Your browser doesn't support javascript.
Show: 20 | 50 | 100
Results 1 - 20 de 460
Filter
1.
Laryngo- Rhino- Otologie ; 101:S307, 2022.
Article in English | EMBASE | ID: covidwho-1967677

ABSTRACT

Introduction As part of the immune response to the COVID-19-vaccine a multitude of anti-COVID-antibodies is formed. A part of these antibodies can bind to the body-s own tissue and facilitate autoinflammatory processes. Such autoimmune-inflammatory processes are suspected to be behind various symptoms of the COVID disease and the long-COVID syndrome. So far, numerous reports on neuro-otological symptoms in the context of COVID infection have been published. The present report describes patients who presented in a university ENT outpatient department with vestibulo-cochlear symptoms in connection with a COVID vaccination. Methods All patients who presented with dizziness, tinnitus and hearing impairment for the first time in a direct temporal context (max. 3 days after vaccination) tot he vaccination were examined by an ENT specialist and further examined using subjective and objective audiometry and, depending on the symptoms, using vestibular diagnostics. Results An otitis media was not found in any patient. A cochlear genesis of the vestibulo-cochlear symptoms could be demonstrated in all patients. One patient has isolated symptoms with hearing loss, all others also suffered from tinnitus or dizziness. In all patients, the symptoms resolved after drug therapy was carried out. Discussion Vaccine-associated hearing loss has also been described in the case of influenza vaccination. We were unable to provide direct evidence of the COVID vaccination as the triggering factor for the vestibulo-cochlear symptoms. An association of these symptoms with the vaccination cannot be ruled out though. The most likely mechanism is an immunoglobulin-triggered specific autoimmune response.

2.
Journal of Hepatology ; 77:S142, 2022.
Article in English | EMBASE | ID: covidwho-1967495

ABSTRACT

Background and aims: In trials conducted in India, recombinant granulocyte colony stimulating factor (GCSF) improved survival in alcohol-associated hepatitis (AH). The aim of this trial was to determine the safety and efficacy of pegfilgrastim, a long-acting recombinant GCSF, in patients with AH in the United States. Method: This prospective, open label trial randomized patients with a clinical diagnosis of AH and a Maddrey discriminant function score ≥32 to standard of care (SOC) or SOC+pegfilgrastim (0.6 mg subcutaneously) on Day 1 and Day 8. SOC was 28 days of either pentoxifylline or prednisolone, as determined by the patient’s primary physician. The second injection of pegfilgrastim was not administered if the white blood cell count exceeded 30, 000/mm3 on Day 8. Primary outcomewas survival at Day 90. Secondary outcomes included the incidence of acute kidney injury (AKI), hepatorenal syndrome (HRS), hepatic encephalopathy, or infections. Results: The study was terminated early due to COVID19 pandemic. Eighteen patients were randomized to SOC and 16 to SOC+pegfilgrastim. All patients received prednisolone as SOC. Nine patients failed to receive a second dose of pegfilgrastin due to WBC>30, 000/ mm3 on Day 8. Survival at 90 days was similar in both groups (SOC: 0.83 [95% confidence interval {CI}: 0.57–0.94] vs. pegfilgrastim: 0.73 [95% CI: 0.44–0.89];p > 0.05). The incidences of AKI, HRS, hepatic encephalopathy, and infections were similar in both treatment arms and therewere no serious adverse events attributed to pegfilgrastim. Conclusion: This phase II trial found no survival benefit at 90 days among subjects with AH who received pegfilgrastim+prednisolone compared with subjects receiving prednisolone alone.

3.
Journal of Hepatology ; 77:S63, 2022.
Article in English | EMBASE | ID: covidwho-1967494

ABSTRACT

Background and aims: Identification and staging of fibrosis is a critical part of assessment for people with alcohol related liver disease. For those presenting acutely in hospital, staging tests are frequently deferred until out-patient review. However, engagement with elective services is often poor in those with ongoing alcohol use, leaving investigation incomplete and the need for hepatology followup uncertain. To mitigate this, we instituted an in-patient fibrosis assessment service within our Alcohol Care Team (ACT) and evaluated the results. Method: From February 2020-October 2021, we sought out acutely admitted patients who had been identified as drinking excessively (more than the United Kingdom guidance of 14 units/week) and who had previously not engaged with the ACT for staging of suspected liver disease. All patients were staged by Fibroscan (Echosens). Enhanced Liver Fibrosis (ELF) test was additionally performed when it became available at our facility. Implementation of the pilot was delayed and disrupted due to the impact of Covid-19 on service delivery, with most patients identified from March 2021 onwards. Results: 70 patients were identified-45 (64%) male, 25 (36%) female, with median age 53 years (range 25–80 yr). Fibroscan results ranged from 3.4 kPa–75 kPa. 40 (57%)were normal (<7.0 kPa),13 (19%) F1–F3 (7.1 kPa–18.5 kPa) and 17 (24%) F4 (>18.5 kPa). ELF was performed in 32 (46%) patients;19 (59%) showed severe fibrosis (score 9.8–14.3) and 13 (41%) moderate fibrosis (score 7.9–9.6). ELF and Fibroscan werewell matched for identification of cirrhosis, with cirrhotic range Fibroscan results only found in those with severe fibrosis on ELF, suggesting either test could be used to rule out cirrhosis in this group. Following Fibroscan assessment, annual ACT follow-up was arranged for all patients in F1–F3 range, and the 25 patients with a normal Fibroscan who continued to drink excessively. Patients with any results in the cirrhotic rangewere referred to hepatology for ongoing management. Conclusion: By performing fibrosis assessment during an inpatient stay, wewere able to exclude significant liver disease in many people we had previously been unable to stage, providing important information to the patient and avoiding unnecessary hepatology follow-up. Provision of in-patient non-invasive fibrosis assessment may therefore be a valuable addition to hospital ACT services for capturing patients who poorly engage.

