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3.
Actas Dermosifiliogr ; 2024 Feb 01.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-38307164

RESUMO

BACKGROUND: Combinations of topical (TT) and biological therapies (BT) are a common thing in the routine clinical practice. However, the scientific medical literature on how TT is, actually, used after the initiation of BT is scarce, particularly in combination with anti-IL17, or anti-IL23. OBJECTIVES: To describe the frequency of the concomitant use of TT + BT at baseline and after a 6-month course of several drugs (anti-IL17, ustekinumab, and anti-IL23). Our secondary endpoints are to describe the type of topical therapy used, compare the frequency of use of TT among the different groups of BT, describe the survival of topical therapy in these patients, and identify the factors that can impact the use or discontinuation of topical therapy in these patients (clinical response, quality of life, type of drug, etc.). MATERIALS AND METHODS: This was a retrospective, observational, and single-center study of patients with moderate-to-severe psoriasis treated with anti-IL17 (secukinumab, ixekizumab), anti-IL17R (brodalumab), ustekinumab, and guselkumab from January 2015 through December 2020. RESULTS: We included a total of 138 patients. When treatment started, 82.7% were on TT (55% daily), and after 6 months, 86.6% had discontinued TT. Regarding the analysis by type of drug, at 6 months, we found that 100% of the patients with BRO had discontinued topical treatment. We did not find any significant differences in the frequency of use of TT based on the BT used during the 6-month course of treatment. The estimated mean course of TT was 4.3 months (SD, 6.7). Also, the estimated mean course of TT was significantly shorter in the group of patients who achieved PASI100 (2.8 months vs. 8.1 months). CONCLUSIONS: In our cohort, we saw a significant decrease in the frequency of use of TT at 6 months after starting BT in the routine clinical practice. This reduction occurred earlier in patients who improved their objective clinical response and quality of life.

5.
Actas dermo-sifiliogr. (Ed. impr.) ; 115(1): 1-9, jan. 2024. ilus, tab, graf
Artigo em Inglês | IBECS | ID: ibc-229328

RESUMO

Background and objective The treatment of psoriasis should not only focus on skin affectations but also weigh the parameters for health-related quality of life (HRQoL), thereby tackling the concept of cumulative life course impairment (CLCI) and treating the patient from a holistic perspective. The CRYSTAL study aimed to characterize psoriasis with real-word data from Spanish clinical practice in patients with moderate to severe disease who received continuous systemic treatment for at least 24 weeks by using the absolute Psoriasis Area and Severity Index (PASI) score and its correlation to HRQoL. Material and methods This was a non-interventional, cross-sectional study conducted in 30 centers in Spain, with 301 patients between the ages of 18 and 75 years. The study collected data regarding current treatment and absolute PASI and their relationship to HRQoL using the Dermatology Life Quality Index (DLQI), to activity impairment using the Work Productivity and Activity Impairment (WPAI) questionnaire, and to treatment satisfaction. Results The mean (SD) age was 50.5 (12.5) years, with a duration of disease of 14 (14.1) years. The mean (SD) absolute PASI reported was 2.3 (3.5), with 28.7% of patients presenting with PASI from >1 to ≤3 and 22.6% with PASI>3. Higher PASI scores were associated with higher DLQI (p<0.001) and WPAI scores and lower levels of treatment satisfaction (p<0.001). Conclusions These data indicate that achieving lower absolute PASI values may correlate not only with better HRQoL but also with better work productivity and treatment satisfaction (AU)


