Abstract Background In patients with IBD quality of life (QoL) is a fundamental long-term therapeutic target1. Given the significant role that school plays in the daily lives of paediatric patients, understanding its impact on their QoL is crucial2. The present study aimed to evaluate patients’ perspectives on their relationship with school, with the goal of identifying areas for practical improvement. Methods An anonymized survey was distributed (02/2020-11/2024) to all paediatric IBD patients and families registered with the Italian patient association AMICI. Data collected included disease type, sex and school grade (primary, secondary school, college), along with disease awareness and responses to a 20-item questionnaire evaluating various aspects of the school experience (Table 1). Questions included binary (yes/no) or ternary (often/sometimes/never) response options. Results A total of 362 patients (54% females; median age 16 years, IQR 13-18) responded to the survey, with the majority attending secondary school or college (326/362, 90%). Most respondents reported being aware of their disease (327/362, 90%; 38% with Crohn’s disease, 48% with ulcerative colitis) and its chronic nature (311/362, 86% - Table 2). While a significant proportion (269/362, 74%) expressed a positive attitude towards school and had disclosed their condition to at least 1 person within the school environment (286/362, 79%), several challenges were identified. In terms of empathy, only 25% (91/362) and 23% (84/362) felt to be often understood by teachers and peers, respectively. Toilet access was problematic, with just 48% (172/362) reporting unrestricted access and 62% (225/362) expressing fear of using school bathrooms (Table 1). Additionally, 25% (91/362) reported being teased due to their condition, while 22% (80/362) experienced direct aggression and/or physical/verbal bullying. Almost half (172/362, 48%) attended school despite feeling unwell to avoid criticism, with a minority having access to a support teacher (54/362, 15%) or opportunities to catch up on missed lessons (191/362, 53%). To address these issues, patients’ suggestions were training programs to educate teachers/peers (108/362, 29%) and practical improvements in restroom access/organization and absences management (51/362, 14%). Conclusion Despite existing awareness campaigns, national/international initiatives to educate school staff/peers and foster understanding should be implemented to ensure a more inclusive school environment, improving paediatric IBD QoL. Patient associations can play a pivotal role by identifying patients daily needs and facilitating collaboration between healthcare providers, educators and policymakers to develop tailored programs addressing emergent challenges. References 1.Turner D, Ricciuto A, Lewis A, et al. STRIDE-II: An Update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): Determining Therapeutic Goals for Treat-to-Target strategies in IBD. Gastroenterology. 2021;160(5):1570-1583. doi:10.1053/j.gastro.2020.12.031 2.Freckmann M, Seipp A, Laass MW, et al. School-related experience and performance with inflammatory bowel disease: results from a cross-sectional survey in 675 children and their parents. BMJ Open Gastroenterol. 2018;5(1):e000236. doi:10.1136/bmjgast-2018-000236
Abstract Background Acute severe ulcerative colitis (ASUC) is a serious, potentially life-threatening condition. Hospital admission and prompt medical therapy with intravenous steroids is crucial, but rescue medical therapy is frequently needed, and surgery is often required. Our aim was to assess the adherence to main diagnostic and management recommendations within the MASC multinational study. Methods MASC was a prospective, multinational cohort study, including all consecutive patients hospitalized for ASUC between February 2019-January 2020. The primary outcome was surgery during the first 90 days after admission. We used descriptive statistics to determine the proportion of patients fulfilling each diagnostic and treatment recommendation according to ECCO and AGA. Results A total of 823 patients from 123 centers in 32 countries in five continents were included (median age 39 years [IQR, 28-54], 56% male, 64% non-smokers; Table 1). Most cases (74%) had a previous diagnosis of ulcerative colitis, and around half (48%) with prior ASUC episodes. Upon admission, they were under 5-ASA therapy (60%), thiopurines (14%), or biologics (21%). They were mostly admitted to the Gastroenterology ward (74%). During the initial assessment, 112 patients (15%) did not have stool culture or C. difficile testing, and CMV was evaluated in 50% of cases. Endoscopic assessment was performed in 66% of patients, mainly by flexible rectosigmoidoscopy (74%). Regarding treatment, 3.4% of patients received exclusive parenteral nutrition, 70% low molecular weight heparin, and 42% prophylactic antibiotics (Table 2). Steroids were started after a median of 0 days (IQR, 0-1), mostly with methylprednisolone or hydrocortisone (64%), 26% with other steroids, and 7% were managed without steroids. Infliximab was started in 159 patients (19%) after a median of 6 days (IQR, 4-8) after starting steroids, with 27% after >7 days. Most of the patients (93%) had some type of tuberculosis screening done prior to infliximab. Twenty-eight patients (3.4%) started cyclosporine. Thirty-two patients (4%) received other rescue therapy different from infliximab or cyclosporin. Colectomy was performed in 25 patients (3%). Conclusion The diagnostic and medical management of ASUC remains heterogeneous and different from current recommendations. This context demands more evidence and consensus on the best management of ASUC.
