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1.
Gut ; 2022.
Article in English | ProQuest Central | ID: covidwho-2161876

ABSTRACT

ObjectivesThe long-term consequences of COVID-19 infection on the gastrointestinal tract remain unclear. Here, we aimed to evaluate the prevalence of gastrointestinal symptoms and post-COVID-19 disorders of gut–brain interaction after hospitalisation for SARS-CoV-2 infection.DesignGI-COVID-19 is a prospective, multicentre, controlled study. Patients with and without COVID-19 diagnosis were evaluated on hospital admission and after 1, 6 and 12 months post hospitalisation. Gastrointestinal symptoms, anxiety and depression were assessed using validated questionnaires.ResultsThe study included 2183 hospitalised patients. The primary analysis included a total of 883 patients (614 patients with COVID-19 and 269 controls) due to the exclusion of patients with pre-existing gastrointestinal symptoms and/or surgery. At enrolment, gastrointestinal symptoms were more frequent among patients with COVID-19 than in the control group (59.3% vs 39.7%, p<0.001). At the 12-month follow-up, constipation and hard stools were significantly more prevalent in controls than in patients with COVID-19 (16% vs 9.6%, p=0.019 and 17.7% vs 10.9%, p=0.011, respectively). Compared with controls, patients with COVID-19 reported higher rates of irritable bowel syndrome (IBS) according to Rome IV criteria: 0.5% versus 3.2%, p=0.045. Factors significantly associated with IBS diagnosis included history of allergies, chronic intake of proton pump inhibitors and presence of dyspnoea. At the 6-month follow-up, the rate of patients with COVID-19 fulfilling the criteria for depression was higher than among controls.ConclusionCompared with controls, hospitalised patients with COVID-19 had fewer problems of constipation and hard stools at 12 months after acute infection. Patients with COVID-19 had significantly higher rates of IBS than controls.Trial registration numberNCT04691895.

2.
The American Journal of Gastroenterology ; 117(10S):e521-e522, 2022.
Article in English | ProQuest Central | ID: covidwho-2111053

ABSTRACT

Introduction: Upadacitinib(UPA), has shown superior efficacy to placebo(PBO) in patients with moderate to severe active ulcerative colitis(UC) in two Phase 3 induction studies .1,2 Patients demonstrating clinical response per Adapted Mayo score with UPA 45mg once daily(QD) after 8 weeks(wks) induction were enrolled to U-ACHIEVE Maintenance. Methods: U-ACHIEVE Maintenance efficacy data from the intent-to-treat(ITT) population, defined as UPA 45mg QD 8wk induction responders enrolled per protocol for 52wk maintenance, and safety data from the safety population, defined as patients who received ≥1 dose of study therapy(ITT plus patients receiving up to 44wksmaintenanceper prior versions of protocol amendments). Non-responder imputation incorporating multiple imputations to handle missing data due to COVID-19 was used. a Based on adjusted Cochran–Mantel–Haenszel test adjusted for strata (corticosteroid use at Week 0 (yes or no), clinical remission status at Week 0 (yes or no), biologic-IR status at baseline (biologic-IR or non-biologic-IR)). b Per Adapted Mayo score ≤2: stool frequency subscore ≤1 and not greater than induction baseline, RBS=0, and ES ≤1. c Maintenance of clinical response, defined as a decrease in Adapted Mayo score ≥2 and ≥30% from induction baseline, plus a decrease in RBS ≥1 or an absolute RBS ≤1, at Week 52 among patients who achieved clinical response at the end of the induction therapy. d ES ≤1. e Maintenance of CR at Week 52 among patients with CR at the end of the induction therapy. f CR at Week 52 and corticosteroid-free for ≥90 days prior to Week 52 among patients with CR at the end of the induction therapy. g Endoscopic improvement at Week 52 among patients with endoscopic improvement at the end of the induction therapy. h ES=0. i ES ≤1 and Geboes score ≤3.1. j ES=0 and Geboes score < 2.0.

