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1.
Front Immunol ; 13: 920333, 2022.
Article in English | MEDLINE | ID: covidwho-1963484

ABSTRACT

Introduction: Patients with Inflammatory Bowel Disease (IBD) frequently receive immunomodulating treatment, which may render them at increased risk of an attenuated immune response upon vaccination. In this study, we assessed the effects of different types of commonly prescribed immunosuppressive medications on the serological response after vaccination against SARS-CoV-2 in patients with IBD. Methods: In this prospective observational cohort study, IgG antibody titers against SARS-CoV-2 were measured 2-10 weeks after completion of standard vaccination regimens in patients with IBD. Clinical characteristics, previous history of SARS-CoV-2 infection, type of vaccine (mRNA- or vector-based) and medication use were recorded at the time of sampling. Subsequently, a chemiluminescent microparticle immunoassay was used for the quantitative determination of IgG antibodies against the receptor-binding domain (RBD) of the S1 subunit of the spike protein of SARS-CoV-2. Results: Three hundred and twelve (312) patients with IBD were included (172 Crohn's disease [CD] and 140 ulcerative colitis [UC]). Seroconversion (defined as titer of >50 AU/ml) was achieved in 98.3% of patients. Antibody concentrations were significantly lower in patients treated with TNF-α-antagonists vs. non-users of TNF-α-antagonists (geometric mean [95% confidence interval]: 2204 [1655-2935] vs. 5002 [4089-6116] AU/ml, P<0.001). In multivariable models, use of TNF-α-antagonists (P<0.001), vector vaccines (P<0.001), age (>50 years) (P<0.01) and CD (P<0.05) were independently associated with lower anti-SARS-CoV-2 antibody titers. In patients who received mRNA vaccines, users of thiopurines (either prescribed as monotherapy or in combination with biologicals) demonstrated significantly lower antibody titers compared to thiopurine non-users (P<0.05). Conclusion: Despite reassuring findings that most patients with IBD have detectable antibodies after anti-SARS-CoV-2 vaccination, TNF-α-antagonists were found to be strongly associated with an attenuated IgG antibody response after vaccination against SARS-CoV-2, independent of vaccine type, the time elapsed after vaccination and blood sampling, prior SARS-CoV-2 infection and patient age. Patients treated with thiopurines and receiving mRNA-based vaccines demonstrated lower anti-SARS-CoV-2 antibody titers compared with non-users.


Subject(s)
COVID-19 Vaccines , COVID-19 , Crohn Disease , Inflammatory Bowel Diseases , Tumor Necrosis Factor Inhibitors , Antibodies, Viral , Antibody Formation , COVID-19/immunology , COVID-19 Vaccines/administration & dosage , Crohn Disease/drug therapy , Humans , Immunoglobulin G , Inflammatory Bowel Diseases/drug therapy , Middle Aged , Prospective Studies , SARS-CoV-2 , Tumor Necrosis Factor Inhibitors/therapeutic use
2.
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
3.
Cochrane Database Syst Rev ; 5: CD013070, 2022 05 13.
Article in English | MEDLINE | ID: covidwho-1843835

