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BACKGROUND: Dysmorphic concern is an overconcern with an imagined or slight defect in physical appearance that can be a symptom of body dysmorphic disorder (BDD). Appearance-related concerns are frequently reported by people with dermatological conditions. However, relatively little remains known about the relationship between dysmorphic concern and other variables within persons with different skin conditions. OBJECTIVES: The aim of this multicentre, cross-sectional study was to investigate gender differences regarding dysmorphic concern and the prevalence of BDD in a large sample of patients with skin conditions, in relation to sociodemographic, clinical and psychological variables. METHODS: Participants aged ≥18 years with skin conditions were consecutively enrolled in dermatological clinics of 22 European centres. Dysmorphic concern and the possible presence of BDD were measured using the Dysmorphic Concern Questionnaire (DCQ) and compared between men and women in relation to sociodemographic, clinical and psychological variables, and separately for each skin condition. RESULTS: The DCQ questionnaire was completed by 5290 dermatological patients. In all categories, mean scores were significantly higher in women than in men. Mean DCQ scores were also higher in women for most skin conditions, with the highest effect size in vitiligo. The percentage of patients who screened positive for BDD on the DCQ was 10.5%, 7.7% of men and 12.7% of women. The prevalence of BDD positive was 6.9% in patients with mild clinical severity, 11.1% for moderate and 19.1% for severe condition. In the multivariate model in patients with mild skin condition, the presence of BDD was positively associated with stress and stigma both in men and in women. CONCLUSIONS: Dysmorphic concern and BDD were more frequent in women than in men with skin conditions. Both received and actual stigmatization might have an impact on body-related concerns, in particular in women, who may be more at risk for sociocultural reasons.
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Chronic pruritus (CP) is frequent in general medicine and the most common complaint in general dermatology. The prevalence of CP is expected to rise in the future due to the ageing population. The clinical presentation, underlying aetiology and treatment strategy of CP are heterogeneous. Also, individual treatment aims and physical, psychic and economic burdens of patients might vary. Chronic prurigo (CPG) is the most severe disease in the chronic pruritus spectrum, being associated with long-standing scratch-induced skin lesions and a therapy refractory itch-scratch-cycle. It is thus important to raise disease awareness for CP and CPG in the general public and among decision-makers in the health system. Further, there is a need to support a rational clinical framework to optimize both diagnostics and therapeutics. Currently, there is still a shortcoming regarding approved therapies and understanding CP/CPG as severe medical conditions. Therefore, the EADV Task Force Pruritus decided to publish this white paper based on several consensus meetings. The group consented on the following goals: (a) ensure that CP is recognized as a serious condition, (b) increase public awareness and understanding of CP and CPG as chronic and burdensome diseases that can greatly affect a person's quality of life, (c) clarify that in most cases CP and CPG are non-communicable and not caused by a psychiatric disease, (d) improve the support and treatment given to patients with CP to help them manage their disease and (e) publicize existing therapies including current guidelines. We aim to point to necessary improvements in access and quality of care directed to decision-makers in health policy, among payers and administrations as well as in practical care.
