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1.
Clin Transplant ; 38(5): e15315, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38686443

RESUMEN

Kidney transplantation is the most successful kidney replacement therapy available, resulting in improved recipient survival and societal cost savings. Yet, nearly 70 years after the first successful kidney transplant, there are still numerous barriers and untapped opportunities that constrain the access to transplant. The literature describing these barriers is extensive, but the practices and processes to solve them are less clear. Solutions must be multidisciplinary and be the product of strong partnerships among patients, their networks, health care providers, and transplant programs. Transparency in the referral, evaluation, and listing process as well as organ selection are paramount to build such partnerships. Providing early culturally congruent and patient-centered education as well as maximizing the use of local resources to facilitate the transplant work up should be prioritized. Every opportunity to facilitate pre-emptive kidney transplantation and living donation must be taken. Promoting the use of telemedicine and kidney paired donation as standards of care can positively impact the work up completion and maximize the chances of a living donor kidney transplant.


Asunto(s)
Accesibilidad a los Servicios de Salud , Fallo Renal Crónico , Trasplante de Riñón , Obtención de Tejidos y Órganos , Humanos , Obtención de Tejidos y Órganos/métodos , Fallo Renal Crónico/cirugía , Donadores Vivos/provisión & distribución , Listas de Espera
5.
Drug Des Devel Ther ; 18: 277-289, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38333897

RESUMEN

Atopic dermatitis (AD) is the most common inflammatory skin disease in children. Children with severe AD have a multidimensional disease burden characterized by skin lesions, itching, frequent infections, sleep deprivation, and a high rate of comorbidities. These impact the mental health and overall quality of life of not only the children but also of their parents and caregivers. There are few effective available treatment options for young children with severe AD that are suitable for long-term use. Due to their adverse effects, practice guidelines consider systemic agents inappropriate for this age group, although they are still used off-label in extreme cases. The biologic dupilumab has recently been approved for children aged 6-11 years with severe (EU) and moderate-to-severe (USA) AD, offering hope to this population of patients with a high unmet clinical need. The purpose of this review is to describe the unmet needs of AD patients aged 6-11 years prior to dupilumab approval and to summarize existing clinical data supporting dupilumab's safety and efficacy in these children.


Asunto(s)
Dermatitis Atópica , Humanos , Niño , Preescolar , Dermatitis Atópica/tratamiento farmacológico , Calidad de Vida , Índice de Severidad de la Enfermedad , Anticuerpos Monoclonales Humanizados/efectos adversos , Resultado del Tratamiento , Método Doble Ciego
6.
BMC Nephrol ; 25(1): 36, 2024 Jan 25.
Artículo en Inglés | MEDLINE | ID: mdl-38273245

RESUMEN

BACKGROUND: Gender and racial disparities in kidney transplant access are well established, however how gender and race interact to shape access to kidney transplant is less clear. Therefore, we examined existing literature to assess what is known about the potential interaction of gender and race and the impact on access to kidney transplantation in the US. METHODS: Following PRISMA guidelines, we conducted a scoping review and included quantitative and qualitative studies published in English between 1990 and May 31, 2023 among adult end-stage kidney disease patients in the US. All studies reported on access to specific transplant steps or perceived barriers to transplant access in gender and race subgroups, and the intersection between the two. We narratively synthesized findings across studies. RESULTS: Fourteen studies met inclusion criteria and included outcomes of referral (n = 4, 29%), evaluation (n = 2, 14%), waitlisting (n = 4, 29%), transplantation (n = 5, 36%), provider perceptions of patient transplant candidacy (n = 3, 21%), and patient preferences and requests for a living donor (n = 5, 36%). Overall, we found that White men have the greatest access at all steps of the transplant process, from referral to eventual living or deceased donor transplantation. In contrast, women from racial or ethnic minorities tend to have the lowest access to kidney transplant, in particular living donor transplant, though this was not consistent across all studies. CONCLUSIONS: Examining how racism and sexism interact to shape kidney transplant access should be investigated in future research, in order to ultimately shape policies and interventions to improve equity.


