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1.
J Crohns Colitis ; 14(12): 1780-1784, 2020 Dec 02.
Article in English | MEDLINE | ID: covidwho-1672170

ABSTRACT

BACKGROUNDS AND AIMS: We aimed to evaluate the safety of Bacille Calmette-Guérin [BCG] vaccination in infants born to mothers receiving anti-tumour necrosis factor [anti-TNF] therapy for inflammatory bowel disease. METHODS: Adverse events of BCG vaccination were evaluated in 90 infants who were last exposed to anti-TNF agents at a median of gestational week 30. RESULTS: After receiving BCG vaccination at a median age of 6 months [range, 0.25-11 months], three infants [3.3%] showed injection site swelling, two of whom also showed axillar lymphadenopathy. The rates of adverse events were similar between infants who were last exposed to anti-TNF agents before the third trimester [n = 35] and those who were last exposed in the third trimester [n = 55] [2.9% vs 3.6%; p = 1.00]. All adverse events were spontaneously resolved and there were no serious adverse events such as active tuberculosis infection or death. CONCLUSIONS: BCG vaccination after 6 months of age is of low risk in infants exposed to anti-TNF agents in utero.


Subject(s)
BCG Vaccine/adverse effects , COVID-19/complications , Inflammatory Bowel Diseases/diagnosis , Pneumonia/etiology , Tumor Necrosis Factor Inhibitors/adverse effects , BCG Vaccine/therapeutic use , COVID-19/drug therapy , COVID-19/epidemiology , Female , Humans , Infant , Infant, Newborn , Inflammatory Bowel Diseases/epidemiology , Male , Pneumonia/epidemiology , Tumor Necrosis Factor Inhibitors/therapeutic use
3.
RMD Open ; 7(3)2021 12.
Article in English | MEDLINE | ID: covidwho-1561469

ABSTRACT

BACKGROUND: The persistence of the SARS-CoV2 pandemic, partly due to the appearance of highly infectious variants, has made booster vaccinations necessary for vulnerable groups. Questions remain as to which cohorts require SARS-CoV2 boosters. However, there is a critical lack of data on the dynamics of vaccine responses in patients with chronic inflammatory diseases (CID) undergoing immunosuppressive/disease modifying anti-rheumatic (DMARD) treatment. Here, we present the first data regarding the decline of the vaccine-induced humoral immune responses in patients with CID. METHODS: 23 patients with CID were monitored clinically and for anti-spike IgG and IgA levels, neutralization efficacy and antigen-specific CD4+ T cell responses over the first 6 months after SARS-CoV2 vaccination. 24 healthy individuals were included as controls. RESULTS: While anti-spike IgG-levels declined in CID patients and healthy controls, patients receiving anti-TNF treatment showed significantly greater declines at 6 months post second vaccination in IgG and especially neutralizing antibodies. IgA levels were generally lower in CID patients, particularly during anti-TNF therapy. No differences in SARS-CoV2 spike-specific CD4+ T-cell frequencies were detected. CONCLUSION: Although the long-term efficacy of SARS-CoV2 vaccination in CID patients undergoing disease-modifying therapy is still not known, the pronounced declines in humoral responses towards SARS-CoV2 6 months after mRNA vaccination in the context of TNF blockade should be considered when formulating booster regimens. These patients should be considered for early booster vaccinations.


Subject(s)
COVID-19 Vaccines/immunology , COVID-19 , Immunity, Humoral , Tumor Necrosis Factor Inhibitors/adverse effects , Antibodies, Viral/blood , Antirheumatic Agents/adverse effects , COVID-19/immunology , COVID-19/prevention & control , Humans , Immunosuppressive Agents/adverse effects
5.
Gastroenterology ; 160(3): 809-822.e7, 2021 02.
Article in English | MEDLINE | ID: covidwho-990009

ABSTRACT

BACKGROUND AND AIMS: The host receptor for severe acute respiratory syndrome coronavirus 2, angiotensin-converting enzyme 2 (ACE2), is highly expressed in small bowel (SB). Our aim was to identify factors influencing intestinal ACE2 expression in Crohn's disease (CD), ulcerative colitis (UC), and non-inflammatory bowel disease (IBD) controls. METHODS: Using bulk RNA sequencing or microarray transcriptomics from tissue samples (4 SB and 2 colonic cohorts; n = 495; n = 387 UC; n = 94 non-IBD), we analyzed the relationship between ACE2 with demographics and disease activity and prognosis. We examined the outcome of anti-tumor necrosis factor and anti-interleukin-12/interleukin-23 treatment on SB and colonic ACE2 expression in 3 clinical trials. Univariate and multivariate regression models were fitted. RESULTS: ACE2 levels were consistently reduced in SB CD and elevated in colonic UC compared with non-IBD controls. Elevated SB ACE2 was also associated with demographic features (age and elevated body mass index) associated with poor coronavirus disease 2019 outcomes. Within CD, SB ACE2 was reduced in patients subsequently developing complicated disease. Within UC, colonic ACE2 was elevated in active disease and in patients subsequently requiring anti-tumor necrosis factor rescue therapy. SB and colonic ACE2 expression in active CD and UC were restored by anti-cytokine therapy, most notably in responders. CONCLUSIONS: Reduced SB but elevated colonic ACE2 levels in IBD are associated with inflammation and severe disease, but normalized after anti-cytokine therapy, suggesting compartmentalization of ACE2-related biology in SB and colonic inflammation. The restoration of ACE2 expression with anti-cytokine therapy might be important in the context of severe acute respiratory syndrome coronavirus 2 infection and potentially explain reports of reduced morbidity from coronavirus disease 2019 in IBD patients treated with anti-cytokines.


