14 results on '"J M, Carrascosa"'
Search Results
2. Economic Impact of Atopic Dermatitis in Adults: A Population-Based Study (IDEA Study)
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A, Sicras-Mainar, R, Navarro-Artieda, and J M, Carrascosa Carrillo
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Adult ,Male ,Adolescent ,National Health Programs ,Comorbidity ,Health Care Costs ,Middle Aged ,Health Surveys ,Dermatitis, Atopic ,Young Adult ,Socioeconomic Factors ,Spain ,Health Resources ,Humans ,Female ,Aged ,Retrospective Studies - Abstract
To determine resource usage and costs associated with atopic dermatitis in adults according to severity and comorbid conditions in daily clinical practice.We performed an observational, retrospective study based on a review of registries of patients aged ≥18 years who sought health care in 2013 and 2014 in an area of Catalonia, Spain, with a population of 215,634 persons. We established 3 classes of severity depending on the treatment prescribed. The variables evaluated were total comorbid conditions, concomitant/specific medication, and direct/indirect health care costs. The statistical analysis was based on multiple regression models. Statistical significance was set at P.05.We included 6,186 patients with a diagnosis of atopic dermatitis (mean age, 47.1 years; women, 61.6%). We established 3 groups based on severity, as follows: mild (n=3,445 [55.7%]); moderate (n=2,361 [38.2%]); and severe (n=380 [6.1%]). Severe atopic dermatitis was associated with risk of presenting comorbid conditions (β=0.192), namely, asthma (β=0.138), depression (β=0.099), cardiovascular events (β=0.087), obesity (β=0.085), and smoking (β=0.025); P.001. Costs reached €9.3 million (health care costs, 75.5%; loss of productivity, 24.5%), with an average unit cost of €1,504 per year. The corrected average unit cost (ANCOVA) was greater in severe atopic dermatitis compared with moderate and mild disease (€3,397 vs. €2,111 vs. €885; P.001), respectively.Severe atopic dermatitis generates considerable usage of health care resources and high costs for the National Health System. These are in proportion with the severity of the disease. General comorbid conditions and asthma were the factors with the greatest impact on health care costs.
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- 2017
3. Description of Patients Treated with Biologic Drugs as First-Line Systemic Therapy in the BIOBADADERM Registry Between 2008 and 2016
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G, Carretero Hernández, C, Ferrándiz, R, Rivera Díaz, E, Daudén Tello, P, de la Cueva-Dobao, F J, Gómez-García, E, Herrera-Ceballos, I, Belinchón Romero, J L, López-Estebaranz, M, Alsina Gibert, J L, Sánchez-Carazo, M, Ferrán Farrés, A, González Quesada, J M, Carrascosa Carrillo, M, Llamas-Velasco, M V, Mendiola Fernández, D, Ruiz Genao, C, Muñoz Santos, I, García-Doval, and M A, Descalzo
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Adult ,Male ,Biological Products ,Drug Substitution ,Tumor Necrosis Factor-alpha ,Antibodies, Monoclonal ,Comorbidity ,Middle Aged ,Drug Utilization ,Age Distribution ,Spain ,Humans ,Psoriasis ,Female ,Registries ,Immunosuppressive Agents ,Aged - Abstract
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.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.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.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.
