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1.
J Eur Acad Dermatol Venereol ; 38(1): 167-174, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-37641982

RESUMO

BACKGROUND: Omalizumab, an anti-IgE monoclonal antibody, is an effective treatment in chronic spontaneous urticaria (CSU). Predictors of fast and good response for omalizumab treatment have not yet been identified and characterized. OBJECTIVE: To evaluate whether soluble FcεRI (sFcεRI), a marker of IgE-mediated mast cell activation, predicts the time of response to omalizumab in CSU. METHODS: Sera of 67 CSU patients were obtained before omalizumab treatment and analysed for sFcεRI levels by ELISA (2 ng/mL was used as cut-off for elevated sFcɛRI). Treatment response during the first 4 weeks was assessed with the urticaria activity score (UAS7), urticaria control test (UCT) and the rolling UAS7 (rUAS7). RESULTS: Elevated pre-treatment sFcɛRI levels were detected in more than 70% of patients with completely controlled disease (UCT = 16) and well-controlled disease (UCT = 12-15) and were significantly associated with disease control (χ2 = 4.94, p < 0.05). More than half of the patients (14/25) with low levels had poor disease control (UCT < 12). Of the patients who achieved complete and marked UAS7 response, respectively, 75% and 63% had elevated baseline sFcɛRI levels. Post-treatment UAS7 scores were lower in patients with elevated sFcɛRI levels reaching statistical significance at Week 3 (p < 0.05). Patients with elevated baseline sFcɛRI levels achieved rUAS7 ≤ 6 and = 0 earlier than those with lower levels (Days 9 vs. 13 and Days 12 vs. 14, respectively). CONCLUSION: Elevated sFcεRI serum levels predict early and good response to treatment with omalizumab, which may help to better design treatment options for CSU patients.


Assuntos
Antialérgicos , Urticária Crônica , Omalizumab , Humanos , Antialérgicos/uso terapêutico , Urticária Crônica/tratamento farmacológico , Imunossupressores/uso terapêutico , Omalizumab/uso terapêutico , Resultado do Tratamento
2.
J Eur Acad Dermatol Venereol ; 36(11): 2064-2075, 2022 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-35699348

RESUMO

BACKGROUND: Pruritus is prevalent in psoriasis but still many features of pruritus, its response to therapy and its burden in psoriasis remain to be better characterized. OBJECTIVE: To investigate characteristics and burden of pruritus in an international cohort of patients with psoriasis. METHODS: This cross-sectional study included a total of 634 patients and 246 controls from Germany, Poland and Russia. Physicians examined and interviewed participants, recording clinical characteristics, such as severity, therapy and localization of psoriatic lesions. Participants filled out self-reported questionnaires including questions on pruritus severity and impact, characteristics, and response to therapy, and quality of life (QoL). Localization patterns of pruritus and skin lesions were visualized using body heat maps. RESULTS: Most patients (82%) experienced pruritus throughout their disease, and 75% had current pruritus. The majority of patients (64%) perceived pure pruritus, and those who reported additional painful and/or burning sensations (36%) reported overall stronger pruritus. The scalp was the most frequently reported localization of pruritus, even in the absence of skin lesions. Body surface area (BSA) of pruritus was not linked to pruritus intensity, but to BSA of psoriatic lesions (rho = 0.278; P < 0.001). One third of patients (31%) reported impaired sex-life, and 4% had suicidal ideations due to pruritus. In up to one third of patients, psoriasis therapies had little or no effect on pruritus. The only therapeutic option offered to some of these patients were antihistamines, which appeared to be effective in most cases. CONCLUSION: Pruritus is highly prevalent in psoriasis and is linked to a significant burden. Current psoriasis therapies are frequently insufficient to control pruritus. Managing psoriasis should include the assessment and control of itch. Efficient antipruritic therapies should be developed and be made available for patients with psoriasis.