ABSTRACT

BACKGROUND: Crohn's disease (CD) is an inflammatory bowel disease that causes inflammation and stricture, of any part of the mucosa and the gut wall. It forms skip lesions, sparing the areas in between the affected parts of the gastrointestinal tract. Crohn's disease could have one of three complications; fistula, intestinal obstruction due to stricture, or gastrointestinal inflammation presenting as severe diarrhoea. Stem cell therapy (SCT) is an innovative treatment that has been recently used in CD. The exact role of SCT in CD is still unclear. Stem cells modify the immunity of the patients or act as a "reset tool" for the immune system as in the case of systemically-injected stem cells, or regenerate the affected area of necrotic and inflammatory tissue as in the case of local injection into the lesion. Stem cells are a wide variety of cells including pluripotent stem cells or differentiated stem cells. The hazards range from rejection to symptomatic manifestations as fever or increase infection.  OBJECTIVES: The objective of this Cochrane systematic review is to assess the effects of stem cell transplantation compared to standard of care alone or with placebo on efficacy and safety outcomes in patients with refractory CD. SEARCH METHODS: We searched MEDLINE, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), and clinical trial registries (Clinicaltrials.gov, World Health Organization-International Clinical Trials Registry Platform WHO ICTRP) from inception to 19 March 2021, without any language, publication year, or publication status restrictions. In addition, we searched references of included studies and review articles for further references. An update of the published studies was done during the writing of the review. SELECTION CRITERIA: We included only randomised controlled trials (RCTs) that assessed the effectiveness and safety of SCT in refractory CD versus standard care alone (control) or with placebo. DATA COLLECTION AND ANALYSIS: Two review authors (SEN and SFA) independently screened the studies retrieved from the search results for inclusion, extracted data and assessed the risk of bias. Any disagreement was resolved through a consensus between the authors. We used standard methodological procedures expected by Cochrane. MAIN RESULTS: We conducted our search on 19 March 2021 and identified 639 records. We added two records by a manual search of the published reviews on the topic to a total of 641 records. The Covidence program removed 125 duplicates making a total of 516 reports. Two review authors (SEN and SFA) screened titles and abstracts and excluded 451 records with the remaining 65 for full-text records screened independently by the two authors; only 18 studies were considered for inclusion.  We included seven RCTs with a total of 442 participants for the meta-analysis. The intervention group included 234 patients, and the control group included 208 patients. Nine trials are ongoing and, two abstracts are awaiting classification. All patients in the control and intervention groups received the standard therapy for CD. Only three studies used blinding methods for the control group in the form of a placebo, with one study of the three stated that the blinding method was inefficient. The patients and personnel were aware of the intervention in the rest of the four studies as they were open-label trials. However, the effect of unblinding was balanced by the low risk of detection bias in five of the included studies. The evidence is uncertain about the effect of SCT on achieving clinical remission as compared to control/placebo (risk ratio (RR) 1.88, 95% Confidence Interval (CI) 0.80 to 4.41; 3 studies; low-certainty evidence). The evidence is very uncertain about the effect of SCT on achieving Crohn's Disease Activity Index (CDAI) <150 at 24 weeks compared to control (RR1.02 95% CI 0.67 to 1.56; 4 studies; very-low certainty evidence). SCT is likely to achieve fistula closure as compared to the control/placebo both in the short term (RR 1.48, 95% CI 1.12 to 1.96); low-certainty evidence) and in the long term (RR 1.42, 95% CI 1.09 to 1.87; 4 studies; low-certainty evidence) follow-up. The evidence is very uncertain about the effect of SCT to cause no difference in the number of total adverse events as compared to the control/placebo (RR 0.99, 95% CI [0.88 to  1.13); 4 studies; very-low-certainty evidence). However, SCT is likely to increase the number of serious adverse events as compared to the control/placebo (RR 1.22, 95% CI 0.88 to 1.67; 7 studies; low-certainty evidence). The evidence is very uncertain about the effect of SCT to decrease the withdrawal due to adverse events as compared to the control/placebo (RR 0.78, 95% CI 0.32 to 1.89; 3 studies; very-low certainty evidence). Funding by pharmaceutical companies was found in three studies, with one including more than 50% of our studied population. AUTHORS' CONCLUSIONS: SCT shows an uncertain effect on clinical remission with low certainty of evidence. SCT shows an uncertain effect on CDAI score to reach <150 after 24 weeks of treatment, with very low certainty evidence. SCT shows beneficial effects on fistula-closure during short and long-term follow-up with low-certainty evidence in both outcomes. There was no change in the total number of adverse events with SCT as compared to control, with very low certainty evidence. While there was a moderate effect on increasing the number of serious adverse events in the SCT group, as compared to the control with low-certainty evidence. Withdrawal due to adverse events was slightly higher in the control group with very low certainty evidence. All the participants were refractory to standard medical treatment, but the number of participants was small, this may limit the generalizability of the results. Further research is needed for validation. More objective outcomes are needed in the assessment of stem cell effectiveness in the treatment of Crohn's disease, especially the intestinal CD subtype; with standardization of the dose, methods of stem cell preparation, route of administration, and inclusion criteria to the studies to achieve clear results.