3.
The American Journal of Gastroenterology ; 117(10S):e497-e498, 2022.
Article in English | ProQuest Central | ID: covidwho-2111047

ABSTRACT

Introduction: In patients with moderate to severe Crohn's disease (CD), the ADVANCE and MOTIVATE phase 3 induction studies showed intravenous (IV) risankizumab (RZB), an anti-p19 interleukin-23 inhibitor, to be superior to placebo (PBO) for achieving clinical and endoscopic endpoints at Week (Wk) 12.1 Here, we evaluated the long-term efficacy and safety of RZB during the FORTIFY maintenance study in patients with delayed clinical response to IV RZB induction. [...]patients receiving RZB SC (180 mg or 360 mg) also achieved endoscopic response (36.7%, 45.5%), endoscopic remission (40.0%, 42.4%), deep remission (40.0%, 39.4%), ulcer free endoscopy (27.6%, 24.2%), and the combined endpoint of SF/APS clinical remission + endoscopic response (23.3%, 36.4%). [...]a dose-response trend was observed, with numerically higher response rates observed with RZB 360 mg SC relative to 180 mg SC for most outcomes, including clinical remission (CDAI and SF/APS), CDAI clinical response, enhanced clinical response, endoscopic response, endoscopic remission, and the composite endpoint of SF/APS clinical remission + endoscopic response. Efficacy and Safety after 52-Weeks Maintenance SC RZB Dosing in Delayed Responders (NRI-NCa) Responder Group Treatment Group, n (%) [95% CI] CDAI Clinical Response Enhanced Clinical Response CDAI Clinical Remission SF/APS Clinical Remission Endoscopic Response Ulcer Free Endoscopy Endoscopic Remission SF/APS Clinical Remission and Endoscopic Response Deep Remission RZB 180 mg SC delayed responders, Wk 24 53.3 (6/30) [35.5, 71.2] 56.7 (17/30) [38.9, 74.4] 53.3 (16/30) [35.5, 71.2] 43.3 (13/30) [25.6, 61.1] 36.7 (11/30) [19.4, 53.9] 27.6 (8/29) [11.3, 43.9] 40.0 (12/30) [22.5, 57.5] 23.3 (7/30) [8.2, 38.5] 40.0 (12/30) [22.5, 57.5] RZB 360 mg SC delayed responders, Wk 24 75.8 (25/33) [61.1, 90.4] 66.7 (22/33) [50.6, 82.8] 66.7 (22/33) [50.6, 82.8] 54.5 (18/33) [37.6, 71.5] 45.5 (15/33) [28.5, 62.4] 24.2 (8/33) [9.6, 38.9] 42.4 (14/33) [25.6, 59.3] 36.4 (12/33) [20.0, 52.8] 39.4 (13/33) [22.7, 56.1] Responder Group Treatment Group, (E/100PYs) Deaths Serious infections All treatment emergent adverse events AE related to COVID-19 Serious AE Hepatic events Injection site reactions AE leading to discontinuation of study drug Crohn's Disease RZB 180 mg SC (N=31) (PYs=27.5) delayed responders, Wk 24 0 0 132 (479.8) 0 6 (21.8) 0 6 (21.8) 2 (7.3) 7 (25.4) RZB 360 mg SC (N=33) (PYs=32.1) delayed responders, Wk 24 0 1 (3.1) 83 (258.9) 0 4 (12.5) 1 (3.1) 2 (6.2) 0 7 (21.8)

4.
Curr Drug Targets ; 2022 09 22.
Article in English | MEDLINE | ID: covidwho-2054725

ABSTRACT

SARS-CoV-2 is a novel coronavirus expanded worldwide, generating a pandemic of acute respiratory syndrome called "coronavirus disease 2019" (COVID-19), which resulted in a global health crisis. The spectrum of COVID-19 manifestations ranges from none or mild symptoms to severe respiratory failure associated with systemic manifestations, mostly gastrointestinal symptoms. Hypercoagulability is an important feature of COVID-19 disease, which can potentially influence patients' prognosis. Therefore, gastroenterologists should focus on subjects with concomitant hypercoagulable gastrointestinal disorders as they may display a higher risk of thrombotic complications during SARS-CoV-2 infection. The aim of this review is to summarize the available evidence regarding the interplay of the prothrombotic pathogenetic mechanisms of both COVID-19 and hypercoagulable digestive diseases and the possible clinical implications. We summarized the potential interplay of prothrombotic mechanismsof both COVID-19 and hypercoagulable digestive diseases in the graphical abstract.