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Prurigo , Prurido , Humanos , Prurido/terapia , Prurido/etiologia , Doença Crônica , Prurigo/terapia , Prurigo/complicações , Comitês ConsultivosRESUMO
BACKGROUND: Itch as the most common symptom in dermatology has been shown to be related to psychological factors such as stress, anxiety and depression. Moreover, associations were found between perceived stigmatization and itch. However, studies investigating the differences between patients with dermatoses with and without itch regarding perceived stress, stigmatization, anxiety and depression are missing. Therefore, one of the aims of the second study of the European Society for Dermatology and Psychiatry (ESDaP study II) was to investigate these relationships in a large cohort of patients with different itchy dermatoses. RESULTS: 3399 patients with 14 different itchy dermatoses were recruited at 22 centres in 17 European countries. They filled in questionnaires to assess perceived stigmatization, stress, signs of clinically relevant anxiety or depression, itch-related quality of life, the overall health status, itch duration, frequency and intensity. The most significant association between the severity of itching and the perception of stress was observed among individuals with rosacea (correlation coefficient r = 0.314). Similarly, the strongest links between itch intensity and experiences of stigmatization, anxiety, and depression were found in patients with seborrheic dermatitis (correlation coefficients r = 0.317, r = 0.356, and r = 0.400, respectively). Utilizing a stepwise linear regression analysis, it was determined that within the entire patient cohort, 9.3% of the variation in itch intensity could be accounted for by factors including gender, levels of anxiety, depression, and perceived stigmatization. Females and individuals with elevated anxiety, depression, and perceived stigmatization scores reported more pronounced itch intensities compared to those with contrary attributes. CONCLUSION: This study underscores the connection between experiencing itch and its intensity and the psychological strain it places on individuals. Consequently, psychological interventions should encompass both addressing the itch itself and the interconnected psychological factors. In specific cases, it becomes imperative for dermatologists to direct individuals towards suitable healthcare resources to undergo further psychological assessment.
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Ansiedade , Depressão , Prurido , Estresse Psicológico , Humanos , Prurido/psicologia , Depressão/psicologia , Feminino , Masculino , Estresse Psicológico/psicologia , Ansiedade/psicologia , Europa (Continente) , Pessoa de Meia-Idade , Adulto , Dermatopatias/psicologia , Qualidade de Vida , Estereotipagem , Inquéritos e Questionários , Idoso , Índice de Gravidade de DoençaRESUMO
BACKGROUND: Generalized pustular psoriasis (GPP) is a rare, inflammatory skin disease characterized by widespread eruption of sterile pustules with or without systemic symptoms. OBJECTIVES: This study aimed to describe the demographics of patients with GPP in Central and Eastern Europe (CEE), present the clinical characteristics of individual GPP flares and explore the current treatment landscape. METHODS: Patient demographics were collected at the times of last observation and previous treatment. Characteristics of a patient's last (most recent) and most severe (from all documented episodes) flare were provided at clinician's discretion. RESULTS: Fifty-eight patients were recruited from 12 centres in nine CEE countries; median (range) age was 61 (16-92) years and 60.3% (35 out of 58) were female. The most common comorbidities were hypertension (43.1% [25 out of 58]) and hyperlipidaemia (32.8% [19 out of 58]). Thirty-four patients (58.6%) presented with concomitant plaque psoriasis before or during the course of GPP. Data from two separate flares were recorded in 26 individuals; in 32 patients, the most recent flare was reported as the most severe. Over 90% of patients with a flare episode classified as most severe by clinicians were hospitalized, with >75% of these individuals having a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) total score of 3 or 4. Systemic symptoms were more common in patients with a GPPGA score of 3 or 4 but were also manifest in individuals with a GPPGA score ≤2. A significant correlation was observed between a combined systemic disease score of clinical and laboratory features and both GPPGA total score (r = 0.385, p < 0.001) and GPPGA pustulation subscore (r = 0.305, p < 0.05). CONCLUSIONS: Considerable heterogeneity in the presentation of GPP flares was observed, both between patients and within-patient. All GPP flares were associated with a significant clinical burden, highlighting the unmet need for accurate and early diagnosis.