Asunto(s)
Fallo Renal Crónico , Trasplante de Riñón , Adulto , Masculino , Humanos , Estados Unidos/epidemiología , Femenino , Disparidades en Atención de Salud , Listas de Espera , Fallo Renal Crónico/cirugía , Donadores Vivos
8.
Am J Kidney Dis ; 2023 Dec 07.
Artículo en Inglés | MEDLINE | ID: mdl-38070590

RESUMEN

RATIONALE & OBJECTIVE: Few older adults with kidney failure engage in shared decision making (SDM) for kidney replacement therapy. The lack of instruments to assess SDM-relevant knowledge domains may contribute to this. We assessed the reliability and validity of a new instrument, the Rating of CKD Knowledge Older Adults (Know-CKD). STUDY DESIGN: Multistage process, including a stakeholder-engaged development phase, pilot testing, and validation of a knowledge instrument using a cross-sectional survey of older adults with CKD. SETTING & PARTICIPANTS: 363 patients aged 70+years with nondialysis advanced chronic kidney disease (CKD) (estimated glomerular filtration rate [eGFR]<30mL/min/1.73m2) in Boston, Chicago, Portland, ME, and San Diego from June 2018 and January 2020. EXPOSURE: Educational level, higher literacy (Single Item Literacy Screener [SILS]) and numeracy (Subjective Numeracy Scale [SNS]), having participated in clinic-sponsored dialysis education, and self-reported "feeling informed" about options for treatment. OUTCOME: Validity and reliability of the Know-CKD instrument. ANALYTICAL APPROACH: Reliability was assessed with the Kuder-Richardson-20 coefficient. Construct validity was demonstrated by testing a priori hypotheses using t test, analysis of variance (ANOVA) tests, and linear regression analyses. RESULTS: The mean (± SD) participant age was 77.6±5.9 years, and mean eGFR was 22.7±7.2mL/min/1.73m2; 281 participants (78%) self-reported as White. The 12-item Know-CKD assessment had good reliability (Kuder-Richardson-20 reliability coefficient=0.75), and a mean score of 58.2% ± 22.3 SD. The subscales did not attain acceptable reliability. The proportion answering correctly on each item ranged from 20.1% to 91.7%. In examining construct validity, the hypothesized associations held; Know-CKD significantly associated with higher education (ß=6.98 [95% CI, 1.34-12.61], P=0.02), health literacy (ß = -12.67 [95% CI, -19.49 to-5.86], P≤0.001), numeracy per 10% higher (ß=1.85 [95% CI, 1.02-2.69], P≤0.001), and attendance at dialysis class (ß=18.28 [95% CI, 13.30-23.27], P≤0.001). These associations were also observed for the subscales except for prognosis (not associated with literacy or numeracy). LIMITATIONS: Know-CKD is only available in English and has been used only in research settings. CONCLUSIONS: For older adults facing dialysis initiation decisions, Know-CKD is a valid, reliable, and easy to administer measure of knowledge. Further research should examine the relationship of kidney disease knowledge and SDM, patient satisfaction, and clinical outcomes. PLAIN-LANGUAGE SUMMARY: The Rating of CKD Knowledge Among Older Adults (Know-CKD) study measures knowledge of chronic kidney disease (CKD) and is designed for older adults. Most existing knowledge measures for CKD focus on people of all ages and all CKD stages. This measure is useful because it will allow researchers to assess how well patient education efforts are working. Patient education is a way to help patients make decisions about their care. We describe how the measure was developed by a team of doctors, researchers, and patients, and how the measure performed among persons with advanced CKD aged 70 years and older. Know-CKD can inform efforts to improve shared decision-making research and practice for older patients with kidney disease.

9.
Health Psychol Rep ; 11(3): 223-240, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-38084267

RESUMEN

BACKGROUND: Research has shown that employees subjected to acute stressors at work can suffer devastating repercussions. However, little is known about how employees who are experiencing ongoing chronic anxiety or have stable resources respond to acute stressors, particularly regarding their physiological responses to these situations. This study examines the physiological effects of an acute stressor when workers are already under chronic anxiety (i.e., cognitive anxiety and somatic anxiety) or when they have a stable resource (i.e., job control). PARTICIPANTS AND PROCEDURE: Data were collected from 230 full-time employees working at three major oil companies in Brazil. First, demographic, anxiety, and job control measures were collected via questionnaire. Later, muscle tension, skin temperature, and heart rate were collected during a simulated task to assess the physiological response to stress. Hypotheses were tested by repeated measures general linear modeling. RESULTS: The findings indicated that when employees were exposed to an acute stressor, those with chronic cognitive and somatic anxiety exhibited more heightened physiological responses than those lower on chronic anxiety. Further, compared to those with low control, employees with stable, high control over their work experienced a lower physiological reaction to the acute stressor. CONCLUSIONS: Chronic anxiety generates high levels of physiological arousal and hyper-responsiveness to acute environmental stressors. Also, employees possessing stable resources, such as job control, experience reduced physiological responsivity to an acute stressor.