Summary Randomized clinical trials and observational studies on the implementation of clinical governance models, in patients who had experienced a fragility fracture, were examined. Literature was systematically reviewed and summarized by a panel of experts who formulated recommendations for the Italian guideline. Purpose After experiencing a fracture, several strategies may be adopted to reduce the risk of recurrent fragility fractures and associated morbidity and mortality. Clinical governance models, such as the fracture liaison service (FLS), have been introduced for the identification, treatment, and monitoring of patients with secondary fragility fractures. A systematic review was conducted to evaluate the association between multidisciplinary care systems and several outcomes in patients with a fragility fracture in the context of the development of the Italian Guidelines. Methods PubMed, Embase, and the Cochrane Library were investigated up to December 2020 to update the search of the Scottish Intercollegiate Guidelines Network. Randomized clinical trials (RCTs) and observational studies that analyzed clinical governance models in patients who had experienced a fragility fracture were eligible. Three authors independently extracted data and appraised the risk of bias in the included studies. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation methodology. Effect sizes were pooled in a meta-analysis using random-effects models. Primary outcomes were bone mineral density values, antiosteoporotic therapy initiation, adherence to antiosteoporotic medications, subsequent fracture, and mortality risk, while secondary outcomes were quality of life and physical performance. Results Fifteen RCTs and 62 observational studies, ranging from very low to low quality for bone mineral density values, antiosteoporotic initiation, adherence to antiosteoporotic medications, subsequent fracture, mortality, met our inclusion criteria. The implementation of clinical governance models compared to their pre-implementation or standard care/non-attenders significantly improved BMD testing rate, and increased the number of patients who initiated antiosteoporotic therapy and enhanced their adherence to the medications. Moreover, the treatment by clinical governance model respect to standard care/non-attenders significantly reduced the risk of subsequent fracture and mortality. The integrated structure of care enhanced the quality of life and physical function among patients with fragility fractures. Conclusions Based on our findings, clinicians should promote the management of patients experiencing a fragility fracture through structured and integrated models of care. The task force has formulated appropriate recommendations on the implementation of multidisciplinary care systems in patients with, or at risk of, fragility fractures.
Purpose Since vertebral fragility fractures (VFFs) might increase the risk of subsequent fractures, we evaluated the incidence rate and the refracture risk of subsequent vertebral and non-vertebral fragility fractures (nVFFs) in untreated patients with a previous VFF. Methods We systematically searched PubMed, Embase, and Cochrane Library up to February 2022 for randomized clinical trials (RCTs) that analyzed the occurrence of subsequent fractures in untreated patients with prior VFFs. Two authors independently extracted data and appraised the risk of bias in the selected studies. Primary outcomes were subsequent VFFs, while secondary outcomes were further nVFFs. The outcome of refracture within ≥ 2 years after the index fracture was measured as (i) rate, expressed per 100 person-years (PYs), and (ii) risk, expressed in percentage. Results Forty RCTs met our inclusion criteria, ranging from medium to high quality. Among untreated patients with prior VFFs, the rate of subsequent VFFs and nVFFs was 12 [95% confidence interval (CI) 9–16] and 6 (95% CI 5–8%) per 100 PYs, respectively. The higher the number of previous VFFs, the higher the incidence. Moreover, the risk of VFFs and nVFFs increased within 2 (16.6% and 8%) and 4 years (35.1% and 17.4%) based on the index VFF. Conclusion The highest risk of subsequent VFFs or nVFFs was already detected within 2 years following the initial VFF. Thus, prompt interventions should be designed to improve the detection and treatment of VFFs, aiming to reduce the risk of future FFs and properly implement secondary preventive measures.
