Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 33
Filtrar
Mais filtros

Base de dados
Tipo de documento
Intervalo de ano de publicação
1.
Scand J Rheumatol ; 52(3): 259-267, 2023 05.
Artigo em Inglês | MEDLINE | ID: mdl-35302402

RESUMO

OBJECTIVES: To examine the prevalence of sleep disturbances, quantified by the Pittsburgh Sleep Quality Index (PSQI), in patients with psoriatic arthritis (PsA), psoriasis (PsO) and healthy controls (HCs), explore associations between PSQI and clinical and patient-reported outcomes, and evaluate the effect of treatment on PSQI. METHOD: Patients were included from the Parker Institute's PsA patient cohort to evaluate the prevalence of sleep disturbances. Univariate and multivariate regression analyses were used to explore associations between sleep disturbance and outcome measures. Treatment effect in PsA patients was assessed with a mixed-effect model for repeated measures. RESULTS: In total, 109 PsA patients, 20 PsO patients, and 20 HCs were included. Sleep disturbances were reported by 66.1% of PsA patients, 45.0% of PsO patients, and 15.0% of HCs. Univariate regression analyses revealed statistically significant associations (p < 0.001) between PSQI and Disease Activity Score (DAS28CRP), tender points, visual analogue scale (VAS) patient global and pain, Psoriatic Arthritis Impact of Disease fatigue, Health Assessment Questionnaire (HAQ), and painDETECT score. Multivariate regression analysis demonstrated VAS patient global, VAS pain, and tender points as being independently associated with PSQI. The mixed-effect model revealed no effect of treatment. CONCLUSION: More PsA patients than PsO patients and HCs reported sleep disturbances. Sleep disturbances were associated with inflammatory and non-inflammatory measures possibly explaining the limited effect of treatment. This demonstrates the need for interdisciplinary approaches to improve the management of sleep disturbance in PsA.Trial registration: ClinicalTrials.gov (NCT02572700).


Assuntos
Artrite Psoriásica , Psoríase , Humanos , Artrite Psoriásica/complicações , Artrite Psoriásica/epidemiologia , Artrite Psoriásica/diagnóstico , Dor , Prevalência , Psoríase/complicações , Psoríase/epidemiologia , Sono
2.
J Eur Acad Dermatol Venereol ; 36(6): 797-806, 2022 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-35238067

RESUMO

Psoriasis is a chronic systemic inflammatory disorder associated with several comorbidities in addition to the characteristic skin lesions. Metabolic syndrome (MetS) is the most frequent comorbidity in psoriasis and a risk factor for cardiovascular disease, a major cause of death among patients with psoriasis. Although the exact causal relationship between these two disorders is not fully established, the underlying pathophysiology linking psoriasis and MetS seems to involve overlapping genetic predispositions and inflammatory pathways. Dysregulation of the IL-23/Th-17 immune signalling pathway is central to both pathologies and may be key to promoting susceptibility to metabolic and cardiovascular diseases in individuals with and without psoriasis. Thus, biological treatments for psoriasis that interrupt these signals could both reduce the psoriatic inflammatory burden and also lessen the risk of developing atherosclerosis and cardiometabolic diseases. In support of this hypothesis, improvement of skin lesions was associated with improvement in vascular inflammation in recent imaging studies, demonstrating that the beneficial effect of biological agents goes beyond the skin and could help to prevent cardiovascular disease. This review will summarize current knowledge on underlying inflammatory mechanisms shared between psoriasis and MetS and discuss the most recent clinical evidence for the potential for psoriasis treatment to reduce cardiovascular risk.


