psoriasis cases and 1,436 controls of European ancestry. We followed up 21 promising SNPs in 5,048 psoriasis cases and 5,041 controls. Our results provide strong support for the association of at least seven genetic loci and psoriasis (each with combined P < 5 x 10(-8)). Loci with confirmed association include HLA-C, three genes involved in IL-23 signaling (IL23A, IL23R, IL12B), two genes that act downstream of TNF-alpha and regulate NF-kappaB signaling (TNIP1, TNFAIP3) and two genes involved in the modulation of Th2 immune responses (IL4, IL13). Although the proteins encoded in these loci are known to interact biologically, we found no evidence for epistasis between associated SNPs. Our results expand the catalog of genetic loci implicated in psoriasis susceptibility and suggest priority targets for study in other auto-immune disorders.

Nat Genet. 2009 Feb;41(2):199-204

Safety and efficacy of a milk-derived extract in the treatment of plaque psoriasis: an open-label study.

BACKGROUND: XP-828L is a nutraceutical compound obtained by the extraction of a growth factors-enriched protein fraction from bovine milk. XP-828L may improve psoriasis. OBJECTIVES: An open-label study was performed to determine the efficacy, tolerability and safety of XP-828L in the treatment of plaque psoriasis. METHODS: Eleven adult patients with chronic, stable plaque psoriasis on 2% or more of body surface area (BSA) received 5 g of oral XP-828L twice daily for 56 days. RESULTS: All 11 patients completed the 56 days of treatment. At day 28, 6 of the 11 patients showed a reduction in PASI score. At 56 days, seven subjects had a decrease in PASI score ranging from 9.5% to 81.3%. Eight (8) out of 11 patients agreed to participate in an additional 8-week extension treatment phase. Improvement of psoriasis was maintained during the extension period. No clinically significant adverse events or laboratory abnormalities occurred. CONCLUSION: XP-828L may improve psoriasis in patients with mild-to-moderate psoriasis.

J Cutan Med Surg. 2005 Dec;9(6):271-5

XP-828L in the treatment of mild to moderate psoriasis: randomized, double-blind, placebo-controlled study.

BACKGROUND: XP-828L, a protein extract obtained from sweet whey, has demonstrated potential benefit for the treatment of mild to moderate psoriasis in an open-label study. OBJECTIVE: To study in a randomized, double-blind, placebo-controlled study the safety and efficacy of XP-828L in the treatment of mild to moderate psoriasis. DESIGN: XP-828L 5 g/d (group A, n = 42) or placebo (group B, n = 42) was given orally for 56 days followed by XP-828L 5 g/d in group A and by XP-828L 10 g/d in group B for an additional 56 days. RESULTS: Patients receiving XP-828L 5 g/d for 56 days had an improved Physician’s Global Assessment (PGA) score compared with patients under placebo (p < .05). Considering the data of group A only, the PGA score improved from day 1 to day 56 (p < .01); the Psoriasis Area and Severity Index score improved as well, but to a lesser extent (p < .05). CONCLUSION: Oral administration of 5 g/d XP-828L compared with a placebo significantly improved the PGA score of patients with mild to moderate psoriasis.

J Cutan Med Surg. 2006 Sep-Oct;10(5):241-8

Association of patient-reported psoriasis severity with income and employment.

OBJECTIVE: We sought to examine whether psoriasis severity was associated with patient income and employment. METHODS: Respondents (> 30 years old) to National Psoriasis Foundation surveys (2003-2005) were classified by reported body surface area as having mild (< 3%), moderate (3%-10%), or severe (> 10%) psoriasis. The relationship between severity and household income (< $30,000 vs > or = $30,000) and employment was assessed by logistic regression, adjusting for age, age at onset, sex, race, and drug treatment. RESULTS: Probability of low income (< $30,000) was significantly greater among patients with severe disease than those with mild disease (P = .0002). Patients with severe disease had lower probability of working full time compared with patients with mild psoriasis but it was not statistically significant. Significantly more patients with severe psoriasis (17%) versus mild (6%) reported that psoriasis was the reason for not working (P = .01). LIMITATIONS: Household income was self-reported and may be influenced by household composition, which is unknown. Psoriasis severity was patient reported and not physician assessed. CONCLUSIONS: This study demonstrated that income and employment were negatively impacted among patients with severe psoriasis compared with mild psoriasis.

J Am Acad Dermatol. 2007 Dec;57(6):963-71

Treatments for psoriasis and the risk of malignancy.