Assuntos
Antipruriginosos , Psoríase , Antipruriginosos/uso terapêutico , Estudos Transversais , Humanos , Prurido/tratamento farmacológico , Psoríase/tratamento farmacológico , Qualidade de Vida , Índice de Gravidade de Doença
3.
J Eur Acad Dermatol Venereol ; 36(5): 688-697, 2022 May.
Artigo em Inglês | MEDLINE | ID: mdl-35020226

RESUMO

BACKGROUND: Sleep, which is crucial for restoring of physiological functions and health, is reportedly impaired in psoriasis. The role of different potential sleep confounding factors, including detailed pruritus characteristics, and the complex interplay between psychological variables (anxiety and depression), pruritus and sleep disturbance in psoriasis remain insufficiently investigated. OBJECTIVES: To investigate sleep characteristics and to identify clinical, demographic and psychological factors associated with sleep disturbance in psoriasis. METHODS: This cross-sectional study included 334 psoriasis patients (response rate 86%) and 126 control subjects (response rate 82%). Measures included sleep quality [Pittsburgh Sleep Quality Index (PSQI)], psoriasis severity, pruritus characteristics, including average pruritus intensity [visual analogue scale (VAS)], severity of comorbidities, anxiety and depression (Hospital Anxiety and Depression Scale - HADS) and quality of life (Dermatology Life Quality Index - DLQI, and Short Form 12 - SF12). RESULTS: Fifty-nine per cent of patients and 34% of control subjects (P < 0.001) suffered from sleep disturbance (PSQI > 5). Patients slept 1 h less than control subjects (median 6 vs. 7 h, P < 0.001). Patients without pruritus had less impaired sleep (global PSQI) than patients with strong (P < 0.001) and very strong pruritus (P < 0.001). Anxiety (HADS-A) and depression (HADS-D) levels were the strongest predictors of sleep impairment, followed by pruritus exacerbation at night, age, female sex, pruritus exacerbation in the morning, average pruritus intensity (VAS), diagnosed depression and gastroesophageal reflux disease, altogether explaining 32%-37% of the variance in global sleep quality. Both anxiety (HADS-A) and depression (HADS-D) were significant mediators explaining the association between pruritus intensity (VAS) and sleep impairment in 42% and 37% respectively. CONCLUSIONS: Sleep disturbance in patients with psoriasis is highly prevalent. Patients with psoriasis should be assessed for sleep impairment, pruritus, anxiety and depression. Reduction in pruritus should be considered as an important therapeutic goal, along with therapies aimed at reducing anxiety and depression.


Assuntos
Psoríase , Transtornos do Sono-Vigília , Adulto , Ansiedade/complicações , Ansiedade/epidemiologia , Estudos Transversais , Depressão/complicações , Depressão/epidemiologia , Depressão/psicologia , Feminino , Humanos , Prevalência , Prurido/complicações , Prurido/etiologia , Psoríase/complicações , Psoríase/epidemiologia , Psoríase/psicologia , Qualidade de Vida , Índice de Gravidade de Doença , Sono , Transtornos do Sono-Vigília/complicações , Transtornos do Sono-Vigília/epidemiologia
4.
J Eur Acad Dermatol Venereol ; 36(1): 91-99, 2022 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-34622498

RESUMO

BACKGROUND: Comprehensive data on the epidemiology and comorbidities of chronic urticaria (CU) in Germany are either limited, or not contemporary. OBJECTIVES: To investigate the epidemiology of CU, overall comorbidities and healthcare resource utilized by patients with CU in Germany, using an anonymized statutory health insurance (SHI) database. METHODS: Anonymized SHI claims research database of the Institute for Applied Health Research, Berlin [InGef] (01 January 2015-30 September 2018) was used to analyse insured individuals with a confirmed diagnosis of CU (ICD-10-GM codes). Twelve-month diagnosed prevalence and incidence, comorbidities (vs. atopic dermatitis and psoriasis), and healthcare utilization by patients with CU were investigated. RESULTS: Of 4 693 772 individuals of all ages listed in the database, 3 538 540 were observable during 2017. Overall, 17 524 patients (˜0.5%) were diagnosed with CU; chronic spontaneous urticaria (CSU: 71.2%), chronic inducible urticaria (CIndU: 19.7%), CSU+CIndU (9.1%). Females, vs. males, had higher diagnosed prevalence (0.62% vs. 0.37%) and diagnosed incidence (0.18% vs. 0.11%) of CU among all patients. Patients most frequently visited general practitioners (41.3% of total visits). Hypertensive diseases (43.5%), lipoprotein metabolism disorders (32.1%) and affective disorders (26.0%) were the most frequently reported comorbidities of special interest. Rates of most comorbidities of special interests were similar to atopic dermatitis and psoriasis patients, and all higher vs. overall population. More than half (54.1%) of all CU patients were not prescribed any treatment. Second-generation H1 -antihistamines were the most commonly prescribed medication for adult (17.9%) and paediatric (27.9%) patients. Patients with CIndU (paediatric, 15.5%; adult, 7.8%) were more often hospitalized versus patients with CSU (paediatric, 9.9%; adult, 4.6%). CONCLUSIONS: In Germany, prevalence of CU along with multiple comorbidities may pose increased burden on the healthcare system. Awareness of adhering to treatment guidelines, and aiming for complete control of urticaria, needs to be driven and may improve outcomes.