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- 2017
4. Risk of adverse events in psoriasis patients receiving classic systemic drugs and biologics in a 5-year observational study of clinical practice: 2008-2013 results of the Biobadaderm registry
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G, Carretero, C, Ferrandiz, E, Dauden, F, Vanaclocha Sebastián, F J, Gómez-García, E, Herrera-Ceballos, P, De la Cueva-Dobao, I, Belinchón, J L, Sánchez-Carazo, M, Alsina-Gibert, J L, López-Estebaranz, M, Ferrán, R, Torrado, J M, Carrascosa, C, Carazo, R, Rivera, R, Jiménez-Puya, I, García-Doval, and Sagrario, Galiano Mejias
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Adult ,Male ,medicine.medical_specialty ,Dermatology ,Antibodies, Monoclonal, Humanized ,Lower risk ,Risk Assessment ,Receptors, Tumor Necrosis Factor ,Etanercept ,Keratolytic Agents ,Internal medicine ,Ustekinumab ,medicine ,Humans ,Psoriasis ,Prospective Studies ,Registries ,Adverse effect ,Prospective cohort study ,Aged ,Proportional Hazards Models ,Biological Products ,Proportional hazards model ,business.industry ,Incidence (epidemiology) ,Anti-Inflammatory Agents, Non-Steroidal ,Hazard ratio ,Adalimumab ,Antibodies, Monoclonal ,Middle Aged ,Acitretin ,Infliximab ,Surgery ,Methotrexate ,Infectious Diseases ,Spain ,Immunoglobulin G ,Relative risk ,Cyclosporine ,Female ,business ,Immunosuppressive Agents ,medicine.drug - Abstract
Background Biobadaderm is the Spanish registry of psoriasis patients receiving systemic treatment in clinical practice. Objective To compare the safety of biologics and classic systemic treatment. Methods Prospective cohort of patients receiving biologics and classic systemic therapies between 2008 and 2013 in 12 hospitals are included. We registered demographic data, diagnoses, comorbidities, treatments and adverse events (AE). We obtained raw relative risks (RR) for specific AE. Multivariate analysis consisted of Cox models adjusting for age, gender, chronic hepatic disease and previous cancer. Results A total of 1030 patients received biologics (2061 AE in 3681 person-years), 926 patients classic systemic drugs (1015 AE in 1517 person-years). Ninety-three per cent of AE in both groups were non-serious, 6% serious and 0.003% fatal. The age- and gender-adjusted hazard ratio of AE was lower in the biologics group [hazard ratio 0.6 (95% CI: 0.5–0.7)].We found no differences in rates of serious and mortal AE. Some system organ class AE rates differed between both groups. As limitations: Prescription bias might affect the incidence of AE in both groups. Association of drug and AE was based on timing: associations might not be causal. Conclusion Patients receiving biologics had lower risk of AE. We did not find differences in the risk of serious or fatal AE.
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- 2014
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5. Body mass index in patients with moderate-to-severe psoriasis in Spain and its impact as an independent risk factor for therapy withdrawal: results of the Biobadaderm Registry
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J M, Carrascosa, M, Vilavella, I, Garcia-Doval, G, Carretero, F, Vanaclocha, E, Daudén, F J, Gómez-García, E, Herrera-Ceballos, P, De la Cueva Dobao, I, Belinchón, J L, Sánchez-Carazo, M, Alsina, J L, López-Estebaranz, M, Ferrán, F, Peral, R, Torrado, R, Rivera, R, Jiménez-Puya, M V, Mendiola, C, Ferrándiz, and Beatriz, Perez Zafrilla
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medicine.medical_specialty ,Population ,Comorbidity ,Dermatology ,Overweight ,Severity of Illness Index ,Body Mass Index ,Drug withdrawal ,Risk Factors ,Internal medicine ,Psoriasis ,Prevalence ,medicine ,Humans ,Obesity ,Prospective Studies ,Registries ,Risk factor ,Adverse effect ,education ,Biological Products ,education.field_of_study ,business.industry ,medicine.disease ,Discontinuation ,Treatment Outcome ,Infectious Diseases ,Withholding Treatment ,Spain ,Multivariate Analysis ,Physical therapy ,medicine.symptom ,business ,Body mass index - Abstract
Background There are few data on the prevalence of obesity in the general psoriasis population and on the real impact of obesity on the management of psoriasis patients in the clinical setting. Objectives To evaluate the prevalence of overweight and obesity in patients with moderate-to-severe psoriasis compared to the general population and to assess the relationship between Body Mass Index (BMI) and the risk of discontinuing treatment. Methods Patients registered on Biobadaderm, a prospective registry, were grouped according the different categories of BMI and compared to the general Spanish population. Drug survival was analysed considering only drug withdrawal due to lack of effectiveness, remission and adverse events. Results A total of 1162 moderate-to-severe psoriasis patients on systemic conventional or biological treatment were recruited. The prevalence of obesity was found to be significantly higher in psoriasis patients than in the general Spanish population (P
