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1.
Lasers Surg Med ; 55(1): 105-115, 2023 01.
Artigo em Inglês | MEDLINE | ID: mdl-36229952

RESUMO

OBJECTIVE: Microwave thermolysis (MWT) is an emerging treatment for axillary hyperhidrosis reducing both sweat and odor. No prior studies have investigated and compared the different available energy settings of the MWT device. This study evaluated patient-reported outcome measures (PROMs) for axillary hyperhidrosis and osmidrosis following MWT treatment with two different energy levels. METHODS: Twenty adults with axillary hyperhidrosis and osmidrosis reported sweat on Hyperhidrosis Disease Severity scale (HDSS: 1-4) and odor on Odor scale (OS: 1-10), respectively, supplemented by overall Dermatology Life Quality Index (DLQI: 0-30). This was a prospective, randomized, patient-blinded and intraindividually controlled study with 3 months follow-up (FU). Randomization comprised MWT treatment of one axilla with a standard medium energy setting (energy level 3) and the contralateral axilla with a standard high energy setting (energy level 5). RESULTS: At baseline, patients reported substantial sweat and odor, negatively affecting their quality of life. At 3 months FU, PROMs showed improved quality of life with significantly reduced odor and sweat. Overall DLQI was reduced from a median of 10 to 4, with a median 6.5-point reduction (p = 0.0002). HDSS was reduced from a median of 4 to 2 on both sides, with a median reduction of 1 for medium energy level and 2 points for high energy level (p = 0.014). OS was reduced from a median of 8 to 3 for both energy levels, with a median reduction of 3.5 and 4.5 points for the medium and high energy level, respectively (p = 0.017). Local skin reactions were mild and transient, but slightly more pronounced following treatment with the high energy level. CONCLUSION: MWT effectively improved patients' quality of life, axillary sweat, and odor 3 months after on baseline treatment. Treatment with the high energy level presented a subtle but significant increase of efficacy based on PROMs for both sweat and odor. Patients were willing to accept a higher amount of temporary local skin reactions from a higher energy setting when experiencing greater odor and sweat reduction.


Assuntos
Hiperidrose , Micro-Ondas , Adulto , Humanos , Micro-Ondas/uso terapêutico , Axila , Qualidade de Vida , Estudos Prospectivos , Resultado do Tratamento , Índice de Gravidade de Doença , Hiperidrose/terapia , Medidas de Resultados Relatados pelo Paciente
2.
J Eur Acad Dermatol Venereol ; 36(2): 263-270, 2022 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-34747547

RESUMO

BACKGROUND: Occupational hand eczema is common among hairdressers and implementing effective preventive measures requires a good understanding of the disease's epidemiology. OBJECTIVE: To investigate the long-term development of hand eczema (HE) in hairdressers. METHODS: A prospective cohort study of all hairdressers graduating from Danish hairdressing vocational schools from 1985 to 2007 was conducted. A self-administered questionnaire was sent in 2009 with follow-up in 2020. Data from the Danish labour market supplementary pension scheme provided information on yearly affiliation with the hairdressing trade. RESULTS: The cumulative lifetime prevalence of HE increased from 42.3% at baseline to 45.2% at follow-up (odds ratio [OR], 1.1; 95% confidence interval [CI], 1.0-1.2). The incidence rate decreased from 42.8 cases/1000 person-years (95% CI, 40.8-44.8) at baseline to 3.4 cases/1000 person-years (95% CI, 2.5-4.6) within the follow-up period. HE onset occurred within 8 years of beginning an apprenticeship for >90% of cases and occurred within the apprenticeship period for 68% of cases. The risk factors associated with having had HE at baseline were a previous positive patch test (adjusted OR [aOR], 5.3; 95% CI, 4.2-6.6), a history of atopic dermatitis (aOR, 3.4; 95% CI, 2.9-4.0) and female sex (aOR, 1.8; 95% CI 1.4-2.3). The most important risk factors at follow-up were previous HE (aOR, 10.1; 95% CI, 7.3-13.8) and a positive patch test within the follow-up period (aOR, 4.5; 95% CI, 3.0-6.8). Among the hairdressers who had HE at baseline, 65.5% exhibited remission, whereas 34.6% had persistent and often severe HE at follow-up. Hairdressers with persistent HE were the subgroup of the study population most frequently affected by the risk factors identified for HE. CONCLUSIONS: Primary prevention of HE should focus on hairdressing apprentices and fully trained hairdressers who have recently graduated. Approximately one-third of trained hairdressers develop persistent and often severe HE, emphasizing the need for early intervention.