4.
Journal of Hepatology ; 77:S14, 2022.
Article in English | EMBASE | ID: covidwho-1967492

ABSTRACT

Background and aims: Approval of a drug therapy for NASH requires a very good safety/tolerability profile and acceptable therapeutic index. MAESTRO-NAFLD-1 (NCT04197479) is a randomized doubleblind (DB) Phase 3 clinical trial of placebo (PBO) versus resmetirom (RES), a once-a-day oral selective thyroid hormone receptor β agonist, in >1100 patients with NAFLD with safety as the primary end point. Method: Enrollment was Dec 2019 to Oct 2020 at 79 US sites. Requirements included 3 metabolic risk factors, fibroscan (FS) ≥5.5 kPa/CAP≥280 dBm, MRI-PDFF≥8%. Randomization was 1:1:1:1 to 3 DB arms, PBO, 80 or 100 mg RES (n = 972) or an 100 mg open label (OL) arm (n = 171). The primary objective was to evaluate the safety and tolerability of 80 or 100 mg RES versus PBO measured by the incidence of adverse events (AEs). Results: At baseline the DB safety population (n = 969) was age 55.9 (11.8);female, 54.4%, white 88.6%;hispanic 34.7%;BMI 35.3 (6.0) type 2 diabetes 49%, hypertension 76.1%, dyslipidemia 87.9%;FS 7.4 (4.7) kPa. Discontinuations (22.5%) did not differ by treatment, most patient decision (pandemic related). DB compliancewas impacted by COVID drug kit delays. AE withdrawals were 80 mg, 2.4%;100 mg, 2.8%;PBO, 1.3%. The primary objective was met. TEAEs were 80 mg, 88.4%;100 mg, 86.1%;PBO, 81.8%. TEAEs ≥grade 3 severity were 80 mg, 7.6%;100 mg, 9.0%;PBO, 9.1%. AEs in excess of PBOwere grade 1–2 AEs of diarrhea (80 mg, 23.5%;100 mg, 31.2%;PBO, 13.8%) and nausea (80 mg, 11.9%;100 mg, 18.2%;PBO, 7.9%), in the first few weeks. ALT increases ≥3XULN were 80 mg, 0.61%;100 mg, 0.31%;PBO,1.6%. Therewere no changes in bodyweight or HR. BP decreased by 2–3 mmHg in the RES arms. Key 2o end points were met (Table). Comparative mean reduction in FS VCTE was not significant;a responder analysis of FS and MRE showed significant reductions with RES treatment. Conclusion: RES achieved the primary safety end point in this 52- week Phase 3 NAFLD clinical trial that identified patients by metabolic risk and non-invasive imaging. Key 2o end points were met including LDL-C, ApoB, triglycerides, MRI-PDFF, FS (CAP).(Table Presented) 1MRE combined RES groups.

5.
Gastroenterology ; 162(7):S-1284, 2022.
Article in English | EMBASE | ID: covidwho-1967448

ABSTRACT

BACKGROUND: Turmeric (curcumin) is a commonly used over-the-counter herbal product whose uses include diarrhea, arthritis, cancer and even COVID-19. Recently turmeric has been implicated in cases of clinically apparent liver injury with jaundice. The aim of this case series is to describe the clinical, histologic and human leukocyte antigen (HLA) associations of turmeric-associated hepatotoxicity as seen in the U.S. Drug Induced Liver Injury Network (DILIN) Prospective Study. METHODS: All adjudicated cases enrolled in DILIN between 2003-2020 with turmeric as an implicated product were reviewed. Causality was assessed using a 5-point expert opinion score. Available products were collected and analyzed for the presence of turmeric using ultra-high-performance liquid chromatography. Genetic analyses included HLA sequencing. RESULTS: Of 1697 cases of drug-induced liver injury judged to be definite, highly likely or probable (high confidence), nine (0.5%) were attributed to turmeric, all of which were enrolled since 2012, and 6 since 2017 (Figure). The 9 cases included 7 women, 8 whites, with a mean age of 51 years (range, 35-62 years) and BMI 25 kg/m2 (range, 15-40). Seven patients used alcohol, but none to excess, and none had underlying liver disease. Turmeric was used for an average of 102 days before onset of injury (range, 30-425 days). Initial mean ALT was 1179 U/L (range, 328-2245), ALP 211 U/L (41-441), total bilirubin 5.9 mg/dL (1.2-10.8), and INR 1.0 (0.9-1.2). Six patients developed jaundice, and serum bilirubin peaked at 9.6 mg/dL (0.8-26), and INR 2.3 (1.0- 9.7). Liver injury was hepatocellular in 8 patients (mean R = 22). Five patients had elevated antinuclear antibody (ANA) titer and two anti-smooth muscle (ASM) antibody, but none were treated with corticosteroids. Liver biopsy in 5 patients showed portal and lobular mixed inflammatory infiltrates with lymphocytes and eosinophils typical of drug-induced liver injury. Five patients were hospitalized, and one patient died of acute liver failure. Chemical analysis confirmed the presence of turmeric in all 7 products analyzed;3 also contained piperine (black pepper), and none contained green tea. Of 7 patients with HLA typing available, 4 carried HLA-B*35:01, a class I HLA allele previously implicated in both green tea and Polygonum multiflorum hepatotoxicity. CONCLUSION: Liver injury due to turmeric appears to be increasing, perhaps, reflecting usage patterns or increased combination with black pepper, which increases its absorption. Turmeric liver injury, similar to that caused by other polyphenolic herbal products, is typically hepatocellular, with a latency of 1 to 6 months, and is linked to HLA-B*35:01. While most cases are self-limited, the injury can be severe and result in death or liver transplantation.

