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1.
Lancet ; 401(10383): 1159-1171, 2023 04 08.
Article in English | MEDLINE | ID: covidwho-2303058

ABSTRACT

BACKGROUND: Etrasimod, a once-daily, oral, sphingosine 1-phosphate (S1P) receptor modulator that selectively activates S1P receptor subtypes 1, 4, and 5, with no detectable activity on S1P2,3, is in development for the treatment of immune-mediated diseases, including ulcerative colitis. In these two phase 3 trials, we aimed to evaluate the safety and efficacy of etrasimod in adult patients with moderately to severely active ulcerative colitis. METHODS: In two independent randomised, multicentre, double-blind, placebo-controlled, phase 3 trials, ELEVATE UC 52 and ELEVATE UC 12, adults with active moderate-to-severe ulcerative colitis and an inadequate or loss of response or intolerance to at least one approved ulcerative colitis therapy were randomly assigned (2:1) to once-daily oral etrasimod 2 mg or placebo. Patients in ELEVATE UC 52 were enrolled from 315 centres in 40 countries. Patients in ELEVATE UC 12 were enrolled from 407 centres in 37 countries. Randomisation was stratified by previous exposure to biologicals or Janus kinase inhibitor therapy (yes vs no), baseline corticosteroid use (yes vs no), and baseline disease activity (modified Mayo score [MMS]; 4-6 vs 7-9). ELEVATE UC 52 comprised a 12-week induction period followed by a 40-week maintenance period with a treat-through design. ELEVATE UC 12 independently assessed induction at week 12. The primary efficacy endpoints were the proportion of patients with clinical remission at weeks 12 and 52 in ELEVATE UC 52 and week 12 in ELEVATE UC 12. Safety was evaluated in both trials. ELEVATE UC 52 and ELEVATE UC 12 were registered with ClinicalTrials.gov, NCT03945188 and NCT03996369, respectively. FINDINGS: Patients in ELEVATE UC 52 were enrolled between June 13, 2019, and Jan 28, 2021. Patients in ELEVATE UC 12 were enrolled between Sept 15, 2020, and Aug 12, 2021. ELEVATE UC 52 and ELEVATE UC 12 screened 821 patients and 606 patients, respectively, with 433 and 354 subsequently undergoing random assignment. The full analysis set of ELEVATE UC 52 comprised 289 patients assigned to etrasimod and 144 to placebo. In ELEVATE UC 12, 238 patients were assigned to etrasimod and 116 to placebo. In ELEVATE UC 52, a significantly greater proportion of patients in the etrasimod group achieved clinical remission compared with patients in the placebo group at completion of the 12-week induction period (74 [27%] of 274 patients vs ten [7%] of 135 patients; p<0·0001) and at week 52 (88 [32%] of 274 patients vs nine [7%] of 135 patients; p<0·0001). In ELEVATE UC 12, 55 (25%) of 222 patients in the etrasimod group had clinical remission compared with 17 (15%) of 112 patients in the placebo group at the end of the 12-week induction period (p=0·026). Adverse events were reported in 206 (71%) of 289 patients in the etrasimod group and 81 (56%) of 144 patients in the placebo group in ELEVATE UC 52 and 112 (47%) of 238 patients in the etrasimod group and 54 (47%) of 116 patients in the placebo group in ELEVATE UC 12. No deaths or malignancies were reported. INTERPRETATION: Etrasimod was effective and well tolerated as an induction and maintenance therapy in patients with moderately to severely active ulcerative colitis. Etrasimod is a treatment option with a unique combination of attributes that might address the persistent unmet needs of patients with ulcerative colitis. FUNDING: Arena Pharmaceuticals.


