Characterization of Patients with Psoriasis in Challenging-to-Treat Body Areas in the Corrona Psoriasis Registry.

BACKGROUND: Real-world studies evaluating patients with challenging-to-treat localizations of psoriasis (scalp, nail, and palmoplantar) are limited. OBJECTIVE: To characterize patients with versus without psoriasis in challenging-to-treat areas seen in routine US clinical practice. METHODS: This retrospective observational study included all adult patients with psoriasis enrolled in the Corrona Psoriasis Registry between April 2015 and May 2018 who initiated a biologic therapy at registry enrollment. Patients were stratified by the presence of scalp, nail, or palmoplantar psoriasis (nonmutually exclusive groups). Patient demographics, clinical char-acteristics, disease activity, and patient-reported outcome measures (pain, fatigue, itch, EuroQol visual analog scale [EQ VAS], Dermatology Life Quality Index [DLQI], and Work Productivity and Activity Impairment questionnaire [WPAI]) were assessed at registry enrollment and compared between patients with versus without each challenging-to-treat area using nonparametric Kruskal-Wallis tests for continuous variables and χ2 or Fisher exact tests for categorical variables. Generalized linear regression models were used to estimate differences in disease activity and patient-reported outcomes between patients with versus without each challenging-to-treat area. RESULTS: Among 2,042 patients with psoriasis (mean age [±SD], 49.6 ± 14.7 years; 51.5% male), 38.4% had psoriatic arthritis (PsA), 38.1% had scalp psoriasis, 16.0% had nail psoriasis, 10.9% had palmoplantar psoriasis, and 26.2% had a combination of ≥2 challenging-to-treat areas and PsA; only 34.2% had body plaque psoriasis without PsA or challenging-to-treat areas. Patients in all challenging-to-treat groups reported higher (mean [95% CI]) itch (scalp, 58.01 [57.62-58.40] vs. 54.35 [53.99-54.72]; nail, 56.42 [56.02-56.81] vs. 55.59 [55.20-55.97]; palmoplantar, 60.22 [59.86-60.59] vs. 55.15 [54.79-55.54]) and lower EQ VAS (scalp, 68.12 [67.78-68.48] vs. 69.46 [69.12-69.81]; nail, 66.21 [65.89-66.55] vs. 69.48 [69.14-69.83]; palmoplantar, 66.21 [66.07-66.75] vs. 69.29 [68.94-69.94]) scores than those without the respective challenging-to-treat localization. Patients with nail or palmoplantar psoriasis reported higher pain, fatigue, and DLQI scores than those without. Higher proportions of patients with scalp or palmoplantar psoriasis reported work impairment compared with those without. CONCLUSION: Two-thirds of patients with psoriasis who initiated biologic therapy had PsA and/or ≥1 challenging-to-treat area. Patients with challenging-to-treat areas had worse patient-reported outcome scores than those without, indicating a significant burden of challenging-to-treat areas on patients' quality of life.

Combination Use of Systemic Therapies in Psoriasis: Baseline Characteristics from the Corrona Psoriasis Registry

IMPORTANCE: There are increasing options for systemic combination therapy for psoriasis but a lack of literature around the characteristics of patients who are started on these regimens. OBJECTIVE: We aimed to determine how combination systemic therapy patients differ from monotherapy patients in their social, medical, or treatment history. DESIGN: This was a cross-sectional study of patients enrolled in the Corrona Psoriasis Registry. Descriptive characteristics were compared in biologic monotherapy and combination therapy groups. SETTING: The Corrona PsO registry is a prospective multicenter observational disease-based registry with patients recruited from 154 private and academic practice sites in the US and Canada with 373 participating dermatologists. PARTICIPANTS: Patients 18 years of age or older who enrolled in the Corrona Psoriasis Registry between April 2015 and March 2017 and initiated an eligible biologic therapy at the time of enrollment were included. EXPOSURES: Eligible biologic therapies included adalimumab, etanercept, infliximab, ixekizumab, secukinumab, and ustekinumab. Non-biologic and small molecule adjunctive therapies included acitretin, apremilast, CsA, and MTX. RESULTS: Patients on combination therapy were more likely to identify as black, to have Medicaid, and to report disabled work status. While combination therapy patients were more likely to have concomitant PsA, no major differences were seen in disease morphology, duration, IGA, PASI, or BSA affected at treatment initiation. CONCLUSIONS: Various demographic and socioeconomic factors are associated with use of combination systemic therapy compared to use of systemic monotherapy for psoriasis. An association with commonly used disease severity indices was not observed. RELEVANCE: An understanding of which patients are more likely to be prescribed combination systemic therapy will provide important context for long-term efficacy and safety data as they become available.

