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BACKGROUND AND OBJECTIVE: Psoriasis often precedes the onset of psoriatic arthritis (PsA), so dermatologists often face the challenge of early identifying signs of PsA in patients with psoriasis. Our aim was to validate the Spanish version of the PURE-4 questionnaire as a screening tool for PsA, evaluate its performance in terms of sensitivity, specificity, feasibility, reliability, and build validity. METHODS: This was a cross-sectional, observational, multicenter trial of adult patients with psoriasis. Initially, patients were assessed by a dermatologist and completed 2 self-administered versions (in print and online) of the PURE-4 questionnaire. Afterwards, the rheumatologist, blinded to the PURE-4 results, assessed the presence/absence of PsA, being the reference to determine the performance of the PURE-4 questionnaire. RESULTS: A total of 268 patients were included (115 [42.9%] women; mean age, 47.1±12.6). The prevalence of PsA according to rheumatologist diagnosis was 12.7% (34 patients). The mean PURE-4 score for patients with psoriasis diagnosed with PsA was 2.3±1.1, and 1.3±1.3 for patients without PsA (P<.001). The cutoff value ≥2 demonstrated the best performance for detecting PsA, with a negative predictive value of 95.1% (95% confidence interval, 90.3-97.6). CONCLUSIONS: The PURE-4 questionnaire demonstrated good performance in detecting PsA, with an optimal cutoff point ≥2. This simple tool could facilitate early referral of patients to the rheumatology unit.
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Antecedentes y objetivos La psoriasis afecta a un gran porcentaje de mujeres en edad fértil. Nuestro objetivo fue conocer las inquietudes de las mujeres con psoriasis en relación con la planificación familiar. Material y métodos Estudio observacional, descriptivo, transversal y multicéntrico realizado entre marzo del 2020 y octubre del 2021. Se recabaron datos sociodemográficos e inquietudes relacionadas con la planificación familiar de mujeres entre 18-45 años con psoriasis en placas y candidatas a recibir tratamiento sistémico. Resultados Se reclutaron 153 pacientes de 11 centros españoles (edad media: 35,4 ± 8 años, duración media de la enfermedad: 16,7 años); 38,4% de los casos tenían una enfermedad moderada/grave para los médicos, aunque la percepción de la actividad era significativamente superior para las pacientes. En una de cada tres mujeres, la enfermedad limitaba o retrasaba el deseo gestacional. Existía preocupación de que la enfermedad empeorara al tener que retirar o cambiar un fármaco o que los tratamientos perjudicaran al bebé. Alrededor de la mitad de las pacientes no había recibido información sobre planificación familiar en la consulta, especialmente aquellas mujeres sin embarazos previos. Las mujeres con tratamiento biológico (58,7%) tenían mejor situación clínica, mejor calidad de vida y menos alteraciones en la esfera sexual que las pacientes sin tratamiento biológico. Conclusiones Las pacientes con psoriasis tienen numerosas preocupaciones relacionadas con la planificación familiar. En algunos casos, estos miedos podrían llevar a retrasar y/o limitar el deseo gestacional. Sería necesario incrementar la información que se da a las pacientes y mejorar la formación de los dermatólogos en este tema (AU)
Background and objective A significant proportion of women of childbearing age have psoriasis. The aim of this study was to examine family planning concerns in this population. Material and methods Observational, descriptive, cross-sectional, multicenter study conducted between March 2020 and October 2021. We collected sociodemographic data and analyzed responses to a family planning questionnaire administered to women aged 18 to 45 years with plaque psoriasis who were candidates for systemic treatment. Results We studied 153 patients (mean [SD] age, 35.4 [8.0] years; mean disease duration, 16.7 years) being treated at 11 Spanish hospitals. Overall, 38.4% of women were considered to have moderate to severe psoriasis by their physicians; perceived severity ratings were significantly higher among women. Psoriasis affected the women's desire to become pregnant or led to their delaying pregnancy in 1 in 3 respondents. They were concerned that their condition might worsen if they had to discontinue or switch treatment or that the treatment might harm the baby. Approximately half of the women had not received family planning counseling from their physicians, and this was more likely to be the case among never-pregnant women. Women on biologic therapy (58.7%) had better psoriasis control and a better quality of life than women on other treatments. Their sexual health was also less affected. Conclusions Women with psoriasis have numerous family planning concerns, which in some cases can lead them to delay pregnancy or affect their desire to become pregnant. Dermatologists need to receive better training regarding family planning in women with psoriasis so that they can provide their patients with more and better information (AU)
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Humanos , Femenino , Embarazo , Adulto , Servicios de Planificación Familiar , Psoriasis , Calidad de Vida , Índice de Severidad de la Enfermedad , Encuestas y Cuestionarios , Estudios TransversalesRESUMEN
