Psoriasis Publications

OBJECTIVE: The 24-week Etanercept Assessment of Safety and Effectiveness (EASE) study evaluated the effectiveness and tolerability of continuous versus interrupted etanercept treatment in patients with moderate to severe plaque psoriasis. The objective of this analysis was to assess patient-reported outcomes (PROs) and health-care resource utilization (HRU) data from the EASE study.

METHODS: Patients received open-label etanercept 50 mg twice weekly for 12 weeks and then received either continued or interrupted (single round of discontinuation and re-treatment with etanercept) etanercept 50 mg once weekly for the second 12 weeks. PROs included the following: 1) the patient global assessments of psoriasis, joint pain, and itching scores; 2) the Dermatology Life Quality Index; 3) the Medical Outcomes Study Short Form 36 vitality domain; 4) the Beck Depression Inventory; 5) the European Quality-of-Life Group Feeling Thermometer; and 6) a patient satisfaction survey. HRU was evaluated using the Economic Implications of Psoriasis patient questionnaire.

RESULTS: Continuous treatment with etanercept 50 mg twice weekly for 12 weeks followed by 50 mg once weekly for 12 weeks produced sustained and clinically important improvements in PROs and reductions in HRU. Reductions in some outcome measures after treatment discontinuation at week 12 were observed in the interrupted group; however, most changes did not revert to baseline levels, consistent with some residual clinical effect, and re-treatment produced improvements similar to week 12 levels.

CONCLUSIONS: Continuous etanercept treatment provided greater sustained improvements in PROs than interrupted therapy; however, interrupting etanercept therapy, if needed, has predictable and manageable effects.

BACKGROUND: Interleukins 12 and 23 have important roles in the pathophysiology of psoriasis. We assessed ustekinumab, a human monoclonal antibody directed against these cytokines, for the treatment of psoriasis.

METHODS: In this phase III, parallel, double-blind, placebo-controlled study, 766 patients with moderate-to-severe psoriasis were randomly assigned to receive ustekinumab 45 mg (n=255) or 90 mg (n=256) at weeks 0 and 4 and then every 12 weeks; or placebo (n=255) at weeks 0 and 4, with subsequent crossover to ustekinumab at week 12. Patients who were initially randomised to receive ustekinumab at week 0 who achieved long-term response (at least 75% improvement in psoriasis area and severity index [PASI 75] at weeks 28 and 40) were re-randomised at week 40 to maintenance ustekinumab or withdrawal from treatment until loss of response. Both randomisations were done with a minimisation method via a centralised interactive voice response system. The primary endpoint was the proportion of patients achieving PASI 75 at week 12. Analyses were by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00267969.

FINDINGS: All randomised patients were included in the efficacy analysis. 171 (67.1%) patients receiving ustekinumab 45 mg, 170 (66.4%) receiving ustekinumab 90 mg, and eight (3.1%) receiving placebo achieved PASI 75 at week 12 (difference in response rate vs placebo 63.9%, 95% CI 57.8-70.1, p<0.0001 for 45 mg and 63.3%, 57.1-69.4, p<0.0001 for 90 mg). At week 40, long-term response had been achieved by 150 patients in the 45 mg group and 172 patients in the 90 mg group. Of these, 162 patients were randomly assigned to maintenance ustekinumab and 160 to withdrawal. PASI 75 response was better maintained to at least 1 year in those receiving maintenance ustekinumab than in those withdrawn from treatment at week 40 (p<0.0001 by log-rank test). During the placebo-controlled phase, adverse events occurred in 278 (54.5%) of the 510 patients receiving ustekinumab and 123 (48.2%) of the 255 receiving placebo. Serious adverse events occurred in six (1.2%) of 510 patients receiving ustekinumab and in two (0.8%) of 255 receiving placebo in this phase. The pattern of adverse events was much the same in the placebo crossover and randomised withdrawal phases as it was in the placebo-controlled phase.

INTERPRETATION: Ustekinumab seems to be efficacious for the treatment of moderate-to-severe psoriasis; dosing every 12 weeks maintains efficacy for at least a year in most patients.

There have been several articles and reports in recent months about comorbidities and risks that affect psoriasis patients in addition to their underlying disease. This piece reviews the current literature and begins to address what should be done with this new information by updating the clinician about what health screening tests, preventative exams, and referrals should be considered in this population.

