Post-intervention Status in Patients With Refractory Myasthenia Gravis Treated With Eculizumab During REGAIN and Its Open-Label Extension

OBJECTIVE: To evaluate whether eculizumab helps patients with anti-acetylcholine receptor-positive (AChR+) refractory generalized myasthenia gravis (gMG) achieve the Myasthenia Gravis Foundation of America (MGFA) post-intervention status of minimal manifestations (MM), we assessed patients' status throughout REGAIN (Safety and Efficacy of Eculizumab in AChR+ Refractory Generalized Myasthenia Gravis) and its open-label extension. METHODS: Patients who completed the REGAIN randomized controlled trial and continued into the open-label extension were included in this tertiary endpoint analysis. Patients were assessed for the MGFA post-intervention status of improved, unchanged, worse, MM, and pharmacologic remission at defined time points during REGAIN and through week 130 of the open-label study. RESULTS: A total of 117 patients completed REGAIN and continued into the open-label study (eculizumab/eculizumab: 56; placebo/eculizumab: 61). At week 26 of REGAIN, more eculizumab-treated patients than placebo-treated patients achieved a status of improved (60.7% vs 41.7%) or MM (25.0% vs 13.3%; common OR: 2.3; 95% CI: 1.1-4.5). After 130 weeks of eculizumab treatment, 88.0% of patients achieved improved status and 57.3% of patients achieved MM status. The safety profile of eculizumab was consistent with its known profile and no new safety signals were detected. CONCLUSION: Eculizumab led to rapid and sustained achievement of MM in patients with AChR+ refractory gMG. These findings support the use of eculizumab in this previously difficult-to-treat patient population. CLINICALTRIALSGOV IDENTIFIER: REGAIN, NCT01997229; REGAIN open-label extension, NCT02301624. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that, after 26 weeks of eculizumab treatment, 25.0% of adults with AChR+ refractory gMG achieved MM, compared with 13.3% who received placebo

Minimal Symptom Expression' in Patients With Acetylcholine Receptor Antibody-Positive Refractory Generalized Myasthenia Gravis Treated With Eculizumab

The efficacy and tolerability of eculizumab were assessed in REGAIN, a 26-week, phase 3, randomized, double-blind, placebo-controlled study in anti-acetylcholine receptor antibody-positive (AChR+) refractory generalized myasthenia gravis (gMG), and its open-label extension

Effetti delle modificazioni artificiali del microclima sulla qualità dell’uva della cv ‘Pinot nero’

Sono stati studiati gli effetti, sulla qualità dell’uva della cv Pinot nero, di defogliazione della zona dei grappoli, effettuata all’allegagione e all’invaiatura, e della copertura della zona dei grappoli con reti di diversi strati e mantenuta sulla fascia produttiva dall’allegagione all’invaiatura, dall’allegagione alla raccolta e dall’invaiatura alla raccolta. I risultati hanno mostrato che gli zuccheri sono diminuiti in relazione alla riduzione precoce di superficie fogliare. Una defogliazione effettuata ad allegagione completata ha determinato un aumento di antociani e flavonoidi. Tuttavia la ricerca ha messo in evidenza il ruolo significativo della temperatura sulla sintesi degli antociani più che di quello della luce ricevuta dai grappoli. L’abbattimento della radiazione solare con la copertura con rete dall’allegagione in poi ha determinato una riduzione della sintesi delle proantocianidine e dei polifenoli totali piuttosto che di antociani. I fenomeni di degradazione di tutti i polifenoli sono stati più intensi nelle tesi defogliate e quando la rete veniva rimossa all’invaiatura

PRE DAWN, STEM AND LEAF WATER POTENTIAL EVOLUTION IN VITIS VINIFERA L. CV NERO D’AVOLA/1103 P. UNDER DIFFERENT WATER REGIME

