Etanercept, Adalimumab und Ustekinumab bei Psoriasis: Analyse von 209 Behandlungsreihen in Österreich.

HINTERGRUND UND ZIELE: Biologika werden häufig zur Behandlung der Psoriasis eingesetzt und wurden in zahlreichen klinischen Studien getestet. Allerdings können sich Wirkungen und Nebenwirkungen (AEs) bei "real-world"-Patienten unterscheiden, da diese keiner solch strengen Auswahl und Überwachung unterzogen werden. Wir haben Therapieadhärenz ("Medikamenten-Überlebenszeit"), Wirksamkeit und AEs (Qualität, Zeitpunkt des Auftretens) bei "real-world"-Psoriasis-Patienten, die mit Etanercept, Adalimumab oder Ustekinumab behandelt wurden, untersucht. PATIENTEN UND METHODEN: Retrospektive Datenanalyse (1. Januar 2004 bis 30. Juni 2015) an Patienten, die an einer Psoriasis-Klinik in einem österreichischen Krankenhaus behandelt wurden. Alle Patienten, die mindestens eine Dosis von Etanercept, Adalimumab oder Ustekinumab erhalten hatten, wurden in die Analyse einbezogen. Wir analysierten Demographie, Therapieadhärenz, den Psoriasis Area and Severity Index (PASI) sowie Qualität und Zeitpunkt des Auftretens von AEs. ERGEBNISSE: In 209 Behandlungsreihen variierte die geschätzte mittlere Therapieadhärenz zwischen den verschiedenen Behandlungen: 21 Monate (SE: 6,9) für Etanercept, 61 Monate (SE: 9,4) für Adalimumab und 65 Monate (SE 1,4) für Ustekinumab. Männliches Geschlecht und Vorbehandlung mit einem Biologikum waren positive Prädiktoren für längere Therapie mit Adalimumab. Wir fanden keinen signifikanten Unterschied in der am PASI gemessenen Arzneimittelwirksamkeit. SCHLUSSFOLGERUNGEN: Die meisten AEs treten während des ersten Jahres der Behandlung auf. Adalimumab und Ustekinumab zeichnen sich im Vergleich zu Etanercept durch eine längere Therapieadhärenz aus.

Etanercept, adalimumab, and ustekinumab in psoriasis: analysis of 209 treatment series in Austria.

BACKGROUND AND OBJECTIVES: Widely used in the treatment of psoriasis, biologics have been tested in numerous clinical trials. However, drug efficacies and adverse events (AEs) may differ in 'real-world' patients as they do not undergo as rigorous selection and monitoring. Our objective was to examine drug survival, efficacy, and AEs (quality, time of onset) in 'real-world' psoriasis patients treated with etanercept, adalimumab, and ustekinumab. PATIENTS AND METHODS: Retrospective data analysis (Jan 1, 2004 to Jun 30, 2015) of patients treated at a psoriasis clinic in an Austrian hospital. All patients who had received at least one dose of etanercept, adalimumab, or ustekinumab were included in the analysis. We analyzed: demographics, drug survival, Psoriasis Area and Severity Index (PASI), as well as quality and time of onset of AEs. RESULTS: In 209 treatment series, the estimated median drug survival varied among the various treatments: 21 months (SE: 6.9) for etanercept, 61 months (SE: 9.4) for adalimumab, and 65 months (SE 1.4) for ustekinumab. Male gender and pretreatment with a biologic were positive predictors of longer drug survival in adalimumab. We found no significant difference in drug efficacy as determined by PASI. CONCLUSIONS: Most AEs occur during the first year of treatment. Adalimumab and ustekinumab are marked by longer drug survival compared to etanercept.

The burden of malignant melanoma--lessons to be learned from Austria.

AIM OF STUDY: Incidence rates of melanoma, generated by cancer registries (CRs), are susceptible to reporting inconsistencies due to increasing decentralisation of diagnosis. We therefore independently assessed the burden of melanoma in Austria. METHODS: We collected histopathological reports on melanoma of all patients diagnosed in Austria in 2011. Demographic and clinical characteristics, histopathological tumour stages were assessed. Their regional distributions and incidence rates were analysed and compared with data of national and international CRs. RESULTS: A total of 5246 patients were diagnosed with 1951 in-situ and 3295 invasive melanomas in Austria in 2011 (population 8.4 million). Age, sex and anatomic distribution corresponded to findings in other European countries, however, the incidence of 25/100,000 (world age-standardised rate) for invasive melanomas was two-fold higher than published by the Austrian CR (12/100,000). Varying frequencies in diagnosing thin melanomas (≤1 mm; n = 4415) accounted exclusively for significant regional disparities, while advanced tumours (>1 mm; n = 761) were evenly distributed. Western Austria showed the highest rates (36/100,000). Patients from eastern Austria whose melanomas were diagnosed in laboratories in western Austria (n = 76) showed significantly higher proportions of in-situ lesions (n = 43; 57%) compared to those whose tumours were diagnosed in eastern Austria (n = 4014; in-situ = 1369; 34%) (p < 0.0001). CONCLUSIONS: In Austria, the melanoma burden and its potential socio-economic implications are significantly underestimated. Similarities of incidences indicate this could affect other European countries with well-established CRs and compromise international comparability of data. Austrian regional disparities suggest overdiagnosis of thin melanomas due to the variability of pathologists' thresholds for the diagnosis of early stage tumours.

Relevance of calcitonin cut-off in the follow-up of medullary thyroid carcinoma for conventional imaging and 18-fluorine-fluorodihydroxyphenylalanine PET.

AIM: The American thyroid association (ATA) recommends that additional imaging procedures supplement cervical ultrasonography (US) in any patient with a basal calcitonin value above 150 pg/ml in the follow-up of medullary thyroid carcinoma (MTC). The aim of the present study was to reaffirm or challenge this cut-off for 18-Fluorine-Fluorodihydroxyphenylalanine positron emission tomography (18F-DOPA PET) and conventional imaging ultrasonography (US), computed tomography (CT), magnetic resonance imaging (MRI)). MATERIALS AND METHODS: Thirty-nine patients (18 females, 21 males), mean age 62 years, range from 35 to 86, followed-up for MTC were included in the present retrospective study. In our patients 64 18F-DOPA scans, 28 neck US, 28 CT and 8 MRI were performed. For all cases basal calcitonin values were available. Sensitivity and specificity of 18F-DOPA PET and conventional imaging (US, CT, MRI) related to calcitonin values were calculated. RESULTS: According to the calcitonin cut-off of 150 pg/ml, we found the following sensitivities and specificities: 79% and 80% for 18F-DOPA PET, 75% and 92% for US, 80% and 25% for CT, 50% and 75% for MRI. Taking the level of detectable calcitonin, we calculated the following sensitivities: 52% for 18F-DOPA PET, 46% for US, 79% for CT and 38% for MRI. CONCLUSION: We cannot confirm the calcitonin cut-off proposed by the ATA for the detection of MTC recurrences and contemporaneously we cannot state that 18F-DOPA PET has a very high sensitivity. For the neck region 18F-DOPA PET and US showed similar results. 18F-DOPA PET/CT seems to be the best imaging modality for whole-body tumor detection. Bone metastases are best detected by MRI.

Efficacy of intravenous immunoglobulins in livedoid vasculopathy: long-term follow-up of 11 patients.

BACKGROUND: Evidence for the efficacy of various therapies of livedoid vasculopathy (LV) is limited. OBJECTIVE: We sought to determine efficacy and tolerability of 2 g/kg of intravenous immunoglobulins (IVIG) every 4 weeks in patients with LV. METHODS: This was a long-term follow-up study of 11 patients with LV treated with 2 g/kg of IVIG assessing the clinical characteristics, disease course, and quality of life. RESULTS: The treatment regimen led to complete remission of ulcerations and pain in 17 of 29 disease episodes (59%) after 3 cycles and in 25 of 29 episodes (86%) after 6 cycles. Two disease episodes showed remission after 7 and 8 cycles, resulting in a total number of remissions of 27 (93%). Subscore analysis showed resolution of pain in 80% after 2 IVIG cycles. Disease severity and quality of life were significantly improved after 6 cycles. Median duration of remissions was 26.7 months after initial and 7.5 months after subsequent disease episodes. LIMITATIONS: This was a retrospective study that did not include the comparison of IVIG efficacy and its impact on quality of life with treatment options. CONCLUSIONS: In our patients with LV, high-dose IVIG led to fast and complete resolution of pain and ulcerations and to substantial improvement in quality of life.