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1.
Drugs Aging ; 39(9): 715-727, 2022 09.
Artículo en Inglés | MEDLINE | ID: mdl-35859228

RESUMEN

BACKGROUND: Psoriasis is a common inflammatory disease in any age group, but also in older patients (≥ 65 years of age). Since older patients are often excluded from clinical trials, limited data specifically on this growing population are available, e.g. regarding the safety and performance of biological treatment. AIMS: We aimed to give insight into this specific population by comparing the drug survival and safety of biologics in older patients with that in younger patients. METHODS: In this real-world observational study, data from 3 academic and 15 non-academic centers in The Netherlands were extracted from the prospective BioCAPTURE registry. Biologics included in this study were tumor necrosis factor (TNF)-α, interleukin (IL)-17, IL-12/23, and IL-23 inhibitors. Patients were divided into two age groups: ≥ 65 years and < 65 years. The Charlson Comorbidity Index (CCI) was used to measure comorbid disease status, and all adverse events (AEs) that led to treatment discontinuation were classified according to the Medical Dictionary for Regulatory Activities (MedDRA) classification. All AEs that led to treatment discontinuation were studied to check whether they could be classified as serious AEs (SAEs). Kaplan-Meier survival curves for overall 5-year drug survival and split according to reasons of discontinuation (ineffectiveness or AEs) were constructed. Cox regression models were used to correct for possible confounders and to investigate associations with drug survival in both age groups separately. Psoriasis Area and Severity Index (PASI) scores during the first 2 years of treatment and at the time of treatment discontinuation were assessed and compared between age groups. RESULTS: A total of 890 patients were included, of whom 102 (11.4%) were aged ≥ 65 years. Body mass index, sex, and distribution of biologic classes (e.g. TNFα, IL12/23) were not significantly different between the two age groups. A significantly higher CCI score was found in older patients, indicative of more comorbidity (p < 0.001). The 5-year ineffectiveness-related drug survival was lower for older patients (44.5% vs. 60.5%; p = 0.006), and the 5-year overall (≥ 65 years: 32.4% vs. < 65 years: 42.1%; p = 0.144) and AE-related (≥ 65 years: 82.1% vs. < 65 years: 79.5%; p = 0.913) drug survival was comparable between age groups. Of all AEs (n = 155) that led to discontinuation, 16 (10.3%) were reported as SAEs but these only occurred in younger patients. After correcting for confounders, the same trends were observed in the drug survival outcomes. Linear regression analyses on PASI scores showed no statistical differences at 6, 12, 18, and 24 months of treatment between age groups. CONCLUSIONS: This study in a substantial, well-defined, prospective cohort provides further support that the use of biologics in older patients seems well-tolerated and effective. Biologic discontinuation due to AEs did not occur more frequently in older patients. Older patients discontinued biologic treatment more often due to ineffectiveness, although no clear difference in PASI scores was observed. More real-world studies on physician- and patient-related factors in older patients are warranted.


Asunto(s)
Productos Biológicos , Psoriasis , Anciano , Productos Biológicos/uso terapéutico , Humanos , Estudios Prospectivos , Psoriasis/tratamiento farmacológico , Sistema de Registros , Resultado del Tratamiento
2.
J Eur Acad Dermatol Venereol ; 33(10): 1913-1920, 2019 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-31177583

RESUMEN

BACKGROUND: Female sex has been reported as a predictor for treatment discontinuation with biological therapies for psoriasis, although reasons remain unclear. It can be hypothesized that lower satisfaction with biological treatment in women might add to the lower drug survival rates. OBJECTIVES: To identify possible differences in satisfaction with biological treatment between female and male patients using the Treatment Satisfaction Questionnaire for Medication (TSQM). METHODS: Data of psoriasis patients treated with biologics were obtained from the prospective, multicentre, daily-practice BioCAPTURE registry. Longitudinal TSQM data were analysed by linear mixed models. Relevant patient characteristics were incorporated as possible confounding factors. Post hoc analysis of adverse events was performed in order to investigate differences between sexes. RESULTS: We included 315 patients with 396 corresponding treatment episodes (137 adalimumab, 90 etanercept, 137 ustekinumab, 24 secukinumab and 8 infliximab). Almost forty per cent of the patients were female. Women had significantly lower baseline PASI scores (P = 0.01). Longitudinal analyses demonstrated lower TSQM scores for 'side-effects' (P = 0.05) and 'global satisfaction' (P = 0.01) in female patients compared with male patients over 1 year of treatment. Women reported more relevant adverse events in the context of biologic treatment compared to men (rate ratio 1.79; P < 0.001), with more fungal (rate ratio 2.20; P = 0.001) and herpes simplex infections (rate ratio 3.25; P = 0.005). CONCLUSIONS: This study provides a prospective, longitudinal analysis of treatment satisfaction with biologics in female and male patients with psoriasis. Women were slightly less satisfied with treatment regarding side-effects and global satisfaction. Differences in treatment satisfaction and side-effects might add to the fact that women discontinue biological treatments more often.


