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5.
J Dermatolog Treat ; 33(5): 2554-2559, 2022 Aug.
Article in English | MEDLINE | ID: mdl-35083945

ABSTRACT

INTRODUCTION: Atopic dermatitis (AD) is a difficult-to-treat inflammatory skin disease with a high impact on patients' quality of life. Dupilumab, an IL-4 and IL-13 inhibitor, was the first monoclonal antibody approved for the treatment of moderate-to-severe AD and is currently approved in patients aged 6 or older. METHODS: This is a nationwide, multicenter, retrospective, 48-week study designed by the Portuguese Group of AD to assess real-world efficacy and safety of dupilumab for the treatment of AD. RESULTS: A total of 169 patients were enrolled, with a mean disease duration of 22.75 (±11.98) years. The percentage of patients achieving an improvement of at least 75% in Eczema Area and Severity Index (EASI) compared to baseline (EASI75 response) at weeks 12 and 48 was 67.6% and 74.1%, respectively. In the same timepoints, 25.0% and 44.1% achieved an EASI90 response. Patient-reported outcome measures also improved throughout the study period. Regarding safety, 32.0% of the patients developed adverse events, with conjunctivitis (26.6%), persistent facial erythema (4.7%), and arthritis/arthralgia (3.6%) as the more frequently reported. CONCLUSION: Data from real-world populations are crucial to guide clinicians in their daily decisions. This study provides data demonstrating that dupilumab is an effective and safe therapeutic option for AD.


Subject(s)
Dermatitis, Atopic , Antibodies, Monoclonal, Humanized , Dermatitis, Atopic/drug therapy , Humans , Portugal , Quality of Life , Retrospective Studies , Severity of Illness Index , Treatment Outcome
6.
J Investig Allergol Clin Immunol ; 30(6): 430-438, 2020.
Article in English | MEDLINE | ID: mdl-31530518

ABSTRACT

BACKGROUND AND OBJECTIVE: To investigate the quality of life (QOL) of and to characterize patients with atopic dermatitis (AD) in Portugal. METHODS: This was a cross-sectional study of patients with AD and other eczemas. Skindex-29, Skindex-teen, and the Childhood Atopic Dermatitis Impact Scale (CADIS) were the instruments used to assess QOL in adults, teenagers, and children, respectively. The SF-12 was also used, and disease severity was evaluated using the Patient-Oriented SCORAD (PO-SCORAD) instrument. Associations with QOL were assessed based on the odds ratio (OR). P values <.05 and 95%CIs were considered statistically significant. RESULTS: The study population comprised 162 participants aged 0.5-74 years. We found that 37.3% of AD patients consider their disease disabling and that more than half of the patients feel stigmatized by society. The mean Skindex score for AD was 39.68, and the impact on QOL was severe in 44%. "Symptoms" was the most affected category in adults. AD was moderate to severe in 87% of the sample. One of the factors that most influenced poorer QOL in AD was age: with increasing age, the Skindex is likely to increase (OR, 1.03; 95%CI, 1.00-1.06). "Considering the disease a disability" was also associated (OR, 6.72; 95%CI, 2.56-17.63). QOL worsens with increasingly affected body area (OR, 1.07; 95%CI, 1.03-1.11) and the presence of edema (OR, 2.0; 95%CI, 1.23-3.40). CONCLUSIONS: This is the first study to provide data on QOL in patients with AD in Portugal. Our data show an expected negative impact. More awareness-raising activities are needed to increase knowledge, decrease stigmatization, and, consequently, address the factors involved in the QOL of patients with AD.


Subject(s)
Dermatitis, Atopic/epidemiology , Quality of Life , Adolescent , Adult , Aged , Aged, 80 and over , Allergens/immunology , Child , Cost of Illness , Dermatitis, Atopic/diagnosis , Dermatitis, Atopic/etiology , Dermatitis, Atopic/therapy , Disease Management , Disease Susceptibility , Female , Humans , Infant , Infant, Newborn , Male , Middle Aged , Odds Ratio , Portugal/epidemiology , Public Health Surveillance , Risk Factors , Severity of Illness Index , Treatment Outcome , Young Adult
7.
Br J Dermatol ; 182(6): 1423-1429, 2020 06.
Article in English | MEDLINE | ID: mdl-31444799

