Disease burden among patients with atopic dermatitis treated with systemic therapy for 4-12 months: results from the CorEvitas Atopic Dermatitis Registry.

BACKGROUND: Real-world data on the effectiveness of systemic therapy in atopic dermatitis (AD) are limited. METHODS: Adult patients with AD in the CorEvitas AD registry (2020-2021) who received systemic therapies for 4-12 months prior to enrollment were included based on disease severity: body surface area (BSA) 0%-9% and BSA ≥10%. Demographics, clinical characteristics, and outcomes were assessed using descriptive statistics. Pairwise effect sizes (ES) were used to compare BSA groups. RESULTS: The study included 308 patients (BSA 0%-9%: 246 [80%]; BSA ≥10%: 62 [20%]). Despite systemic therapy, both BSA groups reported the use of additional topical therapy and the presence of lesions at difficult locations. Moderate-to-severe AD (vIGA-AD®) was reported by 11% (BSA 0%-9%) and 66% (BSA ≥10%; ES = 0.56) of patients. Mean disease severity scores: total BSA (2% and 22%; ES = 3.59), EASI (1.1 and 11.1; ES = 2.60), and SCORAD (12.1 and 38.0; ES = 1.99). Mean scores for PROs: DLQI (3.7 and 7.5; ES = 0.75), and peak pruritus (2.2 and 4.5; ES = 0.81). Inadequate control of AD was seen in 27% and 53% of patients (ES = 0.23). CONCLUSIONS: Patients with AD experience a high disease burden despite systemic treatment for 4-12 months. This study provides potential evidence of suboptimal treatment and the need for additional effective treatment options for AD.

This real-world study assessed clinical characteristics and overall disease burden in adult patients with atopic dermatitis (AD) who were receiving systemic therapy for 4­12 months.Patients reported greater involvement of back and anterior trunk, and lesions at difficult locations. Irrespective of body surface area involvement, patients continued to experience inadequate control of AD, varied disease severity, and impact on quality of life.The study provides potential evidence of suboptimal treatment and the need for effective treatment options for the management of AD. Besides clinical outcomes, treating dermatologists and dermatology practitioners should include patient-reported outcomes in routine clinical care to determine the best treatment options for their patients.

Comparative effectiveness of TNF inhibitor vs IL-6 receptor inhibitor as monotherapy or combination therapy with methotrexate in biologic-experienced patients with rheumatoid arthritis: An analysis from the CorEvitas RA Registry.

OBJECTIVE: Randomized controlled trials (RCTs) in biologic-naïve rheumatoid arthritis (RA) patients with high disease activity and inadequate response/intolerance to methotrexate have shown interleukin-6 (IL-6) receptor inhibitors (IL-6Ri) to be superior to tumor necrosis factor inhibitors (TNFi) as monotherapy. This observational study aimed to compare the effectiveness of TNFi vs IL-6Ri as mono- or combination therapy in biologic/targeted synthetic (b/ts) -experienced RA patients with moderate/high disease activity. METHODS: Eligible b/ts-experienced patients from the CorEvitas RA registry were categorized as TNFi and IL-6Ri initiators, with subgroups initiating as mono- or combination therapy. Mixed-effects regression models evaluated the impact of treatment on Clinical Disease Activity Index (CDAI), patient-reported outcomes, and disproportionate pain (DP). Unadjusted and covariate-adjusted effects were reported. RESULTS: Patients initiating IL-6Ri (n = 286) vs TNFi monotherapy (n = 737) were older, had a longer RA history and higher baseline CDAI, and were more likely to initiate as third-line therapy; IL-6Ri (n = 401) vs TNFi (n = 1315) combination therapy initiators had higher baseline CDAI and were more likely to initiate as third-line therapy. No significant differences were noted in the outcomes between TNFi and IL-6Ri initiators (as mono- or combination therapy). CONCLUSION: This observational study showed no significant differences in outcomes among b/ts-experienced TNFi vs IL-6Ri initiators, as either mono- or combination therapy. These findings were in contrast with the previous RCTs in biologic-naïve patients and could be explained by the differences in the patient characteristics included in this study. Further studies are needed to help understand the reasons for this discrepancy in the real-world b/ts-experienced population.

Socioeconomic impact of treatment with biological disease-modifying antirheumatic drugs in Japanese patients with rheumatoid arthritis.