Background and objective A significant proportion of women of childbearing age have psoriasis. The aim of this study was to examine family planning concerns in this population. Material and methods Observational, descriptive, cross-sectional, multicenter study conducted between March 2020 and October 2021. We collected sociodemographic data and analyzed responses to a family planning questionnaire administered to women aged 18 to 45 years with plaque psoriasis who were candidates for systemic treatment. Results We studied 153 patients (mean [SD] age, 35.4 [8.0] years; mean disease duration, 16.7 years) being treated at 11 Spanish hospitals. Overall, 38.4% of women were considered to have moderate to severe psoriasis by their physicians; perceived severity ratings were significantly higher among women. Psoriasis affected the women's desire to become pregnant or led to their delaying pregnancy in 1 in 3 respondents. They were concerned that their condition might worsen if they had to discontinue or switch treatment or that the treatment might harm the baby. Approximately half of the women had not received family planning counseling from their physicians, and this was more likely to be the case among never-pregnant women. Women on biologic therapy (58.7%) had better psoriasis control and a better quality of life than women on other treatments. Their sexual health was also less affected. Conclusions Women with psoriasis have numerous family planning concerns, which in some cases can lead them to delay pregnancy or affect their desire to become pregnant. Dermatologists need to receive better training regarding family planning in women with psoriasis so that they can provide their patients with more and better information (AU)
Antecedentes y objetivos La psoriasis afecta a un gran porcentaje de mujeres en edad fértil. Nuestro objetivo fue conocer las inquietudes de las mujeres con psoriasis en relación con la planificación familiar. Material y métodos Estudio observacional, descriptivo, transversal y multicéntrico realizado entre marzo del 2020 y octubre del 2021. Se recabaron datos sociodemográficos e inquietudes relacionadas con la planificación familiar de mujeres entre 18-45 años con psoriasis en placas y candidatas a recibir tratamiento sistémico. Resultados Se reclutaron 153 pacientes de 11 centros españoles (edad media: 35,4 ± 8 años, duración media de la enfermedad: 16,7 años); 38,4% de los casos tenían una enfermedad moderada/grave para los médicos, aunque la percepción de la actividad era significativamente superior para las pacientes. En una de cada tres mujeres, la enfermedad limitaba o retrasaba el deseo gestacional. Existía preocupación de que la enfermedad empeorara al tener que retirar o cambiar un fármaco o que los tratamientos perjudicaran al bebé. Alrededor de la mitad de las pacientes no había recibido información sobre planificación familiar en la consulta, especialmente aquellas mujeres sin embarazos previos. Las mujeres con tratamiento biológico (58,7%) tenían mejor situación clínica, mejor calidad de vida y menos alteraciones en la esfera sexual que las pacientes sin tratamiento biológico. Conclusiones Las pacientes con psoriasis tienen numerosas preocupaciones relacionadas con la planificación familiar. En algunos casos, estos miedos podrían llevar a retrasar y/o limitar el deseo gestacional. Sería necesario incrementar la información que se da a las pacientes y mejorar la formación de los dermatólogos en este tema (AU)
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Humanos , Femenino , Embarazo , Adulto , Servicios de Planificación Familiar , Psoriasis , Calidad de Vida , Índice de Severidad de la Enfermedad , Encuestas y Cuestionarios , Estudios TransversalesRESUMEN
BACKGROUND AND OBJECTIVE: A significant proportion of women of childbearing age have psoriasis. The aim of this study was to examine family planning concerns in this population. MATERIAL AND METHODS: Observational, descriptive, cross-sectional, multicenter study conducted between March 2020 and October 2021. We collected sociodemographic data and analyzed responses to a family planning questionnaire administered to women aged 18 to 45 years with plaque psoriasis who were candidates for systemic treatment. RESULTS: We studied 153 patients (mean [SD] age, 35.4 [8.0] years; mean disease duration, 16.7 years) being treated at 11 Spanish hospitals. Overall, 38.4% of women were considered to have moderate to severe psoriasis by their physicians; perceived severity ratings were significantly higher among women. Psoriasis affected the women's desire to become pregnant or led to their delaying pregnancy in 1 in 3 respondents. They were concerned that their condition might worsen if they had to discontinue or switch treatment or that the treatment might harm the baby. Approximately half of the women had not received family planning counseling from their physicians, and this was more likely to be the case among never-pregnant women. Women on biologic therapy (58.7%) had better psoriasis control and a better quality of life than women on other treatments. Their sexual health was also less affected. CONCLUSIONS: Women with psoriasis have numerous family planning concerns, which in some cases can lead them to delay pregnancy or affect their desire to become pregnant. Dermatologists need to receive better training regarding family planning in women with psoriasis so that they can provide their patients with more and better information.