Antecedentes y objetivo El tratamiento de la psoriasis debe centrarse más allá de las afectaciones cutáneas, y valorar la calidad de vida relacionada con la salud (CVRS), abordando así el concepto de discapacidad acumulada en el transcurso vital y tratando al paciente desde una perspectiva holística. El estudio CRYSTAL tuvo como objetivo caracterizar la psoriasis con datos de la práctica clínica española en pacientes con enfermedad moderada a grave que recibieron tratamiento sistémico continuado durante al menos 24 semanas mediante la puntuación absoluta del Índice de la Severidad del área de Psoriasis (PASI) (medida del estado de la enfermedad en un momento dado y no por comparación con una puntuación basal) y su correlación con la CVRS. Material y métodos Se trata de un estudio no intervencionista, transversal, realizado en 30 centros de España, con 301 pacientes de edades comprendidas entre los 18 y los 75 años. Se recogieron datos relativos al tratamiento actual y al PASI absoluto y su relación con la CVRS mediante el Índice de Calidad de Vida en Dermatología (DLQI), con el deterioro de la actividad mediante el Cuestionario para el Deterioro de la Actividad y la Productividad Laboral (WPAI) y con la satisfacción con el tratamiento. Resultados La edad media (DE) fue de 50,5 (12,5) años, con una duración de la enfermedad de 14 (14,1) años. La media (DE) del PASI absoluto notificado fue de 2,3 (3,5), con 28,7% de pacientes que presentaban un PASI de > 1 a ≤ 3 y 22,6% con un PASI > 3. Las puntuaciones más altas del PASI se asociaron a puntuaciones más altas del DLQI (p < 0,001) y del WPAI y a niveles más bajos de satisfacción con el tratamiento (p < 0,001). Conclusiones Estos datos indican que alcanzar valores absolutos más bajos de PASI puede correlacionarse no solo con una mejor CVRS, sino también con una mejor productividad laboral y satisfacción con el tratamiento (AU)


Assuntos
Humanos , Masculino , Feminino , Adolescente , Adulto Jovem , Adulto , Pessoa de Meia-Idade , Idoso , Qualidade de Vida , Psoríase/epidemiologia , Psoríase/terapia , Índice de Gravidade de Doença , Estudos Transversais , Inquéritos e Questionários , Espanha/epidemiologia
6.
Actas dermo-sifiliogr. (Ed. impr.) ; 115(1): t1-t9, jan. 2024. ilus, tab, graf
Artigo em Espanhol | IBECS | ID: ibc-229329

RESUMO

Antecedentes y objetivo El tratamiento de la psoriasis debe centrarse más allá de las afectaciones cutáneas, y valorar la calidad de vida relacionada con la salud (CVRS), abordando así el concepto de discapacidad acumulada en el transcurso vital y tratando al paciente desde una perspectiva holística. El estudio CRYSTAL tuvo como objetivo caracterizar la psoriasis con datos de la práctica clínica española en pacientes con enfermedad moderada a grave que recibieron tratamiento sistémico continuado durante al menos 24 semanas mediante la puntuación absoluta del Índice de la Severidad del área de Psoriasis (PASI) (medida del estado de la enfermedad en un momento dado y no por comparación con una puntuación basal) y su correlación con la CVRS. Material y métodos Se trata de un estudio no intervencionista, transversal, realizado en 30 centros de España, con 301 pacientes de edades comprendidas entre los 18 y los 75 años. Se recogieron datos relativos al tratamiento actual y al PASI absoluto y su relación con la CVRS mediante el Índice de Calidad de Vida en Dermatología (DLQI), con el deterioro de la actividad mediante el Cuestionario para el Deterioro de la Actividad y la Productividad Laboral (WPAI) y con la satisfacción con el tratamiento. Resultados La edad media (DE) fue de 50,5 (12,5) años, con una duración de la enfermedad de 14 (14,1) años. La media (DE) del PASI absoluto notificado fue de 2,3 (3,5), con 28,7% de pacientes que presentaban un PASI de > 1 a ≤ 3 y 22,6% con un PASI > 3. Las puntuaciones más altas del PASI se asociaron a puntuaciones más altas del DLQI (p < 0,001) y del WPAI y a niveles más bajos de satisfacción con el tratamiento (p < 0,001). Conclusiones Estos datos indican que alcanzar valores absolutos más bajos de PASI puede correlacionarse no solo con una mejor CVRS, sino también con una mejor productividad laboral y satisfacción con el tratamiento (AU)