OBJECTIVES: We evaluate the socioeconomic impact of treatment with biological and targeted synthetic disease-modifying antirheumatic drugs in Japanese patients with rheumatoid arthritis. METHODS: We analysed data retrospectively from the prospective observational CorEvitas RA Japan Registry (March 2016-February 2020). Patients were categorised into paid workers (PWs) and home workers (HWs) and further based on drug classes. We assessed medication persistence, treatment outcomes, health care resource utilisation, and socioeconomic impact over 12 months, including direct (drugs and health care resource utilisation) and indirect (loss of productivity) costs. RESULTS: Overall, 187 PWs and 114 HWs were identified. Over 12 months, medication persistence was high, treatment outcomes improved, and outpatient visits reduced in both groups. Following treatment initiation, direct costs increased, whereas indirect (loss of productivity) costs decreased in both groups. The unadjusted socioeconomic impact [Japanese yen (JPY)] increased across all drug classes in PWs (range: 29,700-151,700) and HWs (range: -28,700 to 83,000). Adjusted change in monthly socioeconomic impact was JPY 29,700-138,900 for PWs and JPY -28,000 to 92,800 for HWs. CONCLUSIONS: In this study of Japanese patients with rheumatoid arthritis, the socioeconomic burden increased across patient groups and drug classes. The decrease in indirect (loss of productivity) costs partially offset the increase in direct costs.

Social influence of adult children on parental health behavior among South Asian immigrants: findings from the MASALA (Mediators of Atherosclerosis in South Asians Living in America) study.

Objectives: Examine the social influence of adult children on the cardiovascular-related health behaviors of older South Asian (SA) immigrants to inform lifestyle interventions.Design: This mixed-methods study used data from an ancillary study of social networks (2014-2018) in the Mediators of Atherosclerosis in South Asians Living in America cohort. Phase 1 was a quantitative analysis of self-reported diet and physical activity among SA adults (n = 448, mean age = 58 years, SD 8.4) who named at least one adult child to their social network. The Alternative Healthy Eating Index (AHEI) was used to measure parents' diet; higher numbers indicate a healthier diet (range 0-110). Phase 2 was a thematic content analysis of in-depth qualitative interviews from a subsample of these parents (n = 23, mean age = 55, SD 7.6).Results: Parents with an adult child in their network who consumed uncooked vegetables daily had mean parental AHEI score 1.5 points higher (adjusted p-value = 0.03) than those who had a child in the network who ate uncooked vegetables less often. When at least one adult child in their network ate fresh fruit daily compared to less frequently or when at least one child ate non-SA food daily compared to less frequently, mean parental AHEI scores were higher by 2.0 (adjusted p-value = 0.01) and 1.6 (adjusted p-value = 0.03) points respectively. Parents with an adult child in their network who exercised at least weekly were more likely to meet guideline-recommended physical activity levels than parents with children who exercised less often (76% v. 56%, adjusted p-value = 0.02). Adult children provided social support and were seen as 'role models' for healthy behavior, especially when adopting Western health behaviors.Conclusion: Positive role modeling and support from adult children were important facilitators of healthy behavior change in older SA immigrants and can inform health behavior interventions for SA adults.

The South Asian Healthy Lifestyle Intervention (SAHELI) trial: Protocol for a mixed-methods, hybrid effectiveness implementation trial for reducing cardiovascular risk in South Asians in the United States.

Intensive lifestyle interventions targeting diet and physical activity are recommended for reducing atherosclerotic cardiovascular disease (ASCVD) risk in adults. However, existing interventions often do not reach immigrant populations because of a mismatch between the social, cultural, and environmental context of immigrants and Western bio behavioral models which underpin evidence-based lifestyle interventions. The South Asian Healthy Lifestyle Intervention (SAHELI) study is a type 1 hybrid design randomized controlled trial aimed at reducing ASCVD risk in South Asian Americans, a group at higher ASCVD risk than whites and other Asian Americans. The objective is to evaluate the clinical effectiveness and implementation potential of a community-based, culturally-adapted lifestyle intervention for South Asian adults. Participants (n = 550) will be randomized to printed healthy lifestyle education materials or SAHELI, a group-based lifestyle change program that includes weekly classes for 16 weeks and 4 booster classes though month 11. SAHELI integrates evidence-based behavior change strategies with culturally-adapted strategies and group motivational interviewing to improve diet, physical activity, and stress management. Follow-up assessments will occur at 6 and 12 months. We hypothesize that the SAHELI intervention group will have greater improvements in clinical ASCVD risk factors (weight, blood pressure, glycated hemoglobin, and lipids), physical activity, and psychosocial outcomes than the print material group at 6- and 12- months. We will use mixed-methods to examine SAHELI's potential for reach, adoption, implementation, and maintenance from the perspective of multiple stakeholders. This study offers the potential to increase the reach and effectiveness of evidence-based lifestyle interventions for South Asian adults at increased risk for ASCVD.

