Psoriasis Publications

BACKGROUND: Psoriasis has a profound negative effect on quality of life that is often underappreciated by health care professionals and the public.

OBJECTIVE: We sought to assess the perception of the burden of psoriasis relative to other medical conditions in first-year medical students, and to determine if wearing a temporary tattoo simulating psoriasis during a teaching exercise would change their perceptions.

METHODS: Participants completed a questionnaire assessing their perception of the impact of psoriasis and other common medical conditions (visual analog scale). Participants then wore a temporary tattoo of a psoriatic lesion for 24 hours and completed the same questionnaire after this exercise.

RESULTS: Of 91 students approached, 61 completed the study. At baseline, psoriasis (mean = 23.6) and eczema (mean = 23.3) were perceived as having the lowest physical burden of diseases queried (P < .0001), whereas the mental impact of psoriasis was scored comparably with arthritis, heart disease, and diabetes (mean = 45.1-56.7), but lower than cancer (mean = 82.2) and depression (mean = 93.8). After the exercise, the perception of the impact of eczema (physical: mean = 37.3, P < .0001; mental: mean = 66.6, P = .0005) and psoriasis (physical: mean = 37.8, P = .0014; mental: mean = 68.6, P = .0293) was significantly increased.

LIMITATIONS: The exercise did not simulate the chronic nature of psoriasis or the scaling and pruritic characteristics of psoriatic lesions. The survey instrument used to assess empathy has not been previously validated and statistical analysis was limited by small sample size and the absence of a control group.

CONCLUSIONS: Temporary tattoos are a novel and effective method of teaching medical students about the psychological burden of psoriasis.

BACKGROUND: Patients with psoriasis are known to have an increased number of cardiovascular (CV) risk factors and be at increased risk for CV events.

OBJECTIVES: We sought to describe and characterize the underdiagnosis and undertreatment of CV risk factors in patients with moderate to severe psoriasis.

METHODS: Medical histories including diabetes, hypertension, and hyperlipidemia were obtained from 2899 patients in 3 phase III ustekinumab trials, a therapeutic anti-interleukin (IL)-12/IL-23p40 monoclonal antibody. Reported history was compared with measured fasting glucose, fasting lipids, and blood pressure. Ten-year Framingham risk scores and the proportion of patients achieving glycemic, lipid, and blood pressure targets were evaluated.

RESULTS: Significant risk factors existed in patients with moderate to severe psoriasis (58.6% and 28.8% of patients had ≥ 2 and ≥ 3 established CV risk factors, respectively). Based on Framingham risk score, 18.6% of patients were at high risk and 12.3% were at intermediate risk for CV events. At baseline, a small proportion of patients with diabetes (2.3%), hypertension (9.1%), or hyperlipidemia (4.9%) were previously without a diagnosis. However, 19.1%, 21.8%, and 38.6% of patients with diabetes, hypertension, or hyperlipidemia, respectively, were untreated at baseline, and the proportion at treatment goal was not ideal (hypertension 59.6% and hyperlipidemia 69.7%), especially for diabetes (36.7%).

LIMITATIONS: Results are based on a clinical trial population and findings may not be generalizable to the general psoriasis population.

CONCLUSIONS: In this moderate to severe psoriasis population, a high prevalence of undiagnosed and undertreated CV risk factors existed, emphasizing the importance of screening patients with psoriasis for CV risk factors.

BACKGROUND: Treating psoriasis in pregnant and lactating women presents a special challenge. For ethical reasons, prospective randomized control trials have not been conducted in this patient population although these patients do encounter new-onset psoriasis in addition to flares and may require treatment throughout their pregnancies.

OBJECTIVE: Our aim was to arrive at consensus recommendations on treatment options for psoriasis in pregnant and lactating women.

METHODS: The literature was reviewed regarding all psoriasis therapies in pregnant and lactating women.