10.
Br J Dermatol ; 2023 Dec 04.
Artículo en Inglés | MEDLINE | ID: mdl-38048385

RESUMEN

BACKGROUND: Few large-scale international studies broadly characterized the burden of atopic dermatitis (AD) across age groups among children and adolescents. OBJECTIVE: To better characterize the AD burden in pediatric subjects by disease severity. METHODS: This cross-sectional, web-based survey of pediatric subjects (6 months to <18 years old) was conducted in 18 countries representing North America, Latin America, Europe, Middle East/Eurasia, and East Asia. Subjects with diagnosed AD were identified based on the International Study of Asthma and Allergies in Childhood criteria and self-/parent-report of ever being told by a physician that they/their child had eczema. AD severity was assessed using Patient Oriented Eczema Measure and Patient Global Assessment. Outcomes included measures of itch, skin pain, sleep, health-related quality-of-life (HRQoL), missed school days, and atopic comorbidities. RESULTS: The survey included 1489 children 6 months to < 6 years; 2898 children 6 to < 12 years; and 3078 adolescents 12 to < 18 years diagnosed with AD. Although the burden of mild AD was substantial, pediatric subjects with moderate or severe AD had more itch, skin pain, sleep problems, and impaired HRQoL, and missed more school days relative to those with mild AD; greater burden was observed among severe relative to moderate AD. At least one atopic comorbidity was present in 92·5% of all respondents. CONCLUSIONS: These results highlight the burden of AD in pediatric subjects especially those with moderate-to-severe disease, and suggest the need for assessments that include the impact of AD on function and daily life.

11.
Kidney Int Rep ; 8(12): 2580-2591, 2023 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-38106598

RESUMEN

Introduction: We examined sex/gender disparities across the continuum of transplant care by attributed cause of end-stage kidney disease (ESKD). Methods: All adults (18-79 years; N = 43,548) with new-onset ESKD in Georgia, North Carolina, or South Carolina between 2015 and 2019 were identified from the United States Renal Data System (USRDS). Individuals were linked to the Early Steps to Transplant Access Registry (E-STAR) to obtain data on referral and evaluation. Waitlisting data was ascertained from USRDS. Using a Cox-proportional hazards model, with follow-up through 2020, we assessed the association between sex/gender and referral within 12 months (among all incident dialysis patients), evaluation start within 6 months (among referred patients), and waitlisting (among all evaluated patients) by attributed cause of ESKD (type 1 diabetes mellitus, type 2 diabetes mellitus, hypertension, glomerulonephritis, cystic disease, and other). Results: Overall, women (vs. men) with type 2 diabetes-attributed ESKD were 13% (crude hazard ratio [HR]: 0.87 [0.83-0.91]), 14% (crude HR: 0.86 [0.81-0.91]), and 14% (crude HR: 0.86 [0.78-0.94]) less likely to be referred, evaluated, and waitlisted, respectively. Women (vs. men) with hypertension-attributed ESKD were 14% (crude HR: 0.86 [0.82-0.90]) and 8% (crude HR: 0.92 [0.87-0.98]) less likely to be referred and evaluated, respectively, but similarly likely to be waitlisted once evaluated (crude HR: 1.06 [0.97-1.15]). For all other attributed causes of ESKD, there was no sex/gender disparity in referral, evaluation, or waitlisting rates. Conclusion: In the Southeast United States, sex/gender disparities in early access to kidney transplantation are specific to people with ESKD attributed to type 2 diabetes and hypertension.

