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1.
Pediatr Dermatol ; 41(2): 204-209, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38308453

RESUMO

BACKGROUND AND OBJECTIVE: Current regulatory labeling recommends avoiding live vaccine use in dupilumab-treated patients. Clinical data are not available to support more specific guidance for live or live attenuated vaccines administration in dupilumab-treated patients. METHODS: Children (6 months-5 years old) with moderate-to-severe atopic dermatitis (AD) enrolled in a phase 2/3 clinical trial of dupilumab (LIBERTY AD PRESCHOOL Part A/B; NCT03346434) and subsequently participated in the LIBERTY AD PED-OLE (NCT02612454). During these studies, protocol deviations occurred in nine children who received measles, mumps, rubella (MMR) vaccine with or without varicella vaccine; five with a ≤12-week gap between dupilumab administration and vaccination and four with a >12-week gap after discontinuing dupilumab. RESULTS: Nine children (1 female; 8 male) had severe AD at baseline (8-56 months old). Of the nine children, five had a ≤12-week gap ranged 1-7 weeks between dupilumab administration and vaccination who received MMR vaccine (n = 2) or MMR and varicella vaccines (n = 3); among these, one resumed dupilumab treatment as early as 2 days and four resumed treatment 18-43 days after vaccination. No treatment-emergent adverse events, including serious adverse events and infections, were reported within the 4-week post-vaccination period in any children. CONCLUSIONS: In this case series of dupilumab-treated children with severe AD who received MMR vaccine with or without varicella vaccine, no adverse effects (including vaccine-related infection) were reported within 4 weeks after vaccination. Further studies are warranted to evaluate the safety, tolerability, and immune response to live attenuated vaccines in dupilumab-treated patients.


Assuntos
Anticorpos Monoclonais Humanizados , Dermatite Atópica , Caxumba , Criança , Pré-Escolar , Humanos , Masculino , Feminino , Lactente , Vacinas Atenuadas/efeitos adversos , Vacina contra Sarampo-Caxumba-Rubéola/efeitos adversos , Dermatite Atópica/tratamento farmacológico , Vacina contra Varicela/efeitos adversos , Caxumba/induzido quimicamente , Caxumba/prevenção & controle , Vacinação/efeitos adversos
2.
Lancet ; 400(10356): 908-919, 2022 09 17.
Artigo em Inglês | MEDLINE | ID: mdl-36116481

RESUMO

BACKGROUND: Current systemic treatments for children younger than 6 years with moderate-to-severe atopic dermatitis that is uncontrolled with topical therapies might have suboptimal efficacy and safety. Dupilumab is approved for older children and adults with atopic dermatitis and for other type 2 inflammatory conditions. We aimed to evaluate efficacy and safety of dupilumab with concomitant low-potency topical corticosteroids in children aged 6 months to younger than 6 years with moderate-to-severe atopic dermatitis. METHODS: This randomised, double-blind, placebo-controlled, parallel-group, phase 3 trial was conducted in 31 hospitals, clinics, and academic institutions in Europe and North America. Eligible patients were aged 6 months to younger than 6 years, with moderate-to-severe atopic dermatitis (Investigator's Global Assessment [IGA] score 3-4) diagnosed according to consensus criteria of the American Academy of Dermatology, and an inadequate response to topical corticosteroids. Patients were randomly assigned (1:1) to subcutaneous placebo or dupilumab (bodyweight ≥5 kg to <15 kg: 200 mg; bodyweight ≥15 kg to <30 kg: 300 mg) every 4 weeks plus low-potency topical corticosteroids (hydrocortisone acetate 1% cream) for 16 weeks. Randomisation was stratified by age, baseline bodyweight, and region. Patient allocation was done via a central interactive web response system, and treatment allocation was masked. The primary endpoint at week 16 was the proportion of patients with IGA score 0-1 (clear or almost clear skin). The key secondary endpoint (coprimary endpoint for the EU and EU reference market) at week 16 was the proportion of patients with at least a 75% improvement from baseline in Eczema Area and Severity Index (EASI-75). Primary analyses were done in the full analysis set (ie, all randomly assigned patients, as randomly assigned) and safety analyses were done in all patients who received any study drug. This study was registered with ClinicalTrials.gov, NCT03346434. FINDINGS: Between June 30, 2020, and Feb 12, 2021, 197 patients were screened for eligibility, 162 of whom were randomly assigned to receive dupilumab (n=83) or placebo (n=79) plus topical corticosteroids. At week 16, significantly more patients in the dupilumab group than in the placebo group had IGA 0-1 (23 [28%] vs three [4%], difference 24% [95% CI 13-34]; p<0·0001) and EASI-75 (44 [53%] vs eight [11%], difference 42% [95% CI 29-55]; p<0·0001). Overall prevalence of adverse events was similar in the dupilumab group (53 [64%] of 83 patients) and placebo group (58 [74%] of 78 patients). Conjunctivitis incidence was higher in the dupilumab group (four [5%]) than the placebo group (none). No dupilumab-related adverse events were serious or led to treatment discontinuation. INTERPRETATION: Dupilumab significantly improved atopic dermatitis signs and symptoms versus placebo in children younger than 6 years. Dupilumab was well tolerated and showed an acceptable safety profile, similar to results in older children and adults. FUNDING: Sanofi and Regeneron Pharmaceuticals.