Asunto(s)
Productos Biológicos/uso terapéutico , Fármacos Dermatológicos/uso terapéutico , Satisfacción del Paciente , Psoriasis/tratamiento farmacológico , Adalimumab/uso terapéutico , Adulto , Anticuerpos Monoclonales Humanizados/uso terapéutico , Productos Biológicos/efectos adversos , Fármacos Dermatológicos/efectos adversos , Etanercept/uso terapéutico , Femenino , Herpes Simple/inducido químicamente , Humanos , Infliximab/uso terapéutico , Estudios Longitudinales , Masculino , Cumplimiento de la Medicación , Persona de Mediana Edad , Micosis/inducido químicamente , Estudios Prospectivos , Sistema de Registros , Factores Sexuales , Encuestas y Cuestionarios , Ustekinumab/uso terapéutico
3.
Thromb Res ; 173: 35-41, 2019 01.
Artículo en Inglés | MEDLINE | ID: mdl-30468951

RESUMEN

BACKGROUND: Elastic compression stockings (ECS) are uncomfortable to wear but may prevent post-thrombotic syndrome (PTS). The ability to predict PTS may help clinical decision making regarding the optimal duration of ECS after deep vein thrombosis (DVT). AIMS: Predefined endpoint analysis of the Octavia study that randomized patients who compliantly used ECS up to one year after DVT to continue or discontinue ECS treatment. Primary aim was to identify predictors of PTS. METHODS: Patient characteristics were collected and ultrasonography was performed to assess reflux, residual thrombosis and persistent thrombus load 12 months after DVT. Multivariable analyses were performed to identify factors related to PTS. RESULTS: Thrombus score ≥ 3, BMI ≥ 26, duration of symptoms before DVT diagnosis ≥ 8 days and a Villalta score of 2-4 points were statistically significant predictors of PTS. The predictive value for PTS for the assessed variables was not different between the 2 treatment groups. In the stop ECS group, 3.2% (95%CI 0.08-18) of patients without any predictors for PTS were diagnosed with mild PTS during follow-up, and none with severe PTS, for a sensitivity of 98% (95% CI 89-100), a specificity of 14% (95% CI 10-20), a positive predictive value of 20% (95% CI 19-22), and a negative predictive value of 97% (95% CI 81-100). CONCLUSION: We identified 4 predictors of PTS occurring in the 2nd year after DVT. Our findings may be used to decide on whether to continue ECS treatment for an additional year, after one year of compliant ECS use, keeping in mind that patients with none of the predictors will have the lowest PTS incidence.


Asunto(s)
Síndrome Postrombótico/prevención & control , Medias de Compresión , Trombosis de la Vena/prevención & control , Anciano , Femenino , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Síndrome Postrombótico/diagnóstico , Síndrome Postrombótico/etiología , Pronóstico , Trombosis de la Vena/complicaciones , Trombosis de la Vena/diagnóstico
4.
Br J Dermatol ; 176(4): 1001-1009, 2017 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-27579864