5.
Clin Gastroenterol Hepatol ; 18(13): 3055, 2020 12.
Article in English | MEDLINE | ID: covidwho-1382281

Subject(s)
COVID-19 , Diarrhea , Humans , SARS-CoV-2
6.
J Multidiscip Healthc ; 15: 815-824, 2022.
Article in English | MEDLINE | ID: covidwho-1896596

ABSTRACT

Systemic sclerosis (SSc) is a rare connective tissue disease characterised by immune dysfunction, vascular damage and fibrosis affecting the skin and multiple internal organs. The clinical spectrum of SSc is wide and its manifestations may lead to severe morbidity and mortality, in addition to a great impact on patients' quality of life. Due to the multifaceted clinical manifestations of SSc, its management requires a combined expertise of different medical specialists to guarantee an adequate disease control and prevent organ complications. Multi-disciplinary teams (MDT), which are composed by physicians and other specialized health professionals, represent therefore a key element for the comprehensive management of SSc patients. Moreover, MTD can improve communication and patients' empowerment while the presence of dedicated nurses can help patients to ask questions about their condition. The scope of this narrative review is to analyse the available evidences regarding the role of MDT in the management of SSc patients, and how this holistic approach may improve different disease domains and the overall prognosis. MDT regarding the cardiovascular and lung complication are the more represented in literature, given the great impact in prognosis. Nonetheless, MDT have been shown to be fundamental also in other disease domains as they can intercept early manifestations, thus stratifying patients based on the individual risks in order to personalize patients' follow-up. MDTs may also minimize the treatment delay, enabling fast-track specialist referral. On the other hand, there are few trials specifically studying MDT in SSc and several authors have highlight the lack of standardization.

7.
Lancet ; 399(10340): 2015-2030, 2022 05 28.
Article in English | MEDLINE | ID: covidwho-1895514

ABSTRACT

BACKGROUND: Risankizumab, an interleukin (IL)-23 p19 inhibitor, was evaluated for safety and efficacy as induction therapy in patients with moderately to severely active Crohn's disease. METHODS: ADVANCE and MOTIVATE were randomised, double-masked, placebo-controlled, phase 3 induction studies. Eligible patients aged 16-80 years with moderately to severely active Crohn's disease, previously showing intolerance or inadequate response to one or more approved biologics or conventional therapy (ADVANCE) or to biologics (MOTIVATE), were randomly assigned to receive a single dose of intravenous risankizumab (600 mg or 1200 mg) or placebo (2:2:1 in ADVANCE, 1:1:1 in MOTIVATE) at weeks 0, 4, and 8. We used interactive response technology for random assignment, with stratification by number of previous failed biologics, corticosteroid use at baseline, and Simple Endoscopic Score for Crohn's disease (SES-CD). All patients and study personnel (excluding pharmacists who prepared intravenous solutions) were masked to treatment allocation throughout the study. Coprimary endpoints were clinical remission (defined by Crohn's disease activity index [CDAI] or patient-reported outcome criteria [average daily stool frequency and abdominal pain score]) and endoscopic response at week 12. The intention-to-treat population (all eligible patients who received at least one dose of study drug in the 12-week induction period) was analysed for efficacy outcomes. Safety was assessed in all patients who received at least one dose of study drug. Both trials were registered on ClinicalTrials.gov, NCT03105128 (ADVANCE) and NCT03104413 (MOTIVATE), and are now complete. FINDINGS: Participants were enrolled between May 10, 2017, and Aug 24, 2020 (ADVANCE trial), and Dec 18, 2017 and Sept 9, 2020 (MOTIVATE trial). In ADVANCE, 931 patients were assigned to either risankizumab 600 mg (n=373), risankizumab 1200 mg (n=372), or placebo (n=186). In MOTIVATE, 618 patients were assigned to risankizumab 600 mg (n=206), risankizumab 1200 mg (n=205), or placebo (n=207). The primary analysis population comprised 850 participants in ADVANCE and 569 participants in MOTIVATE. All coprimary endpoints at week 12 were met in both trials with both doses of risankizumab (p values ≤0·0001). In ADVANCE, CDAI clinical remission rate was 45% (adjusted difference 21%, 95% CI 12-29; 152/336) with risankizumab 600 mg and 42% (17%, 8-25; 141/339) with risankizumab 1200 mg versus 25% (43/175) with placebo; stool frequency and abdominal pain score clinical remission rate was 43% (22%, 14-30; 146/336) with risankizumab 600 mg and 41% (19%, 11-27; 139/339) with risankizumab 1200 mg versus 22% (38/175) with placebo; and endoscopic response rate was 40% (28%, 21-35; 135/336) with risankizumab 600 mg and 32% (20%, 14-27; 109/339) with risankizumab 1200 mg versus 12% (21/175) with placebo. In MOTIVATE, CDAI clinical remission rate was 42% (22%, 13-31; 80/191) with risankizumab 600 mg and 40% (21%, 12-29; 77/191) with risankizumab 1200 mg versus 20% (37/187) with placebo; stool frequency and abdominal pain score clinical remission rate was 35% (15%, 6-24; 66/191) with risankizumab 600 mg and 40% (20%, 12-29; 76/191) with risankizumab 1200 mg versus 19% (36/187) with placebo; and endoscopic response rate was 29% (18%, 10-25; 55/191) with risankizumab 600 mg and 34% (23%, 15-31; 65/191) with risankizumab 1200 mg versus 11% (21/187) with placebo. The overall incidence of treatment-emergent adverse events was similar among the treatment groups in both trials. Three deaths occurred during induction (two in the placebo group [ADVANCE] and one in the risankizumab 1200 mg group [MOTIVATE]). The death in the risankizumab-treated patient was deemed unrelated to the study drug. INTERPRETATION: Risankizumab was effective and well tolerated as induction therapy in patients with moderately to severely active Crohn's disease. FUNDING: AbbVie.


