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1.
Actas Dermosifiliogr ; 113(4): 401-406, 2022 Apr.
Article in English, Spanish | MEDLINE | ID: mdl-35428502

ABSTRACT

Childhood-onset psoriasis generally follows an indolent course but patients with moderate or severe disease may require systemic treatment. The aim of this study was to determine the relative proportion of children and young people aged up to 21 years with moderate to severe psoriasis in the BIOBADADERM registry and to analyze the characteristics of these patients, treatments used, and adverse events. Of the 3946 patients in the registry, 24 were aged 21 years or younger. They had mean age of 16.1 years on starting treatment. When the registry was started, they had a Psoriasis Area and Severity Index of 9.4 and 67% were being treated with a conventional systemic drug. Treatment was discontinued in 14 patients (58%) due to adverse events or a loss or lack of effectiveness. In conclusion, the BIOBADADERM registry shows that young people account for a small proportion of psoriasis patients receiving systemic treatment, and they are more likely to be treated using conventional systemic drugs.


Subject(s)
Biological Products , Psoriasis , Adolescent , Biological Products/therapeutic use , Child , Humans , Psoriasis/chemically induced , Psoriasis/drug therapy , Psoriasis/epidemiology , Registries
2.
Photodermatol Photoimmunol Photomed ; 38(4): 365-372, 2022 Jul.
Article in English | MEDLINE | ID: mdl-34817897

ABSTRACT

BACKGROUND: Transplant recipients are particularly prone to the development of skin cancer, and overexposure to UV radiation during outdoor activities increases the risk of carcinogenesis. OBJECTIVE: The aim of this study was to analyze sun-related behaviors and knowledge in transplant athletes, examine the frequency of sunburns, and explore associations with a history of skin cancer. MATERIALS AND METHODS: Cross-sectional descriptive study. Participants (n = 170) in the XXI World Transplant Games from >50 countries completed a questionnaire on sun protection habits and knowledge, type of transplant, immunosuppressive therapy, and personal history of skin cancer. RESULTS: The most common transplanted organs were the kidney (n = 79), the liver (n = 33), and the heart (n = 31). Overall, 61.3% of athletes had been doing sport for >15 years and 79.5% spent >1-2 h a day outdoors. Fifteen % of athletes had a history of skin cancer. The prevalence of sunburn in the previous year was 28.9%, higher in athletes aged <50 years (37.2%); without a primary school education (58.3%), not taking cyclosporin (32.6%), and athletes who played basketball (75%). The main sun protection measures used were sunscreen (68.9%) and sunglasses (67.3%). Use of a hat or cap was the only measure significantly associated with a reduced prevalence of sunburn. CONCLUSIONS: Despite high awareness that sun exposure increases the risk of skin cancer, sunburn was common in transplant athletes. Efforts should be made to strengthen multidisciplinary sun protection education strategies and ensure periodic dermatologic follow-up to prevent sun-induced skin cancer in this population.


Subject(s)
Skin Neoplasms , Sunburn , Athletes , Cross-Sectional Studies , Habits , Health Knowledge, Attitudes, Practice , Humans , Skin Neoplasms/epidemiology , Skin Neoplasms/etiology , Skin Neoplasms/prevention & control , Sunburn/prevention & control , Sunlight/adverse effects , Sunscreening Agents/therapeutic use , Surveys and Questionnaires
4.
Sci Total Environ ; 754: 142258, 2021 Feb 01.
Article in English | MEDLINE | ID: mdl-33254946