Association of Social Networks and Physical Activity in South Asians: The Mediators of Atherosclerosis in South Asians Living in America Cohort Study.

BACKGROUND: Eliminating racial/ethnic disparities in physical activity remains a challenge in the United States. South Asian immigrants in the United States have particularly low physical activity levels, and evidence suggests that social context may be important. This study examined associations between personal social networks and moderate to vigorous leisure-time physical activity (MVPA) among South Asians in the United States. METHODS: We used cross-sectional data (2014-2017) from 689 South Asians (aged 43-85 y) who participated in the Mediators of Atherosclerosis in South Asians Living in America study. Self-reported physical activity and egocentric network data were collected from participants about their network members. Regression models were used to determine associations between social network characteristics and participants' MVPA. RESULTS: Participants were on average 59 years old (SD = 9) and reported 1335 metabolic equivalent minutes per week of MVPA (interquartile range = 735, 2212). Having network members who exercised or who were exercise partners associated with increased MVPA in men (ß coefficient = 241 MET min/wk [95% confidence interval, 63 to 419] and ß = 520 MET min/wk [95% confidence interval, 322 to 718], respectively). For women, the association was only significant if the exercise partner was a spouse. CONCLUSION: Physical activity interventions utilizing network members as exercise partners may have potential in South Asians but must consider gender differences.

Recruitment and retention of US South Asians for an epidemiologic cohort: Experience from the MASALA study.

INTRODUCTION: There are few longitudinal studies about South Asians (SAs) and little information about recruitment and retention approaches for this ethnic group. METHODS: We followed 906 SAs enrolled in the Mediators of Atherosclerosis in South Asians Living in America (MASALA) cohort for 5 years. Surviving participants were invited for a second clinical exam from 2015 to 2018. A new wave of participants was recruited during 2017-2018. We assessed the yields from different methods of recruitment and retention. RESULTS: A total of 759 (83%) completed the second clinical exam, and 258 new participants were enrolled. Providing a nearby community hospital location for the study exam, offering cab/shared ride reimbursement, and conducting home visits were the most effective methods for enhancing retention. New participant recruitment targeted women and individuals with lower socioeconomic status, and we found that participant referrals and active community engagement were most effective. Mailing invitational letters to those identified by electronic health records had very low yield. CONCLUSION: Recruitment and retention strategies that address transportation barriers and increase community engagement will help increase the representation of SAs in health research.

Social network body size is associated with body size norms of South Asian adults.

AIMS: To examine the association between social network body size and body size norms in South Asian adults. METHODS: Participants (n = 766) from the Mediators of Atherosclerosis in South Asians Living in America (MASALA) study (2014-2018) provided detailed information about their five closest network members. Participants' perceptions of their network members' body sizes, their own body size (self-body size), and a healthy body size for men and women (body size norms) were assessed using the Stunkard 9-figure scale. Adjusted hierarchical linear regression models were used to examine associations between the average body size of network members and perceived body size norms. RESULTS: Participants' average age was 59.1 years (SD = 9.2) and 44.1% were women. Participants reported an average network body size of 4.0 (SD = 1.1). The average body size norm for male and female Stunkard images was 3.6 (SD = 1.0) and 3.4 (SD = 0.8), respectively. Social network body size was positively associated with increasing body size norms (ß-coefficient = 0.31, 95% CI: 0.26, 0.36), independent of self-body size. DISCUSSION: Social networks may influence body size norms in South Asian adults. Long-term follow up of the MASALA cohort will determine if social network body size and body size norms are associated with weight- control behaviors and weight change.