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Psoríase , Humanos , Psoríase/terapia , Psoríase/epidemiologia , Psoríase/complicações , Feminino , Adulto , Masculino , Pessoa de Meia-Idade , Adolescente , Idoso , Adulto Jovem , Idoso de 80 Anos ou mais , Europa Oriental/epidemiologia , Europa (Continente)/epidemiologia , Índice de Gravidade de Doença , Hipertensão/epidemiologia , Hipertensão/complicaçõesRESUMO
INTRODUCTION: Given the chronic nature of psoriasis (PsO), more studies are needed that directly compare the effectiveness of different biologics over long observation periods. This study compares the effectiveness and durability through 12 months of anti-interleukin (IL)-17A biologics relative to other approved biologics in patients with moderate-to-severe psoriasis in a real-world setting. METHODS: The Psoriasis Study of Health Outcomes (PSoHO) is an ongoing 3-year, prospective, non-interventional cohort study of 1981 adults with chronic moderate-to-severe plaque psoriasis initiating or switching to a new biologic. The study compares the effectiveness of anti-IL-17A biologics with other approved biologics and provides pairwise comparisons of seven individual biologics versus ixekizumab. The primary outcome was defined as the proportion of patients who had at least a 90% improvement in Psoriasis Area and Severity Index score (PASI90) and/or a score of 0 or 1 in static Physician Global Assessment (sPGA). Secondary objective comparisons included the proportion of patients who achieved PASI90, PASI100, a Dermatology Life Quality Index (DLQI) score of 0 or 1, and three different measures of durability of treatment response. Unadjusted response rates are presented alongside the primary analysis, which uses frequentist model averaging (FMA) to evaluate the adjusted comparative effectiveness. RESULTS: Compared to the other biologics cohort, the anti-IL-17A cohort had a higher response rate (68.0% vs. 65.1%) and significantly higher odds of achieving the primary outcome at month 12. The two cohorts had similar response rates for PASI100 (40.5% and 37.1%) and PASI90 (53.9% and 51.7%) at month 12, with no significant differences between the cohorts in the adjusted analyses. At month 12, the response rates across the individual biologics were 53.5-72.6% for the primary outcome, 27.6-48.3% for PASI100, and 41.7-61.4% for PASI90. CONCLUSIONS: These results show the comparative effectiveness of biologics at 6 and 12 months in the real-world setting.
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BACKGROUND: The fixed dose combination of calcipotriene (CAL) and betamethasone dipropionate (BDP) is a well-established topical treatment option for psoriasis based on strong scientific rationale for the single agents having complementary efficacy and safety. CAL/BDP PAD-cream is an easily spreadable cream based on PAD Technology™, an innovative formulation and drug delivery system. OBJECTIVES AND METHODS: A Phase 3, multicentre, randomized, investigator-blind, active and vehicle-controlled trial enrolling 490 patients with mild to moderate psoriasis according to the Physician Global Assessment (PGA) scale was conducted in three European countries. Products were applied once daily for 8 weeks. The aim of the trial was to evaluate the efficacy and safety of CAL/BDP PAD-cream as well as treatment acceptability compared to CAL/BDP gel and PAD-cream vehicle. Primary endpoint was percentage change in modified Psoriasis Area and Severity Index (mPASI) from baseline to Week 8. RESULTS: The percentage mean change from baseline to Week 8 in mPASI for CAL/BDP PAD-cream (67.5%) was superior compared to PAD-cream vehicle (11.7%; p < 0.0001) and non-inferior to CAL/BDP gel (63.5%). The proportion of patients achieving PGA treatment success (at least two-step improvement to clear or almost clear) after 8 weeks was superior for CAL/BDP PAD-cream (50.7%) compared to PAD-cream vehicle (6.1%, p < 0.0001) and statistically significantly greater than CAL/BDP gel (42.7%, p = 0.0442). Patient-reported psoriasis treatment convenience score (PTCS) for CAL/BDP PAD-cream was rated superior to CAL/BDP gel at Week 8 (p < 0.0001) and the mean change in DLQI from baseline to Week 8 improved statistically significantly more in the CAL/BDP PAD-cream group compared to both PAD-cream vehicle (p < 0.0001) and CAL/BDP gel (p = 0.0110). Safety assessments during the trial demonstrated that CAL/BDP PAD-cream was well-tolerated. CONCLUSION: CAL/BDP PAD-cream is a novel topical treatment of psoriasis that has a high efficacy and a favourable safety profile combined with a superior patient-reported treatment convenience.