Subject(s)
Angiotensin-Converting Enzyme 2/metabolism , Anti-Inflammatory Agents/therapeutic use , Colitis, Ulcerative/drug therapy , Crohn Disease/drug therapy , Intestines/drug effects , Tumor Necrosis Factor Inhibitors/therapeutic use , Tumor Necrosis Factor-alpha/antagonists & inhibitors , Adolescent , Adult , Aged , Aged, 80 and over , Angiotensin-Converting Enzyme 2/genetics , Anti-Inflammatory Agents/adverse effects , COVID-19/enzymology , COVID-19/immunology , COVID-19/virology , Case-Control Studies , Child , Child, Preschool , Colitis, Ulcerative/enzymology , Colitis, Ulcerative/genetics , Colitis, Ulcerative/immunology , Crohn Disease/enzymology , Crohn Disease/genetics , Crohn Disease/immunology , Databases, Genetic , Female , Gene Expression Regulation, Enzymologic , Host-Pathogen Interactions , Humans , Intestines/enzymology , Intestines/immunology , Male , Middle Aged , North America , RNA, Messenger/genetics , RNA, Messenger/metabolism , Receptors, Virus/metabolism , SARS-CoV-2/enzymology , SARS-CoV-2/immunology , Severity of Illness Index , Treatment Outcome , Tumor Necrosis Factor Inhibitors/adverse effects , Tumor Necrosis Factor-alpha/metabolism , Young Adult
6.
J Am Acad Dermatol ; 84(1): 70-75, 2021 01.
Article in English | MEDLINE | ID: covidwho-943232

ABSTRACT

BACKGROUND: Data on the impact of biologics and immunomodulators on coronavirus disease 2019 (COVID-19)-related outcomes remain scarce. OBJECTIVE: We sought to determine whether patients taking tumor necrosis factor inhibitors (TNFis) or methotrexate are at increased risk of COVID-19-related outcomes. METHODS: In this large comparative cohort study, real-time searches and analyses were performed on adult patients who were diagnosed with COVID-19 and were treated with TNFis or methotrexate compared with those who were not treated. The likelihood of hospitalization and mortality were compared between groups with and without propensity score matching for confounding factors. RESULTS: More than 53 million (53,511,836) unique patient records were analyzed, of which 32,076 (0.06%) had a COVID-19-related diagnosis documented starting after January 20, 2020. Two hundred fourteen patients with COVID-19 were identified with recent TNFi or methotrexate exposure compared with 31,862 patients with COVID-19 without TNFi or methotrexate exposure. After propensity matching, the likelihood of hospitalization and mortality were not significantly different between the treatment and nontreatment groups (risk ratio = 0.91 [95% confidence interval, 0.68-1.22], P = .5260 and risk ratio = 0.87 [95% confidence interval, 0.42-1.78], P = .6958, respectively). LIMITATIONS: All TNFis may not behave similarly. CONCLUSION: Our study suggests that patients with recent TNFi or methotrexate exposure do not have increased hospitalization or mortality compared with patients with COVID-19 without recent TNFi or methotrexate exposure.


Subject(s)
COVID-19/diagnosis , Hospitalization/statistics & numerical data , Immunosuppressive Agents/adverse effects , Methotrexate/adverse effects , Tumor Necrosis Factor Inhibitors/adverse effects , Adult , Aged , COVID-19/immunology , COVID-19/mortality , COVID-19/virology , Case-Control Studies , Female , Humans , Male , Middle Aged , Propensity Score , Retrospective Studies , SARS-CoV-2/immunology , SARS-CoV-2/isolation & purification , Severity of Illness Index
7.
Gut ; 70(4): 725-732, 2021 04.
Article in English | MEDLINE | ID: covidwho-883380

