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1.
Dermatol Ther (Heidelb) ; 13(11): 2549-2571, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37747670

RESUMO

INTRODUCTION: Assessing treatment response is key to determining treatment value in atopic dermatitis (AD). Currently, response is assessed using various clinician- or patient-reported measures and response criteria. This variation creates a mismatch of evidence across trials, hindering the ability of clinicians, regulators, and payers to compare the efficacy of treatments. This review identifies which measures and criteria are used to determine response in clinical trials and health technology assessments (HTAs). Moreover, it systematically reviews the psychometric performance of those measures and criteria to understand which perform best in capturing patient-relevant symptoms and treatment benefits. METHODS: A scoping review of clinical trials and HTAs in AD identified the following measures for inclusion: the Eczema Area and Severity Index (EASI), the Investigator's Global Assessment (IGA), the Dermatology Life Quality Index (DLQI) and the Peak Pruritus Numerical Rating Scale (PP-NRS). A systematic search was performed in MEDLINE and Embase to identify studies testing the psychometric performance of these measures in adults or adolescents with AD. RESULTS: A lack of consistency in the assessment of response was observed across clinical trials and HTAs. Important gaps in psychometric evidence were identified. No content validations of the EASI and IGA in AD were found, while some quantitative studies suggested that these measures fail to capture itch, a core symptom. The PP-NRS and DLQI performed well. No studies compared the performance of different response criteria. CONCLUSION: Content validation of the PP-NRS confirmed the importance of itch as a core symptom and treatment priority in AD; however, itch is not well covered in the EASI or IGA. Including the PP-NRS in clinical trials and HTAs will better capture patient-relevant benefit and response. Although various response criteria were used, no studies compared the performance of different criteria to inform which were most appropriate to compare treatments in clinical trials and HTAs.


The assessment of treatment response is important in determining treatment value in atopic dermatitis (AD). This study aimed to identify which outcome measures and criteria are used to determine treatment response in clinical trials and health technology assessments (HTAs). The psychometric performance of identified outcome measures and criteria was then systematically reviewed to understand which perform best in capturing patient-relevant symptoms and treatment benefits in AD. The review identified and included the Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), Dermatology Life Quality Index (DLQI) and Peak Pruritus Numerical Rating Scale (PP-NRS) as response measures. Lack of consistency in how response is assessed across clinical trials and HTAs makes it difficult for clinicians and payers to compare the efficacies and cost-effectivenesses of different treatments and to make optimal treatment decisions. The review found that content validity (the extent to which a measure covers those symptoms and treatment benefits which are important to patients) was not assessed for EASI and IGA. EASI and IGA are often used to assess response in clinical trials and HTAs, but they miss key elements of the patient-relevant disease impact and treatment benefit, including itch. Treatments leading to improvements in missed symptoms (e.g. itch) will be undervalued using EASI and IGA, decreasing the chances of regulatory approval and reimbursement. Moreover, response criteria used in clinical trials and HTAs are sometimes adopted in prescriber settings. Here, if response assessment does not capture patient-relevant benefit, patients' access to tailored treatment may be restricted due to the perceived non-response.

2.
Eur J Dermatol ; 29(5): 518-523, 2019 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-31647462

RESUMO

Immunosuppressants used in organ transplant patients increase the risk of non-melanoma skin cancer. This study aimed to evaluate patient behaviours towards skin cancer prevention methods and to understand characteristics of a future prevention strategy based on patients' perspective. Carenity, a global online patient community, enabled the recruitment of 200 adult patients with solid organ transplants from four European countries: France, Italy, Spain and Germany. Most patients were well informed about the risk of skin cancer, but only 27% (53/200) monitored their skin. Most patients exposed themselves to intense sun exposure once a month or more. Nevertheless, more than half of patients were motivated to use additional prevention strategies and limit their sun exposure. The most appropriate prevention strategy was reported to be the use of a cosmetically attractive, water-resistant, paraben/fragrance-free cream. A one-size-fits-all approach is not an appropriate prevention strategy and an adapted approach based on patients' preferences may significantly contribute to better compliance and adherence.