Advances in the understanding and treatment of psoriasis in the past several years have been remarkable. New frontiers include better understanding the immunologic pathways that underlie the disease and the development of personalized strategies to maximize the benefit and minimize the risk for patients. Although a cure may not be imminent, there are some strategies under examination that may lead us closer to this goal.

BACKGROUND: Current research has confirmed that many inflammatory autoimmune (AI) diseases are due to derangements in multiple cytokine pathways. Some of these cytokines appear to play comparable key roles across diseases, suggesting that a similar underlying systemic inflammatory cascade could be responsible for various disease states. A recent study supports the hypothesis of a common cytokine-based pathology by showing that having one AI disease significantly increased the risk of having another AI disease. Psoriasis is an AI, manifesting as a chronic inflammatory skin condition and is clearly associated with other conditions, most obviously psoriatic arthritis (PsA).

OBJECTIVE: We sought to examine whether patients with PsA enrolled in managed health care plans carry a higher AI disease burden than patients with cutaneous psoriasis only (PsO).

METHODS: Patients 18 years or older enrolled in a health claims database were classified by two clinical subtypes: PsA and PsO. Control subjects were matched 3:1 to patients with psoriasis on age, sex, census region, and length of previous medical insurance coverage. AI disease diagnoses were identified through International Classification of Diseases, Ninth Revision codes. The association of other AI diseases with each psoriasis cohort was assessed using a prevalence ratio.

RESULTS: PsO was associated with a higher prevalence ratio for the 3 gastrointestinal diseases: Crohn disease (1.6 [confidence interval {CI} 1.4-2.0]), ulcerative colitis (1.3 [CI 1.1-1.6]), and inflammatory bowel disease (1.4 [CI 1.2-1.6]). PsA was also associated with a higher prevalence ratio for the gastrointestinal diseases: Crohn disease (2.1 [CI 1.3-3.3]), ulcerative colitis (2.0 [CI 1.3-3.1]), and inflammatory bowel disease (1.8 [CI 1.3-2.5]). Patients with PsA had an increased prevalence ratio associated with giant cell arteritis (4.8 [CI 1.5-15.7]) and pulmonary fibrosis (1.9 [CI 1.2-3.0]).

LIMITATIONS: Detection and misclassification biases may have affected these findings.

CONCLUSIONS: These findings support the hypothesis that PsA and PsO are associated with development of other AI diseases. The data suggest that evaluating patients with psoriasis for other associated disorders in a prospective manner may be important, because they may be more likely to experience the onset of another AI disease. Treatment planning for these patients could, therefore, require the medical management of more than one AI disease. Further, our data suggest that PsA and PsO may be divergent in ways previously not described that could inform future research.

BACKGROUND: Topical coal tar is a well known and effective treatment for psoriasis, but the messiness, staining, odor, and inconvenience associated with its use make patient satisfaction and compliance a challenge.

OBJECTIVE: To determine the efficacy, patient tolerability, and cosmetic acceptability of a new topical liquor carbonis distillate (LCD) 15% solution compared with calcipotriene (calcipotriol) cream in patients with moderate, chronic plaque psoriasis.

STUDY DESIGN: A randomized, single-blind, active-controlled, parallel-group, clinical trial consisting of a 12-week treatment phase and a 6-week post-treatment follow-up phase.

SETTING: Outpatient dermatology research unit in an academic hospital.

PATIENTS: Sixty adults with moderate, chronic plaque psoriasis (3-15% body surface area affected) not receiving other psoriasis therapies.

INTERVENTION: Patients were randomized to apply either an LCD 15% solution (Psorent) or a commercially available calcipotriene 0.005% cream (Dovonex) to their psoriasis areas (excluding the head) twice daily at home for 12 weeks.

ASSESSMENTS: A blinded investigator evaluated the patients' psoriasis using a modified Psoriasis Area and Severity Index (PASI) that excluded the head, and a Physician's Global Assessment (PGA) scale at weeks 0 (baseline), 2, 4, 8, and 12 (end of treatment), and 18 (6 weeks after treatment was withdrawn). Patients assessed their psoriasis symptoms and quality of life and completed a cosmetic acceptability survey about their medication.

OUTCOME MEASURES: The changes in the baseline PASI scores after 12 weeks of treatment were compared between LCD and calcipotriene groups. Additional comparisons were performed for success rates during treatment (PASI 75 and PASI 50), changes in PGA scores, patient-reported psoriasis symptom scores, patients' quality-of-life scores, and recurrence rates during post-treatment follow-up.