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Fármacos Dermatológicos , Psoríase , Humanos , Combinação de Medicamentos , Psoríase/tratamento farmacológico , Psoríase/induzido quimicamente , Calcitriol/efeitos adversos , Betametasona/efeitos adversos , Resultado do Tratamento , Emolientes/uso terapêutico , Fármacos Dermatológicos/efeitos adversosRESUMO
BACKGROUND: Rapid skin improvement is a key treatment goal of patients with moderate-to-severe psoriasis (PsO). OBJECTIVES: To compare the speed of clinical improvement of approved biologics on the symptoms and signs of psoriasis assessed by patients using the validated Psoriasis Symptoms and Signs Diary (PSSD) through 12 weeks. METHODS: Psoriasis Study of Health Outcomes (PSoHO) is an international, prospective, non-interventional study that compares the effectiveness of anti-interleukin (IL)-17A biologics versus other biologics, together with pairwise comparisons of ixekizumab versus five individual biologics in patients with PsO. Using the PSSD 7-day recall period, patients assessed the symptoms (itch, skin tightness, burning, stinging and pain) and signs (dryness, cracking, scaling, shedding/flaking, redness and bleeding) of their psoriasis (0-10). Symptom and sign summary scores (0-100) are derived from the average of individual scores. Percentage change in summary scores and proportion of patients with clinically meaningful improvements (CMI) in PSSD summary and individual scores are evaluated weekly. Longitudinal PSSD data are reported as observed with treatment comparisons analysed using mixed model for repeated measures (MMRM) and generalized linear mixed models (GLMM). RESULTS: Across cohorts and treatments, eligible patients (n = 1654) had comparable baseline PSSD scores. From Week 1, the anti-IL-17A cohort achieved significantly larger score improvements in PSSD summary scores and a higher proportion of patients showed CMIs compared to the other biologics cohort through 12 weeks. Lower PSSD scores were associated with a greater proportion of patients reporting their psoriasis as no longer impacting their quality-of-life (DLQI 0,1) and a high level of clinical response (PASI100). Results also indicate a relationship between an early CMI in PSSD score at Week 2 and PASI100 score at Week 12. CONCLUSIONS: Treatment with anti-IL-17A biologics, particularly ixekizumab, resulted in rapid and sustained patient-reported improvements in psoriasis symptoms and signs compared with other biologics in a real-world setting.
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Produtos Biológicos , Psoríase , Humanos , Anticorpos Monoclonais/uso terapêutico , Estudos Prospectivos , Índice de Gravidade de Doença , Psoríase/complicações , Psoríase/tratamento farmacológico , Psoríase/diagnóstico , Medidas de Resultados Relatados pelo Paciente , Produtos Biológicos/uso terapêutico , Dor/tratamento farmacológico , Resultado do TratamentoRESUMO
PURPOSE: In intracranial wide-neck aneurysms, simple coil embolization is often not a feasible treatment option. Balloon-assisted coiling comes with the drawback of blood flow impairment, whereas permanent stent placement requires long-term antiplatelet therapy. Temporary stent-assisted coiling (coiling assisted by temporary stenting, CATS) is an alternative that eliminates both disadvantages. Because prior studies included only small numbers of patients, it was our aim to analyze the safety and effectiveness of this technique in a larger cohort of patients. METHODS: We retrospectively evaluated all endovascular aneurysm treatments at our institution from 2011 to 2020. Out of a total of 688 aneurysm treatments, we intended to perform 95 (14%) with temporary stent-assisted coiling and included them in our study. RESULTS: Sixty-four (64)% of aneurysms were acutely ruptured, 3% were symptomatic but unruptured, and 33% were incidental. Successful stent recovery was possible in 93% of treatments. Initial complete and adequate occlusion rate were 53% and 82%, respectively. Long-term follow-up at 6 and 12 months was available for 71% and 44% of cases. Aneurysm recurrence was observed in 10% of cases after 6 months, and in 17% after 1 year or later. Periprocedural complications were noted in 12 cases (13%), of which only 1 complication was definitely associated with temporary stent-assisted coiling (1%). One of the periprocedural complications resulted in neurological damage, the other complications were asymptomatic. CONCLUSION: Temporary stent-assisted coiling appears to be a safe and effective treatment method in intracranial wide-neck aneurysms. Procedural safety appears to be comparable with balloon remodeling or permanent stent-assisted coiling, but it comes with the further benefit of diminished need for posttreatment antiplatelet therapy, which may improve the outcome of patients. However, to define the true value and potential benefit of this technique, further prospective studies are required.