Assuntos
Doenças Cardiovasculares , Síndrome Metabólica , Psoríase , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/etiologia , Comorbidade , Humanos , Síndrome Metabólica/complicações , Síndrome Metabólica/epidemiologia , Psoríase/complicações , Psoríase/tratamento farmacológico , Psoríase/epidemiologia , Fatores de Risco
3.
J Eur Acad Dermatol Venereol ; 36(12): 2291-2300, 2022 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-35924437

RESUMO

Psoriasis studies increasingly employ outcomes that indicate complete disease resolution, yet remission and cure are poorly defined for psoriasis. We conducted a systematic literature review to identify definitions of psoriasis remission and cure reported in the literature. Medline, EMBASE, and The Cochrane Central Register of Controlled Trials databases were searched on July 22, 2020, for full-text studies providing definitions for psoriasis remission/cure. Definitions were analysed descriptively for endpoint, time-frame, on/off treatment, patient-reported outcomes, and disease domains. We identified 106 studies that provided 41 unique remission definitions. Most definitions included endpoints based on Psoriasis Area and Severity Index (PASI), such as PASI75 (n = 16 studies), PASI90 (n = 10), PASI100 (n = 10), and PASI of 0 (n = 3), and descriptive endpoints related to 'skin clearance' (n = 18). Few definitions specified time-frame, on/off treatment or other psoriasis-related disease domains. One small consensus-initiative defined drug-free remission for plaque psoriasis by BSA of 0 without any therapy for at least 12 months. While there is no cure for psoriasis, seven studies defined psoriasis cure using similar endpoints to those used to define remission. We identified a variety of definitions of psoriasis remission. These results will inform the development of consensus-based definitions for psoriasis remission to support efforts to improve research and clinical outcomes.


Assuntos
Psoríase , Humanos , Psoríase/tratamento farmacológico , Resultado do Tratamento , Índice de Gravidade de Doença
4.
Br J Dermatol ; 185(6): 1124-1134, 2021 12.
Artigo em Inglês | MEDLINE | ID: mdl-33913511

RESUMO

BACKGROUND: Secukinumab [an interleukin (IL)-17A inhibitor] has demonstrated significantly higher efficacy vs. etanercept (a tumour necrosis factor inhibitor) and ustekinumab (an IL-12/23 inhibitor) in patients with moderate-to-severe plaque psoriasis. OBJECTIVES: To report 52-week results from a prespecified analysis of patients with active psoriatic arthritis (PsA) having concomitant moderate-to-severe plaque psoriasis from the head-to-head EXCEED monotherapy study comparing secukinumab with adalimumab. METHODS: Patients were randomized to receive secukinumab 300 mg via subcutaneous injection at baseline, week 1-4, and then every 4 weeks until week 48 or adalimumab 40 mg via subcutaneous injection every 2 weeks from baseline until week 50. Assessments in patients with concomitant moderate-to-severe psoriasis, defined as having affected body surface area > 10% or Psoriasis Area and Severity Index (PASI) ≥ 10 at baseline, included musculoskeletal, skin and quality-of-life outcomes. Missing data were handled using multiple imputation. RESULTS: Of the 853 patients [secukinumab (N = 426), adalimumab (N = 427)], 211 (24·7%) had concomitant moderate-to-severe psoriasis [secukinumab (N = 110, 25·8%), adalimumab (N = 101, 23·7%)]. Up to week 50, 5·5% of patients discontinued secukinumab vs.17·8% in the adalimumab group. The proportion of patients who achieved American College of Rheumatology (ACR) 20 response was 76·4% with secukinumab vs. 68·3% with adalimumab (P = 0·175), PASI 100 response was 39·1% vs. 23·8% (P = 0·013), and simultaneous improvement in ACR 50 and PASI 100 response at week 52 was 28·2% vs. 17·7%, respectively (P = 0·06). Secukinumab demonstrated consistently higher responses vs. adalimumab across skin endpoints. CONCLUSIONS: This prespecified analysis in PsA patients with concomitant moderate-to-severe plaque psoriasis in the EXCEED study provides further evidence that IL-17 inhibitors offer a comprehensive biological treatment to manage the concomitant features of psoriasis and PsA.


