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Hypertension, diabetes, and corresponding annual clinical testing utilization: Comparison between Asian Indians and other races/ethnicities

Visaria, A; Islam, S; Polamarasetti, P; James, J; Raju, P; Sharma, A; Khangura, K K; Thawani, R; Dodani, S
Asian Indians are at increased risk of developing cardiometabolic diseases. We sought to determine differences between Asian Indians and other races/ethnicities in hypertension and diabetes prevalence and associated annual blood pressure (BP) and fasting blood glucose (FBG) testing. A total of 257,652 adults >=18 years from the 2011-2018 U.S. National Health Interview Surveys (NHIS) were included. BP and FBG testing in the past 12 months was defined dichotomously (yes/not yes). Racial/ethnic groups included non-Hispanic White (NHW), non-Hispanic Black (NHB), Asian Indian, Other Asians, and Hispanic/Multiracial. We used logistic regression, adjusting for covariates and the survey design. Analyses were completed from 08/2020-06/2021. Asian Indians (N = 3049) had 21% and 99% higher odds of hypertension and diabetes, respectively, than NHWs (aOR [95% CI]; hypertension: 1.21[1.04,1.40], diabetes: 1.99[1.64,2.41]). Accordingly, Asian Indians without diabetes had significantly higher odds of FBG screening than NHWs (Asian Indian: 1.41[1.25,1.59], NHB: 0.99 [0.95,1.04], Other Asian: 1.07[0.98, 1.18], Hispanic: 1.13[1.07,1.20]). Asian Indians without hypertension had a 14% insignificant increase in BP testing compared to NHWs (1.14[0.97,1.33]). Predictors of testing in Asian Indians included older age, doctor's visit, graduate-level education, insurance coverage, and history of hypertension or diabetes. NHBs with diabetes and Hispanics with hypertension had lower odds of FBG testing (0.75[0.66,0.84]) and BP testing (0.85[0.79,0.92]), respectively, than NHWs. Asian Indians have higher odds of diabetes and hypertension than NHWs and higher, but relatively lower, odds of FBG and BP testing. Increasing routine BP and FBG testing in Asian Indians in younger adults may allow for earlier detection of high-risk individuals.
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EMBASE:2013931297
ISSN: 0091-7435
CID: 4977772

Understanding the impact of blood pressure guidelines and variability on hypertension diagnoses [Letter]

Visaria, A; Raju, P; Islam, S; James, J; Polamarasetti, P
EMBASE:634759745
ISSN: 1473-5598
CID: 5025372

Lupus Nephritis and Renal Outcomes in African-Americans: The Accelerating Medicines Partnership Cohort Experience [Meeting Abstract]