Assuntos
Dermatite Atópica , Fármacos Dermatológicos , Adolescente , Adulto , Criança , Dermatite Atópica/tratamento farmacológico , Fármacos Dermatológicos/efeitos adversos , Glucocorticoides/uso terapêutico , Humanos , Imunoglobulina A/uso terapêutico , Preparações Farmacêuticas , Índice de Gravidade de Doença , Resultado do Tratamento , Estados Unidos
3.
Pharm Res ; 40(11): 2653-2666, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-38082089

RESUMO

BACKGROUND: While the majority of patients with atopic dermatitis (AD) achieve disease control with dupilumab treatment, there is variability in which patients achieve clear disease. The predictors of these responses are currently unclear. Integrated models were developed to evaluate the exposure-response (E-R) relationship of dupilumab in children, adolescents, and adults with AD. METHODS: Data from six Phase II and III clinical studies were pooled (2,366 adults [> 18 years], 243 adolescents [≥ 12 to < 18 years] and 359 children [≥ 6 to < 12 years]) for model development. Efficacy was assessed using the Eczema Area and Severity Index (EASI) and Investigator's Global Assessment (IGA). Indirect response models were applied to link measures of efficacy and functional serum dupilumab concentrations. The covariates on individual placebo-corrected response were assessed. Clinical trial scenarios were simulated to compare E-R relationships across age groups. Safety was not explored. RESULTS: After correcting for differences in placebo response and dupilumab exposure: 1) older age, higher body weight, lower baseline thymus and activation-regulated chemokine, and Asian race were associated with slightly lower EASI response, and no clear covariates were identified on IGA response; 2) clinical trial simulations generally showed slightly higher response at a given dupilumab concentration in children compared to adults and adolescents with severe and moderate AD. CONCLUSIONS: The collectively tested covariates explain some of the variability in dupilumab response in patients with AD. Patients in all age groups showed adequate response to dupilumab; however, children showed slightly higher drug effects compared to adults and adolescents at equivalent concentrations.


Assuntos
Dermatite Atópica , Adolescente , Adulto , Criança , Humanos , Dermatite Atópica/tratamento farmacológico , Método Duplo-Cego , Injeções Subcutâneas , Índice de Gravidade de Doença , Resultado do Tratamento , Ensaios Clínicos Fase II como Assunto , Ensaios Clínicos Fase III como Assunto
4.
J Am Acad Dermatol ; 89(2): 309-315, 2023 08.
Artigo em Inglês | MEDLINE | ID: mdl-36806642

RESUMO

Atopic dermatitis (AD) is a chronic inflammatory skin disease that can significantly decrease quality of life. AD is commonly associated with comorbidities including ocular surface disease (OSD). Conjunctivitis is the most common OSD associated with AD and can increase in incidence with use of monoclonal antibody biologics that target the type 2 inflammatory pathway. The objective of this review is to raise awareness of comorbid OSD in AD patients that dermatologists may encounter, with a focus on conjunctivitis, and equip dermatologists to address mild ocular concerns. We provide background on the subtypes and pathogenesis of comorbid OSD in AD patients and describe OSD associated with type 2 inflammation-inhibiting AD biologics. We also discuss screening and diagnosis, recommended treatment options for dermatologists, and when to refer to an eye care specialist. This multispecialty approach aims to support the overall health of AD patients and provide optimal patient care.