Subject(s)
Biological Products , Crohn Disease , Abdominal Pain , Antibodies, Monoclonal , Biological Products/therapeutic use , Crohn Disease/drug therapy , Humans , Induction Chemotherapy
8.
Lancet ; 399(10341): 2113-2128, 2022 06 04.
Article in English | MEDLINE | ID: covidwho-1878425

ABSTRACT

BACKGROUND: There is a great unmet need for advanced therapies that provide rapid, robust, and sustained disease control for patients with ulcerative colitis. We assessed the efficacy and safety of upadacitinib, an oral selective Janus kinase 1 inhibitor, as induction and maintenance therapy in patients with moderately to severely active ulcerative colitis. METHODS: This phase 3, multicentre, randomised, double-blind, placebo-controlled clinical programme consisted of two replicate induction studies (U-ACHIEVE induction [UC1] and U-ACCOMPLISH [UC2]) and a single maintenance study (U-ACHIEVE maintenance [UC3]). The studies were conducted across Europe, North and South America, Australasia, Africa, and the Asia-Pacific region at 199 clinical centres in 39 countries (UC1), 204 clinical centres in 40 countries (UC2), and 195 clinical centres in 35 countries (UC3). Patients aged 16-75 years with moderately to severely active ulcerative colitis (Adapted Mayo score 5-9; endoscopic subscore 2 or 3) for at least 90 days were randomly assigned (2:1) to oral upadacitinib 45 mg once daily or placebo for 8 weeks (induction studies). Patients who achieved clinical response following 8-week upadacitinib induction were re-randomly assigned (1:1:1) to upadacitinib 15 mg, upadacitinib 30 mg, or placebo for 52 weeks (maintenance study). All patients were randomly assigned using web-based interactive response technology. The primary endpoints were clinical remission per Adapted Mayo score at week 8 (induction) and week 52 (maintenance). The efficacy analyses in the two induction studies were based on the intent-to-treat population, which included all randomised patients who received at least one dose of treatment. In the maintenance study, the primary efficacy analyses reported in this manuscript were based on the first 450 (planned) clinical responders to 8-week induction therapy with upadacitinib 45 mg once daily. The safety analysis population in the induction studies consisted of all randomised patients who received at least one dose of treatment; in the maintenance study, this population included all patients who received at least one dose of treatment as part of the primary analysis population. These studies are registered at ClinicalTrials.gov, NCT02819635 (U-ACHIEVE) and NCT03653026 (U-ACCOMPLISH). FINDINGS: Between Oct 23, 2018, and Sept 7, 2020, 474 patients were randomly assigned to upadacitinib 45 mg once daily (n=319) or placebo (n=155) in UC1. Between Dec 6, 2018, and Jan 14, 2021, 522 patients were randomly assigned to upadacitinib 45 mg once daily (n=345) or placebo (n=177) in UC2. In UC3, a total of 451 patients (21 from the phase 2b study, 278 from UC1, and 152 from UC2) who achieved a clinical response after 8 weeks of upadacitinib induction treatment were randomly assigned again to upadacitinib 15 mg (n=148), upadacitinib 30 mg (n=154), and placebo (n=149) in the primary analysis population. Statistically significantly more patients achieved clinical remission with upadacitinib 45 mg (83 [26%] of 319 patients in UC1 and 114 [34%] of 341 patients in UC2) than in the placebo group (seven [5%] of 154 patients in UC1 and seven [4%] of 174 patients; p<0·0001; adjusted treatment difference 21·6% [95% CI 15·8-27·4] for UC1 and 29·0% [23·2-34·7] for