6.
Gastroenterology ; 162(7):S-1251, 2022.
Article in English | EMBASE | ID: covidwho-1967440

ABSTRACT

Background and Aim: The COVID-19 pandemic has modified liver disease-related care delivery with implementation of telemedicine, previously unavailable in safety net settings. We aimed to assess patient satisfaction with telemedicine for hepatology care (telehepatology) in vulnerable populations with fatty liver disease (FLD). Methods: From 06/01/2020-11/ 30/2021, 218 consecutive participants with non-alcoholic or alcohol-related FLD with or without advanced fibrosis/cirrhosis receiving care in hepatology clinics within the San Francisco safety net health care system were surveyed by phone or in person. Sociodemographic and clinical parameters were captured by self-report and through the electronic medical record. Satisfaction with telehepatology was measured using a Likert scale from 1-5 with 1 representing “very dissatisfied” and 5 representing “very satisfied”. Median time of survey assessment since onset of the pandemic (03/01/2020) was 60.3 (range 8.7-90.3) weeks. Alcohol use in the prior 12 months was categorized as none, moderate (#1 drink/day for women and #2 drinks/day for men), and heavy (>moderate). Severity of liver disease was assessed by liver biopsy (n=97), MR elastography (n=88), or presence of liver nodularity on abdominal imaging (n=33). Descriptive analyses were performed and multivariable models were used to assess factors associated with satisfaction with telehepatology, adjusting for age, sex, and time since pandemic onset. Results: Median participant age was 52 years, 62% were female;60% Hispanic, 20% Asian, 11% White, 3% Black, 6% other race/ethnicity;and 75% were non-English speakers. 37% used alcohol (23% had heavy alcohol use), 40% had diabetes, and 35% had advanced (stage 3-4) fibrosis/cirrhosis. 166 participants (76%) had received telemedicine care and 126 (58%) had telehepatology. Overall, 72% reported satisfaction (55% very satisfied) with telehepatology. A similar proportion of those with and without advanced fibrosis/cirrhosis were satisfied with telehepatology (70% vs 71%, p=1.0). Alcohol consumption (vs none) especially moderate use appeared to be associated with less satisfaction (Coef -1.1, p=0.004 for moderate use and Coef -0.5, p=0.2 for heavy use) but no other sociodemographic or clinical factors were associated with telehepatology satisfaction on multivariable analysis. Conclusions: In this diverse and vulnerable population, in which a significant proportion had advanced fibrosis/cirrhosis FLD, over 70% were satisfied with telehepatology. Importantly, alcohol use negatively impacted perceived satisfaction with telehepatology, suggesting that patients who use alcohol may benefit from adaptations to telemedicine care delivery. As vulnerable populations have known barriers to healthcare access, telehepatology represents an important modality for liver care, and has the potential for reducing health disparities.

7.
Gastroenterology ; 162(7):S-1250-S-1251, 2022.
Article in English | EMBASE | ID: covidwho-1967438

ABSTRACT

Background: Tocilizumab is a humanized monoclonal antibody that targets Interleukin-6 receptors. Recent trials have shown that tocilizumab may be effective against COVID-19. It is also known that tocilizumab may be associated with mild aminotransferase elevation, however, there are very limited data on hepatotoxicity of tocilizumab in patients with COVID- 19. Here we report our institutional experience on the development of liver injury after tocilizumab use in hospitalized patients with COVID-19. Methods: We analyzed all consecutive adult hospitalized patients who had PCR confirmed COVID-19 and were admitted to our hospital network between January 1st, 2021, and November 15th, 2021. To be considered eligible for inclusion patients should had an admission liver injury panel and at least one additional follow-up panel before discharge. Patients with baseline alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times of the upper normal limit were excluded. Liver injury was measured by ALT, AST, or total bilirubin elevation. Grading was based on the Common Terminology Criteria for Adverse Events version 5.0. The primary outcome of interest was to estimate the incidence of liver injury among patients who received tocilizumab. As a secondary outcome, we examined the association of all-grade liver injury with tocilizumab use by utilizing a multivariate logistic regression model adjusted for demographics, comorbidities, Remdesivir use, and baseline COVID-19 severity based on the NEWS score. Results: Among 1409 consecutive hospitalized patients who met the inclusion criteria, we identified 87 patients who received tocilizumab. Baseline patient characteristics are depicted on Table 1. We found that the incidence of any grade AST elevation was higher in the tocilizumab versus non-tocilizumab group (24.1% vs 13%;p=0.015), with similar findings in ALT (32.1% vs 18%;p=0.016) and bilirubin (18% vs 4.5% p<0.001) (Table 2). Likewise, in our multivariate logistic regression model, patients who received tocilizumab were more likely to have had elevated ALT (OR 2.16;95% CI: 1.31-3.55), AST (OR 2.56;95% CI: 1.48-4.43), or bilirubin (OR 3.30;95% CI: 1.57-6.92), compared to those who did not receive the drug. Conclusion: While tocilizumab is frequently utilized in the treatment of COVID-19 patients, few studies have evaluated its hepatotoxic potential in this population. Based on our institutional experience, tocilizumab use in hospitalized patients with COVID-19 is associated with ALT, AST, and bilirubin elevation even after adjusting for COVID-19 severity. However, the majority of hepatic injury events were graded as level I (mild injury) and severe hepatotoxicity was rare. Further studies are needed to confirm these findings, while monitoring of hepatic function after tocilizumab use is warranted, especially in patients with chronic liver disease. (Table Presented)

8.
Gastroenterology ; 162(7):S-1249, 2022.
Article in English | EMBASE | ID: covidwho-1967434

ABSTRACT

Background: Alcohol-associated hepatitis (AH) is the most severe form of alcohol-related liver disease, with rising incidence. Stay-at-home orders for the COVID-19 pandemic were associated with increased alcohol consumption. Online sales reported a 262% increase from March 2019 to 2020. Aims: The purpose of this study was to track the epidemiology of hospitalizations for AH by sex before and after the COVID-19 pandemic. We hypothesized that AH would be more severe in females and younger individuals during the pandemic. Methods: Using the Discharge Database, we identified all hospitalizations for adults > 18-years-old in Alberta with international classification of disease-10 codes for AH between March 2018 and September 2020. We merged this dataset with provincial laboratory data to identify all inpatient lab values. We calculated Model for End-Stage Liver Disease (MELD) and Maddrey scores and validated a laboratory-based algorithm for AH. Severe AH was defined as Maddrey score > 32. Onset of the pandemic was defined as March 2020. Stratified by pandemic onset, descriptive statistics were done with Chi-squared and Kruskal Wallis tests. Inpatient mortality was assessed as a primary outcome. Binomial regression was used to assess changes in frequency of admission for AH with the denominator as all cirrhosisrelated admissions over the same time-period. Results: We identified 991 hospitalizations for AH prior to the pandemic (n=381, 38.5% female) and 417 during the pandemic (n= 144, 34.5% female). Hospitalizations for AH significantly increased during the pandemic (p = 0.04) (Figure 1). Median Maddrey score for females (30.5) before the pandemic was significantly higher than for males (22.9), p < 0.01. During the pandemic, median Maddrey for females (28.7) was higher than males 21.4, p = 0.07. Median age at admission was significantly lower for both males and females during the pandemic (age 44 and 41, respectively) as compared to prior (age 47 and 45, respectively) p < 0.05. There was no significant difference in MELD between sexes before (13.5 for females, 14.0 for males, p = 0.15) and during the pandemic (13.3 for females, 13.0 for males, p = 0.75). Additionally, there was no significant difference in mortality between sexes before (10.4% in females, 11.5% in males, p = 0.22) and after the pandemic (9.2% in females, 9.9% in males, p = 0.67). Conclusions: Hospitalizations for AH rose during the pandemic and occurred at younger ages. There was no significant difference in disease severity or mortality before and during the pandemic. Females have more severe AH by Maddrey score, but not by MELD than males. Public health efforts should continue to be made to educate about the harms of alcohol excess and offer community support. Future studies will expand the trend through multiple pandemic waves. (Figure Presented)