Subject(s)
Colitis, Ulcerative , Janus Kinase Inhibitors , Adult , Humans , Colitis, Ulcerative/drug therapy , Colitis, Ulcerative/pathology , Acetates/therapeutic use , Indoles , Janus Kinase Inhibitors/therapeutic use , Double-Blind Method , Remission Induction , Treatment Outcome
2.
J Crohns Colitis ; 2022 Jun 29.
Article in English | MEDLINE | ID: covidwho-2227464

ABSTRACT

INTRODUCTION: There are concerns on the potential impact of the COVID-19 outbreak on patients with inflammatory bowel disease (IBD). AIM: To report the impact of the COVID-19 outbreak in a European prospective cohort study of patients with IBD. PATIENTS AND METHODS: We prospectively collected data from 5,457 patients with IBD nested in the ongoing I-CARE project and still followed up in April 2020, with monthly online monitoring of clinical activity, treatment, imaging and endoscopy. Investigators were also contacted to report incidental cases. RESULTS: In total, 233 (4.3%) reported COVID-19 and 12 (0.2%) severe COVID-19, with no COVID-19 deaths. The risk of COVID-19 in patients with IBD was not increased compared to the general population (SIR: 1.18 95%CI [1.03-1.34], p = 0.009), as well as the risk of severe COVID-19 (SIR: 0.69 95%CI [0.35-1.20], p = 0.93). We did not observe any negative impact of the different IBD-related medication on the risk of either COVID-19 or severe COVID-19. In 2020, the COVID-19 outbreak resulted in a drastic decrease in endoscopic and imaging procedures from March to May 2020 compared to 2018 and 2019. No impact on clinical IBD disease activity as well as ongoing treatment were noted. CONCLUSION: No increase in either COVID-19 or severe COVID-19 incidences were observed in patients with IBD. There was no impact of COVID-19 on IBD-related medication and clinical activity. Access to endoscopy and imaging was restricted during the first months of the first COVID-19 outbreak.

3.
The American Journal of Gastroenterology ; 117(10S):e672-e673, 2022.
Article in English | ProQuest Central | ID: covidwho-2111059

ABSTRACT

Introduction: The COVID-19 pandemic presented challenges around disease management, lifestyle changes, and provision of care for patients (pts) with ulcerative colitis (UC). The survey aimed to understand how the COVID-19 pandemic impacted pts with UC and assessed overall disease management, telehealth use, healthcare experience, perceived quality of care, emotional well-being, reliance on alternative support systems, and preferences for virtual/in-person interactions with doctors. Disease management before, during, and after the COVID-19 pandemic: reliance on alternative support systems for management of ulcerative colitis Prior to the pandemic During the pandemic Plan to do after the pandemic Have never done or plan to do Talked openly with their doctor about how their disease impacts their life 54% 54% 44% 17% Set goals with their doctor for managing their disease 48% 46% 40% 25% Communicated with a nurse at their doctor’s office between appointments 45% 40% 34% 32% Used an online patient portal to contact their doctor’s office or see lab results 31% 47% 33% 32% Used social media to connect with other patients or learn about ulcerative colitis 24% 39% 27% 46% Used symptom tracking or disease management apps 23% 31% 29% 48% Relied on information from patient advocacy groups 19% 27% 22% 54% Relied on patient support groups 15% 22% 22% 59% Had virtual appointments with their doctor 13% 55% 32% 31%

4.
The American Journal of Gastroenterology ; 117(10S), 2022.
Article in English | ProQuest Central | ID: covidwho-2111052