Background and objective The treatment of psoriasis should not only focus on skin affectations but also weigh the parameters for health-related quality of life (HRQoL), thereby tackling the concept of cumulative life course impairment (CLCI) and treating the patient from a holistic perspective. The CRYSTAL study aimed to characterize psoriasis with real-word data from Spanish clinical practice in patients with moderate to severe disease who received continuous systemic treatment for at least 24 weeks by using the absolute Psoriasis Area and Severity Index (PASI) score and its correlation to HRQoL. Material and methods This was a non-interventional, cross-sectional study conducted in 30 centers in Spain, with 301 patients between the ages of 18 and 75 years. The study collected data regarding current treatment and absolute PASI and their relationship to HRQoL using the Dermatology Life Quality Index (DLQI), to activity impairment using the Work Productivity and Activity Impairment (WPAI) questionnaire, and to treatment satisfaction. Results The mean (SD) age was 50.5 (12.5) years, with a duration of disease of 14 (14.1) years. The mean (SD) absolute PASI reported was 2.3 (3.5), with 28.7% of patients presenting with PASI from >1 to ≤3 and 22.6% with PASI>3. Higher PASI scores were associated with higher DLQI (p<0.001) and WPAI scores and lower levels of treatment satisfaction (p<0.001). Conclusions These data indicate that achieving lower absolute PASI values may correlate not only with better HRQoL but also with better work productivity and treatment satisfaction (AU)


Assuntos
Humanos , Masculino , Feminino , Adolescente , Adulto Jovem , Adulto , Pessoa de Meia-Idade , Idoso , Qualidade de Vida , Psoríase/epidemiologia , Psoríase/terapia , Índice de Gravidade de Doença , Estudos Transversais , Inquéritos e Questionários , Espanha/epidemiologia
8.
Actas Dermosifiliogr ; 115(1): T1-T9, 2024 Jan.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-37923068

RESUMO

BACKGROUND AND OBJECTIVE: The treatment of psoriasis should not only focus on skin affectations but also weigh the parameters for health-related quality of life (HRQoL), thereby tackling the concept of cumulative life course impairment (CLCI) and treating the patient from a holistic perspective. The CRYSTAL study aimed to characterize psoriasis with real-word data from Spanish clinical practice in patients with moderate to severe disease who received continuous systemic treatment for at least 24 weeks by using the absolute Psoriasis Area and Severity Index (PASI) score and its correlation to HRQoL. MATERIAL AND METHODS: This was a non-interventional, cross-sectional study conducted in 30 centers in Spain, with 301 patients between the ages of 18 and 75 years. The study collected data regarding current treatment and absolute PASI and their relationship to HRQoL using the Dermatology Life Quality Index (DLQI), to activity impairment using the Work Productivity and Activity Impairment (WPAI) questionnaire, and to treatment satisfaction. RESULTS: The mean (SD) age was 50.5 (12.5) years, with a duration of disease of 14 (14.1) years. The mean (SD) absolute PASI reported was 2.3 (3.5), with 28.7% of patients presenting with PASI from >1 to ≤3 and 22.6% with PASI>3. Higher PASI scores were associated with higher DLQI (p<0.001) and WPAI scores and lower levels of treatment satisfaction (p<0.001). CONCLUSIONS: These data indicate that achieving lower absolute PASI values may correlate not only with better HRQoL but also with better work productivity and treatment satisfaction.