PURPOSE:Preventing fragility fractures by treating osteoporosis may reduce disability and mortality worldwide. Algorithms combining clinical risk factors with bone mineral density have been developed to better estimate fracture risk and possible treatment thresholds. This systematic review supported panel members of the Italian Fragility Fracture Guidelines in recommending the use of best-performant tool. The clinical performance of the three most used fracture risk assessment tools (DeFRA, FRAX, and FRA-HS) was assessed in at-risk patients.METHODS:PubMed, Embase, and Cochrane Library were searched till December 2020 for studies investigating risk assessment tools for predicting major osteoporotic or hip fractures in patients with osteoporosis or fragility fractures. Sensitivity (Sn), specificity (Sp), and areas under the curve (AUCs) were evaluated for all tools at different thresholds. Quality assessment was performed using the Quality Assessment of Diagnostic Accuracy Studies-2; certainty of evidence (CoE) was evaluated using the Grading of Recommendations Assessment, Development and Evaluation approach.RESULTS:Forty-three articles were considered (40, 1, and 2 for FRAX, FRA-HS, and DeFRA, respectively), with the CoE ranging from very low to high quality. A reduction of Sn and increase of Sp for major osteoporotic fractures were observed among women and the entire population with cut-off augmentation. No significant differences were found on comparing FRAX to DeFRA in women (AUC 59-88% vs. 74%) and diabetics (AUC 73% vs. 89%). FRAX demonstrated non-significantly better discriminatory power than FRA-HS among men.CONCLUSION:The task force formulated appropriate recommendations on the use of any fracture risk assessment tools in patients with or at risk of fragility fractures, since no statistically significant differences emerged across different prediction tools.
Abstract Background Real-world treatment of ulcerative colitis (UC) requires a patient-centric, holistic definition of ‘comprehensive remission' that goes beyond standard regulatory definitions. In an international initiative, we reviewed aspects of UC that affect patients and attempted to achieve consensus on which aspects should be considered in a definition of ‘comprehensive remission’, using a modified Delphi process. This initiative summarized expert consensus recommendations on aspects of UC that are important to patients and that affect their lives, how to measure and score these aspects, and objective markers of mucosal inflammation that are relevant to evaluate in remission, such as endoscopic and histological activity and inflammatory biomarkers. Methods The Delphi consensus panel comprised 10 physicians with expertise in UC and one patient advocate, and two additional physicians chaired the process. To inform the Delphi statements, we asked 18 patients about their experiences of living with UC in remission, asked panel members about their experience of treating patients and systematically reviewed associations between outcome measures in UC. Panel members voted on a 6-point Likert scale in three rounds of anonymous voting, the final round of which was preceded by a live discussion. Consensus was met if ≥ 67% of the panel agreed with the statement (4–6 on the 6-point Likert scale). Statements not meeting consensus in voting rounds 1 and 2 were revised and any not meeting consensus by the end of voting round 3 were discarded (Figure 1). Results The panel agreed that a definition of comprehensive remission should include aspects of UC that are currently measured in clinical trials (blood in stools, stool frequency, disease-related quality of life [QoL], endoscopic remission, histological inflammatory activity, inflammatory biomarkers and discontinuation of corticosteroids), but also additional patient-reported symptoms should be added. These were bowel urgency, abdominal pain, extra-intestinal manifestations, fatigue and sleep disturbance (Table 1). Suggestions for how the severity could be measured and thresholds for remission were agreed for each aspect, with the exception of extra-intestinal manifestations. Disease activity evaluated using ultrasound was voted as important to consider but was not recommended to be included in a measure of comprehensive remission at this stage. Conclusion We used a robust methodology to reach agreement and provide recommendations on the aspects of UC that can be used to define comprehensive remission and assessed in clinical practice. We plan to develop this as a combined measure which may also have applicability in clinical trials.