12.
Pediatr Dermatol ; 40(5): 851-856, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37581214

RESUMEN

BACKGROUND: Atopic dermatitis (AD) is a chronic skin condition that is associated with significant patient burden and decreased health-related quality of life (HRQoL). We report results of the real-world Epidemiology of Children with Atopic Dermatitis Reporting on their Experience study in Japanese pediatric patients, focusing on the impact of AD severity on disease burden. METHODS: Children and adolescents aged 6 months to 17 years (or their caregivers/parents) completed an online survey between September 26, 2018, and March 5, 2019. Patients with diagnosed AD (i.e., met International Study of Asthma and Allergies in Childhood criteria and had a self-reported AD diagnosis) were evaluated for disease severity using the Patient-Oriented Eczema Measure (POEM). Impact of AD severity on AD symptoms (itching, pain, and sleep disturbance), disease flares, atopic comorbidities, healthcare resource utilization, school days missed, and HRQoL were assessed. RESULTS: Of 5702 Japanese pediatric patients, 547 had diagnosed AD and were included in this analysis. Based on POEM scores, AD severity was clear/mild in 346 patients (63.3%), moderate in 177 (32.5%), and severe in 24 (4.4%). Across all age groups (i.e., less than 6, 6-11, and 12-17 years), increased AD severity was associated with increased AD symptom severity, number of flares, atopic comorbidities, healthcare resource utilization, and school absences, as well as worsened HRQoL. CONCLUSIONS: This population-based study of Japanese children and adolescents showed that greater AD severity had a high impact on disease burden.

13.
Rev. Odontol. Araçatuba (Impr.) ; 44(2): 9-12, maio-ago. 2023.
Artículo en Inglés | LILACS, BBO - Odontología | ID: biblio-1427966

RESUMEN

The glossopharyngeal nerve (IX cranial nerve) is a mixed nerve, with both motor and sensory function. This relates to the tongue and pharynx. Glossopharyngeal neuralgia is a rare nervous neuropathy, with poristic, lancinating and paritary crises, usually unilateral. The aim of the study was to review the literature on glossopharyngeal neuralgia of the nerve (IX cranial nerve), highlighting the anatomical aspects of this nerve and the possible causes and complications of neuralgia as well as forms of treatment. A literature review was carried out in the international Pubmed database. The literature review included 72 articles from 2015 to 2021. The keywords used were: "anatomy of glossopharyngeal neuralgia". Of the 72 articles, 7 were used for this literature review. Uncommon as nervous/glossophingeal etiologies and pathologies are neurological abnormalities/neurovarises and pathologies are neurovascular/neurovariseal lesions. Pharmacological treatment approaches mentioned in the literature were therapy with antiepileptics and antidepressants such as carbamazepine and gabapentin; a microvascular decompression; and gamma knife radiosurgery(AU)


O nervo glossofaríngeo (IX par de nervo craniano) é um nervo misto, contendo função tanto motora como sensitiva. Este nervo relaciona-se com a língua e com a faringe. A neuralgia do nervo glossofaríngeo é uma neurapatia rara, sendo caracterizada por crises dolorosas, lancinantes e paroxísticas, geralmente unilaterais. O objetivo do estudo foi realizar uma revisão de literatura sobre a neuralgia do nervo glossofaríngeo (IX par de nervo craniano), destacando os aspectos anatômicos deste nervo e as possíveis causas e complicações da neuralgia bem como formas de tratamento. Foi realizada uma revisão da literatura na base de dados internacional Pubmed. A revisão da literatura incluiu 72 artigos no período de 2015 a 2021. As palavras-chave utilizadas foram: "anatomia da neuralgia do glossofaríngeo". Dos 72 artigos, 7 foram utilizados para esta revisão de literatura. Verificouse que a neuralgia do nervo glossofaríngeo é incomum e as etiologias mais encontradas foram compressão neurovascular/variações vasculares, patologias e traumas. As abordagens dos tratamentos mencionadas na literatura foram a terapia farmacológica da área com antiepilépticos e antidepressivos, como carbamazepina e gabapentina; a descompressão microvascular; e radiocirurgia com faca gama(AU)


Asunto(s)
Enfermedades del Nervio Glosofaríngeo , Nervio Glosofaríngeo , Neuralgia , Nervios Craneales , Neuralgia/complicaciones , Neuralgia/etiología , Neuralgia/terapia
14.
Am J Clin Dermatol ; 24(5): 787-798, 2023 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-37300760