UC2). In the maintenance study, clinical remission was achieved by statistically significantly more patients receiving upadacitinib (15 mg 63 [42%] of 148; 30 mg 80 [52%] of 154) than those receiving placebo (18 [12%] of 149; p<0·0001; adjusted treatment difference 30·7% [21·7-39·8] for upadacitinib 15 mg vs placebo and 39·0% [29·7-48·2] for upadacitinib 30 mg vs placebo). The most commonly reported adverse events in UC1 were nasopharyngitis (15 [5%] of 319 in the upadacitinib 45 mg group vs six [4%] of 155 in the placebo group), creatine phosphokinase elevation (15 [4%] vs three [2%]), and acne (15 [5%] vs one [1%]). In UC2, the most frequently reported adverse event was acne (24 [7%] of 344 in the upadacitinib 45 mg group vs three [2%] of 177 in the placebo group). In both induction studies, serious adverse events and adverse events leading to discontinuation of treatment were less frequent in the upadacitinib 45 mg group than in the placebo group (serious adverse events eight [3%] vs nine (6%) in UC1 and 11 [3%] vs eight [5%] in UC2; adverse events leading to discontinuation six [2%] vs 14 [9%] in UC1 and six [2%] vs nine [5%] in UC2). In UC3, the most frequently reported adverse events (≥5%) were worsening of ulcerative colitis (19 [13%] of 148 in the upadacitinib 15 mg group vs 11 [7%] of 154 in the upadacitinib 30 mg group vs 45 [30%] of 149 in the placebo group), nasopharyngitis (18 [12%] vs 22 [14%] vs 15 [10%]), creatine phosphokinase elevation (nine [6%] vs 13 [8%] vs three [2%]), arthralgia (nine [6%] vs five [3%] vs 15 [10%]), and upper respiratory tract infection (seven [5%] vs nine [6%] vs six [4%]). The proportion of serious adverse events (ten [7%] vs nine [6%] vs 19 [13%]) and adverse events leading to discontinuation (six [4%] vs ten [6%] vs 17 [11%]) was lower in both upadacitinib groups than in the placebo group. Events of cancer, adjudicated major adverse cardiac events, or venous thromboembolism were reported infrequently. There were no treatment-related deaths. INTERPRETATION: Upadacitinib demonstrated a positive efficacy and safety profile and could be an effective treatment option for patients with moderately to severely active ulcerative colitis. FUNDING: AbbVie.


Subject(s)
Acne Vulgaris , Colitis, Ulcerative , Nasopharyngitis , Colitis, Ulcerative/drug therapy , Creatine Kinase , Double-Blind Method , Heterocyclic Compounds, 3-Ring , Humans , Severity of Illness Index , Treatment Outcome
9.
Arch Physiol Biochem ; : 1-8, 2022 May 26.
Article in English | MEDLINE | ID: covidwho-1864883

ABSTRACT

Context: Patients with inflammatory bowel disease (IBD) were found to have the higher intestinal expression of Angiotensin-Converting Enzyme2 (ACE2) that could consequently increase susceptibility to COVID-19 infection.Objective: This study reports the outcomes of COVID-19 infection in a large cohort of IBD patients. We compare levels of serum ACE and IFN-α between COVID19 patients with and without IBD. We performed a cross-sectional retrospective multicenter study.Methods: We enrolled patients with IBD screened for SARS-COV-2 in six medical centres in Iran from June to November 2020. The blood samples were drawn to measure COVID-19 IgM and IgG, and serum levels of sACE2, sACE1, and interferon-α, regardless of suspicious symptoms have done the molecular test.Results: A total of 534 IBD patients were included in the study. Of these, 109 (20.0%) cases had detectable IgG and IgM against SARS-CoV-2. sACE2 levels were higher in IBD patients than controls, whereas ACE1and IFN-α levels were similar among groups.