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Aneurisma Roto , Aneurisma da Aorta Abdominal , Implante de Prótese Vascular , Embolização Terapêutica , Procedimentos Endovasculares , Aneurisma Intracraniano , Humanos , Estudos Retrospectivos , Inibidores da Agregação Plaquetária , Aneurisma da Aorta Abdominal/complicações , Aneurisma da Aorta Abdominal/terapia , Stents/efeitos adversos , Aneurisma Intracraniano/diagnóstico por imagem , Aneurisma Intracraniano/terapia , Aneurisma Intracraniano/complicações , Resultado do Tratamento , Embolização Terapêutica/métodos , Aneurisma Roto/terapia , Angiografia CerebralRESUMO
BACKGROUND AND PURPOSE: Because stroke therapy has changed with the introduction of endovascular stroke treatment as a standard approach, studies on intrahospital causes of death from stroke are no longer up-to-date. The purpose of this observational study was to present the causes of death during hospitalization of patients with ischemic stroke who received endovascular stroke treatment, with the focus on a differentiation of curative and secondary palliative treatment. MATERIALS AND METHODS: We studied a total cohort of 1342 patients who received endovascular stroke treatment in a tertiary stroke center (Aachen, Germany) between 2010 and 2020 and analyzed the causes of death in all 326 consecutive deceased patients. We distinguished between curative treatment and a secondary palliative approach and analyzed causes of death and treatment numbers across the years. RESULTS: In the entire cohort of 326 deceased patients, the most common cause of death was of a cerebrovascular nature (51.5%), followed by pneumonia and sepsis (25.8%) and cardiovascular causes (8.3%). Neurovascular causes constituted 75.8% of reasons for palliation. In the group with a secondary palliative approach, causes of death were neurovascular in 54.0% of patients and pneumonia and sepsis in 26.0% of patients. CONCLUSIONS: Cerebrovascular causes in patients with stroke play a major role in the intrahospital causes of death and reasons for palliation. Considering the large proportion of secondarily palliative-treated patients, reasons for palliation should be considered instead of causes of death to avoid concealment by, for example, life-terminating measures.
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Procedimentos Endovasculares , Pneumonia , Sepse , Acidente Vascular Cerebral , Humanos , Causas de Morte , Acidente Vascular Cerebral/terapia , Acidente Vascular Cerebral/etiologia , Causalidade , Pneumonia/etiologia , Sepse/etiologia , Resultado do Tratamento , Procedimentos Endovasculares/efeitos adversosRESUMO
In southwest Florida, Karenia brevis (K. brevis) blooms occur frequently, can be very intense and persist over several years. Individuals living in coastal communities around the Gulf of Mexico are particularly vulnerable to brevetoxins released by K. brevis in seawater and carried inland within marine aerosol. Exposure to K. brevis occurs during residential, recreational, and occupational activities and has been associated with upper respiratory tract (URT) symptoms in healthy and medically vulnerable individuals. Additionally, ingestion of brevetoxin-contaminated seafood causes neurotoxic shellfish poisoning (NSP), and severe headaches prompting emergency department visits which occur in excess during K. brevis blooms. The current study examined a dose-response relationship between K. brevis in coastal waters and URT and NSP-like symptoms and headaches among southwest Florida residents. Data on past medical history (PMH) and medical symptoms were collected from the participants (n = 258) in five southwest Florida counties between June 2019 to August 2021. A dose-response relationship was observed between K. brevis blooms and reporting of URT and NSP-like symptoms and headaches. Reporting of NSP-like symptoms was higher among participants with a PMH of migraines, chronic fatigue syndrome (CFS) and mild memory loss, while the association of headaches with K. brevis blooms was accentuated among individuals with a PMH of migraines. These results suggest further investigations into the threshold of aerosolized brevetoxin dose required to elicit URT, headaches and/or NSP-like symptoms. These symptoms ultimately cause significant public health safety concerns, primarily among vulnerable populations with preexisting neurological conditions.