Assuntos
Dermatite Ocupacional , Eczema , Dermatoses da Mão , Dinamarca/epidemiologia , Dermatite Ocupacional/epidemiologia , Dermatite Ocupacional/etiologia , Eczema/epidemiologia , Feminino , Seguimentos , Dermatoses da Mão/epidemiologia , Dermatoses da Mão/etiologia , Humanos , Prevalência , Estudos Prospectivos
3.
J Eur Acad Dermatol Venereol ; 34(7): 1516-1523, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31989688

RESUMO

BACKGROUND: Clinical studies on psoriasis in adolescents have mainly been performed in patients with severe psoriasis. Population-based studies of clinical characteristics and risk factors for later cardiovascular and metabolic disease in children and adolescents are lacking. OBJECTIVES: To examine the clinical characteristics of adolescents with psoriasis nested in a general population cohort. Furthermore, to investigate cardiovascular and metabolic risk factors in the adolescents with psoriasis compared to parentally predisposed and non-predisposed adolescents without psoriasis from the same birth cohort. METHODS: We identified adolescents with and without psoriasis using a nationwide general population birth cohort in Denmark. A clinical examination included skin inspection and scoring of psoriasis severity, completion of a questionnaire on psoriasis and comorbidities, physical measurements, and blood sampling. Participants also completed self-administered questionnaires on quality of life and mental health. RESULTS: We included 81 adolescents with psoriasis and 234 controls (110 with genetic predisposition for psoriasis and 124 without predisposition). Median age was 15.6 (13.5-18.5) years, and in those with active psoriasis, median Psoriasis Area and Severity Index score was 1.2 (0.1-11.4). The scalp was the most common site of psoriasis, both at debut and at time of examination. Diaper rash in infancy was more frequent in the psoriasis group. No significant differences regarding quality of life, anxiety and depression were found. More adolescents with psoriasis were obese (8.6% vs. 1.7%, P = 0.008), and physical measures of abdominal obesity were also significantly higher. HbA1c was significantly higher (31.55 vs. 30.81 mmol/mol, P = 0.048), while no differences were found for blood pressure, lipids or high-sensitivity C-reactive protein. In a subgroup analysis, this was evident in the non-predisposed psoriasis-free controls only. CONCLUSIONS: Overall, adolescents with psoriasis from this general population had mild disease. Still, early markers of cardiovascular and metabolic disease were elevated.


Assuntos
Doenças Cardiovasculares , Psoríase , Adolescente , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/etiologia , Criança , Humanos , Obesidade , Psoríase/epidemiologia , Qualidade de Vida , Fatores de Risco , Inquéritos e Questionários
4.
Br J Dermatol ; 181(2): 332-337, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-30677133

RESUMO

BACKGROUND: Traditionally, psoriasis in certain body sites such as the scalp, nails, palms, soles and intertriginous areas has been acknowledged as difficult to treat. OBJECTIVES: To investigate the body location of treatment-resistant psoriasis in patients treated with biologic agents in real-world clinical practice, and to study the association between localization and quality of life. METHODS: This was an observational, noninterventional, study. We investigated the skin and/or nail location of treatment-resistant psoriasis in patients with moderate-to-severe psoriasis treated for > 6 months with biologic agents. A partial or good response to treatment was defined as having a Psoriasis Area and Severity Index (PASI) score ≥ 1 and ≤ 5. Experienced PASI assessors used a uniform data collection form in which the body area was divided into 26 regions and 20 nails. RESULTS: We included 146 patients with chronic plaque-type psoriasis (109 men, 74·7%, mean ± SD age 49·8 ± 13·7 years), with a median PASI score of 2·4 (interquartile range 1·2-3·2). The median PASI reduction from treatment initiation was 86·1% (interquartile range 78·1-91·3). The most common site of recalcitrant psoriasis was the anterior lower leg [49·3%; 95% confidence interval (CI) 41·2-57·4]. Further common sites of recalcitrant psoriasis were the posterior lower leg (24·7%; 95% CI 17·7-31·6), elbow (35·6%; 95% CI 27·8-43·4) and the scalp (19·2%; 95% CI 12·8-25·6%). No association between Dermatology Life Quality Index and specific areas of recalcitrant psoriasis were observed. CONCLUSIONS: In real-world clinical practice, the most common sites of recalcitrant psoriasis in patients treated with biologic agents are the anterior lower leg, posterior lower leg and elbows. Recalcitrant psoriasis in no specific area caused a greater impact on quality of life than any other area.