Assuntos
Conjuntivite , Dermatite Atópica , Oftalmopatias , Humanos , Dermatite Atópica/complicações , Dermatite Atópica/diagnóstico , Dermatite Atópica/tratamento farmacológico , Qualidade de Vida , Oftalmopatias/complicações , Conjuntivite/tratamento farmacológico , Conjuntivite/etiologia , Inflamação/complicações
5.
J Drugs Dermatol ; 22(8): 742-753, 2023 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-37556523

RESUMO

Pediatric psoriasis (PsO) and its associated comorbidities carry physical and psychosocial burdens in children and adolescents, which can negatively impact quality of life. However, features distinguishing pediatric PsO from eczema and other common inflammatory skin diseases may not be obvious to primary care providers, which may contribute to underrecognition and misdiagnosis. Accurate diagnosis of pediatric PsO is critical for managing the physical and psychological burdens associated with this disease. This review aims to support pediatricians with enough information to confidently diagnose pediatric PsO, assess associated physical and mental health comorbidities, and recommend first-line treatment options for children with mild to moderate PsO. To accomplish this, we provide information that distinguishes the appearance and symptoms of pediatric PsO from other common pediatric skin conditions. In addition, comorbidities and some of the mental health challenges associated with pediatric PsO are reviewed to help pediatricians provide appropriate care for patients in their clinical practice. Hebert AA, Browning J, Kwong PC, et al. Diagnosis and management of pediatric psoriasis: an overview for pediatricians. J Drugs Dermatol. 2023;22(8):742-752. doi:10.36849/JDD.7531.


Assuntos
Psoríase , Qualidade de Vida , Humanos , Masculino , Feminino , Criança , Adolescente , Psoríase/diagnóstico , Psoríase/terapia , Guias de Prática Clínica como Assunto , Pediatras
6.
Pediatr Dermatol ; 40(5): 789-808, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37316462

RESUMO

Methotrexate (MTX) is a readily accessible drug, first used in 1948 and employed for a wide variety of indications since then. However, despite widespread off-label use, FDA labeling does not include approved indications for the use of MTX for many inflammatory skin diseases in pediatric patients, including morphea, psoriasis, atopic dermatitis, and alopecia areata, among others. Without published treatment guidelines, some clinicians may be hesitant to use MTX off-label, or uncomfortable prescribing MTX in this population. To address this unmet need, an expert consensus committee was convened to develop evidence- and consensus-based guidelines for use of MTX to treat pediatric inflammatory skin disease. Clinicians with experience and expertise in clinical research, drug development, and treating inflammatory skin disease in pediatric patients with MTX were recruited. Five committees were created based on major topic areas: (1) indications and contraindications, (2) dosing, (3) interactions with immunizations and medications, (4) adverse effects (potential for and management of), and (5) monitoring needs. Pertinent questions were generated and addressed by the relevant committee. The entire group participated in a modified Delphi process to establish agreement on recommendations for each question. The committee developed 46 evidence- and consensus-based recommendations, each with >70% agreement among members, across all five topics. These are presented in tables and text, along with a discussion of supporting literature, and level of evidence. These evidence- and consensus-based recommendations will support safe and effective use of MTX for the underserved population of pediatric patients who may benefit from this valuable, time-honored medication.


Assuntos
Dermatite Atópica , Psoríase , Humanos , Criança , Metotrexato , Consenso , Psoríase/tratamento farmacológico , Dermatite Atópica/tratamento farmacológico
7.
J Am Acad Dermatol ; 86(4): 758-765, 2022 04.
Artigo em Inglês | MEDLINE | ID: mdl-34756933

RESUMO

BACKGROUND: Patients with atopic dermatitis (AD) are considered at increased risk of developing other type 2 inflammatory diseases. However, real-world evidence based on large commercially insured pediatric populations in the United States is scarce. OBJECTIVE: To use a large claims database (IBM MarketScan 2013-2017) in the United States to assess prevalence and incidence of type 2 inflammatory diseases in pediatric patients with AD. METHODS: Pediatric patients with AD were matched 1:1 to patients without AD. Prevalence was assessed for conjunctivitis, rhinitis, urticaria, asthma, eosinophilic esophagitis, and chronic rhinosinusitis/nasal polyps at the 12 months' post-index date (the first AD diagnosis date for patients with AD; a randomly selected outpatient visit for control patients). The incidence of other type 2 inflammatory diseases post-index was assessed among patients 0-2 years of age. RESULTS: A total of 244,776 AD and matched non-AD patients were selected. The prevalence and incidence of type 2 inflammatory diseases were higher among patients with AD. Overall, the prevalence more than doubled for asthma, eosinophilic esophagitis, urticaria, and rhinitis, and increased with AD severity. LIMITATIONS: AD identification was based on billing diagnoses; the observation period was only 12 months; and the study was limited to commercially insured patients. CONCLUSION: The burden of type 2 inflammatory diseases in pediatric patients with AD is substantial, highlighting the need to optimize management of AD and its numerous associated morbidities.