ABSTRACT

Groundwater plays an important role in the economic development of the Chaco-Pampean Plain (Argentina), where industry, agriculture and cattle farming are the main economic activities. The 66% of the country's population lives in this area. The low slopes of this region condition the water movement and the occurrence of physical and chemical processes. The aim of this work is to update the hydrological conceptual model of the Del Azul Creek basin (Buenos Aires Province), a sub-humid and continental plain, using environmental tracers. In total, the study was based on the analysis of 201 samples (stable isotopes) and 184 samples (chemical data) including rainwater, surface water and groundwater. The temporal and spatial variation in the isotopic composition of rainfall and the hydrological physical-processes, evaporation, surface water-groundwater interaction and recharge were studied. Isotopic compositions of rainfall revealed a seasonal variation across the basin. Low δ18O rainfalls occur during the coldest seasons, while high δ18O rainfalls occur during the warmest seasons. The isotopic compositions of rainfall varied only during the cold period in the upper basin. At this time, the lowest δ18O rainfall fell in the upper basin, while in the other areas and during the warmer seasons, no differences were observed. Evaporation was a relevant process in the flatter area of the basin, mainly during the warmest seasons. Samples taken from the wetlands and from the lower section of the Del Azul Creek were strongly evaporated. In the first 30 m depth of the aquifer, groundwater reflected the isotopic composition of rainfall from the warmest seasons, thus revealing seasonal preferential recharge and a good hydraulic connection. This study provides direct evidence showing that both evaporation and the surface water-groundwater interaction are processes that play a key role in the control of the isotopic and chemical composition of water.

6.
Actas Dermosifiliogr (Engl Ed) ; 112(4): 295-301, 2021 Apr.
Article in English, Spanish | MEDLINE | ID: mdl-33197438

ABSTRACT

Sonidegib is an antagonist of the transmembrane protein Smoothened in the Hedgehog signaling pathway. It is indicated for the treatment of locally advanced basal cell carcinoma (BCC) that is not amenable to curative surgery or radiotherapy. Sonidegib's efficacy and safety were demonstrated in the phase 2 BOLT trial, where 61% (95% CI, 48-72%) of patients with locally advanced BCC treated with sonidegib 200 mg achieved an objective response to treatment with a mean time to response of 4 months. The median duration of response was 26.1 months and the median progression-free survival was 22.1 months. The most common adverse events were muscle spasms (54.4%), hair loss (49.4%), and loss of taste (44.3%); most events were grade 1 or 2. In this review, we summarize the main findings on the efficacy, safety, and tolerability of sonidegib and discuss the management of locally advanced BCC with this drug.


Subject(s)
Antineoplastic Agents , Carcinoma, Basal Cell , Skin Neoplasms , Antineoplastic Agents/adverse effects , Biphenyl Compounds , Carcinoma, Basal Cell/drug therapy , Hedgehog Proteins/therapeutic use , Humans , Pyridines , Skin Neoplasms/drug therapy
7.
Actas dermo-sifiliogr. (Ed. impr.) ; 111(9): 752-760, nov. 2020. tab, graf
Article in Spanish | IBECS | ID: ibc-201004

ABSTRACT

ANTECEDENTES Y OBJETIVOS: Las guías sobre el tratamiento de la psoriasis habitualmente no incluyen las recomendaciones acerca de cuál debe ser la primera línea de tratamiento sistémico o biológico. Los objetivos de este estudio fueron describir las tendencias en la prescripción del primer fármaco biológico y comparar la retirada de los fármacos y las tasas de efectos adversos a lo largo de los 10 años de seguimiento. MATERIAL Y MÉTODOS: Se utilizó el registro Biobadaderm para determinar cuál fue el primer fármaco biológico indicado en pacientes con psoriasis naïve para biológicos, así como cuál es la tasa de efectos adversos y los motivos de suspensión de los fármacos. Los resultados obtenidos se compararon en tres periodos distintos de tiempo (2008-2010, 2011-2014, 2015-2018). RESULTADOS: Los fármacos anti-TNF fueron los biológicos prescritos con mayor frecuencia entre los años 2008 y 2010. Ustekinumab se convirtió en el tratamiento biológico más indicado a partir de 2014. El motivo principal de suspensión de los tratamientos fueron los efectos adversos, la falta de eficacia y la remisión de la enfermedad. La probabilidad de suspender los fármacos por uno de estos motivos fue cada vez menor si se compara con el periodo de tiempo previo. CONCLUSIONES: El presente estudio identifica cuáles fueron las tendencias en la prescripción del primer fármaco biológico en la práctica clínica habitual entre los años 2008 y 2018. Sugiere que los dermatólogos estamos cada vez más seguros en cuanto al perfil de seguridad y somos cada vez más exigentes en cuanto a la eficacia de los fármacos