ABSTRACT

Introduction: Eligible patients(N=526) with moderate to severe active Crohn’s Disease(CD), defined as average daily stool frequency(SF)≥4 and/or abdominal pain score(APS)≥2, and a Simple Endoscopic Score for CD(SES-CD) (excluding the narrowing component subscore) ≥6(≥4 for subjects with isolated ileal disease). PBO % [95% CI] h Co-Primary Endpoints Clinical remission, wk 12  Per CDAI a  Per SF/APS b 29.1 [22.4, 35.8] 22.2 [16.0, 28.3] 49.5 [44.2, 54.8] 50.7 [45.5, 56.0] 20.8 [12.7, 28.8]** 28.7 [20.9, 36.4]** Endoscopic response c , wk 12 13.1 [8.1, 18.0] 45.5 [40.3, 50.8] 33.0 [26.2, 39.9]** Key Secondary Endpoints Clinical Remission, wk 4  Per CDAI a  Per SF/APS b 26.7 [20.2, 33.3] 14.8 [9.5, 20.0] 37.1 [32.1, 42.2] 35.7 [30.7, 40.7] 10.8 [2.9, 18.6]* 21.2 [14.3, 28.2]** Corticosteroid-free clinical remission, wk 12  per CDAI d  per SF/APS d (N=64) 15.7 [6.8, 24.7] 12.5 [4.4, 20.6] (N=126) 42.9 [34.2, 51.5] 44.4 [35.8, 53.1] 27.7 [15.7, 39.8]** 32.6 [21.5, 43.7]** Clinical Response CR-100 e  Week 2  Week 12 20.4 [14.4, 26.5] 37.3 [30.1, 44.5] 32.2 [27.3, 37.1] 56.6 [51.4, 61.8] 11.7 [4.2, 19.2]* 19.8 [11.3, 28.4]** Endoscopic remission f , wk 12 7.4 [3.5, 11.3] 28.9 [24.2, 33.7] 21.8 [15.8, 27.8]** Patient randomization was stratified by baseline corticosteroid use, endoscopic disease severity, and the number of previously failed biologics. All patients within this dataset were included here within the ITT population. a Clinical remission per CDAI = per US, CDAI < 150. b Clinical remission per SF/APS = per EU, average daily SF ≤ 2.8 and average daily APS ≤ 1.0 and both not greater than baseline c Endoscopic response = decrease in SES-CD > 50% from baseline (or for subjects with a baseline SES-CD of 4, at least a 2-point reduction from baseline), as scored by a central reviewer. d Corticosteroid-free clinical remission = discontinuation of corticosteroid use and achievement of clinical remission per CDAI or SF/APS at wk 12 among patients on corticosteroids at baseline. e Clinical response-100 = decrease of ≥ 100 points in CDAI from baseline. f Endoscopic remission = SES-CD ≤ 4, at least a 2-point reduction versus baseline and no subscore >1 in any individual variable, as scored by a central reviewer. g Results are based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C). h 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel (CMH) test adjusted for randomization strata. **P ≤ .0001 or *P ≤ .01 vs PBO;Average daily abdominal pain score, APS;Coronavirus disease 2019, COVID-19;Confidence Interval, CI;Crohn’s Disease Activity Index, CDAI;Simple Endoscopic Score for CD, SES-CD, Placebo, PBO;Once daily, QD;average daily very soft/liquid stool frequency, SF;Upadacitinib, UPA.

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.
Infect Dis Health ; 27(4): 203-210, 2022 11.
Article in English | MEDLINE | ID: covidwho-1945136

ABSTRACT

BACKGROUND: Exposure of healthcare workers (HCW) to SARS-CoV-2 is a public health concern. Not only are HCWs particularly exposed to SARS-CoV-2, but their contamination can also weaken the healthcare system. METHODS: We analyzed exposure of French University Hospital HCWs to SARS-CoV-2 through history of positive RT-PCR test and SARS-CoV-2 seroprevalence. Potential risk factors, such as age, BMI, having children or not, working in a COVID-19 unit, or smoking were explored. RESULTS: From May to June 2020, among the 8960 employees of the University Hospital of Nancy, a serological test was performed in 4696 HCWs. The average (SD) age was 40.4 (11.4) years, and the sample included 3926 women (83.6%). Of the 4696 HCWs, 1050 were smokers (22.4%). Among them, 2231 HCWs had a history of COVID-19 symptoms and/or flu-like syndrome (47.5%) and 238 were seropositive (5.1%). Neither gender, sex, BMI, nor having children were associated with a history of positive RT-PCR test or seropositive status. Previous work in a COVID-19 unit was associated with a history of positive RT-PCR test (p = 0.045), but not with seroprevalence (p = 0.215). As expected, history of COVID-19 clinical manifestations was more frequent in HCWs with positive serology than in HCWs with negative serology (adjusted OR = 1.9, 95%CI [1.4-2.5], p < 0.001). Less expected, smoking was associated with a reduced risk of seropositivity among HCWs (adjusted OR = 0.6, 95%CI [0.4-0.9], p = 0.019). CONCLUSION: HCW are patently exposed to SARS-CoV-2. Care to COVID-19 patients was not associated with a higher SARS-CoV-2 seroprevalence. Smoking appears here associated to a lower seroprevalence.