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Dinoflagellida , Transtornos de Enxaqueca , Intoxicação por Frutos do Mar , Cefaleia , Humanos , Neurotoxinas , Sistema RespiratórioRESUMO
BACKGROUND: Patients with prurigo nodularis (PN) have multiple itchy nodules, impaired quality of life and sleep deprivation. Prurigo nodularis patients have a high burden of disease, primarily due to the intensity of the itch. It is reasonable to expect that rapid relief of itch - and associated improvement of sleep - are highly valued clinical outcomes for patients. Nemolizumab is an IL-31A-receptor inhibitor that modulates the neuroimmune response with reported positive efficacy and safety data in a phase 2 study of PN. OBJECTIVES: To evaluate the onset of action of nemolizumab on itch and sleep disturbances. METHODS: Post hoc analysis of a phase 2 trial of nemolizumab 0.5 mg/kg SC vs. placebo in patients (n = 70) with moderate-to-severe PN (≥20 nodules) and severe pruritus (NRS ≥ 7). Time to significant reduction was assessed for peak pruritus (PP) and sleep disturbance (SD) using numerical rating scales (NRS), also assessed was scratching time during sleep. RESULTS: Nemolizumab significantly reduced itch vs. placebo within 48 h (PP NRS -19.5% vs. -5.8%, respectively, P = 0.014). Significant difference between nemolizumab and placebo in reducing itch by ≥4 on PP NRS was achieved at Day 3 (23.5% vs. 0%, P < 0.001). A significant difference in SD NRS was reported by Day 4 (-24.0% vs. -4.3% placebo, P = 0.012). In addition, there was a separation between groups in SD responders (decrease of ≥4 points) in favour of nemolizumab by Day 2 (8.8% vs. 0%, P = 0.037). Sleep continued improving through Week 4, when there was a -56.0% reduction in SD NRS vs. -22.9% placebo (P < 0.001). Actigraphy data showed improvement in scratch/sleep duration for nemolizumab vs. placebo, respectively, by Week 1 (-32.15 vs. +28.15 min/h, P = 0.001). CONCLUSION: Nemolizumab has a rapid and robust onset of action in PN with itch reduction and improvement of sleep within 48 h.
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Prurigo , Transtornos do Sono-Vigília , Anticorpos Monoclonais Humanizados , Humanos , Prurigo/complicações , Prurigo/tratamento farmacológico , Prurido/tratamento farmacológico , Prurido/etiologia , Qualidade de Vida , Sono , Transtornos do Sono-Vigília/tratamento farmacológico , Transtornos do Sono-Vigília/etiologiaRESUMO
BACKGROUND: Several inflammatory dermatoses, including dermatomyositis (DM), may present as erythematous papules or plaques on the dorsal aspects of the hands over the joints. Limited skin involvement in these entities may pose a diagnostic challenge. (Video)dermoscopy is being utilized more frequently to aid in the differential diagnosis of inflammatory skin conditions. OBJECTIVE: To describe the dermoscopic findings in Gottron's papules and compare them with dermoscopic features of other dermatoses involving the dorsal aspects of the hands. METHODS: Videodermoscopic images from patients presenting with erythematous papules or plaques on the dorsal surface of the hands were retrospectively analysed for the presence of standardized dermoscopic parameters. RESULTS: Dermoscopic images from patients with DM (n = 12), psoriasis (n = 19), chronic dermatitis (n = 16), mycosis fungoides (n = 7), lichen planus (n = 5) and pityriasis rubra pilaris (n = 3) were included. Gottron's papules were characterized by pleomorphic vessels (dotted vessels accompanied by thick or thin linear vessels with branches or linear curved vessels) in 66.7% of cases, arranged in an unspecified pattern (91.7%), and accompanied by white or pink structureless areas (75.0%). Psoriatic plaques were characterized by dotted vessels arranged in a uniform pattern (94.7%). Vessels arranged in a ring pattern were nearly exclusively observed in psoriasis, while yellow structureless areas and erosions were more frequently present in chronic dermatitis. White lines, corresponding to Wickham striae, were specific for lichen planus. CONCLUSIONS: Videodermoscopy might be of value in differentiating Gottron's papules from other dermatoses involving dorsa of the hands.