BACKGROUND AND OBJECTIVES: Current psoriasis guidelines do not usually include recommendations about first line classical or biologic treatment. The objectives of this study were: to describe shifts in the prescription of the first biological treatment, and to compare treatment withdrawal and rates of adverse events over ten years. MATERIAL AND METHODS: Biobadaderm registry was analyzed to describe: first biological prescription in bio-naïve patients, adverse events rate and reasons for drug withdrawal comparing three periods of time (2008-2010, 2011-2014, 2015-2018). RESULTS: Anti-TNF drugs were the most prescribed biological drug from 2008 to 2010. Ustekinumab has become the most prescribed first biologic since 2014. The main reasons for drug discontinuation were adverse events, lack of efficacy and remission. In each period any treatment was less likely to be discontinued due to any of these three reasons comparing to the previous period. CONCLUSIONS: The present study identifies trends in prescription of the first biological antipsoriatic drug in clinical practice from 2008 to 2018. It suggests that we have become more comfortable with the safety profile and more exigent with the efficacy of the drugs


Subject(s)
Humans , Female , Adult , Middle Aged , Biological Therapy/methods , Psoriasis/therapy , Biological Products/adverse effects , Cohort Studies , Immunosuppressive Agents/adverse effects , Biological Products/therapeutic use , Withholding Treatment , Prospective Studies , Psoriasis/diagnosis , Statistics, Nonparametric , Confidence Intervals , Antibodies, Monoclonal/adverse effects , Interleukin-17/antagonists & inhibitors
8.
Actas Dermosifiliogr (Engl Ed) ; 111(9): 752-760, 2020 Nov.
Article in English, Spanish | MEDLINE | ID: mdl-33058793

ABSTRACT

BACKGROUND AND OBJECTIVES: Current psoriasis guidelines do not usually include recommendations about first line classical or biologic treatment. The objectives of this study were: to describe shifts in the prescription of the first biological treatment, and to compare treatment withdrawal and rates of adverse events over ten years. MATERIAL AND METHODS: Biobadaderm registry was analyzed to describe: first biological prescription in bio-naïve patients, adverse events rate and reasons for drug withdrawal comparing three periods of time (2008-2010, 2011-2014, 2015-2018). RESULTS: Anti-TNF drugs were the most prescribed biological drug from 2008 to 2010. Ustekinumab has become the most prescribed first biologic since 2014. The main reasons for drug discontinuation were adverse events, lack of efficacy and remission. In each period any treatment was less likely to be discontinued due to any of these three reasons comparing to the previous period. CONCLUSIONS: The present study identifies trends in prescription of the first biological antipsoriatic drug in clinical practice from 2008 to 2018. It suggests that we have become more comfortable with the safety profile and more exigent with the efficacy of the drugs.


Subject(s)
Biological Products , Psoriasis , Drug Prescriptions , Humans , Psoriasis/drug therapy , Registries , Tumor Necrosis Factor Inhibitors
9.
BMC Infect Dis ; 20(1): 186, 2020 Feb 28.
Article in English | MEDLINE | ID: mdl-32111168

ABSTRACT

BACKGROUND: The presentation of clinical leptospirosis has been historically associated with animal workers, slaughterhouse workers and medical veterinarians. This association has shifted to be related to flooding events and outdoor activities; few cases are related to high-risk factors found in immunosuppressed patients. Scarcely a handful of cases have serological evidence of immune response against Leptospira serovar Bratislava representing serogroup Australis, a serovar associated with poor reproductive performance in swine and horses, and recently with cats. CASE PRESENTATION: Herein, we describe a rare clinical presentation of disseminated Leptospira infection in an immunosuppressed 65-year-old woman. She was admitted to the emergency room with fever, bacteraemia, bilateral uveitis and pulmonary involvement. The patient denied outdoor activities; she only had wide exposure to faeces and urine from cats living in her home. Her medical history included idiopathic thrombocytopenic purpura (ITP) diagnosed at the age of 18. She did not respond to medical treatment, and a splenectomy was performed. At age 60, she was diagnosed with Chronic Myeloid Leukemia (CML), and was treated with a tyrosine kinase inhibitor (TKI) -Imatinib. The patient voluntarily discontinued the treatment for the last 6 months. After extensive workup, no microorganisms were identified by the commonly used stains in microbiology. The diagnosis was performed through dark-field microscopy, microagglutination test (MAT), Leptospira genus-specific PCR, the IS1500 PCR for identification of pathogenic species, and 16S based sequencing for the genus identification. CONCLUSION: Immunosuppressed patients may acquire uncommon infections from ubiquitous microorganisms. In this case, serology evidence of exposure to Leptospira serovar Bratislava by MAT and the presence of the Leptospira genus were identified. It should be on mind for the diagnosis in otherwise healthy patients, and thoroughly search on splenectomised patients exposed to animals. Additionally, this report highlights the usefulness of PCR for diagnosis of this potentially life-threatening illness.