Characterization of disease burden, comorbidities, and treatment use in a large, US-based cohort: Results from the Corrona Psoriasis Registry.

BACKGROUND: Psoriasis is an immunodysregulatory inflammatory disease associated with comorbidities affecting quality of life. With the advent of new treatments, there is growing need to assess the long-term safety and efficacy of treatments in a real-world setting. OBJECTIVE: The objective of the Corrona Psoriasis Registry is to study the comparative safety and efficacy of Food and Drug Administration-approved biologic treatments. METHODS: A cross-sectional study of patients enrolled in the registry, who initiated or switched to a systemic therapy at enrollment or previous 12 months. Descriptive characteristics (demographics, clinical and patient-reported outcomes, comorbidities, and treatment history) were examined at registry enrollment. RESULTS: As of October 1, 2016, there were 1942 patients enrolled in the registry: 23% on apremilast, 4% on other nonbiologic systemic medications, 25% on interleukin (IL) 17A inhibitors, 22% on an IL-12/23 inhibitor, and 26% on tumor necrosis factor inhibitors. Overall, mean disease duration was 15.6 years, and 40% had a concurrent psoriatic arthritis diagnosis. About 66% had >3% body surface area involvement and 49% had a moderate or severe Investigator Global Assessment. LIMITATIONS: Selection and channeling bias can result in potential confounding that needs to be addressed in modeled analyses. CONCLUSION: This disease-based registry cohort represents a population exposed to multiple therapies, long disease duration, and multiple comorbidities and can be used to examine comparative safety and efficacy of various therapies.

Dietary antioxidant intake and its association with cognitive function in an ethnically diverse sample of US adults.

BACKGROUND: Dietary antioxidants can inhibit reactions accompanying neurodegeneration and thus prevent cognitive impairment. We describe associations of dietary antioxidants with cognitive function in a large biracial population, while testing moderation by sex, race, and age and mediation by depressive symptoms. METHODS: This was a cross-sectional analysis of 1274 adults (541 men and 733 women) aged 30 to 64 years at baseline (mean [standard deviation] = 47.5 [9.3]) in the Healthy Aging in Neighborhoods of Diversity Across the Lifespan Study, Baltimore city, MD. Cognitive performance in the domains of memory, language/verbal, attention, spatial, psychomotor speed, executive function, and global mental status were assessed. The 20-item Center for Epidemiologic Studies Depression Scale was used to measure depressive symptoms. Dietary intake was assessed with two 24-hour recalls, estimating daily consumption of total carotenoids and vitamins A, C, and E per 1000 kcal. RESULTS: Among key findings, 1 standard deviation (∼ 2.02 mg/1000 kcal) higher vitamin E was associated with a higher score on verbal memory, immediate recall (ß = +0.64 [0.19], p = .001), and better language/verbal fluency performance (ß = +0.53 [0.16], p = .001), particularly among the younger age group. Women with higher vitamin E intake (ß = +0.68 [0.21], p = .001) had better performance on a psychomotor speed test. The vitamin E-verbal memory association was partially mediated by depressive symptoms (proportion mediated = 13%-16%). CONCLUSIONS: In sum, future cohort studies and dietary interventions should focus on associations of dietary vitamin E with cognitive decline, specifically for domains of verbal memory, verbal fluency, and psychomotor speed.

The impact of conventional dietary intake data coding methods on foods typically consumed by low-income African-American and White urban populations.