Fava, A; Li, J; Carlucci, P; Wofsy, D; James, J; Putterman, C; Diamond, B; Fine, D; Monroy-Trujillo, J; Haag, K; Deonaraine, K; Apruzzese, W; Buyon, J; Petri, M
Background/Purpose: The Accelerating Medicines Partnership (AMP) will use multi-omics modalities including single cell RNA sequencing to understand lupus nephritis with the ultimate goal to devise novel and personalized treatment strategies. African-Americans have more lupus nephritis and worse outcomes in terms of end stage renal disease. We report here the clinical findings to date on African-American patients in the AMP cohort.
Method(s): We included 118 patients with urine protein-to-creatinine ratio (UPCR) >= 1 and biopsy proven class III, IV, V or mixed lupus nephritis at time of enrollment. All patients met revised ACR or SLICC classification criteria. Clinical data were obtained at baseline, 12, 26, and 52 weeks after the renal biopsy. Response status at week 52 was defined as follows. Complete: UPCR <= 0.5, normal serum creatinine (sCr) or < 25% increase from baseline if abnormal, and prednisone < 10mg daily; partial: UPCR > 0.5 but <= 50% of the baseline value and same sCr and prednisone rules as complete response; no response: UPCR > 50% of baseline value or new abnormal elevation of sCr or >= 25% from baseline or prednisone >= 10mg daily.
Result(s): Table 1 shows that African Americans were more likely to have class V lupus nephritis (38% vs 22.5%, p=0.06), were less serologically active (low C3 50% vs 77.5%, p=0.002; anti-dsDNA 63% vs 79%, p=0.006), and were more likely to have elevated serum creatinine (55% vs 30%, p=0.03). Caucasians were older (47 vs 34 years, p=< 0.001) and more likely to be at their first biopsy (64% vs 31%, p=0.04). Table 2 shows the differences based on the first biopsy versus a repeat biopsy. African-Americans were significantly less likely to have a treatment response at the first biopsy. Regardless of first or later biopsy, they were less likely to have low C3. Table 3 shows multi-variate models. African-American patients at their first episode of lupus nephritis were less likely to respond to treatment (37.5% vs 75%, p=0.018) independently of histological features including class, activity and chronicity.
Conclusion(s): The AMP cohort demonstrates the current unmet clinical need to improve treatment of lupus nephritis in the United States. African-American lupus nephritis is different in terms of ISN class, serologies, first biopsy, and worse in terms of response status even after adjusting for activity and chronicity. Personalized treatments should be developed to improve outcomes in high risk populations such as African-Americans.Table 1. Patients characteristics by race/ethnicity. Data are presented as n (%) or mean (SD). Two patients identified as "Other" and are not shown in this Table. P values > 0.1 are indicated as ns
EMBASE:634235306
ISSN: 2326-5205
CID: 4804742

The Value of Renal Biopsy at Lower Levels of Proteinuria in Patients Enrolled in the Lupus Accelerating Medicines Partnership [Meeting Abstract]

Carlucci, P; Deonaraine, K; Fava, A; Li, J; Wofsy, D; James, J; Putterman, C; Diamond, B; Fine, D; Monroy-Trujillo, J; Haag, K; Apruzzese, W; Belmont, H M; Izmirly, P; Connery, S; Payan-Schober, F; Furie, R; Berthier, C; Dall'Era, M; Cho, K; Kamen, D; Kalunian, K; Petri, M; Buyon, J
Background/Purpose: Lupus nephritis continues to be the complication with the highest standardized mortality ratio in Systemic Lupus Erythematosus (SLE), and a late diagnosis associates with worse outcomes. Clinicians traditionally rely on proteinuria to drive decisions regarding renal biopsy and subsequent management. Since threshold levels for such determinations are variable but critically important, this study leveraged the well-phenotyped multi-center multi- racial Accelerating Medicines Partnership (AMP) lupus nephritis cohort, to address whether urine protein to creatinine ratios (UPCR) between.5 and 1 differ from higher ratios with regard to clinical, serologic and histologic variables.
Method(s): 239 patients fulfilling ACR or SLICC criteria for SLE with a random or 24 hr uPCR > or =.5 and histologic biopsy Class III, IV, V, or mixed were consecutively enrolled in AMP at the time of renal biopsy and demographics, clinical history, medications, disease activity as assessed by the hybrid SELENA-SLEDAI were recorded. Patients with biopsy Classes I, II and VI were ineligible. Patients were followed at 3, 12, 26 and 52 weeks.
Result(s): At baseline, 38 patients had a UPCR < 1 (A), 113 had a UPCR 1-3 (B), and 88 had a UPCR > 3 (C). There were 14 additional patients with UPCR < 1, and 11 patients with UPCR > 1 who had biopsy class I or II. In group A, there were significantly more male patients (44% A; 23% B; 26% C, p=0.012) with no differences in age, race or ethnicity. Neither the SLEDAI nor serologic parameters (anti-dsDNA, C3, or C4) distinguished among the groups. Those in group C had a significantly increased creatinine and decreased hemoglobin and albumin compared to the other two groups (Table 1). Patients in group A trended toward having an increased frequency of proliferative histology (Table 2). This trend was not observed when considering patients for whom this was their first biopsy, but was significant for repeat biopsy patients (56% A; 41% B; 24% C, p=0.03). The activity index was independent of UPCR regardless of biopsy number. However, those in group C had a significantly higher chronicity index than those with lower UPCR. This correlation was shown for patients with a repeat biopsy (r=0.2299, p=0.003) but not first biopsy patients (r=0.0891, p=0.45). Although medications did not differ at baseline among the groups, at 12 weeks, for each group significantly more patients were taking Mycophenolate Mofetil than at the time of biopsy (Table 3).
Conclusion(s): A significant proportion of both first and recurrent biopsies in patients with a UPCR < 1 have proliferative histology and accompanying activity scores similar to that of patients with nephrotic range proteinuria. These results support renal biopsy at thresholds lower than a UPCR of 1 since histologic findings can inform therapeutic decisions
EMBASE:634233229
ISSN: 2326-5205
CID: 4804822