10.
Biomedicines ; 10(4)2022 Apr 03.
Article in English | MEDLINE | ID: covidwho-1776130

ABSTRACT

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has raised concerns in patients with inflammatory bowel disease (IBD), not only due to consequences of coronavirus disease 2019 itself but also as a possible cause of IBD relapse. The main objective of this study was to assess the role of SARS-CoV-2 in IBD clinical recurrence in a cohort of patients undergoing biological therapy. Second, we evaluated the difference in C-reactive protein (CRP) levels between the start and end of the follow-up period (ΔCRP) and the rate of biological therapy discontinuation. Patients with IBD positive for SARS-CoV-2 infection were compared with non-infected patients. IBD recurrence was defined as the need for intensification of current therapy. We enrolled 95 IBD patients with SARS-CoV-2 infection and 190 non-infected patients. During follow-up, 11 of 95 (11.6%) SARS-CoV-2-infected patients experienced disease recurrence compared to 21 of 190 (11.3%) in the control group (p = 0.894). Forty-six (48.4%) SARS-CoV-2-infected patients discontinued biological therapy versus seven (3.7%) in the control group (p < 0.01). In the multivariate analysis, biological agent discontinuation (p = 0.033) and ΔCRP (p = 0.017), but not SARS-CoV-2 infection (p = 0.298), were associated with IBD recurrence. SARS-CoV-2 infection was not associated with increased IBD recurrence rates in this cohort of patients treated with biological agents.

12.
Aliment Pharmacol Ther ; 55(6): 658-669, 2022 03.
Article in English | MEDLINE | ID: covidwho-1672990

ABSTRACT

BACKGROUND: Recruitment rates for Crohn's disease and ulcerative colitis clinical trials continue to decrease annually. The inability to reach recruitment targets and complete trials has serious implications for stakeholders in the inflammatory bowel disease (IBD) community. Action is required to ensure patients with an unmet medical need have access to new therapies to improve the management of their IBD. AIMS: Identify challenges contributing to recruitment decline in IBD clinical trials and propose potential solutions. METHODS: PubMed and Google were used to identify literature, regulatory guidelines and conference proceedings related to IBD clinical trials and related concepts. Data on IBD clinical trials conducted between 1989 and 2020 were extracted from the Trialtrove database. RESULTS: Key aspects that may improve recruitment rates were identified. An increasingly patient-centric approach should be taken to study design including improvements to the readability of key trial documentation and inclusion of patient representatives in trial planning. Placebo is unappealing to patients; approaches including platform trials should be explored to minimise placebo exposure. Non-invasive imaging, biomarkers and novel digital endpoints should continue to be examined to reduce the burden on patients. Reducing the administrative burden associated with trials via the use of electronic signatures, for example, may benefit study sites and investigators. Changes implemented to IBD trials during the COVID-19 pandemic provided examples of how trial conduct can be rapidly and constructively adapted. CONCLUSIONS: To improve recruitment in Crohn's disease and ulcerative colitis trials, the IBD community should address a broad range of issues related to clinical trial conduct.


Subject(s)
COVID-19 , Colitis, Ulcerative , Inflammatory Bowel Diseases , Colitis, Ulcerative/drug therapy , Humans , Inflammatory Bowel Diseases/drug therapy , Pandemics , Randomized Controlled Trials as Topic , SARS-CoV-2
13.
Adv Ther ; 39(6): 2342-2364, 2022 06.
Article in English | MEDLINE | ID: covidwho-1607755