9.
Gastroenterology ; 162(7):S-1247-S-1248, 2022.
Article in English | EMBASE | ID: covidwho-1967430

ABSTRACT

Introduction COVID-19 vaccines have been shown to be effective in preventing hospitalization due to COVID-19 infection. However, safety remains a concern. Some studies have linked the vaccine to the development of autoimmune diseases such as myocarditis and immune thrombocytopenic purpura. During the summer of 2021, an increasing number of case reports began to emerge documenting a small number of individuals who developed autoimmune hepatitis (AIH) following COVID-19 vaccination. These cases are rare, novel, and very little is known. In our systematic review, we analyzed every published case of AIH and reviewed their characteristic findings, treatment, and outcomes. Methods We searched PubMed, Embase, and Web of Science from 1 December 2019 to 1 November 2021. Keywords included but were not limited to “COVID-19,” “vaccine,” and “autoimmune hepatitis.” Two researchers independently extracted information from the articles about vaccine type, patient history, characteristics, laboratory values, histology results, treatment regimens, and disease course. Results Thirty-two patients developed AIH after receiving a COVID-19 vaccine (16 Pfizer-BioNTech, 13 Moderna, 3 Oxford-AstraZeneca), of whom 17 were from the United States, 11 were from Europe, 3 were from Asia, and 1 was from Australia. Sixty-nine percent of patients were women and 58% had no history of liver or autoimmune disease. Jaundice was the most common symptom (81%). Nineteen percent of patients were initially asymptomatic and presented with abnormal liver enzymes found during routine bloodwork. (Table 1) Mean ALT, AST, and bilirubin were 1231 U/L, 921 U/L, and 14 mg/dL. Anti-nuclear antibody and anti-smooth muscle antibody were positive in 56% and 28% of patients. Liver biopsy was performed in 81% of patients with findings strongly suggestive of AIH. Corticosteroids were used in 74% of patients with a mean time to disease resolution of 28 days. Improvement or complete resolution was seen in 97% of patients. (Table 2) One patient died despite aggressive steroid treatment. Discussion COVID- 19 vaccine-induced AIH is extremely rare with just 32 documented cases in the literature. Although causality cannot be proved, this phenomenon should not be treated as coincidence. Clinicians should be aware of this rare but real complication and suspect vaccine-induced AIH in patients who present with jaundice and abnormal liver enzymes following COVID- 19 vaccination. Treatment with corticosteroids appears to be highly effective, with improvement or resolution in 97% of patients. Our findings highlight the rarity of COVID-19 vaccine-induced AIH and should under no circumstances deter individuals from getting vaccinated as the benefits of vaccination far outweigh the risks. (Table Presented)

10.
Gastroenterology ; 162(7):S-1246-S-1247, 2022.
Article in English | EMBASE | ID: covidwho-1967427

ABSTRACT

Introduction: Exacerbation of pre-existing autoimmune disease and de novo vaccine-related autoimmunity after SARS-CoV-2 vaccine has been reported. These observations could lead to vaccine hesitancy among autoimmune hepatitis (AIH) patients. We aimed to assess hesitancy as well as prevalence of flare and disease onset after vaccination in an online AIH cohort. Methods: Electronic invitation to complete a vaccine-specific questionnaire was posted weekly to the Autoimmune Hepatitis Association (www.aihep.org) social media communities (membership: 4700) over 3-weeks. Individuals 18 years or older with AIH diagnosis made by a physician were eligible. Vaccine hesitancy was defined as not receiving SARS-CoV-2 vaccine. AIH flare was defined as abnormal liver tests, when previously normal for 1 year, requiring escalation of immunosuppression within 2 months of SARS-CoV-2 vaccine. Continuous variables were summarized as means and standard deviations and pvalues were obtained using the Student's T-test. P-values for discrete variables were obtained from the Chi-Square test. The study was approved by local institutional review board. Results: A total of 643 individuals, 91.9% female, 91.8% white, mean age of 54 years and disease duration of 7 years, completed the questionnaire. A majority (599, 93.2%) had received at least 1 dose of vaccine including Pfizer-BioNTech (50.2%), Moderna (35.2%), AstraZeneca (11.1%), and Johnson & Johnson (3.5%). Hesitant patients were less likely female (79.5% vs 92.8%), younger (48 vs 55 years) and had higher prevalence of COVID- 19 infection (27.3% vs 10.2%) compared to vaccinated (p < 0.005 for all). Among those eligible, 95.3% received a second dose and 53.7% a third dose. Five patients did not receive a second vaccine dose because of prior adverse reactions or liver test elevations. A third dose was not administered to 263 patients because it was too early (57%), patient choice (21%), adverse side effects (9%), initial vaccine was Johnson & Johnson (7%), or abnormal liver tests (6%). Among those with normal liver tests prior to vaccination, 5% (15/288) reported increased tests after first or second dose. Liver test elevations were more likely in non-white (67% vs 95%, p = 0.001) and Hispanic/Latino patients (27% vs 4%, p = 0.001) compared to those without elevations. Only 2 patients had disease flare after first dose, whereas no AIH flares were reported after second. New diagnosis of AIH was reported 2 months beyond vaccination in 7% of vaccinated patients (42/599): 16 after first dose and 26 after second dose. Conclusion: SARS-CoV-2 vaccine hesitancy among AIH patients was minimal compared to the national average. Reports of liver test elevation and disease flare were rare after vaccination. New AIH diagnosis near vaccine was reported, yet new diagnosis was also observed in vaccine hesitant patients. (Table Presented)