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- 2013
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6. Solar urticaria: Epidemiology and clinical phenotypes in a Spanish series of 224 patients
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A, Pérez-Ferriols, M, Barnadas, J, Gardeazábal, D, de Argila, J M, Carrascosa, P, Aguilera, A, Giménez-Arnau, T, Rodríguez-Granados, M V, de Gálvez, and J, Aguilera
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Adult ,Male ,Adolescent ,Urticaria ,Incidence ,Histamine Antagonists ,Middle Aged ,Phototherapy ,Young Adult ,Phenotype ,Spain ,Child, Preschool ,Sunlight ,Humans ,Female ,Photosensitivity Disorders ,Child ,Aged ,Retrospective Studies - Abstract
Solar urticaria is a chronic inducible urticaria also classified as an idiopathic dermatosis. The objective of this paper is to define the phenotypic characteristics of solar urticaria and to evaluate its incidence.This was a retrospective multicenter study in which data were gathered on the epidemiology and clinical, photobiologic, laboratory, and therapeutic characteristics of solar urticaria.A total of 224 patients (141 women and 83 men) were included from 9 photobiology units. The mean age of the patients was 37.9 years (range, 3-73 years). A history of atopy was detected in 26.7%, and the most common presentation was allergic rhinitis (16.5%). Clinical signs were limited to sun-exposed areas in 75.9% of patients. The light spectrum most commonly implicated was visible light only (31.7%), and in 21% of cases it was only possible to trigger solar urticaria with natural light. The treatments most widely used by photobiology experts were oral antihistamines (65.46%), followed by different forms of phototherapy (34%). Complete resolution was observed most often in patients with solar urticaria triggered exclusively by visible or natural light, with statistically significant differences with respect to other wavelengths (P.05). No increase in the annual incidence of solar urticaria was observed.We have presented the largest series of solar urticaria published to date. The epidemiological, clinical, and photobiologic findings confirm previously reported data, although there was a particularly high rate of negative phototests in our series. Reactivity exclusively to visible or natural light was associated with a higher probability of resolution. No increasing trend was observed in the annual incidence.
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- 2016
7. Management of Biologic Therapy in Moderate to Severe Psoriasis in Surgical Patients: Data From the Spanish Biobadaderm Registry
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S, Galiano Mejías, G, Carretero, C, Ferrandiz, F, Vanaclocha, E, Daudén, F J, Gómez-García, E, Herrera-Ceballos, I, Belinchón-Romero, J L, Sánchez-Carazo, J L, López-Estebaranz, M, Alsina, M, Ferrán, R, Torrado, J M, Carrascosa, R, Rivera, M, Llamas-Velasco, R, Jiménez-Puya, Mª V, Mendiola, D, Ruiz-Genao, M A, Descalzo, and P, de la Cueva Dobao
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Adult ,Male ,Contraindications, Drug ,Antibiotic Prophylaxis ,Middle Aged ,Biological Factors ,Postoperative Complications ,Treatment Outcome ,Elective Surgical Procedures ,Spain ,Antirheumatic Agents ,Surgical Procedures, Operative ,Preoperative Care ,Humans ,Psoriasis ,Anesthesia ,Female ,Registries ,Immunosuppressive Agents ,Aged ,Retrospective Studies - Abstract
We now have considerable experience in the use of biologic agents to treat psoriasis, but doubts about management arise in certain clinical settings. Surgery is one of them. Although treatment guidelines advise that biologics be suspended before major surgery, data about actual clinical practices and associated complications are lacking. We aimed to analyze current practice in the clinical management of these cases.Retrospective study of cases in the Biobadaderm database. We analyzed the management of biologic therapy in patients with psoriasis who underwent surgical procedures.Forty-eight of the 2113 patients registered in Biobadaderm underwent surgery. The largest percentage of procedures (31%) involved skin lesions. Biologic treatment was interrupted in 42% of the cases. No postsurgical complications were significantly related to treatment interruption. Likewise we detected no associations between treatment interruption and other variables, such as sex, age, or duration or severity of psoriasis.Continuity of biologic treatment and the risk of postsurgical complications were not associated in this study, although conclusions are limited by the small sample size.