Assuntos
Asma , Dermatite Atópica , Esofagite Eosinofílica , Rinite , Urticária , Asma/epidemiologia , Criança , Dermatite Atópica/diagnóstico , Dermatite Atópica/epidemiologia , Humanos , Prevalência
8.
J Drugs Dermatol ; 21(8): 897-899, 2022 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-35946980

RESUMO

Psoriasis, a chronic inflammatory skin condition, affects about 2% of children. A small subset have isolated nail involvement refractory to topical treatment that can be disabling. The development of targeted biologic agents offers safe, effective options for children with moderate-to-severe skin and nail disease. A few are now Food and Drug Administration (FDA)-approved for children. J Drugs Dermatol. 2022;21(8):897-899. doi:10.36849/JDD.6888.


Assuntos
Produtos Biológicos , Doenças da Unha , Psoríase , Produtos Biológicos/efeitos adversos , Pré-Escolar , Humanos , Doenças da Unha/diagnóstico , Doenças da Unha/tratamento farmacológico , Unhas , Psoríase/diagnóstico , Psoríase/tratamento farmacológico , Resultado do Tratamento
9.
Pediatr Dermatol ; 39(2): 187-196, 2022 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-35083774

RESUMO

BACKGROUND/OBJECTIVE: Patients with moderate-to-severe atopic dermatitis (AD) have increased risk of cutaneous and extracutaneous infections. Dupilumab has previously been associated with reduced risk of serious/severe infections and non-herpetic skin infections in adults with moderate-to-severe AD. This analysis assessed infection rates with dupilumab versus placebo in pediatric patients with moderate-to-severe and severe AD participating in clinical trials. METHODS: This is a pooled analysis from two 16-week, randomized, placebo-controlled, phase 3 clinical trials of dupilumab: monotherapy in adolescents aged 12-17 years with moderate-to-severe AD (LIBERTY AD ADOL, NCT03054428) and with concomitant topical corticosteroids in children aged 6-11 years with severe AD (LIBERTY AD PEDS, NCT03345914). Data were pooled according to treatment received: placebo/approved dupilumab doses/other studied dupilumab doses/all dupilumab doses. Exposure-adjusted rates (patients with ≥1 event per 100 patient-years [nP/100 PY]) were used to compare treatment groups. RESULTS: Overall, 612 patients were included: 205 received placebo and 407 received dupilumab (261 received approved dupilumab doses and 146 received other studied dupilumab doses). Overall infection rates were numerically lower with dupilumab versus placebo (nP/100 PY: placebo, 227; approved dupilumab, 173; other dupilumab, 206; all dupilumab, 184). Total skin infections were numerically less frequent in all dupilumab-treated groups versus placebo (nP/100 PY: placebo, 67; approved dupilumab, 30; other dupilumab, 46; all dupilumab, 36). CONCLUSIONS: These data suggest that dupilumab treatment in children and adolescents with AD does not increase infection risk overall and is associated with lower rates of skin infections compared with placebo.


Assuntos
Dermatite Atópica , Dermatopatias Infecciosas , Adolescente , Adulto , Anticorpos Monoclonais Humanizados , Criança , Dermatite Atópica/complicações , Dermatite Atópica/tratamento farmacológico , Método Duplo-Cego , Humanos , Índice de Gravidade de Doença , Dermatopatias Infecciosas/complicações , Resultado do Tratamento
10.
Pediatr Dermatol ; 38(5): 1400-1403, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34515370

RESUMO

Many over-the-counter (OTC) products are marketed to treat molluscum contagiosum, a common childhood viral infection with an estimated point prevalence of 5%-11%. As optimal treatment has not been defined, a comprehensive internet search was performed to identify OTC products marketed for treating molluscum and to collect information on packaging, ingredients, application instructions, and dosing. Nine OTC products were identified and varied widely in cost, packaging size, and ingredients; six of the nine products contained Thuja occidentalis. Overall, the majority of OTC package labels do not include sufficient information about their plant-based ingredients or appropriate dosing.


Assuntos
Molusco Contagioso , Criança , Humanos , Molusco Contagioso/tratamento farmacológico
11.
Pediatr Dermatol ; 38(4): 904-907, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-33977558

RESUMO

Mucous membrane pemphigoid (MMP) is a rare chronic immunobullous disease that involves the mucous membranes and may result in significant scarring and complications if diagnosis is delayed. MMP typically occurs in elderly patients, with very few cases reported in children. Here, we present a 12-year-old female patient with childhood-onset oral and genital MMP, clinically suspected to be lichen sclerosus, but eventually diagnosed as MMP after multiple supportive biopsies and confirmatory direct immunofluorescence. Although treatment was challenging, the combined use of systemic corticosteroids, dapsone, and mycophenolate mofetil was ultimately successful in achieving disease control.