Renal Responder Status and Associated Clinical Variables in the Lupus Accelerating Medicines Partnership Cohort [Meeting Abstract]

Carlucci, P; Fava, A; Deonaraine, K; Li, J; Wofsy, D; James, J; Putterman, C; Diamond, B; Fine, D; Monroy-Trujillo, J; Haag, K; Apruzzese, W; Belmont, H M; Izmirly, P; Connery, S; Payan-Schober, F; Furie, R; Berthier, C; Dall'Era, M; Cho, K; Kamen, D; Kalunian, K; Petri, M; Buyon, J
Background/Purpose: Poor therapeutic response rates contribute to the increased morbidity and mortality associated with lupus nephritis. Early identification of patients likely to respond is crucial as delays in treatment associate with worse outcomes. This study evaluated response using prospectively collected data obtained from the multi-ethnic/racial, multi-center Accelerating Medicines Partnership (AMP) lupus nephritis cohort. This cohort represents a real-world clinical setting using provider chosen standard of care and uniform collection of data.
Method(s): This study included SLE patients based on ACR or SLICC classification enrolled in AMP who met the following criteria: urine protein-creatine ratio (UPCR) > 1 at entry, and histologic biopsy Class III, IV, V, or mixed. Patients were followed at 3, 12, 26 and 52 wks with demographics, history, laboratory results, disease activity, and medica-tions recorded at each visit. Follow up data were available for 136 patients at 26 wks and 118 at 52 wks. Complete response was defined as a reduction in UPCR to <.5, a normal serum creatinine or no greater than 125% of baseline, and < 10 mg prednisone at time of response assessment. Patients were partial responders if UPCR decreased > 50% but remained >.5 and nonresponders if < 50% reduction in UPCR and/or did not meet the other response criteria.
Result(s): Medications were reported at 12 wks (Table 1). The complete response rate was 26% at both 26 and 52 wks. For patients undergoing a first biopsy, the rates were 37% and 40% and for those with repeat biopsies, the rates were lower at 21% and 19% respectively (p=0.042 at 26 wks; p=0.015 at 52 wks). The complete response at 26 wks was generally sustained with only 4 of 27 patients experiencing a relapse at 52 wks. At 26 wks, patients with membranous histology were less likely to be complete responders than patients with proliferative histology. This trend was observed regardless of biopsy number and persisted for response status at 52 wks. Although baseline activity score did not predict responder status, complete responders had a significantly lower chronicity index than nonresponders (mean + SD, 2.26 + 2.22 vs 3.83 + 2.57, p=0.016) at 26 wks with similar results at 52 wks. Responder status at 26 and 52 wks whether first or repeat biopsy was independent of extrarenal disease at entry (Table 2). Complete responder status was associated with positive anti-dsDNA serology at baseline for repeat biopsy patients. Complete responders had a greater change in C3, hemoglobin, lymphocyte count, albumin, and UPCR at 12 wks compared to baseline values than nonresponders (Table 3). Similar trends were observed when considering response status at 52 wks.
Conclusion(s): The low complete response rates reported in the AMP cohort are consistent with findings in blinded controlled trials of standard-of-care therapies and support the critical need for new therapeutics particularly in patients undergoing repeat biopsies and those with increased chronicity
EMBASE:634233223
ISSN: 2326-5205
CID: 4804832