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- 2016
8. Prevalence of psoriasis in Spain in the age of biologics
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C, Ferrándiz, J M, Carrascosa, and M, Toro
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Adult ,Male ,Biological Products ,Young Adult ,Cross-Sectional Studies ,Adolescent ,Spain ,Prevalence ,Humans ,Psoriasis ,Female ,Middle Aged - Abstract
The prevalence of psoriasis in Spain was estimated to be 1.4% before the advent of biologic agents. Fifteen years later, new therapeutic options based on biologic agents have led to greater awareness of the disease and better understanding; case detection and diagnosis may have improved as a result.To investigate the current prevalence of psoriasis in Spain and compare the results with those of an earlier study that used the same methodology.Population-based cross-sectional survey. Information was collected through computer-assisted telephone interviews with a randomly selected representative sample of the Spanish population (12,711 individuals from 4,754 households). Interviews were conducted by trained personnel using a questionnaire.The prevalence was 2.3% and there were no statistically significant differences between the sexes. Prevalence increased with age (range with highest prevalence, 60-69 years). Central Spain-a region with a cold, dry climate-had the highest prevalence, but differences between regions were not significant.Psoriasis is substantially more prevalent in Spain than was previously estimated. The increase in prevalence may reflect greater awareness and better diagnosis of the disease rather than a true increase in number of cases.
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- 2013
9. Spanish evidence-based guidelines on the treatment of psoriasis with biologic agents, 2013. Part 1: on efficacy and choice of treatment. Spanish Psoriasis Group of the Spanish Academy of Dermatology and Venereology
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L, Puig, J M, Carrascosa, G, Carretero, P, de la Cueva, R F, Lafuente-Urrez, I, Belinchón, M, Sánchez-Regaña, M, García-Bustínduy, M, Ribera, M, Alsina, C, Ferrándiz, E, Fonseca, V, García-Patos, E, Herrera, J L, López-Estebaranz, S E, Marrón, J C, Moreno, J, Notario, R, Rivera, C, Rodriguez-Cerdeira, A, Romero, R, Ruiz-Villaverde, R, Taberner, and D, Vidal
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Adult ,Male ,Cost-Benefit Analysis ,Severity of Illness Index ,Biological Factors ,Sex Factors ,Meta-Analysis as Topic ,Pregnancy ,Humans ,Multicenter Studies as Topic ,Psoriasis ,Treatment Failure ,Child ,Clinical Trials as Topic ,Evidence-Based Medicine ,Drug Substitution ,Arthritis, Psoriatic ,Age Factors ,Combined Modality Therapy ,Acitretin ,Pregnancy Complications ,Treatment Outcome ,Photochemotherapy ,Spain ,Female ,Immunosuppressive Agents - Abstract
Biologic therapy is a well-established strategy for managing moderate and severe psoriasis. Nevertheless, the high cost of such therapy, the relatively short span of clinical experience with biologics, and the abundance of literature now available on these agents have made evidence-based and consensus-based clinical guidelines necessary. The ideal goal of psoriasis treatment is to achieve complete or nearly complete clearing of lesions and to maintain it over time. Failing that ideal, the goal would be to reduce involvement to localized lesions that can be controlled with topical therapy. Although current evidence allows us to directly or indirectly compare the efficacy or risk of primary or secondary failure of available biologics based on objective outcomes, clinical trial findings cannot be directly translated to routine practice. As a result, the prescribing physician must tailor the treatment regimen to the individual patient. This update of the clinical practice guidelines issued by the Spanish Academy of Dermatology and Venereology (AEDV) on biologic therapy for psoriasis incorporates information from the most recent publications on this topic.
