Long-term (1 year) efficacy of etanercept in moderate-to-severe psoriasis. Results of a multicentric observational study in Spain.

BACKGROUND: Information on the long-term efficacy of etanercept (ETN) treatment of moderate-to-severe psoriasis according to the Summary of Product Characteristics (SmPC) is scarce. OBJECTIVES: We report the efficacy results of an observational clinical trial including 202 patients treated for 12 months with ETN according to SmPC. METHODS: Concomitant topical treatment was permitted throughout the study period. Efficacy assessment was done by intention-to-treat analysis with last observation carried forward. RESULTS: Mean % Body Surface Area (BSA) and Psoriasis Area and Severity Index (PASI) decreased from 39.0% and 22.2% at baseline to 7.9% and 4.4%, respectively, at 12 months. Throughout the study duration, PASI 50, PASI 75 and PASI 90 response rates ranged from 72.8% to 95.7%, 55.6% to 84.3%, and 36.1% to 62.2%, respectively. Body mass index and body weight had minor effects on treatment efficacy. CONCLUSION: ETN treatment according to the SmPC provided sustained improvement of psoriasis throughout one year.

Prevalence and clinical features of psoriatic arthritis in psoriasis patients in Spain. Limitations of PASE as a screening tool.

BACKGROUND: Diagnosing and initiating treatment of psoriatric arthritis (PsA) as early as possible is essential to prevent irreversible joint destruction and poor clinical outcomes. Dermatologists are uniquely placed to identify early symptoms of PsA in psoriasis patients but levels of under- and late-diagnosis remain high. OBJECTIVE: To evaluate the prevalence and clinical features of PsA in Spanish psoriatic patients attended by dermatologists and then referred to rheumatologic units for PsA diagnosis confirmation. METHODS: a multicenter, non-interventional, cross-sectional trial conducted at 40 hospitals in Spain. Patients were initially screened for PsA by a dermatologist based on clinical evaluation and results from the Psoriatic Arthritis Screening and Evaluation (PASE) Questionnaire. All patients were then evaluated by a blinded rheumatologist for the presence of PsA using Moll and Wright criteria and Classification Criteria for Psoriatic Arthritis (CASPAR). RESULTS: Of 375 psoriatic patients enrolled at dermatology units, 28.6% patients scored ≥44 in PASE, whereas 32.3% patients screened positive for suspicion of PsA (clinical evaluation and/or PASE). Correlation of suspicion of PsA by dermatologists and PASE score was 0.368 (Pearson correlation coefficient). Following rheumatologic assessment, prevalence of PsA was 22.9% (86/375 patients) according to Moll and Wright and CASPAR criteria. The correlation of diagnosis of PsA between dermatologists and rheumatologists was 0.410 (Kappa Index). CONCLUSIONS: Prevalence of PsA in our study was within the range reported in other studies. Our analyses found only a moderate correlation in the diagnosis of PsA between dermatologists and rheumatologists. The screening questionnaire, PASE, showed a moderate predictive value for the diagnosis of PsA.

Assessment of cardiovascular risk in patients with moderate to severe plaque psoriasis.

BACKGROUND: Cardiovascular morbidity and mortality have been demonstrated to be greater in psoriasis patients than in the general population. Our study aimed to assess the 10-year cardiovascular risk in patients with moderate to severe psoriasis compared with those suffering from other dermatological diseases, using the calibrated Framingham risk score and the Systematic Coronary Risk Evaluation (SCORE) risk charts. METHODS: A cross-sectional, multicentre study was made of 477 patients, of whom 238 had moderate to severe psoriasis (cases) and 239 were diagnosed with another dermatological disease (controls). RESULTS: The proportion of patients with intermediate to high 10-year cardiovascular risk using the Framingham equation was significantly higher among psoriasis patients (38.5%; 80/208) than among the controls with other dermatological diseases (23.4%; 50/214, P<.05). No significant differences were observed between the 2 groups with respect to cardiovascular risk using the SCORE risk charts (P=.591). The case group included a greater proportion of obese and morbidly obese patients, as well as patients with higher triglyceride and low density lipoprotein cholesterol levels (P<.05); while high density lipoprotein cholesterol levels were significantly more favorable in patients in the control group (P<.05). CONCLUSIONS: Cardiovascular risk was greater in patients with moderate to severe psoriasis than in patients with other dermatological conditions, suggesting that early detection and tailored management of risk factors is essential to reducing cardiovascular morbidity in these patients.

Efficacy and safety of clinical use of etanercept for the treatment of moderate-to-severe psoriasis in Spain: results of a multicentric prospective study at 12 months follow-up.