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Servicios de Planificación Familiar , Psoriasis , Humanos , Femenino , Embarazo , Adulto , Estudios Transversales , Calidad de Vida , Encuestas y Cuestionarios , Psoriasis/tratamiento farmacológicoRESUMEN
BACKGROUND AND OBJECTIVE: A significant proportion of women of childbearing age have psoriasis. The aim of this study was to examine family planning concerns in this population. MATERIAL AND METHODS: Observational, descriptive, cross-sectional, multicenter study conducted between March 2020 and October 2021. We collected sociodemographic data and analyzed responses to a family planning questionnaire administered to women aged 18 to 45 years with plaque psoriasis who were candidates for systemic treatment. RESULTS: We studied 153 patients (mean [SD] age, 35.4 [8.0] years; mean disease duration, 16.7 years) being treated at 11 Spanish hospitals. Overall, 38.4% of women were considered to have moderate to severe psoriasis by their physicians; perceived severity ratings were significantly higher among women. Psoriasis affected the women's desire to become pregnant or led to their delaying pregnancy in 1 in 3 respondents. They were concerned that their condition might worsen if they had to discontinue or switch treatment or that the treatment might harm the baby. Approximately half of the women had not received family planning counseling from their physicians, and this was more likely to be the case among never-pregnant women. Women on biologic therapy (58.7%) had better psoriasis control and a better quality of life than women on other treatments. Their sexual health was also less affected. CONCLUSIONS: Women with psoriasis have numerous family planning concerns, which in some cases can lead them to delay pregnancy or affect their desire to become pregnant. Dermatologists need to receive better training regarding family planning in women with psoriasis so that they can provide their patients with more and better information.
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Servicios de Planificación Familiar , Psoriasis , Humanos , Femenino , Embarazo , Adulto , Estudios Transversales , Calidad de Vida , Encuestas y Cuestionarios , Psoriasis/tratamiento farmacológicoRESUMEN
BACKGROUND: In recent years, remarkable improvements in our understanding of atopic dermatitis (AD) have revolutionized treatment perspectives, but access to reliable data from clinical practice is essential. MATERIALS AND METHOD: The Spanish Atopic Dermatitis Registry, BIOBADATOP, is a prospective, multicenter database that collects information on patients of all ages with AD requiring systemic therapy with conventional or novel drugs. We analyzed the registry to describe patient characteristics, diagnoses, treatments, and adverse events (AEs). RESULTS: We studied data entries for 258 patients who had received 347 systemic treatments for AD. Treatment was discontinued in 29.4% of cases, mostly due to a lack of effectiveness (in 10.7% of cases). A total of 132 AEs were described during follow-up. Eighty-six AEs (65%) were linked to a systemic treatment, most commonly dupilumab (39AEs) and cyclosporine (38AEs). The most common AEs were conjunctivitis (11patients), headache (6), hypertrichosis (5), and nausea (4). There was 1severe AE (acute mastoiditis) associated with cyclosporine. CONCLUSIONS: Initial findings on AEs from the Spanish BIOBADATOP registry are limited by short follow-up times precluding comparisons or calculation of crude and adjusted incidence rates. At the time of our analysis, no severe AEs had been reported for novel systemic therapies. BIOBADATOP will help answer questions on the effectiveness and safety of conventional and novel systemic therapies in AD.