ABSTRACT

BACKGROUND: A long-term prospective observational safety study is essential to characterize fully the safety profile of systemic immunomodulating therapies for patients with atopic eczema. The TREatment of ATopic eczema (TREAT) Registry Taskforce offers a large platform to conduct such research using national registries that collect the same data using a predefined core dataset. OBJECTIVES: To present a protocol for a safety study comparing dupilumab with other systemic immunomodulating therapies in children and adults with moderate-to-severe atopic eczema, to assess the long-term safety risk of these therapies in a routine clinical care setting. METHODS: We describe a registry-embedded international observational prospective cohort study. Adult and paediatric patients who start treatment with dupilumab or another systemic immunomodulating agent for their atopic eczema will be included. The primary end point is the incidence of malignancies (excluding nonmelanoma skin cancer) compared between the treatment groups. Secondary end points include other serious adverse events and adverse events of special interest, such as eye disorders and eosinophilia. CONCLUSIONS: This protocol delineates a safety study for dupilumab in adult and paediatric patients with atopic eczema, using a standardized methodological approach across several national registries. The protocol could also be used for other novel systemic immunomodulating therapies, and could provide licensing and reimbursement authorities, pharmaceutical companies and clinicians with safety evidence from a routine clinical care setting. What's already known about this topic? There is a need for long-term data on the safety of systemic immunomodulating therapies in patients with atopic eczema. Regulatory bodies, such as the European Medicines Agency, increasingly stipulate the collection of such data as part of the licensing agreement for new treatments, to assess the new agent's long-term safety profile against established therapies. Large numbers of patients with a long duration of follow-up are necessary in order to detect rare events like malignancies. What does this study add? The TREAT Registry Taskforce offers a platform to conduct such research with a network of multiple national atopic eczema research registries. We present a protocol for an investigator-initiated multicentre safety study comparing dupilumab with other systemic immunomodulating therapies in adults and subsequently adolescents and children with moderate-to-severe atopic eczema. This protocol can be used as a framework for similar studies for other novel systemic immunomodulating therapies across both adult and paediatric populations.


Subject(s)
Dermatitis, Atopic , Eczema , Adolescent , Adult , Antibodies, Monoclonal, Humanized , Child , Dermatitis, Atopic/drug therapy , Humans , Observational Studies as Topic , Prospective Studies , Registries , Treatment Outcome
8.
J. investig. allergol. clin. immunol ; 30(6): 430-438, 2020. tab, graf
Article in English | IBECS | ID: ibc-202595

ABSTRACT

OBJECTIVES: To investigate the quality of life (QOL) of and to characterize patients with atopic dermatitis (AD) in Portugal. METHODS: This was a cross-sectional study of patients with AD and other eczemas. Skindex-29, Skindex-teen, and the Childhood Atopic Dermatitis Impact Scale (CADIS) were the instruments used to assess QOL in adults, teenagers, and children, respectively. The SF-12 was also used, and disease severity was evaluated using the Patient-Oriented SCORAD (PO-SCORAD) instrument. Associations with QOL were assessed based on the odds ratio (OR). P values <.05 and 95%CIs were considered statistically significant. RESULTS: The study population comprised 162 participants aged 0.5-74 years. We found that 37.3% of AD patients consider their disease disabling and that more than half of the patients feel stigmatized by society. The mean Skindex score for AD was 39.68, and the impact on QOL was severe in 44%. "Symptoms" was the most affected category in adults. AD was moderate to severe in 87% of the sample. One of the factors that most influenced poorer QOL in AD was age: with increasing age, the Skindex is likely to increase (OR, 1.03; 95%CI, 1.00-1.06). "Considering the disease a disability" was also associated (OR, 6.72; 95%CI, 2.56-17.63). QOL worsens with increasingly affected body area (OR, 1.07; 95%CI, 1.03-1.11) and the presence of edema (OR, 2.0; 95%CI, 1.23-3.40). CONCLUSIONS: This is the first study to provide data on QOL in patients with AD in Portugal. Our data show an expected negative impact. More awareness-raising activities are needed to increase knowledge, decrease stigmatization, and, consequently, address the factors involved in the QOL of patients with AD