RESULTS: Topical therapies including emollients and low- to moderate-potency topical steroids are first-line therapy for patients with limited psoriasis who are pregnant or breast-feeding. The consensus was that second-line treatment for pregnant women is narrowband ultraviolet B phototherapy or broadband ultraviolet B, if narrowband ultraviolet B is not available. Lastly, tumor necrosis factor-α inhibitors including adalimumab, etanercept, and infliximab may be used with caution as may cyclosporine and systemic steroids (in second and third trimesters). Some specific strategies may be used to minimize risk and exposure.

LIMITATIONS: There are few evidence-based studies on treating psoriasis in pregnant and lactating women.

CONCLUSIONS: Because there will always be a question of ethical concerns placing pregnant and lactating women in prospective clinical trials, investigation of both conventional and biologic agents are unlikely to ever be performed. Some of these medications used to treat psoriasis are known abortifacients, mutagens, or teratogens and must be clearly avoided but others can be used with relative confidence in select patients with appropriate counseling of risks and benefits.

BACKGROUND: Symptoms of psoriasis can be embarrassing and distressing, and may increase risk of developing psychiatric disorders in young people.

OBJECTIVE: We sought to compare incidences of psychiatric disorders between pediatric patients with psoriasis and psoriasis-free control subjects.

METHODS: Patients (<18 years) with continuous health plan enrollment 6 months before and after first psoriasis diagnosis (index date) were selected (Thomson Reuters MarketScan database, 2000-2006 [Thomson Reuters, New York, NY]). Patients with psoriasis (N = 7404) were matched 1:5 on age and sex to psoriasis-free control subjects (N = 37,020). Patients were followed from index date to first diagnosis of a psychiatric disorder (ie, alcohol/drug abuse, depression, anxiety disorder, bipolar disorder, suicidal ideation, eating disorder), end of data availability, or disenrollment. Patients with psychiatric diagnoses or psychotropic medication use before the index date were excluded. Cox proportional hazard models controlling for age, sex, and comorbidities were used to estimate the effect of psoriasis on risks of developing psychiatric disorders.

RESULTS: Patients with psoriasis were significantly more at risk of developing psychiatric disorders versus control subjects (5.13% vs 4.07%; P = .0001; hazard ratio = 1.25; P = .0001), especially depression (3.01% vs 2.42%; P = .0036; hazard ratio = 1.25; P = .0053) and anxiety (1.81% vs 1.35%; P = .0048; hazard ratio = 1.32; P = .0045).

LIMITATIONS: Retrospective, observational studies of medical claims data are typically limited by overall quality and completeness of data and accuracy of coding for diagnoses and procedures.

CONCLUSIONS: Pediatric patients with psoriasis had an increased risk of developing psychiatric disorders, including depression and anxiety, compared with psoriasis-free control subjects.

BACKGROUND: Long-term observational studies can better characterize the impact of systemic agents on psoriasis.

OBJECTIVE: To describe the on-going Psoriasis Longitudinal Assessment and Registry (PSOLAR) study.

METHODS: PSOLAR is a large, international, long-term, prospective, disease-based registry enrolling patients with psoriasis who are receiving, or are candidates for, treatment with systemic therapies. The registry fulfills postmarketing regulatory commitments and charges a global Steering Committee to manage epidemiological research on psoriasis and its therapies. Key demographics, disease characteristics, and medication history are collected at enrollment. Adverse events and efficacy data are collected longitudinally.

RESULTS: The August 2011 annual database extract includes 9,495 patients enrolled at 266 global centers. At entry, mean percent of body surface area affected by psoriasis was 12.3% (peak, 29.5%). Approximately 80% of patients were overweight/obese, more than one-third had cardiovascular disease (38.8%) or psoriatic arthritis as captured by the treatment center (37.1%), and over half had received one or two biologic agents (58.8%) or phototherapy (54.8%). Mean duration of participation is 1.3 years, and annual withdrawal rates are less than 6.5%. Of 9,495 patients, 7,476 have been exposed to at least one biologic agent. Serious infections, malignancies, all-cause mortality, and major adverse cardiovascular events (ie, myocardial infarction, stroke, cardiovascular death) occurred at rates of 1.40, 0.61, 0.37, and 0.36 per 100 patient-years of follow-up, respectively.