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Dermatitis Atópica , Humanos , Dermatitis Atópica/tratamiento farmacológico , Dermatitis Atópica/epidemiología , Estudios Prospectivos , Ciclosporina/uso terapéutico , Administración Cutánea , Sistema de Registros , Resultado del Tratamiento , Índice de Severidad de la EnfermedadRESUMEN
OBJECTIVE: Patients with nonmelanoma skin cancer (NMSC)-ie, basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)-have an increased risk of developing a second skin cancer. The aim of this study was to describe the frequency, incidence per 1000 person-years, and predictors of a second skin cancer in a cohort of patients with NMSC treated with Mohs micrographic surgery (MMS). MATERIAL AND METHODS: Prospective study of a national cohort of patients with NMSC who underwent MMS at 22 Spanish hospitals between July 2013 and February 2020; case data were recorded in the REGESMOHS registry. The study variables included demographic characteristics, frequency and incidence per 1000 person-years of second skin cancers diagnosed during the study period, and risk factors identified using mixed-effects logistic regression. RESULTS: We analyzed data for 4768 patients who underwent MMS; 4397 (92%) had BCC and 371 (8%) had SCC. Mean follow-up was 2.4 years. Overall, 1201 patients (25%) developed a second skin cancer during follow-up; 1013 of the tumors were BCCs (21%), 154 were SCCs (3%), and 20 were melanomas (0.4%). The incidence was 107 per 1000 person-years (95% CI, 101-113) for any cancer, 90 per 1000 person-years (95% CI, 85-96) for BCC, 14 (95% CI, 12-16) per 1000 person-years for SCC, and 2 (95% CI, 1-3) per 1000 person-years for melanoma. More men than women developed a subsequent skin cancer (738 [61%] vs 463 [39%]). The main risk factors were a history of multiple tumors before diagnosis (relative risk [RR], 4.6; 95% CI, 2.9-7.1), immunosuppression (RR, 2.1; 95% CI, 1.4-3.1), and male sex (RR, 1.6; 95% CI, 1.4-1.9). CONCLUSION: Patients have an increased risk of developing a second tumor after MMS treatment of NMSC. Risk factors are a history of multiple tumors at diagnosis, immunosuppression, and male sex.
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Carcinoma Basocelular , Carcinoma de Células Escamosas , Melanoma , Neoplasias Basocelulares , Neoplasias Cutáneas , Carcinoma Basocelular/epidemiología , Carcinoma Basocelular/patología , Carcinoma Basocelular/cirugía , Carcinoma de Células Escamosas/epidemiología , Carcinoma de Células Escamosas/patología , Carcinoma de Células Escamosas/cirugía , Estudios de Cohortes , Femenino , Humanos , Masculino , Melanoma/complicaciones , Cirugía de Mohs , Estudios Prospectivos , Factores de Riesgo , Neoplasias Cutáneas/epidemiología , Neoplasias Cutáneas/etiología , Neoplasias Cutáneas/cirugíaRESUMEN
BACKGROUND AND AIMS: The Wound-QoL is a validated and feasible questionnaire for measuring disease-specific health-related quality of life in chronic wounds, originally developed for use in German. The objective of this study was to translate the Wound-QoL for use in clinical care and in clinical trials in Spain and to validate this version. MATERIALS AND METHODS: Two independent fourth- and back translations of the Wound-QoL from the original German version were conducted, followed by an expert consensus of the resulting versions. After refinement, the final tool was piloted in N=10 patients and then used in the validation study. RESULTS: A total of 115 patients were recruited. Mean age was 69.5 (SD 14.5) years, 60.0% were female. The Spanish version of Wound-QoL showed high internal consistency (Cronbach's alpha>0.8 in all scales). Factor analysis resulted in the same scales as the original version. There were satisfactory distribution characteristics of the global score and the subscales. Construct validity and convergent validity with other outcomes (generic QoL, healing rate) were satisfactory. The vast majority of patients considered the Wound-QoL a simple and feasible tool. Mean time needed for completing the questionnaire was 5minutes. Overall, 99.1% of the participants found it easy to understand the questions and 94.7% stated that the questionnaire suits the personal situation. CONCLUSIONS: The Spanish version of the Wound-QoL shows good validity in clinical practice. It can be recommended for use in clinical routine and trials.
