Prospective multicenter study of HX575 (biosimilar epoetin-\u3b1) in patients with chronic kidney disease applying a target hemoglobin of 10--12 g/dl

HX575 was approved in the European Union in August 2007 as the first-ever biosimilar epoetin-\u3b1 product. The present study extended the safety database on HX575 by monitoring adverse events (AEs) in clinical practice. Hemoglobin (Hb) levels and HX575 doses were recorded for the assessment of efficacy. This open, 6-month single-arm study was conducted in 10 European countries with a target enrollment of 1,500 patients with anemia due to chronic kidney disease (CKD). HX575 was intravenously (i.v.) administered aiming at an Hb target of 10 - 12 g/dl. Most patients (92.3%) had already received erythropoiesis stimulating agents (ESAs) treatment before enrolment into this study; the recorded treatments mainly comprised i.v. or subcutaneous (s.c.) administration of epoetin-\u3b1, epoetin-\u3b2 or darbepoetin. The study period covered 770 patient years. The observed AE profile was in line with expectations for this patient population. Thrombotic vascular events (TVEs) were reported in 11.9% of patients (0.2612 per patient year). Tumor incidence was 1.4% (0.0299 per patient year). No subject developed anti-epoetin antibodies. Mean Hb levels were effectively maintained between 11.2 and 11.3 g/dl following the conversion from a broad spectrum of pre-study ESA treatments with stable overall mean i.v. HX575 doses. The proportion of patients within the Hb target range increased from 57.5% at baseline to 66.8% at study end

Planck intermediate results. VIII. Filaments between interacting clusters

About half of the baryons of the Universe are expected to be in the form of filaments of hot and low-density intergalactic medium. Most of these baryons remain undetected even by the most advanced X-ray observatories, which are limited in sensitivity to the diffuse low-density medium. Aims. The Planck satellite has provided hundreds of detections of the hot gas in clusters of galaxies via the thermal Sunyaev-Zel\u2019dovich (tSZ) effect and is an ideal instrument for studying extended low-density media through the tSZ effect. In this paper we use the Planck data to search for signatures of a fraction of these missing baryons between pairs of galaxy clusters. Methods. Cluster pairs are good candidates for searching for the hotter and denser phase of the intergalactic medium (which is more easily observed through the SZ effect). Using an X-ray catalogue of clusters and the Planck data, we selected physical pairs of clusters as candidates. Using the Planck data, we constructed a local map of the tSZ effect centred on each pair of galaxy clusters. ROSAT data were used to construct X-ray maps of these pairs. After modelling and subtracting the tSZ effect and X-ray emission for each cluster in the pair, we studied the residuals on both the SZ and X-ray maps. Results. For the merging cluster pair A399-A401 we observe a significant tSZ effect signal in the intercluster region beyond the virial radii of the clusters. A joint X-ray SZ analysis allows us to constrain the temperature and density of this intercluster medium. We obtain a temperature of kT = 7.1 \ub1 0.9 \u2009 keV (consistent with previous estimates) and a baryon density of (3.7 \ub1 0.2) 7 10-4 \u2009cm-3. Conclusions. The Planck satellite mission has provided the first SZ detection of the hot and diffuse intercluster gas