Assuntos
Urticária Crônica , Urticária , Adulto , Criança , Doença Crônica , Comorbidade , Feminino , Alemanha/epidemiologia , Humanos , Masculino , Aceitação pelo Paciente de Cuidados de Saúde , Urticária/epidemiologia
6.
Br J Dermatol ; 184(2): 226-236, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-32956489

RESUMO

Chronic urticaria (CU) affects about 1% of the world population of all ages, mostly young and middle-aged women. It usually lasts for several years (> 1 year in 25-75% of patients) and often takes > 1 year before effective management is implemented. It presents as chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU) or both in the same person. More than 25% of cases are resistant to H1 -antihistamines, even at higher doses, and third- and fourth-line therapies (omalizumab and ciclosporin) control the disease only in two-thirds of H1 -antihistamine-resistant patients. Here we review the impact of CU on different aspects of patients' quality of life and the burden of this chronic disease for the patient and society. CU may have a strong impact on health-related quality of life (HRQoL), particularly when CSU is associated with angio-oedema and/or CIndU (Dermatology Life Quality Index > 10 in 30% of patients). Comorbidities, such as anxiety and depression, which are present in more than 30% of patients with CSU, compound HRQoL impairment. Severe pruritus and the unpredictable occurrence of weals and angio-oedema are responsible for sleep disorders; sexual dysfunction; limitations on daily life, work and sports activities; interfering with life within the family and in society; and patients' performance at school and work (6% absenteeism and 25% presenteeism). Apart from treatment costs, with annual values between 900 and 2400 purchasing power parity dollars (PPP$) in Europe and the USA, CU is associated with a high consumption of medical resources and other indirect costs, which may reach a total annual cost of PPP$ 15 550.


Assuntos
Urticária Crônica , Urticária , Doença Crônica , Europa (Continente) , Feminino , Humanos , Pessoa de Meia-Idade , Omalizumab/uso terapêutico , Qualidade de Vida , Urticária/tratamento farmacológico , Urticária/epidemiologia
7.
J Eur Acad Dermatol Venereol ; 35(3): 721-729, 2021 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-32946615

RESUMO

BACKGROUND: Chronic urticaria (CU) is a common disease, characterized by the recurrent appearance of wheals, angioedema or both for more than 6 weeks. Its underlying biology is not well understood, and many patients do not obtain sufficient relief from recommended treatments. Patient registries are rapidly growing as a form of research, because they can provide powerful, data-driven insights about the epidemiology of diseases, real-world effectiveness of treatments, rare patient types, safety monitoring, healthcare costs and opportunities for quality improvement of healthcare delivery. OBJECTIVES: The Chronic Urticaria Registry (CURE) has been designed to improve the scientific understanding, clinical treatment and healthcare planning of CU patients. This report describes the rationale, methods and initial implementation of this registry. METHODS: Chronic Urticaria Registry is an ongoing, prospective, international, multicentre, observational, voluntary registry of patients with CU. Participation in CURE is open to any physician treating CU patients, regardless of location, medical specialty or type of practice setting. CURE aims to collect data on all CU patients, with no intentional selection or exclusion criteria. It collects baseline and follow-up data on the patient's demographics, history, symptoms, trigger and risk factors, therapies and healthcare utilization. RESULTS: Chronic Urticaria Registry is a landmark achievement of the global urticaria medical community. As of 26 February 2020, 39 centres around the world have joined the registry and 35 have entered baseline data on a total of 2946 patients. Publications of this data will be forthcoming soon. CONCLUSIONS: Chronic Urticaria Registry is eagerly seeking the participation of more physicians and the support of more governmental, charitable and commercial sponsors from around the world. Here, in this paper, we invite other physicians to join this unique project to improve the lives of patients with CU.