Assuntos
Artrite Psoriásica , Psoríase , Adalimumab , Anticorpos Monoclonais Humanizados , Artrite Psoriásica/tratamento farmacológico , Método Duplo-Cego , Humanos , Psoríase/tratamento farmacológico , Índice de Gravidade de Doença , Resultado do Tratamento
5.
J Eur Acad Dermatol Venereol ; 35(1): 195-202, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-32531094

RESUMO

BACKGROUND: Hidradenitis suppurativa (HS) has been associated with auto-inflammatory conditions, yet the risk of developing connective tissue disease (CTD), morphoea and systemic vasculitis has not been well-characterized. OBJECTIVES: We sought to evaluate the risk of developing CTD, morphoea and systemic vasculitis in patients with HS. METHODS: Using claims data, we identified patients with HS and used 2 : 1 risk-set sampling to identify patients without HS. Patients with existing CTD were excluded. Patient follow-up lasted until first occurrence of the following events: the occurrence of outcome (i.e. systemic lupus erythematosus, morphoea, systemic sclerosis, Sjogren's Syndrome and systemic vasculitis), death, disenrolment or end of data stream. Hazard ratios (HR) of developing CTD, morphoea and systemic vasculitis were computed after 1 : 1 propensity score (PS) matching. RESULTS: After 2 : 1 risk-set sampling, we identified 78 122 HS patients and 156 247 non-HS comparators. The mean follow-up was 540 days. After PS matching, HS patients had an increased risk of systemic lupus erythematosus HR = 1.63 (1.31-2.03) and morphoea HR = 2.02 (1.32-3.11), compared to non-HS patients. We did not observe an increased risk for systemic sclerosis HR = 0.90 (0.59-1.44), Sjogren's Syndrome HR = 0.91 (0.73-1.14) or systemic vasculitis HR = 0.87 (0.64-1.20). CONCLUSION: In this population-based study, we observed an increased risk of developing systemic lupus erythematous and morphoea subsequent to a first-recorded diagnosis of hidradenitis suppurativa.


Assuntos
Doenças do Tecido Conjuntivo , Hidradenite Supurativa , Esclerodermia Localizada , Síndrome de Sjogren , Vasculite Sistêmica , Doenças do Tecido Conjuntivo/complicações , Doenças do Tecido Conjuntivo/epidemiologia , Hidradenite Supurativa/complicações , Hidradenite Supurativa/epidemiologia , Humanos
6.
Br J Dermatol ; 182(2): 410-417, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-31049930

RESUMO

BACKGROUND: The European League Against Rheumatism/American College of Rheumatology classification criteria for inflammatory myopathies are able to classify patients with skin-predominant dermatomyositis (DM). However, approximately 25% of patients with skin-predominant DM do not meet two of the three hallmark skin signs and fail to meet the criteria. OBJECTIVES: To develop a set of skin-focused classification criteria that will distinguish cutaneous DM from mimickers and allow a more inclusive definition of skin-predominant disease. METHODS: An extensive literature review was done to generate items for the Delphi process. Items were grouped into categories of distribution, morphology, symptoms, antibodies, histology and contextual factors. Using REDCap™, participants rated these items in terms of appropriateness and distinguishing ability from mimickers. The relevance score ranged from 1 to 100, and the median score determined a rank-ordered list. A prespecified median score cut-off was decided by the steering committee and the participants. There was a pre-Delphi and two rounds of actual Delphi. RESULTS: There were 50 participating dermatologists and rheumatologists from North America, South America, Europe and Asia. After a cut-off score of 70 during the first round, 37 of the initial 54 items were retained and carried over to the next round. The cut-off was raised to 80 during round two and a list of 25 items was generated. CONCLUSIONS: This project is a key step in the development of prospectively validated classification criteria that will create a more inclusive population of patients with DM for clinical research. What's already known about this topic? Proper classification of patients with skin-predominant dermatomyositis (DM) is indispensable in the appropriate conduct of clinical/translational research in the field. The only validated European League Against Rheumatism/American College of Rheumatology criteria for idiopathic inflammatory myopathies are able to classify skin-predominant DM. However, a quarter of amyopathic patients still fail the criteria and does not meet the disease classification. What does this study add? A list of 25 potential criteria divided into categories of distribution, morphology, symptomatology, pathology and contextual factors has been generated after several rounds of consensus exercise among experts in the field of DM. This Delphi project is a prerequisite to the development of a validated classification criteria set for skin-predominant DM.