Assuntos
Psoríase , Qualidade de Vida , Humanos , Adolescente , Adulto Jovem , Adulto , Pessoa de Meia-Idade , Idoso , Espanha/epidemiologia , Estudos Transversais , Psoríase/complicações , Psoríase/tratamento farmacológico , Pele , Índice de Gravidade de Doença , Resultado do Tratamento
9.
Actas Dermosifiliogr ; 115(1): 1-9, 2024 Jan.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-37429433

RESUMO

BACKGROUND AND OBJECTIVE: The treatment of psoriasis should not only focus on skin affectations but also weigh the parameters for health-related quality of life (HRQoL), thereby tackling the concept of cumulative life course impairment (CLCI) and treating the patient from a holistic perspective. The CRYSTAL study aimed to characterize psoriasis with real-word data from Spanish clinical practice in patients with moderate to severe disease who received continuous systemic treatment for at least 24 weeks by using the absolute Psoriasis Area and Severity Index (PASI) score and its correlation to HRQoL. MATERIAL AND METHODS: This was a non-interventional, cross-sectional study conducted in 30 centers in Spain, with 301 patients between the ages of 18 and 75 years. The study collected data regarding current treatment and absolute PASI and their relationship to HRQoL using the Dermatology Life Quality Index (DLQI), to activity impairment using the Work Productivity and Activity Impairment (WPAI) questionnaire, and to treatment satisfaction. RESULTS: The mean (SD) age was 50.5 (12.5) years, with a duration of disease of 14 (14.1) years. The mean (SD) absolute PASI reported was 2.3 (3.5), with 28.7% of patients presenting with PASI from >1 to ≤3 and 22.6% with PASI>3. Higher PASI scores were associated with higher DLQI (p<0.001) and WPAI scores and lower levels of treatment satisfaction (p<0.001). CONCLUSIONS: These data indicate that achieving lower absolute PASI values may correlate not only with better HRQoL but also with better work productivity and treatment satisfaction.


Assuntos
Psoríase , Qualidade de Vida , Humanos , Adolescente , Adulto Jovem , Adulto , Pessoa de Meia-Idade , Idoso , Espanha/epidemiologia , Estudos Transversais , Psoríase/complicações , Psoríase/tratamento farmacológico , Pele , Índice de Gravidade de Doença , Resultado do Tratamento
10.
Artigo em Inglês | MEDLINE | ID: mdl-37567861

RESUMO

BACKGROUND: Guselkumab is a monoclonal antibody that blocks the IL-23 pathway with proven efficacy and tolerability in the treatment of moderate-to-severe plaque psoriasis. OBJECTIVES: To assess the persistence, effectiveness and safety of guselkumab in patients with moderate-to-severe psoriasis in real clinical practice in Spain. METHODS: SPRING was a Phase IV, retrospective and non-interventional study analysing patients with moderate-to-severe plaque psoriasis who had initiated guselkumab under clinical practice conditions at least 12 months before inclusion in the study. The primary endpoint was persistence (non-persistence: discontinuation or interruption ≥90 days). Effectiveness was assessed using the Psoriasis Area Severity Index (PASI) and Investigator Global Assessment (IGA). Dermatology Life Quality Index (DLQI) and safety were also evaluated. RESULTS: A total of 284 patients were included between September 2020 and June 2021. The 1-year probability of persistence was 89.6% (86.1%-93.3%). The 1-year probability of persistence was also calculated according to prior biologic treatment, being 90.3% for biologic-naïve patients and 89.5% for patients who received one or more biologic therapies before guselkumab. Additionally, patients were also classified based on the frequency of the administration of guselkumab treatment; the 1-year probability of persistence was 91.9% in patients receiving guselkumab according to the Summary of Product Characteristics and 89.3% in patients with lengthened intervals of administration. After 1 year, PASI 90 was achieved by 56.4% of patients, IGA 0/1 response and BSA <3% were achieved by 65.5% and 77.8% of patients, respectively, and 65.8% achieved a minimal clinically significant difference (>4-point reduction) in the DLQI score at 1 year. Twenty-six adverse reactions (4 of them serious) were reported in 16 patients. CONCLUSIONS: This study suggests that guselkumab has high persistence in real clinical practice in Spain, independently of the previous biologic treatments and changes in the frequency of treatment. Effectiveness and safety are consistent with previously published data.