Clinical Features and Select Dysregulated Immune Parameters Distinguish Blood Relatives Who Remain Clinically Stable or Progress to Incomplete Lupus or Classified SLE in the Lupus Autoimmunity in Relatives (LAUREL) Follow-up Cohort [Meeting Abstract]

Munroe, M; Young, K; Norris, J; Guthridge, J; Kamen, D; Niewold, T; Gilkeson, G; Weisman, M; Ishimori, M; Wallace, D; Karp, D; Harley, J; James, J
Background/Purpose: Identifying populations at risk of SLE is essential to curtail inflammatory damage and identify individuals for prevention trials. Unaffected blood relatives (BRs) of lupus patients have increased risk of SLE. Some BRs have autoantibodies (AutoAbs) or SLE clinical features, but do not progress, some progress, but do not meet the required >= 4 ACR classification criteria (incomplete lupus, ILE), while others progress to classified SLE. The goal of this study is to determine factors that distinguish previously healthy BRs who remain stable or subsequently progress to ILE or SLE.
Method(s): This is a nested study of re-enrolled BRs of SLE patients (n=436) who previously enrolled in a genetics study (mean time to follow-up = 6.3 yrs) and did not meet SLE classification at baseline (BL). Of the 177 (41%) and 259 (59%) who did/did not meet additional ACR criteria at follow-up (FU) in this cohort, we compared the 56 BRs who transitioned to SLE (>=4 ACR criteria) to 34 BRs who met 3 ACR criteria (ILE) at FU and 154 race/sex/age (+/- 5 years) matched BRs with < 3 ACR criteria at FU. BRs provided clinical and demographic information, and completed the SLE-specific portion of the CTD Screening Questionnaire (CSQ) at BL and FU. Medical records were reviewed for ACR classification criteria. BL and FU plasma samples were assessed for autoantibody production (ANA, anti-dsDNA, aCL, Ro, La, Sm, nRNP, and ribosomal p antibodies) and for 52 soluble inflammatory and regulatory mediators by xMAP and ELISA assay.
Result(s): 133/244 (55%) of BRs evaluated in this nested cohort did not have any change in ACR criteria between BL and FU (Fig. 1, red circles, Nonprogressors [NP]), while the remaining 111 BRs accrued >=1 classification criteria (Fig. 1, black circles, Progressors). There was no difference in time to FU between NP and Progressor BRs. No significant differences were seen in ACR criteria, either at BL or FU, between BRs with ILE at BL who were NP vs. those who progressed to SLE at FU. Yet, a number of differences were seen at BL in BRs meeting 2 ACR criteria at BL who were NP vs. those who progressed to ILE or SLE at FU. NP BRs with BL ACR Score = 2 were more likely to meet immunologic criteria (p< 0.0001), while those BRs with ACR score <= 2 who progressed to ILE or SLE were more likely to meet clinical criteria at BL, particularly malar rash (p=0.0126) or arthritis (p=0.0054). In addition, these same NP had significantly lower SLE-CSQ scores and features at BL (Fig. 2A), with lower plasma levels of IL-2Ralpha and lower ANA titers. At FU, ACR Score = 2 NP had lower levels of BLyS and accumulated fewer AutoAbs (Fig. 2B). At both BL and FU, levels of the regulatory mediator Native TGF-beta were significantly higher in ACR Score = 2 NP (Fig. 2B). For those BRs with ILE at BL, those who progressed to SLE at FU had higher BL levels of SCF, MCP-3, and more AutoAb specificities than BL ILE NP BRs, with no difference in levels of Native TGF-beta (Fig. 2C).
Conclusion(s): BRs of known SLE patients who progress to ILE or SLE compared to BRs who remain stable are more likely to have elevated inflammatory mediators, reduced regulatory mediators, and meet as few as one clinical ACR classification criterion. This suggests that ANA or serologic positivity alone is not predictive of progression to ILE or SLE in lupus relatives
EMBASE:634233200
ISSN: 2326-5205
CID: 4804842

