Search

Summary Background Etrolizumab is a gut-targeted anti-β7 integrin monoclonal antibody. In an earlier phase 2 induction study, etrolizumab significantly improved clinical remission relative to placebo in patients with moderately to severely active ulcerative colitis. The HIBISCUS studies aimed to compare the efficacy and safety of etrolizumab to adalimumab and placebo for induction of remission in patients with moderately to severely active ulcerative colitis. Methods HIBISCUS I and HIBISCUS II were identically designed, multicentre, phase 3, randomised, double-blind, placebo-controlled and active-controlled studies of etrolizumab, adalimumab, and placebo in adult (18–80 years) patients with moderately to severely active ulcerative colitis (Mayo Clinic total score [MCS] of 6–12 with an endoscopic subscore of ≥2, a rectal bleeding subscore of ≥1, and a stool frequency subscore of ≥1) who were naive to tumour necrosis factor inhibitors. All patients had an established diagnosis of ulcerative colitis for at least 3 months, corroborated by both clinical and endoscopic evidence, and evidence of disease extending at least 20 cm from the anal verge. In both studies, patients were randomly assigned (2:2:1) to receive subcutaneous etrolizumab 105 mg once every 4 weeks; subcutaneous adalimumab 160 mg on day 1, 80 mg at week 2, and 40 mg at weeks 4, 6, and 8; or placebo. Randomisation was stratified by baseline concomitant treatment with corticosteroids, concomitant treatment with immunosuppressants, and baseline disease activity. All patients and study site personnel were masked to treatment assignment. The primary endpoint was induction of remission at week 10 (defined as MCS of 2 or lower, with individual subscores of 1 or lower, and rectal bleeding subscore of 0) with etrolizumab compared with placebo. Pooled analyses of both studies comparing etrolizumab and adalimumab were examined for several clinical and endoscopic endpoints. Efficacy was analysed using a modified intent-to-treat population, defined as all randomly assigned patients who received at least one dose of study drug. These trials are registered with ClinicalTrials.gov , NCT02163759 (HIBISCUS I), NCT02171429 (HIBISCUS II). Findings Between Nov 4, 2014, and May 25, 2020, each study screened 652 patients (HIBISCUS I) and 613 patients (HIBISCUS II). Each study enrolled and randomly assigned 358 patients (HIBISCUS I etrolizumab n=144, adalimumab n=142, placebo n=72; HIBISCUS II etrolizumab n=143; adalimumab n=143; placebo n=72). In HIBISCUS I, 28 (19·4%) of 144 patients in the etrolizumab group and five (6·9%) of 72 patients in the placebo group were in remission at week 10, with an adjusted treatment difference of 12·3% (95% CI 1·6 to 20·6; p=0·017) in favour of etrolizumab. In HIBISCUS II, 26 (18·2%) of 143 patients in the etrolizumab group and eight (11·1%) of 72 patients in the placebo group were in remission at week 10, with an adjusted treatment difference of 7·2% (95% CI –3·8 to 16·1; p=0·17). In the pooled analysis, etrolizumab was not superior to adalimumab for induction of remission, endoscopic improvement, clinical response, histological remission, or endoscopic remission; however, similar numerical results were observed in both groups. In HIBISCUS I, 50 (35%) of 144 patients in the etrolizumab group reported any adverse event, compared with 61 (43%) of 142 in the adalimumab group and 26 (36%) of 72 in the placebo group. In HIBISCUS II, 63 (44%) of 143 patients in the etrolizumab group reported any adverse event, as did 62 (43%) of 143 in the adalimumab group and 33 (46%) in the placebo group. The most common adverse event in all groups was ulcerative colitis flare. The incidence of serious adverse events in the pooled patient population was similar for etrolizumab (15 [5%] of 287) and placebo (seven [5%] of 144) and lower for adalimumab (six [2%] of 285). Two patients in the etrolizumab group died; neither death was deemed to be treatment related. Interpretation Etrolizumab was superior to placebo for induction of remission in HIBISCUS I, but not in HIBISCUS II. Etrolizumab was well tolerated in both studies. Funding F Hoffmann-La Roche.

si descrive il contenuto sia dal punto di vista qualitativo che quantitativo della banca di forme di resistenza presente nei sedimenti del golfo di Valona

the distribution of mesozooplankton has been established in the Bay of Vlora due to the collection of replicate samples from 17 different stations, and two different periods (seasons). A clearly confined area has not been individuated, probably due to the steep copasts