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- 2013
10. Latent tuberculosis infection and active tuberculosis in patients with psoriasis: a study on the incidence of tuberculosis and the prevalence of latent tuberculosis disease in patients with moderate-severe psoriasis in Spain. BIOBADADERM registry
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A I, Sánchez-Moya, I, García-Doval, G, Carretero, J, Sánchez-Carazo, C, Ferrandiz, E, Herrera Ceballos, M, Alsina, M, Ferrán, J-L, López-Estebaranz, F, Gómez-García, P, De la Cueva Dobao, J-M, Carrascosa, F, Vanaclocha, I, Belinchón, F, Peral, E, Dauden, and David, Moreno
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Adult ,Male ,medicine.medical_specialty ,Tuberculosis ,Prevalence ,Dermatology ,Disease ,Severity of Illness Index ,Cohort Studies ,Latent Tuberculosis ,Internal medicine ,Psoriasis ,Epidemiology ,medicine ,Humans ,Latent tuberculosis ,business.industry ,Incidence (epidemiology) ,Incidence ,Middle Aged ,bacterial infections and mycoses ,medicine.disease ,Surgery ,Infectious Diseases ,Spain ,Practice Guidelines as Topic ,Female ,Guideline Adherence ,Risk assessment ,business - Abstract
Introduction The incidence of tuberculosis (TB) or the prevalence of latent tuberculosis infection (LTBI) in psoriasis patients has not been described in the Spanish population. We carried out a study with the objectives: (i) To describe the incidence of TB in patients with psoriasis on systemic treatment in the Spanish population; (ii) To determine the prevalence of LTBI in patients who are candidates for biological treatment; and (iii) To investigate the level of compliance with current recommendations for LTBI and TB screening. Methods Data were obtained from BIOBADADERM (Spanish registry for systemic biological and non-biological treatments in psoriasis). An analysis was performed of the exposed cohort to determine the prevalence of LTBI and to describe compliance with the screening guidelines. Results A total of 1425 patients were registered in BIOBADADERM. They included 793 (56%) patients exposed to biological treatment and 632 (44%) treated with conventional systemic drug. Overall follow-up was 3720 person-years. Of the 793, 20.5% (163) were diagnosed with LTBI before starting biological treatment. The rate of active TB for the exposed cohort was 145 cases × 100 000 patient-years (95% CI 54–389). No case of TB was found in the control group. Screening for LTBI was performed in 83% of the exposed sample. Conclusion Patients with psoriasis who are exposed to biological treatment appear to be at greater risk for tuberculosis. In Spain, up to 20% of patients with psoriasis who are candidates for biological therapy have LTBI. There continues to be a significant percentage of errors in compliance with clinical guidelines.
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- 2012
11. Effect of narrowband ultraviolet B therapy on inflammatory markers and body fat composition in moderate to severe psoriasis
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J, Romaní, A, Caixàs, J M, Carrascosa, M, Ribera, M, Rigla, and J, Luelmo
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Adult ,Male ,Metabolic Syndrome ,Cholesterol, HDL ,Cholesterol, LDL ,Middle Aged ,Body Mass Index ,Treatment Outcome ,Spain ,Case-Control Studies ,Body Fat Distribution ,Carbohydrate Metabolism ,Humans ,Psoriasis ,Female ,Ultraviolet Therapy ,Waist Circumference ,Biomarkers ,Calcifediol - Abstract
Previous studies have shown increased prevalence of metabolic syndrome in patients with psoriasis.To characterize the anthropometric and metabolic profile of Spanish patients with moderate to severe psoriasis compared with controls without psoriasis matched for gender, age and body mass index (BMI), and to evaluate the impact of narrowband ultraviolet B (NB-UVB) therapy on patient profiles.Baseline waist circumference, body fat composition, lipid, carbohydrate and calcium metabolism profile, inflammation markers, homocysteine, vitamins D, B(6) and B(12) and folic acid of 50 patients with psoriasis and 50 matched controls were recorded then evaluated after NB-UVB in patients with psoriasis and correlated with clinical outcome.Despite very similar BMIs, 54% of patients met International Diabetes Foundation criteria for metabolic syndrome compared with 42% of controls (P = 0·01); body fat was 29·9% in patients and 28·0% in controls (P = 0·037), correlating with waist circumference; while patient atherogenic profiles were less favourable, with higher apolipoprotein B and low density lipoprotein cholesterol than controls, and both patients and controls showed insufficient vitamin D serum levels (20 ng mL(-1)). Mean improvement of Psoriasis Area and Severity Index (PASI) after NB-UVB was 78·2%. Ferritin, B(12) and C-reactive protein decreased significantly after NB-UVB therapy. Vitamin D levels reached adequate levels after phototherapy; however, no relationship with PASI improvement was observed.We characterized inflammatory and atherogenic profiles of Spanish patients with psoriasis compared with matched controls. After NB-UVB therapy we demonstrated improvement in psoriasis and some systemic inflammation markers, which were not mediated by enhancement of vitamin D synthesis.