Assuntos
Produtos Biológicos/farmacologia , Psoríase/tratamento farmacológico , Qualidade de Vida , Adulto , Produtos Biológicos/uso terapêutico , Resistência a Medicamentos , Cotovelo , Feminino , Humanos , Perna (Membro) , Masculino , Pessoa de Meia-Idade , Psoríase/complicações , Psoríase/diagnóstico , Índice de Gravidade de Doença
5.
Br J Dermatol ; 179(2): 301-308, 2018 08.
Artigo em Inglês | MEDLINE | ID: mdl-29363093

RESUMO

BACKGROUND: Treatment and care of moderate-to-severe psoriasis require lifelong consultations with a dermatologist with close monitoring of systemic treatment. OBJECTIVES: To investigate the effect of patient-initiated care consultation (PICC) for patients with psoriasis in a dermatology outpatient clinic. METHODS: A prospective randomized controlled trial with patients on well-controlled systemic treatment randomized to either (i) the PICC group, where they participated in one annual consultation with a dermatologist but were able to initiate consultations when needed; or (ii) routine care, where they participated in a consultation every 12-16 weeks. The primary outcome was the Dermatology Life Quality Index (DLQI). Other outcomes were safety, patient adherence and satisfaction with healthcare assessed at baseline and after 52 weeks. The study was registered with clinical trials number NCT02382081. RESULTS: In total 150 patients were included, with 58·0% treated with biologics, 37·3% with methotrexate and 4·7% with acitretin. At week 52 no statistically significant mean difference between groups was detected in DLQI (0·28, 95% confidence interval -0·35 to 0·9) or Psoriasis Area and Severity Index (-0·24, 95% confidence interval -0·84 to 0·36). Patients in the PICC group requested 63% fewer consultations with a dermatologist: mean 2·5 ± 0·1 vs. 5·1 ± 0·6 (P = 0·001). Patient adherence and safety with treatment monitoring were equal between groups, but the PICC group was significantly better at attending consultations than the control group (P = 0·003). CONCLUSIONS: PICC offers additional clinical benefits over routine care, making patients less dependent on clinical visits. The intervention adds no harm to monitoring systemic treatment, and patients report high quality of life and satisfaction with healthcare.


Assuntos
Fármacos Dermatológicos/uso terapêutico , Participação do Paciente , Psoríase/tratamento farmacológico , Qualidade de Vida , Encaminhamento e Consulta , Adulto , Idoso , Dermatologistas , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Cooperação do Paciente/estatística & dados numéricos , Satisfação do Paciente/estatística & dados numéricos , Estudos Prospectivos , Psoríase/diagnóstico , Psoríase/psicologia , Índice de Gravidade de Doença , Resultado do Tratamento
6.
Br J Dermatol ; 179(6): 1376-1384, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-29704428

