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Purpose Estimate effects of ranibizumab on diabetic retinopathy (DR) severity in US Hispanic and non-Hispanic white persons with center-involved diabetic macular edema (DME) causing vision impairment for whom ranibizumab treatment would be considered. Patients and methods This model simulated DR severity outcomes over 2 years in the better-seeing eye using US census, National Health and Nutrition Examination Survey, Wisconsin Epidemiologic Study of Diabetic Retinopathy, and Los Angeles Latino Eye Study data. Baseline DR severity estimated from Diabetic Retinopathy Clinical Research Network trial data. Changes in DR severity after 2 years, with/without monthly ranibizumab (0.3 or 0.5 mg), were estimated from Phase III clinical trial data (RIDE/RISE) using a 2-dimensional Monte Carlo simulation model. Number of patients over a 2-year period for whom 1) DR severity worsening was avoided, 2) DR severity improved, and 3) selected clinical events related to proliferative DR (PDR) occurred, was estimated. Results An estimated 37,274 US Hispanic and non-Hispanic white persons were projected to have DR with center-involved DME and be eligible for ranibizumab treatment. The number of persons with moderately severe non-proliferative DR (NPDR) or less severe DR at baseline who would worsen to PDR and experience a PDR complication over 2 years would be reduced from 437 with no ranibizumab to 19 with ranibizumab (95% reduction; 95% simulation interval [SI], 79-100%). The number of persons with severe NPDR or less severe DR at baseline who would be expected to improve by ≥2 DR severity levels over 2 years would increase from 1706 with no ranibizumab to 13,042 with ranibizumab (682% increase; 95% SI, 478-967%). Conclusion This model estimates that ranibizumab treatment in US Hispanic and non-Hispanic white patients with center-involved DME causing vision impairment would potentially reduce the number of patients with worsening DR and potentially increase the number with DR improvements.

Aims: Protocol T (NCT01627249) was a head-to-head study conducted by the Diabetic Retinopathy Clinical Research Network that compared intravitreal aflibercept, bevacizumab, and ranibizumab for the treatment of diabetic macular edema (DME). A cost-effectiveness analysis accompanying the 1-year data of Protocol T revealed that aflibercept was not cost-effective vs ranibizumab for all patients, but could have been cost-effective in certain patient sub-groups if the 1-year results were extrapolated out to 10 years. The present study evaluated the cost-effectiveness of US Food and Drug Administration-approved anti-vascular endothelial growth factor agents (ranibizumab, aflibercept) for treatment of DME using the 2-year data from Protocol T. Methods: Costs of aflibercept 2.0 mg or ranibizumab 0.3 mg, visual acuity (VA)-related medical costs, and quality-adjusted life-years (QALYs) were simulated for eight VA health states. Treatment, adverse event management, and VA-related healthcare resource costs (2016 US dollars) were based on Medicare reimbursement and published literature. VA-related health utilities were determined using a published algorithm. Patients were stratified by baseline VA: 20/40 or better; 20/50 or worse. Results: Total 2-year costs were higher, and QALYs similar, for aflibercept vs ranibizumab in the full cohort ($44,423 vs $34,529; 1.476 vs 1.466), 20/40 or better VA sub-group ($40,854 vs $31,897; 1.517 vs 1.519), and 20/50 or worse VA sub-group ($48,214 vs $37,246; 1.433 vs 1.412), respectively. Incremental cost-effectiveness ratios in the full cohort and 20/50 or worse VA sub-group were $986,159/QALY and $523,377/QALY, respectively. These decreased to $711,301 and $246,978 when analyses were extrapolated to 10 years. Limitations: Key potential limitations include the fact that VA was the only QALY parameter analyzed and the uncertainty surrounding the role of better- and worse-seeing eye VA in overall functional impairment. Conclusions: This analysis suggests that aflibercept is not cost-effective vs ranibizumab for patients with DME, regardless of baseline vision.