Pre dawn, stem and leaf water potential evolution under different water regime were investigated in Nero d’Avola cultivar grafted onto 1103 Paulsen. The study was carried out in Rapitalà winery located in Alcamo DOC area in western Sicily. The vines were 2.4 m x 0.95 m spaced, for a density of 4385 vines/ha. Vines were trained to a vertical trellis system, spur pruned. The vineyard was drip irrigated (4 l/h). Three treatments were applied: 1. vines grown without irrigation water: dry condition; 2. vines irrigated until véraison with 560 m3 : late stress; 3. vines irrigated until ripeness with 1120 m3 : no stress. The aim of the study was to find the different behaviors of Ψp, Ψl e Ψs during the season. Water potential measurements (Pre dawn (Ψp), leaf water potential at midday (Ψl) and Stem water potential (Ψs) in bagged leaves at midday, both in shaded leaves) were determined using a Scholander Chamber, the day before and after each irrigation. Different water potential methods showed water content variation (in following irrigation) in different dates. In dry condition Ψp was good indicator of plant water condition whereas Ψl e Ψs during the season, had variable behaviour. Ψp evidenced better differences, between irrigated and not irrigated vines, compare to Ψs and Ψl respectively. So that Ψp is good indicator of irrigation response, in the earlier season. However Ψs and Ψl were good indicators of irrigation response during the end of the season. Higher variability was respectively found for Ψl and Ψs than Ψp This was due to the environmental condition influences. In conclusion a higher number of leaves samples is necessary for Ψs and Ψl than Ψ

Association of maternal hypertension and chorioamnionitis with preterm outcomes

OBJECTIVES: We compared the relative effect of hypertensive disorders of pregnancy and chorioamnionitis on adverse neonatal outcomes in very preterm neonates, and studied whether gestational age (GA) modulates these effects. METHODS: A cohort of neonates 23 to 30 weeks' GA, born in 2008 to 2011 in 82 hospitals adhering to the Italian Neonatal Network, was analyzed. Infants born from mothers who had hypertensive disorders (N = 2096) were compared with those born after chorioamnionitis (N = 1510). Statistical analysis employed logistic models, adjusting for GA, hospital, and potential confounders. RESULTS: Overall mortality was higher after hypertension than after chorioamnionitis (odds ratio [OR], 1.39; 95% confidence interval [CI], 1.08-1.80), but this relationship changed across GA weeks; the OR for hypertension was highest at low GA, whereas from 28 weeks' GA onward, mortality was higher for chorioamnionitis. For other outcomes, the relative risks were constant across GA; infants born after hypertension had an increased risk for bronchopulmonary dysplasia (OR, 2.20; 95% CI, 1.68-2.88) and severe retinopathy of prematurity (OR, 1.48; 95% CI, 1.02-2.15), whereas there was a lower risk for early-onset sepsis (OR, 0.25; 95% CI, 0.19-0.34), severe intraventricular hemorrhage (OR, 0.65; 95% CI, 0.48-0.88), periventricular leukomalacia (OR, 0.70; 95% CI, 0.48-1.01), and surgical necrotizing enterocolitis or gastrointestinal perforation (OR, 0.47; 95% CI, 0.31-0.72). CONCLUSIONS: Mortality and other adverse outcomes in very preterm infants depend on antecedents of preterm birth. Hypertension and chorioamnionitis are associated with different patterns of outcomes; for mortality, the effect changes across GA weeks. Copyright \uc2\ua9 2014 by the American Academy of Pediatrics

Long-term efficacy and safety of eculizumab in Japanese patients with generalized myasthenia gravis: A subgroup analysis of the REGAIN open-label extension study

The terminal complement inhibitor eculizumab was shown to improve myasthenia gravis-related symptoms in the 26-week, phase 3, randomized, double-blind, placebo-controlled REGAIN study (NCT01997229). In this 52-week sub-analysis of the open-label extension of REGAIN (NCT02301624), eculizumab's efficacy and safety were assessed in 11 Japanese and 88 Caucasian patients with anti-acetylcholine receptor antibody-positive refractory generalized myasthenia gravis. For patients who had received placebo during REGAIN, treatment with open-label eculizumab resulted in generally similar outcomes in the Japanese and Caucasian populations. Rapid improvements were maintained for 52 weeks, assessed by change in score from open-label extension baseline to week 52 (mean [standard error]) using the following scales (in Japanese and Caucasian patients, respectively): Myasthenia Gravis Activities of Daily Living (−2.4 [1.34] and − 3.3 [0.65]); Quantitative Myasthenia Gravis (−2.9 [1.98] and − 4.3 [0.79]); Myasthenia Gravis Composite (−4.5 [2.63] and − 4.9 [1.19]); and Myasthenia Gravis Quality of Life 15-item questionnaire (−8.6 [5.68] and − 6.5 [1.93]). Overall, the safety of eculizumab was consistent with its known safety profile. In this interim sub-analysis, the efficacy and safety of eculizumab in Japanese and Caucasian patients were generally similar, and consistent with the overall REGAIN population