Subject(s)
Crohn Disease , Hematopoietic Stem Cell Transplantation , Constriction, Pathologic , Crohn Disease/drug therapy , Humans , Inflammation , Remission Induction
4.
Gastroenterol Clin North Am ; 51(2): 425-440, 2022 06.
Article in English | MEDLINE | ID: covidwho-1804127

ABSTRACT

The incidence and prevalence of inflammatory bowel disease (IBD) is increasing in the elderly population. Compared with patients with onset during younger years, patients with elderly-onset IBD have a distinct clinical presentation, disease phenotype, and natural history. Genetics contribute less to pathogenesis of disease, whereas aging-related biological changes, such as immunosenescence and dysbiosis, are associated with elderly-onset IBD. Frailty is an increasingly recognized predictor of adverse outcomes. As an increasingly wider array of biologic and small molecule therapeutic options becomes available, data regarding efficacy and safety of these agents in patients are paramount given the unique characteristics of this population.


Subject(s)
Colitis, Ulcerative , Crohn Disease , Inflammatory Bowel Diseases , Aged , Biology , Colitis, Ulcerative/drug therapy , Crohn Disease/drug therapy , Crohn Disease/epidemiology , Humans , Incidence , Inflammatory Bowel Diseases/therapy
5.
Nat Rev Gastroenterol Hepatol ; 19(4): 216, 2022 04.
Article in English | MEDLINE | ID: covidwho-1783992
6.
Can J Gastroenterol Hepatol ; 2021: 7591141, 2021.
Article in English | MEDLINE | ID: covidwho-1551096

ABSTRACT

Background and Aims: The impact of COVID-19 has been of great concern in patients with inflammatory bowel disease (IBD) worldwide, including an increased risk of severe outcomes and/or possible flare of IBD. This study aims to evaluate prevalence, outcomes, the impact of COVID-19 in patients with IBD, and risk factors associated with severe COVID-19 or flare of IBD activity. Methods: A consecutive cohort of IBD patients who were diagnosed with COVID-19 infection and followed up at the McGill University Health Care Centre was obtained between March 1, 2020, and April 30, 2021. Demographics, comorbidities, IBD (type, treatments, pre- and post-COVID-19 clinical activity, biomarkers, and endoscopic activity), and COVID-19-related outcomes (pneumonia, hospitalization, death, and flare of IBD disease) were analyzed. Results: A cohort of 3,516 IBD patients was included. 82 patients (2.3%) were diagnosed with COVID-19 infection (median age: 39.0 (IQR 27.8-48.0), 77% with Crohn's disease, 50% were female). The prevalence of COVID-19 infection in IBD patients was significantly lower compared to the general population in Canada and Quebec (3.5% versus 4.3%, p < 0.001). Severe COVID-19 occurred in 6 patients (7.3%); 2 patients (2.4%) died. A flare of IBD post-COVID-19 infection was reported in 8 patients (9.8%) within 3 months. Biologic therapy was held during active COVID-19 infection in 37% of patients. Age ≥55 years (odds ratio (OR): 11.1, 95% CI: 1.8-68.0), systemic corticosteroid use (OR: 4.6, 95% CI: 0.7-30.1), active IBD (OR: 3.8, 95% CI: 0.7-20.8), and comorbidity (OR: 4.9, 95% CI: 0.8-28.6) were factors associated with severe COVID-19. After initial infection, 61% of IBD patients received COVID-19 vaccinations. Conclusion: The prevalence of COVID-19 infection among patients with IBD was lower than that in the general population in Canada. Severe COVID-19, mortality, and flare of IBD were relatively rare, while a large proportion of patients received COVID-19 vaccination. Older age, comorbidities, active IBD disease, and systemic corticosteroid, but not immunosuppressive or biological therapy, were associated with severe COVID-19 infection.