Abstract Background Acute severe ulcerative colitis (ASUC) is a potentially life-threatening condition, requiring immediate hospitalization. Delayed colectomy is associated with increased risk of post-operative complications. This study aimed to identify early predictors of failure to medical treatment and need for colectomy in patients with ASUC. Methods The Management of Acute Severe ulcerative Colitis (MASC) Audit was an international, prospective, observational, cohort study, in which data on consecutive patients hospitalised for ASUC at participating units over a minimum 6-month period in 2019-20 were collated. The need for surgery during the first 90 days after admission was the primary outcome of the study. Data on all consecutive patients admitted for ASUC at the participating units were prospectively entered in an online secure database. A multivariate regression logistic model was developed to identify early predictors of colectomy. The study was developed by a multidisciplinary panel of collaborators, including gastroenterologists, surgeons, and patients, and it was discussed at the 5th IBD National Study Group of the ECCO. The study was led by the European Society of Coloproctology (https://tinyurl.com/vfwmahva). Results Out of 706 patients included in the database, data from 699 patients from 123 centres located in 32 different countries were included in the analysed (Figure 1). Median age was 38 (IQR, 28-54) years; 265 (38%) patients had a previous admission for UC and 39 (6%) had undergone previous appendicectomy. At admission, 13% patients were on monotherapy with 5-ASA, 19% systemic steroids, and 19% biologic agents. Within 90 days after admission, 258 (37%) patients required surgery: 29.7% received second-line and 1.4% received third-line medical therapy. Overall mortality was 1%. Among those patients requiring surgery, postoperative morbidity was 36% (Table 1). Being a current smoker (OR 2.6, 95%CI 1.2-6.0), previous appendicectomy (OR 6.3, 95%CI 2.1-20.0), previous admission for UC (OR 2.6, 95%CI 1.5-4.4), admission to a surgical unit (OR 9.8, 95%CI 4.3-22.5), type of pre-admission therapy and C-reactive protein levels on day 3 after admission (OR 1.01 per mg/L, 95%CI 1.00-1.01, ROC curve in Figure 2) were independent predictors of failed medical treatment. Conclusion Mortality for ASUC did not exceed 1% in this series. Patients who smoked or had previous appendicectomy were at increased risk of medical failure. These factors seem to challenge the current knowledge on UC course, and the findings merit further investigation. C-reactive protein on day 3 after admission was identified as a potential marker to predict the subsequent need for surgery.
A bstract A search for the exclusive decays of the Higgs and Z bosons to a ϕ or ρ meson and a photon is performed with a pp collision data sample corresponding to an integrated luminosity of up to 35 . 6 fb −1 collected at $$ \sqrt{s}=13 $$ s = 13 TeV with the ATLAS detector at the CERN Large Hadron Collider. These decays have been suggested as a probe of the Higgs boson couplings to light quarks. No significant excess of events is observed above the background, as expected from the Standard Model. Upper limits at 95% confidence level were obtained on the branching fractions of the Higgs boson decays to ϕ γ and ρ γ of 4 . 8 × 10 −4 and 8 . 8 × 10 −4 , respectively. The corresponding 95% confidence level upper limits for the Z boson decays are 0 . 9 × 10 −6 and 25 × 10 −6 for ϕ γ and ρ γ, respectively.