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Calidad de Vida , Traducciones , Anciano , Análisis Factorial , Femenino , Humanos , España , Encuestas y CuestionariosRESUMEN
OBJECTIVE: To document the efficacy of a combined therapeutic strategy in achieving rapid wound healing in patients with long-standing ulcers. MATERIALS AND METHODS: Outpatients with hard-to-heal venous leg ulcers were included in an interventional, prospective, single-arm, mono-centre study and treated with autologous punch grafting, TLC-NOSF dressing and multi-type compression therapy. The primary outcome was the percentage of healed wounds by week 12. Secondary outcomes included time-to-reach wound closure, wound area reduction, treatment acceptability and safety. RESULTS: From November 2018 to October 2019, 42 patients with 51 ulcers were included (23 males, 70.6±40.8 years old, with multiple comorbidities). Despite poor wound healing prognosis at baseline (47% of recurrent ulcers, with a mean duration of 15 months and a mean area of 12.6cm2), wound healing was achieved in 47 ulcers (92%) after a mean period of treatment of 25±13 days. A relative wound area reduction>75% was also reached in three additional ulcers by the last evaluation visit. No adverse event related to the procedure was reported throughout the study period. The associated treatment were very well tolerated and accepted by the patients. CONCLUSIONS: The evaluated procedure induced fast re-epithelisation of the treated ulcers. Based on our experience, this simple and successful reparative strategy may be considered as an interesting option in the treatment of venous leg ulcers of poor prognosis.
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Vendajes , Vendajes de Compresión , Trasplante de Piel , Úlcera Varicosa/terapia , Técnicas de Cierre de Heridas , Cicatrización de Heridas , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Proyectos Piloto , Estudios Prospectivos , Recurrencia , Factores de Tiempo , Trasplante Autólogo , Resultado del Tratamiento , Úlcera Varicosa/diagnóstico , Úlcera Varicosa/fisiopatologíaRESUMEN
Compression therapy is the basis for treating the cause of venous ulcers and preventing recurrence. Various systems are currently available for applying compression and adapting them to patients' needs can improve adherence to treatment. Understanding the principles that underlie compression therapy is essential for success. Although this paper focuses mainly on venous ulcers, compression has also proven beneficial for other conditions, such as lymphedema and wounds resulting from injury or inflammation.
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Úlcera Varicosa , Humanos , Inflamación , Presión , Recurrencia , Prevención Secundaria , Úlcera Varicosa/prevención & controlRESUMEN
BACKGROUND: Treatment persistence is becoming a useful measure to evaluate long-term effectiveness and safety of biological therapies in real-world settings. OBJECTIVE: The main objective of this study was to explore the scientific opinion of a panel of dermatologists and hospital pharmacists to reach a consensus about the impact, causes, and best strategies and interventions that might be associated with improved drug persistence in patients with psoriasis in Spain. METHODS: This research was conducted using a modified Delphi method organized in two rounds and involving a panel of 90 dermatologists and 34 hospital pharmacists. A questionnaire of 70 items was developed. The items proposed to reach a consensus included topics such as definitions and measures in the treatment of psoriasis, analysis of treatment persistence, factors that may influence treatment persistence, impact of treatment persistence and economic cost of treatment. RESULTS: Dermatologists reached a consensus on 77.1% of the items proposed, and hospital pharmacists reached a consensus on 71.4%. Both groups agreed that it is important to use standardized measures in the evaluation of treatment maintenance over time. Dermatologists agreed that treatment survival, persistence and retention are synonymous, but hospital pharmacists considered only treatment persistence as a valid term. In addition, panelists agreed that drug persistence is an indicator of success in the treatment of psoriasis that may be influenced by a drug's effectiveness and safety profile, as well as by patient satisfaction. They agreed that the different causes of treatment discontinuation should be considered in Kaplan-Meier analysis of treatment persistence. Moreover, treatment persistence was agreed to decrease the cost of therapy. CONCLUSION: This Delphi consensus highlights the different perspectives of dermatologists and hospital pharmacists regarding the interpretation of treatment persistence, and the challenge of harmonizing the results obtained.
