Background For adolescent patients (aged ≥ 12 to < 18 years) with uncontrolled moderate-to-severe atopic dermatitis (AD), 16 weeks of treatment with dupilumab resulted in substantial clinical benefit compared with placebo, with an acceptable safety profile. However, long-term data on the approved dose regimens of dupilumab in adolescents with AD are lacking. Objectives This open-label extension study (LIBERTY AD PED-OLE, NCT02612454) reports the long-term safety, efficacy, and pharmacokinetics of dupilumab in adolescents with moderate-to-severe AD who had participated in dupilumab parent trials. Methods Patients enrolled under the original study protocol received subcutaneous dupilumab according to a weight-based regimen (2 or 4 mg/kg every week). Following protocol amendment, patients were switched to subcutaneous dupilumab 300 mg every 4 weeks (q4w) irrespective of weight, and newly enrolled patients were started on dupilumab 300 mg q4w. Patients with an inadequate clinical response (Investigator’s Global Assessment [IGA] score of 0/1 was not reached) to the q4w regimen could be uptitrated to the approved dupilumab dose regimens of 200 or 300 mg every 2 weeks (body weight < 60 or ≥ 60 kg, respectively). Patients whose IGA score of 0/1 was maintained continuously for a 12-week period after week 40 were discontinued from dupilumab, monitored for relapse, and re-initiated on dupilumab if required. Results Data for 294 patients (mean age 14.7 years) were analyzed, 102 (34.7%) of whom had completed the 52-week visit at the database lock. The dupilumab long-term safety profile was comparable to that seen in adults and consistent with the known safety profile. Most treatment-emergent adverse events were mild/moderate. By week 52, 42.7% of patients had an IGA score of 0/1 (clear/almost clear), and 93.1%, 81.2%, and 56.4%, respectively, had at least a 50%, 75%, or 90% improvement in Eczema Area and Severity Index (EASI). Most (70.9%) patients required uptitration to the approved dupilumab dose regimen. The proportions of uptitrated patients with an IGA score of 0/1 or 75% improvement in EASI increased over time, reaching 35.7% and 51.9%, respectively, 48 weeks after the first uptitration visit. By week 52, 29.4% of patients had clear/almost clear skin sustained for 12 weeks and had stopped medication; 56.7% relapsed and were subsequently re-initiated on treatment, with a mean time to re-initiation of 17.5 (± standard deviation 17.3) weeks. Conclusions Consistent with results seen with short-term treatment, long-term treatment with dupilumab showed an acceptable safety profile while providing incremental clinical benefit with continued treatment over time. The high proportion of patients who needed uptitration because of inadequate response to q4w dosing supports the q2w dose regimen as optimal for this age group. Finally, the majority of patients who stopped medication after having clear/a...

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Introduction: The Patient-Oriented Eczema Measure (POEM) assesses patient-reported severity of atopic dermatitis (AD) symptoms, whereas the Children's Dermatology Life Quality Index (CDLQI) measures how AD affects health-related quality of life (HRQoL) in children. Although the POEM and CDLQI have established thresholds for clinically meaningful

Background: This study examined the association between quality of processes of diabetes care in terms of adherence to American Diabetes Association (ADA)recommended guidelines and health care utilization in patients with diabetes. Methods: Adults with diabetes were identified from the pool of five panels of the Medical Expenditure Panel Survey, a nationally representative US sample, between 2012 and 2017. The Diabetes Care Survey was used to determine adherence to the ADA-recommended guidelines for processes of diabetes care if all of the following were performed annually: glycosylated hemoglobin check, foot examination, dilated eye examination, lipid panel, influenza immunization, blood pressure check, and dental examination. Health care utilization in terms of inpatient hospitalization, and emergency department (ED) and outpatient visits were estimated using two-part hurdle models. Results: An estimated 26.3 million adults with diabetes were derived from the pooled 5-panel data, of which 7.8% met the ADA-recommended guidelines for processes of diabetes care, and adherence rates of individual recommendations were generally below 50%. Overall, adults who adhered to the ADArecommendations were older, non-Hispanic white, and married nonsmokers with private insurance and higher income. Mean inpatient hospital stays, ED, and outpatient visits between ADA-adherent vs nonadherent patients were 0.98 vs 1.62 (P < .001), 0.36 vs 0.39 (P = .074), and 17.9 vs 12.8 (P < .001), respectively. Conclusions: Socioeconomic disadvantage and minority status were linked with nonadherence to the ADA-recommended processes of diabetes care. Adherence to the ADA recommendation was associated with significant reduction in inpatient hospitalization and a trend toward less ED visits. Our findings may apply to the United States and are likely to be different in other parts of the world.