Subject(s)
COVID-19 , Crohn Disease , Inflammatory Bowel Diseases , Adult , Aged , COVID-19 Vaccines , Crohn Disease/drug therapy , Crohn Disease/epidemiology , Female , Humans , Inflammatory Bowel Diseases/complications , Inflammatory Bowel Diseases/drug therapy , Inflammatory Bowel Diseases/epidemiology , Middle Aged , SARS-CoV-2
7.
BMJ Case Rep ; 14(11)2021 Nov 19.
Article in English | MEDLINE | ID: covidwho-1526469

ABSTRACT

We present a patient with an acute kidney injury thought secondary to acute interstitial nephritis as a result of vedolizumab maintenance therapy for Crohn's disease. This appears to be a rare but serious side effect in patients receiving this treatment which clinicians should consider in the event of renal dysfunction.


Subject(s)
Crohn Disease , Nephritis, Interstitial , Antibodies, Monoclonal, Humanized/adverse effects , Crohn Disease/drug therapy , Humans , Nephritis, Interstitial/chemically induced
8.
Viruses ; 13(11)2021 10 24.
Article in English | MEDLINE | ID: covidwho-1481024

ABSTRACT

Vaccines to prevent the impact of SARS-CoV-2 are now available, including for patients with autoimmune diseases. However, there is no information about how inflammatory bowel disease (IBD) treatment could impact the cellular and humoral immune responses. This study evaluated SARS-CoV-2-specific humoral and cellular responses after vaccination with a two-dose schedule in a Crohn's disease patient treated with Infliximab (10 mg/kg); we included comparisons with a monozygotic twin. The results showed that the Crohn's disease's twin (twin 2) had no antibody detection and reduced activation of CD4+ T cell responses, unlike the twin without the autoimmune disease (twin 1). Twin 2 developed antigen-specific central memory CD8+ T-cells and IFNγ production after the second dose of COVID-19 vaccination, similar to twin 1. These findings elucidated the role of T-cell immunity after COVID-19 immunization on IBD patients despite the lack of antibody production. Finally, our observation supports the consensus recommendation for IBD patients to receive COVID-19 vaccines.


Subject(s)
CD4-Positive T-Lymphocytes/immunology , CD8-Positive T-Lymphocytes/immunology , Crohn Disease/immunology , Lymphocyte Activation , /immunology , Adult , Antibodies, Viral/blood , Crohn Disease/drug therapy , Female , Humans , Immunity, Humoral , Infliximab/therapeutic use , Interferon-gamma/analysis , SARS-CoV-2/immunology , Spike Glycoprotein, Coronavirus/immunology , Twins, Monozygotic
9.
Aliment Pharmacol Ther ; 54(11-12): 1432-1441, 2021 12.
Article in English | MEDLINE | ID: covidwho-1480095

ABSTRACT

BACKGROUND: Older age and comorbidities are the main risk factors for adverse COVID-19 outcomes in patients with inflammatory bowel disease (IBD). The impact of IBD medications is still under investigation. AIMS: To assess risk factors for adverse outcomes of COVID-19 in IBD patients and use the identified risk factors to build risk indices. METHODS: Observational cohort study. Univariable and multivariable logistic regression was used to identify risk factors associated with pneumonia, hospitalisation, need for ventilatory support, and death. RESULTS: Of the 937 patients (446 with ulcerative colitis [UC]) evaluated, 128 (13.7%) had asymptomatic SARS-CoV-2 infection, 664 (70.8%) had a favourable course, and 135 (15.5%) had moderate or severe COVID-19. In UC patients, obesity, active disease and comorbidities were significantly associated with adverse outcomes. In patients with Crohn's disease (CD), age, obesity, comorbidities and an additional immune-mediated inflammatory disease were identified as risk factors. These risk factors were incorporated into two indices to identify patients with UC or CD with a higher risk of adverse COVID-19 outcomes. In multivariable analyses, no single IBD medication was associated with poor COVID-19 outcomes, but anti-TNF agents were associated with a lower risk of pneumonia in UC, and lower risks of hospitalisation and severe COVID-19 in CD. CONCLUSION: The course of COVID-19 in patients with IBD is similar to that in the general population. IBD patients with active disease and comorbidities are at greater risk of adverse COVID-19 outcomes. IBD medications do not pose additional risks. The risk indices may help to identify patients who should be prioritised for COVID-19 re-vaccination or for therapies for SARS-CoV-2 infection.