RESULTS: Both treatment groups showed improvement in psoriasis severity and quality of life. However, the LCD group had greater mean reductions in PASI scores: 58% vs 37% in the calcipotriene group (p < 0.05) at week 12. Additionally, the LCD group had more patients (14/27) with absent or minimal psoriasis on the PGA scale than the calcipotriene group (6/28) by the end of treatment (p < 0.05). LCD-treated patients also maintained their improvement better than calcipotriene-treated patients through week 18 after treatment was withdrawn for 6 weeks. Both treatments were well tolerated and cosmetically acceptable to patients.

CONCLUSION: The newly formulated LCD solution, applied twice daily at home for 12 weeks, was more effective and as well tolerated and cosmetically acceptable as the calcipotriene cream over 12 weeks of treatment and 6 weeks of follow-up. The LCD solution is a patient-accepted and effective corticosteroid-sparing treatment alternative for psoriasis patients.

BACKGROUND: Past studies suggest an association between psoriasis and the risk of developing coronary heart disease. The objectives of this study were to estimate the 10-year risks of coronary heart disease and stroke in patients with moderate to severe psoriasis, to compare risks between patients and the general population, and to determine whether risk profiles are affected by disease severity.

METHODS: Data were pooled from patients with moderate to severe psoriasis (Psoriasis Area and Severity Index [PASI] score> or =10) who were enrolled in Phase II (M02-528) or Phase III trials (Comparative Study of HUMIRA vs Methotrexate vs Placebo In PsOriasis PatieNts[CHAMPION], Randomized Controlled EValuation of Adalimumab Every Other Week Dosing in Moderate to Severe Psoriasis TriAL[REVEAL]) evaluating adalimumab. Risks of coronary heart disease and stroke were estimated using the Framingham risk score algorithm and a stroke risk function based on the Framingham Heart Study cohorts. To compare risks between patients with psoriasis and the general population, average population risks were imputed on the basis of age and gender. Wilcoxon rank-sum tests evaluated risk differences between patients with psoriasis and the general population and between patients with moderate psoriasis and patients with severe psoriasis.

RESULTS: A total of 1591 patients were identified, including 1082 patients with PASI scores> or =10 and < or = 20 and 509 patients with PASI scores>20. Patients with PASI scores from 10 to 20 and PASI scores>20 had similar 10-year risks of coronary heart disease (12.3% and 12.2%; P=.49) and stroke (8.3% and 8.7%; P=.28). Compared with the general population, 10-year risks of patients with psoriasis were 28% greater for coronary heart disease (P<.001) and 11.8% greater for stroke (P=.02).

CONCLUSION: Patients with moderate to severe psoriasis had increased risks of coronary heart disease and stroke compared with the general population.

Therapeutic experience strongly supports the use of TNF antagonists as important modalities in the treatment of psoriatic arthritis and plaque psoriasis. Studies with anti-IL-12/23 therapeutic agents, which act in different steps of the psoriatic inflammatory cascade, have also shown demonstrable efficacy. Here, we discuss this approach and its potential within the armamentarium for the treatment of psoriasis. Evidences that the selective blocking of IL-23 may be effective and safe therapy are also addressed.

BACKGROUND: Anxiety, depression, and impaired health-related quality of life (HRQoL) are common in patients with psoriasis.

OBJECTIVE: We sought to analyze the effect of ustekinumab on these conditions in patients with moderate-to-severe psoriasis.

METHODS: Patients with moderate-to-severe psoriasis (n = 1230) were randomized 1:1:1 to receive 45 mg of ustekinumab, 90 mg of ustekinumab, or placebo. The Hospital Anxiety and Depression Scale was used to measure anxiety and depression, and the Dermatology Life Quality Index to measure HRQoL.

RESULTS: At baseline, 40.3% and 26.7% of patients reported symptoms of anxiety and depression, respectively, and 54.6% reported Dermatology Life Quality Index scores greater than 10, indicating a very high impact of disease on HRQoL. Greater improvements at week 12 in mean Hospital Anxiety and Depression Scale-Anxiety (13.9%), Hospital Anxiety and Depression Scale-Depression (29.3%), and Dermatology Life Quality Index (76.2%) scores were reported in ustekinumab groups compared with placebo (P < .001 each).

LIMITATIONS: Results for these measures are reported only through 24 weeks.