13.
J Eur Acad Dermatol Venereol ; 36(10): 1774-1783, 2022 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-35460287

RESUMO

BACKGROUND: Limited data are available on long-term efficacy and safety of biologics in patients with psoriasis and metabolic syndrome (MetS), a common comorbidity. OBJECTIVES: This analysis updates tildrakizumab efficacy and safety for up to 5 years in patients with and without MetS. METHODS: This was a post hoc analysis of the double-blind, randomized, placebo-controlled, phase 3 reSURFACE 1 (NCT01722331) and reSURFACE 2 (NCT01729754) trials in adult patients with moderate to severe chronic plaque psoriasis. Analyses included data through Week 244 from patients who continuously received tildrakizumab 100 (TIL100) or 200 mg (TIL200) and entered the extension studies, stratified by baseline MetS status. Efficacy was assessed via Psoriasis Area and Severity Index (PASI) scores. Safety was evaluated from exposure-adjusted incidence rates (EAIRs) of treatment-emergent adverse events (TEAEs). RESULTS: reSURFACE 1 and reSURFACE 2 analyses included 26 and 44 TIL100-treated patients with MetS, 98 and 167 TIL100-treated patients without MetS, 34 and 30 TIL200-treated patients with MetS, and 111 and 130 TIL200-treated patients without MetS, respectively. There were no clinically relevant differences in PASI 75/90/100 response rates at Week 244 between patients with vs without MetS. The proportion of patients with vs without MetS achieving absolute PASI score <3 at Week 244 was 53.8% vs 69.4% and 77.3% vs 80.8% in reSURFACE 1 and 2, respectively, for TIL100-treated patients and 58.8% vs 72.1% and 63.3% vs 72.3%, respectively, for TIL200-treated patients. In both studies, median reduction from baseline PASI score at all time points in patients with vs without MetS was >83% vs >89% for TIL100 and >85% vs >90% for TIL200. Pooled EAIRs of TEAEs, serious TEAEs, and TEAEs of special interest were similar in patients with and without MetS. CONCLUSIONS: Tildrakizumab maintains efficacy and a favorable safety profile over 5 years in patients with psoriasis regardless of MetS status.


Assuntos
Anticorpos Monoclonais Humanizados , Síndrome Metabólica , Psoríase , Adulto , Anticorpos Monoclonais Humanizados/efeitos adversos , Método Duplo-Cego , Humanos , Síndrome Metabólica/complicações , Síndrome Metabólica/tratamento farmacológico , Psoríase/complicações , Psoríase/tratamento farmacológico , Resultado do Tratamento
14.
Actas Dermosifiliogr ; 113(4): 401-406, 2022 Apr.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-35428502

RESUMO

Childhood-onset psoriasis generally follows an indolent course but patients with moderate or severe disease may require systemic treatment. The aim of this study was to determine the relative proportion of children and young people aged up to 21 years with moderate to severe psoriasis in the BIOBADADERM registry and to analyze the characteristics of these patients, treatments used, and adverse events. Of the 3946 patients in the registry, 24 were aged 21 years or younger. They had mean age of 16.1 years on starting treatment. When the registry was started, they had a Psoriasis Area and Severity Index of 9.4 and 67% were being treated with a conventional systemic drug. Treatment was discontinued in 14 patients (58%) due to adverse events or a loss or lack of effectiveness. In conclusion, the BIOBADADERM registry shows that young people account for a small proportion of psoriasis patients receiving systemic treatment, and they are more likely to be treated using conventional systemic drugs.