BACKGROUND: There are multiple therapeutic options for the treatment of moderate to severe psoriasis. The process of choosing among potential treatment options requires both the physician and the patient to weigh the benefits of individual modalities against their potential risks. Traditional systemic therapies for psoriasis, including methotrexate (MTX) and cyclosporine (CsA), have a well-documented array of toxicities, particularly end-organ toxicities. Over the past several years, the use of biologic therapies for the treatment of moderate to severe psoriasis has been a major clinical and research focus. With the advent of these novel immunosuppressive therapies, one of the central safety issues surrounding these agents is their potential to increase the risk of malignancy. OBJECTIVE: Our objective was to review the risk of malignancy associated with therapies for moderate to severe psoriasis, including phototherapy, traditional systemic therapies, and biologic therapies. We reviewed the existing body of literature in order to define the known incidence of malignancy associated with psoralen and ultraviolet A (PUVA), narrowband and broadband ultraviolet B (UVB), MTX, CsA, mycophenolate mofetil (MMF), and biologic therapies, including alefacept, efalizumab, infliximab, etanercept, adalimumab, and ustekinumab. RESULTS: PUVA, when given long term, is associated with increased risks of cutaneous squamous cell carcinoma and malignant melanoma. Reviews of studies on UVB, both narrowband and broadband, do not indicate any increased risk of nonmelanoma skin cancer or melanoma. The traditional systemic psoriasis therapies-MTX, CsA, and MMF-may be associated with an increased risk of lymphoproliferative disorders during treatment, demonstrated in clinical trials in patients with rheumatoid arthritis and documented in case reports concerning psoriasis patients. The risk of malignancy with biologic therapy is still unclear. However, the majority of studies examining this carcinogenic risk suggest that tumor necrosis factor-alpha inhibitors may cause a slightly increased risk of cancer, including nonmelanoma skin cancer and hematologic malignancies. LIMITATIONS: The majority of studies cited in this review lack the power and randomization of large clinical trials, as well as the long-term follow-up periods which would further substantiate the hypothetical link between these antipsoriatic treatment regimens and the potential for malignancy. Because of the substantial lack of clinical data, the majority of studies evaluated focus on the treatment of patients with rheumatoid arthritis, which is a systemic inflammatory disorder comparable to psoriasis. Additionally, the increased risk of malignancy associated with psoriasis itself is a confounding factor. CONCLUSION: Many of the therapies for moderate to severe psoriasis, including PUVA, traditional systemic therapies, and some biologic therapies, may increase the risk of malignancy. Appropriate patient counseling and selection, as well as clinical follow-up, are necessary to maximize safety with these agents. Further long-term study is necessary to more precisely quantify the risks associated with biologic therapies.

J Am Acad Dermatol. 2009 Jun;60(6):1001-17

Topical 8-methoxypsoralen enhances the therapeutic results of targeted narrowband ultraviolet B phototherapy for plaque-type psoriasis.

Targeted broadband ultraviolet B (UVB) phototherapy as well as 308-nm excimer laser have been reported to significantly improve or clear localized psoriatic plaques within 5 to 10 treatments when medium fluences [i.e. 4-6 multiples of minimal erythema doses (MED)] were used. Our study was conducted to determine the effects of different concentrations of topical 8-methoxypsoralen (8-MOP) cream when used in combination with targeted UV phototherapy with regard to number of treatments and cumulative UV doses to clear localized psoriasis. Ten evaluable patients with stable plaque-type psoriasis completed the study. Three different concentrations of 8-MOP creams (0.001%, 0.01% and 0.1%) were applied prior to irradiation with 4 MEDs of targeted narrowband UVB (NB-UVB), whereas 0.001% 8-MOP cream was used in conjunction with 5 J/cm(2) UVA. All irradiations took place once weekly for 12 weeks. Psoriasis severity index (PSI) score was used to evaluate the efficacy of the treatment. With area-under-the-curve analysis, 0.1% 8-MOP/NB-UVB was superior to other modalities in reducing the PSI scores. The number of treatments and cumulative NB-UVB doses necessary to achieve PSI-95, a 95% reduction in the scores, was also lower in the 0.1% 8-MOP/NB-UVB group, although the differences were not statistically significant. We conclude that topical 8-MOP cream enhances the therapeutic effects of targeted NB-UVB phototherapy without significantly increasing the short-term adverse effects.

J Eur Acad Dermatol Venereol. 2008 Jan;22(1):50-5

308 nm monochromatic excimer light in dermatology: personal experience and review of the literature.

For over five years, we have been using a new ultraviolet B ray source, a Xenon-Chloride lamp emitting non-coherent, monochromatic 308-nm light that represents the natural evolution of the excimer laser. A source of monochromatic excimer light (MEL) produces 50 mW/cm(2) power density at a distance of 15 cm from the source and has a maximum irradiating area of 504 cm(2), this feature representing the greatest therapeutic advantage offered by 308 nm sources. On the other hand, the benefits offered by the MEL compared to traditional phototherapies are essentially correlated to the fact that there is no need to administer oral psoralens (PUVA therapy) and that sessions need to be repeated only every 7-15 days, an important condition for the improvement of the patient’s quality of life (since at least 2-3 weekly sessions are required with the traditional UVB therapy). Using MEL, UV B light can be applied on the entire body, with partial subintrant skin irradiations, or on one or just a few individual patches, taking care to accurately protect the healthy surrounding skin and allowing for a phototherapy exclusively targeted onto the lesion to be treated. Clinical indications and the reasons for choosing MEL for the treatment of photosensitive skin disorders are virtually identical to those stated for PUVA therapy or narrowband UV B light. Due to the absence of photosensitizing substances and drug-induced toxicity, patients who work in the open air, pregnant women and patients suffering from liver or kidney failure can also be treated. Furthermore, the short time required for sessions, the duration of cycles and the selective exposure of the skin areas to be treated undoubtedly represent significant benefits for patients in terms of safety and efficacy. In addition to psoriasis, the use of MEL can also be extended to other pathologies such as vitiligo, alopecia areata, atopic dermatitis and patch-stage IA mycosis fungoides with encouraging results.

G Ital Dermatol Venereol. 2008 Oct;143(5):329-37

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