Assuntos
Urticária Crônica , Urticária , Doença Crônica , Humanos , Estudos Prospectivos , Sistema de Registros , Urticária/tratamento farmacológico , Urticária/epidemiologia
8.
J Eur Acad Dermatol Venereol ; 33(9): 1755-1761, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31199524

RESUMO

BACKGROUND: In skin diseases and experimental models of pruritus, pure itch is accompanied by additional sensations that are poorly characterized. OBJECTIVES: This study compared the sensory qualities evoked by different models of experimentally induced pruritus including skin prick testing (SPT) with histamine or capsaicin and application of cowhage spicules. SPT as a method of capsaicin application was validated for this purpose. METHODS: Two pilot experiments were performed in eight healthy volunteers. First, a concentration of 8% capsaicin was identified as evoking a reproducible itch using SPT. Further, a list of the seven most frequently reported sensations was chosen after SPT with 10 mg/mL histamine, 8% capsaicin and application of 40-45 cowhage spicules. Finally, 31 subjects were challenged with the same itch-inducers. Wheal and flare were measured at 10, 20, 40, 60 and 90 min, itch intensity every minute for 30 min, and the overall evaluation of sensory descriptors were recorded on a 100-mm visual analogue scale once itching had subsided. RESULTS: Skin prick testing with histamine and capsaicin resulted in flare reactions, which were 23% smaller for capsaicin (P < 0.001). Histamine, capsaicin and cowhage-induced pruritus, the duration of which was shorter for cowhage than for histamine (13.5 ± 1.4 vs. 8.8 ± 1.2 min, P = 0.005). Different mediators induced sensations of different intensities. Capsaicin produced less itch and physical urge to scratch than histamine (P = 0.001) and cowhage (P < 0.001). However, both capsaicin and cowhage induced more burning than histamine (P = 0.002 and P = 0.04, respectively). Provocation with cowhage caused more intense sensations of pricking than histamine (P = 0.033). CONCLUSION: This study shows that provocation with histamine, capsaicin and cowhage results in itch responses that are different in their duration, the profile of accompanying sensations, and the flare that comes with the itch.


Assuntos
Capsaicina/efeitos adversos , Histamina/efeitos adversos , Mucuna/efeitos adversos , Prurido/etiologia , Adulto , Feminino , Voluntários Saudáveis , Humanos , Masculino , Medição da Dor , Testes Cutâneos , Fatores de Tempo
10.
Allergy ; 73(7): 1489-1496, 2018 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-29405310

RESUMO

BACKGROUND: Mastocytosis is a heterogeneous disease characterized by a clonal expansion of mast cells in various organs. The vast majority of patients suffer from signs and symptoms caused by mediator release from mast cells. Although the disease burden is high, there is currently no specific and validated instrument to measure and monitor signs and symptoms in patients with mastocytosis. OBJECTIVE: To develop and validate a disease-specific tool to measure and monitor the activity of signs and symptoms in patients with mastocytosis, the Mastocytosis Activity Score (MAS). METHODS: Nineteen potential MAS items were developed in a combined approach consisting of semi-structured patient interviews, expert input and literature research. Item selection was performed by impact analysis with 76 patients followed by a review for face validity. The resulting MAS was tested for validity, reliability and influence factors. In parallel, a US American English version of the MAS was developed. RESULTS: A total of 68 mastocytosis patients took part in the MAS validation study. The final 9-item MAS was found to have a three-domain structure ("skin," "gastrointestinal tract" and "other"), a valid total score and an excellent test-retest reliability. Multiple regression analysis revealed that disease duration, age or gender is not a significant determinant of the MAS results. CONCLUSIONS: The MAS is a disease-specific, valid and reliable patient-reported outcome measure for adult patients with cutaneous and indolent systemic mastocytosis. It may serve as a valuable tool to measure and monitor mastocytosis activity, both, in clinical trials and in routine care.