OBJECTIVE: Analysing dietary data to capture how individuals typically consume foods is dependent on the coding variables used. Individual foods consumed simultaneously, like coffee with milk, are given codes to identify these combinations. Our literature review revealed a lack of discussion about using combination codes in analysis. The present study identified foods consumed at mealtimes and by race when combination codes were or were not utilized. DESIGN: Duplicate analysis methods were performed on separate data sets. The original data set consisted of all foods reported; each food was coded as if it was consumed individually. The revised data set was derived from the original data set by first isolating coded foods consumed as individual items from those foods consumed simultaneously and assigning a code to designate a combination. Foods assigned a combination code, like pancakes with syrup, were aggregated and associated with a food group, defined by the major food component (i.e. pancakes), and then appended to the isolated coded foods. SETTING: Healthy Aging in Neighborhoods of Diversity across the Life Span study. SUBJECTS: African-American and White adults with two dietary recalls (n 2177). RESULTS: Differences existed in lists of foods most frequently consumed by mealtime and race when comparing results based on original and revised data sets. African Americans reported consumption of sausage/luncheon meat and poultry, while ready-to-eat cereals and cakes/doughnuts/pastries were reported by Whites on recalls. CONCLUSIONS: Use of combination codes provided more accurate representation of how foods were consumed by populations. This information is beneficial when creating interventions and exploring diet-health relationships.

Concomitant urea stabilization and phosphorus recovery from source-separated fresh urine in magnesium anode-based peroxide-producing electrochemical cells.

In this study, we investigated the recovery of nitrogen (N) and phosphorus (P) from fresh source-separated urine with a novel electrochemical cell equipped with a magnesium (Mg) anode and carbon-based gas-diffusion cathode. Recovery of P, which exists primarily as phosphate (PO43-) in urine, was achieved through pH-driven precipitation. Maximizing N recovery requires simultaneous approaches to address urea and ammonia (NH3). NH3 recovery was possible through precipitation in struvite with soluble Mg supplied by the anode. Urea was stabilized with electrochemically synthesized hydrogen peroxide (H2O2) from the cathode. H2O2 concentrations and resulting urine pH were directly proportional to the applied current density. Concomitant NH3 and PO43- precipitation as struvite and urea stabilization via H2O2 electrosynthesis was possible at lower current densities, resulting in urine pH under 9.2. Higher current densities resulted in urine pH over 9.2, yielding higher H2O2 concentrations and more consistent stabilization of urea at the expense of NH3 recovery as struvite; PO43- precipitation still occurred but in the form of calcium phosphate and magnesium phosphate solids.

Synthesis of Petitjeanite Bi3O(OH)(PO4)2 Photocatalytic Microparticles: Effect of Synthetic Conditions on the Crystal Structure and Activity toward Degradation of Aqueous Perfluorooctanoic Acid (PFOA).

The discovery of synthetic Bi3O(OH)(PO4)2 [BOHP] and its application toward photocatalytic oxidation of the water contaminant perfluorooctanoic acid (PFOA) have prompted further interest in development. Despite its high activity toward PFOA degradation, the scarce appearance in the literature and lack of research have left a knowledge gap in the understanding of BOHP synthesis, formation, and photocatalytic activity. Herein, we explore the crystallization of BOHP microparticles via hydrothermal syntheses, focusing on the influence of ions and organics present in the reaction solution when using different hydroxide amendments (NaOH, NH4OH, NMe4OH, and NEt4OH). To better understand the unique structure-activity aspects of BOHP, the related bismuth oxy phosphate (BOP) structural family was also explored, including A-BOP (A = Na+ and K+) and M-BOP derivatives (M = Ca2+, Sr2+, and Pb2+). Results from materials characterization, including X-ray diffraction, scanning electron microscopy, and energy-dispersive X-ray spectroscopy, indicated that the crystal structure, morphology, and atomic composition were significantly influenced by solution pH, inorganic metal cations (Na+, K+, Ca2+, Sr2+, and Pb2+), and organic amines. Experiments involving ultraviolet photocatalytic destruction of PFOA by a BOHP suspension revealed that catalytic activity was influenced by the choice of reagents and their variable effect on surface facet growth and crystal defects in the resulting microparticles. Together, this work provides a strategy for crystal facet and surface defect engineering with the potential to expand to other metal oxides within the hydrothermal system.

Serum ferritin levels associated with increased risk for developing CHD in a low-income urban population.