RESUMO

BACKGROUND: Sleep is essential for daytime functioning and health. Given the physical symptoms of psoriasis, a higher prevalence of sleep disorders can be expected. So far, the studies examining sleep disturbance in psoriasis have been of less-than-optimal methodological quality and with mixed results. OBJECTIVES: To examine the prevalence of sleep disturbance in patients with plaque psoriasis compared with a control group, to evaluate associations with health-related quality of life (HRQoL) and examine possible disease-related predictors of disturbed sleep. METHODS: We used a cross-sectional, case-controlled design. Participants included 179 consecutively recruited patients with plaque psoriasis and 105 controls. Measures included psoriasis severity (Psoriasis Area and Severity Index); HRQoL (Dermatology Life Quality Index); insomnia severity [Insomnia Severity Index (ISI)]; sleep quality [Pittsburgh Sleep Quality Index (PSQI)]; stress (Perceived Stress Scale); itch (Itch Severity Scale); and depressive symptoms (Beck Depression Inventory). Analyses included group comparisons and regression analyses to identify predictors of sleep disturbance. RESULTS: A total of 25% of patients with psoriasis reported clinical insomnia (ISI > 15), compared with 10·5% of controls. In all, 53·6% of patients with psoriasis were poor sleepers (PSQI > 5), compared with 21·9% of controls. Itch was statistically significantly associated with all sleep-related outcomes. CONCLUSIONS: A higher proportion of patients with psoriasis experience poor sleep than controls from the general population. Itch was the main predictor of impaired sleep. Improved control of psoriasis with decreased itch may improve sleep disturbance in psoriasis.


Assuntos
Prurido/epidemiologia , Psoríase/complicações , Qualidade de Vida , Transtornos do Sono-Vigília/epidemiologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos de Casos e Controles , Estudos Transversais , Depressão/diagnóstico , Depressão/epidemiologia , Depressão/psicologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prevalência , Prurido/etiologia , Psoríase/diagnóstico , Psoríase/psicologia , Escalas de Graduação Psiquiátrica/estatística & dados numéricos , Índice de Gravidade de Doença , Transtornos do Sono-Vigília/etiologia , Transtornos do Sono-Vigília/psicologia , Inquéritos e Questionários/estatística & dados numéricos , Adulto Jovem
7.
Br J Dermatol ; 178(4): 879-888, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-29172235

RESUMO

BACKGROUND: Atopic dermatitis (AD) and hand eczema (HE) are common chronic and relapsing inflammatory skin conditions that often co-occur. OBJECTIVES: While several studies have addressed their relationship, the exact association estimate is unknown. METHODS: We systematically reviewed published literature on the association between AD and HE in PubMed, Embase and Web of Science using the following search terms: (atopic dermatitis OR atopic eczema) AND (hand dermatitis OR hand eczema). Meta-analyses were then performed to examine the association between AD and the point, 1-year and lifetime prevalence of HE, respectively. RESULTS: We identified 35 relevant studies, of which 26 were included in the meta-analyses. AD was associated with an increased prevalence of HE with regard to point [odds ratio (OR) 2·35; 95% confidence interval (CI) 1·47-3·76], 1-year (OR 4·29; 95% CI 3·13-5·88) and lifetime prevalence (OR 4·06; 95% CI 2·72-6·06). Furthermore, positive associations between AD and occupational HE were identified when assessing the 1-year (OR 4·31; 95% CI 2·08-8·91) and lifetime prevalence (OR 2·81; 95% CI 2·08-3·79). Similar positive associations were found in the general population studies, i.e. OR 4·19 (95% CI 3·46-5·08) and OR 5·69 (95% CI 4·41-7·36). CONCLUSIONS: Important study limitations include the wide use of questionnaire studies, and lack of prospective studies as well as poor clinical phenotype descriptions. In conclusion, our systematic review and meta-analysis showed that patients with AD had a strongly increased prevalence of HE. Clinicians should continue to guide patients with AD away from occupations with a high risk of HE.


Assuntos
Dermatite Atópica/complicações , Eczema/complicações , Dermatoses da Mão/complicações , Adulto , Criança , Dermatite Atópica/epidemiologia , Dermatite Ocupacional/complicações , Dermatite Ocupacional/epidemiologia , Eczema/epidemiologia , Feminino , Dermatoses da Mão/epidemiologia , Humanos , Masculino , Prevalência
8.
J Eur Acad Dermatol Venereol ; 32(1): 79-85, 2018 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-28796916