ABSTRACT

The coronavirus disease 2019 (COVID-19) pandemic has prompted significant changes in patient care in rheumatology and gastroenterology, with clinical guidance issued to manage ongoing therapy while minimising the risk of nosocomial infection for patients and healthcare professionals (HCPs). Subcutaneous (SC) formulations of biologics enable patients to self-administer treatments at home; however, switching between agents may be undesirable. CT-P13 SC is the first SC formulation of infliximab that received regulatory approval and may be termed a biobetter as it offers significant clinical advantages over intravenous (IV) infliximab, including improved pharmacokinetics and a convenient mode of delivery. Potential benefits in terms of reduced immunogenicity have also been suggested. With a new SC formulation, infliximab provides an additional option for dual formulation, which enables patients to transition from IV to SC administration route without changing agent. Before COVID-19, clinical trials supported the efficacy and safety of switching from IV to SC infliximab for patients with rheumatoid arthritis and inflammatory bowel disease (IBD), and SC infliximab may have been selected on the basis of patient and HCP preferences for SC agents. During the pandemic, patients with rheumatic diseases and IBD have successfully switched from IV to SC infliximab, with some clinical benefits and high levels of patient satisfaction. As patients switched to SC therapeutics, the reduction in resource requirements for IV infusion services may have been particularly welcome given the pandemic, facilitating reorganisation and redeployment in overstretched healthcare systems, alongside pharmacoeconomic benefits and a reduction in exposure to nosocomial infection. Telemedicine and contactless healthcare have been pushed to the forefront during the pandemic, and a lasting shift towards remote patient management and community/home-based drug administration is anticipated. SC infliximab supports the implementation of this paradigm for future improvements of healthcare value delivered. The accumulation of real-world data during the pandemic supports the high level of confidence, with patients, physicians, and healthcare systems benefitting from its uptake.


Subject(s)
Arthritis, Rheumatoid , Biosimilar Pharmaceuticals , COVID-19 , Cross Infection , Inflammatory Bowel Diseases , Arthritis, Rheumatoid/drug therapy , Biosimilar Pharmaceuticals/therapeutic use , Humans , Inflammatory Bowel Diseases/drug therapy , Infliximab/therapeutic use , Treatment Outcome
14.
The American Journal of Gastroenterology ; 116, 2021.
Article in English | ProQuest Central | ID: covidwho-1478570

ABSTRACT

Endpoints presented here are the percentage of patients in clinical remission at wk 8, per Adapted Mayo score, and the percentage of patients with a clinical response at wk 2, per partial Adapted Mayo score (both defined in Table footnotes), respectively, in patients who were on concomitant CS at baseline, at a dose maintained to the end of induction and in those treated with UPA without concomitant CS. Similar results were found with the clinical response rate at wk 2, with no difference between UPA-treated patients who received baseline CS (U-ACHIEVE: 58.1%;U-ACCOMPLISH: 55.1%) and those that received UPA without CS (U-ACHIEVE: 61.4%;U-ACCOMPLISH: 67.7%). Subjects were considered "non-responder" for binary endpoints at and after the UC-related corticosteroids censoring time point through the end of the Induction Study. † Dosing for main corticosteroids were as follows: prednisone. 10-40 mg QD, budesonide, 9 mg QD;or beclomethasone, 5 mg QD. § 95% CI for response rate is the synthetic result based on Student's t-distribution from PROC MIANALYZE procedure if there were missing data due to COVID-19 or is based on the normal approximation to the binomial distribution if there are no missing data due to COVID-19. ‡ 95% CI for response rate difference was calculated based on normal approximation to the binomial distribution.