Subject(s)
COVID-19 , Colitis, Ulcerative , Crohn Disease , Inflammatory Bowel Diseases , Aged , Crohn Disease/complications , Crohn Disease/drug therapy , Crohn Disease/epidemiology , Humans , Inflammatory Bowel Diseases/complications , Inflammatory Bowel Diseases/drug therapy , Inflammatory Bowel Diseases/epidemiology , SARS-CoV-2 , Tumor Necrosis Factor Inhibitors
10.
PLoS One ; 16(10): e0258537, 2021.
Article in English | MEDLINE | ID: covidwho-1477535

ABSTRACT

BACKGROUND: Real-world big data studies using health insurance claims databases require extraction algorithms to accurately identify target population and outcome. However, no algorithm for Crohn's disease (CD) has yet been validated. In this study we aim to develop an algorithm for identifying CD using the claims data of the insurance system. METHODS: A single-center retrospective study to develop a CD extraction algorithm from insurance claims data was conducted. Patients visiting the Kitasato University Kitasato Institute Hospital between January 2015-February 2019 were enrolled, and data were extracted according to inclusion criteria combining the Tenth Revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-10) diagnosis codes with or without prescription or surgical codes. Hundred cases that met each inclusion criterion were randomly sampled and positive predictive values (PPVs) were calculated according to the diagnosis in the medical chart. Of all cases, 20% were reviewed in duplicate, and the inter-observer agreement (Kappa) was also calculated. RESULTS: From the 82,898 enrolled, 255 cases were extracted by diagnosis code alone, 197 by the combination of diagnosis and prescription codes, and 197 by the combination of diagnosis codes and prescription or surgical codes. The PPV for confirmed CD cases was 83% by diagnosis codes alone, but improved to 97% by combining with prescription codes. The inter-observer agreement was 0.9903. CONCLUSIONS: Single ICD-code alone was insufficient to define CD; however, the algorithm that combined diagnosis codes with prescription codes indicated a sufficiently high PPV and will enable outcome-based research on CD using the Japanese claims database.


Subject(s)
Algorithms , Crohn Disease/diagnosis , Adult , Crohn Disease/drug therapy , Crohn Disease/surgery , Cross-Sectional Studies , Databases, Factual , Drug Prescriptions/statistics & numerical data , Female , Hospitals, University , Humans , Japan , Male , Middle Aged , Retrospective Studies , Surgical Procedures, Operative/statistics & numerical data
13.
J Gastroenterol Hepatol ; 36(11): 3033-3040, 2021 Nov.
Article in English | MEDLINE | ID: covidwho-1276707