Subject(s)
COVID-19 , SARS-CoV-2 , Child , Female , Humans , Adult , Seroepidemiologic Studies , COVID-19/epidemiology , Health Personnel , Risk Factors
9.
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
10.
Clin Drug Investig ; 42(6): 477-489, 2022 Jun.
Article in English | MEDLINE | ID: covidwho-1878006

ABSTRACT

Subcutaneous infliximab recently received approval for the treatment of various immune-mediated inflammatory diseases in Europe, following pivotal clinical trials in patients with rheumatoid arthritis and inflammatory bowel disease. Subcutaneous infliximab demonstrated an improved pharmacokinetic profile compared with intravenous infliximab: the more stable exposure and increased systemic drug concentrations mean it has been cited as a biobetter. Alongside the pharmacokinetic advantages, potential benefits for efficacy, immunogenicity, and health-related quality-of-life outcomes have been suggested with subcutaneous infliximab. During the coronavirus disease 2019 pandemic, the benefits of subcutaneous over intravenous therapies became apparent: switching from intravenous to subcutaneous infliximab reduced the hospital visit-related healthcare resource burden and potential viral transmission. Clinical advantages observed in pivotal trials are also being seen in the real world. Accumulating experience from four European countries (the UK, Spain, France, and Germany) in patients with rheumatic diseases and inflammatory bowel disease supports clinical trial findings that subcutaneous infliximab is well tolerated, increases serum drug concentrations, and offers maintained or improved efficacy outcomes for patients switching from intravenous infliximab. Initial evidence is emerging with subcutaneous infliximab treatment after intravenous infliximab failure. High patient satisfaction and pharmacoeconomic benefits have also been reported with subcutaneous infliximab. Treatments aligned with patient preferences for the flexibility and convenience of at-home subcutaneous administration could boost adherence and treatment outcomes. Altogether, findings suggest that switching from intravenous to subcutaneous infliximab could be advantageous, and healthcare professionals should be prepared to discuss supporting data as part of shared decision making during patient consultations.


The tumor necrosis factor inhibitor infliximab is one treatment option that may be appropriate for patients with immune-mediated inflammatory diseases. Patients may prefer tumor necrosis factor inhibitors administered via the subcutaneous (SC) or intravenous (IV) route, with preferences influencing treatment satisfaction and outcomes. In 2019, CT-P13 SC became the first SC infliximab product to receive regulatory approval in Europe, based on pivotal clinical studies that compared SC infliximab to IV infliximab in patients with rheumatoid arthritis and inflammatory bowel disease. Subcutaneous infliximab is now approved in Europe for the treatment of adults with rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis. Patients began to switch from IV to SC infliximab outside clinical trials in March 2020, during the coronavirus disease 2019 pandemic. Switching from IV to SC infliximab allowed patients to self-administer treatment at home rather than attend hospital for infusions, reducing potential hospital-acquired infections and lessening the strain on healthcare systems during the pandemic. Clinical trial evidence and growing real-world experience demonstrate that SC infliximab offers clinical advantages in terms of an improved pharmacokinetic profile and potential efficacy, immunogenicity, and health-related quality-of-life benefits compared with IV infliximab. Patients have also reported increased satisfaction with SC infliximab after switching from IV infliximab. Together with the long-standing flexibility and convenience benefits of SC administration, the clinical advantages of SC infliximab make it a valid therapeutic option for rheumatoid arthritis and inflammatory bowel disease. This warrants discussion with appropriate patients as part of shared treatment decision making.


Subject(s)
Arthritis, Rheumatoid , Biosimilar Pharmaceuticals , COVID-19 Drug Treatment , Inflammatory Bowel Diseases , Antibodies, Monoclonal/adverse effects , Arthritis, Rheumatoid/drug therapy , Biosimilar Pharmaceuticals/therapeutic use , Humans , Inflammatory Bowel Diseases/chemically induced , Inflammatory Bowel Diseases/drug therapy , Infliximab/therapeutic use , Treatment Outcome
11.
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
12.
Eur J Gastroenterol Hepatol ; 34(4): 398-404, 2022 04 01.
Article in English | MEDLINE | ID: covidwho-1550620