Safety of Obtaining Research Tissue during Clinically Indicated Kidney Biopsies: Data from the Lupus Accelerating Medicines Partnership [Meeting Abstract]

Deonaraine, K; Carlucci, P; Fava, A; Li, J; Wofsy, D; James, J; Putterman, C; Diamond, B; Fine, D; Monroy-Trujillo, J; Haag, K; Apruzzese, W; Belmont, H M; Izmirly, P; Connery, S; Payan-Schober, F; Furie, R; Berthier, C; Dall'Era, M; Cho, K; Kamen, D; Kalunian, K; Petri, M; Buyon, J
Background/Purpose: Lupus nephritis (LN) is a major complication of systemic lupus erythematous (SLE) and affects ~60% of patients during the course of their disease, leading to significant morbidity and mortality. Previous studies examining the safety of percutaneous kidney biopsy to diagnose LN have found variable complication rates depending on disease type studied, ranging from 4-11% in autoimmune/SLE patients to 15-17% in safety studies of any kidney disease. The purpose of our study was to define the safety of obtaining additional tissue for research during clinically indicated renal biopsies in a SLE cohort.
Method(s): Patients were enrolled across 15 clinical US sites in the SLE Accelerating Medicines Partnership (AMP). Kidney biopsies were clinically indicated to evaluate proteinuria (urine protein creatinine ratio [uPCR] > 0.5). Patients with a history of renal transplant, use of rituximab within 6 months of biopsy, and current pregnancy were excluded. Ultrasound/CT-guided kidney biopsies were performed by interventional radiologists/nephrologists generally using an 18-gauge needle although technique, number of routine passes and core lengths varied. An additional core taken solely for research purposes, or a piece of core with sufficient glomeruli remaining from the routine passes and not required for clinical diagnosis, was collected. All adverse events (AEs) occurring within 30 days of biopsy were reported, including duration, severity, type, and resolution.
Result(s): 482 patients underwent a renal biopsy between 2014 and 2020. All patients met criteria for SLE (ACR or SLICC) and the majority were female (85%). Pathologic assessment of clinical biopsies revealed ISN/RPS Class I-VI for most biopsies, although 45 biopsies (9%) yielded a non-LN diagnosis (Table 1). Overall, 37 patients (8%) experienced an AE with several more than one, with a total of 41 AEs reported. Of these AEs, 8 (20%) were considered by the site investigator to be unrelated or unlikely to be related (included pain, shortness of breath, cardiac arrest, fall, and hemoglobin decrease due to sepsis) and 33 (80%) were deemed possibly, probably, or definitely related to the study procedure. Of these events, 9/33 (28%) were mild, 10 (30%) were moderate, and 12 (36%) were deemed severe. In 18 patients (4%) the AEs were considered serious as defined by inpatient or prolonged hospitalization, significant incapacity, or requiring intervention to prevent permanent impairment. The most common related AEs were bleed-related complications, including hematoma, hemorrhage, and hemoglobin decrease (N= 29). Of these, 18 required hospitalization, with 4 of these patients receiving a blood transfusion. All 29 bleed-related complications resolved. The length of the research biopsy did not associate with an AE.
Conclusion(s): Procurement of an additional kidney biopsy core for research purposes in SLE patients undergoing a clinically-indicated kidney biopsy did not result in an increase in adverse events compared to the adverse event rate in prior studies of the safety of percutaneous kidney biopsy. Accordingly, inclusion of a research core should be considered feasible for future studies to advance discovery of new therapeutic targets and prognostic indicators in LN
EMBASE:634233060
ISSN: 2326-5205
CID: 4810622

Glucocorticosteroid usage and major organ damage in patients with systemic lupus erythematosus-meta-analyses of observational studies published between 1979 and 2018 [Meeting Abstract]