LIMITATIONS: PSOLAR may be subject to limitations common to observational studies (eg, participation bias and potential confounders).

CONCLUSION: PSOLAR is a disease-based registry designed to assess therapeutic risk and benefit in the general psoriasis population.

BACKGROUND: Psoriasis affects 7 million people in the United States, causing substantial cost, social stigma, and disability.

OBJECTIVE: The purpose of this study was to evaluate the health effects of skin disease by comparing psoriasis to other primary medical disorders using 3 different scales of health-related quality of life.

METHODS: A self-administered questionnaire consisting of 3 health-related quality of life measures was given sequentially to 35 eligible patients with psoriasis presenting to the Dermatology Branch of the National Cancer Institute (NCI) for an investigational therapeutic protocol.

RESULTS: All patients (100%) agreed to participate. The median Psoriasis Area and Severity Index (PASI) score was 13.0. Overall, 82.9% at least often felt the need to hide their psoriasis, and 74.3% claimed their self-confidence was at least often affected by their psoriasis. The median EQ-5D health state utility score was 13.0% less than healthy individuals (P <.001). On the SF-36, the mean general health score was 13.2% less (P =.005) and the median social functioning score 18.7% less (P =.005) than that of patients with no chronic conditions.

CONCLUSION: Individuals with psoriasis are significantly affected in their health state utility, perception of general health, and social functioning when compared with individuals without chronic disease and those with certain primary medical conditions.

BACKGROUND: In several open-label studies, recombinant human interleukin 10 (rhIL-10), a type 2 anti-inflammatory cytokine, has been reported to improve psoriasis, a disease characterized by type 1 cytokine inflammation.

OBJECTIVE: To evaluate the safety, efficacy, and immunologic parameters in individuals with psoriasis treated with rhIL-10.

DESIGN AND INTERVENTION: Patients received rhIL-10 (20 micro g/kg) or placebo subcutaneously 3 times weekly for 12 weeks in a randomized, double-blind manner.

SETTING AND PATIENTS: National Institutes of Health Clinical Center in Bethesda. Twenty-eight patients with moderate-to-severe psoriasis as defined by a Psoriasis Area Severity Index (PASI) score of 10 or higher.

MAIN OUTCOME MEASURE: The primary clinical end point was the mean percentage change in the PASI score comparing baseline and week 12 scores. Intracellular cytokine production by peripheral blood mononuclear cells (PBMCs) was measured by flow cytometry.

RESULTS: There was no significant difference in the mean percentage change in the PASI score from baseline to week 12 between the rhIL-10-treated group and control patients (17% vs 13% improvement, respectively; P =.69), although a modest trend toward improvement in patients receiving rhIL-10 was documented at both the 6- and 8-week points. Interestingly, proinflammatory and type 1 cytokine production by PBMCs progressively declined in the rhIL-10-treated patients during the entire 12-week study period.

CONCLUSIONS: Treatment with rhIL-10 resulted in only temporary clinical improvement in psoriasis, despite sustained systemic decreases in proinflammatory and type 1 cytokine production. These data suggest that immunotherapy that decreases the ratio of systemic type 1 and type 2 cytokine production does not necessarily lead to improvement of type 1 cytokine-mediated disease.

Psoriasis can have a profound impact on a patient, interfering in all aspects of life. Therefore, measuring the impact of disease and the effects of treatment must include both physiologic measurements as well as health-related quality of life tools. Psychosocial evaluation of patients at risk allows for early interventions that will promote positive patient outcomes and compliance with the treatment pathways.