Subject(s)
Bacteremia/diagnosis , Leptospirosis/diagnosis , Aged , Bacteremia/microbiology , DNA, Bacterial/metabolism , Female , Humans , Immunocompromised Host , Leptospira/genetics , Leptospira/isolation & purification , Leptospirosis/microbiology , Pneumonia, Mycoplasma/diagnosis , Respiratory Insufficiency/diagnosis , Splenectomy , Thorax/diagnostic imaging , Uveitis/diagnosis
11.
J Eur Acad Dermatol Venereol ; 33(2): 288-297, 2019 Feb.
Article in English | MEDLINE | ID: mdl-30022544

ABSTRACT

BACKGROUND: The most effective treatment modality for actinic keratosis (AK) is photodynamic therapy (PDT). Major obstacles of PDT are the need of a special illumination device and pain accompanying the illumination. These issues may be overcome by replacing an artificial high-power light source with natural daylight for more extended illumination at lower light doses. OBJECTIVE: To determine whether BF-200 ALA (a nanoemulsion gel containing 7.8% 5-aminolaevulinic acid) is non-inferior to MAL (a cream containing 16% methyl-aminolaevulinate) in the treatment of mild-to-moderate AK with daylight PDT (dPDT). Non-inferiority of the primary efficacy variable (total lesion clearance rate per patient's side 12 weeks after PDT) is established if the mean response for BF-200 ALA is no worse than for MAL, within a statistical margin of Δ = -12.5%. METHODS: The study was performed as an intraindividual comparison with 52 patients in seven centres in Germany and Spain. Each patient received one dPDT. Results include clinical endpoints as well as 1-year follow-up results. RESULTS: Twelve weeks after a single dPDT, 79.8% of the AK lesions treated with BF-200 ALA gel and 76.5% of the lesions treated with MAL cream were completely cleared. The median of differences was 0.0 with a one-sided 97.5% CI of 0.0, establishing non-inferiority (P < 0.0001). Results for secondary efficacy parameters were in line with the primary outcome. Recurrence rates 1 year after the treatment were 19.9% for lesions treated with BF-200 ALA and 31.6% for lesions treated with MAL. Adverse reactions including pain were mostly mild and transient and identical to those previously described for dPDT. CONCLUSION: Daylight PDT of AK with BF-200 ALA is well-tolerated and non-inferior to MAL/dPDT. The study demonstrates a trend towards higher efficacies after 3 months and significantly lower recurrence rates after 1 year follow-up.


Subject(s)
Aminolevulinic Acid/analogs & derivatives , Keratosis, Actinic/diagnosis , Keratosis, Actinic/drug therapy , Photochemotherapy/methods , Photosensitizing Agents/administration & dosage , Administration, Cutaneous , Aged , Aminolevulinic Acid/administration & dosage , Female , Gels/therapeutic use , Germany , Humans , Male , Prognosis , Severity of Illness Index , Skin Cream/therapeutic use , Spain , Statistics, Nonparametric , Treatment Outcome
12.
Actas dermo-sifiliogr. (Ed. impr.) ; 109(7): 617-623, sept. 2018. tab, graf
Article in Spanish | IBECS | ID: ibc-175643