11.
Gastroenterology ; 162(7):S-1222, 2022.
Article in English | EMBASE | ID: covidwho-1967424

ABSTRACT

Background: Data have shown an increase in alcohol use during the COVID-19 pandemic in North America. While the total number of emergency department (ED) visits decreased during the early pandemic, some studies show that the proportion of alcohol-associated visits increased during this time. There is otherwise a paucity of data on how potentially increased alcohol use during the pandemic has affected healthcare utilization and patient outcomes, especially in patients with liver disease. Methods: Clinical records from a tertiary hospital in Ontario, Canada were reviewed for all adult patients encounters in the ED, urgent care, or inpatient setting for alcohol-associated reasons between April 2019 and October 2019 (pre-pandemic cohort) and between April 2020 and October 2020 (pandemic cohort). Data collected included: age, sex, marital status, rurality and socioeconomic status (by postal code-linked national census data), medical history, alcohol consumption habits, use of medications for alcohol use disorder, alcohol-associated diagnosis (based on ICD-10 code), need for intensive care unit admission, consultations made, discharge disposition, and laboratory results. Bivariate chi-squared analysis was performed to compare data from the pre-pandemic and pandemic cohorts. Results: 528 records in the pre-pandemic cohort and 490 records in the pandemic cohort were ed and summarized (Tables 1 and 2). As compared with the pre-pandemic cohort, patients during the pandemic presenting with alcohol-associated diagnoses were older (43 years, IQR 31-57 vs. 38 years, IQR 24-55;p<.001), more likely to be male (66% vs. 55%;p=.001), have a prior history of habitual heavy alcohol use or alcohol use disorder (77% vs. 63%;p<.001), have a history of a psychiatric disorder (56% vs 46%;p=.003), and to have been previously prescribed medication for alcohol use disorder (18% vs. 5%;p<.001). In the pandemic cohort, there was a greater proportion of encounters for alcohol withdrawal (32% vs. 22%;p=.001), a lower proportion of encounters for alcohol intoxication (46% vs. 56%;p<.001), and a similar proportion of encounters for alcohol-associated liver disease (8% vs. 7%;p=.651) compared to the pre-pandemic cohort. Conclusion: Our data show differences in patient characteristics for patients presenting to hospital for alcohol-associated reasons during the COVID-19 pandemic. As compared with the year before the pandemic, patients were older, more often male, and more likely to have history of psychiatric disorders or heavy alcohol use. One concerning finding was a significant rise in alcohol withdrawal, which could potentially be due to increased consumption of alcohol during the pandemic. These data raise concern for an increase in prevalence of alcohol-associated liver disease in the future, highlighting the need for enhanced alcohol addiction services. (Table Presented)

12.
Gastroenterology ; 162(7):S-1081, 2022.
Article in English | EMBASE | ID: covidwho-1967405

ABSTRACT

Background: The spread of COVID-19 has had a major impact on the health of people worldwide. The clinical background and clinical course of Japanese inflammatory bowel disease (IBD) patients with COVID-19 remains unclear. Patients with IBD are often on immunosuppressive therapy, and there has been concern about the severity of COVID-19. We conducted the multicenter registry study of Japanese patients with inflammatory bowel disease with COVID-19. Methods: This study is an observational cohort of Japanese IBD patients diagnosed with COVID-19, and was registered in the UMIN Clinical Trials Registry (ID UMIN000040656). Data on age, gender, IBD (classification, treatment, and activity), COVID-19 symptoms and severity, and treatment of COVID-19 were analyzed. Results: From 72 facilities in Japan, one hundred eighty-seven patients were registered from June 2020 to October 2021 (Table1). The estimated incidence ratio of COVID19 in Japanese IBD patients was 0.61%. The median age (±SD) was 42.0±15.6, 4.8% of patients were obese with BMI >30, 7.0% were current smokers, and 31.0% had some complications. Of the patients enrolled, 104 had ulcerative colitis, 74 had Crohn's disease, 3 had IBD-Unclassified, and 6 had intestinal Behcet's disease. The majority of IBD patients with COVID-19 (73%) were in clinical remission. COVID-19 cases were most common in the 20-50 age group, but the COVID-19 severity rate according to WHO classification tended to be higher in the elderly than in middle-aged persons (Figure1). In Japan, the second SARS-CoV-2 vaccination rate jumped from 0% to 90% in just four months from May to September 2021 because the elderly received vaccination preferentially. Therefore, during the fifth wave of the epidemic (July-September 2021), infections among elderly IBD patients were particularly low compared with the younger. According to WHO classification regarding COVID-19 severity, 172 patients (92%) had non-severe, 12 (6%) were severe including serious conditions. Most IBD patients (UC and CD) with COVID-19 had no change in disease activity. A logistic regression analysis stepwise method revealed that older age, higher BMI, and steroid use were risk factors for COVID-19 severity. Six of eight patients who had COVID-19 after vaccination were receiving anti-TNF-alpha antibodies. Conclusion: The estimated incidence ratio of COVID19 in Japanese IBD patients was 0.61%. Age, BMI, and steroid use were associated with COVID-19 severity in Japanese IBD patients. (Table Presented) Table1. Case profile of the registered patients (Figure Presented) Figure1. The Age distribution of patients with COVID-19 and the COVID-19 severity rate

13.
Gastroenterology ; 162(7):S-1006-S-1007, 2022.
Article in English | EMBASE | ID: covidwho-1967394

ABSTRACT

Introduction Since inflammatory bowel disease (IBD) patients were excluded from vaccine authorization studies, limited knowledge exists regarding perceptions for and unfavorable effects of COVID-19 vaccination in this group. The aim of this study was to investigate the real world use and adverse events (AE) of vaccines against COVID-19 in IBD patients. Aims and Methods Fully vaccinated IBD patients followed in Greek centers were invited to participate in an anonymous online self reporting survey that included information regarding their demographics, clinical characteristics, treatment, vaccination perceptions and potential AE. Patients were vaccinated with either messenger-RNA or viral vector vaccines that are currently EMA approved. AE were stated as any kind of new symptom or sign onset, including localized (at the injection site) or systematic ones (fatigue, headache, allergic reactions, fever, lymphadenopathy, myalgias/arthralgias and gastrointestinal disorders). Results A total of 1007 IBD patients [male 50.5%, median age (IQR) 44 (35-55) years, Crohn's disease 64.3%, history of COVID-19 infection 2.6%] who completed the survey after they have fulfilled their vaccination program were included. Detailed demographics and clinical characteristics of the study population are presented in Table 1. More than half of the patients (51%) stated that they show confidence in vaccination whereas the rest although hesitant admitted the protection it offers. The median (IQR) time between 2nd vaccine dose and questionnaire completion was 15 (5-43) days. There were no serious AE leading to emergency room visit or hospitalization. Total AE were reported by 81% after dose 1 (D1) and 76% after dose 2 (D2), reduced to 44% and 51% when excluding isolated injection site reactions respectively. Systemic AEs were more common after D2 (P<0.0001). Very few patients reported new onset abdominal symptoms [abdominal pain 4% (D1), 6% (D2) and diarrhea 5% (D1), 7% (D2)]. In the multiple regression analysis AE occurrence was positively associated with young age, female gender and blood type AB rhesus positiveafter both doses, whereas inactive disease was negatively associated with AE only in D1 (p= 0.044) No association with the use of medications including advanced therapy was found (p>0.05), except from corticosteroids after D2 (p=0.003) but it was a small (32/1007 patients) heterogenous (monotherapy, double or triple immunosupression) sample to draw conclusions (Table 2). Conclusions The presence of SARs-CoV-2 vaccination AE in Greek patients with IBD is similar to the reported in other populations. Young age and female gender but not IBD related medications are associated with the development of AEs after both doses. (Table Presented) (Table Presented)