RESUMEN

BACKGROUND: Children with severe atopic dermatitis (AD) have a multidimensional disease burden. OBJECTIVE: Here we assess the clinically meaningful improvements in AD signs, symptoms, and quality of life (QoL) in children aged 6-11 years with severe AD treated with dupilumab compared with placebo. METHODS: R668-AD-1652 LIBERTY AD PEDS was a randomized, double-blinded, placebo-controlled, parallel-group, phase III clinical trial of dupilumab with concomitant topical corticosteroids (TCS) in children aged 6-11 years with severe AD. This post hoc analysis focuses on 304 patients receiving either dupilumab or placebo with TCS and assessed the percentage of patients considered responsive to dupilumab treatment at week 16. RESULTS: At week 16, almost all patients receiving dupilumab + TCS (95%) demonstrated clinically meaningful improvements in AD signs, symptoms, or QoL compared with placebo + TCS (61%, p < 0.0001). Significant improvements were seen as early as week 2 and sustained through the end of the study in the full analysis set (FAS) and the subgroup of patients with an Investigator's Global Assessment score greater than 1 at week 16. LIMITATIONS: Limitations include the post hoc nature of the analysis and that some outcomes were not prespecified; the small number of patients in some subgroups potentially limits generalizability of findings. CONCLUSION: Treatment with dupilumab provides significant and sustained improvements within 2 weeks in AD signs, symptoms, and QoL in almost all children with severe AD, including those who did not achieve clear or almost clear skin by week 16. TRIAL REGISTRATION: NCT03345914. Video Abstract: Does dupilumab provide clinically meaningful responses in children 6 to 11 years old with severe atopic dermatitis? (MP4 99484 kb).


Asunto(s)
Dermatitis Atópica , Fármacos Dermatológicos , Humanos , Niño , Dermatitis Atópica/diagnóstico , Dermatitis Atópica/tratamiento farmacológico , Dermatitis Atópica/complicaciones , Calidad de Vida , Resultado del Tratamiento , Inyecciones Subcutáneas , Método Doble Ciego , Índice de Severidad de la Enfermedad , Fármacos Dermatológicos/uso terapéutico
15.
Cell Calcium ; 113: 102761, 2023 07.
Artículo en Inglés | MEDLINE | ID: mdl-37271052

RESUMEN

Inositol 1,4,5-trisphosphate receptors (IP3Rs) are large tetrameric channels which sit mostly in the membrane of the endoplasmic reticulum (ER) and mediate Ca2+ release from intracellular stores in response to extracellular stimuli in almost all cells. Dual regulation of IP3Rs by IP3 and Ca2+ itself, upstream "licensing", and the arrangement of IP3Rs into small clusters in the ER membrane, allow IP3Rs to generate spatially and temporally diverse Ca2+ signals. The characteristic biphasic regulation of IP3Rs by cytosolic Ca2+ concentration underpins regenerative Ca2+ signals by Ca2+-induced Ca2+-release, while also preventing uncontrolled explosive Ca2+ release. In this way, cells can harness a simple ion such as Ca2+ as a near-universal intracellular messenger to regulate diverse cellular functions, including those with conflicting outcomes such as cell survival and cell death. High-resolution structures of the IP3R bound to IP3 and Ca2+ in different combinations have together started to unravel the workings of this giant channel. Here we discuss, in the context of recently published structures, how the tight regulation of IP3Rs and their cellular geography lead to generation of "elementary" local Ca2+ signals known as Ca2+ "puffs", which form the fundamental bottleneck through which all IP3-mediated cytosolic Ca2+ signals must first pass.


Asunto(s)
Señalización del Calcio , Calcio , Señalización del Calcio/fisiología , Receptores de Inositol 1,4,5-Trifosfato/metabolismo , Calcio/metabolismo , Retículo Endoplásmico/metabolismo , Citosol/metabolismo , Inositol 1,4,5-Trifosfato/metabolismo
16.
J Asthma Allergy ; 16: 383-396, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37077900