For topical medications commonly used to treat dermatologic conditions, outcomes may be affected by the choice of delivery vehicles. The aim of this study was to compare quality of life (QOL), effectiveness, user satisfaction, and cost-effectiveness of 2 clobetasol regimens for the treatment of psoriasis over 14 days. In a single-blind design, 32 patients randomized into 2 groups applied either clobetasol foam 0.05% to the skin and scalp or combination clobetasol cream 0.05% to the skin and clobetasol solution 0.05% to the scalp. Psoriasis severity was measured using the standardized Psoriasis Area and Severity Index (PASI) and self-administered PASI (SAPASI). QOL was assessed via the EuroQoL-5D (EQ-5D) questionnaire and Dermatology Life Quality Index (DLQI). Cost-effectiveness was measured by the amount of medication used per body surface area (BSA) treated and by cost per point improvement in PASI score. In this study, a foam formulation performed better than a cream/solution combination by several measures. A greater absolute improvement in psoriasis severity was seen in the group using the foam than in the group using the cream/solution (mean decrease in PASI=5.0 vs 3.3, P=.05). The PASI score in the foam group decreased by 41% versus 35% in the cream/solution group (P=.17). In scalp psoriasis, the group using the foam had greater improvement in both absolute (P=.03) and percentage (P=.03) terms and than the solution group. When measuring global QOL, foam users had a significantly greater increase in EQ-5D than those using the cream/solution in absolute (P=.05, P=.02) and percentage (P=.04, P=.02) terms (first and second survey components, respectively). Differences in improvement of skin-specific QOL, quantified by DLQI scores between groups, were suggested but not statistically significant. Patients using foam spent less time applying medication compared with previous topical medications (P<.001). No significant difference in cost was appreciated between foam and cream/solution over the period after controlling for BSA (8.18 dollars vs 7.05 dollars per percentage BSA affected, P=.30).

BACKGROUND: The Psoriasis Area and Severity Index (PASI) is the most frequently used clinical severity scale in clinical trials. Drug approval often depends on a 75% improvement in the baseline PASI score, also known as a PASI 75 or Delta PASI 75. This benchmark may be an overly stringent way to determine the success of psoriasis treatments as Delta PASIs appear to under-represent true clinical improvement. This discrepancy may relate to the way numerical values are assigned to the degree of body surface area (BSA) involvement.

OBJECTIVES: To assess whether altering the BSA component of the PASI formula so that it is weighted more heavily will result in a calculated change in psoriasis severity that more closely reflects patient assessment of improvement. Models developed included the Psoriasis Log-based Area and Severity Index (PLASI), which assigns values to the BSA score based on a linear scale using logarithms to define the intervals, and the Psoriasis Exact Area and Severity Index (PEASI), which uses the actual BSA as the multiplicative factor in the area score.

METHODS: Data were abstracted retrospectively from two clinical trials involving psoriasis treatments that used the PASI. The same trained psoriasis graders were involved in both trials. In these trials, baseline and end-point PASI worksheets were completed that included the actual clinician-estimated BSA involvement (0-100%) for each of the four areas (head, upper extremities, trunk and lower extremities). In one of the trials, patients were asked to assess the percentage improvement in their psoriasis at the end of the treatment window. PASIs and Delta PASIs were recalculated based on the new models and all scoring systems were validated by analysing their relationship to patients' self-assessments.

RESULTS: Clinical improvements under the new grading systems translated into greater percentage changes than calculated using the Delta PASI formula. Specifically, the Delta PASI 50 translated to a Delta PLASI 57.2 and Delta PEASI 61.1; Delta PASI 75 was equivalent to Delta PLASI 85.7 and Delta PEASI 91.7. Importantly, Delta PASI tended to be systematically lower than patients' self-assessment, while Delta PLASI and Delta PEASI better matched patients' self-assessments using a best-fit model.

CONCLUSIONS: These results suggest that the Delta PASI underestimates percentage improvement when compared with measures of patient's self-assessment, while Delta PLASI and Delta PEASI correlate better. Prospective studies will have to be performed to confirm these relationships, but weighting BSA more heavily in the severity score may result in a more accurate reflection of clinical status.

BACKGROUND: Skin diseases such as psoriasis can profoundly influence a patient's self-image, self-esteem, and sense of well-being. Psoriasis is a multifactorial inflammatory condition with a disease burden that extends beyond the physical symptoms experienced by patients. Psoriasis affects all aspects of quality of life, including physical, psychologic, social, sexual, and occupational elements.

