Real-World Apremilast Use for Treatment of Plaque Psoriasis in Italy: Patient Perspective, Characteristics, and Clinical Outcomes from the DARWIN Study

IntroductionWhile several european studies have reported real-world apremilast use, patient-perceived benefits, and treatment satisfaction, local reimbursement criteria for apremilast vary and data from Italy are limited.methodsThe cross-sectional DARWIN study enrolled consecutive patients who had initiated apremilast for plaque psoriasis 6 (+/- 1) months prior to enrolment at a single visit across 24 Italian dermatological sites. disease severity was assessed using body surface area (BSA) and physician global assessment (PGA). patient-reported outcomes assessed 6 (+/- 1) months after apremilast initiation were dermatology life quality Index (DLQI), patient benefit Index (PBI), and 9-item treatment satisfaction questionnaire for medication (TSQM-9).ResultsOf 184 patients enrolled between July 2019 and January 2021, 180 were included in the analysis. at apremilast initiation, median (25th-75th percentile) time since psoriasis diagnosis was 8.6 (3.2-22.2) years; median BSA, 10.0% (5.0-16.0); mean (standard seviation, SD) DLQI total score, 13.5 (8.0). over half (54.9%) of patients with available data reported psoriasis had a very or extremely large effect on their quality of life (QoL); half reported itching (50.6%) and/or special areas involvement (50.0%). most (73.9%) had comorbidities and were biologic-naive (81.5%). the most common reasons for initiating apremilast were lack of efficacy of previous treatment (56.7%) and contraindications to other treatments (44.4%). At 6 (+/- 1) months, most patients were continuing apremilast and/or reported a global PBI score >= 1 (minimum clinical benefit) (86.1% and 90.0%, respectively); approximately half achieved BSA <= 3% and/or DLQI total score <= 5 (47.1% and 48.5%); 18.8% achieved PGA = 0; mean (SD) TSQM-9 global treatment satisfaction score was 59.0 (24.8). apremilast was well tolerated; no new safety signals were identified .conclusions patients treated with apremilast for 6 months in Italian clinical practice reported improved QoL, clinically relevant improvements in symptoms, high treatment satisfaction, and high treatment persistence. our data indicate apremilast is a valuable treatment option for moderate plaque psoriasis. study registration clinical trials.gov identifier, NCT04031027

Vulnerability of epitaxial layers and substrates of 4H-SiC to ionizing radiation and thermal treatments

Silicon Carbide (SiC) is a wide-bandgap crystalline semiconductor with an indirect bandgap of 2.3-3.3 eV depending on polytype. 4H-SiC is a very promising semiconductor for high-power devices and high-temperature devices thanks to its superior physical and electrical properties: it exhibits 10 times higher breakdown electric field strength and 3 times higher thermal conductivity than silicon, high chemical inertness, thermal conductivity, mechanical strength, saturation drift velocity [1]. Furthermore, SiC has high radiation hardness thanks to the large values of the threshold energy for defects formation. Consequently, SiC is the most promising semiconductor for fabrication of devices which can operate in extreme conditions, as high levels of irradiation, elevated temperatures, and high chemical activity. Nonetheless, the characteristics of SiC-based devices are influenced by the presence of impurities as well as extended and point defects. In general, the effects of irradiation causes formation of vacancies, interstitials and related defects which may give rise to states in the bandgap influencing the electrical and optical properties of the material [2-3]. Moreover, it has been observed that treatments at temperature of about 2000°C induce the sublimation of Si and the growth of graphene layer on top of SiC in different atmospheres or in vacuum [4-5]. These studies prove the vulnerability of the material. In this work some complementary non-invasive techniques (μ-Raman, steady-state and time resolved photoluminescence spectroscopy) have been used to study the vulnerability of epitaxial layer of 4H-SiC to ionizing radiation (β-rays and X-rays) and to the effects of thermal treatments in a low temperature range (below 2000°C in Ar atmosphere) on substrates of 4H-SiC. The dose range spanned from 1 kGy up to 100 kGy. In the samples irradiated with β-rays the lifetime of the excitonic band decreases when the deposited dose increases. In particular, in the samples with higher native defectiveness the effect starts from lower deposited doses. Conversely, in the samples irradiated with X-rays there aren’t effects at the same deposited dose as β-rays. These findings suggest that irradiation with electrons induces defects related to atomic displacement. The effects of thermal treatments in air, from 100°C up to 900°C, have been explored to study the recovery properties of epitaxial layer of 4H-SiC. The effect of thermal treatments conducted on the substrates were monitored by μ-Raman spectroscopy. Traces of damaged graphene and graphitization have been observed. [1] T. Kimoto P. and J.A. Cooper, Fundamentals of Silicon Carbide Technology. John Wiley & Sons Singapore Pte. Ltd, 2014. [2] A. A. Lebedev et al., Materials Science Forum, 433-436, 2003 [3] A. Le Donne et al., Diamond & Related Materials, 14, 2005 [4] K. V. Emtsev et al., Nature Materials, 8, 203–207, 2009 [5] J. L. Tedesco et al, Appl. Phys. Lett., 96, 222103, 201

1-Year Outcomes After Transfemoral Transcatheter or Surgical Aortic Valve Replacement: Results From the Italian OBSERVANT Study.