RESUMO

BACKGROUND: More than 25% of the adult European population suffers from contact allergy, with fragrance substances recognized as one of the main causes. Since 2005, 26 fragrance contact allergens have been mandatory to label in cosmetic products within the EU if present at 10 ppm or above in leave-on and 100 ppm or above in wash-off cosmetics. OBJECTIVE: To examine exposure, based on ingredient labelling, to the 26 fragrances in a sample of 5588 fragranced cosmetic products. METHODS: The investigated products were identified through a novel, non-profit smartphone application (app), designed to provide information to consumers about chemical substances in cosmetic products. Products registered through the app between December 2015 and October 2016 were label checked according to International Nomenclature of Cosmetic Ingredients (INCI) for the presence of the 26 fragrance substances or the wording 'fragrance/parfum/aroma'. RESULTS: The largest product categories investigated were 'cream, lotion and oil' (n = 1192), 'shampoo and conditioner' (n = 968) and 'deodorants' (n = 632). Among cosmetic products labelled to contain at least one of the 26 fragrances, 85.5% and 73.9% contained at least two and at least three of the 26 fragrances, respectively. Linalool (49.5%) and limonene (48.5%) were labelled most often among all investigated products. Hydroxyisohexyl 3-cyclohexene carboxaldehyde (HICC/Lyral® ) was found in 13.5% of deodorants. Six of the 26 fragrance substances were labelled on less than one per cent of all products, including the natural extracts Evernia furfuracea (tree moss) and Evernia prunastri (oak moss). A total of 329 (5.9%) products had one or more of the 26 fragrance substances labelled but did not have 'parfum/fragrance/aroma' listed on the label. CONCLUSIONS: Consumers are widely exposed to, often multiple, well-established fragrance contact allergens through various cosmetic products intended for daily use. Several fragrance substances that are common causes of contact allergy were rarely labelled in this large sample of cosmetic products.


Assuntos
Desodorantes/química , Dermatite Alérgica de Contato/etiologia , Preparações para Cabelo/química , Aplicativos Móveis , Perfumes/análise , Creme para a Pele/química , Monoterpenos Acíclicos , Aldeídos/análise , Cicloexenos/análise , Humanos , Limoneno , Monoterpenos/análise , Perfumes/efeitos adversos , Extratos Vegetais/análise , Smartphone , Terpenos/análise
9.
Br J Dermatol ; 177(1): 47-62, 2017 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-27580411

RESUMO

The recognition of the central role of interleukin (IL)-17A in the pathogenesis of psoriasis has led to the development of several monoclonal antibodies targeting this cytokine or its receptors for therapeutic purposes. IL-17A also plays an important role in immunological protection against infections, especially those due to Candida spp., as evidenced by findings in patients with genetic defects in IL-17-related immune responses. To assess the potential of anti-IL-17 treatment to promote Candida infections, here we have systematically reviewed published clinical trials of patients with psoriasis or psoriatic arthritis. Candida infections were reported in 4·0% of patients treated with brodalumab, 1·7% with secukinumab and 3·3% with ixekizumab vs. 0·3%, 2·3% and 0·8% of those assigned to placebo, ustekinumab or etanercept, respectively. Although the incidence of Candida infection was found to be increased by only a small degree during anti-IL-17 therapy, patients undergoing such treatment should be monitored for fungal infection and treated as necessary. We propose adoption of the recently updated recommendations for the practical management of Candida infection in patients administered IL-17 inhibitors.


Assuntos
Candidíase/complicações , Interleucina-17/antagonistas & inibidores , Infecções Oportunistas/complicações , Psoríase/complicações , Anticorpos Monoclonais/efeitos adversos , Artrite Psoriásica/complicações , Artrite Psoriásica/tratamento farmacológico , Ensaios Clínicos como Assunto , Humanos , Imunoterapia/efeitos adversos , Psoríase/tratamento farmacológico
10.
Br J Dermatol ; 176(4): 1035-1041, 2017 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-27861735