RESUMEN

BACKGROUND: The efficacy of etanercept and ustekinumab in psoriasis has been compared in one randomized controlled trial. Comparison of the long-term effectiveness of biologics in daily-practice psoriasis treatment is currently lacking. OBJECTIVES: To compare the effectiveness between the three widely used outpatient biologics adalimumab, etanercept and ustekinumab in daily-practice psoriasis treatment and to correct for confounders. METHODS: Data were extracted from the prospective, multicentre BioCAPTURE registry. Multilevel linear regression analyses (MLRAs) and generalized estimating equation (GEE) analyses were performed on the course of mean Psoriasis Area and Severity Index (PASI) and PASI 75 (≥ 75% reduction vs. baseline). Both models were corrected for confounders. Subgroup analyses for biological dose were performed. RESULTS: We included 356 patients with 513 treatment episodes: 178 adalimumab, 245 etanercept and 90 ustekinumab. MLRA showed a similar effectiveness between adalimumab, etanercept and ustekinumab after 1 year, but the highest effectiveness for ustekinumab during 5 years of treatment (P = 0·047; ustekinumab vs. etanercept, P = 0·019). GEE analysis revealed a higher chance of attaining PASI 75 with adalimumab and ustekinumab than with etanercept at 1 year of treatment. A higher than label dose was more often used in patients treated with etanercept (adalimumab, etanercept and ustekinumab: respectively 31·5%, 55·1% and 17% after 1 year, P < 0·001; 39·3%, 71·4% and 24% after 5 years, P < 0·001). CONCLUSIONS: Compared with etanercept, ustekinumab had the highest effectiveness during 5 years of treatment. Patients receiving adalimumab and ustekinumab more often reached PASI 75 than those on etanercept at 1 year of treatment. Dose escalation was more frequent in etanercept and adalimumab than in ustekinumab.


Asunto(s)
Adalimumab/administración & dosificación , Fármacos Dermatológicos/administración & dosificación , Etanercept/administración & dosificación , Psoriasis/tratamiento farmacológico , Ustekinumab/administración & dosificación , Esquema de Medicación , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Sistema de Registros , Índice de Severidad de la Enfermedad , Resultado del Tratamiento
5.
Br J Dermatol ; 176(3): 786-793, 2017 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-27454758

RESUMEN

BACKGROUND: It is important to assess which patients with psoriasis are more likely to achieve high clinical responses on biologics. OBJECTIVES: To assess the number of treatment episodes (TEs) that achieve a 100% improvement in Psoriasis Area and Severity Index (PASI 100), PASI 90 or PASI ≤ 5 at week 24 of biological treatment, and which baseline patient characteristics predict treatment response. METHODS: Data from patients with psoriasis treated with adalimumab, etanercept, infliximab or ustekinumab were extracted from a prospective cohort. TEs with high clinical responses were described. Uni- and multivariate regression analyses were performed with the generalized estimating equation method to elucidate which baseline patient characteristics were predictors for PASI 90 and PASI ≤ 5 at week 24. RESULTS: In total, 454 TEs were extracted (159 adalimumab; 193 etanercept; 19 infliximab; 83 ustekinumab) from 326 patients. At week 24, in 3%, 15% and 59% of TEs, respectively, PASI 100, PASI 90 and PASI ≤ 5 was reached. In TEs without a PASI 100 or PASI 90 response, PASI ≤ 5 was still achieved in 58% and 52%, respectively. Baseline PASI ≥ 10 was a strong predictor for achieving PASI 90; baseline PASI < 10 and a lower baseline body mass index (BMI) were significant predictors for PASI ≤ 5 at week 24. CONCLUSIONS: A limited number of patients achieved PASI 100 or PASI 90 at 24 weeks of biological treatment. Including an absolute PASI score in the assessment of psoriasis severity is important. Baseline BMI was an important, modifiable predictor for a high response.


Asunto(s)
Factores Biológicos/uso terapéutico , Psoriasis/tratamiento farmacológico , Adalimumab/uso terapéutico , Etanercept/uso terapéutico , Femenino , Humanos , Infliximab/uso terapéutico , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Índice de Severidad de la Enfermedad , Resultado del Tratamiento , Ustekinumab/uso terapéutico
6.
BMJ ; 353: i2691, 2016 May 31.
Artículo en Inglés | MEDLINE | ID: mdl-27245485