Assuntos
Mastocitose/diagnóstico , Adulto , Idoso , Gerenciamento Clínico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Qualidade de Vida , Reprodutibilidade dos Testes , Fatores de Risco , Índice de Gravidade de Doença , Inquéritos e Questionários , Adulto Jovem
11.
Allergy ; 73(8): 1724-1734, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-29460968

RESUMO

BACKGROUND: ASSURE-CSU revealed differences in physician and patient reporting of angioedema. This post hoc analysis was conducted to evaluate the actual rate of angioedema in the study population and explore differences between patients with and without angioedema. METHODS: This international observational study assessed 673 patients with inadequately controlled chronic spontaneous urticaria (CSU). Physicians abstracted angioedema data from medical records, which were compared with patient-reported data. Patients in the Yes-angioedema category had angioedema reported in the medical record and a patient-reported source. For those in the No-angioedema category, angioedema was reported in neither the medical record nor a patient-reported source. Those in the Misaligned category had angioedema reported in only one source. Statistical comparisons between Yes-angioedema and No-angioedema categories were conducted for measures of CSU activity, health-related quality of life (HRQoL), productivity and healthcare resource utilization (HCRU). Regression analyses explored the relationship between Dermatology Life Quality Index (DLQI) score and angioedema, adjusting for important covariates. RESULTS: Among evaluable patients, 259 (40.3%), 173 (26.9%) and 211 (32.8%) were in the Yes-angioedema, No-angioedema and Misaligned category, respectively. CSU activity and impact on HRQoL, productivity, and HCRU was greater for Yes-angioedema patients than No-angioedema patients. After covariate adjustment, mean DLQI score was significantly higher (indicating worse HRQoL) for patients with angioedema versus no angioedema (9.88 vs 7.27, P < .001). The Misaligned category had similar results with Yes-angioedema on all outcomes. CONCLUSIONS: Angioedema in CSU seems to be under-reported but has significant negative impacts on HRQoL, daily activities, HCRU and work compared with no angioedema.


Assuntos
Angioedema/complicações , Angioedema/diagnóstico , Urticária/complicações , Urticária/diagnóstico , Atividades Cotidianas , Adulto , Idoso , Idoso de 80 Anos ou mais , Angioedema/economia , Doença Crônica , Feminino , Inquéritos Epidemiológicos , Humanos , Internacionalidade , Masculino , Pessoa de Meia-Idade , Aceitação pelo Paciente de Cuidados de Saúde , Relações Médico-Paciente , Qualidade de Vida , Análise de Regressão , Estudos Retrospectivos , Índice de Gravidade de Doença , Adulto Jovem
12.
Br J Dermatol ; 178(4): e279-e285, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-29441525

RESUMO

Results of clinical trials are the most important information source for generating external clinical evidence. The use of different outcomes across trials, which investigate similar interventions for similar patient groups, significantly limits the interpretation, comparability and clinical application of trial results. Core outcome sets (COSs) aim to overcome this limitation. A COS is an agreed standardized collection of outcomes that should be measured and reported in all clinical trials for a specific clinical condition. The Core Outcome Set Initiative within the Cochrane Skin Group (CSG-COUSIN) supports the development of core outcomes in dermatology. In the second CSG-COUSIN meeting held in 2017, 11 COS development groups working on skin diseases presented their current work. The presentations and discussions identified the following overarching methodological challenges for COS development in dermatology: it is not always easy to define the disease focus of a COS; the optimal method for outcome domain identification and level of detail needed to specify such domains is challenging to many; decision rules within Delphi surveys need to be improved; appropriate ways of patient involvement are not always clear. In addition, there appear to be outcome domains that may be relevant as potential core outcome domains for the majority of skin diseases. The close collaboration between methodologists in the Core Outcome Set Initiative and the international Cochrane Skin Group has major advantages for trialists, systematic reviewers and COS developers.