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Dermatite , Dermatomiosite , Líquen Plano , Psoríase , Neoplasias Cutâneas , Dermatite/complicações , Dermatite/diagnóstico , Dermatomiosite/complicações , Dermoscopia/métodos , Humanos , Inflamação/complicações , Líquen Plano/complicações , Líquen Plano/diagnóstico por imagem , Psoríase/complicações , Psoríase/diagnóstico por imagem , Estudos Retrospectivos , Neoplasias Cutâneas/complicaçõesRESUMO
BACKGROUND: Treatment of prurigo nodularis (PN) is challenging and new treatment options are needed. OBJECTIVE: To evaluate the efficacy and safety of two oral doses of the kappa opioid agonist and mu opioid antagonist nalbuphine extended release (NAL-ER) tablets in a phase 2, multicentre, randomized, double-blind, placebo-controlled trial with an open-label, 50-week extension phase. METHODS: Subjects with moderate-to-severe PN were randomized to NAL-ER 81 mg (NAL-ER81) or 162 mg (NAL-ER162) tablets twice-daily or placebo for 8 weeks of stable dosing following a 2-week titration period. Subjects completing Week 10 with a Worst Itch Numerical Rating Scale (WI-NRS) score ≥5 at the time of rollover (or during the observation period) were eligible for open-label treatment. RESULTS: Of 63 randomized subjects, 62 were treated and comprised the modified intent-to-treat population (MITT), 50 completed 10 weeks of treatment. In the MITT analysis, 8 subjects (44.4%) treated with NAL-ER162 (P = 0.32) and 6 (27.3%) treated with NAL-ER81 (P = 0.78) achieved ≥30% reduction from baseline in 7-day WI-NRS at Week 10 (primary efficacy endpoint) vs. 8 (36.4%) in the placebo group. Itch reduction was significant among 8/12 (66.7%) subjects completing Week 10 treated with NAL-ER162 vs. placebo (8/20, 40.0%; P = 0.03). Additionally, 6 subjects (33.3%) treated with NAL-ER162 and 3 (13.6%) treated with NAL-ER81 achieved ≥50% reduction from baseline in 7-day WI-NRS at Week 10 (coprimary endpoint). Extended open-label treatment was associated with further improvements in itch reduction and favourable changes in PN lesion activity as assessed by Prurigo Activity Score. Adverse events occurred predominantly during dose titration and were of mild-to-moderate severity. The safety profile did not change with extended open-label treatment. CONCLUSION: In adult subjects with PN, oral treatment with NAL-ER 162 mg twice daily provided measurable anti-pruritic efficacy in subjects completing ≥10 weeks of treatment and was well tolerated (ClinicalTrials.gov: NCT02174419).