BACKGROUND: The efficacy of etanercept in the treatment of psoriasis has been demonstrated in several clinical trials, but information regarding results derived from prospective observational studies in clinical practice is scarce. OBJECTIVES: To evaluate the efficacy and safety of etanercept administration according to routine clinical use in moderate-to-severe plaque psoriasis. MATERIALS AND METHODS: Postauthorization, prospective study, carried out at 59 dermatology units in Spain. Patients diagnosed with moderate-to-severe plaque psoriasis received etanercept during a 12-month period. RESULTS: Altogether, 444 patients were enrolled. Overall, 325 patients (73.2%) initiated etanercept treatment at a dose of 50 mg twice weekly; 96 patients (21.6%) received etanercept as a continuous regimen for the entire study period, and 348 patients (79.4%) an intermittent regimen. Among these, 185 patients (41.6% overall) received one course of treatment, stopped at various study points and did not restart etanercept treatment, whereas the remaining 163 patients (36.7% overall) stopped etanercept treatment, lost response, relapsed and were retreated. Most patients who interrupted etanercept treatment did so at month 6. Altogether, 79.7% of patients completed the study period. Etanercept treatment resulted in significant improvement in disease activity. A Psoriasis Area and Severity Index (PASI) 75 response was achieved by 76.1% of patients at month 6. Out of 252 adverse events reported, 31 were considered severe. Three possibly treatment-related malignancies were detected during the study. No opportunistic infections, tuberculosis or demyelinating events were reported. CONCLUSION: The PASI 75 response rate at month 6 in this observational, naturalistic study is similar to those observed in recent published trials with etanercept, and within the range of those reported for other marketed biologicals.

[Mental disorders in psychiatric outpatients in Spain]. / Trastornos mentales en pacientes de atención especializada en el ámbito extrahospitalario español.

OBJECTIVES: The aim of data presented is to increase knowledge about the morbidity and impact of mental disorders in Spanish psychiatry. The objective is to describe, based on real practice conditions, the most prevalent mental disorders in a sample of Spanish patients treated in outpatient Psychiatry centers. MATERIAL AND METHOD: Epidemiological, naturalistic, prospective, cross-sectional study, carried out in the outpatient psychiatry setting in Spain in 2006. Mental disorders were assessed using the International Neuropsychiatric Interview (MINI). RESULTS: A total of 1,436 patients, 72% of whom were women, mean age of 49.2 ± 13.3 years, were included. According to the MINI assessment, 90.3 % of the patients were diagnosed of at least one mental disorder. The most prevalent mental disorders were: recurrent major depressive episode (27.2%, 353 patients); only current major depressive episode (2 weeks) (25.9%, 336 patients); current dysthymic disorder (last 2 years) (25.9%, 336 patients); current major depressive episode with melancholy symptoms (18.7%, 243 patients); current generalized anxiety disorder (16.6 %, 215 patients). CONCLUSIONS: The study results show the prevalence of mental disorders in a sample representative of the Spanish population, treated in outpatient specialized Psychiatry centers. Mood and generalized anxiety disorders were the most prevalent disorders.

Trastornos mentales en pacientes de atención especializada en el ámbito extrahospitalario español / Mental disorders in psychiatric outpatients in Spain

Objetivos. El propósito de los datos presentados es ampliar el conocimiento sobre la morbilidad y el impacto de los trastornos mentales en la psiquiatría española. El objetivo es describir, conforme a la práctica clínica habitual, los trastornos mentales más prevalentes en una muestra de pacientes españoles tratados en centros ambulatorios de Psiquiatría. Material y Método. Estudio epidemiológico, naturalístico, prospectivo, de corte transversal, realizado en el ámbito de la psiquiatría ambulatoria en España en el año 2006. Los trastornos mentales fueron evaluados mediante la Entrevista Neuropsiquiátrica Internacional (MINI).Resultados. Se incluyeron en el estudio un total de 1.436 pacientes, de los cuales el 72% fueron mujeres, con una edad media de 49,2 ± 13,3 años. Según la MINI el 90,3% de los pacientes fueron diagnosticados de al menos un trastorno mental. Los trastornos mentales más prevalentes fueron: episodio depresivo mayor recidivante (27,2%, 353 pacientes); solo episodio depresivo mayor actual (2 semanas) (25,9%, 336 pacientes); trastorno distímico actual (últimos 2 años) (25,9%, 336 pacientes); episodio depresivo mayor actual con síntomas melancólicos (18,7%, 243 pacientes); trastorno de ansiedad generalizada actual (16,6%, 215 pacientes). Conclusiones. Los resultados del estudio muestran la prevalencia de los trastornos mentales en una muestra representativa de la población española que acude a centros ambulatorios de Atención Especializada Psiquiátrica. Destacan por su mayor prevalencia los trastornos del estado del humor y trastorno de ansiedad generalizada (AU)