ABSTRACT

INTRODUCCIÓN Y OBJETIVOS: La utilización clínica habitual de los fármacos biológicos en el tratamiento de la psoriasis es en segunda línea, es decir, tras el uso previo de un fármaco clásico. Sin embargo, en casos particulares -particularidades del paciente o criterio médico- se realiza la indicación en primera línea. No existen estudios sobre las características demográficas, clínicas y de seguridad de los pacientes que reciben fármaco biológico en primera línea. Como objetivo primario se pretende determinar dichas características de acuerdo con la iniciación de la terapia biológica en primera o segunda línea. MATERIAL Y MÉTODO: Se realizó un estudio descriptivo, multicéntrico, de 181 pacientes que iniciaron tratamiento biológico como primer fármaco sistémico para control de su psoriasis moderada-grave, y que forman parte del Registro Español de Acontecimientos Adversos Asociados con Medicamentos Biológicos en Dermatología, entre enero de 2008 y noviembre de 2016. RESULTADOS: Los pacientes de ambos grupos son muy similares, si bien se evidencia que el grupo que recibe el biológico en primera línea presenta una edad más avanzada, sin que se justifique por gravedad de la enfermedad (PASI) ni por el tiempo de evolución de esta desde el diagnóstico. En este grupo de pacientes es más frecuente la presencia de hipertensión, diabetes y hepatopatía. No hemos encontrado diferencias en motivos de suspensión ni seguridad entre ambos grupos. CONCLUSIONES: No se han encontrado diferencias relevantes entre los 2 grupos, lo cual refuerza la seguridad de los fármacos biológicos en este contexto


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


Subject(s)
Humans , Male , Female , Adult , Middle Aged , Aged , Biological Products/therapeutic use , Immunosuppressive Agents/therapeutic use , Psoriasis/drug therapy , Registries , Antibodies, Monoclonal/therapeutic use , Age Distribution , Antibodies, Monoclonal/adverse effects , Biological Products/adverse effects , Comorbidity , Drug Substitution , Drug Utilization , Immunosuppressive Agents/adverse effects , Psoriasis/epidemiology , Spain/epidemiology , Tumor Necrosis Factor-alpha/antagonists & inhibitors
13.
Actas Dermosifiliogr (Engl Ed) ; 109(7): 617-623, 2018 Sep.
Article in English, Spanish | MEDLINE | ID: mdl-29887167

ABSTRACT

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.


Subject(s)
Biological Products/therapeutic use , Immunosuppressive Agents/therapeutic use , Psoriasis/drug therapy , Registries , Adult , Age Distribution , Aged , Antibodies, Monoclonal/adverse effects , Antibodies, Monoclonal/therapeutic use , Biological Products/adverse effects , Comorbidity , Drug Substitution , Drug Utilization , Female , Humans , Immunosuppressive Agents/adverse effects , Male , Middle Aged , Psoriasis/epidemiology , Spain/epidemiology , Tumor Necrosis Factor-alpha/antagonists & inhibitors
16.
J Eur Acad Dermatol Venereol ; 31(12): 2025-2029, 2017 Dec.
Article in English | MEDLINE | ID: mdl-28750139

ABSTRACT

BACKGROUND: T1 melanoma substaging was recently modified by the American Joint Committee on Cancer (AJCC). Although sentinel lymph node (SLN) positivity is the most important prognostic factor in melanoma, there is a lack of consensus on whether SLN biopsy should be performed in patients with thin melanoma (≤1 mm). OBJECTIVE: The main aim of this study was to investigate predictors of SLN positivity in patients with thin melanoma, with a special emphasis on mitotic rate. A secondary aim was to evaluate survival in this group of patients. MATERIALS AND METHODS: Retrospective multicenter observational study with analysis of age, sex, tumour location, thickness, mitotic rate, regression and microscopic satellites. Predictive factors were identified using a classification and regression tree (CART) approach. Melanoma-specific survival according to SLN status was estimated using Kaplan-Meier curves. RESULTS: We analysed 203 patients with a melanoma ≤1 mm. Using the new AJCC staging criteria, the CART algorithm identified a 7.5% likelihood of SLN positivity in T1a patients. In the case of T1b melanoma, there was a 14.3% likelihood of SLN positivity in patients with a mitotic rate >1 mitosis/mm2 and a 3.2% likelihood in those with ≤1 mitoses/mm2 . None of the patients with T1b disease who had ≤1 mitoses/mm2 and regression had SLN positivity. In T1b patients, 5-year melanoma-specific survival was 98.7% in the SLN-negative group and 75% in the SLN-positive group (P = 0.05). When stratified by mitotic rate, survival was 100% for patients with a mitotic rate of ≤1 mitoses/mm2 and 91.4% for those with >1 mitosis/mm2 (P = 0.022). There were no deaths in the T1a subgroup. CONCLUSIONS: Sentinel lymph node metastasis was less common in patients with T1b melanoma who had a mitotic rate of ≤1 mitoses/mm2 . Performance of SLN biopsy should be carefully considered in this subgroup of patients, particularly considering the good prognosis.