Tamburino C, Barbanti M, D'Errigo P, Ranucci M, Onorati F, Covello RD, Santini F, Rosato S, Santoro G, Fusco D, Grossi C, Seccareccia F; OBSERVANT Research Group. Collaborators (209) Marra S, Marra S, D'Amico M, Gaita F, Moretti C, De Benedictis M, Aranzulla T, Pistis G, Reale M, Bedogni F, Brambilla N, Ferrario M, Ferrero L, Vicinelli P, Colombo A, Chieffo A, Ferrari A, Inglese L, Casilli F, Ettori F, Frontini M, Antona C, Piccaluga E, Klugmann S, De Marco F, Tespili M, Saino A, Leonzi O, Rizzi A, Grisolia E, Franceschini Grisolia E, Isabella G, Fraccaro C, Bernardi G, Bisceglia T, Armellini I, Vischi M, Parodi E, Vignali L, Ardissimo D, Marzocchi A, Marrozzini C, Cremonesi A, Colombo F, Giannini C, Pierli C, Iadanza A, Santoro G, Meucci F, Berti S, Mariani M, Tomai F, Ghini A, Violini R, Confessore P, Crea F, Giubilato S, Sardella G, Mancone M, Ribichini F, Vassanelli C, Dandale R, Giudice P, Vigorito F, Liso A, Specchia L, Indolfi C, Spaccarotella C, Stabile A, Gandolfo C, Tamburino C, Ussia G, Comoglio C, Dyrda O, Rinaldi M, Salizzoni S, Micalizzi E, Grossi C, Di Gregorio O, Scoti P, Costa R, Casabona R, Del Ponte S, Panisi P, Spira G, Troise G, Messina A, Viganò M, Aiello M, Alfieri O, Denti P, Menicanti L, Agnelli B, Donatelli F, Muneretto C, Frontini M, Rambaldini M, Frontini M, Gamba A, Tasca G, Ferrazzi P, Terzi A, Antona C, Gelpi G, Martinelli L, Bruschi G, Graffigna AC, Mazzucco A, Pappalardo A, Gatti G, Livi U, Pompei E, Coppola R, Gucciardo M, Parodi E, Albertini A, Caprili L, Ghidoni I, Gabbieri D, La Marra M, Aquino T, Gherli T, Policlinico S, Di Bartolomeo R, Savini C, Popoff G, Innocenti D, Bortolotti U, Pratali S, Stefano P, Blanzola C, Glauber M, Cerillo A, Chiaramonti F, Pardini A, Fioriello F, Torracca L, Rescigno G, De Paulis R, Nardella S, Musumeci F, Luzi G, Possati G, Bonalumi G, Covino E, Pollari F, Sinatra R, Roscitano A, Chiariello L, Nardi P, Lonobile T, Baldascino F, Di Benedetto G, Mastrogiovanni G, Piazza L, Marmo J, Vosa C, De Amicis V, Speziale G, Visicchio G, Spirito R, Gregorini R, Specchia L, Villani M, Pano MA, Bortone A, De Luca Tupputi Schinosa L, De Cillis E, Gaeta R, Di Natale M, Cassese M, Antonazzo A, Argano V, Santaniello E, Patanè L, Gentile M, Tribastone S, Follis F, Montalbano G, Pilato M, Stringi V, Patanè F, Salamone G, Ruvolo G, Pisano C, Mignosa C, Bivona A, Cirio EM, Lixi G, Seccareccia F, D'Errigo P, Rosato S, Maraschini A, Badoni G, Tamburino C, Santoro G, Santini F, Grossi C, Ranucci M, Covello RD, Fusco D, Onorato F, De Palma R, Scandotto S, Orlando A, Copello F, Borgia P, Marchetta F, Porcu R. BACKGROUND: There is a paucity of prospective and controlled data on the comparative effectiveness of transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) in a real-world setting. OBJECTIVES: This analysis aims to describe 1-year clinical outcomes of a large series of propensity-matched patients who underwent SAVR and transfemoral TAVR. METHODS: The OBSERVANT (Observational Study of Effectiveness of SAVR-TAVI Procedures for Severe Aortic Stenosis Treatment) trial is an observational prospective multicenter cohort study that enrolled patients with aortic stenosis (AS) who underwent SAVR or TAVR. The propensity score method was applied to select 2 groups with similar baseline characteristics. All outcomes were adjudicated through a linkage with administrative databases. The primary endpoints of this analysis were death from any cause and major adverse cardiac and cerebrovascular events (MACCE) at 1 year. RESULTS: The unadjusted enrolled population (N = 7,618) included 5,707 SAVR patients and 1,911 TAVR patients. The matched population had a total of 1,300 patients (650 per group). The propensity score method generated a low-intermediate risk population (mean logistic EuroSCORE 1: 10.2 ± 9.2% vs. 9.5 ± 7.1%, SAVR vs. transfemoral TAVR; p = 0.104). At 1 year, the rate of death from any cause was 13.6% in the surgical group and 13.8% in the transcatheter group (hazard ratio [HR]: 0.99; 95% confidence interval [CI]: 0.72 to 1.35; p = 0.936). Similarly, there were no significant differences in the rates of MACCE, which were 17.6% in the surgical group and 18.2% in the transcatheter group (HR: 1.03; 95% CI: 0.78 to 1.36; p = 0.831). The cumulative incidence of cerebrovascular events, and rehospitalization due to cardiac reasons and acute heart failure was similar in both groups at 1 year. CONCLUSIONS: The results suggest that SAVR and transfemoral TAVR have comparable mortality, MACCE, and rates of rehospitalization due to cardiac reasons at 1 year. These data need to be confirmed in longer term and dedicated ongoing randomized trial