Assuntos
Dermatomiosite , Reumatologia , Ásia , Técnica Delphi , Dermatomiosite/diagnóstico , Europa (Continente) , Humanos , América do Norte
7.
Clin Exp Dermatol ; 45(1): 89-91, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31120600

RESUMO

Determining the risk of progression to systemic lupus erythematosus (SLE) among patients diagnosed with discoid lupus erythematosus (DLE), and the time frame of this risk, are important clinical questions. Past reports have demonstrated a wide time frame of progression from DLE to SLE, with mean time to progression of approximately 8 years. Using data obtained from an academic lupus centre, we identified 32 patients who progressed from DLE to SLE. In our cohort, we found that the median time to progression from DLE to SLE was 453 days, much sooner than previously reported. We believe this information can help inform clinicians on monitoring visit intervals and how best to counsel patients on SLE progression.


Assuntos
Progressão da Doença , Lúpus Eritematoso Discoide , Lúpus Eritematoso Sistêmico , Adolescente , Adulto , Feminino , Humanos , Lúpus Eritematoso Discoide/tratamento farmacológico , Lúpus Eritematoso Discoide/fisiopatologia , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Tempo
8.
J Eur Acad Dermatol Venereol ; 34(6): 1257-1262, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31919919

RESUMO

BACKGROUND: Epithelial surface disruption in genital psoriatic lesions may manifest as erosions, fissures and/or ulcers, causing pain and significantly impacting a patient's sexual health. OBJECTIVE: To evaluate the impact of erosions, fissures and/or ulcers in genital psoriatic lesions on pain and sexual activity in patients with moderate-to-severe genital psoriasis (GenPs) and treatment responses to ixekizumab vs. placebo until Week 12. METHODS: This post hoc subgroup analysis of patients presenting with and without erosions, fissures and/or ulcers in genital lesions from a phase IIIb multicentre, randomized, double-blind, placebo-controlled study (IXORA-Q; NCT02718898) in 149 adults with moderate-to-severe GenPs treated with subcutaneous ixekizumab (80 mg every 2 weeks; n = 75) or placebo (n = 74) evaluated outcomes for clinician-rated GenPs severity (static Physician's Global Assessment of Genitalia; sPGA-G) and patient-reported genital pain and itch (Genital Psoriasis Symptoms Scale; GPSS) and sexual health (Genital Psoriasis Sexual Frequency Questionnaire; GenPs-SFQ). RESULTS: At baseline, 38% (n = 57) of patients presented with genital erosions, fissures and/or ulcers independent of overall body surface area involvement (<10% or ≥10%). These signs were associated with higher scores for disease severity (sPGA-G) and pain (GPSS) but not sexual health (GenPs-SFQ). Complete resolution of these signs was observed in 62% of ixekizumab-treated patients (25% for placebo) at Week 1 and 83% (21% for placebo) at Week 12. Patients treated with ixekizumab reported significant improvements in pain, itch, disease severity and sexual health over 12 weeks compared to placebo and irrespective of the presence/absence of genital erosions, fissures and/or ulcers at baseline. CONCLUSION: Ixekizumab led to rapid and sustained resolution of erosions, fissures and/or ulcers and significant improvements in GenPs severity, genital pain and sexual health. Ixekizumab may help to improve the well-being of patients with GenPs.


Assuntos
Fármacos Dermatológicos , Psoríase , Saúde Sexual , Adulto , Anticorpos Monoclonais Humanizados , Fármacos Dermatológicos/uso terapêutico , Método Duplo-Cego , Genitália , Humanos , Dor/tratamento farmacológico , Psoríase/complicações , Psoríase/tratamento farmacológico , Índice de Gravidade de Doença , Resultado do Tratamento
9.
J Eur Acad Dermatol Venereol ; 34(12): 2809-2820, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-32271970