15.
World J Gastroenterol ; 27(32): 5448-5459, 2021 Aug 28.
Article in English | MEDLINE | ID: covidwho-1379994

ABSTRACT

BACKGROUND: Intestinal ischemia has been described in case reports of patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) disease (coronavirus disease 19, COVID-19). AIM: To define the clinical and histological, characteristics, as well as the outcome of ischemic gastrointestinal manifestations of SARS-CoV-2 infection. METHODS: A structured retrospective collection was promoted among three tertiary referral centres during the first wave of the pandemic in northern Italy. Clinical, radiological, endoscopic and histological data of patients hospitalized for COVID-19 between March 1st and May 30th were reviewed. The diagnosis was established by consecutive analysis of all abdominal computed tomography (CT) scans performed. RESULTS: Among 2929 patients, 21 (0.7%) showed gastrointestinal ischemic manifestations either as presenting symptom or during hospitalization. Abdominal CT showed bowel distention in 6 patients while signs of colitis/enteritis in 12. Three patients presented thrombosis of main abdominal veins. Endoscopy, when feasible, confirmed the diagnosis (6 patients). Surgical resection was necessary in 4/21 patients. Histological tissue examination showed distinctive features of endothelial inflammation in the small bowel and colon. Median hospital stay was 9 d with a mortality rate of 39%. CONCLUSION: Gastrointestinal ischemia represents a rare manifestation of COVID-19. A high index of suspicion should lead to investigate this complication by CT scan, in the attempt to reduce its high mortality rate. Histology shows atypical feature of ischemia with important endotheliitis, probably linked to thrombotic microangiopathies.


Subject(s)
COVID-19 , Gastrointestinal Diseases , Humans , Pandemics , Retrospective Studies , SARS-CoV-2
16.
World J Gastroenterol ; 27(27): 4276-4297, 2021 Jul 21.
Article in English | MEDLINE | ID: covidwho-1344407

ABSTRACT

Over the past decades, the treatment of inflammatory bowel diseases (IBD) has become more targeted, anticipating the use of immune-modifying therapies at an earlier stage. This top-down approach has been correlated with favorable short and long-term outcomes, but it has also brought with it concerns regarding potential infectious complications. This large IBD population treated with immune-modifying therapies, especially if combined, has an increased risk of severe infections, including opportunistic infections that are sustained by viral, bacterial, parasitic, and fungal agents. Viral infections have emerged as a focal safety concern in patients with IBD, representing a challenge for the clinician: they are often difficult to diagnose and are associated with significant morbidity and mortality. The first step is to improve effective preventive strategies, such as applying vaccination protocols, adopt adequate prophylaxis and educate patients about potential risk factors. Since viral infections in immunosuppressed patients may present atypical signs and symptoms, the challenges for the gastroenterologist are to suspect, recognize and diagnose such complications. Appropriate treatment of common viral infections allows us to minimize their impact on disease outcomes and patients' lives. This practical review supports this standard of care to improve knowledge in this subject area.


Subject(s)
Colitis , Inflammatory Bowel Diseases , Opportunistic Infections , Virus Diseases , Humans , Immunocompromised Host , Inflammatory Bowel Diseases/epidemiology , Inflammatory Bowel Diseases/therapy , Opportunistic Infections/diagnosis , Opportunistic Infections/epidemiology , Opportunistic Infections/prevention & control , Virus Diseases/epidemiology
17.
Gastroenterology ; 160(6): 2223-2224, 2021 05.
Article in English | MEDLINE | ID: covidwho-1298861
18.
J Crohns Colitis ; 14(14 Suppl 3): S820, 2020 10 21.
Article in English | MEDLINE | ID: covidwho-1281856
20.
Expert Opin Biol Ther ; 22(1): 17-29, 2022 01.
Article in English | MEDLINE | ID: covidwho-1266067

ABSTRACT

INTRODUCTION: Major challenges have been posed by the coronavirus disease 2019 pandemic in the routine management of patients with inflammatory bowel disease (IBD). The need for constant monitoring of diseases activity and prompt adjustment of therapy have been balanced with the risk of contagion related to face-to-face consultations. Therefore, digital health initiatives have been pursued for safety reasons as vicarious instruments to avoid overcrowding of the IBD clinics. However, concerns and skepticism about the feasibility of digital health and telemedicine modalities limited their uptake in clinical practice in the pre-pandemic period. AREAS COVERED: We conducted a literature overview on the current state of the art and the potential future benefits deriving from the integration of telemedicine systems, home-based laboratory tests, and self-administered drugs into IBD daily practice. EXPERT OPINION: Digital health and telemedicine approaches at distance have been experimented as effective tools to avoid overcrowding of clinics and reduce risk from SARS-CoV2 exposure. Home-based point of care testing, such as fecal calprotectin and dried blood samples, might represent an effective method of remote monitoring of patients particularly when in-person visits are precluded. High expectations are placed on the use of self-administered advanced therapies, such as new subcutaneous formulation of biologics.


Subject(s)
COVID-19 , Inflammatory Bowel Diseases , Telemedicine , Humans , RNA, Viral , SARS-CoV-2
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