Assuntos
Penfigoide Mucomembranoso Benigno , Penfigoide Bolhoso , Idoso , Criança , Dapsona/uso terapêutico , Feminino , Genitália , Humanos , Mucosa Bucal , Mucosa , Penfigoide Mucomembranoso Benigno/diagnóstico , Penfigoide Mucomembranoso Benigno/tratamento farmacológico
12.
J Am Acad Dermatol ; 82(4): 887-894, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-31586600

RESUMO

BACKGROUND: Although a variety of ablative, topical, and systemic therapies are used for molluscum contagiosum (MC), none has been well studied or approved by the US Food and Drug Administration. OBJECTIVES: To compare the efficacy and tolerability of topical SB206 (berdazimer sodium gel coadministered with hydrogel) with vehicle. METHODS: A 12-week, phase 2, multicenter, randomized, double-blind, vehicle-controlled clinical trial of topical SB206. RESULTS: A total of 256 patients (mean age, approximately 7 years) participated. Of patients who completed 12 weeks of treatment (n = 217), all MC lesions cleared in 20.0% of patients who received vehicle compared with 13.2%, 41.0%, and 35.1% of patients treated with twice daily SB206 4%, 8%, and 12%, respectively, and 41.9% of patients treated with once daily SB206 12%. Application-site erythema occurred in 10.6% of patients treated with SB206. Application-site reactions were the most common adverse events leading to treatment discontinuation, affecting 2 patients (approximately 4%) in each of the SB206 4%, 8%, and 12% twice daily groups and 0 patients in the vehicle or SB206 12% once daily groups. LIMITATIONS: A larger study is needed to confirm the efficacy of SB206 12% once daily and provide additional safety assessments. CONCLUSION: Of the doses studied, SB206 12% applied once daily provided the best balance between MC lesion clearance and tolerability for evaluation in a larger study.


Assuntos
Antivirais/administração & dosagem , Antivirais/efeitos adversos , Molusco Contagioso/tratamento farmacológico , Siloxanas/administração & dosagem , Siloxanas/efeitos adversos , Administração Cutânea , Adolescente , Adulto , Antivirais/uso terapêutico , Criança , Pré-Escolar , Método Duplo-Cego , Esquema de Medicação , Toxidermias/etiologia , Eritema/induzido quimicamente , Feminino , Géis , Humanos , Masculino , Pessoa de Meia-Idade , Siloxanas/uso terapêutico , Resultado do Tratamento , Adulto Jovem
13.
J Am Acad Dermatol ; 82(3): 651-660, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-31400453

RESUMO

BACKGROUND: Real-world evidence on treatment patterns of pediatric patients with atopic dermatitis (AD) is sparse. OBJECTIVE: To assess current treatment patterns in pediatric AD patients. METHODS: Retrospective observational analysis of commercial insurance and Medicaid administrative claims data (January 2011-December 2016) for pediatric AD patients, stratified by age and provider type. RESULTS: The analytic sample comprised 607,258 pediatric AD patients. Median observation period was 30.3 months. Overall, 78.6% were prescribed ≥1 AD medication; 86.7% were prescribed topical corticosteroids, and 5.4% were prescribed a calcineurin inhibitor. Systemic corticosteroids (SCSs) were prescribed for 24.4% of patients, 51.8% of whom did not have asthma or allergic comorbidities. Of the 46.6% prescribed an antihistamine and 16.2% prescribed montelukast, 62.0% and 41.3%, respectively, did not have asthma or allergic comorbidities. Systemic immunosuppressants were rarely prescribed (<0.5%). Higher potency topical corticosteroid and SCS use increased with age. Treatment patterns varied by provider type; specialists were more likely to prescribe higher potency topicals and/or systemics, regardless of patient age. A minority of patients were treated by or referred to a specialist. LIMITATIONS: Identification of AD patients relied on billing diagnoses; the disease severity was proxied by the treatment prescribed. CONCLUSION: Results indicate that SCSs, despite known risks, and other medications with disproven efficacy in AD are frequently prescribed, suggesting a need for safer and more effective alternatives.