OBJECTIVE: The present study examined the association of serum ferritin with CHD risk using the Framingham Heart Study's 10-year risk algorithm. DESIGN: Ordinal logistic regression modelling was used to interpret risk. Proportional odds modelling assessed four divisions of ranked CHD risk (4, high; 3, increased; 2, slight; 1, minimal), separately by sex. SETTING: Baltimore, MD, USA. SUBJECTS: African-American and white participants (n 1823) from baseline of the Healthy Aging in Neighborhoods of Diversity across the Life Span (HANDLS) study, aged 30-64 years. RESULTS: For men, there was a 0·5 % increase in risk for every 10-unit rise in serum ferritin (pmol/l). Other significant predictors included increased BMI, white race, unemployment and C-reactive protein ≥9·5 mg/l. For women, there was a 1·5 % [corrected] increase in risk per 10-unit rise in serum ferritin (pmol/l). Other significant predictors included increased BMI, lower education, unemployment and C-reactive protein ≥9·5 mg/l. CONCLUSIONS: Serum ferritin is a significant predictor of 10-year hard CHD risk for HANDLS study participants, a low-income, urban population. Serum ferritin, independent of elevated C-reactive protein, was associated with increased 10-year CHD risk for HANDLS participants. To our knowledge, these data provide the first evidence of the role of serum ferritin as a risk factor for hard CHD in African-American and white postmenopausal women in the USA. Future research on cardiovascular events from this prospective study may confirm the association.

Receiver-operating characteristics of adiposity for metabolic syndrome: the Healthy Aging in Neighborhoods of Diversity across the Life Span (HANDLS) study.

OBJECTIVE: To assess the predictive values of various adiposity indices for metabolic syndrome (MetS) among adults using baseline data from the Healthy Aging in Neighborhoods of Diversity across the Life Span (HANDLS) cohort. DESIGN: In a cross-sectional study, BMI, waist circumference (WC), body composition by dual-energy X-ray absorptiometry (DEXA) and metabolic risk factors such as TAG, HDL cholesterol, blood pressure, fasting glucose and insulin, uric acid and C-reactive protein were measured. Receiver-operating characteristic (ROC) curves and logistic regression analyses were conducted. SETTING: Baltimore, Maryland. SUBJECTS: White and African-American US adults (n 1981), aged 30-64 years. RESULTS: In predicting risk of MetS using obesity-independent National Cholesterol Education Program Adult Treatment Panel III criteria, percentage total body fat mass (TtFM) assessed using DEXA measuring overall adiposity had no added value over WC. This was true among both men (area under the ROC curve (AUC) = 0.680 v. 0.733 for TtFM and WC, respectively; P < 0.05) and women (AUC = 0.581 v. 0.686). Percentage rib fat mass (RbFM) was superior to TtFM only in women for MetS (AUC = 0.701 and 0.581 for RbFM and TtFM, respectively; P < 0.05), particularly among African-American women. Elevated percentage leg fat mass (LgFM) was protective against MetS among African-American men. Among white men, BMI was inferior to WC in predicting MetS. Optimal WC cut-off points varied across ethnic-sex groups and differed from those recommended by the National Institutes of Health/North American Association for the Study of Obesity. CONCLUSIONS: The study provides evidence that WC is among the most powerful tools to predict MetS, and that optimal cut-off points for various indices including WC may differ by sex and race.

Characterization of insufficient responders to ustekinumab in patients with moderate-to-severe psoriasis in the US Corrona Psoriasis Registry.

OBJECTIVE: Biologic therapies have revolutionized the management of moderate-to-severe psoriasis; however, there are a limited number of US real-world studies characterizing patients based on response to these treatments. This study examined characteristics at enrollment and change in outcomes of US patients with moderate-to-severe psoriasis who achieved insufficient responses with ustekinumab. METHODS: This study included patients enrolled in the Corrona Psoriasis Registry from April 2015 to June 2018 who initiated ustekinumab at enrollment and who were stratified based on achievement of psoriasis body surface area improving to <3% or by 75% from enrollment to the 6-month follow-up visit (response vs insufficient response). Patient demographics and disease characteristics were described at enrollment, and changes in outcomes were assessed at 6-month follow-up for ustekinumab responders and insufficient responders. RESULTS: Of the 178 patients who initiated ustekinumab in the Corrona Psoriasis Registry and had ≥1 follow-up visit, 99 (55.6%) were classified as responders at the 6-month follow-up visit. Logistic regression modeling showed that increasing age was significantly associated with a decreased likelihood of achieving a response (OR, 0.981 [95%CI, 0.962-0.999]; p = .049). CONCLUSIONS: These findings may help dermatologists characterize patients with moderate-to-severe psoriasis who have inadequate responses to biologic treatments.