Assuntos
Ensaios Clínicos como Assunto/normas , Dermatologia/normas , Avaliação de Resultados em Cuidados de Saúde/normas , Tomada de Decisões , Humanos , Relações Interprofissionais
13.
Clin Exp Allergy ; 48(4): 433-444, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-29369455

RESUMO

BACKGROUND: Cholinergic urticaria (CholU), a common form of chronic inducible urticaria, is characterized by itchy weals that occur in response to physical exercise or passive warming. CholU patients frequently exhibit a high burden of disease. As of yet, no specific instrument is available to assess their disease-related quality-of-life (QoL) impairment. OBJECTIVE: The aim of this study was to develop and validate the first disease-specific QoL instrument for CholU patients, the Cholinergic Urticaria Quality-of-Life Questionnaire (CholU-QoL). METHODS: Using a combined approach of the literature search, semistructured patient interviews and expert opinion, we developed 96 potential CholU-QoL items. Subsequent item selection was performed by means of impact analysis complemented by an expert review for face validity. The resulting final CholU-QoL was then tested for levels of validity, reliability and influence factors in 88 CholU patients. In parallel, an US American-Canadian English version of the CholU-QoL was developed. RESULTS: The final 28-item CholU-QoL was found to have a 5-domain structure ("symptoms," "functional life," "social interaction," "therapy," "emotions") with excellent internal consistency. The CholU-QoL also showed a valid total score, and good levels of convergent validity, known-groups validity, as well as test-retest reliability. Multiple regression analysis found no significant drivers of the CholU-QoL total score. CONCLUSIONS AND CLINICAL RELEVANCE: The CholU-QoL is the first disease-specific QoL instrument for CholU and also the first specific QoL measure in the field of chronic inducible urticarias. It may serve as a valuable tool for clinical trials and improve routine patient management.


Assuntos
Qualidade de Vida , Índice de Gravidade de Doença , Inquéritos e Questionários , Urticária/complicações , Adolescente , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Reprodutibilidade dos Testes , Adulto Jovem
14.
Allergy ; 73(1): 251-255, 2018 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-28815631

RESUMO

The urticaria activity score (UAS) is the gold standard for assessing disease activity in patients with chronic spontaneous urticaria (CSU). Two different versions, the UAS7 and UAS7TD , are currently used in clinical trials and routine care. To compare both versions and to obtain data on their interpretability, 130 CSU patients applied both versions and globally rated their disease activity as none, mild, moderate, or severe. UAS7 and UAS7TD values correlated strongly (r = .90, P < .001). Interquartile ranges for UAS7 and UAS7TD values for mild, moderate, and severe CSU were 11-20 and 10-24, 16-30 and 16-32, and 27-37 and 28-40. UAS7 values were slightly, but significantly lower as compared to UAS7TD values (mean difference: 1.6 ± 4.6, P < .001). This difference was driven by lower wheal subscores (2.1 ± 3.5, P < .001) and was most pronounced in patients with severe CSU (2.5 ± 5.6, P < .01). The UAS7/UAS7TD ratio was 0.96 ± 0.21 and did not differ significantly between mild, moderate, and severe CSU. Since the results of both UAS versions are comparable, we recommend the use of the UAS7, which is less burdensome in administration and scoring.


Assuntos
Urticária/diagnóstico , Adulto , Biomarcadores , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde , Reprodutibilidade dos Testes , Índice de Gravidade de Doença
15.
J Eur Acad Dermatol Venereol ; 32(7): 1059-1065, 2018 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-28857299