RESUMO

BACKGROUND: For more than 30 years, fragrance mix I (FMI) has been the most important screening marker for fragrance contact allergy. Meanwhile, governmental and corporate initiatives have been implemented, aimed at reducing sensitization to fragrance allergens, including the single constituents of FMI. OBJECTIVES: To examine trends in contact allergy to FMI from 1986 to 2015 in patients with dermatitis, and to test the hypothesis that sensitization to the fragrance screening marker has decreased within recent years. METHODS: This was a cross-sectional registry study on patch test results to FMI among consecutively tested patients with dermatitis from a single university clinic across three 10-year periods. From 2006 to 2015, data on eczema location according to the MOAHLFA index (male; occupation; atopic dermatitis; hand; leg; face; age ≥ 40 years), clinical relevance of sensitization, and cosmetic exposures were available. RESULTS: Of 24 168 patients, 7·8% (95% confidence interval 7·4-8·1) were sensitized to FMI. For women, a significant trend (P = 0·004) was observed for an increase in sensitization to FMI across the three decades. From 2011 to 2015, the prevalence of contact allergy to FMI increased significantly for women (8·0% vs. 10·4%, P = 0·002) and men (4·4% vs. 7·3%, P = 0·002) compared with the previous 5-year period. From 2006 to 2015, clinical relevance was established in 78·2% of FMI-positive patients with no differences over time. An increase (28·6% vs. 36·1%, P = 0·05) in FMI-positive patients suffering from facial dermatitis was observed for the period 2011 to 2015 compared with 2006 to 2010. CONCLUSIONS: The prevalence of contact allergy to FMI has been increasing in recent years. There was no demonstrable effect of previous preventive initiatives.


Assuntos
Dermatite Alérgica de Contato/epidemiologia , Perfumes/efeitos adversos , Adulto , Idoso , Artrite Reativa , Estudos Transversais , Dinamarca/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Testes do Emplastro , Prevalência
11.
Br J Dermatol ; 176(1): 176-183, 2017 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-27343839

RESUMO

BACKGROUND: In the light of the exceptionally high rates of contact allergy to the preservative methylisothiazolinone (MI), information about cross-reactivity between MI, octylisothiazolinone (OIT) and benzisothiazolinone (BIT) is needed. OBJECTIVES: To study cross-reactivity between MI and OIT, and between MI and BIT. METHODS: Immune responses to MI, OIT and BIT were studied in vehicle and MI-sensitized female CBA mice by a modified local lymph node assay. The inflammatory response was measured by ear thickness, cell proliferation of CD4+ and CD8+ T cells, and CD19+ B cells in the auricular draining lymph nodes. RESULTS: MI induced significant, strong, concentration-dependent immune responses in the draining lymph nodes following a sensitization phase of three consecutive days. Groups of MI-sensitized mice were challenged on day 23 with 0·4% MI, 0·7% OIT and 1·9% BIT - concentrations corresponding to their individual EC3 values. No statistically significant difference in proliferation of CD4+ and CD8+ T cells was observed between mice challenged with MI compared with mice challenged with BIT and OIT. CONCLUSIONS: The data indicate cross-reactivity between MI, OIT and BIT, when the potency of the chemical was taken into account in choice of challenge concentration. This means that MI-sensitized individuals may react to OIT and BIT if exposed to sufficient concentrations.


Assuntos
Desinfetantes/farmacologia , Linfonodos/efeitos dos fármacos , Tiazóis/farmacologia , Animais , Linfócitos B/efeitos dos fármacos , Linfócitos B/imunologia , Linfócitos T CD4-Positivos/efeitos dos fármacos , Linfócitos T CD4-Positivos/imunologia , Linfócitos T CD8-Positivos/efeitos dos fármacos , Linfócitos T CD8-Positivos/imunologia , Proliferação de Células/efeitos dos fármacos , Relação Dose-Resposta a Droga , Interações Medicamentosas , Orelha Externa/efeitos dos fármacos , Feminino , Imunidade Celular/fisiologia , Ensaio Local de Linfonodo , Linfonodos/imunologia , Ativação Linfocitária/efeitos dos fármacos , Ativação Linfocitária/imunologia , Camundongos , Camundongos Endogâmicos CBA , Tiazóis/administração & dosagem , Tiazóis/síntese química , Tiazóis/química
12.
Br J Dermatol ; 177(6): 1495-1502, 2017 12.
Artigo em Inglês | MEDLINE | ID: mdl-28646580

RESUMO

The introduction of biological drugs for the treatment of patients with psoriasis has revolutionized treatment paradigms and enabled numerous patients to achieve disease control with an acceptable safety profile. However, the high cost of biologics limits access to these medications for the majority of patients worldwide. In recent years, the introduction of biosimilars for inflammatory diseases has become a fast evolving field. The future use of biosimilars offers the potential for decreased cost and increased access to biologics for patients with psoriasis. For approval of biosimilars, different regulatory agencies use highly variable methods for definition, production, approval, marketing and postmarketing surveillance. Due to potential interchangeability between biologics and biosimilars, traceability and pharmacovigilance are required to collect accurate data about adverse events in patients with psoriasis; spontaneous reporting, registries and use of 'big data' should facilitate this process on a global basis. The current article describes biosimilar regulatory guidelines and examples of biosimilar uptake in clinical practice in several countries around the world. As it is apparent that biological therapy treatment decisions may become more physician independent, the International Psoriasis Council recommends that dermatologists should take an active role in the development of biosimilar prescribing policies with their respective healthcare settings and government agencies.