Assuntos
Dermatite Atópica/tratamento farmacológico , Dermatologia , Pediatria , Padrões de Prática Médica , Criança , Pré-Escolar , Análise de Dados , Feminino , Humanos , Lactente , Seguro Saúde/estatística & dados numéricos , Masculino , Estudos Retrospectivos
14.
J Am Acad Dermatol ; 83(5): 1282-1293, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32574587

RESUMO

BACKGROUND: Children with severe atopic dermatitis (AD) have limited treatment options. OBJECTIVE: We report the efficacy and safety of dupilumab + topical corticosteroids (TCS) in children aged 6-11 years with severe AD inadequately controlled with topical therapies. METHODS: In this double-blind, 16-week, phase 3 trial (NCT03345914), 367 patients were randomized 1:1:1 to 300 mg dupilumab every 4 weeks (300 mg q4w), a weight-based regimen of dupilumab every 2 weeks (100 mg q2w, baseline weight <30 kg; 200 mg q2w, baseline weight ≥30 kg), or placebo; with concomitant medium-potency TCS. RESULTS: Both the q4w and q2w dupilumab + TCS regimens resulted in clinically meaningful and statistically significant improvement in signs, symptoms, and quality of life (QOL) versus placebo + TCS in all prespecified endpoints. For q4w, q2w, and placebo, 32.8%, 29.5%, and 11.4% of patients, respectively, achieved Investigator's Global Assessment scores of 0 or 1; 69.7%, 67.2%, and 26.8% achieved ≥75% improvement in Eczema Area and Severity Index scores; and 50.8%, 58.3%, and 12.3% achieved ≥4-point reduction in worst itch score. Response to therapy was weight-dependent: optimal dupilumab doses for efficacy and safety were 300 mg q4w in children <30 kg and 200 mg q2w in children ≥30 kg. Conjunctivitis and injection-site reactions were more common with dupilumab + TCS than with placebo + TCS. LIMITATIONS: Short-term 16-week treatment period; severe AD only. CONCLUSION: Dupilumab + TCS is efficacious and well tolerated in children with severe AD, significantly improving signs, symptoms, and QOL.


Assuntos
Corticosteroides/administração & dosagem , Anticorpos Monoclonais Humanizados/administração & dosagem , Dermatite Atópica/tratamento farmacológico , Administração Tópica , Anticorpos Monoclonais Humanizados/efeitos adversos , Criança , Método Duplo-Cego , Combinação de Medicamentos , Feminino , Humanos , Masculino , Estudos Prospectivos , Índice de Gravidade de Doença , Resultado do Tratamento
15.
J Am Acad Dermatol ; 82(2): 407-411, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31606479

RESUMO

BACKGROUND: Atopic dermatitis (AD) is a common, chronic type 2 inflammatory skin disease, typically starting in infancy, with increased risk for subsequent extracutaneous atopic morbidities. Dupilumab is the first biologic agent targeting type 2 inflammation approved by the U.S. Food and Drug Administration (USFDA); it was licensed in 2017 for adults with moderate to severe AD and 2 years later for adolescents. Systemic treatment for pediatric AD remains a significant unmet medical need. OBJECTIVE: To analyze off-label use of dupilumab in children with AD. METHODS: Multicenter retrospective review that evaluated children who were prescribed dupilumab for moderate to severe AD. RESULTS: One hundred eleven of 124 patients (89.5%) gained access to dupilumab after a mean of 9 weeks. The dosing range was 4 to 15.5 mg/kg for the loading dose and 2.0 to 15.3 mg/kg every other week for maintenance. The range was widest for 6- to 11-year-olds and was related to use of either full or half of adult dosing. Associated morbidities, treatment response, and adverse events were comparable to those in previous adolescent and adult trials. LIMITATIONS: The retrospective design of the study limited uniform data collection. CONCLUSION: Access to dupilumab was achievable for the majority of children after a mean 9-week delay because of insurance payment denial. This review supports dupilumab response and tolerability in children. Optimal dosing for patients younger than 12 years has not been defined. Availability of the drug in 2 different concentrations is an important safety issue.


Assuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , Dermatite Atópica/tratamento farmacológico , Uso Off-Label/estatística & dados numéricos , Criança , Pré-Escolar , Feminino , Humanos , Lactente , Masculino , Estudos Retrospectivos , Índice de Gravidade de Doença
16.
J Am Acad Dermatol ; 83(3): 839-846, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32344071