An Exercise Intervention for South Asian Mothers with Risk Factors for Diabetes.

PURPOSE: South Asians (Indians, Pakistanis, Bangladeshis, Sri Lankans, Nepalis, and Bhutanese) in the United States have a very high prevalence of type 2 diabetes mellitus (DM). This pilot study evaluated a culturally-tailored exercise intervention among South Asian immigrant mothers with DM risk factors. METHODS: Through an academic-community partnership, South Asian women with risk factors for DM and who had at least one child between 6-14 years were enrolled into this single-arm study. The intervention for the mothers included 16-weeks of twice weekly exercise classes, self-monitoring with activity trackers, goal-setting, and classes on healthy eating. Based on prior community-based participatory research, children were offered exercise classes during the mothers' classes. The primary efficacy outcomes were change in mothers' moderate/vigorous physical activity and body weight pre- and post-intervention (16-weeks). Program adherence, clinical, and psychosocial outcomes were measured. A qualitative process evaluation was conducted to understand participant perspectives. RESULTS: Participants' (n=30) average age was 40 (SD=5) years., 57% had a high school education or less, and all were overweight/obese.. At baseline, women were not meeting recommended physical activity guidelines. Overall, participants attended 75% of exercise classes. Compared to baseline, participants' weight decreased by 3.2 lbs. (95% CI: -5.5, -1.0) post-intervention. Among women who attended at least 80% of classes (n=17), weight change was -4.8 lbs, (95% CI: -7.7, -1.9). Change in accelerometer-measured physical activity was not significant; however exercise-related confidence increased from baseline (p-value <0.01). Women described multiple physical and psychosocial benefits from the intervention. CONCLUSION: This pilot study suggests that a culturally-tailored exercise intervention that included exercise classes for children was feasible and had physical and psychosocial benefits in South Asian mothers with risk factors for DM.

Mediators of Atherosclerosis in South Asians Living in America: Use of Web-Based Methods for Follow-Up and Collection of Patient-Reported Outcome Measures.

BACKGROUND: A key challenge for longitudinal cohort studies is follow-up and retention of study participants. Participant follow-up in longitudinal cohort studies is costly and time-consuming for research staff and participants. OBJECTIVE: This study determined the feasibility and costs of using Web-based technologies for follow-up and collection of patient-reported outcomes in the Mediators of Atherosclerosis in South Asians Living in America (MASALA) study. METHODS: The MASALA study is a community-based cohort of 906 South Asians in the United States. Since the baseline in-person visits (2010-2013), a yearly telephone follow-up survey was used to assess participants' health status and incidence of cardiovascular disease. A Web-based version of the follow-up survey was developed using the REDCap (Research Electronic Data Capture) Web app. Participants from the Chicago field center who were due for their annual follow-up and who had a valid email address were sent an email link to a secure online portal where they could complete the survey. Telephone follow-up was used with nonresponders. RESULTS: A link to the Web survey was emailed to 285 participants (February to October 2014) and the overall completion rate was 47.7% (136/285). One-third of participants who were unresponsive (n=36) to annual telephone follow-up completed the Web survey. Web responders were younger, more likely to be married, and to have higher education and income compared (P<.05) to telephone-only responders. Web survey development involved 240 hours of research staff time. Since launching, the Web-based survey has required 3 hours per week of staff time. CONCLUSIONS: Although electronic follow-up will not be a panacea for cohort operations, it will serve as an adjunctive strategy to telephonic follow-up for maximizing cohort retention with lower costs.

Qualitative Process Evaluation of a Community-Based Culturally Tailored Lifestyle Intervention for Underserved South Asians.

Introduction There are few examples of effective cardiovascular disease prevention interventions for South Asians (SAs). We describe the results of a process evaluation of the South Asian Heart Lifestyle Intervention for medically underserved SAs implemented at a community-based organization (CBO) using community-based participatory research methods and a randomized control design (n = 63). Method Interviews were conducted with 23 intervention participants and 5 study staff using a semistructured interview guide focused on participant and staff perceptions about the intervention's feasibility and efficacy. Data were thematically analyzed. Results Intervention success was attributed to trusted CBO setting, culturally concordant study staff, and culturally tailored experiential activities. Participants said that these activities helped increase knowledge and behavior change. Some participants, especially men, found that self-monitoring with pedometers helped motivate increased physical activity. Participants said that the intervention could be strengthened by greater family involvement and by providing women-only exercise classes. Staff identified the need to reduce participant burden due to multicomponent intervention and agreed that the CBO needed greater financial resources to address participant barriers. Conclusion Community-based delivery and cultural adaptation of an evidence-based lifestyle intervention were effective and essential components for reaching and retaining medically underserved SAs in a cardiovascular disease prevention intervention study.