RATIONALE: ACE2, a critical SARS-CoV-2 entry receptor, has reduced expression in those with allergic sensitizations. Consequently, SARS-CoV-2 infections may impact patients with allergic asthma (AA) or no evidence of allergic asthma (NEAA) differently. We explore demographics of SARS-CoV-2-infected AA and NEAA patients. METHODS: Retrospective data were obtained from the US-representative COVID-19 Optum Electronic Health Record dataset through 10/15/2020. Index was the earliest date of presumed diagnosis or laboratory-confirmed SARS-CoV-2 infection (CDC guidelines) from 02/20/2020, defined as (1) diagnosis code of U07.1/U07.2, or (2) positive diagnostic test for SARS-CoV-2, (3) diagnosis code of B97.29 without a negative molecular SARS-CoV-2 test within a 14-day window (+/-7 days). Patients SARS-CoV-2-positive with evidence of moderate-to-severe asthma at any time (ICD-10 J45.4X or J45.5X) were included. AA was defined as positive specific IgE (≥0.35 kU/L) serum test or skin prick test (code 95004) ordered by a specialist (eg, allergist, pulmonologist, dermatologist) or omalizumab use. NEAA was defined as failing to meet the AA definition and patients with allergic comorbidities were excluded. Baseline demographic and clinical characteristics were obtained 6-12 months before COVID-19 diagnosis. RESULTS: The database included 242,280 SARS-CoV-2-positive patients;569 (0.2%) had evidence of comorbid AA and 3137 (1.3%) had asthma and NEAA. For AA patients, mean (SD) age at index was 48.2 (18.2) years;70.3% were female, with 54.3% White, 26.4% Black, and 12.5% Hispanic (Table 1). Most AA patients were from the US Midwest and Northeast (80.5%). NEAA patients had similar demographics: mean (SD) age at index was 50.7 (19.5) years;67.6% female;with 60.0% White, 21.5% Black, and 13.0% Hispanic;and 81.5% were from the US Midwest and Northeast. A greater proportion of patients had severe asthma in AA versus NEAA groups (220/569 [38.7%] versus 457/3137 [14.6%]). More patients with AA versus NEAA used asthma biologic treatment (62/569 [10.9%] vs 27/3137 [0.9%]). Comorbid conditions (hypertension, diabetes, pregnancy, chronic obstructive pulmonary disease, and Charlson Comorbidity Index), body mass index, and smoking history were comparable between groups. A higher proportion of NEAA patients were current smokers. CONCLUSIONS: A smaller proportion of patients with SARS-CoV-2 infection in this retrospective analysis had comorbid AA versus NEAA, whereas patient demographics and comorbidities were generally comparable between groups. Differences included the proportion of patients with severe asthma and biologic treatment use (greater in AA), and current smoking (lower in AA). The observed lower prevalence of AA versus NEAA in SARS-CoV-2-positive patients warrants further investigation.

Background Chronic spontaneous urticaria (CSU), also known as chronic idiopathic urticaria, may produce hives, itch, and angioedema. The Urticaria Activity and Impact Measure (U-AIM) is a newly developed 9-item patient-reported measure designed for use in routine clinical practice to assess CSU activity and impact during the previous 7 days. Objective To evaluate validity, responsiveness, and clinically meaningful change of the U-AIM. Methods Data from a 24-week, open-label, single-arm period of a randomized, placebo-controlled study of omalizumab were used to assess the psychometric properties of U-AIM items for itch, hives, and angioedema. Results A total of 206 patients (75% female; mean age, 44.6 years) were enrolled. At baseline, U-AIM results included prevalent severe itch (55%) and more than 12 hives (67%), angioedema (15%), and bother by itch (84%), hives (84%), and angioedema (49%). The Urticaria Patient Daily Diary (UPDD) mean weekly scores were 15.4 (itch severity), 16.8 (number of hives), and 32.2 (Urticaria Activity Score [UAS7]). At baseline, week 12, and week 24, U-AIM itch and hives items and UAS7 proxy scores (the sum of itch severity and number of hives during 7 days) demonstrated strong correlation coefficients with their corresponding measures from the UPDD (itch severity: 0.634–0.806; hives number: 0.735–0.843; UAS7 proxy: 0.724–0.852). Changes in U-AIM scores differentiated patients by their perspective of symptom improvement. Meaningful change thresholds were established for itch severity and number of hives scores (range, 0.8–1.0 for both) and the UAS7 proxy score (range, 10.5–12.5). Conclusion The U-AIM is valid and responsive to change and may help clinicians monitor CSU activity and track treatment effectiveness.