RESUMEN

OBJECTIVE:  To study whether stopping elastic compression stockings (ECS) after 12 months is non-inferior to continuing them for 24 months after proximal deep venous thrombosis. DESIGN:  Multicentre single blind non-inferiority randomised controlled trial. SETTING:  Outpatient clinics in eight teaching hospitals in the Netherlands, including one university medical centre. PARTICIPANTS:  Patients compliant with compression therapy for 12 months after symptomatic, ultrasound proven proximal deep venous thrombosis of the leg. INTERVENTIONS:  Continuation or cessation of ECS 12 months after deep venous thrombosis. MAIN OUTCOME MEASURES:  The primary outcome was the incidence of post-thrombotic syndrome 24 months after diagnosis of deep venous thrombosis, as assessed by the standardised Villalta scale in an intention to treat analysis. The predefined non-inferiority margin was 10%. The main secondary outcome was quality of life (VEINES-QOL/Sym). RESULTS:  518 patients compliant with ECS and free of post-thrombotic syndrome were randomised one year after diagnosis of deep venous thrombosis to stop or continue ECS therapy for another year. In the stop-ECS group, 51 of 256 patients developed post-thrombotic syndrome, with an incidence of 19.9% (95% confidence interval 16% to 24%). In the continue-ECS group, 34 of 262 patients developed post-thrombotic syndrome (incidence 13.0%, 9.9% to 17%), of whom 85% used ECS six or seven days a week during the study period, for an absolute difference of 6.9% (95% confidence interval upper limit 12.3%). Because the upper limit of the 95% confidence interval exceeds the predefined margin of 10%, non-inferiority was not reached. The number needed to treat to prevent one case of post-thrombotic syndrome by continuing ECS was 14 (95% confidence interval lower limit 8). Quality of life did not differ between the two groups. CONCLUSION:  Stopping ECS after one year in compliant patients with proximal deep venous thrombosis seemed not to be non-inferior to continuing ECS therapy for two years in this non-inferiority trial. TRIAL REGISTRATION:  Netherlands Trial Register NTR1442.


Asunto(s)
Tratamiento Conservador , Extremidad Inferior/irrigación sanguínea , Síndrome Postrombótico , Medias de Compresión , Venas , Trombosis de la Vena , Adulto , Anciano , Tratamiento Conservador/instrumentación , Tratamiento Conservador/métodos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Evaluación de Procesos y Resultados en Atención de Salud , Síndrome Postrombótico/diagnóstico , Síndrome Postrombótico/etiología , Síndrome Postrombótico/fisiopatología , Síndrome Postrombótico/prevención & control , Prevención Terciaria/instrumentación , Prevención Terciaria/métodos , Factores de Tiempo , Ultrasonografía/métodos , Venas/diagnóstico por imagen , Venas/fisiopatología , Trombosis de la Vena/complicaciones , Trombosis de la Vena/diagnóstico , Trombosis de la Vena/fisiopatología , Trombosis de la Vena/terapia
8.
Br J Dermatol ; 175(2): 340-7, 2016 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-26989852

RESUMEN

BACKGROUND: Predictors for successful treatment are important for personalized medicine. Predictors for drug survival of biologics in psoriasis have been assessed, but not split for different biologics or for the reason of discontinuation. OBJECTIVES: To compare long-term drug survival between the outpatient biologics adalimumab, etanercept and ustekinumab in patients with psoriasis, and to elucidate predictors for overall survival and drug discontinuation due to ineffectiveness and side-effects for each biologic separately. METHODS: Ten years of data were extracted from the prospective, multicentre, long-term BioCAPTURE registry. Kaplan-Meier survival analyses and confounder-corrected multivariate Cox regression analysis for drug survival (MCR-DS) were performed to compare drug survival between biologics. To elucidate the predictors for different reasons of discontinuation for each biologic, univariate Cox regression analyses and multivariate Cox regression analyses for predictors (MCR-P) with backward selection were performed. RESULTS: In total, 526 treatment episodes - 186 adalimumab, 238 etanercept and 102 ustekinumab - were included covering 1333 treatment years. MCR-DS showed a significantly higher overall survival for ustekinumab compared with adalimumab and etanercept. MCR-P showed that higher body mass index (BMI) was a predictor for discontinuation due to ineffectiveness for etanercept and ustekinumab and that female sex was a predictor for discontinuation due to side-effects for adalimumab, etanercept and ustekinumab. CONCLUSIONS: Ustekinumab has the highest confounder-corrected long-term drug survival in psoriasis treatment, compared with adalimumab and etanercept. Higher BMI is a predictor for discontinuation due to ineffectiveness in etanercept and ustekinumab, and female sex is a consistent predictor for discontinuation due to side-effects in all three outpatient biologics.