A search for leptoquarks decaying into the bτ final state is performed using Run 2 proton-proton collision data from the Large Hadron Collider, corresponding to an integrated luminosity of 139 fb−1 at √(s) = 13 TeV recorded by the ATLAS detector. The benchmark models considered in this search are vector leptoquarks with electric charge of 2/3e and scalar leptoquarks with an electric charge of 4/3e. No significant excess above the Standard Model prediction is observed, and 95
Abstract Background Telemedicine is one of the major changes that clinicians have encountered over the past decade; in particular during the COVID-19 pandemic, televisits were rapidly implemented to guarantee patients’ assistance, with the intention of Health Care Providers (HCPs) to continue to use them beyond the pandemic. The aim of our national survey was to evaluate the current usage of telemedicine for IBD patients from their perspective, investigating patients’ impressions about telemedicine and factors affecting them through a Machine Learning (ML) analysis. Methods In March 2021, the Italian IBD patients’ association (AMICI Onlus) distributed to their members - through its mailing list and on social media platforms - an anonymous online questionnaire investigating the use of telemedicine. Socio-demographic and IBD characteristics were collected; the usage, patients’ satisfaction and trust of telemedicine were assessed through Likert scales. ML tools - Decision Trees (DT) and Random Forest (RF) - were applied to identify the determinants of patient’s perceptions about telemedicine; the produced RF ranking displays two indicators: %IncMSE and IncNodePurity. Results Nine hundred and seventy-eight IBD patients (women 58.9%) from every Italian region completed the questionnaire. Among the respondents, 87 (8.9%) personally had a telemedicine experience; 153 reported that their Centre performed a telemedicine service during the COVID-19 pandemic (24.2% televisits, 39.2% e-mails, 24.8% phone-calls, 3.9 % dedicated website, 7.9% others). Overall, 707 (72.3%) would trust a telemedicine service, 760 (77.7%) would like to have it also with another HCP (e.g., nutritionist, psychologist) and 778/961 (81%) would like to use telemedicine in the future (17 did not answer to this specific question); 792 (81%) stated they thought useful to have the possibility to use telemedicine and 847 (86.6%) would like their Centre to offer them this facility. Considering this last question as the output at the DT, the variable which have been found to influence the most this patients’ willingness is patient’s perception of the usefulness of telemedicine in treating their disease, since it represented the root of the tree explaining the results. The RF rankings confirmed that this variable influenced the most patients’ perception with the highest levels of %IncMSE and IncNodePurity(Figure 1). Conclusion The practice of telemedicine in the management of IBD patients has not been very relevant throughout Italy so far (less than 10%), but more than four every five respondents would like to use telemedicine. Machine learning analysis shows that the perceived usefulness of telemedicine service is the key point for patients who would like it was a part of usual clinical practice.
We present a measurement of the W boson mass in W-->e(nu) decays using 1 fb-1 of data collected with the D0 detector during Run II of the Fermilab Tevatron collider. With a sample of 499830 W-->e(nu) candidate events, we measure M(W)=80.401+/-0.043 GeV. This is the most precise measurement from a single experiment.
This Letter reports the observation of WWW production and a measurement of its cross section using 139 fb^{-1} of proton-proton collision data recorded at a center-of-mass energy of 13 TeV by the ATLAS detector at the Large Hadron Collider. Events with two same-sign leptons (electrons or muons) and at least two jets, as well as events with three charged leptons, are selected. A multivariate technique is then used to discriminate between signal and background events. Events from WWW production are observed with a significance of 8.0 standard deviations, where the expectation is 5.4 standard deviations. The inclusive WWW production cross section is measured to be 820±100 (stat)±80 (syst) fb, approximately 2.6 standard deviations from the predicted cross section of 511±18 fb calculated at next-to-leading-order QCD and leading-order electroweak accuracy.