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Gastroenteropatias , Nalbufina , Prurigo , Adulto , Método Duplo-Cego , Humanos , Nalbufina/efeitos adversos , Prurigo/complicações , Prurigo/tratamento farmacológico , Prurido/induzido quimicamente , Prurido/complicações , Prurido/tratamento farmacológico , Resultado do TratamentoAssuntos
Prurigo , Causalidade , Humanos , Prurigo/diagnóstico , Prurido/diagnóstico , Prurido/etiologiaAssuntos
Fármacos Dermatológicos , Doenças da Unha , Psoríase , Anticorpos Monoclonais Humanizados , Criança , Fármacos Dermatológicos/uso terapêutico , Humanos , Doenças da Unha/tratamento farmacológico , Psoríase/complicações , Psoríase/tratamento farmacológico , Índice de Gravidade de Doença , Resultado do TratamentoRESUMO
BACKGROUND: Chronic pruritus (CP) is a subjective symptom, and it is necessary to assess its intensity with validated patient-reported outcome tools in order to allow determination of the treatment course. OBJECTIVES: So far, the itch intensity scales were validated in small cohorts and in single languages. Here, we report the validation of the numerical rating scale, the verbal rating scale and the visual analogue scale for the worst and average pruritus intensity in the last 24h in several languages across Europe and across different pruritic dermatoses. METHODS: After professional translation, the intensity scales were digitized for use as a tablet computer application. Validation was performed in clinics for Dermatology in Austria, France, Germany, Italy, Poland, Russia, Spain, Switzerland and Turkey. RESULTS: A total of 547 patients with contact dermatitis, chronic nodular prurigo, psoriasis vulgaris, lichen planus or cutaneous T-cell lymphoma were included. The intensity scales showed a high level of reproducibility and inter-correlations with each other. The correlation with the Dermatology Life Quality Index was weak to strong in nearly all countries and dermatoses with the exception of France and patients with chronic nodular prurigo, for which no statistically significant correlations were found. CONCLUSIONS: The numerical rating scale, the verbal rating scale und the visual analogue scales are valid instruments with good reproducibility and internal consistency in German (Germany, Austria, Switzerland), French, Italian, Polish, Russian, Spanish and Turkish for different pruritic dermatoses. VAS worst was the best reproducible and consistent measuring instrument in all countries.
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Prurido , Qualidade de Vida , Áustria , Europa (Continente) , França , Alemanha , Humanos , Itália , Polônia , Estudos Prospectivos , Prurido/diagnóstico , Prurido/epidemiologia , Reprodutibilidade dos Testes , Federação Russa , Índice de Gravidade de Doença , Espanha , Inquéritos e Questionários , Suíça/epidemiologia , TurquiaAssuntos
Dermatite Atópica , Eczema , Adulto , Criança , Dermatite Atópica/diagnóstico , Humanos , Índice de Gravidade de DoençaRESUMO
BACKGROUND: Psoriasis is a chronic skin condition that in one third of cases starts in the first two decades of life. The disease might impact the quality of life (QoL) of the affected children and their caregivers. The issue of gender differences in the assessment of psychological burden of dermatological conditions has been the subject of few studies with contradictory results. OBJECTIVES: The aim of this study was to investigate the differences in the impact of childhood psoriasis on mothers' and fathers' well-being using Family Dermatology Life Quality Index (FDLQI). METHODS: Forty-five children with psoriasis (31 girls and 14 boys; mean age ± standard deviation (SD) 10.53 ± 3.44 years) and their parents (45 mothers and 45 fathers) were included in the study. Both parents of each child were asked to separately fill in the validated Polish version of the FDLQI questionnaire. RESULTS: Comparing the FDLQI scores, the QoL of mothers was significantly more impaired than the QoL of fathers (13.44 ± 6.46 versus 9.53 ± 6.12 points; P < 0.0001). In mothers, childhood psoriasis had a significantly greater impact in the areas of emotional distress (P = 0.007), dealing with other people's reactions (P < 0.0001), social life (P = 0.02), amount of time spent caring for the child's skin (P = 0.0001) and extra housework (P = 0.0005), compared to fathers. The FDLQI scores of both mothers and fathers were independent of the impairment of children's QoL or the severity of psoriasis, except for positive correlation between mothers' FDLQI scores and children's BSA (R = 0.31; P = 0.03). CONCLUSIONS: Differences in the impact of childhood skin diseases on mothers' and fathers' well-being should be taken into consideration while developing educational programmes for patients and their families. There is a need for further, multi-centre research that would take into account geographical and cultural differences, in order to reliably assess the impact of childhood psoriasis on various aspects of caregivers' QoL.