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Productos Biológicos/uso terapéutico , Fármacos Dermatológicos/uso terapéutico , Dermatólogos , Cumplimiento de la Medicación , Farmacéuticos , Psoriasis/tratamiento farmacológico , Productos Biológicos/efectos adversos , Productos Biológicos/economía , Consenso , Técnica Delphi , Fármacos Dermatológicos/efectos adversos , Fármacos Dermatológicos/economía , Humanos , Estimación de Kaplan-Meier , Satisfacción del Paciente , Psoriasis/economía , Índice de Severidad de la Enfermedad , España , Terminología como Asunto , Resultado del TratamientoRESUMEN
BACKGROUND: The effectiveness of topical therapies in psoriasis is dependent on, amongst other factors, patient adherence. Together with treatment effectiveness and reduction of symptoms, speed of onset and health-related quality of life (HRQoL) are important influencers of adherence. METHODS: This pooled analysis of three Phase II/III trials evaluated the efficacy of topical fixed-dose combination calcipotriol 50 µg/g plus betamethasone dipropionate 0.5 mg/g cutaneous foam (Cal/BD foam) vs. foam vehicle at early timepoints in mild-to-severe psoriasis using clinically meaningful modified Psoriasis Area and Severity Index (mPASI) and Dermatology Life Quality Index (DLQI) targets. RESULTS: A greater proportion of Cal/BD-foam- vs. foam-vehicle-treated patients achieved absolute mPASI targets 0 (15.1% vs. 1.0%), ≤1 (41.4% vs. 5.2%), ≤3 (78.5% vs. 29.2%) and ≤5 (90.2% vs. 62.5%) at week 4 (P < 0.001; all targets). Significant differences between Cal/BD-foam- vs. foam-vehicle-treated patients were observed as early as week 1 in those achieving mPASI ≤1 (6.8% vs. 1.5%; P < 0.01), ≤3 (40.4% vs. 22.8%; P < 0.001) and ≤5 (69.7% vs. 50.8%; P < 0.001). In patients with more severe psoriasis (baseline mPASI >10), a greater proportion of Cal/BD-foam- vs. foam-vehicle-treated patients achieved mPASI ≤1 (20.2% vs. 5.9%; P < 0.05), ≤3 (49.2% vs. 8.8%; P < 0.001) and ≤5 (63.7% vs. 26.5%; P < 0.001) at week 4. In patients with severely impaired HRQoL (baseline DLQI >10), a greater proportion of Cal/BD-foam- vs. foam-vehicle-treated patients achieved target DLQI ≤1 or 0 (week 4: DLQI ≤1, 25.0% vs. 4%; P = 0.001; DLQI 0, 17.4% vs. 2.0%; P = 0.006). CONCLUSION: We report rapid onset of action and greater efficacy with Cal/BD foam vs. foam vehicle, even in patients with more severe psoriasis, manageable with topical treatments. This may support physician management of patient expectations and improve patient adherence, translating into overall topical treatment effectiveness.