RESUMO

BACKGROUND: Psoriatic arthritis (PsA) is a chronic, systemic immune-mediated inflammatory musculoskeletal disease. The onset of dermatologic symptoms often precedes rheumatic manifestations. Tofacitinib is an oral Janus kinase inhibitor for the treatment of PsA that has been shown to improve dermatologic symptoms in patients with PsA. OBJECTIVES: To investigate the efficacy of tofacitinib in improving dermatologic endpoints in adult patients with active PsA. METHODS: This analysis included data from two placebo-controlled, double-blind, phase 3 studies in patients with active PsA and an inadequate response (IR) to ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD) who were tumor necrosis factor inhibitor (TNFi)-naïve (OPAL Broaden; NCT01877668) or an IR to ≥1 TNFi (OPAL Beyond; NCT01882439). Patients had active plaque psoriasis at screening and received a stable dose of one csDMARD during the study. Patients were randomized to tofacitinib 5 mg twice daily (BID), 10 mg BID, adalimumab 40 mg subcutaneous injection once every 2 weeks (OPAL Broaden only) or placebo (to Month 3). Dermatologic endpoints: Psoriasis Area and Severity Index (PASI) total score; PASI90 overall; PASI75 and PASI90 by baseline PASI severity; Physician's Global Assessment of Psoriasis; Nail Psoriasis Severity Index; Dermatology Life Quality Index total and sub-dimension scores; Itch Severity Item; and Patient's Global Joint and Skin Assessment-Visual Analog Scale-Psoriasis question. RESULTS: In patients with active PsA, including those stratified by mild or moderate/severe dermatologic symptoms, greater improvements from baseline and percentage of responders were observed in tofacitinib-treated patients vs. placebo for the majority of analyzed dermatologic endpoints at Months 1 and 3, and improvements were maintained to Month 12 in OPAL Broaden and Month 6 in OPAL Beyond. Similar effects were observed in adalimumab-treated patients vs. placebo in OPAL Broaden across dermatologic endpoints. CONCLUSIONS: Tofacitinib provides a treatment option for patients with active PsA, including the burdensome dermatologic symptoms of PsA.


Assuntos
Artrite Psoriásica , Psoríase , Adulto , Artrite Psoriásica/tratamento farmacológico , Método Duplo-Cego , Humanos , Piperidinas , Psoríase/tratamento farmacológico , Pirimidinas/uso terapêutico , Pirróis/uso terapêutico , Qualidade de Vida , Resultado do Tratamento
10.
J Eur Acad Dermatol Venereol ; 34(9): 2051-2058, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32027420

RESUMO

INTRODUCTION: The National Psoriasis Foundation (NPF) published treat-to-target guidelines for psoriasis, yet their applicability in clinical practice remains unknown. OBJECTIVES: To estimate the proportion of psoriasis patients meeting the NPF's body surface area (BSA) 'target' (≤1%) and 'acceptable' (≤3%) response criteria and the cross-sectional associations of these criteria with patient-reported outcomes (PROs) in the Corrona Psoriasis Registry. METHODS: Separately for three independent cross-sectional cohorts of patients at the (i) enrolment, (ii) 6-month and (iii) 12-month visits, we calculated the proportion of patients with BSA ≤1% and ≤3%. Furthermore, we calculated odds ratios estimating the risk of PROs associated with not meeting criteria in the 6-month cohort. RESULTS: The enrolment, 6- and 12-month cohorts included 2794, 1310 and 629 patients, respectively. At enrolment, 24% of patients had a BSA ≤ 1% and 41% a BSA ≤ 3%. In the 6-month cohort, 43%/64% had a BSA ≤ 1%/BSA ≤ 3%. In the 12-month cohort, 46%/69% of patients had a BSA ≤ 1%/BSA ≤ 3%. Patients not at target/acceptable criteria had higher odds for worse quality of life compared with those who were. CONCLUSION: While most patients at 6- and 12-month visits were at the 'acceptable' response, less than half were at the 'target' response despite systemic therapy. There remain unmet needs to optimize psoriasis therapy and further validate current treat-to-target guidelines.