OBJECTIVE: The goal of this article was to review the published literature on the impact of psoriasis on quality of life.

METHODS: Relevant studies were identified through a comprehensive search of MEDLINE, EMBASE, and the Derwent Drug File databases of English-language articles published between 1993 and 2005 using the terms psoriasis in combination with quality of life, cost, cost-benefit analysis, economic, employment, days lost, healthcare, hospitalization, managed care, outcomes research, occupation, payers, and psychosocial. The reference lists of identified articles were checked for additional studies that might have been missed in the original searches.

RESULTS: Data suggest that social stigmatization, high stress levels, physical limitations, depression, employment problems and other psychosocial co-morbidities experienced by patients with psoriasis are not always proportional to, or predicted by, other measurements of disease severity such as body surface area involvement or plaque severity.

CONCLUSION: It is essential to include measures of psychosocial morbidity when assessing psoriasis severity and treatment efficacy because of the substantial role that psychosocial burden plays in patient perception of disease severity, quality of life, and disease course.

The cost effectiveness of treatments for psoriasis has been evaluated previously by several different investigators. Such evaluations should be updated as new products or data become available. To this end, a comparison of expected treatment-related clinical and economic outcomes is undertaken from the payer perspective using a disease-intervention model, decision analyses, and newly emergent information. The model is based on academy guidelines and recommended clinical practice. Model inputs (clinical and cost data) are culled from the medical literature and advisory clinical assessment surveys. Comparable therapies are various topical pharmacotherapies and phototherapies, including the 308-nm excimer laser (XTRAC, PhotoMedex, Montgomeryville, PA). Analytic results indicate that clinical and economic outcomes are influenced by treatment selections but are muted by the rotational nature of treatment regimens. Multiple analyses are required to reveal individual product performance. On the basis of these analyses, the addition of the 308-nm excimer laser to the rotational mix of treatments commonly utilized as second-line therapies for mild-to-moderate plaque psoriasis is expected to add incremental clinical benefit for patients without incremental cost for payers, because the laser can replace both more costly and less costly alternatives for appropriately selected patients who require a different therapeutic modality to maintain or improve their responsiveness.

Psoriasis is a common, chronic, distressing skin disorder that frequently affects the scalp, skin, nails and joints. Despite treatment, many patients suffer from unremitting disease and decreased quality of life. Scalp-type psoriasis is particularly difficult to treat. Although topical corticosteroids are the mainstay of therapy for moderate-to-severe disease, patients frequently object to the messiness and unfavourable cosmetic appearance of topical treatments. In this context, foam vehicles, which have the advantage of minimal residue and increased ease of application, have emerged as novel alternatives to traditional creams, ointments and solutions. Clobetasol propionate foam 0.05% (OLUX, Connetics Corporation), a high potency topical steroid, has been shown to alleviate symptoms of several dermatological conditions, including scalp and body psoriasis, improve disease severity and increase quality of life. Dose should be limited to 50 g/week, given the risk of adrenal suppression. Because patient preference is an important determinant of medication efficacy in clinical practice, clobetasol foam is a useful new formulation in the treatment of psoriasis and other skin conditions.

In this randomized, double-blind, phase III trial, patients with psoriasis received etanercept for 24 weeks or placebo for 12 weeks followed by etanercept for 12 weeks. At week 12, improvement in Dermatology Life Quality Index was 47% to 61% with etanercept compared with 11% with placebo (P < .0001). Etanercept rapidly and substantially improved patients' health-related quality of life.

OBJECTIVE: Recently a number of new therapies have been introduced to treat psoriasis, but concerns have been expressed about their high cost. The purpose of this study was to determine whether most psoriasis treatments lie within the accepted range of cost-utility.

METHODOLOGY: 32 patients with moderate to severe psoriasis were administered the Euro-Qol 5 Dimension (EQ-5D) survey to calculate their health state utility. Economic modeling was performed with a range of therapeutic costs applying the calculated utility score. Paired t-tests were used to calculate significance.