Asunto(s)
Adalimumab/efectos adversos , Antiinflamatorios/efectos adversos , Etanercept/efectos adversos , Psoriasis/tratamiento farmacológico , Ustekinumab/efectos adversos , Adalimumab/administración & dosificación , Antiinflamatorios/administración & dosificación , Factores Biológicos/efectos adversos , Índice de Masa Corporal , Esquema de Medicación , Sustitución de Medicamentos , Etanercept/administración & dosificación , Femenino , Humanos , Estimación de Kaplan-Meier , Cuidados a Largo Plazo , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Sistema de Registros , Caracteres Sexuales , Ustekinumab/administración & dosificación
9.
Br J Dermatol ; 171(5): 1091-8, 2014 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-24861358

RESUMEN

BACKGROUND: Treatment goals have been developed to optimize daily clinical practice psoriasis care, but have not yet been studied in real life. OBJECTIVES: To investigate to what extent treatment decisions made by dermatologists in daily clinical practice for patients with psoriasis on biologics are already in accordance with treatment goals without the active application of the treatment goals algorithm. METHODS: Data were extracted from a prospective daily practice cohort of patients with psoriasis on biologics. Analysis was done on effectiveness (Psoriasis Area and Severity Index score) and quality of life (Dermatology Life Quality Index questionnaire). Treatment decisions such as dosage adjustments, combination treatments, or switching therapy were compared with the treatment goals algorithm. RESULTS: In 64% (253 of 395) of visits, physicians followed the treatment goals algorithm. There were 162 (41%) visits in which there should have been a treatment modification according to treatment goals (group Modify) and a modification was indeed made in 59 of these 162 visits (36%). In 233 (59%) visits no treatment modification was necessary (group Continue) and therapy was indeed not modified in 194 of 233 visits (83%). CONCLUSIONS: Physicians acted in accordance with treatment goals in the majority of patient visits. In the patient group not achieving these goals, physicians should have modified therapy according to treatment goals but continued the same therapeutic regimen in the majority of visits. Optimizing therapy and defining barriers in the latter group might increase treatment results in daily practice psoriasis care.


Asunto(s)
Factores Biológicos/uso terapéutico , Fármacos Dermatológicos/uso terapéutico , Psoriasis/tratamiento farmacológico , Adalimumab , Anticuerpos Monoclonales/uso terapéutico , Anticuerpos Monoclonales Humanizados/uso terapéutico , Toma de Decisiones , Sustitución de Medicamentos , Quimioterapia Combinada , Etanercept , Femenino , Objetivos , Humanos , Inmunoglobulina G/uso terapéutico , Infliximab , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Calidad de Vida , Receptores del Factor de Necrosis Tumoral/uso terapéutico , Ustekinumab
10.
Br J Dermatol ; 171(5): 1189-96, 2014 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-24807471

RESUMEN

BACKGROUND: Drug survival is a marker for treatment success. To date, no analyses relating dermatological quality-of-life measures to drug survival have been published. OBJECTIVES: (i) To describe 1-year drug survival for adalimumab, etanercept and ustekinumab in a daily practice psoriasis cohort, and (ii) to introduce the concept of 'happy' drug survival, defined as Dermatology Life Quality Index (DLQI) ≤ 5 combined with being 'on drug' at a specific time point. METHODS: Data were extracted from a prospective registry. Drug survival was analysed using Kaplan-Meier estimates. 'Happy' drug survival was calculated, with data split into 'happy' (DLQI ≤ 5) vs. 'unhappy' (DLQI > 5) at baseline and months 3, 6, 9 and 12. RESULTS: 249 treatment episodes were included (101 adalimumab, 82 etanercept, 66 ustekinumab). The 1-year drug survival rates for ustekinumab, adalimumab and etanercept were 85%, 74% and 68%, respectively. Ustekinumab showed a better confounder-corrected drug survival vs. etanercept [hazard ratio (HR) 3·8, P = 0·02] and a trend towards better survival vs. adalimumab (HR 2·3, P = 0·1). At baseline, the majority (n = 115, 73%) was considered 'unhappy' and a minority 'happy' (n = 42, 27%) (ratio 'happy':'unhappy' was 1 : 2.7). The percentage of treatment episodes with 'happy' on-drug patients increased to 79% after 1 year. CONCLUSIONS: Ustekinumab showed a better overall drug survival than etanercept, and a trend towards a better overall drug survival than adalimumab. After 1 year, patients reported to be 'happy' in 79% of episodes and 'unhappy' in 21%. We introduced the new concept of 'happy' drug survival because the proportion of on-drug patients with good quality of life is an important indicator for treatment success.