Mak, A; Cheung, M W L; Leong, W Y J; Dharmadhikari, B; Kow, N Y; Petri, M; Manzi, S; Clarke, A; Aranow, C; Arnaud, L; Askanase, A; Bae, S -C; Bernatsky, S; Bruce, I; Buyon, J; Chatham, W W; Costedoat-Chalumeau, N; Dooley, M A; Fortin, P; Ginzler, E M; Gladman, D; Gordon, C; Hanly, J G; Inanc, M; Isenberg, D A; Jacobsen, S; James, J; Jonsen, A; Kalunian, K C; Kamen, D; Lim, S S; Morand, E; Peschken, C; Pons-Estel, B A; Rahman, A; Ramsey-Goldman, R; Romero-Diaz, J; Ruiz-Irastorza, G; Sanchez-Guerrero, J; Steinsson, K; Svenungsson, E; Urowitz, M; Van, Vollenhoven R; Vinet, E; Voskuyl, A; Wallace, D J; Alarcon, G
Background/Purpose : The impact of glucocorticoid (GC) use on major organ damage in SLE patients has not been formally studied by amalgamating the relevant data published in the literature over the past 40 years. We aimed to study the association between GC use and the occurrence of major organ damage in SLE patients by performing meta-analyses of observational studies published between 1970 and December 2018. Methods : Literature search on PubMed (from 1966 to December 2018) for prevalence and longitudinal studies which reported GC exposure (proportion of GC users in the cohort [%GC use] and/or GC use in defined doses) and the occurrence (prevalence/incidence) of major organ damage in SLE patients using the keywords cataract, cerebrovascular (CVA), stroke, cardiovascular (CVS), angina, myocardial infarction (MI), coronary artery bypass, osteoporosis, avascular necrosis (AVN) and osteonecrosis in respective combinations with lupus was conducted. Studies with sample size < 50 and observation duration < 12 months were excluded. The logit of the proportion of patients with disease damage was modelled as a random effect in the meta-analysis, which was employed to study the association between the proportion of patients with organ damage and variables of GC use (mean daily [mg/day] and cumulative [gm] prednisone [PDN] doses and %GC use). A 2-stage estimation of the random-effects logistic regression models was used with restricted maximum likelihood estimation. Univariate associations between organ damage and moderators were examined for statistical significance, and variables related to GC use were adjusted for SLE disease duration in multivariate models if their univariate P values were < 0.2. Results : Out of 8,882 publications screened, 212 articles involving 205,619 SLE patients were eligible for the metaanalyses (Figure 1), of which 97 were prevalence and 115 were longitudinal studies. Univariate analyses of prevalence studies revealed that mean daily PDN dose (odds ratio [OR]=1.10, p=0.007) and lower proportion of female in the cohort (OR=0.002, p=0.002) were associated with the prevalence of overall CVS events. Mean daily PDN dose (OR=1.52, p< 0.001) and %GC use (OR=2,255.2, p< 0.001) were associated with the prevalence of AVN. A significant association between cumulative PDN dose and prevalence of CVA was found after multivariate adjustment for SLE disease duration (OR=1.07, p=0.017). In longitudinal studies, a significant association was identified between cumulative PDN dose and incidence of cataracts after adjustment for SLE disease duration (OR=1.04, p=0.013). While the incidence of MI in SLE patients has dropped over the past 40 years (OR=0.94, p=0.002), it was associated with % GC use after adjustment for SLE disease duration (OR=8.18, p=0.012). Interestingly, significant univariate associations were found between antimalarial use and lower prevalence of MI (OR=0.05, p=0.002) and lower incidence of CVA (OR=0.20, p=0.032). Conclusion : Independent of SLE disease duration, cumulative PDN dose was associated with higher prevalence of CVA and incidence of cataracts, and higher incidence of MI was associated with overall GC use
EMBASE:633059985
ISSN: 2326-5205
CID: 4633432