Assuntos
Cooperação do Paciente/psicologia , Preferência do Paciente/psicologia , Assunção de Riscos , Neoplasias Cutâneas/prevenção & controle , Protetores Solares/uso terapêutico , Adulto , Europa (Continente) , Conhecimentos, Atitudes e Prática em Saúde , Inquéritos Epidemiológicos/métodos , Humanos , Hospedeiro Imunocomprometido , Imunossupressores/efeitos adversos , Internet , Pessoa de Meia-Idade , Transplante de Órgãos , Fatores de Risco
3.
Pediatr Infect Dis J ; 33(12): 1246-54, 2014 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-25037033

RESUMO

BACKGROUND: The immunogenicity and safety of the investigational diphtheria, tetanus, acellular pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b (Hib) and meningococcal serogroup C (MenC) heptavalent combination vaccine were compared with those of licensed control vaccines. METHODS: In this open, phase II, randomized study (NCT01090453), 480 infants from Germany, France and Canada received the heptavalent vaccine (Hepta group) or hexavalent and monovalent MenC control vaccines (HexaMenC group) co-administered with a 13-valent pneumococcal conjugate vaccine at 2, 4 and 12 months of age. Immunogenicity was measured 1 month after the second primary dose, and before and 1 month after the booster dose. Safety and reactogenicity were also evaluated. RESULTS: Non-inferiority of immune responses to MenC and Hib induced by 2-dose primary vaccination with the heptavalent vaccine versus control vaccines was demonstrated. In exploratory analyses, postprimary and postbooster functional antibody geometric mean titers against MenC tended to be lower (1119.5 vs. 3200.5; 2653.8 vs. 6028.4) and antibody geometric mean concentrations against Hib higher (1.594 vs. 0.671 µg/mL; 17.678 vs. 13.737 µg/mL) in the Hepta versus the HexaMenC group. The heptavalent and control vaccines were immunogenic to all other antigens, although immune responses to poliovirus were lower than expected in both groups. No differences in safety and reactogenicity profiles were detected between groups. CONCLUSIONS: The heptavalent vaccine induced non-inferior MenC and Hib responses compared with control vaccines. Both vaccination regimens, when administered at 2, 4 and 12 months of age, had comparable safety profiles and were immunogenic to all antigens, with lower-than-expected responses to poliomyelitis.


Assuntos
Vacina contra Difteria, Tétano e Coqueluche/efeitos adversos , Vacina contra Difteria, Tétano e Coqueluche/imunologia , Vacinas Anti-Haemophilus/efeitos adversos , Vacinas Anti-Haemophilus/imunologia , Vacinas contra Hepatite B/efeitos adversos , Vacinas contra Hepatite B/imunologia , Vacinas Meningocócicas/efeitos adversos , Vacinas Meningocócicas/imunologia , Vacina Antipólio de Vírus Inativado/efeitos adversos , Vacina Antipólio de Vírus Inativado/imunologia , Anticorpos Antibacterianos/sangue , Canadá , Vacina contra Difteria, Tétano e Coqueluche/administração & dosagem , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/patologia , Feminino , França , Alemanha , Vacinas Anti-Haemophilus/administração & dosagem , Vacinas contra Hepatite B/administração & dosagem , Humanos , Lactente , Masculino , Vacinas Meningocócicas/administração & dosagem , Vacina Antipólio de Vírus Inativado/administração & dosagem , Vacinas Combinadas/administração & dosagem , Vacinas Combinadas/efeitos adversos , Vacinas Combinadas/imunologia
4.
Pediatr Infect Dis J ; 32(7): 777-85, 2013 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-23838777

RESUMO

BACKGROUND: Combination vaccines offer protection against multiple diseases with fewer injections. This study evaluated the immunogenicity and safety of an investigational diphtheria, tetanus, acellular pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b (Hib) and meningococcal serogroup C (MenC) heptavalent combination vaccine (heptavalent vaccine) given as 4 doses at 2, 3, 4 and 12-18 months of age. METHODS: In this randomized, open, phase II study (NCT00970307/NCT01171989) conducted in Poland, 421 infants were enrolled to receive the heptavalent vaccine or licensed comparator vaccines. Immunogenicity against study vaccine antigens was measured prior to and 1 month after primary and booster vaccinations. Safety and reactogenicity of the vaccines were also evaluated. RESULTS: The primary noninferiority objectives of the MenC and Hib immune responses induced by the heptavalent vaccine versus comparator vaccines were reached after primary vaccination, but no statistical conclusion could be drawn after booster dose. One month after primary and booster vaccinations, ≥98.4% of the heptavalent vaccine recipients were seroprotected for MenC and Hib. Exploratory analyses indicated that the heptavalent vaccine induced higher postprimary vaccination antibody geometric mean concentrations against Hib, but lower postprimary and postbooster vaccinations geometric mean titers against MenC compared with the relevant comparator vaccines. The reactogenicity profiles of the vaccines were acceptable, although 1 infant vaccinated with the heptavalent vaccine experienced a serious adverse event (thrombocytopenia) considered possibly related to vaccination. CONCLUSIONS: The heptavalent vaccine was immunogenic and had a clinically acceptable safety profile when administered to infants and toddlers.