Assuntos
Medicamentos Biossimilares/uso terapêutico , Fármacos Dermatológicos/uso terapêutico , Psoríase/tratamento farmacológico , Medicamentos Biossimilares/efeitos adversos , Fármacos Dermatológicos/efeitos adversos , Dermatologistas/psicologia , Aprovação de Drogas , Saúde Global , Humanos , Legislação de Medicamentos , Guias de Prática Clínica como Assunto , Padrões de Prática Médica , Vigilância de Produtos Comercializados
13.
Br J Dermatol ; 177(1): 23-33, 2017 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-27639072

RESUMO

Biosimilars are drugs that are similar, but not identical, to originator biologics. Preclinical analytical studies are required to show similarity on a molecular and structural level, but efficacy and safety studies in humans are essential to determining biosimilarity. In this review, written by members of the International Psoriasis Council, we discuss how biosimilars are evaluated in a clinical setting, with emphasis on extrapolation of indication, interchangeability and optimal clinical trial design.


Assuntos
Medicamentos Biossimilares/uso terapêutico , Psoríase/tratamento farmacológico , Anticorpos Monoclonais Humanizados/uso terapêutico , Ensaios Clínicos como Assunto , Aprovação de Drogas , Humanos , Guias de Prática Clínica como Assunto
14.
Dermatol Ther ; 30(6)2017 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-28906051

RESUMO

Secukinumab (anti-IL17A) is effective as treatment for moderate to severe plaque psoriasis, but real-life data on effectiveness and safety lack. We aimed to present real-life data of all Danish patients treated with secukinumab (n = 69). At baseline, before initiation of treatment with secukinumab 300 mg (47.8%) or off-label treatment with secukinumab 150 mg (52.2%), the median PASI score was 7.1. A total of 66.7% (34/51) and 52.9% (27/51) of patients still on secukinumab at week 12 achieved a PASI (Psoriasis Area and Severity Index)-50 and PASI-75 of 66.7% and 52.9%, respectively. A total of 83.0% (44/53) and 60.4% (32/53) of the patients had a PASI-score < 5 and PASI-score < 2, respectively, after 12 weeks on treatment with secukinumab. A third of the patients had secukinumab discontinued due to limited clinical improvement or adverse events (n = 23) within a median of 92 days (interquartile range 51-212 days). Notably, the majority of the patients may represent a particularly difficult-to-treat group of patients, as 92.8% had been refractory to other biologic treatment. A total of 26.1% (n = 18) experienced adverse events. Secukinumab appears to be an effective treatment option with a favorable side effect profile in patients with plaque psoriasis who are refractory to or have side effects of traditional biologic drugs.


Assuntos
Anticorpos Monoclonais/uso terapêutico , Fármacos Dermatológicos/uso terapêutico , Psoríase/tratamento farmacológico , Pele/efeitos dos fármacos , Adulto , Anticorpos Monoclonais/efeitos adversos , Anticorpos Monoclonais Humanizados , Dinamarca , Fármacos Dermatológicos/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Psoríase/diagnóstico , Psoríase/imunologia , Indução de Remissão , Estudos Retrospectivos , Índice de Gravidade de Doença , Pele/imunologia , Pele/patologia , Fatores de Tempo , Resultado do Tratamento
17.
J Eur Acad Dermatol Venereol ; 31(5): 887-893, 2017 May.
Artigo em Inglês | MEDLINE | ID: mdl-28000306