RESUMO

BACKGROUND: An Investigator Global Assessment (IGA) is recommended by health agencies for drug registration in atopic dermatitis (AD). Current IGA scales lack standardization. OBJECTIVES: To develop an IGA scale, training module, and clinical certification examination for use in AD trials; establish content validity; and assess reliability. METHODS: Expert dermatologists participated in the development of the validated IGA for AD (vIGA-ADTM). Reliability (interrater and intrarater) was assessed by 2 web-based surveys. Clinical certification for investigators consisted of a training module and examination. RESULTS: Expert consensus was achieved around a 5-point IGA scale including morphologic descriptions, and content validity was established. Survey 1 showed strong interrater reliability (Kendall's coefficient of concordance W [Kendall's W], 0.809; intraclass correlation [ICC], 0.817) and excellent agreement (weighted kappa, 0.857). Survey 2, completed 5 months after training of dermatologists, showed improvements in scale reliability (Kendall's W, 0.819; ICC, 0.852; weighted kappa, 0.889). In this study, 627 investigators completed vIGA-AD training and certification. LIMITATIONS: Ratings were assessed on photographs. CONCLUSION: A validated IGA scale and training module were developed with the intent of harmonizing assessment of disease severity in AD trials. Strong reliability and excellent agreement between assessments were observed.


Assuntos
Consenso , Dermatite Atópica/diagnóstico , Avaliação de Resultados em Cuidados de Saúde/normas , Índice de Gravidade de Doença , Adulto , Criança , Conferências de Consenso como Assunto , Dermatite Atópica/terapia , Dermatologistas/normas , Dermatologistas/estatística & dados numéricos , Humanos , Variações Dependentes do Observador , Fotografação , Reprodutibilidade dos Testes , Pele/diagnóstico por imagem , Inquéritos e Questionários/estatística & dados numéricos , Telecomunicações
17.
BMC Dermatol ; 20(1): 24, 2020 12 20.
Artigo em Inglês | MEDLINE | ID: mdl-33341118

RESUMO

BACKGROUND: An estimated 50% of children in the US are Medicaid-insured. Some of these patients have poor health literacy and limited access to medications and specialty care. These factors affect treatment utilization for pediatric patients with atopic dermatitis (AD), the most common inflammatory skin disease in children. This study assesses and compares treatment patterns and healthcare resource utilization (HCRU) between large cohorts of Medicaid and commercially insured children with AD. METHODS: Pediatric patients with AD were identified from 2 large US healthcare claims databases (2011-2016). Included patients had continuous health plan eligibility for ≥6 months before and ≥12 months after the first AD diagnosis (index date). Patients with an autoimmune disease diagnosis within 6 months of the index date were excluded. Treatment patterns and all-cause and AD-related HCRU during the observation period were compared between commercially and Medicaid-insured children. RESULTS: A minority of children were evaluated by a dermatology or allergy/immunology specialist. Several significant differences were observed between commercially and Medicaid-insured children with AD. Disparities detected for Medicaid-insured children included: comparatively fewer received specialist care, emergency department and urgent care center utilization was higher, a greater proportion had asthma and non-atopic morbidities, high- potency topical corticosteroids and calcineurin inhibitors were less often prescribed, and prescriptions for antihistamines were more than three times higher, despite similar rates of comorbid asthma and allergies among antihistamine users. Treatment patterns also varied substantially across physician specialties. CONCLUSIONS: Results suggest barriers in accessing specialty care for all children with AD and significant differences in management between commercially and Medicaid-insured children. These disparities in treatment and access to specialty care may contribute to poor AD control, especially in Medicaid-insured patients.


Assuntos
Dermatite Atópica/terapia , Acessibilidade aos Serviços de Saúde/estatística & dados numéricos , Disparidades em Assistência à Saúde/estatística & dados numéricos , Seguro Saúde/estatística & dados numéricos , Medicaid/estatística & dados numéricos , Adolescente , Criança , Pré-Escolar , Dermatite Atópica/diagnóstico , Dermatite Atópica/economia , Feminino , Letramento em Saúde , Acessibilidade aos Serviços de Saúde/economia , Disparidades em Assistência à Saúde/economia , Humanos , Lactente , Recém-Nascido , Seguro Saúde/economia , Masculino , Medicaid/economia , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Estudos Retrospectivos , Fatores Socioeconômicos , Estados Unidos
18.
Pediatr Dermatol ; 37(3): 568-569, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-32101632

RESUMO

PHACE syndrome classically presents with a large, segmental facial infantile hemangioma (IH) associated with structural and vascular abnormalities involving the head and neck, heart, and eyes. We evaluated an infant who presented with ptosis caused by a clinically subtle, deep right-sided periorbital IH identified on MRI that also incidentally revealed hypoplasia of the right common carotid and right internal carotid arteries, supporting a diagnosis of PHACE syndrome. She subsequently developed acute-onset, transient right-sided facial erythema without anisocoria, triggered by feeding and emotional stress. We believe this represents a Frey syndrome-like developmental dysautonomia, previously unreported in association with PHACE syndrome, suggesting an associated defect in neurovascular embryogenesis.