ABSTRACT

BACKGROUND AND AIMS: The use of telemedicine dramatically increased during the COVID-19 pandemic. We collected patients and physicians experience on telemedicine in the field of inflammatory bowel disease (IBD). METHODS: We conducted a nationwide survey between September 2020 and January 2021. A self-administered questionnaire was sent to participants through mailing lists of the national patients' association and IBD expert groups. RESULTS: Overall, 300 patients and 110 gastroenterologists filled out the survey. On a 10 points scale of satisfaction with telemedicine, 60% of patients noted a score ≥8 and 52.7% of physicians ≥7. Patients and gastroenterologists felt that the duration of teleconsultations appeared to be shorter than in-person visits in 57.5 and 55.1% of cases, respectively. All participants agreed that telemedicine is appropriate in dedicated situations and not for flare-up consultations. For 55.1% of patients, quality of care was the same via telemedicine, whereas 51.4% of gastroenterologists believed they managed less well their patients. Lack of clinical examination being pointed out as the main limitation of telemedicine. Three-quarters of patients and gastroenterologists would agree to use telemedicine more often in the future. CONCLUSION: Patients and gastroenterologists were satisfied with telemedicine and would be willing to use it in the future. However, telemedicine does not replace in-person visits and should be discussed on a case-by-case basis.


Subject(s)
COVID-19 , Inflammatory Bowel Diseases , Physicians , Telemedicine , COVID-19/epidemiology , Humans , Inflammatory Bowel Diseases/diagnosis , Inflammatory Bowel Diseases/epidemiology , Inflammatory Bowel Diseases/therapy , Pandemics , SARS-CoV-2 , Surveys and Questionnaires
13.
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
14.
Gastroenterology ; 160(6): 2223-2224, 2021 05.
Article in English | MEDLINE | ID: covidwho-1298861
15.
J Crohns Colitis ; 14(14 Suppl 3): S820, 2020 10 21.
Article in English | MEDLINE | ID: covidwho-1281856
17.
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
18.
Dig Dis Sci ; 67(6): 2067-2073, 2022 06.
Article in English | MEDLINE | ID: covidwho-1224997

ABSTRACT

BACKGROUND: Vaccination against COVID-19 is a major public health challenge, including the community of patients with inflammatory bowel disease. Vaccination coverage is suboptimal in inflammatory bowel disease population. It is of paramount importance to ensure an effective and rapid vaccination program with the adherence of the largest number of well-informed patients. AIMS: We assessed the acceptance of COVID-19 vaccination among inflammatory bowel disease patients. METHODS: We performed a survey as part of routine practice, between January 8th and February 22nd, 2021. All consecutive adult patients followed at Nancy University Hospital for inflammatory bowel disease were included. Patients completed a self-administered, structured, paper-based questionnaire. Demographic data, medical history, knowledge, and perceptions of COVID-19 vaccination were collected. RESULTS: Among the 104 patients who responded to the survey, 57 patients (54.8%) had intent to receive the COVID-19 vaccine. Vaccine efficacy, social responsibility, herd immunity, and desire to return to normal life were associated with self-reported willingness to receive a vaccine (20.2%, 20.2%, 11.5%, and 15.4%, respectively). Unknown long-term safety, risk of adverse reaction to vaccine and concern that the vaccine is being developed too quickly were the most commonly reported reasons for non-uptake (27.9%, 15.4%, and 12.5%, respectively). CONCLUSION: Half of the patients with inflammatory bowel disease would like to be vaccinated against SARS-CoV-2. This rate is similar to that reported in the French general population. Despite some concerns, patients with inflammatory bowel disease understood the necessity to be vaccinated against COVID-19.


Subject(s)
COVID-19 Vaccines , COVID-19 , Inflammatory Bowel Diseases , Vaccination , Adult , COVID-19/epidemiology , COVID-19/prevention & control , Health Knowledge, Attitudes, Practice , Humans , Inflammatory Bowel Diseases/epidemiology , Surveys and Questionnaires , Vaccination/psychology
19.
Gastroenterology ; 160(5): 1881, 2021 04.
Article in English | MEDLINE | ID: covidwho-1189301
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