Subject(s)
Melanoma/genetics , Mitotic Index , Skin Neoplasms/genetics , Adult , Female , Humans , Lymphatic Metastasis , Male , Melanoma/pathology , Middle Aged , Retrospective Studies , Sentinel Lymph Node , Sentinel Lymph Node Biopsy , Skin Neoplasms/pathology
17.
J Eur Acad Dermatol Venereol ; 31(10): 1700-1708, 2017 Oct.
Article in English | MEDLINE | ID: mdl-28485816

ABSTRACT

BACKGROUND: Little is known about the adverse events (AEs) that lead to suspension of systemic treatments for psoriasis in clinical practice. OBJECTIVE: The study aimed to investigate AEs associated with discontinuation of systemic therapy in patients with psoriasis in a clinical setting (Biobadaderm). MATERIALS AND METHODS: Multicentre, prospective, cohort study of patients with moderate-to-severe plaque psoriasis receiving systemic therapies from January 2008 to November 2015, in 12 hospitals in Spain. The incidence rate (IR) was used to compare biologics and classic systemic therapies. RESULTS: A total of 4218 courses of treatment were given to 1938 patients. A total of 447 (11%) treatments were discontinued due to AEs. The IR of AE associated with discontinuation of systemic therapies was 13 events/100 patient-years (PY) (95% CI: 12.14-13.93), 9.34 events/100 PY (95% CI: 8.44-10.33) for biologics and 19.67 (95% CI: 17.9-21.6) events/100 PY for classics (P < 0.001). Of 810 discontinuation-related AEs, 117 (14%) were serious. The highest IRs were for cyclosporine [49.18/100 PY (95% CI: 41.91-57.72)] and infliximab [26.52/100 PY (95% CI: 20.98-33.51). Ustekinumab presented the lowest IR (2.6/100 PY (95% CI: 1.83-3.69). LIMITATIONS: Observational study with potential selection bias. CONCLUSION: Biologic therapies are associated with a lower rate of discontinuation-related AEs than are classic therapies in real clinical practice. Ustekinumab showed the lowest incidence.


Subject(s)
Biological Products/adverse effects , Dermatologic Agents/adverse effects , Psoriasis/drug therapy , Substance Withdrawal Syndrome/physiopathology , Adult , Adverse Drug Reaction Reporting Systems , Female , Humans , Male , Middle Aged , Prospective Studies , Registries , Severity of Illness Index , Spain
19.
J Eur Acad Dermatol Venereol ; 31(6): 1021-1028, 2017 Jun.
Article in English | MEDLINE | ID: mdl-28252811

ABSTRACT

BACKGROUND: There are a limited number of studies comparing psoriasis patients without psoriatic arthritis (PsA) to those with arthritis. Previous results are controversial. OBJECTIVES: To perform a comparative analysis of the phenotype, baseline comorbidities, therapeutic profile and incidence of adverse events (particularly overall adverse events, infections and infestations, malignancies and psychiatric disorders) among psoriatic patients with/without PsA. METHODS: All the patients on the Biobadaderm registry, a prospective inception cohort of psoriasis patients on systemic therapy, were included. Patients were divided into two groups: those with psoriasis without arthritis at the time of entry into the cohort (Pso group) and those with psoriasis and psoriatic arthritis (PsA group) at entry. Patients were followed until the censorship date (last visit in a lost-to-follow-up patient, or 10 November 2015, whichever occurred first). We excluded all the patients who developed any kind of signs and/or symptoms of joint involvement during the follow-up. A descriptive analysis was performed. We estimated incidence ratios (IRR) of adverse events during systemic treatment using a mixed-effects Poisson regression. RESULTS: We included 2120 patients: 1871 (88%) patients with psoriasis without arthritis and 249 (12%) with psoriasis and PsA. The follow-up time was 5020 patients-year in the Pso group and 762 patients-year in the PsA group. Patients with PsA had more comorbidities, particularly hypertension and liver disease; used a higher number of systemic therapies, particularly anti-TNFα drugs and combination therapy; and presented more adverse events (IRR adjusted = 1.29; 95% CI: [1.05-1.58]), particularly serious adverse events (IRR adjusted = 1.51; 95% CI: [1.01-2.26]) and infections/infestations (IRR adjusted = 1.88; 95% CI: [1.27-2.79]), independently of the associated comorbidities and present/past therapies. CONCLUSIONS: Given the differences between patients with psoriasis alone or with psoriasis associated with PsA, patients with psoriasis and PsA should be followed and managed more closely and with specific attention.