14.
Gastroenterology ; 162(7):S-1006, 2022.
Article in English | EMBASE | ID: covidwho-1967393

ABSTRACT

Introduction: Pivotal anti-SARS-CoV-2 vaccines clinical trials did not include patients with immune-mediated conditions such as inflammatory bowel disease (IBD). We aimed to describe the implementation of anti-SARS-CoV-2 vaccines among IBD patients, patients' concerns before vaccination and side-effect profile of the anti-SARS-CoV-2 vaccines using real-world data. Methods: An anonymous web-based self-completed survey was distributed in 36 European countries between June and July 2021. The results of patients' characteristics, concerns, vaccination status and side-effect profile were analysed using descriptive statistics and logistic regression. Results: Among the 3272 IBD patients completing the survey (0.1% of the IBD European population), 79.6% had received at least one dose of anti-SARS-CoV- 2 vaccine, and 71.7% had completed the vaccination process. Most of the patients (70.6%) were vaccinated with the Pfizer-BioNTech (BNT162b2) vaccine. Patients over 60 years old had a significantly higher rate of vaccination (OR 2.98, 95% CI 2.20-4.03, p<0.001). Patients' main concerns before vaccination were the possibility of having worse vaccine-related adverse events due to their IBD (24.6%), having an IBD flare after vaccination (21.1%) and reduced vaccine efficacy due to IBD or associated immunosuppression (17.6%). After the first dose of the vaccine, 72.4% had local symptoms at the injection site and 51.4% had systemic symptoms (5 patients had non-specified thrombosis). Adverse events were less frequent after the second dose of the vaccine and in older patients. When comparing with previous studies from the general population, the IBD patients answering the survey did not seem to have increased side effects (table 1). Only a minority of the patients were hospitalized (0.3%), needed a consultation (3.6%) or had to change IBD therapy (13.4%) after anti- SARS-CoV-2 vaccination. Conclusion: Although IBD patients raised concerns about the safety and efficacy of anti-SARS-CoV-2 vaccines, the implementation of vaccination in those responding to our survey was high and the adverse events were comparable to the general population, with minimal impact on their IBD. (Table Presented)

15.
Gastroenterology ; 162(7):S-601, 2022.
Article in English | EMBASE | ID: covidwho-1967350

ABSTRACT

Introduction: The International Organization for the Study of Inflammatory Bowel Disease (IBD) has recommended vaccination of all patients with IBD as soon as they are able to receive the vaccine, regardless of immune-modifying therapies or disease activity. Nevertheless, some articles have shown a large percentage of individuals who are unwilling to receive the COVID-19 vaccine with fear of potential adverse events. Moreover, IBD patients were excluded from safety and efficacy phase III vaccine trials, as well as those treated with immunosuppressive therapies. Thus, we performed a monocentric real-life survey to assess the adverse events of COVID-19 vaccination among patients with IBD under biologic therapy. Methods: All adult individuals with IBD undergoing biological treatment and followed at Centro Hospitalar Universitário de São João were included. Each patient answered a telephone questionnaire conducted by a gastroenterologist. Results: A total of 301 patients agreed to participate in the study, the majority females (53.2%), with a median age of 42 years old (IQR 32-54). IBD diagnosis included Crohn's disease (76.7%) and ulcerative colitis (23.3%). The proportions of patients receiving tumor necrosis factor inhibitors, ustekinumab and vedolizumab were 75.4%, 13.0% and 11.6%, respectively. This cohort included 239 vaccinated patients (59.0% Pfizer-BioNTech, 20.5% Moderna, 14.2% Janssen and 6.3% AstraZeneca), 173 (57.5%) of whom had complete vaccination. Of the remaining individuals, only 12 did not intend to be vaccinated. The main reasons were: fear of potential adverse events (50.0%), lack of confidence in the vaccine development process (25.0%) and little information about vaccination in IBD patients (16.6%). Among vaccinated patients, the overall adverse events frequency was 56.8% after dose 1 (D1) and 74.1% after dose 2 (D2). The most common symptoms were localized injection-site reactions and fatigue. The vast majority of adverse events were mild and lasted only a few days. Only 4 (1.7%) patients had IBD exacerbation after the vaccine. No serious adverse events were reported and any patient was hospitalized. The percentage of adverse events was higher among patients younger than 50 years (77.6% vs 62.5% after D1, p=0.011;83.0% vs 58.8% after D2, p=0.002). No significant differences were seen based on sex, vaccine type, biologic drug or disease type. Compared to the general population, a lower percentage of IBD patients suffered from local or systemic reactions during the first week after vaccination (Figure 1). Conclusion: We found a high acceptance rate and a good safety profile of SARS-CoV-2 vaccination in IBD patients treated with biologics drugs. Indeed, adverse events were common but overall mild and transitory. These data support the prioritization and rapid vaccination of these individuals. (Figure Presented) Figure 1 – Adverse reactions occurring within seven days after vaccination in IBD patients compared with the general population.