ABSTRACT

BACKGROUND AND AIM: One of the most impacted regions by the pandemic globally, Latin America is facing socioeconomic and health-care challenges that can potentially affect disease outcomes. Recent data suggest that inflammatory bowel disease (IBD) patients do not have an increased risk of the development of COVID-19 complications. However, the impact of COVID-19 on IBD patients living in least developed areas remains to be fully elucidated. This study aims to describe the outcomes of IBD patients diagnosed with COVID-19 in countries from Latin America based on data from the SECURE-IBD registry. METHODS: Patients from Latin America enrolled in the SECURE-IBD registry were included. Descriptive analyses were used to summarize clinical and sociodemographic characteristics. The studied outcomes were (i) a composite of need for intensive care unit admission, ventilator use, and/or death (primary outcome) and (ii) a composite of any hospitalization and/or death (secondary outcome). Multivariable regression was used to identify risk factors of severe COVID-19. RESULTS: During the study period, 230 cases (Crohn's disease: n = 115, ulcerative colitis: n = 114, IBD-unclassified [IBD-U]: n = 1) were reported to the SECURE-IBD database from 13 different countries. Primary outcome was observed in 17 (7.4%) patients, and the case fatality rate was 1.7%. In the adjusted multivariable model, the use of systemic corticosteroids (odds ratio [OR] 10.97; 95% confidence interval [CI]: 3.44-34.99) was significantly associated with the primary outcome. Older age (OR 1.03; 95% CI: 1.00-1.05), systemic corticosteroids (OR 9.33; 95% CI: 3.84-22.63), and the concomitant presence of one (OR 2.14; 95% CI: 0.89-5.15) or two (OR 10.67; 95% CI: 1.74-65.72) comorbidities were associated with the outcome of hospitalization or death. CONCLUSION: Inflammatory bowel disease patients with COVID-19 in Latin America appear to have similar outcomes to the overall global data. Risk factors of severe COVID-19 are similar to prior reports.


Subject(s)
COVID-19/diagnosis , Colitis, Ulcerative/drug therapy , Inflammatory Bowel Diseases/complications , Adrenal Cortex Hormones/therapeutic use , Aged , COVID-19/epidemiology , Colitis, Ulcerative/epidemiology , Crohn Disease/drug therapy , Crohn Disease/epidemiology , Humans , Inflammatory Bowel Diseases/drug therapy , Inflammatory Bowel Diseases/epidemiology , Latin America/epidemiology , Registries , SARS-CoV-2
16.
Scand J Gastroenterol ; 56(5): 545-551, 2021 05.
Article in English | MEDLINE | ID: covidwho-1152953

ABSTRACT

BACKGROUND AND AIMS: Patients with inflammatory bowel diseases (IBD) have experienced changes to the routine management because of the SARS-CoV-2 pandemic. The aim of this study was to examine patients with IBD's adherence to the restrictions imposed by society and the hospital, worries and concerns regarding medical treatment and clinical follow-up under the pandemic. METHODS: IBD patients (≥18 years) at the outpatient clinic at Oslo University Hospital were included and answered a self-report questionnaire including concerns regarding their disease, medical therapy and follow-up during SARS-CoV-2 pandemic. RESULTS: In total, 522 IBD patients were included, 317 Crohn's disease, 205 ulcerative colitis, 386 patients <50 years. Eighteen percent were in obligatory quarantine, and more often patients <50 years compared to patients ≥50 years. Five patients tested positive to SARS- CoV-2. A higher proportion <50 years reported worries for their medical treatment and risk of COVID -19 disease compared to those ≥50 years. Forty percent avoided family, two-thirds avoided friends, and 4% cancelled their scheduled consultation at the hospital. The hospital changed physical consultation to telephone consultation for 15% of the patients. The preferred follow-up was physical consultation. A higher proportion of the patients <50 years preferred telephone consultation compared to those ≥50 years. Four out of five IBD patients were satisfied with the information about their IBD and COVID-19. CONCLUSIONS: SARS-CoV-2 pandemic affects the daily lives for patients with IBD. It is important to develop evidence-base guidelines in follow-up and treatment, as well as patient information about COVID-19and IBD.