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- 2012
12. [Vitamin D: evidence and controversies]
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Y, Gilaberte, J, Aguilera, J M, Carrascosa, F L, Figueroa, J, Romaní de Gabriel, and E, Nagore
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Clinical Trials as Topic ,Neoplasms, Radiation-Induced ,Skin Neoplasms ,Ultraviolet Rays ,Infections ,Vitamin D Deficiency ,Bone and Bones ,Immunity, Innate ,Autoimmune Diseases ,Diet ,Habits ,Diabetes Mellitus, Type 1 ,Cardiovascular Diseases ,Spain ,Neoplasms ,Sunlight ,Humans ,Psoriasis ,Vitamin D ,Skin - Abstract
Vitamin D enhances musculoskeletal health and reduces mortality related to bone disease in some populations, particularly the elderly and other high-risk groups. Evidence suggests that vitamin D has an impact in cancer, cardiovascular disease, autoimmune processes, and infections. Epidemiologic studies have also detected vitamin D deficits or insufficiency in nearly all the world's populations. Such evidence has led to debate related, to a certain degree, to photoprotective measures that aim at protecting against skin cancer. The latest recommendations of the American Institute of Medicine consider that serum levels of 20 ng/mL (50 nmol/L) appear to be adequate in the general population and achievable even with minimal sun exposure. If these figures are reliable, the apparent pandemic of vitamin D deficiency reported in recent years may be exaggerated. This article reviews the evidence and issues under discussion, looking especially at the role ultraviolet radiation plays in synthesizing vitamin D in the skin. The conclusion is that sun exposure should not be used as the only source of vitamin D given that it is also clearly carcinogenic for the skin. A healthful approach combines moderate sun exposure, adequate food sources of the vitamin, and supplements whenever required.
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- 2010
13. [BIOBADADERM, the Spanish Registry of Adverse Events Associated with Biologic Drugs in Dermatology: first report]
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R, Rivera, I, García-Doval, G, Carretero, E, Daudén, J, Sánchez-Carazo, C, Ferrándiz, E, Herrera, M, Alsina, M, Ferrán, J L, López-Estebaranz, F, Gómez, J M, Herranz, J M, Carrascosa, and F, Vanaclocha
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Cohort Studies ,Male ,Biological Products ,Drug-Related Side Effects and Adverse Reactions ,Spain ,Humans ,Psoriasis ,Female ,Registries ,Middle Aged ,Retrospective Studies - Abstract
The Working Group on Psoriasis of the Spanish Academy of Dermatology and Venereology has initiated BIOBADADERM, a registry of patients with psoriasis receiving treatment with biologic drugs, in order to assess the long-term risk of adverse events (AEs).A multicenter study was undertaken in 2 cohorts of patients with psoriasis: patients receiving biologic therapy and patients receiving nonbiologic systemic therapy other than phototherapy. Similar numbers of patients were included in each group. Information was recorded on demographic and clinical variables, treatment, and relevant AEs. The risk of specific AEs was determined by comparison of the frequencies for those events in the 2 cohorts.Data on the 2 cohorts were evaluated for the period from October, 2008 to November, 2009 alongside retrospective data on patients treated with biologics since 2005. Thirteen Spanish hospitals participated in the study. A total of 632 patients were included in the analysis: 417 treated with biologic drugs and 215 controls. Suspension of biologic therapy due to AEs was rare (72 cycles, 10%). A total of 232 AEs were reported in patients receiving biologic therapy. The majority were not serious. The most frequent AEs were infections (mostly upper respiratory tract infections and nasopharyngitis), followed by conditions affecting the skin or subcutaneous tissue. Forty-three AEs were reported in control subjects. The most frequent events were metabolic and nutritional abnormalities and abnormal transaminase levels. Comparison of the incidence of any AE in patients treated with biologics compared with control subjects revealed a relative risk of 2.2 (P.001) The relative risks of infections or infestations and disorders of the skin or subcutaneous tissue in patients receiving biologic drugs were 23 (P.01) and 4.9 (P.05), respectively.Patients treated with biologic drugs had a greater number of AEs, particularly infections and skin conditions. Definitive conclusions, however, are difficult to draw due to the small number of patients included in the registry, particularly in the control cohort, and the short follow-up period. Differences in the percentages of events reported by the different hospitals reveal the difficulties associated with the concept of AEs in clinical practice and highlight the need to harmonize criteria in the future. Since the problems identified in this analysis should be overcome in future years, we expect BIOBADADERM to become an important source of information on the safety profile of biologic drugs in dermatology.
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- 2010
14. [Actas Dermosifiliográficas 2010: the year after the centenary]
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E, Daudén, I, Longo, D, de Argila, and J M, Carrascosa
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Publishing ,Bibliometrics ,Spain ,Education, Medical, Continuing ,Dermatology ,Periodicals as Topic ,Goals ,Accreditation - Published
- 2010
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