Characterization of insufficient responders to anti-tumor necrosis factor therapies in patients with moderate to severe psoriasis: real-world data from the US Corrona Psoriasis Registry.

OBJECTIVE: Biologic therapies have dramatically changed the management of moderate to severe psoriasis; however, few US real-world studies characterize the unmet needs of patients who do not respond to biologic therapies. This study examined the characteristics at enrollment of patients with moderate to severe psoriasis who had insufficient responses to anti-tumor necrosis factor therapies (anti-TNFs). METHODS: Patients enrolled in the Corrona Psoriasis Registry from April 2015 to June 2018 who initiated an anti-TNF at enrollment were stratified on the basis of body surface area (BSA) improvement to <3% or a 75% improvement from enrollment to the 6-month follow-up visit (response versus insufficient response). Patient demographics and disease characteristics were described at enrollment, and changes in outcomes were assessed at 6-month follow-up for those who received anti-TNFs. RESULTS: Of 180 anti-TNF initiators who had ≥1 follow-up visit, 50.6% were classified as responders. Logistic regression modeling showed that female sex was significantly associated with a decreased likelihood of achieving a response (OR = 0.534, 95% CI = 0.289-0.988, p = .046). CONCLUSION: Despite the small sample size and short follow-up period, these findings may help dermatologists to identify patients with moderate to severe psoriasis who have unmet treatment needs.

The sex-specific role of plasma folate in mediating the association of dietary quality with depressive symptoms.

Folate deficiency has been implicated in the etiology of unipolar depression. In this study, we attempted to cross-link plasma folate, depressive symptoms, and dietary quality (or dietary intake of folate) together in a comprehensive framework, while examining effect modification of those associations by sex. This was a cross-sectional, population-based study of 1681 participants aged 30-64 y (Healthy Aging in Neighborhoods of Diversity across the Lifespan Study). Participants were administered the Center for Epidemiologic Studies Depression scale (CES-D). Measures of plasma folate and dietary intakes (2 24-h recalls) from which the 2005-Healthy Eating Index (HEI) was computed were available. Multivariate logistic regression and structural equation modeling (SM) were conducted. Compared with the lowest tertile, the middle and uppermost tertiles of plasma folate were associated with a 39-40% reduced odds of elevated CES-D (> or =16) among women [adjusted odds ratio (T(3) vs. T(1)) = 0.60 (95% CI = 0.42-0.86); P = 0.006]. Confounding of this association by HEI(total) was noted among both men and women, although dietary folate did not confound this association appreciably. In SM, plasma folate completely mediated the inverse HEI(total)-CES-D association among men only, specifically for HEI(2) (higher intakes of whole fruits), HEI(3) (total vegetables), HEI(5) (total grains), HEI(6) (whole grains), HEI(7) (milk), and HEI(12) (lower discretionary energy). Among women, HEI(total) and 4 components had an inverse direct effect on CES-D score, suggesting a mechanism that is independent of plasma folate. Depressive symptoms in our study may be alleviated by improving overall dietary quality, with plasma folate playing a potential mediating role only among men.

Impact of psoriasis severity on patient-reported clinical symptoms, health-related quality of life and work productivity among US patients: real-world data from the Corrona Psoriasis Registry.