Subject(s)
COVID-19 , Colitis, Ulcerative , Crohn Disease , Immunosuppressive Agents/therapeutic use , Patient Compliance , Patient Preference , Adult , Attitude to Health , COVID-19/epidemiology , COVID-19/prevention & control , Colitis, Ulcerative/drug therapy , Colitis, Ulcerative/epidemiology , Colitis, Ulcerative/psychology , Communicable Disease Control/methods , Communicable Disease Control/statistics & numerical data , Continuity of Patient Care/standards , Crohn Disease/drug therapy , Crohn Disease/epidemiology , Crohn Disease/psychology , Female , Humans , Male , Middle Aged , Norway/epidemiology , Patient Compliance/psychology , Patient Compliance/statistics & numerical data , Physical Distancing , Remote Consultation/statistics & numerical data , SARS-CoV-2 , Self Report
17.
Eur J Gastroenterol Hepatol ; 33(3): 443-447, 2021 03 01.
Article in English | MEDLINE | ID: covidwho-1057900

ABSTRACT

The course of coronavirus 19 (COVID-19) might be determined by certain comorbidities (e.g. diabetes, hypertension and other cardiovascular diseases) and advanced age. Because the impact of immunosuppression on disease severity is not entirely clear, management of patients under immunosuppressive treatment remains controversial. Six cases of inflammatory bowel disease (IBD) patients with COVID-19 on immunosuppressive medication are presented. The aim of this study was to describe patients' clinical manifestation and chronologic development of virus-specific antibodies of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection before and after restart with immunosuppressive/biological therapy as an indicator for a specific immune response. All patients were tested for the presence of SARS-CoV-2-RNA with PCR, were in clinical remission prior to COVID-19 and only one patient continued his immunosuppressive treatment during the COVID-19 infection. Initial symptoms of COVID-19 were pyrexia, diarrhea, cephalea, and dysgeusia and anosmia. No patient needed admission to hospital or ICU. The SARS-CoV-2 antibody development was described to be late in three of the six patients. Late antibody development seems to be more frequent in older patients and in patients with combined immunosuppressive treatment. In this scenario, SARS-CoV-2 antibody testing could be useful prior to restarting immunosuppressive therapy.


Subject(s)
Antibodies, Viral/blood , COVID-19/immunology , Colitis, Ulcerative/drug therapy , Crohn Disease/drug therapy , Immunity, Humoral , Immunocompromised Host , Immunosuppressive Agents/administration & dosage , SARS-CoV-2/immunology , Adult , Aged , Biomarkers/blood , COVID-19/blood , COVID-19/diagnosis , COVID-19/virology , COVID-19 Serological Testing , Colitis, Ulcerative/diagnosis , Colitis, Ulcerative/immunology , Crohn Disease/diagnosis , Crohn Disease/immunology , Drug Administration Schedule , Female , Host-Pathogen Interactions , Humans , Immunosuppressive Agents/adverse effects , Male , Middle Aged , Retrospective Studies , Time Factors , Young Adult
18.
Dig Dis Sci ; 66(12): 4191-4196, 2021 12.
Article in English | MEDLINE | ID: covidwho-1037968

ABSTRACT

BACKGROUND: The outbreak of COVID19 evolved rapidly into a global pandemic, forcing hospitals, including inflammatory bowel disease (IBD) referral units, to change their practices to ensure quality of care. AIMS: To describe the clinical outcomes and the fulfilment of the treatment schedule of patients with IBD treated with biological agents in a single-center of a red-zone of the pandemic, and to report the patients' perceptions about COVID-19 and the measures adopted at our center. METHODS: Therapeutic adherence and clinical outcomes were collected for all patients undergoing treatment with intravenous biologicals and subcutaneous biologicals at our center. A telephone survey was also performed to assess these patients' perceptions of the COVID pandemic and the related measures adopted at their IBD unit. RESULTS: A total of 234 patients were included (117 on intravenous and 117 on subcutaneous biologicals). Only 10% of patients postponed intravenous infusions intentionally and 5% postponed the collection of subcutaneous biologicals at the hospital pharmacy. Only five confirmed COVID-19 cases were registered (2.1%), all of them of mild severity. One hundred and fifty-five patients participated in the survey (77 on intravenous and 78 on subcutaneous drugs). Fear of going to the hospital was the most common reason for postponing biological administrations. Among those on combination therapy, only 7% admitted to have withdrawn immunosuppressants. CONCLUSIONS: Adherence to intravenous and subcutaneous biological therapies during the pandemic was high in a single-center cohort of IBD patients even though the cumulative incidence of confirmed COVID-19 was low.