RESULTS: At the conclusion of 2 weeks of therapy, the mean psoriasis area and severity index (PASI) improved 35% to 7.2 (p<0.001). The mean health state utility score on the EQ-5D improved 11.5% from 77.7 units before therapy to 86.7 units after therapy (p=0.007).

CONCLUSION: A therapy that achieves at least a PASI 35 would be considered cost-effective by conventional standards if it does not exceed $33 600 in cost.

BACKGROUND: Medication nonadherence is a significant problem in psoriasis. Although previous research has aimed to quantify the prevalence of nonadherence in topical medication users, patient motivations for intentional nonadherence are not fully understood.

OBJECTIVE: Our purpose was to determine the relative importance of factors contributing to nonadherence in topical corticosteroid users with psoriasis.

METHODS: A survey was distributed to psoriasis patients visiting an outpatient clinic.

RESULTS: Among the 53 persons surveyed, medication nonadherence was 40%. Frustration with medication efficacy, inconvenience, and fear of side effects were the most important reasons patients deviated from usage instructions. Subjects who did not receive instructions on topical treatment duration used corticosteroids longer (>8 weeks) than subjects who were instructed (P < .05).

LIMITATIONS: A relatively small sample size prevented trends in demographic predictors of adherence from reaching statistical significance. The patient self-report format has the potential to introduce recall bias.

CONCLUSIONS: Factors contributing to intentional nonadherence, including dissatisfaction with efficacy, inconvenience, and fear of side effects, are the most important patient-identified barriers to appropriate use of topical steroids in psoriasis. Clear patient instructions on the intended steroid treatment duration may reduce adverse effects from overuse.

Aberrant cytokine expression has been proposed as an underlying cause of psoriasis, although it is unclear which cytokines play critical roles. Interleukin (IL)-23 is expressed in human psoriasis and may be a master regulator cytokine. Direct intradermal administration of IL-23 in mouse skin, but not IL-12, initiates a tumor necrosis factor-dependent, but IL-17A-independent, cascade of events resulting in erythema, mixed dermal infiltrate, and epidermal hyperplasia associated with parakeratosis. IL-23 induced IL-19 and IL-24 expression in mouse skin, and both genes were also elevated in human psoriasis. IL-23-dependent epidermal hyperplasia was observed in IL-19-/- and IL-24-/- mice, but was inhibited in IL-20R2-/- mice. These data implicate IL-23 in the pathogenesis of psoriasis and support IL-20R2 as a novel therapeutic target.

OBJECTIVE: The effect of adalimumab on patient-reported outcomes (PROs) was evaluated in patients with moderate to severe psoriasis during the initial 16-week, double-blind period of a 52-week, Phase III, multicenter trial.

METHODS: Patients were randomized to placebo or adalimumab 80 mg at Week 0 and 40 mg every other week from Week 1 to Week 15. PROs were evaluated throughout the study and included the Dermatology Life Quality Index (DLQI), the Short Form 36 Health Survey (SF-36), the Work Productivity and Activity Impairment Questionnaire-Specific Health Problem (WPAI-SHP), and several patient-rated symptom scales.

RESULTS: The adalimumab-treated group reported significantly greater improvements in DLQI total score (p<0.001), SF-36 Physical Component Summary score (p<0.001), and Mental Component Summary score (p<0.001) compared with the placebo-treated group over 16 weeks. Significant differences, favoring adalimumab, were also seen for the DLQI subscale scores (p < 0.001); SF-36 scale scores (p<0.001); WPAI-SHP work impairment (p<0.001), activity limitation (p<0.001), and overall work impairment scores (p<0.001); patient's global assessment of disease severity (p<0.001), psoriasis pain (p<0.001), and psoriasis-related pruritus (p = 0.002).

CONCLUSION: Adalimumab was efficacious in improving dermatology-specific and general health-related quality of life, work and activity limitations, and psoriasis-related symptoms in patients with moderate to severe psoriasis over a 16-week period.