OBJECTIVES: This analysis examined the association between psoriasis severity, assessed by body surface area (BSA) and the Investigator's Global Assessment (IGA; previously used only in clinical trials), and patient-reported outcomes (PROs) in a real-world setting. DESIGN: Cross-sectional analysis within the Corrona Psoriasis Registry, an independent, prospective registry. SETTING: 70 dermatology practices in the USA. PARTICIPANTS: 1529 adult patients with psoriasis being treated with biological or non-biological systemic psoriasis treatment by 31 May 2016. PRIMARY AND SECONDARY OUTCOME MEASURES: Psoriasis severity was assessed by percentage of affected BSA (mild (0%-5%), moderate (>5%-10%), severe (>10%-15%), very severe (>15%)) and IGA scores (clear/almost clear (0-1), mild (2), moderate (3), severe (4)). PROs (pain, itch, fatigue; Dermatology Life Quality Index [DLQI]; EuroQoL Visual Analogue Scale [EQ-VAS]; Work Productivity and Activity Impairment [WPAI]) were compared across BSA and IGA levels using analysis of variance and X2 tests. The association between psoriasis severity and PROs was examined using multivariable regression models. RESULTS: The mean age was 50.6 years and 47% of patients were female. Consistently with more severe psoriasis, symptoms worsened, DLQI scores increased (p<0.05 for each level of BSA and IGA), EQ-VAS decreased (p<0.05 for each level of BSA and IGA) and WPAI scores increased. By BSA score, moderate to very severe psoriasis was associated with poorer outcomes for the 'impairment while working' and 'daily activities impaired' WPAI domains (all p<0.05 vs mild psoriasis). Very severe psoriasis was associated with increased 'work hours missed' and 'work hours affected' (both p<0.05 vs mild psoriasis) Findings were similar by IGA. Results were confirmed by multivariable regression analyses. CONCLUSIONS: In a real-world setting, more severe psoriasis, assessed by BSA and IGA, was consistently associated with worse PROs.

Changes in Treatment Patterns in Patients with Psoriatic Arthritis Initiating Biologic and Nonbiologic Therapy in a Clinical Registry.

OBJECTIVE: Treatment options for psoriatic arthritis (PsA) have increased and improved in the past decade; treatment patterns in PsA remain poorly understood. Understanding current practices would aid in treatment management of patients with PsA. METHODS: This observational study was based on data from the Corrona registry of adult patients with PsA in North America collected between January 1, 2004, and December 31, 2012. Patients were divided among 3 therapy cohorts: tumor necrosis factor inhibitor (TNFi) monotherapy, methotrexate (MTX) monotherapy, and TNFi and MTX combination therapy. Patients were further divided among 3 study periods to understand changes over time: 2004-2006, 2007-2009, and 2010-2012. Data were collected on persistence, discontinuation, restarting, switching, adding/dropping therapy, and dose stretching. RESULTS: This study included 520 patients: 190 TNFi monotherapy, 217 MTX monotherapy, and 113 combination therapy; 110 from 2004 to 2006, 192 from 2007 to 2009, and 218 from 2010 to 2012. Over time, the proportion of patients initiating TNFi monotherapy decreased, while the proportion initiating combination therapy remained constant. The percentage of patients who were persistent decreased over time across all therapy cohorts, but remained higher in TNFi monotherapy than in other cohorts. Duration of persistence decreased over time. Patients initiating MTX monotherapy were more likely than their TNFi counterparts to add therapy. CONCLUSION: Treatment patterns in patients with PsA have changed from 2004 to 2012. Physicians are not more likely to initiate TNFi monotherapy, although clinical evidence supporting its effectiveness has increased over this study period, and patients remain more persistent with it.

Increased healthcare resource utilization in higher disease activity levels in initiators of TNF inhibitors among US rheumatoid arthritis patients.

OBJECTIVE: Determine healthcare resource utilization (HCRU) in biologic-naïve initiators of TNF inhibitors (TNFis) associated with their disease activity from a national cohort of rheumatoid arthritis (RA) patients. METHODS: RA patients were identified at their first TNFi initiation (index date) in the Corrona registry. Patients with age of RA onset <18, comorbid psoriasis/psoriatic arthritis, fibromyalgia, or osteoarthritis were excluded. Patients were categorized into disease activity (DA) strata by the lowest level of DA (and sustaining low levels for at least two visits) using the Clinical Disease Activity Index (CDAI) across all visits in Corrona while on a TNFi during 1 year after initiation. Rates of all-cause and RA-related hospitalizations, rheumatologist visits, and joint surgeries while on TNFi therapy were reported and compared across DA levels along with the incidence rate ratio (IRR) adjusted for age, gender, and RA duration using Poisson mixed models. RESULTS: Of 1931 RA patients: 15% achieved sustained remission, 22% remission, 14% sustained low DA, 23% low DA and 27% moderate/high DA (M/HDA). Those in M/HDA had statistically higher rates of hospitalizations (37.3 per 100 patient years (py), 95% CI: 31.6-43.7 and joint surgeries (20.8 per 100 py, 95% CI: 16.6-25.8) compared to the sustained remission cohort, resulting in respective IRRs of 2.3 (p < 0.001) and 1.7 (p = 0.046). CONCLUSION: Many biologic naïve RA patients initiating TNFi failed to achieve sustained remission during a 1 year period while remaining on TNFi therapy. Patients in higher DA levels had higher HCRU rates vs. patients in sustained remission, suggesting that achieving treat-to-target goals would reduce health care expenses.