Purpose Estimate effects of ranibizumab on diabetic retinopathy (DR) severity in US Hispanic and non-Hispanic white persons with center-involved diabetic macular edema (DME) causing vision impairment for whom ranibizumab treatment would be considered. Patients and Methods This model simulated DR severity outcomes over 2 years in the better-seeing eye using US census, National Health and Nutrition Examination Survey, Wisconsin Epidemiologic Study of Diabetic Retinopathy, and Los Angeles Latino Eye Study data. Baseline DR severity estimated from Diabetic Retinopathy Clinical Research Network trial data. Changes in DR severity after 2 years, with/without monthly ranibizumab (0.3 or 0.5 mg), were estimated from Phase III clinical trial data (RIDE/RISE) using a 2-dimensional Monte Carlo simulation model. Number of patients over a 2-year period for whom 1) DR severity worsening was avoided, 2) DR severity improved, and 3) selected clinical events related to proliferative DR (PDR) occurred, was estimated. Results An estimated 37,274 US Hispanic and non-Hispanic white persons were projected to have DR with center-involved DME and be eligible for ranibizumab treatment. The number of persons with moderately severe non-proliferative DR (NPDR) or less severe DR at baseline who would worsen to PDR and experience a PDR complication over 2 years would be reduced from 437 with no ranibizumab to 19 with ranibizumab (95% reduction; 95% simulation interval [SI], 79–100%). The number of persons with severe NPDR or less severe DR at baseline who would be expected to improve by ≥2 DR severity levels over 2 years would increase from 1706 with no ranibizumab to 13,042 with ranibizumab (682% increase; 95% SI, 478–967%). Conclusion This model estimates that ranibizumab treatment in US Hispanic and non-Hispanic white patients with center-involved DME causing vision impairment would potentially reduce the number of patients with worsening DR and potentially increase the number with DR improvements.

Diabetes mellitus remains the leading cause of new cases of blindness among US adults. Routine dilated eye examinations can facilitate early detection and intervention for diabetes-related eye disease, providing an opportunity to reduce the risk for diabetes-related blindness in working-aged Americans. The Healthcare Effectiveness Data and Information Set (HEDIS) established criteria for performing dilated eye examination in patients with diabetes.To obtain information about adherence and nonadherence to diabetic eye examinations among insured patients to understand the barriers to routine dilated eye examinations, and to identify ways to improve the quality of care for these patients.This retrospective claims analysis is based on administrative claims from the HealthCore Integrated Research Database, a broad database representing claims from a large commercially insured population. Patients with diabetes and who had ≥1 dilated eye examinations between August 1, 2011, and July 31, 2013, were defined as adherent to the HEDIS recommendations. The analysis was augmented with findings from focus groups. The patient focus groups included adherent and nonadherent patients. The provider focus group participants were general practice or internal medicine physicians and ophthalmologists who provided medical care for the study population. For the administrative claims analysis, comparisons between the adherent and nonadherent patients were performed usingOf 339,646 patients with diabetes identified in a claims data set, 43% were adherent and 57% were nonadherent to the HEDIS eye examination performance measure. The common barriers to routine eye examination cited by 29 patients across 4 focus groups included a lack of understanding of insurance benefits (N = 15), a lack of awareness of the importance of dilated eye examinations (N = 12), and time constraints (N = 12). The common barriers cited by 18 providers included the patient's level of education (N = 13), eye examinations as a lower priority than the management of other diabetes-related health issues (N = 12), and a lack of symptoms (N = 11).Several reasons for patient nonadherence to routine eye examination were identified, including a lack of understanding of insurance benefits, a lack of awareness or low prioritization of having an examination, patient education level, time constraints, and a lack of symptoms. These may be considered by providers and payers when developing programs to increase the rates of eye examinations and improve outcomes among patients with diabetes.