Psoriasis is a chronic inflammatory skin disorder that can cause substantial disability. The recognition of psoriasis as an immunologically mediated disease led to the development of agents that specifically target key steps in the pathological process. This review focuses on these biological agents, and presents results from phase II and III clinical trials together with the safety profile and approved indications for alefacept, efalizumab, etanercept, infliximab and adalimumab. Preliminary safety and efficacy data for the newer therapeutic agents, such as CNTO-1275 and ABT-874, are also described.

The presence and severity of skin and joint symptoms in patients with psoriasis and psoriatic arthritis frequently do not correspond, a discrepancy that has raised the question of whether they represent two related but different disease processes. The fact that some agents seem to work preferentially in one state over the other reinforces this idea. However, there are also several agents with combined efficacy against cutaneous and articular inflammation that appear to support the existence of a common aetiology. Here we review the clinical, epidemiological and genetic evidence for and against a common pathogenesis for the two diseases. We then discuss the cellular and molecular targets of their selected therapies and how they potentially implicate effector pathways as a common immunopathogenic mechanism. Finally, we examine a recently proposed model of psoriasis pathogenesis involving type 1 interferon-producing plasmacytoid dendritic cells and how it may provide further clues to the aetiological links between psoriasis and psoriatic arthritis.

BACKGROUND: Adalimumab is a fully human monoclonal antibody that binds tumor necrosis factor, a key proinflammatory cytokine involved in the pathogenesis of psoriasis.

OBJECTIVE: We sought to evaluate clinical efficacy and safety of adalimumab for moderate to severe psoriasis and investigate continuous versus interrupted therapy.

METHODS: We conducted a 52-week, multicenter study of 1212 patients randomized to receive adalimumab (40 mg) or placebo every other week for the first 15 weeks. At least 75% improvement in the Psoriasis Area and Severity Index (PASI) score was the criterion for advancement through this multiphase study.

RESULTS: At week 16, 71% (578 of 814) of adalimumab- and 7% (26 of 398) of placebo-treated patients achieved greater than or equal to 75% improvement in the PASI score. During weeks 33 to 52, the percentage of patients rerandomized to placebo who lost adequate response (defined as <50% improvement in the PASI response relative to baseline and at least a 6-point increase in PASI score from week 33) was 28% compared with 5% of patients treated continuously with adalimumab.

LIMITATIONS: Lack of an active comparator and evaluation of maintenance of response beyond week 52 are limitations.

CONCLUSION: Adalimumab is efficacious and well-tolerated in the treatment of chronic plaque psoriasis.

TRIAL REGISTRATION: Clinical trials.gov. NCT00237887.

BACKGROUND: Biologics are widely used in the treatment of psoriasis and psoriatic arthritis.

OBJECTIVE: Our aim was to arrive at a consensus on the kind of monitoring and the vaccinations that should be performed before and during biologic therapy.

METHODS: Medical literature and data presented at meetings were reviewed and a consensus conference was held by members of the Medical Board of the National Psoriasis Foundation.

RESULTS: Consensus was established on monitoring and vaccination practices that included discussion and recognition of variations in those practices. History, physical examination, chemistry screen with liver function tests, complete blood cell count, and platelet count and tuberculosis testing are widely obtained at baseline and with variable frequencies thereafter. Patients treated with efalizumab have platelet counts checked more often; liver function tests are repeated more frequently in patients treated with infliximab; patients taking tumor necrosis factor blockers undergo tuberculosis testing more often; and patients treated with alefacept have CD4 counts checked approximately every 2 weeks. Avoidance of live vaccines during biologic therapy and administration of essential vaccines before biologic therapy were discussed, although vaccination is performed only to a variable degree. There was no consistency in the measurement of antinuclear antibodies among the experts.

LIMITATIONS: There are few evidence-based studies on monitoring practices for patients with psoriasis taking biologic therapies.

CONCLUSIONS: In patients taking biologic therapies for psoriasis, monitoring of blood chemistries, blood counts, CD4 counts, antinuclear antibodies, tuberculin skin tests, history, and physical examination may be warranted depending on the particular therapy and the particular patient. Vaccination practices are also addressed.