Assuntos
Psoríase , Qualidade de Vida , Estudos Transversais , Humanos , Medidas de Resultados Relatados pelo Paciente , Prevalência , Psoríase/tratamento farmacológico , Psoríase/epidemiologia , Sistema de Registros , Índice de Gravidade de Doença
12.
Br J Dermatol ; 178(6): 1412-1415, 2018 06.
Artigo em Inglês | MEDLINE | ID: mdl-28667747

RESUMO

Dystrophic calcinosis cutis is a debilitating condition of calcium salt deposition in the skin often occurring in association with connective tissue disease (CTD). Available treatments for calcinosis cutis are unsatisfactory, but given the recent use of topical and intralesional sodium thiosulfate (STS) to treat calcifying disorders, we sought to describe the use of intravenous (IV) STS for CTD-associated dystrophic calcinosis cutis. We report three patients with long-standing and extensive CTD-associated calcinosis cutis treated with IV STS after having failed multiple prior therapies. All three patients experienced fatigue and nausea with STS infusions, and none of the patients had notable clinical or symptomatic improvement of calcinosis. It remains to be seen whether the administration of IV STS earlier in the onset of calcinosis might be of benefit given that these patients all had long-standing and refractory CTD-associated calcinosis. Given the small number of patients in this series, further investigation into the use of IV STS in calcinosis cutis is warranted.


Assuntos
Calcinose/tratamento farmacológico , Doenças do Tecido Conjuntivo/complicações , Fármacos Dermatológicos/administração & dosagem , Dermatopatias/tratamento farmacológico , Tiossulfatos/administração & dosagem , Antioxidantes/administração & dosagem , Quelantes/administração & dosagem , Feminino , Humanos , Infusões Intravenosas , Pessoa de Meia-Idade , Resultado do Tratamento
13.
Br J Dermatol ; 179(3): 642-650, 2018 09.
Artigo em Inglês | MEDLINE | ID: mdl-29654696

RESUMO

BACKGROUND: There is no consensus on core outcome domains for hidradenitis suppurativa (HS). Heterogeneous outcome measure instruments in clinical trials likely leads to outcome-reporting bias and limits the ability to synthesize evidence. OBJECTIVES: To achieve global multistakeholder consensus on a core outcome set (COS) of domains regarding what to measure in clinical trials for HS. METHODS: Six stakeholder groups participated in a Delphi process that included five anonymous e-Delphi rounds and four face-to-face consensus meetings to reach consensus on the final COS. The aim was for a 1 : 1 ratio of patients to healthcare professionals (HCPs). RESULTS: A total of 41 patients and 52 HCPs from 19 countries in four continents participated in the consensus process, which yielded a final COS that included five domains: pain, physical signs, HS-specific quality of life, global assessment and progression of course. A sixth domain, symptoms, was highly supported by patients and not by HCPs but is recommended for the core domain set. CONCLUSIONS: Routine adoption of the COS in future HS trials should ensure that core outcomes of importance to both patients and HCPs are collected.


Assuntos
Ensaios Clínicos como Assunto/normas , Técnica Delphi , Hidradenite Supurativa/terapia , Medidas de Resultados Relatados pelo Paciente , Consenso , Progressão da Doença , Hidradenite Supurativa/complicações , Humanos , Cooperação Internacional , Pesquisa Qualitativa , Qualidade de Vida , Resultado do Tratamento
14.
Br J Dermatol ; 179(4): 844-852, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-29747232