RESUMEN

Purpose: Atopic dermatitis (AD) is a chronic, relapsing and remitting inflammatory skin disease characterized by intense itch. The disease burden includes physical limitations, psychosocial discomfort, and a reduced quality of life (HRQoL). This study presents the results of a parent-reported survey on the psychosocial impact of AD on Italian pre-adolescent children (6-11 years old), with a specific focus on bullying, self-isolation, absenteeism, and presenteeism. Methods: An online questionnaire was sent to 3067 random recipients and 160 matched the inclusion criteria for age, self-reported AD diagnosis, localizations (according to ISAAC), and disease severity (POEM ≥8). 100 children, with comparable ages, not matching the inclusion criteria for AD, were recruited as a control group. Results: Children with AD and their caregivers had a significantly lower quality of sleep (QoS) compared to the control group. The presence of AD was directly responsible for many restless nights, both in children and caregivers (58.9 and 55.4 respectively). Children with AD and their parents also experienced significantly more daytime drowsiness (43.6 and 54.6 days, respectively). Children with AD were more frequently victims of bullying at school (20.0% vs 9.0%; p≤0.05) or in other social environments (16.9% vs 3.0%; p≤0.05). AD caused 17.7 days of absenteeism and 20.1 days of presenteeism per student over the previous 12 months, accounting for 37.8 days of study impairment overall. Severe/very severe AD had a significantly greater impact on presenteeism than moderate AD (25.1 vs 17.5 days; p≤0.05). Presenteeism, which was more pronounced among bullied students, was positively correlated with absenteeism only in the AD cohort. Conclusion: AD has a detrimental impact on the HRQoL of pediatric patients, causing stigmatization and social isolation. Functional distress was also reported by caregivers. Our study might inform the public and policymakers about the disease burden of AD at a young age.

17.
J Clin Med ; 12(8)2023 Apr 20.
Artículo en Inglés | MEDLINE | ID: mdl-37109324

RESUMEN

Pediatric atopic dermatitis (AD) can negatively impact the family quality of life (QoL). We report data from the real-world Epidemiology of Children with Atopic Dermatitis Reporting on their Experience (EPI-CARE) study in Japanese pediatric patients, focusing on disease impact on family QoL. Children and adolescents aged 6 months to <18 years completed an online survey between September 2018-December 2019. The impact of disease severity on family QoL and its effect on parents' time were assessed using the dermatitis family impact (DFI) questionnaire. The impact of a family history of allergic conditions, current residency, second-hand smoke exposure, and household pets on AD prevalence and severity was also assessed. Family QoL decreased as AD severity increased, particularly in families with children aged <6 years; but had the greatest impact on sleep and tiredness in families with children aged <12 years. Parents spent at least 4.6 h/week caring for children <6 years, including those with mild symptoms. Most children (>80%) had a family history of allergic conditions; AD prevalence was increased in those exposed to second-hand smoke or household pets. This study demonstrated that pediatric AD in Japanese individuals has negative impacts on family QoL and that family and household environments can influence pediatric AD prevalence.

19.
JAMA Dermatol ; 159(3): 255-266, 2023 03 01.
Artículo en Inglés | MEDLINE | ID: mdl-36723913

RESUMEN

Importance: Erythrodermic atopic dermatitis (AD) is a severe AD subtype defined by extensive skin involvement, leading to complications and sometimes hospitalization. Objective: To assess dupilumab's efficacy and safety in patients with erythrodermic AD in clinical trials. Design, Setting, and Participants: This post hoc analysis included patients enrolled in 6 multicenter, multinational, randomized, double-blind, placebo-controlled trials. Patients included in this analysis met erythrodermic AD criteria of 90% or greater body surface area (BSA) affected by AD and Global Individual Sign Score for erythema of 1 or higher. Data analyses for this post hoc analysis were conducted between March 5, 2019, and October 24, 2020. Interventions: Dupilumab once weekly or every 2 weeks, or placebo, either as monotherapy or with concomitant topical corticosteroids (TCS). Main Outcomes and Measures: Efficacy (BSA, Eczema Area and Severity Index [EASI] score, Peak Pruritus Numerical Rating Scale [PP-NRS] score), changes in serum biomarkers (thymus and activation-regulated chemokine, total immunoglobulin E, lactate dehydrogenase), and safety (incidence of adverse events) at week 16. Data were pooled within each regimen; monotherapy and concomitant TCS results are shown separately. Results: Of 3075 randomized patients, 209 met criteria for erythrodermic AD at baseline, with the median age being 31 and 39 years in the monotherapy and concomitant TCS trials, respectively, similar to the overall populations (34 and 36 years, respectively); 71.3% (n = 97) and 74.0% (n = 54) of patients, respectively, were male (compared with 58.7% and 60.6% in the overall populations). In patients with erythrodermic AD, dupilumab once weekly and every 2 weeks vs placebo significantly improved percentage of BSA affected by AD (least squares mean percent change [SE]) with monotherapy (-42.0% [7.7%] and -39.9% [6.5%] vs -17.2% [11.0%]; P = .03) and concomitant TCS (-63.2% [6.7%] and -56.1% [9.1%] vs -14.5% [7.3%]; P < .001); EASI score with monotherapy (-58.5% [9.0%] and -58.3% [7.9%] vs -22.3% [12.4%]; P = .004 and P = .003, respectively) and concomitant TCS (-78.9% [7.8%] and -70.6% [10.1%] vs 19.3% [8.2%]; P < .001); and PP-NRS score in monotherapy (-45.9% [7.8%] and -33.9% [6.6%] vs -0.6% [9.4%]; P < .001) and concomitant therapy (-53.0% [8.1%] and -55.7% [10.8%] vs -26.0% [8.8%]; P = .006 and P = .01, respectively). Nominally statistically significant improvement was seen as early as week 1 (EASI and PP-NRS scores with monotherapy). Biomarker levels were significantly reduced vs placebo. The most frequent adverse events in dupilumab-treated patients were injection-site reaction, conjunctivitis, and nasopharyngitis. Conclusions and Relevance: In this post hoc analysis of 6 randomized clinical trials, treatment with dupilumab resulted in rapid, sustained improvements in AD signs and symptoms with acceptable safety in patients with erythrodermic AD, similar to those in the trials' overall patient population. Trial Registration: ClinicalTrials.gov Identifiers: NCT01859988, NCT02277743, NCT02277769, NCT03054428, NCT02260986, NCT02755649.