The Vlora Bay is the only internal sea of the Albanian coastline. The site is of paramount interest for Albanian fishing, being a natural nursery for many fish species of economic importance. The composition of the plankton community in the Vlora Bay has been analysed and particular attention devoted to the unicellular eukaryotes by collecting samples from 16 stations during 2 seasonal cruises (May–June 2007, and January 2008), an effort to date never carried out to know the plankton biodiversity of the area. The microzooplankton community was composed of 122 phytoplankton and 105 microzooplankton taxa, of which 58.2% and 25.0%, respectively, were classified as seasonal (they were recorded only in one of the two considered times). Only four categories (all phytoplanktonic, the diatom Navicula sp., ‘‘undetermined naked dinoflagellates , 15 mm’’, the coccolithophorid Emiliania huxleyi, and the ‘‘undetermined phytoflagellates , 10 mm’’) were recorded in all the sampling stations (at least in one period). The microzooplankton were particularly diversified and characteristic in their Ciliophora components. A statistical analysis of taxa distribution allowed us to identify three distinct areas in the Vlora Bay: internal, intermediate, and external. The extension or the border position of these areas varied with the seasons and according to the microzooplankton group examined. The microzooplankton assemblages of the Vlora Bay showed significant differences with many other sites in the Mediterranean Sea, probably due to the crucial geographic position the bay occupies among different Mediterranean basins.

si descrive la metodica per prelevare, e analizzare campioni di sedimento al fine di trovare forme di resistenza prodotte dal mesozooplankton

Artemia urmiana has been recorded for the first time out of its nominal site (lake Urmia, Iran), in European territory (the Crimean peninsula, Ukraine). The species identification has been carried out on the basis of morphomnetry, SEM, molecular biology, with a multidisciplinary approach.

The alpine lake Gijstova (2365 m asl) has been repeatedly visited in 4 years. samples of zooplankton and of bottom muds have been used to establish the community composition.

Three tourist tracks have been proposed in the Region of Vlore (Southern Albania) to enhance tourism by proposing alternative periods and sites. The Karaburun track, the Orikum track, and the Dajlan-Zvernez track, have been tested, documented, and realized with panel and signal apposition, and a web site has been realized, in the framework of the INTERREG III project PERNATUR

Composition and abundance patterns are described for the plankton assemblages in a shallow submarine cave on the Salento peninsula side of the Otranto Channel (SE Italy). A total of 232 taxa were recognized. The cave plankton appeared more affected by huperbenthos than the outside plankton. Mysidacea represented the most conspicuous component of the cave plankton , with two species typical of Salento caves. Harpacticoida, together with asexual algal propagules, dominated the plankton of the cave numerically, whereas Calanoida and Cyclopoida along with mollusc veligers, characterized the plankton in the outside sector. While the mysid Siriella jaltensis was found outside the cave in nocturnal samples, Hemimysis margalefi appeared to migrate simply along the axis of the cave, never leaving it during night. The community composition changed seasonally over the 1-year period. Therte was a clear horizontal partitioning of the plankton, with significant differences between the two stations inside the cave. Higher water turbulence probably explains the presence of asexual propagules even at the inner station. An explanation of the benthos impoverishment has been proposed as an alternative to the current “trophic depletion” theory.

first report on the whole plankton fauna of hyperhaline lakes of the Crimea. Salt lakes have been distinguished in marine derived and continental derived according to the fauna assemblages.

The north America species Artemia franciscana has been recorded for the first time in the Margherita di Savoia salterns (the largest in Europe), the easternmost site of its european invasion. The species is dangerously competing with the indigenous artemia in the same hypersaline habitat.

La palude del Capitano, sprofondamento carsico allagato e in comunicazione con la falda acquifera, è stata studiata in modo interdisciplinare. l'esplorazione speleosubacquea ha consentito di stabilire una prosecuzione in cunicolo sommerso verso nord-ovest. lo studio del plancton ha consentito di effettuare una prima lista faunistica di questa particolare biocenosi.

A preliminary survey on the zooplankton composition and distribution has been carried out in the Gulf of Vlore to standardise methods. Micro- and Meso-zooplankton were collected from 7 stations with different mesh sized nets, on 7 June 2003. A total of 94 categories were recognised (34 at the species level). Differences between the 6 Gulf stations were less significant than those resulting from the comparison of each of them with the single station of the Otranto Channel. The presence of fish larvae and eggs was recorded, together with the larval stages of Stomatopoda. This allowed us to affirm the importance of the inlet as nursery areas for fishery important species. The degree of confinement of the area was indicated by the indicator species belonging to the copepod family of Acartiidae (Calanoida), and Oithonidae (Cyclopoida), and by the different size of copepods belonging to different populations of the same species. A plan for future investigation has been proposed to monitor the presence (either in space and time) of economically important larvae and juveniles, to understand life cycle timing of their species in the Gulf of Vlore.