RESUMO

BACKGROUND: Genital psoriasis (GenPs) is a common, debilitating and difficult-to-treat manifestation of plaque psoriasis. However, few controlled, interventional studies of GenPs exist. OBJECTIVES: To determine the efficacy of ixekizumab vs. placebo in patients with moderate-to-severe GenPs with ≥ 1% involved body surface area (BSA). METHODS: Patients with moderate-to-severe GenPs, defined as a baseline static Physician's Global Assessment of Genitalia (sPGA-G) score of ≥ 3, with BSA ≥ 1% were randomized 1 : 1 to receive placebo (n = 74) or the recommended dosing of ixekizumab (n = 75). Major outcomes included the percentage of patients achieving 0 or 1 scores on the sPGA-G (primary end point), overall sPGA, GenPs Sexual Frequency Questionnaire (GenPs-SFQ) item 2, and ≥ 3-point improvement from baseline on the GenPs itch numerical rating scale. RESULTS: At week 12, ixekizumab was superior to placebo for sPGA-G 0/1 (73% vs. 8%, P < 0·001), overall sPGA 0/1 (73% vs. 3%, P < 0·001), GenPs-SFQ item 2 score of 0 or 1 (78% vs. 21%, P < 0·001) and genital itch (60% vs. 8%, P < 0·001). No candidiasis was reported, no deaths occurred and one (1%) serious adverse event was reported in a patient receiving placebo. CONCLUSIONS: Ixekizumab was superior to placebo for the treatment of moderate-to-severe GenPs with BSA ≥ 1%. The safety profile of ixekizumab was consistent with previous studies in moderate-to-severe plaque psoriasis.


Assuntos
Anticorpos Monoclonais Humanizados/administração & dosagem , Fármacos Dermatológicos/administração & dosagem , Prurido/tratamento farmacológico , Psoríase/tratamento farmacológico , Adulto , Anticorpos Monoclonais Humanizados/efeitos adversos , Fármacos Dermatológicos/efeitos adversos , Relação Dose-Resposta a Droga , Método Duplo-Cego , Esquema de Medicação , Feminino , Genitália , Humanos , Injeções Subcutâneas , Masculino , Pessoa de Meia-Idade , Placebos/administração & dosagem , Placebos/efeitos adversos , Prurido/diagnóstico , Prurido/etiologia , Psoríase/complicações , Psoríase/diagnóstico , Psoríase/psicologia , Qualidade de Vida , Índice de Gravidade de Doença , Saúde Sexual , Resultado do Tratamento
15.
Br J Dermatol ; 178(3): 715-721, 2018 03.
Artigo em Inglês | MEDLINE | ID: mdl-29080368

RESUMO

BACKGROUND: A core outcomes set (COS) is an agreed minimum set of outcomes that should be measured and reported in all clinical trials for a specific condition. Hidradenitis suppurativa (HS) has no agreed-upon COS. A central aspect in the COS development process is to identify a set of candidate outcome domains from a long list of items. Our long list had been developed from patient interviews, a systematic review of the literature and a healthcare professional survey, and initial votes had been cast in two e-Delphi surveys. In this manuscript, we describe two in-person consensus meetings of Delphi participants designed to ensure an inclusive approach to generation of domains from related items. OBJECTIVES: To consider which items from a long list of candidate items to exclude and which to cluster into outcome domains. METHODS: The study used an international and multistakeholder approach, involving patients, dermatologists, surgeons, the pharmaceutical industry and medical regulators. The study format was a combination of formal presentations, small group work based on nominal group theory and a subsequent online confirmation survey. RESULTS: Forty-one individuals from 13 countries and four continents participated. Nine items were excluded and there was consensus to propose seven domains: disease course, physical signs, HS-specific quality of life, satisfaction, symptoms, pain and global assessments. CONCLUSIONS: The HISTORIC consensus meetings I and II will be followed by further e-Delphi rounds to finalize the core domain set, building on the work of the in-person consensus meetings.


Assuntos
Hidradenite Supurativa/terapia , Ensaios Clínicos como Assunto , Consenso , Conferências de Consenso como Assunto , Técnica Delphi , Saúde Global , Humanos , Resultado do Tratamento
18.
J Eur Acad Dermatol Venereol ; 31(10): 1686-1692, 2017 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-28322474