The mass of the W boson, a mediator of the weak force between elementary particles, is tightly constrained by the symmetries of the standard model of particle physics. The Higgs boson was the last missing component of the model. After observation of the Higgs boson, a measurement of the W boson mass provides a stringent test of the model. We measure the W boson mass, M W , using data corresponding to 8.8 inverse femtobarns of integrated luminosity collected in proton-antiproton collisions at a 1.96 tera–electron volt center-of-mass energy with the CDF II detector at the Fermilab Tevatron collider. A sample of approximately 4 million W boson candidates is used to obtain M W = 80 , 433.5 ± 6.4 stat ± 6.9 syst = 80 , 433.5 ± 9.4 MeV / c 2 , the precision of which exceeds that of all previous measurements combined (stat, statistical uncertainty; syst, systematic uncertainty; MeV, mega–electron volts; c , speed of light in a vacuum). This measurement is in significant tension with the standard model expectation.
This letter presents a search for narrow, high-mass resonances in the Zγ final state with the Z boson decaying into a pair of electrons or muons. The s=13 TeV pp collision data were recorded by the ATLAS detector at the CERN Large Hadron Collider and have an integrated luminosity of 140 fb−1. The data are found to be in agreement with the Standard Model background expectation. Upper limits are set on the resonance production cross section times the decay branching ratio into Zγ. For spin-0 resonances produced via gluon–gluon fusion, the observed limits at 95% confidence level vary between 65.5 fb and 0.6 fb, while for spin-2 resonances produced via gluon–gluon fusion (or quark–antiquark initial states) limits vary between 77.4 (76.1) fb and 0.6 (0.5) fb, for the mass range from 220 GeV to 3400 GeV.
s of the 27th National Congress of Digestive Diseases / Digestive and Liver Disease 53S3 (2021) S87–S219 S159 Gastroenterology, Bologna, Italy, 14UO Gastroenterologia AOUP, Chirurgia Generale, Pisa, Italy, 15Department of Health Promotion SciencesMaternal and Infant CareInternal Medicine and Excellence Specialties “G. D’Alessandro”, Palermo, Italy Background and aim: Vaccine hesitancy, the delay in acceptance or refusal of vaccination despite its availability, threatens the control of infectious diseases. COVID-19 vaccination has been recommended by national and international organizations in patients with Inflammatory Bowel Diseases (IBD). The aim of the study was to evaluate COVID-19 vaccine hesitancy in a population of Italian patients with IBD. Materials and methods: In February 2021 an online questionnaire focused on COVID-19 vaccine was proposed to a representative sample of Italian IBD patients. Socio-demographic characteristics, IBD features, lifestyle, perception of COVID-19, general attitude towards vaccinations and to COVID-19 vaccines were investigated. Patients were divided into willing, hesitant and refusive towards COVID-19 vaccine. The hesitation reasons were investigated. The associations between baseline characteristics and willingness (determinants) were evaluated by calculating crude and adjusted Odds Ratio (AdjOR) with 95% confidence intervals (CI). Results: A total of 1252 surveys were collected. 1005 (80.3%), 222 (18.1%) and 33 (2.63%) patients were defined as willing, hesitant and refusive, respectively. The baseline characteristics are shown below. Concerns for vaccine adverse effects constituted the main reason for refusal (73.4%) (Figure). 49.1% of hesitant patients reported that presence of IBD exerted an influence on their answer. Among the patients willing to be vaccinated whenever possible, 78.2% (786) thought that their IBD represented a valid motivation to access vaccination with priority. Willingness to COVID-19 vaccine was significantly associated with adherence to previous vaccinations (AdjOR 17.6; 95% CI: 11.4-27.2), male gender (1.68 95%; CI: 1.16-2.43), graduation degree (1.48; 95%; CI: 1.03-2.13), perceived higher risk of COVID-19 becaues of IBD (1.47; 95% CI: 1.05-2.08), alcohol intake (1.69; 95% CI: 1.16-2.45). Conversely, the hesitancy was significantly associated with complementary and alternative medicine use (0.58; 95% CI: 0.36-0.92). 