INTRODUCTION: Five to forty percent of patients with cutaneous psoriasis develop an inflammatory, oligoarticular spondyloarthropathy known as psoriatic arthritis.

OBJECTIVE: To compare health-related quality of life (QOL) between cutaneous psoriatic patients with and without psoriatic arthritis.

METHOD: Secondary cross-sectional analysis of data obtained from the 2005 Spring US National Psoriasis Foundation Quality of Life Telephone/Internet Survey. 426 patients with psoriasis and/or psoriatic arthritis were included in the 2005 survey. Among these respondents, the self-reported disease histories of 140 patients with cutaneous psoriasis and psoriatic arthritis were compared with those of 278 patients with cutaneous psoriasis only. Both groups were compared with respect to demographics, skin disease severity, treatment history and satisfaction, and QOL using previously validated assessment scales.

RESULTS: Compared with those with skin psoriasis only, respondents with cutaneous psoriasis and psoriatic arthritis were slightly older, more likely to be female and members of the National Psoriasis Foundation, and more likely to report a younger age of disease onset. They were also more likely to be unemployed, to report their job was affected by their condition, and to report a higher mean estimate of lost annual wages. On both univariate and multivariate analysis, however, no significant differences between groups were detected in skin disease severity, overall QOL, and satisfaction with current treatment options. At the same time, individuals with skin psoriasis and psoriatic arthritis were more likely to be taking systemic agents. They also reported higher mean scores for pain, while those with cutaneous psoriasis reported higher mean scores for self-consciousness only.

CONCLUSION: In contrast to previous reports that did not control for skin disease severity, this study demonstrates that patients with cutaneous psoriasis and psoriatic arthritis do not report significantly worse health-related QOL compared with patients with cutaneous psoriasis only. Nor do they report significantly greater dissatisfaction with current treatment options. These findings may reflect the intrinsic inadequacy of the QOL instruments used in this study for capturing the additional burden of joint disease. Alternatively, these findings may reflect the existence of a threshold of joint disease in patients with skin psoriasis and psoriatic arthritis below which joint symptoms are perceived as negligible relative to cutaneous disease.

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.

OBJECTIVE: To investigate the efficacy and safety of ABT-874, an interleukin 12/23 monoclonal antibody, in psoriasis.

DESIGN: Phase 2, 12-week, multicenter, randomized, double-blind, placebo-controlled trial.

SETTING: Outpatient dermatology clinics. Patients One hundred eighty patients with clinically stable moderate to severe chronic plaque psoriasis. Interventions Patients were randomized in groups of 30 to receive 1 of 6 treatments with ABT-874 provided as a subcutaneous injection: one 200-mg dose at week 0; 100 mg every other week for 12 weeks; 200 mg weekly for 4 weeks; 200 mg every other week for 12 weeks; 200 mg weekly for 12 weeks; or placebo. Main Outcome Measure At least a 75% reduction in the Psoriasis Area and Severity Index.

RESULTS: The percentage of patients achieving a 75% reduction in the Psoriasis Area and Severity Index at week 12 was statistically significantly greater in all of the ABT-874 treatment groups than in the placebo group (200 mg once, 63% [19 of 30]; 100 mg every other week for 12 weeks, 93% [28 of 30]; 200 mg weekly for 4 weeks, 90% [27 of 30]; 200 mg every other week for 12 weeks, 93% [28 of 30]; 200 mg weekly for 12 weeks, 90% [27 of 30]; placebo, 3% [1 of 30]; P < .001). Treatment with ABT-874 was well tolerated. The most common adverse event was injection-site reaction, and the most common infectious adverse events were nasopharyngitis and upper respiratory tract infection. There were no serious infectious adverse events.

CONCLUSIONS: ABT-874, an interleukin 12/23 monoclonal antibody, was highly effective and well tolerated in the treatment of psoriasis. Longer-term studies are required to confirm these findings.