Assuntos
Produtos Biológicos , Psoríase , Adolescente , Produtos Biológicos/uso terapêutico , Criança , Humanos , Psoríase/induzido quimicamente , Psoríase/tratamento farmacológico , Psoríase/epidemiologia , Sistema de Registros
15.
Actas dermo-sifiliogr. (Ed. impr.) ; 113(4): 401-406, Abr. 2022. ilus, graf
Artigo em Espanhol | IBECS | ID: ibc-206455

RESUMO

El comienzo de la psoriasis en la edad pediátrica, aunque generalmente leve, puede requerir tratamiento sistémico en las formas moderadas o graves de la enfermedad. El objetivo de este trabajo es analizar la frecuencia relativa, las características de los pacientes, el tratamiento empleado y los eventos adversos (EA) observados a partir del registro BIOBADADERM en niños y jóvenes con psoriasis moderada-grave. Del total de 3.946 pacientes del registro, se incluyen 24 pacientes menores de 21 años, con una edad media al inicio del tratamiento en BIOBADADERM de 16,1 años y un PASI medio de 9,4. El 67% de los pacientes estaba en tratamiento sistémico clásico al inicio del registro. Catorce pacientes (58%) suspendieron el tratamiento por pérdida o falta de eficacia o por EA. En conclusión, los datos del registro BIOBADADERM muestran que los menores representan un grupo muy pequeño dentro de los pacientes con psoriasis que reciben tratamiento sistémico y son manejados más frecuentemente con tratamientos clásicos (AU)


Childhood-onset psoriasis generally follows an indolent course but patients with moderate or severe disease may require systemic treatment. The aim of this study was to determine the relative proportion of children and young people aged up to 21 years with moderate to severe psoriasis in the BIOBADADERM registry and to analyze the characteristics of these patients, treatments used, and adverse events. Of the 3946 patients in the registry, 24 were aged 21 years or younger. They had mean age of 16.1 years on starting treatment. When the registry was started, they had a Psoriasis Area and Severity Index of 9.4 and 67% were being treated with a conventional systemic drug. Treatment was discontinued in 14 patients (58%) due to adverse events or a loss or lack of effectiveness. In conclusion, the BIOBADADERM registry shows that young people account for a small proportion of psoriasis patients receiving systemic treatment, and they are more likely to be treated using conventional systemic drugs (AU)


Assuntos
Humanos , Masculino , Feminino , Criança , Adolescente , Adulto Jovem , Psoríase/epidemiologia , Índice de Gravidade de Doença , Registros , Espanha/epidemiologia
16.
Actas dermo-sifiliogr. (Ed. impr.) ; 113(4): t401-t406, Abr. 2022.
Artigo em Inglês | IBECS | ID: ibc-206456

RESUMO

Childhood-onset psoriasis generally follows an indolent course but patients with moderate or severe disease may require systemic treatment. The aim of this study was to determine the relative proportion of children and young people aged up to 21 years with moderate to severe psoriasis in the BIOBADADERM registry and to analyze the characteristics of these patients, treatments used, and adverse events. Of the 3946 patients in the registry, 24 were aged 21 years or younger. They had mean age of 16.1 years on starting treatment. When the registry was started, they had a Psoriasis Area and Severity Index of 9.4 and 67% were being treated with a conventional systemic drug. Treatment was discontinued in 14 patients (58%) due to adverse events or a loss or lack of effectiveness. In conclusion, the BIOBADADERM registry shows that young people account for a small proportion of psoriasis patients receiving systemic treatment, and they are more likely to be treated using conventional systemic drugs (AU)


El comienzo de la psoriasis en la edad pediátrica, aunque generalmente leve, puede requerir tratamiento sistémico en las formas moderadas o graves de la enfermedad. El objetivo de este trabajo es analizar la frecuencia relativa, las características de los pacientes, el tratamiento empleado y los eventos adversos (EA) observados a partir del registro BIOBADADERM en niños y jóvenes con psoriasis moderada-grave. Del total de 3.946 pacientes del registro, se incluyen 24 pacientes menores de 21 años, con una edad media al inicio del tratamiento en BIOBADADERM de 16,1 años y un PASI medio de 9,4. El 67% de los pacientes estaba en tratamiento sistémico clásico al inicio del registro. Catorce pacientes (58%) suspendieron el tratamiento por pérdida o falta de eficacia o por EA. En conclusión, los datos del registro BIOBADADERM muestran que los menores representan un grupo muy pequeño dentro de los pacientes con psoriasis que reciben tratamiento sistémico y son manejados más frecuentemente con tratamientos clásicos (AU)