CONCLUSION: Patients receiving ustekinumab reported significant improvements in symptoms of anxiety, depression, and HRQoL.

Psoriasis is associated with significant physical and psychological burden affecting all facets of a patient's life–relationships, social activities, work and emotional wellbeing. The cumulative effect of this disability may be self-perpetuating social disconnection and failure to achieve a 'full life potential' in some patients. Health-related quality of life studies have quantified the burden of psoriasis providing predominantly cross-sectional data and point-in-time images of patients' lives rather than assessing the possible cumulative disability over a patient's lifetime. However, social and economic outcomes indicate there are likely negative impacts that accumulate over time. To capture the cumulative effect of psoriasis and its associated co-morbidities and stigma over a patient's life course, we propose the concept of 'Cumulative Life Course Impairment' (CLCI). CLCI results from an interaction between (A) the burden of stigmatization, and physical and psychological co-morbidities and (B) coping strategies and external factors. Several key aspects of the CLCI concept are supported by data similar to that used in health-related quality of life assessments. Future research should focus on (i) establishing key components of CLCI and determining the mechanisms of impairment through longitudinal or retrospective case-control studies, and (ii) assessing factors that put patients at increased risk of developing CLCI. In the future, this concept may lead to a better understanding of the overall impact of psoriasis, help identify more vulnerable patients, and facilitate more appropriate treatment decisions or earlier referrals. To our knowledge, this is a first attempt to apply and develop concepts from 'Life Course Epidemiology' to psoriasis research.

BACKGROUND: Psoriasis is frequently associated with comorbidities.

OBJECTIVE: To estimate the incremental economic burden associated with comorbidities in patients with psoriasis, accounting for psoriasis severity.

METHODS: Patients continuously enrolled ≥6 months after a randomly selected psoriasis diagnosis date were selected from the Ingenix Impact National Managed Care Database (1999-2004). Comorbidities identified during the 6-month study included: psoriatic arthritis, cardiovascular disease, depression, diabetes, hyperlipidemia, hypertension, obesity, cerebrovascular diseases and peripheral vascular disease. Resource utilization and costs during the 6-month follow-up period were compared for patients with ≥1 comorbidity vs. those without and for patients with a specific comorbidity vs. those without. Adjusted incidence rate ratios (IRRs) and odds ratios (ORs) were estimated for resource utilization using negative binomial and logistic regression models, respectively. Adjusted incremental costs associated with comorbidities were reported using general linear models with log-link and gamma distributions or two-part models. Models controlled for age, sex and psoriasis severity.

RESULTS: A total of 114,512 patients were included; 51% had ≥1 comorbidity. Hyperlipidemia (27%) and hypertension (25%) were most prevalent. Patients with comorbidities were more likely to experience urgent care [OR (95% confidence interval (CI))=1.58 (1.51-1.65)] than patients without comorbidities. They also had significantly greater hospitalization rates [IRR (95% CI)=2.27 (2.13-2.42)] and outpatient visits [IRR (95% CI)=1.53 (1.52-1.55)]. Compared with patients who did not have comorbidities, patients with comorbidities incurred $2184 (P<0.001) greater total costs.

CONCLUSION: Comorbidities present a significant economic burden in patients with psoriasis.

BACKGROUND: Psoriasis is associated with a variety of major physical and mental co-morbidities.

OBJECTIVE: To assess the incremental burden of co-morbidities on patient-reported outcomes and evaluate the efficacy and safety of adalimumab in psoriasis patients with co-morbidities.

STUDY DESIGN: Data were obtained from the initial 16-week, double-blind treatment period of REVEAL (Randomized controlled EValuation of adalimumab Every other week dosing in moderate to severe psoriasis triAL), a randomized, multicenter, phase III clinical trial.

INTERVENTION: Patients with moderate to severe psoriasis were randomized in a 2 : 1 ratio to receive adalimumab 80 mg (two 40 mg injections administered subcutaneously) at baseline followed by one 40 mg injection every other week from week 1 to week 15 or placebo.

MAIN OUTCOME MEASURES: Clinical severity (Psoriasis Area and Severity Index [PASI]) and patient-reported outcomes (Dermatology Life Quality Index [DLQI], Short Form 36 [SF-36] health survey, Work Productivity and Activity Impairment [WPAI] questionnaire) were assessed during the trial. The effect of selected co-morbidities (i.e. hypertension, psoriatic arthritis, hyperlipidemia, obesity, depression, other forms of arthritis, diabetes mellitus, and other cardiovascular diseases) on patient-reported outcomes was evaluated using multivariate analysis of covariance models. Subgroup analyses were performed by co-morbidity type to statistically compare the clinical efficacy, patient-reported outcome benefits, and safety of adalimumab with placebo in the presence of these conditions.

