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.

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 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.

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.

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.

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.

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.

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.

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.

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.

Beverage Consumption Patterns of a Low-Income Population.

High-energy-dense foods provide an inexpensive source of calories. Healthy Aging in Neighborhoods of Diversity across the Life Span study participants (n = 1987), low- to low-middle-income, urban African American and white adults, consumed between 17% and 20% of their daily energy intake from beverages. Of all beverages consumed, calorically sweetened beverages ranked second among African Americans and third among whites. Calorically-sweetened beverage consumption was not influenced by weight status. Increasing awareness of risks for adverse health outcomes associated with selected beverages may improve dietary choices.

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.

Role of depressive symptoms in explaining socioeconomic status disparities in dietary quality and central adiposity among US adults: a structural equation modeling approach.

BACKGROUND: The link between socioeconomic status (SES), depression, dietary quality, and central adiposity remains unclear. OBJECTIVE: Pathways linking SES to dietary quality and central adiposity through depressive symptoms were examined across sex-ethnicity groups. DESIGN: Extensive data on US adults aged 30-64 y from the Healthy Aging in Neighborhoods of Diversity across the Life Span (HANDLS) study were used in multiple linear logistic regression models and structural equation models to test pathway associations. Measures included Center for Epidemiologic Studies-Depression (CES-D) scores, 2005 Healthy Eating Index (HEI) values, and dual-energy X-ray absorptiometry. Sample sizes for most analyses ranged between 1789 for anthropometric outcomes and 1227 for trunk fat outcomes. RESULTS: The CES-D score was associated with lower HEI scores in all sex-ethnicity groups, except in African American men, and with higher waist-to-hip ratios (WHRs) among African American women. A CES-D score > or =16 was positively associated with waist circumference (WC) and with trunk fat among white women and men, respectively. SES was positively related to central adiposity among African American men (central obesity and WC) and African American women (central obesity and percentage trunk fat) but was inversely related to central adiposity among white women. Among whites only, the total positive effect of SES on HEI was significantly mediated by CES-D score. Among white women, the total inverse effect of SES on WC and WHR was significantly explained by the CES-D score and HEI, whereas the CES-D score was positively associated with WHR among African American women, independently of SES. CONCLUSION: Future mental health interventions targeted at reducing SES disparities in dietary quality and central adiposity may have different effects across sex-ethnicity groups.