Assuntos
Humanos , Masculino , Feminino , Criança , Adolescente , Adulto Jovem , Psoríase/epidemiologia , Índice de Gravidade de Doença , Registros , Espanha/epidemiologia
17.
Mol Diagn Ther ; 25(2): 137-161, 2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-33646564

RESUMO

Epigenetics is the study of the mechanisms that regulate gene expression without modifying DNA sequences. Knowledge of and evidence about how epigenetics plays a causative role in the pathogenesis of many skin diseases is increasing. Since the epigenetic changes present in tumor diseases have been thoroughly reviewed, we believe that knowledge of the new epigenetic findings in non-tumor immune-mediated dermatological diseases should be of interest to the general dermatologist. Hence, the purpose of this review is to summarize the recent literature on epigenetics in most non-tumor dermatological pathologies, focusing on psoriasis. Hyper- and hypomethylation of DNA methyltransferases and methyl-DNA binding domain proteins are the most common and studied methylation mechanisms. The acetylation and methylation of histones H3 and H4 are the most frequent and well-characterized histone modifications and may be associated with disease severity parameters and serve as therapeutic response markers. Many specific microRNAs dysregulated in non-tumor dermatological disease have been reviewed. Deepening the study of how epigenetic mechanisms influence non-tumor immune-mediated dermatological diseases might help us better understand the role of interactions between the environment and the genome in the physiopathogenesis of these diseases.


Assuntos
Epigênese Genética , Epigenômica , Predisposição Genética para Doença , Dermatopatias/genética , Metilação de DNA/genética , Regulação da Expressão Gênica/imunologia , Histonas/genética , Humanos , MicroRNAs/genética , Psoríase/genética , Psoríase/imunologia , Psoríase/patologia , Dermatopatias/imunologia , Dermatopatias/patologia
18.
J Eur Acad Dermatol Venereol ; 35(2): 431-440, 2021 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-32426889

RESUMO

INTRODUCTION: Psoriatic disease is associated with considerable impairment of quality of life (QoL). The PROSE study (NCT02752776) investigated the impact of secukinumab treatment on patient-reported outcomes (PRO) in patients with moderate to severe psoriasis stratified by their treatment history. METHODS: PROSE was a prospective, non-randomised, multicentre study. Patients were categorized at baseline according to treatment history as naïve [naïve to any systemic therapy (N = 663)], conventional systemic [previously exposed to ≥1 conventional systemic (CS) therapy (N = 673)] and biologics [previously exposed to ≥1 biologic therapy (N = 324)]. QoL PROs, efficacy and safety of secukinumab 300 mg were assessed for a period of 52 weeks. RESULTS: The primary objective was met with 70.8% patients achieving a Dermatology Life Quality Index (DLQI) 0/1 response at Week 16 (naϊve, 74.7%; CS, 71.3%; biologic, 61.7%), with effects sustained up to Week 52. Mean Family DLQI (FDLQI) score decreased from 11.5 at baseline (naϊve, 11.3; CS, 11.4; biologic, 12.1) to 2.5 at Week 16 (naϊve, 2.5; CS, 2.3; biologic: 3.5). Substantial improvements in EuroQoL 5-Dimension Health Questionnaire, Numeric Rating Scale for pain, itching and scaling, Health Assessment Questionnaire-Disability Index, Treatment Satisfaction Questionnaire for Medication, and Patient Benefit Index were also observed at Week 16. The QoL gains were associated with substantial improvements in Psoriasis Area and Severity Index and Investigator Global Assessment mod 2011 0/1 response. No meaningful difference was observed in the efficacy or QoL improvements across patient subpopulations. All QoL and efficacy parameter improvements were sustained up to Week 52. Secukinumab treatment was well-tolerated, and no new safety signals were observed. CONCLUSION: Secukinumab treatment resulted in complete normalization of QoL in a substantial proportion of psoriasis patients, and their families, regardless of their prior treatment history.