Asunto(s)
Anticuerpos Monoclonales Humanizados/uso terapéutico , Fármacos Dermatológicos/uso terapéutico , Inmunoglobulina G/uso terapéutico , Psoriasis/tratamiento farmacológico , Receptores del Factor de Necrosis Tumoral/uso terapéutico , Adalimumab , Sustitución de Medicamentos , Etanercept , Femenino , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Satisfacción del Paciente , Estudios Prospectivos , Calidad de Vida , Resultado del Tratamiento , Ustekinumab
11.
Br J Dermatol ; 170(5): 1158-65, 2014 May.
Artículo en Inglés | MEDLINE | ID: mdl-24484403

RESUMEN

BACKGROUND: Although the effectiveness of biologics for psoriasis has been measured extensively with objective outcome measures, studies based on subjective, patient-reported outcome measures remain scarce. OBJECTIVES: To investigate satisfaction with medication, as measured by the Treatment Satisfaction Questionnaire for Medication (TSQM) for biologics in daily practice psoriasis care in the first 6 months of treatment; and to identify possible differences in satisfaction with medication between patients experienced (biologics-experienced) and inexperienced (biologics-inexperienced) in the use of biologics. METHODS: TSQM baseline measurements were compared using measurements taken after 6 months, using the Wilcoxon signed-rank test for paired comparisons. Intention-to-treat with last observation carried forward (ITT with LOCF) and as-treated analyses were performed. The difference between biologics-experienced and biologics-inexperienced patients for TSQM was analysed using ITT with LOCF. At 6 months, outcomes for biologics-experienced and biologics-inexperienced patients were compared using the Mann-Whitney U-test. RESULTS: One hundred and six patients were eligible for analysis, and treated with etanercept (n = 34), adalimumab (n = 49) or ustekinumab (n = 23). Fifty-four per cent of patients were biologics-inexperienced. A statistically significant improvement was seen in all domains of the TSQM ('effectiveness', 'side-effects', 'convenience' and 'global satisfaction') by comparison of months 3 or 6 with baseline (all P ≤ 0·02). After 6 months, biologics-inexperienced patients scored better on the 'global satisfaction' domain than biologics-experienced patients (P < 0·01). CONCLUSIONS: We provide a prospective, longitudinal analysis of TSQM for biologics in daily practice psoriasis care. High satisfaction rates were achieved. The 'effectiveness' and 'convenience' domains showed the most room for improvement.


Asunto(s)
Factores Biológicos/uso terapéutico , Productos Biológicos/uso terapéutico , Fármacos Dermatológicos/uso terapéutico , Satisfacción del Paciente , Psoriasis/tratamiento farmacológico , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Psoriasis/psicología , Sistema de Registros , Resultado del Tratamiento
12.
Br J Dermatol ; 168(6): 1343-7, 2013 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-23738641

RESUMEN

BACKGROUND: Fumaric acid esters (FAE) are used as an effective and safe oral treatment for plaque psoriasis in adult patients, but little is known about their efficacy and safety in children with psoriasis. OBJECTIVES: To assess the effectiveness and safety of FAE in the treatment of paediatric psoriasis. METHODS: This is a retrospective analysis of 14 paediatric patients with psoriasis (age <18 years) treated with FAE between 2004 and 2012 at several Dutch university and regional clinics. Patients were identified through databases or registries. RESULTS: The median age at the start of FAE treatment was 15 years (range 8-17 years). The median duration of FAE treatment was 10 months (range 1-80 months), and the median maintenance dosage per day was 360 mg dimethylfumarate (range 240-600 mg). Five patients (36%) achieved a complete clearance of their psoriasis, one patient (7%) had a good improvement, three patients (21%) had a partial response and five patients (36%) were nonresponders. FAE treatment was well tolerated, but two patients (14%) discontinued FAE, one with severe diarrhoea and one with flushes. Five patients (36%) had transient, slightly abnormal laboratory values of liver-function tests or leucocytes that did not necessitate FAE dosage reduction or treatment discontinuation. No serious adverse events occurred. CONCLUSIONS: In this retrospective case series FAE seemed to be an effective and safe treatment for children with psoriasis. FAE may be an attractive therapeutic alternative to the currently used systemic immunosuppressive agents for paediatric patients with psoriasis. Further studies are needed to evaluate the suitability of FAE in paediatric psoriasis.