OBJETIVOS: Investigar la calidad de vida (QOL) y caracterizar a los pacientes con dermatitis atópica (AD) en Portugal. MÉTODOS: Se trata de un estudio transversal de pacientes con AD y otros eczemas. Skindex-29, Skindex-teen y Childhood Atopic Dermatitis Impact Scale (CADIS) fueron los instrumentos utilizados para evaluar la QOL en adultos, adolescentes y niños, respectivamente. También se utilizó el SF-12 y se evaluó la gravedad de la enfermedad a través del SCORAD Orientado por el paciente (PO-SCORAD). Las asociaciones con la QOL se evaluaron según la odds ratio (OR). El IC del 95% y los valores de p <0,05 se consideraron estadísticamente significativos. RESULTADOS: La población del estudio comprendió 162 participantes de entre 0,5 y 74 años. Encontramos que el 37,3% de los pacientes con DA consideran su enfermedad como incapacitante y más de la mitad de los pacientes con DA se sienten estigmatizados por la sociedad. La puntuación media de Skindex para la AD fue de 39,68 y el impacto en la QOL fue severo en el 44%. Síntomas"fue la categoría más afectada en los adultos. La DA fue de moderada a grave en el 87% de la muestra. Uno de los factores que más influyó en una peor calidad de vida en DA fue la edad: a medida que aumenta la edad, es probable que el Skindex aumente (OR: 1,03 [IC 95% 1,00-1,06]). "Considerar la enfermedad como discapacidad" también se asoció, OR: 6,72 (IC 95% 2,56-17,63). La calidad de vida también empeora con el área del cuerpo cada vez más afectada (OR: 1,07 [IC 95% 1,03-1,11] y OR: 2.04 [IC 95% 1,23-3,40], respectivamente). CONCLUSIONES: Este es el primer estudio que proporciona datos sobre la calidad de vida en pacientes con DA en Portugal. Nuestros datos muestran un impacto negativo esperado. Se necesitan más actividades de sensibilización para aumentar el conocimiento, disminuir el estigma y, en consecuencia, abordar los factores involucrados en la calidad de vida de los pacientes con DA


Subject(s)
Humans , Male , Female , Infant, Newborn , Infant , Child, Preschool , Child , Adolescent , Young Adult , Adult , Middle Aged , Aged , Aged, 80 and over , Dermatitis, Atopic/psychology , Quality of Life/psychology , Surveys and Questionnaires , Severity of Illness Index , Reproducibility of Results , Cross-Sectional Studies , Portugal
9.
Actas dermo-sifiliogr. (Ed. impr.) ; 110(9): 744-751, nov. 2019. tab, graf
Article in Spanish | IBECS | ID: ibc-185566

ABSTRACT

Antecedentes y objetivos: Tanto el eccema como la urticaria son enfermedades inflamatorias de la piel. La prevalencia de ambas varía a lo largo de todo el mundo y se desconocen las razones de este hecho. Nuestro objetivo es investigar la prevalencia del eccema y la urticaria en la población portuguesa adulta (≥ 16 años). Materiales y métodos: Se realizó una encuesta telefónica en el último trimestre de 2017. Para calcular las prevalencias, los individuos debían haber sido diagnosticados previamente, por un profesional sanitario, de eccema/urticaria, ser mayores de 16 años y residir en Portugal. La muestra era aproximadamente representativa de la población, región, sexo y grupo de edad. La ratio de odds se empleó para medir las asociaciones con la prevalencia. Se utilizó el software SPSS Statistics, y aquellos datos con un valor p < 0,005 con un intervalo de confianza del 95% fueron considerados estadísticamente significativos. Resultados: Se analizaron 5.000 llamadas telefónicas. La prevalencia en Portugal del eccema y la urticaria es del 4,4% y 3,4%, respectivamente. El Algarve es la región en la que la prevalencia de ambas enfermedades es más alta. Ser mujer es el factor que más influyó en estas enfermedades, con una OR = 1,99 (p < 0,001; IC: 1,49-2,66) para el eccema y OR = 1,73 (p = 0,001; IC: 1,25-2,40) para la urticaria, siendo las prevalencias también más altas (5,7% y 4,2%, respectivamente). Conclusiones: Las prevalencias encontradas son más altas que las observadas en estudios anteriores en Portugal y comparables a los resultados procedentes de otros países. Las comparativas de la prevalencia en el eccema se ven afectadas por varios obstáculos. En cuanto a la urticaria, nuestros resultados parecen estar en consonancia con otros. Ser mujer con eccema y urticaria es más frecuente y representa un factor de riesgo más alto que el ser hombre. De acuerdo con Harrop et al., 2007, en Europa, el eccema atópico supone el 0,14-0,60% del eccema total. En este sentido, podemos estimar que la prevalencia del eccema atópico en Portugal ronda el 0,61-2,64%