RESULTS: Study co-morbidities were each independently associated with significantly greater impairment on at least one general patient-reported outcome measured at baseline (all p < 0.05), with the exception of hyperlipidemia. During the 16-week study, adalimumab patients demonstrated significantly greater PASI 75 response rates (defined as a reduction of at least 75% in PASI scores from baseline) compared with placebo patients for all co-morbidity subgroups. Adalimumab provided consistent improvements in DLQI, SF-36 Physical Component Summary and Mental Component Summary scores, and WPAI total scores from baseline to week 16 within co-morbidity subgroups. Rates of serious adverse events (AEs), serious infectious AEs, and AEs leading to discontinuation were comparable between adalimumab and placebo for patients with co-morbidities.

CONCLUSIONS: Co-morbidities were associated with additionally impaired health-related quality of life and work productivity in patients with psoriasis. Adalimumab significantly improved efficacy and patient-reported outcomes and was well tolerated in patients with co-morbidities.

BACKGROUND: ABT-874, an anti-interleukin-12 and -23 antibody, was previously shown to be significantly more effective compared with placebo during a 12-week phase II study of psoriasis. We report here safety and efficacy data of ABT-874 during subsequent phases of this study.

OBJECTIVE: We sought to examine the preliminary efficacy and safety of ABT-874 for moderate to severe psoriasis beyond 12 weeks.

METHODS: Patients with chronic plaque psoriasis who responded to ABT-874 during the initial randomized, placebo-controlled, 12-week study phase were eligible for a 36-week observation/retreatment phase. During the subsequent 60-week, open-label extension phase, eligible patients were retreated with one of two ABT-874 dosages. Efficacy was measured using Psoriasis Area and Severity Index and physician global assessment scores; safety was monitored by adverse events (AEs), laboratory parameters, and vital signs.

RESULTS: During the observation/retreatment phase, 130 of 180 patients were eligible for retreatment. After 12-week retreatment with ABT-874, 55% to 94% of retreated patients (n = 58) achieved a 75% or greater reduction in Psoriasis Area and Severity Index score. Among patients receiving ABT-874 through the first 48 weeks, there were no deaths and 4 patients with serious AEs; one patient discontinued because of an AE. During the open-label extension (N = 105), there were no deaths or serious infections, and 3 serious AEs.

LIMITATIONS: Lack of placebo or active comparator groups limited statistical analysis in later study phases. Dosing differences existed between groups, and only week-12 responders were eligible for retreatment.

CONCLUSION: ABT-874 continued to show good efficacy and safety during withdrawal and reinitiation of therapy.

BACKGROUND: Psoriasis is an inflammatory disease that not only affects the skin but can also have systemic implications such as obesity and nutritional deficiencies. Carotenoids are vitamin A provitamins with anti-oxidant properties that are present in human tissues including skin.

OBJECTIVES: To determine whether psoriasis is associated with lower levels of skin carotenoid levels.

METHODS: In this cross-sectional study, skin carotenoid levels were measured on the palms of 44 patients with psoriasis and 72 patients without psoriasis. A linear regression model was used to evaluate the relationship between psoriasis and carotenoid levels (primary aim) and to determine if severity of disease was associated with carotenoid levels (secondary aim). Potential confounders included demographic factors, smoking status, body mass index and multivitamin intake.

RESULTS: The mean carotenoid levels in the psoriasis and no psoriasis groups were respectively 22,099 and 29,180 and presence of psoriasis was found to be significantly related to lower levels of carotenoids in both univariable and multivariable analysis (P < 0.05). In the psoriasis group, the Psoriasis Area and Severity Index score was not significantly related to carotenoid levels (P = 0.07).

CONCLUSIONS: Patients with psoriasis appear to have lower skin carotenoid counts than patients without psoriasis.

CONTEXT: Ustekinumab and briakinumab, monoclonal antibodies to the shared p40 subunit of interleukin (IL)-12 and IL-23, have shown efficacy in treating chronic plaque psoriasis (CPP). Preliminary reports of major adverse cardiovascular events (MACEs) in psoriasis patients receiving anti-IL-12/23 agents have prompted concern.

