No abstract

The pharmacokinetic profiles observed in these trials indicate that IGIV-C, 10% may replace, and be administered in a manner similar to, IGIV-SD, 10%.

Macular edema (ME) and central serous retinopathy (CSR) are two macular diseases that affect the central vision of a person if they are left untreated. Optical coherence tomography (OCT) imaging is the latest eye examination technique that shows a cross-sectional region of the retinal layers and that can be used to detect many retinal disorders in an early stage. Many researchers have done clinical studies on ME and CSR and reported significant findings in macular OCT scans. However, this paper proposes an automated method for the classification of ME and CSR from OCT images using a support vector machine (SVM) classifier. Five distinct features (three based on the thickness profiles of the sub-retinal layers and two based on cyst fluids within the sub-retinal layers) are extracted from 30 labeled images (10 ME, 10 CSR, and 10 healthy), and SVM is trained on these. We applied our proposed algorithm on 90 time-domain OCT (TD-OCT) images (30 ME, 30 CSR, 30 healthy) of 73 patients. Our algorithm correctly classified 88 out of 90 subjects with accuracy, sensitivity, and specificity of 97.77%, 100%, and 93.33%, respectively.

No abstract

The objective of this prospective, open-label, single-arm, Phase III study was to assess the effi cacy and safety of Privigen ® , the fi rst 10% liquid intravenous immunoglobulin stabilized with L-proline, in patients with primary immunodefi ciency. As part of a larger study, 19 children (3-11 years) and 12 adolescents (12-15 years) received Privigen 200-741 mg/kg intravenously for 12 months at a maximum infusion rate of 8 mg/kg/min. Thirteen patients received infusions at up to 12 mg/kg/min as part of an extension study. The primary endpoint was the annual rate of acute serious bacterial infections (aSBIs) per patient. Privigen was effective, as indicated by the annual rate of aSBI of 0.12 per patient (upper 1-sided 99% CI 0.499) in 3-to 11-year-olds and 0.10 (CI 0.642) in 12-to 15-year-olds. Three patients experienced 1 aSBI each, but did not discontinue treatment. The annual rate of all infections (including aSBIs) per patient was 4.63 in children and 2.42 in adolescents. The annual rate of days missed from school/day care was 11.5 days in children and 4.8 days in adolescents, consistent with the low annual rate of hospitalization (0.53 days and 0 days, respectively). Privigen administration was well-tolerated even at high infusion rates. The proportion of infusions with temporally associated AEs for the entire pediatric population was 0.18 (upper 1-sided 95% CI 0.221). One patient experienced serious AEs considered related to study drug and was withdrawn. Privigen was effective in sustaining a low incidence of infections, including aSBIs, and showed a good tolerability profi le, with adverse events typical of disease and treatment.