16.
Gastroenterology ; 162(7):S-597-S-598, 2022.
Article in English | EMBASE | ID: covidwho-1967343

ABSTRACT

Background: Vaccination has proven to be an effective public health measure to combat the SARS-CoV-2 pandemic. However, vaccine “hesitancy” has limited uptake in some populations. We surveyed individuals with inflammatory bowel disease (IBD) to explore factors associated with vaccine uptake, concerns, and which sources of information were considered trustworthy surrounding vaccination. Methods: Patients with IBD were recruited from a specialist IBD clinic at a tertiary hospital in Australia, and through a national IBD patient society (Crohn's & Colitis Australia). Patients were invited to complete an anonymous electronicsurvey between 31 October – 17 November 2021. Logistic regression was used to identify variables associated with vaccine uptake, using SPSS (Version 13.0 IBM). Results: There were a total of 441 respondents. Demographic and IBD characteristics are presented in Table 1. There were 337 females and 98 males. 262 (59.4%) had Crohns disease, 161 (36.5%) ulcerative colitis, and 18 (4.1%) indeterminant colitis. Most respondents 411 (93.2%) had received at least 1 dose of COVID-19 vaccination. 283 (61.9%) obtained BNT162b2 Pfizer, 133 (30.2%) ChAdOx1 nCoV-1 Astra Zeneca, and 5 (1.1%) mRNA-1273 Moderna. Most agreed that that vaccination in general was safe 306 (90.1%). Among 30 (6.8%) respondents who had not been vaccinated, concern about experiencing an IBD flare with vaccination and vaccine safety were most commonly identified. Multivariate analysis (Table 2) demonstrated past influenza vaccination (OR 3.28, 95% CI 1.34-8.9, p = 0.009) and self-perceived risk of being more unwell with COVID-19 infection due to IBD was positively associated with COVID-19 vaccine uptake (OR 5.25, 95% CI 1.96-14.04, p <0.001). The perceived risk of COVID-19 vaccination causing an IBD flare, and concern that vaccination is unsafe in pregnancy were both negatively associated with vaccine uptake (OR 0.28, 95% CI 0.10-0.77, p = 0.01) and (OR 0.22, 95% CI 0.08-0.65, p = 0.006) respectively. . Trust in healthcare workers was high with 282 (73.7%) responders ranking them the most trusted source to obtain information surrounding vaccination. Social media was ranked the least trusted source of information by 225 (58.6%). Conclusion: Past influenza vaccination and self-perceived risk of being more unwell with COVID-19 due to IBD, were positive predictors of COVID-19 vaccine uptake in IBD patients. Concerns about an IBD flare with vaccination is a unique consideration in those vaccine hesitant and is a negative predictor of vaccine uptake. Healthcare providers were ranked the most trusted source of information, highlighting the key role they have in exploring vaccination concerns and misconceptions in IBD patients. This is particularly so when navigating rapidly changing vaccine recommendations, and in the consideration of primary third dose and booster vaccination uptake. (Table Presented) (Table Presented)

17.
Gastroenterology ; 162(7):S-564-S-565, 2022.
Article in English | EMBASE | ID: covidwho-1967331

ABSTRACT

Introduction: SARS-CoV-2, the causative organism for COVID-19, uses ACE2 to enter human cells. Pancreatic ductal, acinar and islet cells also express ACE-2;therefore, involvement of the pancreas is plausible. Elevated lipase and cases of acute pancreatitis related to COVID-19 have been reported in previous studies. Patients with chronic pancreatitis (CP) have a low-grade inflammatory state and pancreatic parenchymal fibrosis, which may predispose them to pancreatic injury and worse COVID-19 outcomes. However, large studies reporting the incidence and outcomes of COVID-19 in patients with chronic pancreatitis are lacking. Methods: A retrospective cohort study was performed using TriNetX (a multiinstitutional research network). Prevalence and Incidence Rate Ratio (IRR) (cases/ personday) of COVID-19 were charted for patients with CP between January 2020 and July 2021. Patients diagnosed with COVID-19 during this period were stratified into two groups based on the presence of CP (CP cohort and non-CP cohort). Outcomes of COVID-19 in the CP cohort were compared to the non-CP cohort after 1:1 propensity score matching (PSM) for age, gender, race, diabetes, ischemic heart disease, hypertension, lung disease, cirrhosis, smoking, and alcohol abuse. Results: A total of 4420 patients with CP diagnosed with COVID-19 were identified and compared to 1,169,773 patients without CP. A large proportion of patients with CP were diagnosed with COVID-19 and the IRR peaked between December 2020-January 2021 and then declined subsequently (Figure 1). Patients in the CP cohort were older and had a higher prevalence of multiple comorbidities (Table 1). In crude, unmatched analysis, COVID-19 patients with CP had higher mortality (4.96% vs 2.16%;RR: 2.29, 95% CI:2.02-2.61), need for hospitalization (RR: 3.64, 95% CI:3.47-3.83), critical care need (RR: 3.16, 95% CI:2.86-3.50), and acute kidney injury (AKI) (RR: 3.96, 95% CI:3.71-4.24) compared to patients without CP (Table 1). No residual imbalance was noted (SMD <0.1 for all covariates) after PSM. After PSM, no difference in mortality or rate of mechanical ventilation was noted, however, patients with CP had a significantly higher risk of hospitalizations (RR: 1.51, 95% CI:1.39-1.64) and AKI (RR: 1.28, 95% CI:1.16-1.42) (Table 1). No difference in mortality, hospitalization, and critical care was noted for patients with alcohol-induced CP vs other etiologies. Conclusion: Patients with CP have high mortality and risk of poor outcomes after COVID-19 due to the presence of a significant burden of comorbidities and risk factors for severe COVID-19. In addition, CP is independently associated with higher healthcare utilization and complications such as AKI in patients with COVID-19. (Figure Presented) Figure 1: Prevalence and Incidence rate (cases/person-day) of COVID-19 in patients with chronic pancreatitis (Table Presented) Table 1. Characteristics and outcomes of patients with COVID-19 in matched and unmatched Chronic Pancreatitis (CP) and non-CP cohorts

18.
Gastroenterology ; 162(7):S-363, 2022.
Article in English | EMBASE | ID: covidwho-1967298

ABSTRACT

Background: A recent study showed that CeD patients have greater hesitancy in receiving the COVID-19 vaccine, mainly due to fear of adverse events. It is unclear if the rate of adverse events post-vaccine administration is higher in CeD compared to non-celiac population. Aims: To assess the prevalence of adverse events related to COVID-19 vaccine administration in patients with CeD compared to non-CeD controls, and to explore factors that predict the risk of adverse events related to COVID-19 vaccine. Methods: This is a preliminary analysis of an ongoing study conducted at McMaster Adult Celiac Disease Clinic. We collected data prospectively in a cohort of adult patients with a diagnosis of CeD attending our clinic and compared with non-CeD controls (university personnel). CeD diagnosis was based on serology, biopsy, and HLA DQ2/DQ8 in discrepant cases. Data collected included demographics, CeD activity through serology, adherence to the gluten-free diet (GFD), prior COVID-19 infection, vaccine type and status, and any adverse events. Mild adverse events were classified as pain at the site, fatigue, fever/chills, nausea, headaches. Severe adverse events included anaphylaxis, thrombosis, myocarditis/pericarditis, and hospitalization or emergency visits due to vaccination. Data were expressed as median [IQR] for continuous variables and n/N (%) for categorical variables. Mann-Whitney U test and Fisher exact test were performed using SPSS (v26, IBM Corp) to assess differences between groups and logistic regression to assess predictors of adverse events. Results: An interim analysis was performed in 53 patients with CeD (25% male;median age of 34[25] years) and 46 controls (37% male;median age of 41[22] years). There were no differences in sex between CeD and controls, however, controls were older than CeD (p=0.04). Fifty-five % of CeD patients were strictly adherent with a GFD. There was no difference in the rate of COVID-19 infection between CeD and controls. All CeD patients and controls reported receiving two doses of COVID-19 vaccines. Eighty-three % of CeD received the same vaccine type in both doses, and 17% mixed vaccines vs 81% and 19% respectively for controls. There were no severe adverse events reported by CeD or controls. The most common mild adverse events reported in CeD and controls included pain at the injection site (27% vs 64%;p <0.001) and fatigue (11% vs 46%;p<0.001). Celiac activity, age, sex, or vaccine type did not predict adverse events in CeD patients for either dose. Conclusions: In this preliminary analysis, administration of COVID-19 vaccines did not lead to severe adverse and less mild adverse reactions in patients with CeD compared to non-CeD controls. These results should be confirmed in a larger population, and ideally, in a future multicentre study involving pediatric and adult populations from different countries.