Translating a heart disease lifestyle intervention into the community: the South Asian Heart Lifestyle Intervention (SAHELI) study; a randomized control trial.

BACKGROUND: South Asians (Asian Indians and Pakistanis) are the second fastest growing ethnic group in the United States (U.S.) and have an increased risk of atherosclerotic cardiovascular disease (ASCVD). This pilot study evaluated a culturally-salient, community-based healthy lifestyle intervention to reduce ASCVD risk among South Asians. METHODS: Through an academic-community partnership, medically underserved South Asian immigrants at risk for ASCVD were randomized into the South Asian Heart Lifestyle Intervention (SAHELI) study. The intervention group attended 6 interactive group classes focused on increasing physical activity, healthful diet, weight, and stress management. They also received follow-up telephone support calls. The control group received translated print education materials about ASCVD and healthy behaviors. Primary outcomes were feasibility and initial efficacy, measured as change in moderate/vigorous physical activity and dietary saturated fat intake at 3- and 6-months. Secondary clinical and psychosocial outcomes were also measured. RESULTS: Participants' (n = 63) average age was 50 (SD = 8) years, 63 % were female, 27 % had less than or equal to a high school education, one-third were limited English proficient, and mean BMI was 30 kg/m2 (SD ± 5). There were no significant differences in change in physical activity or saturated fat intake between the intervention and control group. Compared to the control group, the intervention group showed significant weight loss (-1.5 kg, p-value = 0.04) and had a greater sex-adjusted decrease in hemoglobin A1C (-0.43 %, p-value <0.01) at 6 months. Study retention was 100 %. CONCLUSIONS: This pilot study suggests that a culturally-salient, community-based lifestyle intervention was feasible for engaging medically underserved South Asian immigrants and more effective at addressing ASCVD risk factors than print health education materials. TRIAL REGISTRATION: NCT01647438, Date of Trial Registration: July 19, 2012.

Life stage influences on U.S. South Asian women's physical activity.

PURPOSE: South Asian (SA) women in the United States report extremely low rates of leisure time physical activity (PA) compared with women in other ethnic minority groups. This study explored SA women's perspectives on PA during different life stages. DESIGN: This is a community-based participatory research study that used focus groups. SETTING: The study setting was a community-based organization that provides social services to SA immigrants in Chicago, Illinois. PARTICIPANTS: The study team conducted six focus groups (in English and Hindi) with 42 SA women, ages 18 to 71 years. METHOD: A semistructured interview guide was used to foster discussion about perceptions of, barriers to/facilitators of, and suggestions for PA programs. Discussions were transcribed and independently coded by two reviewers using thematic content analysis and guided by a coding scheme that was developed a priori. RESULTS: Participants said that different life stages strongly influenced their PA. PA decreased after marriage and having children. Chronic diseases constrained older women from more vigorous PA. Barriers to PA among younger women were family disapproval and perceptions that PA is unnecessary if you are "skinny." Women agreed that PA is not a priority within the culture, and that interventions must take into account cultural, religious, and family context. CONCLUSION: Sociocultural norms, family constraints, and lack of awareness about the benefits of PA strongly influenced PA among SA women. Culturally salient intervention strategies might include programs in trusted community settings where women can exercise in women-only classes with their children, and targeted education campaigns to increase awareness about the benefits of PA across life stages.

Understanding the high prevalence of diabetes in U.S. south Asians compared with four racial/ethnic groups: the MASALA and MESA studies.