Depression and Cognitive Impairment Are Associated with Low Education and Literacy Status and Smoking but Not Caffeine Consumption in Urban African Americans and White Adults.

Background: Recent research has linked caffeine consumption with a lower risk for depression and cognitive decline. However, no studies have examined the relationship in an African American compared to a white, socioeconomically diverse representative urban sample. Methods: Data from a cross-sectional study were used to determine the associations of caffeine use with depressive symptomatology and cognition in a sample of 1,724 participants in the Healthy Aging in Neighborhoods of Diversity across the Life Span (HANDLS) study. The United States Department of Agriculture's Automated Multiple Pass Method was used by trained interviewers to collect two, in-person 24-hour dietary recalls. Depressive symptoms and global cognition were assessed using two well-validated measures: the Center for Epidemiologic Studies Depressive Scale (CES-D) and Mini Mental State Examination (MMSE), respectively. Usual caffeine intake was based on both recalls. Data were analyzed with t- and chi-square tests, correlation analysis, and ordinal logistic regression. Results: African Americans consumed significantly less caffeine than did whites (89.0±3.2 and 244.0±8.7 mg respectively). Caffeine consumption was not associated with depressive symptomatology or global cognition. Age, less than 5th grade literacy, and less than high school education were significantly associated with both depressive symptoms and cognitive function. Smokers had a 43% greater risk for depression but only a 3% higher risk for cognitive impairment. Conclusion: The low level of dietary caffeine intake in combination with smoking among HANDLS study participants may have influenced the lack of association with depressive symptomatology or global cognition. For this sample, low literacy and education appear more highly associated with depressive symptoms and cognitive function than caffeine intake.

Delays in Initiation of Disease-Modifying Therapy in Rheumatoid Arthritis Patients: Data from a US-Based Registry.

INTRODUCTION: The goal of this study was to evaluate how frequently rheumatoid arthritis (RA) therapy is instituted promptly and to describe the characteristics of patients who are not treated early upon diagnosis. METHODS: The percentage of patients who at the time of enrollment in the Corrona registry were not receiving any RA-directed therapy was evaluated and their characteristics were summarized. The time to subsequent initiation of any RA-directed therapy was also estimated. RESULTS: Among 35,485 patients enrolled in Corrona, 34,735 (97.9%) were on appropriate therapy for RA and 750 (2.1%) had no history of any RA-directed therapy at time of enrollment. Among patients without any history of RA-directed therapy, the overall disease duration was 5.5 ± 9.0 years, with only 50.7% of patients having early disease (duration ≤1 year). Patients with no history of directed RA therapy did not have lower disease activity at enrollment compared with those receiving therapy. Clinical Disease Activity Index (CDAI) was 18.3 ± 15.0; 34% of patients had high and 27.6% moderate disease activity by CDAI. Patients were followed for a median (95% CI) time of 29.5 months (24.6-33.8). During the follow-up period, 372 out of 750 (49.6%) patients initiated RA-directed therapy. The median time to initiation of any RA-directed therapy was 12.1 months (95% CI 9.3-14.8). CONCLUSION: In this registry analysis, approximately 98% of patients were on appropriate RA therapy for their RA. However, a minority of patients with RA did not have a history of receiving disease-modifying therapy within a mean of approximately 5 years of RA onset and approximately 50% of them did not initiate any therapy within 12 months of registry follow-up. This delay in therapy did not appear to be related to a better controlled, or lower, RA disease activity state at the time of enrollment in the registry. FUNDING: Corrona, LLC.

Diet quality is inversely associated with C-reactive protein levels in urban, low-income African-American and white adults.