RESUMO

BACKGROUND: The term prurigo has been used for many decades in dermatology without clear definition, and currently used terminology of prurigo is inconsistent and confusing. Especially, itch-related prurigo remains unexplored regarding the epidemiology, clinical profile, natural course, underlying causes, available treatments and economic burden, although burdensome and difficult to treat. OBJECTIVE: To address these issues, the multicentre European Prurigo Project (EPP) was designed to increase knowledge on chronic prurigo (CPG). In the first step, European experts of the EADV Task Force Pruritus (TFP) aimed to achieve a consensus on the definition, classification and terminology of CPG. Additionally, procedures of the cross-sectional EPP were discussed and agreed upon. METHODS: Discussions and surveys between members of the TFP served as basis for a consensus conference. Using the Delphi method, consensus was defined as an agreement ≥75% among the present members. RESULTS: Twenty-four members of the TFP participated in the consensus conference. Experts consented that CPG should be used as an umbrella term for the range of clinical manifestations (e.g. papular, nodular, plaque or umbilicated types). CPG is considered a distinct disease defined by the presence of chronic pruritus for ≥6 weeks, history and/or signs of repeated scratching and multiple localized/generalized pruriginous skin lesions (whitish or pink papules, nodules and/or plaques). CPG occurs due to a neuronal sensitization to itch and the development of an itch-scratch cycle. CONCLUSION: This new definition and terminology of CPG should be implemented in dermatology to harmonize communication in the clinical routine, clinical trials and scientific literature. Acute/subacute forms of prurigo are separated entities, which need to be differentiated from CPG and will be discussed in a next step. In the near future, the cross-sectional EPP will provide relevant clinical data on various aspects of CPG leading to new directions in the scientific investigation of CGP.


Assuntos
Prurigo/classificação , Terminologia como Assunto , Doença Crônica , Consenso , Técnica Delphi , Humanos
16.
Allergy ; 73(3): 576-584, 2018 03.
Artigo em Inglês | MEDLINE | ID: mdl-29058822

RESUMO

BACKGROUND: The X-ACT study aimed to examine the effect of omalizumab treatment on quality of life (QoL) in chronic spontaneous urticaria (CSU) patients with angioedema refractory to high doses of H1 -antihistamines. METHODS: In X-ACT, a phase III, double-blind, placebo-controlled study, CSU patients (18-75 years) with ≥4 angioedema episodes during the 6 months before inclusion were randomized (1:1) to receive omalizumab 300 mg or placebo every 4 weeks for 28 weeks. Angioedema-related QoL, skin-related QoL impairment, and psychological well-being were assessed. RESULTS: Ninety-one patients were randomized and 68 (omalizumab, n = 35; placebo, n = 33) completed the 28-week treatment period. At baseline, the mean (SD) total Angioedema QoL (AE-QoL; 56.2 [18.7] and 59.9 [19.2]) and Dermatology Life Quality Index (DLQI; 14.6 [5.7] and 16.6 [7.3]) score were high in the omalizumab and placebo group, respectively. At Week 4 (after the first treatment), the least squares mean difference in the AE-QoL and DLQI score between groups was -17.6 (P < .001) and -7.2 (P < .001), respectively. Significant QoL improvements in the omalizumab vs placebo groups continued until Week 28, but returned to placebo levels at the follow-up visit. The mean (SD) baseline 5-item World Health Organization Well-being Index was 10.0 (5.5, omalizumab) and 7.7 (5.3, placebo), which increased above the depression threshold (<13) from Week 4 and throughout with omalizumab but not placebo treatment. Compared to placebo, omalizumab was also associated with decreased fear of suffocation due to angioedema. CONCLUSIONS: Our findings support omalizumab treatment in patients with severe H1-antihistamine-refractory CSU with angioedema.


Assuntos
Angioedema/tratamento farmacológico , Antialérgicos/uso terapêutico , Omalizumab/uso terapêutico , Qualidade de Vida , Urticária/tratamento farmacológico , Adolescente , Adulto , Idoso , Angioedema/etiologia , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Urticária/complicações , Adulto Jovem
17.
Allergy ; 72(12): 2005-2016, 2017 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-28543019