OBJECTIVE: We compared South Asians with four other racial/ethnic groups in the U.S. to determine whether sociodemographic, lifestyle, or metabolic factors could explain the higher diabetes prevalence and whether insulin resistance and ß-cell dysfunction occurred at younger ages and/or lower adiposity levels compared with other groups. RESEARCH DESIGN AND METHODS: We performed a cross-sectional analysis of two community-based cohorts, the Mediators of Atherosclerosis in South Asians Living in America (MASALA) study and the Multi-Ethnic Study of Atherosclerosis (MESA); all participants had no known cardiovascular disease and were between 44 and 84 years of age. We compared 799 South Asians with 2,611 whites, 1,879 African Americans, 1,493 Latinos, and 801 Chinese Americans. Type 2 diabetes was classified by fasting plasma glucose ≥126 mg/dL or use of a diabetes medication. Insulin resistance was estimated by the homeostasis model assessment (HOMA) and ß-cell function was measured by the HOMA-ß model. RESULTS: South Asians had significantly higher age-adjusted prevalence of diabetes (23%) than the MESA ethnic groups (6% in whites, 18% in African Americans, 17% in Latinos, and 13% in Chinese Americans). This difference increased further after adjustment for potential confounders. HOMA of insulin resistance (HOMA-IR) levels were significantly higher and HOMA-ß levels were lower among South Asians compared with all other racial/ethnic groups after adjustment for age and adiposity. CONCLUSIONS: The higher prevalence of diabetes in South Asians is not explained by traditionally measured risk factors. South Asians may have lower ß-cell function and an inability to compensate adequately for higher glucose levels from insulin resistance.

Comparing coronary artery calcium among U.S. South Asians with four racial/ethnic groups: the MASALA and MESA studies.

OBJECTIVES: South Asians (individuals from India, Pakistan, Bangladesh, Nepal, and Sri Lanka) have high rates of cardiovascular disease which cannot be explained by traditional risk factors. Few studies have examined coronary artery calcium (CAC) in South Asians. METHODS: We created a community-based cohort of South Asians in the United States and compared the prevalence and distribution of CAC to four racial/ethnic groups in the Multi-Ethnic Study of Atherosclerosis (MESA). We compared 803 asymptomatic South Asians free of cardiovascular disease to the four MESA racial/ethnic groups (2622 Whites, 1893 African Americans, 1496 Latinos and 803 Chinese Americans). RESULTS: The age-adjusted prevalence of any CAC was similar between White and South Asian men, but was lower in South Asian women compared to White women. After adjusting for all covariates associated with CAC, South Asian men were similar to White men and had higher CAC scores compared to African Americans, Latinos and Chinese Americans. In fully adjusted models, CAC scores were similar for South Asian women compared to all women enrolled in MESA. However, South Asian women ≥70 years had a higher prevalence of any CAC than most other racial/ethnic groups. CONCLUSIONS: South Asian men have similarly high CAC burden as White men, but higher CAC than other racial/ethnic groups. South Asian women appear to have similar CAC burden compared to other women, but have somewhat higher CAC burden in older age. The high burden of subclinical coronary atherosclerosis in South Asians may partly explain higher rates of cardiovascular disease in South Asians.

The South Asian Heart Lifestyle Intervention (SAHELI) study to improve cardiovascular risk factors in a community setting: design and methods.

Disseminating and implementing evidence-based, cardiovascular disease (CVD) prevention lifestyle interventions in community settings and in ethnic minority populations is a challenge. We describe the design and methods for the South Asian Heart Lifestyle Intervention (SAHELI) study, a pilot study designed to determine the feasibility and initial efficacy of a culturally-targeted, community-based lifestyle intervention to improve physical activity and diet behaviors among medically underserved South Asians (SAs). Participants with at least one CVD risk factor will be randomized to either a lifestyle intervention or a control group. Participants in both groups will be screened in a community setting and receive a primary care referral after randomization. Intervention participants will receive 6weeks of group classes, followed by 12weeks of individual telephone support where they will be encouraged to initiate and maintain a healthy lifestyle goal. Control participants will receive their screening results and monthly mailings on CVD prevention. Primary outcomes will be changes in moderate/vigorous physical activity and saturated fat intake between baseline, 3-, and 6-month follow-up. Secondary outcomes will be changes in weight, clinical risk factors, primary care visits, self-efficacy, and social support. This study will be one of the first to pilot-test a lifestyle intervention for SAs, one of the fastest growing racial/ethnic groups in the U.S. and one with disparate CVD risk. Results of this pilot study will provide preliminary data about the efficacy of a lifestyle intervention on CVD risk in SAs and inform community-engaged CVD prevention efforts in an increasingly diverse U.S. population.