OBJECTIVE: To evaluate a possible association between biologic therapies for CPP and MACEs via meta-analysis.

DATA SOURCES: Randomized controlled trials (RCTs) of anti-IL-12/23 (ustekinumab and briakinumab) agents and anti-tumor necrosis factor α (TNF-α) agents (adalimumab, etanercept, and infliximab) used in treating CPP were reviewed using the Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, and Ovid MEDLINE from database inception to May 2011. The results of registered nonpublished completed studies were procured through abstract publications or poster presentations.

STUDY SELECTION: Randomized, placebo-controlled, double-blind, monotherapy studies (with safety outcome data for MACE) of IL-12/23 antibodies and anti-TNF-α agents in adults. Studies of psoriatic arthritis were excluded.

DATA EXTRACTION: Two investigators independently searched data while 6 investigators reviewed the abstracted data.

RESULTS: A total of 22 RCTs comprising 10 183 patients met the predefined inclusion criteria. The primary outcome measure was MACE, a composite end point of myocardial infarction, cerebrovascular accident, or cardiovascular death during the placebo-controlled phase of treatment in patients receiving at least 1 dose of study agent or placebo. Absolute risk differences were used as an effect measure. There was no evidence of statistical heterogeneity across the studies using the I(2) statistic (I(2) = 0), allowing for combination of trial results using the Mantel-Haenszel fixed-effects method. During the placebo-controlled phases of the anti-IL-12/23 studies, 10 of 3179 patients receiving anti-IL-12/23 therapies experienced MACEs compared with zero events in 1474 patients receiving placebo (Mantel-Haenszel risk difference, 0.012 events/person-year; 95% confidence interval [CI], -0.001 to 0.026; P =.12). In the anti-TNF-α trials, only 1 of 3858 patients receiving anti-TNF-α agents experienced a MACE compared with 1 of 1812 patients receiving placebo (Mantel-Haenszel risk difference, -0.0005 events/person-year; 95% CI, -0.010 to 0.009; P = .94).

CONCLUSIONS: Compared with placebo, there was no significant difference in the rate of MACEs observed in patients receiving anti-IL-12/IL-23 antibodies or anti-TNF-α treatments. This study may have been underpowered to identify a significant difference.

BACKGROUND: Psoriasis confers an independent risk of cardiovascular disease that is likely to be related to systemic inflammation. Anti-inflammatory treatment could theoretically reduce the risk of cardiovascular disease, and initial data suggest that treatment may reduce the incidence of cardiovascular risk factors.

OBJECTIVES: To determine the impact of anti-inflammatory therapy on the risk of acute myocardial infarction (MI) in patients with moderate-to-severe psoriasis.

METHODS: Cohort study using administrative and pharmacy claims data from a large U.S. insurer comparing patients with psoriasis aged ≥ 18 years receiving systemic immunomodulatory therapies (methotrexate, ciclosporin, alefacept, efalizumab, adalimumab, etancercept and infliximab) with a control group treated with ultraviolet B phototherapy that has limited systemic anti-inflammatory effects. The risk of acute MI was calculated using a proportional hazards model while controlling for sex, age, hypertension, hyperlipidaemia, diabetes and depression. Significant interaction terms were included in the final model.

RESULTS: The study group included 25,554 patients with psoriasis receiving systemic treatment or phototherapy. There was a trend towards an increased risk of MI in the systemic treatment group but not a significant difference in overall MI risk [hazard ratio (HR) 1·33, 95% confidence interval (CI) 0·90-1·96]. Additionally, there was a significant interaction with age: in patients under 50 years the HR for MI if receiving systemic therapy was 0·65 (95% CI 0·32-1·34), and in patients aged 50-70 years it was 1·37 (95% CI 0·79-2·38).

CONCLUSIONS: Overall, there does not appear to be a reduced risk of MI in patients with psoriasis receiving systemic therapy compared with a group undergoing phototherapy. The risk of MI may vary by age.