Asunto(s)
Dermatitis Atópica , Fármacos Dermatológicos , Eccema , Humanos , Masculino , Adulto , Femenino , Dermatitis Atópica/diagnóstico , Dermatitis Atópica/tratamiento farmacológico , Dermatitis Atópica/complicaciones , Método Doble Ciego , Inyecciones Subcutáneas , Resultado del Tratamiento , Índice de Severidad de la Enfermedad , Ensayos Clínicos Controlados Aleatorios como Asunto , Eccema/tratamiento farmacológico , Glucocorticoides/uso terapéutico , Fármacos Dermatológicos/administración & dosificación , Prurito/etiología , Prurito/inducido químicamente , Biomarcadores
20.
Ann Intern Med ; 176(1): 29-38, 2023 01.
Artículo en Inglés | MEDLINE | ID: mdl-36534976

RESUMEN

BACKGROUND: Older patients with advanced chronic kidney disease (CKD) face difficult decisions about managing kidney failure, frequently experiencing decisional conflict, regret, and treatment misaligned with preferences. OBJECTIVE: To assess whether a decision aid about kidney replacement therapy improved decisional quality compared with usual care. DESIGN: Multicenter, randomized, controlled trial. (ClinicalTrials.gov: NCT03522740). SETTING: 8 outpatient nephrology clinics associated with 4 U.S. centers. PARTICIPANTS: English-fluent patients, 70 years and older with nondialysis CKD stages 4 to 5 recruited from 2018 to 2020. INTERVENTION: DART (Decision-Aid for Renal Therapy) is an interactive, web-based decision aid for older adults with CKD. Both groups received written education about treatments. MEASUREMENTS: Change in the decisional conflict scale (DCS) score from baseline to 3, 6, 12, and 18 months. Secondary outcomes included change in prognostic and treatment knowledge and change in uncertainty. RESULTS: Among 400 participants, 363 were randomly assigned: 180 to usual care, 183 to DART. Decisional quality improved with DART with mean DCS declining compared with control (mean difference, -8.5 [95% CI, -12.0 to -5.0]; P < 0.001), with similar findings at 6 months, attenuating thereafter. At 3 months, knowledge improved with DART versus usual care (mean difference, 7.2 [CI, 3.7 to 10.7]; P < 0.001); similar findings at 6 months were modestly attenuated at 18 months (mean difference, 5.9 [CI, 1.4 to 10.3]; P = 0.010). Treatment preferences changed from 58% "unsure" at baseline to 28%, 20%, 23%, and 14% at 3, 6, 12, and 18 months, respectively, with DART, versus 51% to 38%, 35%, 32%, and 18% with usual care. LIMITATION: Latinx patients were underrepresented. CONCLUSION: DART improved decision quality and clarified treatment preferences among older adults with advanced CKD for 6 months after the DART intervention. PRIMARY FUNDING SOURCE: Patient-Centered Outcomes Research Institute (PCORI).


Asunto(s)
Técnicas de Apoyo para la Decisión , Insuficiencia Renal Crónica , Humanos , Anciano , Insuficiencia Renal Crónica/terapia , Pronóstico , Pacientes , Toma de Decisiones
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