Assuntos
Coartação Aórtica , Anormalidades do Olho , Síndromes Neurocutâneas , Disautonomias Primárias , Sudorese Gustativa , Coartação Aórtica/complicações , Coartação Aórtica/diagnóstico , Criança , Anormalidades do Olho/complicações , Anormalidades do Olho/diagnóstico , Feminino , Humanos , Lactente , Síndromes Neurocutâneas/complicações , Síndromes Neurocutâneas/diagnóstico
19.
Pediatr Dermatol ; 37(3): 424-434, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-32320494

RESUMO

BACKGROUND/OBJECTIVES: The COVID-19 pandemic has raised questions about the approach to management of systemic immunosuppressive therapies for dermatologic indications in children. Change to: Given the absence of data to address concerns related to SARS-CoV-2 infection and systemic immunosuppressive therapies in an evidence-based manner, a Pediatric Dermatology COVID-19 Response Task Force (PDCRTF) was assembled to offer time-sensitive guidance for clinicians. METHODS: A survey was distributed to an expert panel of 37 pediatric dermatologists on the PDCRTF to assess expert opinion and current practice related to three primary domains of systemic therapy: initiation, continuation, and laboratory monitoring. RESULTS: Nearly all respondents (97%) reported that the COVID-19 pandemic had impacted their decision to initiate immunosuppressive medications. The majority of pediatric dermatologists (87%) reported that they were pausing or reducing the frequency of laboratory monitoring for certain immunosuppressive medications. In asymptomatic patients, continuing therapy was the most popular choice across all medications queried. The majority agreed that patients on immunosuppressive medications who have a household exposure to COVID-19 or test positive for new infection should temporarily discontinue systemic and biologic medications, with the exception of systemic steroids, which may require tapering. CONCLUSIONS: The ultimate decision regarding initiation, continuation, and laboratory monitoring of immunosuppressive therapy during the pandemic requires careful deliberation, consideration of the little evidence available, and discussion with families. Consideration of an individual's adherence to COVID-19 preventive measures, risk of exposure, and the potential severity if infected must be weighed against the dermatological disease, medication, and risks to the patient of tapering or discontinuing therapies.


Assuntos
Betacoronavirus , Infecções por Coronavirus/epidemiologia , Terapia de Imunossupressão , Pneumonia Viral/epidemiologia , Dermatopatias/terapia , COVID-19 , Criança , Tomada de Decisão Clínica , Consenso , Humanos , Imunossupressores/uso terapêutico , Pandemias , SARS-CoV-2 , Dermatopatias/etiologia
20.
J Am Acad Dermatol ; 81(2): 412-416, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30771420

RESUMO

BACKGROUND: Access to dermatologists is low among Medicaid-insured patients. Higher clinic nonattendance among Medicaid-insured patients might affect provider decisions to accept these patients. OBJECTIVE: To determine the effect of different scheduling policies on the attendance among children seen at a pediatric dermatology clinic. METHODS: In this retrospective review, we compared nonattendance among children for 3 different scheduling policies implemented over 3 consecutive years. The scheduling policies used were a first-available open scheduling policy, a 2-week in advance scheduling policy, and a 4-week in advance scheduling policy. Subset analyses were performed by clinic location and insurance type. RESULTS: The interval between scheduling and appointment date was directly related to nonattendance rates; rates were higher for Medicaid-insured than privately insured patients. Open scheduling was associated with a 37% nonattendance rate for Medicaid-insured patients and 18% nonattendance rate for privately insured patients. A 4-week in advance scheduling policy significantly decreased the nonattendance rate to 19% among Medicaid-insured and 7% among privately insured patients. A 2-week in advance policy further decreased the nonattendance rate to 11% among Medicaid-insured patients and 4% among privately insured patients. LIMITATIONS: This is a retrospective study, and same-day cancellations were not tracked. CONCLUSION: Decreasing the time interval between scheduling and appointment dates can significantly decrease nonattendance. This strategy might help dermatologists incorporate more Medicaid-insured patients into their practices.


Assuntos
Agendamento de Consultas , Dermatologia/organização & administração , Dermatologia/estatística & dados numéricos , Seguro Saúde/estatística & dados numéricos , Medicaid/estatística & dados numéricos , Pacientes não Comparecentes/estatística & dados numéricos , Adolescente , Criança , Pré-Escolar , Humanos , Lactente , Recém-Nascido , Estudos Retrospectivos , Fatores de Tempo , Estados Unidos
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