Asunto(s)
Fumaratos/administración & dosificación , Inmunosupresores/administración & dosificación , Psoriasis/tratamiento farmacológico , Adolescente , Niño , Dimetilfumarato , Femenino , Fumaratos/efectos adversos , Humanos , Inmunosupresores/efectos adversos , Masculino , Países Bajos , Estudios Retrospectivos , Índice de Severidad de la Enfermedad , Factores de Tiempo , Resultado del Tratamiento
13.
Kidney Int ; 70(4): 765-70, 2006 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-16816841

RESUMEN

Dialysis-associated steal syndrome (DASS) is defined as a clinical condition caused by arterial insufficiency distal to the dialysis access owing to diversion of blood into the fistula or graft. The incidence of symptomatic DASS requiring treatment is 1-8%. The etiology is iatrogenic and symptoms are quite debilitating. Banding of the access inflow has largely been abandoned because of the inherent problem with balancing fistula flow with distal flow complicated by a high incidence of subsequent access thrombosis. In this study, we are reporting a modification to the traditional banding procedure, which markedly improves banding outcomes. We are reporting 16 patients who underwent a new standardized minimally invasive banding procedure performed in an outpatient setting with minimal morbidity. This modified banding procedure requires a small (1-2 cm) skin incision for the placement of a ligature and utilizes a 4 or 5 mm diameter endoluminal balloon to achieve and standardize the desired reduction of inflow size. All 16 patients had immediate symptomatic and angiographic improvement after the procedure. Follow-up showed none of the patients had recurrence of symptoms or thrombosis of the access. In our experience, this procedure is an excellent treatment option because of its simplicity and should be considered as a first-line treatment for patients with DASS.


Asunto(s)
Angioplastia de Balón/métodos , Cateterismo Periférico/métodos , Diálisis Renal/efectos adversos , Síndrome del Robo de la Subclavia/etiología , Síndrome del Robo de la Subclavia/terapia , Adulto , Anciano , Anciano de 80 o más Años , Catéteres de Permanencia/efectos adversos , Femenino , Humanos , Incidencia , Ligadura/métodos , Masculino , Persona de Mediana Edad , Síndrome del Robo de la Subclavia/epidemiología , Trombosis/etiología , Trombosis/prevención & control
15.
Semin Dial ; 13(6): 359-63, 2000.
Artículo en Inglés | MEDLINE | ID: mdl-11130256

RESUMEN

There are more than 300,000 end-stage renal disease (ESRD) patients in the United States, with those on hemodialysis requiring vascular access for dialysis treatment. According to the 1999 annual report of the U.S. Renal Data System (USRDS), the leading cause of morbidity in this patient population is related to vascular access placement and the resultant complications. Vascular access procedures account for more than 10% of the annual ESRD budget and are conservatively estimated at $1 billion annually. The impact of dysfunctional vascular access on physician time, health care resources, and patient quality of life is profound. In 1997 I opened a freestanding, dedicated access center for the diagnosis and treatment of access-related disorders. This article summarizes the experience of this center. In our free-standing dialysis access center, a large referral base has been established consisting of 30 dialysis centers with approximately 2000 patients. During the 27 months from October 1997 to December 1999, 1087 patients were treated. These patients received 2862 access procedures (2.6 procedures/patient). Annualized, this gives a dysfunction rate of 1.15 episodes/patient/year at risk. Endovascular declotting procedures were performed 1282 times (45%) with a success rate (defined as one uneventful hemodialysis following the procedure) of 93% (1187/1282). Prospective angiography followed by percutaneous transluminal angioplasty was performed 703 times (24%). This procedure was successful 695 times for a success rate of 99%. There were 644 (23%) catheter procedures performed consisting of catheter placements, catheter exchanges through new or old tracts, and catheter removals. The success rate for catheter procedures was 99.1%. Complication rates were extremely low, both for major and minor complications, exceeding all published standards. Hemodialysis vascular access can be optimized in a freestanding, focused, outcomes-driven outpatient access center. Outcomes can meet or exceed the National Kidney Foundation Dialysis Outcomes Quality Initiative (NKF-DOQI) guidelines for vascular access while at the same time providing the patient with an outpatient procedure and the referring dialysis unit and nephrologist with an efficient, effective mode of patient care.