54.5% of patients were under the impression to have a higher risk of COVID-19 and 31.8% to have a more severe course due to their IBD. Conclusions: Most IBD patients would accept COVID-19 vaccines, although one in five was hesitant, primarily due to fear of adverse events. Knowledge of determinants and reasons for COVID-19 vaccination acceptance or refusal could be key in developing targeted communication strategies to fight vaccine hesitancy, also in the future for general vaccinations. AF.50 SAFETY AND CLINICAL EFFICACY OF THE DOUBLE SWITCH FROM ORIGINATOR INFLIXIMAB TO BIOSIMILARS CT-P13 AND SB2 IN PATIENTS WITH INFLAMMATORY BOWEL DISEASES (SCESICS): A MULTICENTER COHORT STUDY Mazza S.1, Piazza O Sed N.*1, Conforti F.S.1, Fascì A.1, Casini V.2, Ricci C.3, Munari F.3, Pirola L.4, Invernizzi P.4, Girelli C.5, Lupinacci G.6, Pastorelli L.7, Cavallaro F.1, Ferraris L.8, Colucci A.8, Amato A.9, Tontini G.E.1, Vecchi M.10, Fiorino G.11, Caprioli F.10 1Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Gastroenterology and Endoscopy Unit, Milan, Italy, 2Gastroenterology Unit, Bolognini Hospital, Seriate, Bergamo, Italy, 3Department of Clinical and Experimental Sciences, University of Brescia, Spedali Civili, Brescia, Italy, 4Division of Gastroenterology and Center for Autoimmune Liver Diseases, Department of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy, 5Gastroenterology and Digestive Endoscopy Unit, Busto Arsizio Hospital, Varese, Italy, 6Gastroenterology and Endoscopy Unit, Ospedale Maggiore, Crema, Italy, 7Gastroenterology and Liver Unit, ASST Santi Paolo e Carlo, Ospedale San Paolo, Milan, Italy, 8Gastroenterology and Endoscopy Unit, Gallarate Hospital, Varese, Italy, 9Gastroenterology and Digestive Endoscopy Unit, Valduce Hospital, Como, Italy, 10Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Milan, Italy, 11IBD Center, Humanitas Clinical and Research Center, Rozzano, Milan, Italy Background and aim: Data regarding multiple therapeutic switching from originator infliximab (IFX) to IFX biosimilars in inflammatory bowel diseases (IBD) are lacking. The aim was to evaluate the safety and efficacy of double switch from originator IFX to CT-P13 and subsequently to SB2 in patients with IBD. Materials and methods: Patients undergoing IFX-double switch in 8 Centers in Lombardy (Italy) from November 2018 to May 2019 were retrospectively analyzed. Infliximab discontinuation rate, incidence and type of adverse events (AEs), and clinical remission rate were recorded. A comparison with a control group of IBD patients single-switched from originator IFX to CT-P13 was performed, before and after an inverse probability of treatment weighting (IPTW)based propensity score analysis. Results: Fifty-two double-switched IBD patients were enrolled. The 24and 48-week proportions of patients on IFX therapy following second switch (CTP13 SB2) were 98% (95% CI 94%-100%) and 86% (95% CI 75%-97%), respectively. Four patients experienced a total of 5 AEs, all graded 1-3 according to Common Terminology Criteria for Adverse Events (CTCAE). No infusion reactions were observed. The 24-week and follow-up-end clinical remission rates following second switch were 94% and 92%, respectively. No differences were observed in the safety and efficacy outcomes by comparing the double-switch group with a single-switch group of 66 IBD patients; all these results were confirmed by IPTW-adjusted analysis. Conclusions: Conclusions: The study suggests both the safety and efficacy of the double switch from originator IFX to CT-P13 and SB2 in patients with IBD and demonstrates its non-inferiority to a singleswitch strategy, with potential cost implications.
At the Fermilab Tevatron proton-antiproton ($p\bar{p}$) collider, high-mass electron-neutrino ($e\nu$) pairs are produced predominantly in the process $p \bar{p} \rightarrow W(\rightarrow e\nu) + X$. The asymmetry of the electron and positron yield as a function of their pseudorapidity constrain the slope of the ratio of the $u$- to $d$-quark parton distributions versus the fraction of the proton momentum carried by the quarks. This paper reports on the measurement of the electron-charge asymmetry using the full data set recorded by the Collider Detector at Fermilab in 2001--2011 and corresponding to 9.1~fb$^{-1}$ of integrated luminosity. The measurement significantly improves the precision of the Tevatron constraints on the parton-distribution functions of the proton. Numerical tables of the measurement are provided.