Background and aims: Eczema and urticaria are both inflammatory skin diseases. The prevalence of both diseases varies worldwide and the reasons are unknown. We aimed to investigate the eczema and urticaria prevalence in the Portuguese adult (≥ 16 years-old) population. Materials and methods: A telephone interview survey was performed in the last quarter of 2017. To calculate the prevalences, subjects should have been previously diagnosed with eczema/urticaria by a health professional, be aged ≥ 16 years-old, and reside in Portugal. The sample had a proportion that was approximately representative by population, region, gender, and age group. Odds ratios were performed to measure associations with prevalences. SPSS statistics and values of p < 0.05 with 95% confidence intervals were considered statistically significant. Results: 5,000 phone calls were analysed. The prevalence of eczema and urticaria in Portugal is 4.4% and 3.4%, respectively. Algarve is the region with the highest prevalence for both diseases. Being a female is the factor that most influenced these diseases with an OR = 1.99 (p < 0.001; CI 1.49-2.66) for eczema and 1.73 (p = 0.001; CI 1.25 - 2.40) for urticaria, with also higher prevalences (5.7% and 4.2%, respectively). Conclusions: The prevalences found are higher than in previous studies in Portugal and comparable to results from other countries. Comparisons among prevalence of eczema are affected by several obstacles. Regarding urticaria, our results seem to be in the same line as others. Being female with eczema and urticaria is more common and represents a higher risk factor than male subjects. According to Harrop et al., 2007, in Europe, atopic eczema is 0.14-0.60% of general eczema. In this way, we can estimate that prevalence of atopic eczema in Portugal is around 0.61-2.64%


Subject(s)
Humans , Male , Female , Adolescent , Young Adult , Adult , Middle Aged , Aged , Aged, 80 and over , Eczema/epidemiology , Urticaria/epidemiology , Portugal/epidemiology , Telephone/statistics & numerical data , Confidence Intervals , Surveys and Questionnaires , Odds Ratio , Multivariate Analysis , Risk Factors
10.
Actas Dermosifiliogr (Engl Ed) ; 110(9): 744-751, 2019 Nov.
Article in English, Spanish | MEDLINE | ID: mdl-31153546

ABSTRACT

BACKGROUND AND AIMS: Eczema and urticaria are both inflammatory skin diseases. The prevalence of both diseases varies worldwide and the reasons are unknown. We aimed to investigate the eczema and urticaria prevalence in the Portuguese adult (≥16 years-old) population. MATERIALS AND METHODS: A telephone interview survey was performed in the last quarter of 2017. To calculate the prevalences, subjects should have been previously diagnosed with eczema/urticaria by a health professional, be aged ≥16 years-old, and reside in Portugal. The sample had a proportion that was approximately representative by population, region, gender, and age group. Odds ratios were performed to measure associations with prevalences. SPSS statistics and values of p<0.05 with 95% confidence intervals were considered statistically significant. RESULTS: 5,000 phone calls were analysed. The prevalence of eczema and urticaria in Portugal is 4.4% and 3.4%, respectively. Algarve is the region with the highest prevalence for both diseases. Being a female is the factor that most influenced these diseases with an OR=1.99 (p<0.001; CI 1.49-2.66) for eczema and 1.73 (p=0.001; CI 1.25 - 2.40) for urticaria, with also higher prevalences (5.7% and 4.2%, respectively). CONCLUSIONS: The prevalences found are higher than in previous studies in Portugal and comparable to results from other countries. Comparisons among prevalence of eczema are affected by several obstacles. Regarding urticaria, our results seem to be in the same line as others. Being female with eczema and urticaria is more common and represents a higher risk factor than male subjects. According to Harrop et al., 2007, in Europe, atopic eczema is 0.14-0.60% of general eczema. In this way, we can estimate that prevalence of atopic eczema in Portugal is around 0.61-2.64%.


Subject(s)
Eczema/epidemiology , Urticaria/epidemiology , Adolescent , Adult , Age Distribution , Aged , Aged, 80 and over , Confidence Intervals , Family Characteristics , Health Surveys , Humans , Middle Aged , Portugal/epidemiology , Prevalence , Sex Distribution , Sex Factors , Telephone/statistics & numerical data , Young Adult
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