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Betametasona/análogos & derivados , Calcitriol/análogos & derivados , Fármacos Dermatológicos/uso terapéutico , Psoriasis/tratamiento farmacológico , Administración Cutánea , Betametasona/administración & dosificación , Betametasona/uso terapéutico , Calcitriol/administración & dosificación , Calcitriol/uso terapéutico , Ensayos Clínicos Fase II como Asunto , Ensayos Clínicos Fase III como Asunto , Fármacos Dermatológicos/administración & dosificación , Quimioterapia Combinada , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Multicéntricos como Asunto , Cooperación del Paciente , Ensayos Clínicos Controlados Aleatorios como Asunto , Índice de Severidad de la Enfermedad , Resultado del TratamientoRESUMEN
BACKGROUND: Itch is common in psoriasis, adversely affecting health-related quality of life (HRQoL) and sleep. OBJECTIVE: We evaluated the efficacy of topical fixed-dose combination calcipotriol 50 µg/g plus betamethasone dipropionate 0.5 mg/g cutaneous foam (Cal/BD foam) on itch, itch-related sleep loss and HRQoL vs. foam vehicle. METHODS: We pooled data from three Phase II/III trials (NCT01536886/NCT01866163/NCT02132936) of Cal/BD foam vs. foam vehicle in adults with mild-severe psoriasis. For itch-related analyses, patients with baseline itch visual analogue scale (VAS) >40 (range 0-100) were analysed. Outcomes included the following: itch VAS reduction >40, ≥70% improvement in itch (Itch70) or itch-related sleep loss, 75% improvement in modified Psoriasis Area and Severity Index (excluding head; mPASI75) and Dermatology Life Quality Index (DLQI) scores 0/1 through 4 weeks. RESULTS: Of 837 patients, 800 had baseline itch VAS >0 (Cal/BD foam, n = 610; foam vehicle, n = 190); 484 had baseline itch VAS >40. There was no correlation between itch VAS score and mPASI at baseline (R2 = 0.021). In patients with baseline itch VAS >40, more patients achieved itch VAS reduction >40 in the active vs. vehicle group from Day 5 onwards (Day 5: 57.5% vs. 40.2% [P < 0.05]; Week 4: 83.0% vs. 45.8% [P < 0.001]). More Cal/BD-foam-treated patients achieved Itch70 at Day 3 (34.2% vs. 22.5%; P < 0.05) through to Week 4 (79.3% vs. 38.1%; P < 0.001). In patients with baseline itch VAS >40 and sleep loss >20, improvements in itch-related sleep loss occurred at Week 1 and continued through 4 weeks. Itch-related improvements occurred before improvements in mPASI75. There were significant differences in the proportion of Cal/BD-foam- vs. foam-vehicle-treated patients with baseline DLQI >10 (n = 172 vs. n = 50) achieving DLQI ≤1 (25.0% vs. 4.0%; P = 0.001) and DLQI 0 (17.4% vs. 2.0%; P = 0.006) at Week 4. CONCLUSION: Compared with foam vehicle, Cal/BD foam offers more rapid and effective itch relief, with associated significant improvements in sleep and DLQI.
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Betametasona/análogos & derivados , Calcitriol/análogos & derivados , Prurito/tratamiento farmacológico , Psoriasis/complicaciones , Administración Cutánea , Adulto , Anciano , Betametasona/uso terapéutico , Calcitriol/uso terapéutico , Ensayos Clínicos Fase II como Asunto , Ensayos Clínicos Fase III como Asunto , Combinación de Medicamentos , Disomnias/etiología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Multicéntricos como Asunto , Prurito/etiología , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Método Simple Ciego , Escala Visual AnalógicaRESUMEN
INTRODUCTION AND OBJECTIVES: Biologic drugs are usually prescribed as second-line treatment for psoriasis, that is, after the patient has first been treated with a conventional psoriasis drug. There are, however, cases where, depending on the characteristics of the patient or the judgement of the physician, biologics may be chosen as first-line therapy. No studies to date have analyzed the demographics or clinical characteristics of patients in this setting or the safety profile of the agents used. The main aim of this study was to characterize these aspects of first-line biologic therapy and compare them to those observed for patients receiving biologics as second-line therapy. MATERIAL AND METHOD: We conducted an observational study of 181 patients treated in various centers with a systemic biologic drug as first-line treatment for moderate to severe psoriasis between January 2008 and November 2016. All the patients were registered in the Spanish Registry of Adverse Events Associated with Biologic Drugs in Dermatology. RESULTS: The characteristics of the first- and second-line groups were very similar, although the patients receiving a biologic as first-line treatment for their psoriasis were older. No differences were observed for disease severity (assessed using the PASI) or time to diagnosis. Hypertension, diabetes, and liver disease were all more common in the first-line group. There were no differences between the groups in terms of reasons for drug withdrawal or occurrence of adverse effects. CONCLUSIONS: No major differences were found between patients with psoriasis receiving biologic drugs as first- or second-line therapy, a finding that provides further evidence of the safety of biologic therapy in patients with psoriasis.