RESUMO

BACKGROUND: Chronic spontaneous urticaria (CSU) can be debilitating, difficult to treat, and frustrating for patients and physicians. Real-world evidence for the burden of CSU is limited. The objective of this study was to document disease duration, treatment history, and disease activity, as well as impact on health-related quality of life (HRQoL) and work among patients with inadequately controlled CSU, and to describe its humanistic, societal, and economic burden. METHODS: This international observational study assessed a cohort of 673 adult patients with CSU whose symptoms persisted for ≥12 months despite treatment. Demographics, disease characteristics, and healthcare resource use in the previous 12 months were collected from medical records. Patient-reported data on urticaria and angioedema symptoms, HRQoL, and work productivity and activity impairment were collected from a survey and a diary. RESULTS: Almost 50% of patients had moderate-to-severe disease activity as reported by Urticaria Activity Score. Mean (SD) Dermatology Life Quality Index and Chronic Urticaria Quality of Life Questionnaire scores were 9.1 (6.62) and 33.6 (20.99), respectively. Chronic spontaneous urticaria markedly interfered with sleep and daily activities. Angioedema in the previous 12 months was reported by 66% of enrolled patients and significantly affected HRQoL. More than 20% of patients reported ≥1 hour per week of missed work; productivity impairment was 27%. These effects increased with increasing disease activity. Significant healthcare resources and costs were incurred to treat CSU. CONCLUSIONS: Chronic spontaneous urticaria has considerable humanistic and economic impacts. Patients with greater disease activity and with angioedema experience greater HRQoL impairments.


Assuntos
Efeitos Psicossociais da Doença , Urticária/epidemiologia , Atividades Cotidianas , Adulto , Idoso , Idoso de 80 Anos ou mais , Doença Crônica , Estudos Transversais , Feminino , Fidelidade a Diretrizes , Custos de Cuidados de Saúde , Inquéritos Epidemiológicos , Humanos , Masculino , Pessoa de Meia-Idade , Qualidade de Vida , Sono , Inquéritos e Questionários , Urticária/diagnóstico , Urticária/terapia , Adulto Jovem
18.
World Allergy Organ J ; 10(1): 21, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28546850

RESUMO

BACKGROUND: The current EAACI/GA2LEN/EDF/WAO guideline for urticaria provide specific recommendations for the diagnostic workup and treatment of patients with chronic spontaneous urticaria (CsU). This study explored if physicians in Ecuador know these recommendations and implement them in their actual clinical practice for CsU. METHODS: We investigated physicians who treat CsU patients in a cross-sectional study using a standardized questionnaire. Descriptive statistics were employed, adjusted logistic regression was performed to assess the link of guideline knowledge and use of therapy. RESULTS: Seven hundred forty surveys were collected and analyzed. The mean age of physicians was 42.3 (±12.5) years. Most of the participants (65.1%) were general physicians (GP), 13.7% were pediatricians, 11.0% internists, 6.8% dermatologists or allergists (D/A). Only 18.8% knew the EAACI/GA2LEN/EDF/WAO guideline. 44.5% of GPs searched for CsU etiology in contrast to 90% of D/A. Most common diagnostic test was total serum IgE (83.5%). Most common first line symptomatic treatment was oral corticoids (46.3%), followed by second generation antihistamines (sgAHs, 36.8%). A/D prescribed more sgAHs (regular doses) (74.1 vs 28.6% of GP) (p < 0.05). Experience with omalizumab was reported only by 3.5%, of physicians, and higher rates among who were familiar with the guideline. CONCLUSION: This study shows that the knowledge of guideline recommendations in physicians who treat urticaria patients in Ecuador is low. The diagnostic workup and treatment of CsU patients are largely not in line with guideline recommendations in real life practice settings. We were able to compare results between German and Ecuadorian physicians and found that Ecuadorian physicians have lower awareness of the current guideline (33 vs 18%). Only one-third of physicians reported using regular doses of sgAHs as the first line treatment. Also, only 12.9% of physicians use sgAHs in higher doses and physicians still use fgAHs, particularly pediatricians (42.9%). Our results suggest that disparities in knowledge between physicians from different countries could influence the management of CsU. Knowledge of the guidelines is linked to better choices of treatments. Awareness of guidelines needs to be promoted for better management of chronic urticaria.

20.
Br J Dermatol ; 175(3): 454-5, 2016 09.
Artigo em Inglês | MEDLINE | ID: mdl-27632958
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