Subject(s)
Arthritis, Psoriatic/physiopathology , Phenotype , Registries , Adult , Aged , Arthritis, Psoriatic/complications , Female , Humans , Male
20.
Article in Spanish | BINACIS | ID: biblio-1099744

ABSTRACT

INTRODUCCIÓN: Los Recién Nacidos prematuros tardíos (RNPTT) y los Recién Nacidos de Término Temprano (RNTt) son considerados una población de riesgo, con altos índices de ingreso hospitalario y morbimortalidad, mayor cantidad de días de internación y altas tasas de reingreso hospitalario en comparación a los Recién Nacidos de Término Tardío (RNTT). El Síndrome de distrés respiratorio es uno de los principales diagnósticos al ingreso, requiriendo distintos modos de soporte respiratorio, por lo tanto, requieren de cuidados especiales en unidades de media o alta complejidad, significando así un importante costo en salud. OBJETIVOS: Comparar la frecuencia en que se presenta la morbilidad respiratoria (MR) entre RNPTT y en RNTt Vs Recién Nacido a Termino Tardío (RNTT). Establecer factores asociados a MR. Describir los distintos modos de soporte respiratorio utilizados. PACIENTES Y MÉTODOS: Se incluyeron a todos los RNPTT (34 a 36 SEG), y RNTt (37 a 38 SEG) y se compararon con todos los pacientes RNTT (39 a 41 SEG) durante los años 2011 a 2015. Se excluyó a pacientes con malformación o síndrome genético, o derivados de otro centro médico. Análisis estadístico: La frecuencia de MR se consignó en porcentajes. La misma se comparó en ambos grupos utilizando la prueba de Chicuadrado y se realizó el cálculo de Odss Ratio. Las variables maternas o neonatales asociadas a MR se compararon entre los pacientes con o sin MR utilizando prueba U de Mann-Whitney para las variables continuas y Chi-cuadrado para variables categóricas. Las variables con un valor de P ≤ 0.1 en el análisis univariado se incluyeron en un modelo multivariado de regresión logística. El soporte terapéutico utilizado fue descripto en porcentajes y comparados mediante prueba de Chicuadrado y evaluados mediante odss ratio. RESULTADOS: Durante el periodo evaluado se analizaron los datos de 10512 pacientes de los cuales 766 (7,8%) fueron RNPTT, 3654 (92,6%) RNTt y 6087 (57,90%) RNTT. La frecuencia de MR en los RNPTT fue de 202 (26,4%), en los RNTt fue de 115 (3,15%) Vs 46 (0,76%) en los RNTT. El Odss ratio para MR entre RNPTT y RNTt comparado con RNTT respectivamente fue: OR 47.03, IC95% 33.7 a 65.53, P 0.0001, OR 4.26, IC95% 3.02 a 6.02, P 0.0001. (Siendo los RNTT el grupo control. Ver tabla). En el análisis multivariado se observaron factores de riesgo asociados a MR: Patología asociada al embarazo (OR 4,248, IC95% 2,918 a 6,184, P 0.0001), el Apgar menor a 7 a los 5 min (OR 15,09, IC95% 4,64 a 49,03, P 0.0001), el nacimiento por cesárea (OR 2,96 IC95% 2,32 a 3,78, P 0.0001), sexo masculino (OR 1,5 IC95% 1,21 a 2,01, 0,001). En la evaluación en toda la población general se observó al Retardo de Crecimiento Intrauterino (RCIU) como factor protector de MR, (OR 0.51, IC95% 0,29 a 0,92, P 0.029). Los datos en relación al soporte de oxígeno se muestran en la Tabla1. CONCLUSION: Los recién nacidos prematuros tardíos y los recién nacido termino temprano presentaron mayor morbilidad respiratoria comparado con los recién nacidos termino tardío. Los factores de riesgo más preponderantes para MR fueron la prematurez, el nacimiento por cesárea, nacer con Apgar menor a 7 a los 5 min y la existencia de patología materna asociada al embarazo. Los RNPTT y RNTT son una población de riesgo (mayor requerimiento de internación, más días de internación, mayor morbilidad respiratoria y mayor soporte de oxigeno), por lo que se deben de adoptar medidas preventivas para lograr disminuir los factores de riesgo que generan el nacimiento prematuro tardío y término temprano y así lograr disminuir los índices de morbi mortalidad y costos en salud que estos implican. (AU)