Assuntos
Psoríase , Qualidade de Vida , Anticorpos Monoclonais/uso terapêutico , Anticorpos Monoclonais Humanizados , Método Duplo-Cego , Humanos , Estudos Prospectivos , Psoríase/tratamento farmacológico , Índice de Gravidade de Doença , Resultado do Tratamento
20.
Actas dermo-sifiliogr. (Ed. impr.) ; 111(9): 752-760, nov. 2020. tab, graf
Artigo em Espanhol | IBECS | ID: ibc-201004

RESUMO

ANTECEDENTES Y OBJETIVOS: Las guías sobre el tratamiento de la psoriasis habitualmente no incluyen las recomendaciones acerca de cuál debe ser la primera línea de tratamiento sistémico o biológico. Los objetivos de este estudio fueron describir las tendencias en la prescripción del primer fármaco biológico y comparar la retirada de los fármacos y las tasas de efectos adversos a lo largo de los 10 años de seguimiento. MATERIAL Y MÉTODOS: Se utilizó el registro Biobadaderm para determinar cuál fue el primer fármaco biológico indicado en pacientes con psoriasis naïve para biológicos, así como cuál es la tasa de efectos adversos y los motivos de suspensión de los fármacos. Los resultados obtenidos se compararon en tres periodos distintos de tiempo (2008-2010, 2011-2014, 2015-2018). RESULTADOS: Los fármacos anti-TNF fueron los biológicos prescritos con mayor frecuencia entre los años 2008 y 2010. Ustekinumab se convirtió en el tratamiento biológico más indicado a partir de 2014. El motivo principal de suspensión de los tratamientos fueron los efectos adversos, la falta de eficacia y la remisión de la enfermedad. La probabilidad de suspender los fármacos por uno de estos motivos fue cada vez menor si se compara con el periodo de tiempo previo. CONCLUSIONES: El presente estudio identifica cuáles fueron las tendencias en la prescripción del primer fármaco biológico en la práctica clínica habitual entre los años 2008 y 2018. Sugiere que los dermatólogos estamos cada vez más seguros en cuanto al perfil de seguridad y somos cada vez más exigentes en cuanto a la eficacia de los fármacos


BACKGROUND AND OBJECTIVES: Current psoriasis guidelines do not usually include recommendations about first line classical or biologic treatment. The objectives of this study were: to describe shifts in the prescription of the first biological treatment, and to compare treatment withdrawal and rates of adverse events over ten years. MATERIAL AND METHODS: Biobadaderm registry was analyzed to describe: first biological prescription in bio-naïve patients, adverse events rate and reasons for drug withdrawal comparing three periods of time (2008-2010, 2011-2014, 2015-2018). RESULTS: Anti-TNF drugs were the most prescribed biological drug from 2008 to 2010. Ustekinumab has become the most prescribed first biologic since 2014. The main reasons for drug discontinuation were adverse events, lack of efficacy and remission. In each period any treatment was less likely to be discontinued due to any of these three reasons comparing to the previous period. CONCLUSIONS: The present study identifies trends in prescription of the first biological antipsoriatic drug in clinical practice from 2008 to 2018. It suggests that we have become more comfortable with the safety profile and more exigent with the efficacy of the drugs


Assuntos
Humanos , Feminino , Adulto , Pessoa de Meia-Idade , Terapia Biológica/métodos , Psoríase/terapia , Produtos Biológicos/efeitos adversos , Estudos de Coortes , Imunossupressores/efeitos adversos , Produtos Biológicos/uso terapêutico , Suspensão de Tratamento , Estudos Prospectivos , Psoríase/diagnóstico , Estatísticas não Paramétricas , Intervalos de Confiança , Anticorpos Monoclonais/efeitos adversos , Interleucina-17/antagonistas & inibidores
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