BACKGROUND: C-reactive protein (CRP), an inflammatory biomarker, is influenced by many factors, including socioeconomic position, genetics, and diet. The inverse association between diet and CRP is biologically feasible because micronutrients with antioxidative properties may enable the body to manage the balance between production and accumulation of reactive species that cause oxidative stress. OBJECTIVE: To determine the quality of the diet consumed by urban, low-income African-American and white adults aged 30 to 64 years, and association of diet quality with CRP. DESIGN: Data from a cross-sectional study were used to evaluate diet quality assessed by mean adequacy ratio (MAR). Two 24-hour recalls were collected by trained interviewers using the US Department of Agriculture automated multiple pass method. PARTICIPANTS: The sample consisted of Healthy Aging in Neighborhoods of Diversity across the Life Span baseline study participants, 2004-2009, who completed both recalls (n=2,017). MAIN OUTCOME MEASURES: MAR equaled the average of the ratio of intakes to Recommended Dietary Allowance for 15 vitamins and minerals. CRP levels were assessed by the nephelometric method utilizing latex particles coated with CRP monoclonal antibodies. STATISTICAL ANALYSIS: Linear ordinary least square regression and generalized linear models were performed to determine the association of MAR (independent variable) with CRP (dependent variable) while adjusting for potential confounders. RESULTS: MAR scores ranged from 74.3 to 82.2. Intakes of magnesium and vitamins A, C, and E were the most inadequate compared with Estimated Average Requirements. CRP levels were significantly associated with MAR, dual-energy x-ray absorptiometry-measured body fat, and hypertension. A 10% increase in MAR was associated with a 4% decrease in CRP. CONCLUSIONS: The MAR was independently and significantly inversely associated with CRP, suggesting diet is associated with the regulation of inflammation. Interventions to assist people make better food choices may not only improve diet quality but also their health, thereby possibly reducing risk for cardiovascular disease.

Dietary patterns and sarcopenia in an urban African American and White population in the United States.

The primary objective of this cross-sectional study was to characterize dietary patterns of African Americans and Whites, 30 to 64 years, examined in the Healthy Aging in Neighborhoods of Diversity across the Life Span study. Other objectives of the study were to evaluate micronutrient adequacy of each pattern and to determine the association of diet with sarcopenia. Cluster analysis was used to determine patterns and mean adequacy ratio (MAR) to determine adequacy of 15 micronutrients. Ten clusters were identified: sandwich, sweet drink, pizza, poultry, frozen meal, dessert, alcoholic drink, bread, starchy vegetables, and pasta/rice dish. MAR ranged from 69 for the sweet drink cluster to 82 for the pasta/rice dish cluster. Sarcopenia was present in 6.4% of the sample, ranging from 1.5% in the poultry cluster to 14.1% in the alcoholic drink cluster. This study is the first to report an association between diet and sarcopenia in people younger than 65 years. The identification of presarcopenia has important implications for dietary interventions that might delay age-associated loss of lean mass.

Recruitment and retention strategies for minority or poor clinical research participants: lessons from the Healthy Aging in Neighborhoods of Diversity across the Life Span study.

PURPOSE OF THE STUDY: Investigating health disparities requires studies designed to recruit and retain racially and socioeconomically diverse cohorts. It is critical to address the barriers that disproportionately affect participation in clinical research by minorities and the socioeconomically disadvantaged. This study sought to identify and rectify these barriers to recruit and retain a biracial (African American and non-Hispanic White) and socioeconomically diverse cohort for a longitudinal study. DESIGN AND METHOD: The Healthy Aging in Neighborhoods of Diversity across the Life Span study is a 20-year longitudinal examination of how race and socioeconomic status influence the development of age-related health disparities. One goal was to create a multifactorial recruitment and retention strategy. The recruitment paradigm targeted known barriers and identified those unique to the study's urban environment. The retention paradigm mirrored the recruitment plan but was based on specifically developed approaches. RESULTS: This cohort recruitment required attention to developing community partnerships, designing the research study to meet the study hypotheses and to provide benefit to participants, providing a safe community-based site for the research and creating didactics to develop staff cultural proficiency. These efforts facilitated study implementation and enhanced recruitment resulting in accrual of a biracial and socioeconomically diverse cohort of 3,722 participants. IMPLICATIONS: Recruiting and retaining minority or poor research participants is challenging but possible. The essential facets include clear communication of the research hypothesis, focus on providing a direct benefit for participants, and selection of a hypothesis that is directly relevant to the community studied.