Asunto(s)
Instituciones de Atención Ambulatoria/organización & administración , Fallo Renal Crónico/terapia , Nefrología/organización & administración , Diálisis Renal , Instituciones de Atención Ambulatoria/economía , Atención a la Salud , Humanos , Maryland , Diálisis Renal/economía
17.
Anesthesiology ; 89(6): 1362-72, 1998 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-9856710

RESUMEN

BACKGROUND: Anesthesia personnel are at risk for occupational infection with bloodborne pathogens from contaminated percutaneous injuries (CPIs). Additional information is needed to formulate methods to reduce risk. METHODS: The authors analyzed CPIs collected during a 2-yr period at 11 hospitals, assessed CPI underreporting, and estimated risks of infection with human immunodeficiency virus and hepatitis C virus. RESULTS: Data regarding 138 CPIs were collected: 74% were associated with blood-contaminated hollow-bore needles, 74% were potentially preventable, 30% were considered high-risk injuries from devices used for intravascular catheter insertion or obtaining blood, and 45% were reported to hospital health services. Corrected for injury underreporting, the CPI rate was 0.27 CPIs per yr per person; per full-time equivalent worker, there were 0.42 CPIs/yr. The estimated average 30-yr risks of human immunodeficiency virus or hepatitis C virus infection per full-time equivalent are 0.049% and 0.45%, respectively. Projecting these findings to all anesthesia personnel in the United States, the authors estimate that there will be 17 human immunodeficiency virus infections and 155 hepatitis C virus infections in 30 yr. CONCLUSIONS: Performance of anesthesia tasks is associated with CPIs from blood-contaminated hollow-bore needles. Thirty percent of all CPIs would have been high-risk for bloodborne pathogen transmission if the source patients were infected. Most CPIs were potentially preventable, and fewer than half were reported to hospital health services. The results identify devices and mechanisms responsible for CPIs, provide estimates of risk levels, and permit formulation of strategies to reduce risks.


Asunto(s)
Anestesiología , Patógenos Transmitidos por la Sangre , Transmisión de Enfermedad Infecciosa de Paciente a Profesional , Enfermedades Profesionales/etiología , Enfermedades Cutáneas Infecciosas/etiología , Piel/lesiones , Infecciones por VIH/transmisión , Hepatitis C/transmisión , Humanos , Enfermedades Profesionales/microbiología , Estudios Retrospectivos , Medición de Riesgo , Piel/microbiología , Enfermedades Cutáneas Infecciosas/microbiología
19.
Anesth Analg ; 83(2): 273-8, 1996 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-8694305

RESUMEN

Anesthesia personnel are at risk for occupationally acquired blood-borne infections from human immunodeficiency virus, hepatitis viruses, and others after percutaneous exposures to infected blood or body fluids. The risk is greater after an infected, blood-contaminated, percutaneous injury, especially from a hollow-bore blood-filled needle, than from other types of exposures. Few data are available on the specific occupational hazards to anesthesia personnel from needles and other sharp devices. Fifty-eight percutaneous injuries (PIs) from anesthesia personnel in nine hospitals were analyzed. Thirty-nine of 58 PIs were from contaminated devices (all needles), and 19 were from uncontaminated devices or of unknown contamination status. Forty-three percent of contaminated percutaneous injuries (CPI) were classified as moderate (some bleeding) or severe (deep injury with profuse bleeding), and most were to health-care workers' hands. Fifty-nine percent of CPI were potentially preventable. Eighty-seven percent of CPI were from hollow-bore needles, and 68% of these were potentially preventable. The largest categories of devices causing CPI were needle on syringe, intravenous (i.v.) or arterial catheter needle-stylet, suture needle, and standard hollow-bore needle for secondary i.v. infusion. Most CPI occurred between steps of a multistep procedure (8%), were recapping related (13%), or occurred at other times after use (41%). No CPI were reported from use of needlestick-prevention safety devices. The devices and mechanisms of injury identified in this study provide specific data that may lead to prevention strategies to reduce the risk of PI.


Asunto(s)
Anestesiología/estadística & datos numéricos , Lesiones por Pinchazo de Aguja/epidemiología , Enfermedades Profesionales/epidemiología , Patógenos Transmitidos por la Sangre , Cateterismo Periférico/instrumentación , Contaminación de Equipos , VIH , Traumatismos de la Mano/epidemiología , Hemorragia/epidemiología , Virus de Hepatitis , Humanos , Infusiones Intravenosas/instrumentación , Inyecciones Intravenosas/instrumentación , Agujas , Lesiones por Pinchazo de Aguja/prevención & control , New York/epidemiología , Enfermedades Profesionales/prevención & control , Exposición Profesional , Equipos de Seguridad , Factores de Riesgo , Técnicas de Sutura/instrumentación , Jeringas
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