Psoriasis is an inflammatory disease that affects women in their reproductive years. Other similar diseases have been associated with adverse pregnancy outcomes. We sought to assess whether pregnant women with psoriasis are at higher risk of developing complications, such as preterm birth (PTB) and low birth weight (LBW). A retrospective cohort, performed at two large tertiary centers, evaluated the outcomes of 162 pregnancies in 122 women with psoriasis and 501 pregnancies in 290 women without psoriasis. Univariable and multivariable analyses, adjusting for important demographic factors, comorbidities, or a propensity score, were performed to evaluate the association of psoriasis and a poor outcome composite (POC), including PTB (<37 gestational weeks) and LBW (<2,500  g). Repeated measures analysis was used to account for the multiple pregnancies per woman. Cesarean delivery, preeclampsia/eclampsia, and spontaneous abortion were also evaluated. For women with psoriasis, there was a 1.89-fold increase in odds of POC (95% CI 1.06-3.39) in the univariable analysis. This effect remained statistically significant in the multivariable analyses. Psoriasis was not associated with cesarean delivery, preeclampsia/eclampsia, and spontaneous abortion. This study has shown higher odds of POC in patients with psoriasis. Further larger population-based studies are required to confirm these findings.

BACKGROUND: Psoriasis significantly impairs work productivity and daily activities.

OBJECTIVES: We sought to examine the effects of adalimumab on psoriasis-related work productivity and activity impairment and associations between the impairment and psoriasis severity in patients with moderate to severe psoriasis.

METHODS: Data were from the first 16 weeks of the Randomized controlled EValuation of adalimumab Every other week dosing in moderate to severe psoriasis TriAL (REVEAL). Outcomes as measured by the Work Productivity and Activity Impairment Questionnaire for Psoriasis (WPAI-Psoriasis) included employment status, total work productivity impairment, and total activity impairment. Logistic regression and analyses of covariance were used to assess the effects of adalimumab and treatment response (≥ 75% improvement in Psoriasis Area and Severity Index responders) on WPAI-Psoriasis outcomes. Longitudinal generalized estimating equations and Pearson correlation coefficients were used to assess associations between WPAI outcomes and psoriasis severity.

RESULTS: Greater improvements in total work productivity impairment and total activity impairment were observed with adalimumab treatment versus placebo (15.5 and 11.1 percentage points, respectively; P < .001). Unemployment rate, total work productivity impairment, and total activity impairment were significantly associated with greater baseline psoriasis severity. Changes in WPAI outcomes were significantly correlated with greater psoriasis severity. The Dermatology Life Quality Index had stronger associations with changes in WPAI outcomes compared with clinical severity measures (Psoriasis Area and Severity Index and Physician Global Assessment).

LIMITATIONS: REVEAL only included WPAI data for 16 weeks. Therefore, long-term impact of adalimumab treatment on productivity outcomes could not be assessed. In addition, information on occupational job title or industry was not collected and data were not adjusted for psoriatic arthritis.

CONCLUSIONS: Adalimumab reduced psoriasis-related work productivity and activity impairment in patients with moderate to severe psoriasis.

BACKGROUND: Although there are many psoriasis assessment tools currently published, one of the unmet needs in psoriasis research remains consensus about the single best validated and reproducible assessment tool.

OBJECTIVES: In this systematic review we sought to determine the degree of correlation between two commonly used psoriasis assessment tools, the Psoriasis Area and Severity Index (PASI) and Physician Global Assessment (PGA).

METHODS: Randomized controlled systemic trials in moderate to severe psoriasis were reviewed using the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. We recorded and compared the percent of patients achieving both 75% reduction in PASI score (PASI 75) and PGA 0 or 1 (clear or almost clear) at 8 to 16 weeks, 17 to 24 weeks, and greater than 24 weeks of treatment with the investigational drug.

RESULTS: Our literature review yielded 30 randomized controlled trials using biologic agents in moderate to severe psoriasis. We found that the two assessment tools correlate very tightly except at the lower bounds of therapeutic efficacy. The r(2) values for the correlation between PASI 75 and a score of clear or almost clear on the PGA were 0.9157 at 8 to 16 weeks and 0.892 at 17 to 24 weeks.

LIMITATIONS: Limitations of our study include the small number of randomized controlled trials publishing the percent of patients achieving 75% reduction in PASI score and a score of clear or almost clear on the PGA after 24 weeks of therapy. In addition, our results are not generalizable beyond the patients with moderate to severe plaque psoriasis.

CONCLUSION: The two assessment tools are substantially redundant and either alone is a sufficient tool for assessing psoriasis severity in patients with moderate to severe disease. Because the PASI is better validated and more detailed, it remains the score of choice for clinical trials, but the simpler PGA may be well suited for community-based outcomes projects.