INTRODUCTION: Late Preterm Newborns (LPN) and Early Term newborns (ETN) are considered to be at risk, because they have high rates of hospital admission, morbidity and mortality, more days of hospitalization, and high rates of hospital readmission compared To Late term Newborns (LTN). Respiratory distress syndrome is one of the major diagnoses on admission, requiring different modes of respiratory support, therefore, require special care in medium or high complexity neonatal units, meaning a significant health cost. OBJETIVES: Compare the frequency of respiratory morbidity (RM) between late preterm and early term infants Vs complete or late term newborns. Establish factors associated with RM. Describe the different modes of oxigen respiratory support used. PATIENTS AND METHODS: All LPN (34-36 SEGs) and ETN (37-38 SEGs) were included and compared to all LTN (39-41 SEGs) during the years 2011 to 2015. Were excluded patients With malformation or genetic syndrome, or derived from another medical center. Statistical analysis: The frequency of RM was recorded in percentages. The same was compared in both groups using the Chi-square test and the Odss Ratio calculation was performed. Maternal or neonatal variables associated with RM were compared between patients with or without RM using Mann-Whitney U test for continuous variables and Chisquare for categorical variables. Variables with a value of P ≤ 0.1 in the univariate analysis were included in a multivariate logistic regression model. The therapeutic support used was described in percentages and compared by chi-square test and evaluated by odss ratio. RESULTS: Data from 10512 patients were analyzed in the evaluation periode, of which 766 (7.8%) were LPN, 3654 (92.6%) ETN and 6087 (57.90%) LTN. The frequency of RM in the LPN was 202 (26.4%), in the ETN it was 115 (3.15%) vs 46 (0.76%) in the LTN, the odss ratio for RM comparing LPN and ETN with LTN respectively was: OR 47.03, 95% CI 33.7 to 65.53, P 0.0001, OR 4.26, IC95% 3.02 to 6.02, P 0.0001 (LTN being the control group. See table). In the multivariate analysis it was observed the risk factors asociated with RM: the pathology associated with pregnancy (OR 4.248, 95% CI 2.918 to 6.184, P 0.0001), Apgar less than 7 at 5 min (OR 15.09, 95% CI 4.64 to 49.03, P 0.0001). Cesarean birth (OR 2.96, IC95% 2.32 a 3.78, P 0.0001) and Male sex (OR 1,5 IC95% 1,21 a 2,01 P 0,001). In the evaluation in the general population, the Intrauterine Growth Retardation (IUGR) was observed as a protective factor of MR, (OR 0.51, 95% CI 0.29 to 0.92, P 0.029). The data in relation to the oxygen support are shown in Table 1. CONCLUSION: Late preterm infants and early term infants presented higher respiratory morbidity compared to late term newborns. The most important risk factors for RM were prematurity, cesarean birth, birth with Apgar less than 7 at 5 minutes and the existence of maternal pathology associated with pregnancy. The LPN and ETN are a population at risk (greater requirement of hospitalization, more days of hospitalization, greater respiratory morbidity and greater support of oxygen), so that preventive actions must be taken to reduce the risk factors who give late preterm and early term birth and thus reduce morbidity rates and health costs that these imply. (AU)


Subject(s)
Humans , Infant, Newborn , Respiratory Tract Diseases/epidemiology , Infant, Premature , Risk Factors , Morbidity
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