A diploid parthenogenetic strain of Artemia has been found in the Torre Colimena hypersaline lake. The species coexists with another anostracan of the genus Branchinella. The present described strain is compared, with a multidisciplinary approach, with other parthenogenetic Artemia strains from all the Mediterranean basin.

The species composition of the zooplankton and its variability were studied in an integrated water-sediment analysis for a period of two years in a hypersaline temporary pond in the SE Italy. The zooplankton showed the presence of seasonal species (mainly Anostraca), together with not seasonal but opportunistic ones (mainly Rotifera, and Ciliophora) with a shorter life-cycle. Rotifers, and Ciliates attained 99-100 % of total plankton organisms in certain periods. Resting stages were extracted from the upper 6 cm of 14 sediment cores collected during a dry period (August 1998). A total of 24 resting morphotypes (cysts) were listed: more than double the number of active organisms (11) found in the plankton over the two years studied. The seasonal succession of species was different in the two years. This fact, together with the richness of the cyst bank in the sediments, indicates that in each period the water column shows only a portion of the biodiversity which the sediment contains unexpressed as resting stages. The study of cyst distribution (both horizontal and vertical in sediments) provided complementary suggestions to understand the space-time distribution of the plankton organisms. Laboratorary tests showed that hatching of different cysts generally occurred in a wide range of salinity conditions, and it was not synchronous. This allowed us to assume that even the cyst hatching rate could be an adaptation to highly variable extreme environments.

The species composition of zooplankton and its variability were studied with an integrated water-sediment analysis for a period of two years in a hypersaline temporary pond in SE Italy. The basin was affected by extended drought during summer, and even during the wet period the sodium chloride salinity was never below 42.`0. The zooplankton showed the presence of seasonal species (mainly Anostraca), together with not seasonal, but opportunistic ones (mainly Rotifera, and Ciliophora) with a shorter life cycle. Rotifers (mainly Hexarthra fennica and Proales similis), and ciliates (Fabrea salina) attained 99-100% of total planktonic organisms in certain periods. Resting stages were extracted from the upper 6 cm of 14 sediment cores collected during a dry period (August 1998). A total of 24 resting morphotypes (cysts) were listed—more than double the number of the active organisms (11) found in the plankton over the two years. The seasonal succession of species was different in the two years studied. This fact, together with the richness of the cyst bank of the sediment, indicates that in each period the water column shows only a portion of the biodiversity, which the sediment contains unexpressed as resting stages. The study of cyst distribution (both horizontal and vertical) in sediments provided complementary suggestions to understand the space-time distribution of the plankton organisms. Laboratory tests showed that hatching of different cysts generally occurred in a wide range of salinity conditions, and was not synchronous. This allowed us to assume that even the cyst hatching rate could be an adaptation to highly variable extreme environments., La composición específica del zooplancton y su variabilidad han sido estudiadas con un análisis integrado agua-sedimento, por un periodo de dos años, en una laguna temporal hipersalina en el SE de Italia. La cuenca se vio afectada por una prolongada sequía durante el verano e, incluso durante el periodo húmedo, la salinidad de cloruro sódico nunca fue inferior al 42.5‰. El zooplancton mostró la presencia de especies estacionales (principalmente Anostraca), junto con no estacionales, pero oportunistas (principalmente Rotifera y Ciliophora) con un ciclo de vida más corto. Los rotíferos (principalmente Hexarthra fennica, y Proales similis) y los ciliados (Fabrea salina) alcanzaron el 99-100% del total de organismos planctónicos en ciertos periodos. Los estados durmientes fueron extraídos de los 6 cm superiores de cores (testigos) de 14 cm recogidos durante un periodo seco (agosto 1998). Un total de 24 morfotipos durmientes (quistes) fueron catalogados, más del doble que el número de organismos activos (11) encontrados en los dos años. La sucesión estacional de especies fue diferente en los dos años estudiados. Este hecho, junto con la riqueza del banco de quistes del sedimento, atestigua que la columna de agua muestra en cada periodo sólo una fracción de la biodiversidad, que el sedimento contiene, sin expresarse, como estados durmientes. El estudio de la distribución de los quistes (tanto horizontal como vertical) en el sedimento aportó indicaciones complementarias para entender la distribución espacio-temporal de los organismos del plancton. Ensayos de laboratorio mostraron que la eclosión de los diferentes quistes generalmente ocurre en un amplio rango de condiciones de salinidad, y no fue sincrónico. Esto nos permitió suponer que incluso la tasa de eclosión de los quistes podría ser una adaptación a los muy variables ambientes extremos.