ABSTRACT

OBJECTIVE: We sought to evaluate COVID-19 clinical course in patients with IBD treated with different medication classes and combinations. DESIGN: Surveillance Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD) is a large, international registry created to monitor outcomes of IBD patients with confirmed COVID-19. We used multivariable regression with a generalised estimating equation accounting for country as a random effect to analyse the association of different medication classes with severe COVID-19, defined as intensive care unit admission, ventilator use and/or death. RESULTS: 1439 cases from 47 countries were included (mean age 44.1 years, 51.4% men) of whom 112 patients (7.8%) had severe COVID-19. Compared with tumour necrosis factor (TNF) antagonist monotherapy, thiopurine monotherapy (adjusted OR (aOR) 4.08, 95% CI 1.73 to 9.61) and combination therapy with TNF antagonist and thiopurine (aOR 4.01, 95% CI 1.65 to 9.78) were associated with an increased risk of severe COVID-19. Any mesalamine/sulfasalazine compared with no mesalamine/sulfasalazine use was associated with an increased risk (aOR 1.70, 95% CI 1.26 to 2.29). This risk estimate increased when using TNF antagonist monotherapy as a reference group (aOR 3.52, 95% CI 1.93 to 6.45). Interleukin-12/23 and integrin antagonists were not associated with significantly different risk than TNF antagonist monotherapy (aOR 0.98, 95% CI 0.12 to 8.06 and aOR 2.42, 95% CI 0.59 to 9.96, respectively). CONCLUSION: Combination therapy and thiopurines may be associated with an increased risk of severe COVID-19. No significant differences were observed when comparing classes of biologicals. These findings warrant confirmation in large population-based cohorts.MKH should be changed to MDK for co-last author line.


Subject(s)
Azathioprine , COVID-19 , Inflammatory Bowel Diseases , Mercaptopurine , SARS-CoV-2 , Tumor Necrosis Factor Inhibitors , Adult , Anti-Inflammatory Agents/pharmacology , Azathioprine/administration & dosage , Azathioprine/adverse effects , COVID-19/diagnosis , COVID-19/epidemiology , COVID-19/immunology , Drug Therapy, Combination/methods , Drug Therapy, Combination/statistics & numerical data , Female , Humans , Inflammatory Bowel Diseases/drug therapy , Inflammatory Bowel Diseases/virology , International Cooperation , Male , Mercaptopurine/administration & dosage , Mercaptopurine/adverse effects , Registries/statistics & numerical data , Risk Adjustment , SARS-CoV-2/drug effects , SARS-CoV-2/isolation & purification , Severity of Illness Index , Tumor Necrosis Factor Inhibitors/administration & dosage , Tumor Necrosis Factor Inhibitors/adverse effects
10.
Gastroenterology ; 159(2): 481-491.e3, 2020 08.
Article in English | MEDLINE | ID: covidwho-306282

ABSTRACT

BACKGROUND AND AIMS: The impact of Coronavirus disease 2019 (COVID-19) on patients with inflammatory bowel disease (IBD) is unknown. We sought to characterize the clinical course of COVID-19 among patients with IBD and evaluate the association among demographics, clinical characteristics, and immunosuppressant treatments on COVID-19 outcomes. METHODS: Surveillance Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD) is a large, international registry created to monitor outcomes of patients with IBD with confirmed COVID-19. We calculated age-standardized mortality ratios and used multivariable logistic regression to identify factors associated with severe COVID-19, defined as intensive care unit admission, ventilator use, and/or death. RESULTS: 525 cases from 33 countries were reported (median age 43 years, 53% men). Thirty-seven patients (7%) had severe COVID-19, 161 (31%) were hospitalized, and 16 patients died (3% case fatality rate). Standardized mortality ratios for patients with IBD were 1.8 (95% confidence interval [CI], 0.9-2.6), 1.5 (95% CI, 0.7-2.2), and 1.7 (95% CI, 0.9-2.5) relative to data from China, Italy, and the United States, respectively. Risk factors for severe COVID-19 among patients with IBD included increasing age (adjusted odds ratio [aOR], 1.04; 95% CI, 1.01-1.02), ≥2 comorbidities (aOR, 2.9; 95% CI, 1.1-7.8), systemic corticosteroids (aOR, 6.9; 95% CI, 2.3-20.5), and sulfasalazine or 5-aminosalicylate use (aOR, 3.1; 95% CI, 1.3-7.7). Tumor necrosis factor antagonist treatment was not associated with severe COVID-19 (aOR, 0.9; 95% CI, 0.4-2.2). CONCLUSIONS: Increasing age, comorbidities, and corticosteroids are associated with severe COVID-19 among patients with IBD, although a causal relationship cannot be definitively established. Notably, tumor necrosis factor antagonists do not appear to be associated with severe COVID-19.


Subject(s)
Adrenal Cortex Hormones/adverse effects , Coronavirus Infections/mortality , Immunosuppressive Agents/adverse effects , Inflammatory Bowel Diseases/drug therapy , Pneumonia, Viral/mortality , Population Surveillance , Tumor Necrosis Factor Inhibitors/adverse effects , Adult , Aged , Betacoronavirus , COVID-19 , Comorbidity , Coronavirus Infections/chemically induced , Coronavirus Infections/virology , Critical Care/statistics & numerical data , Female , Hospitalization/statistics & numerical data , Humans , Inflammatory Bowel Diseases/mortality , Inflammatory Bowel Diseases/virology , Male , Middle Aged , Odds Ratio , Pandemics , Pneumonia, Viral/chemically induced , Pneumonia, Viral/virology , Registries , Respiration, Artificial/statistics & numerical data , Risk Factors , SARS-CoV-2 , Sulfasalazine/adverse effects
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