Objectives. The aim of data presented is to increase knowledge about the morbidity and impact of mental disorders in Spanish psychiatry. The objective is to describe, based on real practice conditions, the most prevalent mental disorders in a sample of Spanish patients treated in outpatient Psychiatry centers. Material and Method. Epidemiological, naturalistic, prospective, cross-sectional study, carried out in the outpatient psychiatry setting in Spain in 2006. Mental disorders were assessed using the International Neuropsychiatric Interview (MINI). Results. A total of 1,436 patients, 72% of whom were women, mean age of 49.2 ± 13.3 years, were included. According to the MINI assessment, 90.3 % of the patients were diagnosed of at least one mental disorder. The most prevalent mental disorders were: recurrent major depressive episode (27.2%, 353 patients); only current major depressive episode (2 weeks) (25.9%, 336 patients); current dysthymic disorder (last 2 years) (25.9%, 336 patients); current major depressive episode with melancholy symptoms (18.7%, 243 patients); current generalized anxiety disorder (16.6 %, 215 patients). Conclusions. The study results show the prevalence of mental disorders in a sample representative of the Spanish population, treated in outpatient specialized Psychiatry centers. Mood and generalized anxiety disorders were the most prevalent disorders (AU)

Spanish women's attitudes towards menstruation and use of a continuous, daily use hormonal combined contraceptive regimen.

BACKGROUND: The main objective of this survey was to explore the attitude of Spanish women towards menstruation, as well as their acceptability of a daily, continuous, combination oral contraceptive regimen. STUDY DESIGN: National survey carried out in Spain in 2006. A total of 588 women aged between 18 and 45 years old answered an anonymous questionnaire that included questions regarding menstruation and acceptability of new contraceptive regimens. RESULTS: Overall, 24.5% of women expressed interest in using the continuous oral contraceptive regimen. This percentage increased up to nearly 50% in women younger than 25 years old and those not using any contraceptive method but willing to use them in the future. CONCLUSION: The attitude of Spanish women towards menstruation observed in this survey seems to be more conservative than that obtained in other recent international surveys. An improvement in the education provided by practitioners would help women to make informed decisions.

Effectiveness and safety of venlafaxine extended release in elderly depressed patients.

The main objectives of this multicenter, naturalistic, open-label study is to evaluate the effectiveness, tolerability and safety of venlafaxine extended release (VXR) in a sample of 59 patients older than 60 years of age diagnosed of depressive disorders in the primary care setting. VXR was administered for 24 weeks at daily doses ranging from 75 mg to 225 mg. Effectiveness measurements included the 17 items Hamilton Depression Rating Scale (HAM-D(17)), the Clinical Global Impression Scales for Severity (CGI-S) and Improvement (CGI-I), the Visual Analogical Scale for Pain (P-VAS), and the Mini-Mental State Examination (MMSE) scale. At the endpoint, VXR achieved response and remission rates of 81.6% and 59.2%, respectively. Treatment was associated with a significant improvement of the patient's condition (89.8% of patients were rated by physicians as "much/very much improved"). Painful physical symptoms (p<0.0001) and cognitive state (p=0.0017) scores decreased along the study. A total of 83% of patients completed the study. Seven adverse events were recorded for four patients (6.8% overall). Data of this study suggest that VXR could be an effective and safe therapeutic option in the treatment of geriatric depression, reducing also the associated painful physical symptoms.

Venlafaxine extended-release in patients older than 80 years with depressive syndrome.

OBJECTIVES: The aim of this evaluation was to assess the efficacy and safety of venlafaxine extended-release (ER) in very old primary care out-patients with depressive syndrome and associated anxiety symptoms. METHODS: This was an observational, naturalistic, multicenter, prospective, open-label study in an outpatient population with a diagnosis of depressive syndrome with anxiety symptoms. Minimum scores of 17 and 10 on the Hamilton Rating Scale for Depression (HAM-D(17)) and Anxiety (HAM-A), respectively, were required. Daily doses of 75 mg to 225 mg of venlafaxine extended release (ER) were administered for 24 weeks. Effectiveness for depressive-anxious symptomatology was assessed using the HAM-D(17) and HAM-A scales. PATIENTS: The 97 patients discussed in this report are a subgroup comprising all elderly patients, aged >or= 80 years, who were part of the larger observational, naturalistic, multicenter, prospective, open-label study and who had received venlafaxine ER for a maximum duration of 24 weeks. RESULTS: At endpoint, remission rates were 57.1% (HAM-D(17)