Assuntos
Vacina contra Difteria, Tétano e Coqueluche/efeitos adversos , Vacina contra Difteria, Tétano e Coqueluche/imunologia , Vacinas Anti-Haemophilus/efeitos adversos , Vacinas Anti-Haemophilus/imunologia , Vacinas contra Hepatite B/efeitos adversos , Vacinas contra Hepatite B/imunologia , Vacinas Meningocócicas/efeitos adversos , Vacinas Meningocócicas/imunologia , Vacina Antipólio de Vírus Inativado/efeitos adversos , Vacina Antipólio de Vírus Inativado/imunologia , Vacinação/efeitos adversos , Vacinação/métodos , Anticorpos Antibacterianos/sangue , Atividade Bactericida do Sangue , Vacina contra Difteria, Tétano e Coqueluche/administração & dosagem , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/patologia , Ensaio de Imunoadsorção Enzimática , Vacinas Anti-Haemophilus/administração & dosagem , Vacinas contra Hepatite B/administração & dosagem , Humanos , Lactente , Masculino , Vacinas Meningocócicas/administração & dosagem , Polônia , Vacina Antipólio de Vírus Inativado/administração & dosagem , Vacinas Combinadas/administração & dosagem , Vacinas Combinadas/efeitos adversos , Vacinas Combinadas/imunologia
5.
Eur J Immunol ; 38(5): 1351-7, 2008 May.
Artigo em Inglês | MEDLINE | ID: mdl-18389479

RESUMO

DiC14-amidine cationic liposomes were recently shown to promote Th1 responses when mixed with allergen. To further define the mode of action of diC14-amidine as potential vaccine adjuvant, we characterized its effects on mouse and human myeloid dendritic cells (DC). First, we observed that, as compared with two other cationic liposomes, only diC14-amidine liposomes induced the production of IL-12p40 and TNF-alpha by mouse bone marrow-derived DC. DiC14-amidine liposomes also activated human DC, as shown by synthesis of IL-12p40 and TNF-alpha, accumulation of IL-6, IFN-beta and CXCL10 mRNA, and up-regulation of membrane expression of CD80 and CD86. DC stimulation by diC14-amidine liposomes was associated with activation of NF-kappaB, ERK1/2, JNK and p38 MAP kinases. Finally, we demonstrated in mouse and human cells that diC14-amidine liposomes use Toll-like receptor 4 to elicit both MyD88-dependent and Toll/IL-1R-containing adaptor inducing interferon IFN-beta (TRIF)-dependent responses.


Assuntos
Adjuvantes Imunológicos/farmacologia , Amidinas/farmacologia , Células Dendríticas/efeitos dos fármacos , Receptor 4 Toll-Like/agonistas , Proteínas Adaptadoras de Transporte Vesicular/genética , Adjuvantes Imunológicos/administração & dosagem , Amidinas/administração & dosagem , Animais , Linhagem Celular , Citocinas/metabolismo , Células Dendríticas/metabolismo , Feminino , Humanos , Subunidade p40 da Interleucina-12/metabolismo , Antígeno 96 de Linfócito/genética , Camundongos , Camundongos Endogâmicos BALB C , Camundongos Endogâmicos C57BL , Camundongos Knockout , Camundongos Mutantes , Proteínas Quinases Ativadas por Mitógeno/metabolismo , Células Mieloides/citologia , Fator 88 de Diferenciação Mieloide/genética , NF-kappa B/metabolismo , Fosforilação/efeitos dos fármacos , Receptor 4 Toll-Like/genética , Receptores Toll-Like/genética , Transfecção , Fator de Necrose Tumoral alfa/metabolismo
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