19.
Gastroenterology ; 162(7):S-279, 2022.
Article in English | EMBASE | ID: covidwho-1967268

ABSTRACT

Background and Aims: Initial reports on US COVID-19 showed different outcomes in different races. In this study, we use a diverse large cohort of hospitalized COVID-19 patients to determine predictors of mortality. Methods: We analyzed data from hospitalized COVID- 19 patients (n=5,852) from 8 hospitals. Demographics, comorbidities, symptoms and laboratory data were collected. Results: The cohort contained 3,662 (61.7%) African Americans (AA), 286 (5%) American Latinx (LAT), 1,407 (23.9%), European Americans (EA), and 93 (1.5%) American Asians (AS). Survivors and dead patients' mean ages were 58 and 68 for AA, 58 and 77 for EA, 44 and 61 for LAT, and 51 and 63 for AS. Mortality rates for AA, LAT, and EA were 14.8%, 7.3%, and 16.3%. Mortality increased among patients with the following characteristics: age, male gender, New York region, cardiac disease, COPD, diabetes mellitus, hypertension, history of cancer, immunosuppression, elevated lymphocytes, CRP, ferritin, D-Dimer, creatinine, troponin, and procalcitonin. Use of mechanical ventilation, respiratory failure, shortness of breath (SOB) (p<0.01), fatigue (p=0.04), diarrhea (p=0.02), and increased AST (p<0.01), significantly correlated with death in multivariate analysis. Male sex and EA and AA race/ethnicity had a higher frequency of death. Diarrhea was among the most common GI symptom amongst AAs (6.8%). When adjusting for comorbidities, significant variables were age (over 45 years old), male sex, EA, patients hospitalized in Indiana, Michigan, Georgia, and District of Columbia. When adjusting for disease severity, significant variables were age over 65 years old, male sex, EA as well as having SOB, elevated CRP, and D-dimer. Glucocorticoid usage was associated with an increased risk of COVID- 19 death in our cohort. Conclusion: Among this large cohort of hospitalized COVID-19 patients enriched for African Americans, predictors of mortality include male gender, diarrhea, elevated AST, comorbidities, respiratory symptoms and failure, and elevation of inflammatory- related biomarkers. These findings may reflect the extent of systemic organ involvement by SARS-CoV-2 and subsequent progression to multi-system organ failure. High mortality in AA in comparison with LAT is likely related to a high frequency of comorbidities and older age among AA.

20.
Gastroenterology ; 162(7):S-278, 2022.
Article in English | EMBASE | ID: covidwho-1967264

ABSTRACT

Introduction: More adverse clinical outcomes following SARS-CoV-2 infection are reported in patients treated with infliximab/thiopurines (IFX/THIO), compared with biological monotherapy with anti-TNF or vedolizumab (VDZ). VDZ has been associated with a heightened and more durable serological response after infection and vaccination, compared to IFX. However, whether IBD patients on VDZ have a fully intact systemic response to SARS- CoV2 remains unknown. We explored the serological and functional neutralizing response after SARS-CoV-2 infection in IBD patients treated with VDZ, IFX or IFX/THIO compared to true healthy controls to guide treatment decisions and vaccination strategies. Methods: Serum from 640 IBD patients attending routine infusions in Oxford and London (May to December 2020) was screened by the Abbott assay for SARS-CoV-2 nucleocapsid (N) antibodies. Serum from seropositive patients was compared to seropositive health care workers (Table 1). Antibody reactivity to the SARS-CoV-2 wild type (WT) strain receptor-binding domain (RBD), full-length spike, and N was assayed by IgG/IgA ELISA over time as well as by IgG MSD V-PLEX ELISA at the time of seropositivity. A pseudotyped SARS-CoV-2 virus microneutralization assay was used to detect neutralizing antibodies to the WT, and an ELISA-based inhibition assay to compare differential inhibition of the WT vs. delta variant (DV) SARS-CoV-2 RBD-ACE2 interaction. Results: All IBD patients showed significantly reduced IgG antibody responses compared to healthy controls to all SARS-CoV-2 antigens, using MSD V-PLEX (Figure 1A-C). The greatest reduction in IgG response by ELISA was observed in patients treated with IFX/THIO (p=0.00019), whereas IgG response over time declined significantly faster in the IFX treated group (p=0.019). IgA responses were significantly reduced in the IFX/THIO group compared to healthy controls (p=0.009), but not in the IFX or VDZ group. The rate of decline in these monotherapy groups was not significantly different to healthy controls. Compared to healthy controls, functional SARS-CoV-2 neutralization was reduced in each treatment group (Figure 1D), with the greatest effect in patients receiving IFX/THIO (p=0.00000091). Neutralizing capacity to the DV was significantly reduced in 68.1% of IBD patients (30/44, p=0.0005). Conclusion: Both IFX and VDZ are associated with significantly reduced IgG responses to multiple SARS-CoV-2 antigens, and with impaired functional SARS-CoV-2 neutralizing antibody capacity, compared to healthy individuals. However, whilst IgG and neutralization responses are reduced in IBD patients on biological monotherapy, these findings were most pronounced in the combination treatment group. As neutralizing antibody responses are associated with protection, these observations may impact on decision-making regarding treatment and vaccination strategies.(Table Presented)(Figure Presented)

SELECTION OF CITATIONS
SEARCH DETAIL