Asunto(s)
Productos Biológicos/uso terapéutico , Inmunosupresores/uso terapéutico , Psoriasis/tratamiento farmacológico , Sistema de Registros , Adulto , Distribución por Edad , Anciano , Anticuerpos Monoclonales/efectos adversos , Anticuerpos Monoclonales/uso terapéutico , Productos Biológicos/efectos adversos , Comorbilidad , Sustitución de Medicamentos , Utilización de Medicamentos , Femenino , Humanos , Inmunosupresores/efectos adversos , Masculino , Persona de Mediana Edad , Psoriasis/epidemiología , España/epidemiología , Factor de Necrosis Tumoral alfa/antagonistas & inhibidoresRESUMEN
BACKGROUND: There is currently little information available on the management of patients with psoriasis in the daily clinical practice of dermatologists in Spain. OBJECTIVE: The aim of this study was to survey a group of Spanish dermatologists with particular expertise in the management of psoriasis to determine their opinions on the protocols used in routine clinical practice. MATERIAL AND METHODS: A cross-sectional study based on an online survey about the management of psoriasis sent to 75 dermatologists. The survey, which was specifically designed for the study, included 12questions on different aspects of clinical practice in the treatment of moderate to severe psoriasis. RESULTS: The response rate was 96% (n=72). Biologics were the most widely used monotherapy option. In total, 64.3% of respondents reported that their patients used conventional systemic therapies for 1 to 2years before switching to a biologic drug and that the main reason for the switch was unstable control of disease activity. Overall, 85.7% assigned a "high" or "very high" importance to the use of a Psoriasis Area Severity Index score of <3 as a treatment goal. The drugs of choice among the respondents were etanercept for pediatric patients (78.6%), adalimumab and etanercept for patients with psoriatic arthritis (64.3%), and ustekinumab in patients frequently away from home (78.6%) and patients with a history of multiple sclerosis, demyelinating diseases (64.3%), or poor adherence to treatment (71.4%). CONCLUSION: This study provides a unique overview of the opinions of a representative sample of expert dermatologists on the current use of biologics for the treatment of psoriasis in Spain.
Asunto(s)
Pautas de la Práctica en Medicina/estadística & datos numéricos , Psoriasis/tratamiento farmacológico , Adulto , Antiinflamatorios/uso terapéutico , Productos Biológicos/uso terapéutico , Niño , Contraindicaciones de los Medicamentos , Estudios Transversales , Manejo de la Enfermedad , Sustitución de Medicamentos , Femenino , Encuestas de Atención de la Salud , Humanos , Inmunosupresores/uso terapéutico , Masculino , Selección de Paciente , Psoriasis/epidemiología , Índice de Severidad de la Enfermedad , España/epidemiologíaRESUMEN
BACKGROUND: The elderly population is increasing and more patients in this group undergo Mohs micrographic surgery (MMS). The few publications investigating MMS in elderly people conclude that it is a safe procedure; however, these are single-centre studies without a comparison group. OBJECTIVE: To compare the characteristics of patients, tumours, MMS and 1-year follow-up in patients younger than 80 years, with patients older than 80 years at the time of surgery. METHODS: Data was analysed from REGESMOHS, a prospective cohort study of patients treated with MMS. The participating centres were 19 Spanish hospitals where at least one MMS is performed per week. Data on characteristics of the patient, tumour and surgery were recorded. Follow-up data were collected from two visits; the first within 1 month postsurgery and the second within the first year. RESULTS: From July 2013 to October 2016, 2575 patients that underwent MMS were included in the registry. Of them, 1942 (75.4%) were aged <80 years and 633 (24.6%) were ≥80 years old. In the elderly, the tumour size was significantly higher with a higher proportion of squamous cell carcinoma. Regarding surgery, elderly more commonly had tumours with deeper invasion and required a higher number of Mohs surgery stages, leaving larger defects and requiring more time in the operating room. Despite this, the incidence of postoperative complications was the same in both groups (7%) and there were no significant differences in proportion of relapses in the first-year follow-up. CONCLUSION: The risk of short-term complications and relapses were similar in elderly and younger groups. MMS is a safe procedure in the elderly.