RESUMO

BACKGROUND: Palmoplantar psoriasis has significant physical and emotional impact on patients and can be difficult to treat. OBJECTIVE: To evaluate the efficacy of ixekizumab in the treatment of patients with moderate-to-severe plaque psoriasis and moderate-to-severe non-pustular palmoplantar involvement. METHODS: In three phase 3, double-blind, placebo-controlled trials, patients with moderate-to-severe non-pustular plaque psoriasis [UNCOVER-1 (N = 1296), UNCOVER-2 (N = 1224), UNCOVER-3 (N = 1346)] were randomized to subcutaneous 80 mg ixekizumab every 2 or 4 weeks (Q2W, Q4W), after a 160-mg starting dose, or placebo through week 12. Additional UNCOVER-2 and UNCOVER-3 cohorts were randomized to 50 mg etanercept biweekly. Patients entering the open-label long-term extension (UNCOVER-3) received ixekizumab Q4W weeks 12-60. Moderate-to-severe palmoplantar involvement was defined as Palmoplantar Psoriasis Area and Severity Index (PPASI) ≥8. RESULTS: Twenty-eight percent of UNCOVER-1, UNCOVER-2 and UNCOVER-3 patients had baseline palmoplantar involvement (PPASI ≥0, n = 1092) and 9.1% (n = 350) had moderate-to-severe involvement, with mean baseline PPASI ~20, PASI ~24, and most (>60%) had static Physician's Global Assessment ≥4. Higher percentages of patients treated with ixekizumab vs. placebo or etanercept achieved PPASI 50 (approximately 80% vs. 32.9%, 67.8%; ixekizumab, placebo, etanercept, respectively) and PPASI 75 (approximately 70% vs. 18.8%, 44.1%; ixekizumab, placebo, etanercept, respectively) at week 12 (all P < 0.05). PPASI 100 was achieved by higher percentages of ixekizumab-treated patients vs. placebo (approximately 50% vs. 8.2%, P < 0.001) and ixekizumab Q2W-treated patients vs. etanercept (51.8% vs. 32.2%, P < 0.05). Outcomes were maintained or improved in patients continuing on ixekizumab Q4W through week 60. Differences between ixekizumab and placebo or etanercept were statistically significant as early as week 1. CONCLUSION: In a subpopulation analysis of patients from phase 3 trials with moderate-to-severe non-pustular palmoplantar involvement and moderate-to-severe plaque psoriasis, ixekizumab treatment resulted in greater and more rapid improvements than placebo and etanercept at week 12; improvements were sustained with continued treatment.


Assuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , Fármacos Dermatológicos/uso terapêutico , Etanercepte/uso terapêutico , Psoríase/tratamento farmacológico , Adulto , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Placebos , Psoríase/patologia , Resultado do Tratamento
20.
Clin Exp Dermatol ; 41(5): 486-9, 2016 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-26890045

RESUMO

BACKGROUND: We present the largest set of US prevalence data for psoriasis to date, obtained from three prospective cohort studies describing validated clinical phenotypes of psoriasis, including novel data about the prevalence of inverse (intertriginous) psoriasis in these groups. Nonplaque psoriasis phenotypes have been largely unmeasured in observational and interventional studies, and this has led to an under-recognition of this aspect of psoriatic disease. AIM: To describe the prevalence of nonplaque psoriasis phenotypes in a large prospective cohort. METHODS: We included 3179 women and 646 men in the analysis. Participants in the Nurses Health Study (NHS) and Health Professionals Follow-up Study (HPFS) with physician-diagnosed psoriasis completed a validated, self-administered questionnaire to assess plaque and nonplaque subsets of psoriasis. RESULTS: Psoriasis phenotypes were as follows: plaque 55%, scalp 52%, palmar-plantar 14%, nail 23% and inverse 21% in the NHS (n = 1604); plaque 60%, scalp 56%, palmar-plantar 16%, nail 27% and inverse 24% in the second NHS study (NHS II) (n = 1575); and plaque 55%, scalp 45%, palmar-plantar 12%, nail 27% and inverse 30% in the HPFS (n = 646). Scalp, nail, palmar-plantar and inverse disease represent highly prevalent phenotypes of psoriasis in the USA. CONCLUSION: Scalp, nail, palmar-plantar and inverse disease represent highly prevalent phenotypes of psoriasis.


Assuntos
Psoríase/epidemiologia , Adulto , Idoso , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Fenótipo , Prevalência , Estudos Prospectivos , Psoríase/patologia , Índice de Gravidade de Doença , Estados Unidos/epidemiologia
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA