Roxadustat for the treatment of anaemia in chronic kidney disease patients not on dialysis: a Phase 3, randomized, open-label, active-controlled study (DOLOMITES).

BACKGROUND: Roxadustat, an orally administered hypoxia-inducible factor prolyl hydroxylase inhibitor, is being evaluated for treatment of anaemia of chronic kidney disease (CKD). METHODS: This randomized, open-label, active-controlled Phase 3 study compared roxadustat versus darbepoetin alfa (DA) in non-dialysis-dependent (NDD) CKD patients with anaemia for ≤104 weeks. Doses were titrated to correct and maintain haemoglobin (Hb) within 10.0-12.0 g/dL. The primary endpoint was Hb response in the full analysis set, defined as Hb ≥11.0 g/dL and Hb change from baseline (BL; CFB) ≥1.0 g/dL in patients with BL Hb >8.0 g/dL or CFB ≥2.0 g/dL in patients with BL Hb ≤8.0 g/dL during the first 24 weeks of treatment without rescue therapy (non-inferiority margin, -15%). Key secondary endpoints included change in low-density lipoprotein (LDL), time to first intravenous (IV) iron use, change in mean arterial pressure (MAP) and time to hypertension occurrence. Adverse events were assessed. RESULTS: Of 616 randomized patients (roxadustat, 323; DA, 293), 424 completed treatment (roxadustat, 215; DA, 209). Hb response with roxadustat was non-inferior to DA (roxadustat: 256/286, 89.5% versus DA: 213/273, 78.0%, difference 11.51%, 95% confidence interval 5.66-17.36%). Roxadustat maintained Hb for up to 2 years. Roxadustat was non-inferior to DA for change in MAP and time to occurrence of hypertension and superior for change in LDL and time to first IV iron use. Safety profiles were comparable between groups. Findings suggest that there was no difference between groups regarding the composite endpoints major adverse cardiovascular events (MACEs) and MACE+ [MACE: 0.81 (0.52-1.25), P = 0.339; MACE+: 0.90 (0.61-1.32), P = 0.583]. CONCLUSIONS: Roxadustat is a viable option to treat anaemia in NDD CKD patients maintaining Hb levels for up to 104 weeks.

Roxadustat for the treatment of anemia in chronic kidney disease patients not on dialysis: a Phase 3, randomized, double-blind, placebo-controlled study (ALPS).

BACKGROUND: Roxadustat is an orally active hypoxia-inducible factor prolyl hydroxylase inhibitor for the treatment of chronic kidney disease (CKD) anemia. METHODS: This Phase 3, multicenter, randomized, double-blind, placebo-controlled study examined patients with Stages 3-5 CKD, not on dialysis (NCT01887600). Patients were randomized (2:1) to oral roxadustat or placebo three times weekly for 52-104 weeks. This study examined two primary efficacy endpoints: European Union (European Medicines Agency)-hemoglobin (Hb) response, defined as Hb ≥11.0 g/dL that increased from baseline (BL) by ≥1.0 g/dL in patients with Hb >8.0 g/dL or ≥2.0 g/dL in patients with BL Hb ≤8.0 g/dL, without rescue therapy, during the first 24 weeks of treatment; US Food and Drug Administration-change in Hb from BL to the average Hb level during Weeks 28-52, regardless of rescue therapy. Secondary efficacy endpoints and safety were examined. RESULTS: A total of 594 patients were analyzed (roxadustat: 391; placebo: 203). Superiority of roxadustat versus placebo was demonstrated for both primary efficacy endpoints: Hb response [odds ratio = 34.74, 95% confidence interval (CI) 20.48-58.93] and change in Hb from BL [roxadustat - placebo: +1.692 (95% CI 1.52-1.86); both P < 0.001]. Superiority of roxadustat was demonstrated for low-density lipoprotein cholesterol change from BL, and time to first use of rescue medication (both P < 0.001). The incidences of treatment-emergent adverse events were comparable between groups (roxadustat: 87.7%, placebo: 86.7%). CONCLUSIONS: Roxadustat demonstrated superior efficacy versus placebo in terms of both Hb response rate and change in Hb from BL. The safety profiles of roxadustat and placebo were comparable.

Twenty-Eight Cases of Extraocular Sebaceous Carcinoma: A Correlative Clinicopathological and Immunohistochemical Analysis of Extraocular Sebaceous Carcinomas and Benign Sebaceous Gland Tumors.

ABSTRACT: Extraocular sebaceous carcinoma (ESC) is a rare appendiceal skin tumor. In contrast to ocular sebaceous carcinoma, information about the exact cellular architecture of these lesions is scarce and the histogenesis of ESC is unknown. Here, we extend our previous study and investigate 28 extraocular carcinomas in comparison to 54 benign sebaceous tumors and 8 cases of normal sebaceous glands using a broad spectrum of antibodies against p63, several keratins, adipophilin, EMA, Ki67, androgen receptor, and mismatch repair proteins. This observational study demonstrates that p63- and K5/14-positive basaloid cells are key cells in normal sebaceous gland and in all sebaceous tumors and that these basaloid cells give rise to EMA+, adipophilin+ sebocytes, and K5/14+, K7±, K10± ductal structures. Finally, about half of ESC is associated with superficial in situ neoplasia, which provides evidence that at least part of these carcinomas arises from flat superficial in situ carcinoma. In contrast to the normal sebaceous gland, about half of all sebaceous tumors lack keratin K7. MMR protein IHC-profiles role will be discussed.

Phase 3, Randomized, Double-Blind, Active-Comparator (Darbepoetin Alfa) Study of Oral Roxadustat in CKD Patients with Anemia on Hemodialysis in Japan.

BACKGROUND: Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor approved in China for dialysis-dependent CKD anemia. METHODS: This phase 3, 24-week, double-blind, double-dummy study evaluated roxadustat's noninferiority to darbepoetin alfa for hemodialysis-dependent CKD anemia. We randomly assigned Japanese patients to oral roxadustat three times weekly or to darbepoetin alfa injections once weekly, titrating doses to maintain hemoglobin between 10-12 g/dl. The primary end point was change of average hemoglobin from baseline to weeks 18-24 (∆Hb18-24). Secondary end points were average hemoglobin and proportion of patients with hemoglobin between 10-12 g/dl (maintenance rate) at weeks 18-24, and iron parameters. Safety assessments included treatment-emergent adverse events and adjudicated ophthalmologic findings. RESULTS: We randomly assigned 303 patients to roxadustat (n=151) or darbepoetin alfa (n=152). The difference between roxadustat and darbepoetin alfa in ∆Hb18-24 was -0.02 g/dl (95% confidence interval, -0.18 to 0.15), confirming roxadustat's noninferiority to darbepoetin alfa. Average hemoglobin at weeks 18-24 with roxadustat was 10.99 g/dl (95% confidence interval: 10.88 to 11.10), confirming its efficacy. Among patients with one or more hemoglobin value during weeks 18-24, the maintenance rate was 95.2% with roxadustat and 91.3% with darbepoetin alfa. Serum iron, ferritin, and transferrin saturation remained clinically stable with roxadustat; transferrin and total iron binding capacity increased through week 4 before stabilizing. Common treatment-emergent adverse events were nasopharyngitis, shunt stenosis, diarrhea, contusion, and vomiting. The proportion of patients with new or worsening retinal hemorrhage was 32.4% with roxadustat and 36.6% with darbepoetin alfa. We observed no clinically meaningful changes in retinal thickness groups. CONCLUSIONS: Roxadustat maintained hemoglobin within 10-12 g/dl in patients on hemodialysis and was noninferior to darbepoetin alfa. Treatment-emergent adverse events were consistent with previous reports. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: A Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients with Anemia, NCT02952092 (ClinicalTrials.gov).

Measuring Patient Needs and Benefits in Dermatology using the Patient Benefit Index 2.0: A Validation Study.

This study investigated the validity and feasibility of the Patient Benefit Index 2.0 (PBI 2.0), a short instrument to assess patient-relevant treatment benefit. In a cross-sectional study, patients with skin diseases completed the PBI 2.0 alongside instruments on quality of life and disease-specific PBI long versions to assess convergent validity. Feasibility questions appraise comprehensibility, completeness, length, and readability. Data from a longitudinal study were used to explore responsiveness and test-retest reliability. Most patients rated the PBI 2.0 easy to understand, complete, legible, and not too long. The amount of missing values was overall low. In all groups, except for vitiligo, correlation analyses indicated good convergent validity of PBI 2.0. Responsiveness of the PBI 2.0 could not be clearly confirmed. Retest-reliability achieved satisfactory results. Thus, the PBI 2.0 may be a suitable instrument for its use in different skin diseases. Its broad applicability allows for comparisons across diagnosis groups.

Praxis der Teledermatologie.

HINTERGRUND: Teledermatologische Anwendungen werden im deutschen Versorgungssystem in den nächsten Jahren erheblich an Bedeutung gewinnen. Das vorliegende Empfehlungspapier wurde als Expertenkonsens auf der Basis einer qualifizierten Literaturrecherche und eines strukturierten Entscheidungsprozesses der Autorengruppe entwickelt. ZIELSETZUNG: a) die IST-Analyse zum Einsatz der Telemedizin in der Dermatologie, b) die Bewertung der Evidenz ihres Nutzens und ihrer Sicherheit und, c) die Entwicklung von Verfahrensstandards für die ärztliche Praxis in den deutschsprachigen Ländern. Auf der Basis dieser Erkenntnisse soll durch einen Expertenkonsens eine Handlungsorientierung für den Einsatz der Teledermatologie gegeben werden. METHODEN: Dreistufiges Vorgehen: 1) Systematische Literaturrecherche in den internationalen medizinischen Onlinedatenbanken Pubmed und Embase, 2) Weitere, teils manuelle Recherchen, 3) Expertenkonsens mit einem systematischen Entscheidungsverfahren mit 21 Teilnehmern. ERGEBNISSE: In der strukturierten Literaturrecherche fanden sich 204 wissenschaftliche Originalarbeiten, in denen Anwendungen der Telemedizin bei Hautkrankheiten thematisiert wurden. Diese wurden systematisch aufgearbeitet, analysiert und bewertet. In der zweiten Stufe wurden in einer Handsuche zusätzliche relevante Schriften identifiziert und ebenfalls ausgewertet. Das Expertengremium entwickelte dann auf der Basis der externen Evidenz sowie der internen Diskussion Handlungsempfehlungen für die Praxis. Schlussfolgerung der wissenschaftlichen Studienlage ist, dass die telemedizinische Unterstützung der dermatologischen Behandlung und Prävention bei Einsatz leistungsfähiger Systeme, Kenntnis ihrer Anwendung sowie Beachtung der Indikationen und Kontrainidikationen einen erheblichen Mehrnutzen darstellt. SCHLUSSFOLGERUNGEN: Die Teledermatologie hat in den deutschsprachigen Ländern wie auch weltweit einen zunehmenden Stellenwert und bietet aufgrund des hohen Innovationsgrades eine Vorreiter- und Vorbildfunktion für weitere telemedizinische Anwendungen anderer Fachrichtungen. Eine qualitätsgesicherte teledermatologische Behandlung ist in den deutschsprachigen Ländern praktikabel und kann zu einem relevanten Mehrnutzen in der Versorgung führen. Ihr Einsatz ist immer dann in Erwägung zu ziehen, wenn relevante Zusatznutzen für die Patienten ohne relevante Nachteile für sie und für die Versorgenden zu erwarten sind. Für die teledermatologische Behandlung wurden mit dem vorliegenden Konsensuspapier praxisrelevante Maßgaben festgelegt. Etwaige situationsabhängige Limitationen in der Versorgung sind stets zu beachten.

[Association of Health Insurance and Socio-economic Factors with Health Care for Malignant Melanoma]. / Assoziation von Krankenversicherung und soziodemografischen Faktoren mit der Versorgung maligner Melanome.

Objective: To analyze the relationship between socio-demographic and regional factors, health insurance status and clinical features of malignant melanoma (MM). Methods: Primary data from a nationwide dermato-histopathologic laboratory on all consecutive excisions with proven diagnosis of MM over the 5-year period 2009-2013 were analyzed regarding tumor-specific and socioeconomic characteristics. The tumor depth (Breslow index) being a predictor of invasive MM progression and mortality was defined as a major indicator for early detection and intervention, thus reflecting quality of health care. Results: N=4 840 histologically verified MM samples from 4 583 patients were analyzed; of these, 2 537 (52.4%) were invasive MM. The tumor depth, which was 1.09 mm on average, increased with age from 1.00 mm in the lowest to 1.56 mm in the highest age group, p<0.001). Controlled for age and sex, the members of agricultural health insurances (LKK) and of German local public health insurances (AOK) showed significantly increased tumor depths (1.67 resp. 1.20 mm). The lowest average levels were found in members of the substitute health funds (e. g. Barmer GEK 0.93 mm) and in privately insured persons (0.99 mm). Based on a regional 4-step classification, there was a gradient in MM depth from more populated to more rural areas, ranging from 1.05 mm in nucleated cities to 1.22 in small rural communities. Distribution of MM locations varied significantly by health insurance: The highest proportion of MM in the head/neck area was seen in members of the agricultural (52.3%) and of the local public health insurances (30.2%) vs. 18.5% in patients from the substitute health funds. In contrast, MM located on the trunk and lower extremities was more prevalent in private, substitute and company health insurance funds. Conclusion: Age, gender and health insurance status are relevant determinants of MM health care and progression risk in Germany. Prevention and early detection programs by health insurances should take this into account.

Mitotic rate in primary melanoma: interobserver and intraobserver reliability, analyzed using H&E sections and immunohistochemistry.

BACKGROUND: In 2009, the AJCC issued a revised melanoma staging system. In addition to tumor thickness and ulceration, the mitotic rate was introduced as the third major prognostic parameter for the classification of primary cutaneous melanoma. Given that, according to the 2009 AJCC classification, the detection of one or more dermal tumor mitoses leads to an upstaging - from stage Ia to Ib - of melanomas with a tumor thickness of ≤ 1.0 mm, we set out to investigate the reproducibility of this new parameter. METHODS: In order to assess interobserver reliability, 17 dermatopathologists und pathologists - all well versed in the diagnosis of cutaneous melanoma - analyzed the mitotic rate in 15 thin primary cutaneous melanomas (mean tumor thickness 0.91 mm) using identical slides. Mitotic rates were determined on H&E and phosphohistone H3 (Ser10)-stained samples. Without knowledge of their previous assessment, five of the aforementioned examiners reevaluated the samples after more than one year in order to ascertain intraobserver reliability. RESULTS: Interobserver reliability of the mitotic rate in thin primary melanomas is disappointing and independent of whether H&E or immunohistochemically stained samples are used (kappa value: 0.088 [H&E], 0.154 [IH], respectively). Kappa values improved to 0.345 (H&E) and 0.403 (IH) when using a cutoff of 0/1 vs. 2+ mitoses. Similarly unsatisfactory, kappa values for intraobserver reliability ranged from 0.18 and 0.348, depending on the individual examiner. DISCUSSION: Given the unsatisfactory reproducibility and large variations in assessing the mitotic rate, it remains a matter of debate whether this diagnostic parameter should play a role in therapeutic decisions.

Mitoserate beim primären Melanom: Interobserver- und Intraobserver-Reproduzierbarkeit am HE-Schnitt und in der Immunhistologie.

HINTERGRUND: Die Melanomklassifikation wurde 2009 durch die AJCC revidiert. Für die Klassifizierung primärer Melanome wurde als dritte Größe neben Tumordicke und Ulzeration die Angabe der Mitoserate neu eingeführt. Gemäß der AJCC-2009-Klassifikation des Melanoms führt der Nachweis nur einer oder mehrerer dermaler Tumormitosen bei Melanomen ≤ 1,0 mm Tumordicke zu einer Umgruppierung des Tumors von T1a nach T1b. Dies erklärt, wie wichtig die Frage nach der Reproduzierbarkeit dieses neuen Parameters ist. METHODEN: Zur Prüfung der Interobserver-Reproduzierbarkeit der Mitoserate haben 17 Dermatopathologen und Pathologen, die in der Befundung des kutanen Melanoms sehr erfahren sind, die Mitoserate in 15 dünnen Melanomen mit einer mittleren Tumordicke von 0,91 mm an demselben Tumorschnitt bestimmt. Die Mitoserate wurde am HE-Schnitt und immunhistologisch (IH) mittels des mitosespezifischen Antikörpers Phospho-Histon-H3 (Ser10) bestimmt. Fünf Befunder wiederholten die Bestimmung nach mehr als einem Jahr ohne Kenntnis ihres Vorbefundes zur Ermittlung der Intraobserver-Reproduzierbarkeit. ERGEBNISSE: Die Interobserver-Reproduzierbarkeit der Mitoserate bei dünnen Melanomen ist unbefriedigend und unabhängig davon, ob die Mitoserate am HE-Schnitt oder am immungefärbten Schnitt bestimmt wird (κ-Werte: 0,088 [HE] bzw. 0,154 [IH]). Bei einer Diskriminationsschwelle von 0/1 vs. 2+ Mitosen verbesserte sich der κ-Wert auf 0,345 (HE) bzw. 0,403 (IH). Die Intraobserver-Reproduzierbarkeit lag mit κ-Werten zwischen 0,18 und 0,348 je nach Befunder ebenfalls im unbefriedigenden Bereich. DISKUSSION: Wegen der unbefriedigenden Reproduzierbarkeit und der großen Variation der Befunde zur Mitoserate bleibt es zweifelhaft, ob dieser Befund als Grundlage für Therapieentscheidungen herangezogen werden kann.

Methods of analyzing regional dermatological care as exemplified by the city of Hamburg.

BACKGROUND: The rural-urban divide is often linked to regional inequalities in healthcare. However, studies have also shown regional healthcare disparities within urban areas. To evaluate these studies, further parameters such as accessibility must be added to the standard criteria. The objective of this study was to present methodic tools for evaluating dermatological healthcare provision in Hamburg, primarily focusing on accessibility. METHODS: Analyzing data from 97 districts, the geographical distribution of 101 dermatologists and the physician-patient ratio were determined. In a second step, network analysis regarding accessibility was performed. RESULTS: There are regional inequalities in Hamburg with respect to dermatological care. Depending on the district, the physician-patient ratio ranges from 44.9 % (undersupply) to > 500 % (oversupply). Similar differences exist regarding accessibility. Although 94.5 % of the population of Hamburg is able to reach the nearest dermatologist within ten minutes (by car), it may take more than 30 minutes depending on district and mode of transportation. CONCLUSIONS: Analysis of the physician-patient ratio reveals differences regarding dermatological care in Hamburg. However, results of the network analysis show that these differences do not significantly affect access to dermatological care. Therefore, network analysis should be used as an additional tool to evaluate regional healthcare provision.

Health care characteristics of basal cell carcinoma in Germany: the role of insurance status and socio-demographic factors.

BACKGROUND: In Germany population-based data on health care of basal cell carcinoma (BCC) are rare. OBJECTIVE: To analyze the relationship between socio-demographic and regional factors, health insurance status and clinical features of BCC. METHODS: Data base was from a nationwide dermatopathology laboratory. All consecutive excisions from 2010 were analyzed regarding tumor-specific and socioeconomic characteristics of BCC. RESULTS: 9,467 histologically verified BCC derived from 7,116 patients (54.1 % male, mean age 70 years) were analyzed. 33 % of patients had multiple tumors. The average vertical depth of invasion of BCC was 1.27 mm. It was increased significantly (p ≤ 0.001) in men (1.33 mm vs. 1.19 mm in women) and in persons over 70 years of age (1.36 mm vs. 1.14 mm). Controlled for age and sex, members of agricultural health-insurances (LKK) and of German local public health insurances (AOK) showed the highest tumor depths (1.45 mm resp.1.42 mm). The lowest depths (1.17 mm) were found in insurees of the substitute health funds (Ersatzkassen) (p ≤ 0.001). Vertical depth of invasion was significantly increased for patients living in rural counties (1.34 mm) compared to patients from urban areas (1.21 mm). Furthermore, the distribution of BCC locations varied by type of health insurance. CONCLUSIONS: Area of residence, health insurance status, age and gender are relevant determinants of BCC health care in Germany. Prevention programs and activities to improve early detection by health insurances should take this into account.

Topical long-term therapy of psoriasis with vitamin D3 analogues, corticosteroids and their two compound formulations: position paper on evidence and use in daily practice.

BACKGROUND: Current data from daily practice show that vitamin D3 analogues, corticosteroids and their fixed combination products are used heterogeneously for topical long-term treatment of psoriasis. AIM: To evaluate scientific evidence about topical long-term therapy with vitamin D3 analogues, corticosteroids and their two-compound-products in psoriasis vulgaris and scalp psoriasis and to develop daily practice recommendations. METHODS: Systematic literature review via PubMed and Embase and informal expert consensus. RESULTS: The search strategy identified 21 relevant clinical trials. Best evidence regarding topical long term treatment was available for the two-compound-formulation containing calcipotriene and betamethasone. In a comparative trial in psoriasis vulgaris the two-compound-formulation showed superior tolerability and cost effectiveness compared to monotherapy. In scalp psoriasis the two-compound-gel was superior compared to calcipotriene monotherapy. Standardized and simplified treatment application modes resulted in a better clinical outcome comparing to on-demand therapies. DAILY PRACTICE RECOMMENDATIONS: Patients should be proactively involved in the choice of treatment, formulation and mode of application. Besides long-term treatment with the two-compound-formulation other treatment regimens including calcipotriene monotherapy can also be considered. Due to a favorable risk-benefit ratio in maintenance trials and due to better cost-effectiveness the application of two-compound-products once or twice a week after initial therapy is recommended.

German psoriasis registry PsoBest: objectives, methodology and baseline data.

BACKGROUND: The German psoriasis registry PsoBest records the long-term efficacy, safety, patient benefit and treatment regimens of psoriasis. PATIENTS AND METHODS: Patients with moderate or severe psoriasis are included in PsoBest when treatment with a conventional systemic agent or biologic is started for the first time. Observation time is five years. Standardized physician and patient case report forms are obtained every three to six months. Baseline data of patients included by 31 December 2012 are presented and compared to the national health care study PsoHealth 2007 (n = 2,009). RESULTS: 602 dermatology practices and clinics have been registered and 199 have recruited n = 2,556 patients (63 % by practices, 37 % by clinics). Initially, n = 808 received biologics (316 adalimumab, 34 efalizumab, 209 etanercept, 75 infliximab, 22 golimumab, 152 ustekinumab) and n = 1,651 conventional systemic therapy (928 fumaric acid esters, 518 methotrexate, 161 cyclosporine A, 191 other drugs or UV treatment). Compared to PsoHealth, patients in PsoBest had on average a higher disease severity (PASI 14.7 vs. 10.1; DLQI 11.0 vs. 7.5; EQ-5D VAS 54.0 vs. 64.5), shorter disease duration (18.2 vs. 21.3 yrs.), lower age (47.3 vs. 51.5), higher rates of psoriatic arthritis (20.5 vs. 19.1 %) and nail psoriasis (55.0 vs. 35.6 %). On average patients receiving biologics were younger, more often male and had higher disease severity and comorbidity. CONCLUSIONS: Patients in PsoBest represent patients with a high burden of disease.

Influenza vaccination rate among patients with moderate to severe psoriasis.

BACKGROUND: Patients with chronic inflammatory diseases such as psoriasis vulgaris represent a risk group for developing serious complications after influenza virus infection. By vaccinating this cohort such complications might be prevented. The objective was to determine the vaccination rate among patients with moderate to severe psoriasis and to explore the surrounding circumstances. PATIENTS AND METHODS: A nationwide, non-interventional, cross-sectional study was performed in 1,229 adults with confirmed psoriasis or psoriatic arthritis. The survey consisting of 15 questions about vaccination and vaccination adherence was distributed to patients enrolled in the psoriasis patient registry "PsoBest". RESULTS: About 28 % of the patients (95 %-CI 24.0-31.6) were vaccinated. The mean age was 58 years, 40 % were females. The prevalence of psoriatic arthritis was 28 % at baseline and 39 % during the vaccination period. General practitioners vaccinated 50 % of the patients, while dermatologists suggested vaccination in 7 % of the cases. Fifty percent of the patients reported that they had been vaccinated at their own request. 91 % of the patients had been vaccinated at least once over the past ten years, receiving on average 5.9 influenza vaccinations during the decade. CONCLUSIONS: The vaccination rate in the study cohort was relatively low compared to that in the general population. Influenza vaccination had only been suggested by a small percentage of physicians.

Allergies in Germany -- prevalence and perception by the public.

BACKGROUND: During the recent decades allergies have become more frequent all over the world. However, it is unclear how important the topic of allergies is for the general German population and how appropriately patients with allergies are treated. PATIENTS AND METHODS: A telephone survey was performed on a representative random sample of n = 1,004 adults in Germany. The survey was performed by the Forsa Institute for Social Research and Statistical Analysis, Berlin, Germany, in the period from 31 January to 2 February 2012. RESULTS: Of the interviewees 52% responded that the topic of allergies concerned them; in 33% actually an allergy had been diagnosed by a physician. The proportion of allergies in the population correlated with the level of school education and was higher among people with a higher educational status. No differences in allergy rates were found between Eastern and Western Germany. Among allergic persons, 53% reported to be burdened by their allergy, 48% suffered from impaired performance because of their allergic symptoms. Among people suffering from pollen allergy, only 28% received sublingual immune therapy, with which 70% were satisfied. While 58% practiced self-medication, only 21% of the allergic persons were treated with anti-allergic drugs during their allergy flares. CONCLUSIONS: Allergic diseases are a common, often burdensome problem in the German population, but nevertheless the medical treatment of people affected is still insufficient. The proportion of patients receiving sublingual immune therapy as causal treatment is comparatively low. Active steps are needed to improve the utilization behavior of patients, e. g. to take advice of an allergy specialist.

Iron Parameters in Patients Treated with Roxadustat for Anemia of Chronic Kidney Disease.

Roxadustat is a novel agent with a distinct mechanism of action compared to erythropoiesis-stimulating agents (ESAs) and a potentially different combination of effects on iron parameters. This narrative review describes the effects of roxadustat on iron parameters and on hemoglobin levels in the context of iron supplementation in patients with anemia of non-dialysis-dependent (NDD) or dialysis-dependent (DD) chronic kidney disease (CKD). Roxadustat use was associated with a greater reduction in serum ferritin levels than seen with ESAs and an increase in serum iron levels compared to a decrease with ESAs. Decreases in transferrin saturation in patients treated with roxadustat were relatively small and, in the case of patients with NDD CKD, not observed by Week 52. These changes reflect the concomitant increases in both serum iron and total iron-binding capacity. Compared to placebo and an ESA, roxadustat improved iron availability and increased erythropoiesis while requiring less intravenous iron use. Hepcidin levels generally decreased in patients who received roxadustat compared to baseline values in all CKD populations; these decreases appear to be more robust with roxadustat than with an ESA or placebo. The mechanisms behind the effects of roxadustat and ESAs on iron availability and stores and erythropoiesis appear to differ and should be considered holistically when treating anemia of CKD.