Subject(s)
Biological Products/administration & dosage , COVID-19/prevention & control , Colitis, Ulcerative/drug therapy , Crohn Disease/drug therapy , Delivery of Health Care, Integrated/organization & administration , Medication Adherence , Biological Products/adverse effects , COVID-19/transmission , Colitis, Ulcerative/diagnosis , Colitis, Ulcerative/immunology , Crohn Disease/diagnosis , Crohn Disease/immunology , Cross-Sectional Studies , Drug Administration Schedule , Drug Therapy, Combination , Fear , Female , Health Knowledge, Attitudes, Practice , Humans , Immunosuppressive Agents/administration & dosage , Infusions, Intravenous , Injections, Subcutaneous , Male , Patient Satisfaction , Time Factors , Treatment Outcome
19.
Dig Liver Dis ; 53(3): 277-282, 2021 03.
Article in English | MEDLINE | ID: covidwho-1009433

ABSTRACT

BACKGROUND: Patients receiving biologic therapies are at risk for viral infections. This study investigated the impact of the SARS-CoV-2 infection and the serum prevalence of SARS-CoV-2 antibodies in patients with inflammatory bowel disease (IBD) treated with biologic drugs. METHODS: Information on demography, co-morbidities, clinical data regarding IBD, symptoms suggestive of the SARS-CoV-2 infection, close contacts with SARS-CoV-2 positive patients, hospitalization, and therapies administered for COVID-19 was collected for all patients who were being treated with biologic drugs. All patients underwent SARS-CoV-2 antibody testing. RESULTS: Two hundred and fifty-nine patients (27 children) with a mean age of 42.2 ±â€¯16.7 years (range 9 - 88) and a mean duration of disease of 13.4 ±â€¯10 years (range 0.2 - 49) were enrolled. One hundred four patients (40.2%) had ulcerative colitis, and 155 (59.8%) had Crohn's disease. About the therapy: 62 patients were receiving infliximab, 89 adalimumab, 20 golimumab, 57 vedolizumab, 27 ustekinumab, 1 thalidomide, and 3 an experimental compound. The mean Charlson Comorbidity Index was 2. Thirty-two patients (12.3%) reported respiratory symptoms, and 2 of them were hospitalized (0.77%). Two patients resulted positive for IgG against SARS-CoV-2 (0.77%). CONCLUSIONS: In patients with IBD, treatment with biologic drug does not represent a risk factor for the SARS-CoV-2 infection.


Subject(s)
Biological Products/therapeutic use , COVID-19/epidemiology , Gastrointestinal Agents/therapeutic use , Inflammatory Bowel Diseases/epidemiology , Adalimumab/therapeutic use , Adolescent , Adult , Aged , Aged, 80 and over , Antibodies, Monoclonal/therapeutic use , Antibodies, Monoclonal, Humanized/therapeutic use , Antibodies, Viral/immunology , COVID-19/immunology , COVID-19/physiopathology , COVID-19/therapy , COVID-19 Serological Testing , Child , Colitis, Ulcerative/drug therapy , Colitis, Ulcerative/epidemiology , Crohn Disease/drug therapy , Crohn Disease/epidemiology , Enzyme-Linked Immunosorbent Assay , Female , Hospitalization , Humans , Immunosuppressive Agents/therapeutic use , Inflammatory Bowel Diseases/drug therapy , Infliximab/therapeutic use , Italy/epidemiology , Male , Middle Aged , SARS-CoV-2/immunology , Seroepidemiologic Studies , Thalidomide/therapeutic use , Ustekinumab/therapeutic use , Young Adult
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