Abstract Background Vaccine hesitancy, the delay in acceptance or refusal of vaccination despite its availability, represents a threat to the diffusion and lethality of infectious diseases. COVID-19 vaccination has been recommended by national and international organizations in patients with Inflammatory Bowel Diseases (IBD). The aim of the study was to evaluate COVID-19 vaccine willingness and hesitancy in a population of Italian patients with IBD, and their determinants. Methods In February 2021 an online questionnaire focused on COVID-19 vaccine was proposed to a representative sample of Italian IBD patients. Socio-demographic characteristics, IBD features, lifestyle, perception of COVID-19, general attitude towards vaccinations and to COVID-19 vaccines were investigated. Patients were divided into willing, hesitant and refusive towards COVID-19 vaccine. The hesitation reasons were investigated. The associations between baseline characteristics and willingness (determinants) were evaluated by calculating crude and adjusted Odds Ratio (AdjOR) with 95% confidence intervals (CI). Results The baseline characteristics are shown below. 1252 surveys were collected. 1005 (80.3%), 222 (18.1%) and 33 (2.63 %) patients were defined as willing, hesitant and refusive, respectively. Concerns for vaccine adverse effects constituted the main reason for refusal (73.4%) (Figure). 49.1% of hesitant patients reported that presence of IBD exerted an influence on their answer. Among the patients willing to be vaccinated whenever possible, 78.2% (786) thought that their IBD represented a valid motivation to access vaccination with priority. Willingness to COVID-19 vaccine was significantly associated with adherence to previous vaccinations (AdjOR 17.6, 95% CI 11.4–27.2), male gender (1.68 95% CI 1.16–2.43), graduation degree (1.48, 95% CI 1.03–2.13), perceived higher risk of COVID-19 due to IBD (1.47, 95% CI 1.05–2.08), alcohol intake (1.69, 95% CI 1.16–2.45). Conversely, the hesitancy was significantly associated with use of complementary and alternative medicines (0.58, 95% CI 0.36–0.92). Notably, 54.5% of patients were under the impression to have a higher risk of COVID-19 and 31.8% a more severe course due to their IBD. Age, years, median (IQR) 48 (37–58) Female, n (%) 729 (58.2%) Disease type, n (%) -CD 613 (48.9%) -UC 612 (48.9%) Disease duration, n (%) -≤ 5 years 161 (12.9%) -> 5 years 1,091 (87.1%) Past surgeries 475 (37.9%) Immunosuppressive drug 584 (46.7%) Conclusion Most IBD patients would accept COVID-19 vaccines, though one out of five is hesitant to date, principally due to fear of adverse events. The knowledge of determinants and reasons for COVID-19 vaccination acceptance could be a key element in developing targeted communication strategies to address vaccine hesitancy.
We report an observation of new bottom baryons produced in p (cid:1) p collisions at the Tevatron. Using 1 : 1 fb (cid:2) 1 of data collected by the CDF II detector, we observe four (cid:2) 0 b (cid:1) (cid:3) resonances in the fully reconstructed decay mode (cid:2) 0 b ! (cid:2) (cid:4) c (cid:1) (cid:2) , where (cid:2) (cid:4) c ! pK (cid:2) (cid:1) (cid:4) . We interpret these states as the (cid:3) (cid:5)(cid:1)(cid:6)(cid:3) b baryons and measure the following masses: m (cid:3) (cid:4) b (cid:7) 5807 : 8 (cid:4) 2 : 0 (cid:2) 2 : 2 (cid:5) stat : (cid:6) (cid:3) 1 : 7 (cid:5) syst : (cid:6) MeV =c 2 , m (cid:3)