RESUMO

BACKGROUND: Lichen planus (LP) is a chronic inflammatory disease of unknown aetiology affecting the skin and oral mucosa. Oral lichenoid lesions (OLLs), like oral contact reactions, may resemble oral lichen planus (OLP) both clinically and histopathologically. As OLP and OLL are hyperkeratotic diseases and filaggrin is essential to keratinization, the distribution of filaggrin may be altered in these lesions. OBJECTIVES: To investigate whether patients with OLP/OLL have (i) altered distribution of filaggrin in the oral mucosa; (ii) a higher incidence of mutations in the filaggrin gene (FLG); (iii) active dermatoses, apart from cutaneous LP, than healthy controls; and (iv) patients with OLP/OLL and a defect in the FLG have more widespread oral lesions and report more symptoms than OLP/OLL patients without a concomitant defect in the FLG. METHODS: Forty-nine Caucasian patients (42 women and 7 men, mean age 61.0 ± 10.3 years), with symptomatic OLP, OLL or stomatitis, and 29 matched healthy controls underwent a clinical oral and dermatological examination, oral mucosal biopsy and filaggrin genotyping (testing for R2447X, R501X, 2282del4). Smear tests for Candida spp. were performed in all patients to exclude oral candidiasis. Immunohistochemistry were performed using poly- and monoclonal filaggrin antibodies. RESULTS: The immunoreactivity for filaggrin was significantly more intense in the oral mucosa in the patients with OLP/OLL compared with healthy controls (P = 0.000025). No difference was noted in the incidence of defects in the FLG and active dermatoses between patients and healthy controls. No difference was noted in extension and number of symptoms reported by patients with OLP/OLL with or without a concomitant defect in the FLG. CONCLUSION: OLP/OLL is associated with an altered distribution of filaggrin in the oral mucosa independently of defects in the FLG. Patients with OLP/OLL did not display more active dermatoses other than cutaneous LP when compared to healthy controls.


Assuntos
Proteínas de Filamentos Intermediários/genética , Líquen Plano Bucal/genética , Mucosa Bucal/metabolismo , Mutação , Adulto , Idoso , Estudos de Casos e Controles , Feminino , Proteínas Filagrinas , Humanos , Proteínas de Filamentos Intermediários/metabolismo , Líquen Plano Bucal/metabolismo , Líquen Plano Bucal/patologia , Masculino , Pessoa de Meia-Idade
18.
Clin Oral Investig ; 21(8): 2543-2551, 2017 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-28084550

RESUMO

OBJECTIVE: Dental materials and oral hygiene products may be responsible for oral contact allergic reactions. We aimed to determine the occurrence of allergies in patients with symptomatic oral lichen planus (OLP), oral lichenoid lesions (OLLs) and stomatitis and investigate if patch testing could identify contact allergies to dental materials and oral hygiene products in these patients. METHODS: Forty-nine patients (7 men, 42 women) aged 31 to 77 years (61 ± 10.3 years) with symptomatic OLP, OLL or stomatitis and 29 healthy age- and gender-matched control subjects were included. They underwent an interview, clinical examination, oral mucosal biopsy and epicutan testing to the European baseline series, a toothpaste and dental material series. RESULTS: Nineteen patients had OLP, 19 OLL and 11stomatitis. Oral burning/itching was the most common symptom (83.7%), and 65.3% patients had more than one symptom. Patients visited their dentist more often than the healthy subjects and had statistically higher DMF-T and DMF-S scores. Nineteen patients (38.8%) and 10 healthy control subjects (34.5%) had allergic contact reactions primarily to fragrance ingredients. No differences could be found between OLP, OLL, stomatitis and healthy controls with regard to allergic contact reactions. However, contact allergy to aroma substances differed significantly between the patients and the healthy control subjects (p = 0.02). This type of contact allergy was most common in patients with OLP and OLL (p = 0.01). Avoidance cleared symptoms in all cases. CONCLUSION/CLINICAL RELEVANCE: Allergic reactions to aroma substances in oral hygiene products are common in patients with symptomatic OLP, OLL and stomatitis.


Assuntos
Materiais Dentários/efeitos adversos , Dermatite Alérgica de Contato/etiologia , Líquen Plano Bucal/induzido quimicamente , Higiene Bucal , Estomatite/induzido quimicamente , Adulto , Idoso , Biópsia , Estudos de Casos e Controles , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Testes do Emplastro
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