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1.
J Crohns Colitis ; 2023 May 26.
Article in English | MEDLINE | ID: covidwho-20240062

ABSTRACT

BACKGROUND AND AIMS: The BNT162b2 and mRNA-1273 COVID-19 vaccines are efficacious in patients with inflammatory bowel disease; but there are a lack of data examining if holding immunosuppressive therapy around vaccination improves immune response. We studied the effect of holding IBD medications around the time of vaccination on antibody response and breakthrough COVID-19 infection. METHODS: Partnership to Report Effectiveness of Vaccination in populations Excluded from iNitial Trials of COVID is a prospective cohort of individuals with IBD receiving COVID-19 vaccination. Quantitative measurement of anti-receptor binding domain IgG antibodies to SARS-CoV-2 was performed 8 weeks after completing a vaccination series. RESULTS: 1,854 patients were included; 59% were on anti-TNF (10% of these on combination therapy), 11% on vedolizumab, and 14% on ustekinumab. 11% of participants held therapy before or after vaccine administration for at least 2 weeks. Antibody levels were similar in participants continuing versus holding anti-TNF monotherapy before or after the second vaccine (BNT162b2: 10 µg/mL vs 8.9 µg/mL, mRNA-1273: 17.5 µg/mL vs 14.5 µg/mL). Comparable results were seen in those on combination therapy. Antibody titers in those on ustekinumab or vedolizumab were higher compared to anti-TNF users, but there was no significant difference if drug was held or continued (BNT162b2: 22.5 µg/mL vs 23 µg/mL, mRNA-1273: 88 µg/mL vs 51 µg/mL). Holding therapy was not associated with decreased rate of COVID-19 infection compared to those not holding therapy (BNT162b2: 28% vs 29%; mRNA-1273 19% vs 31%). CONCLUSION: We recommend continuing IBD medications while receiving mRNA COVID-19 vaccination without interruption.

3.
Inflamm Bowel Dis ; 2022 Jul 13.
Article in English | MEDLINE | ID: covidwho-2286413

ABSTRACT

We demonstrate low rates of breakthrough coronavirus disease 2019 (COVID-19) infection and mild course of illness following severe acute respiratory syndrome coronavirus 2 vaccination in a large cohort of inflammatory bowel disease patients. Residence in southern United States and lower median anti-receptor binding antibody level were associated with development of COVID-19.

5.
Inflamm Bowel Dis ; 2023 Feb 15.
Article in English | MEDLINE | ID: covidwho-2239482

ABSTRACT

We evaluated antibody concentrations 6 months after a third coronavirus disease 2019 messenger RNA vaccine dose in patients with inflammatory bowel diseases. Almost all patients had an antibody response, and those with a previous SARS-CoV-2 infection had higher antibody concentrations.

6.
Am J Gastroenterol ; 2022 Oct 28.
Article in English | MEDLINE | ID: covidwho-2242035

ABSTRACT

INTRODUCTION: Children with inflammatory bowel disease (IBD) may respond differently to COVID-19 immunization as compared with healthy children or adults with IBD. Those younger than 12 years receive a lower vaccine dose than adults. We sought to describe the safety and humoral immune response to COVID-19 vaccine in children with IBD. METHODS: We recruited children with IBD, ages 5-17 years, who received ≥ 2 doses of the BNT162b2 vaccine by a direct-to-patient outreach and at select sites. Patient demographics, IBD characteristics, medication use, and vaccine adverse events were collected. A subset of participants had quantitative measurement of anti-receptor binding domain IgG antibodies after 2-part immunization. RESULTS: Our study population included 280 participants. Only 1 participant required an ED visit or hospitalization because of an adverse event. Of 99 participants who underwent anti-receptor binding domain IgG antibody measurement, 98 had a detectable antibody, with a mean antibody level of 43.0 µg/mL (SD 67) and a median of 22 µg/mL (interquartile range 12-38). In adjusted analyses, older age ( P = 0.028) and antitumor necrosis factor monotherapy compared with immunomodulators alone ( P = 0.005) were associated with a decreased antibody level. Antibody response in patients treated with antitumor necrosis factor combination vs monotherapy was numerically lower but not significant. DISCUSSION: Humoral immune response to COVID-19 immunization in children with IBD was robust, despite a high proportion of this pediatric cohort being treated with immunosuppressive agents. Severe vaccine-related AEs were rare. Overall, these findings provide a high level of reassurance that pediatric patients with IBD respond well and safely to SARS-CoV-2 vaccination.

7.
Inflamm Bowel Dis ; 2022 Dec 28.
Article in English | MEDLINE | ID: covidwho-2189109

ABSTRACT

AIM: There are limited data on the impact of 2 vs 3 doses of COVID-19 vaccine in patients with inflammatory bowel disease (IBD). The primary aim of the study was to assess the efficacy of COVID-19 vaccine based on number of administered doses in patients with IBD. METHODS: We conducted a retrospective cohort study using TriNetX, a multi-institutional database to compare patients with IBD who received 1, 2, or 3 doses of BNT162b2 or mRNA-1273 to unvaccinated IBD patients (1.1.2020-7.26.2022) to assess the risk of COVID-19 after 1:1 propensity score matching. We also evaluated the impact of vaccine on a composite of severe COVID-19 outcomes including hospitalization, intubation, intensive care unit care, acute kidney injury, or mortality. RESULTS: After propensity score matching, vaccinated patients with 2 (adjusted OR [aOR], 0.8; 95% confidence interval [CI], 0.6-0.9) and 3 doses (aOR, 0.7; 95% CI, 0.5-0.9) were found to have a lower risk of COVID-19 compared with unvaccinated patients. Vaccinated patients with IBD had a lower risk of severe COVID-19 outcomes (aOR, 0.7; 95% CI, 0.6-0.9) compared with unvaccinated patients. There was no difference in the risk of COVID-19 in IBD patients with 2 compared with 3 doses (aOR, 0.97; 95% CI, 0.7-1.3). However, IBD patients with 2 doses were at an increased risk for hospitalization due to COVID-19 (aOR, 1.78; 95% CI, 1.02-3.11) compared with those that received 3 doses. CONCLUSION: Vaccinated patients with IBD had a lower risk of severe COVID-19 outcomes compared with unvaccinated patients. A third dose of COVID-19 vaccine compared with 2 doses decreases the risk of hospitalization but not breakthrough infection in patients with IBD.

8.
The American Journal of Gastroenterology ; 117(10S), 2022.
Article in English | ProQuest Central | ID: covidwho-2111056

ABSTRACT

Introduction: Studies have demonstrated that patients with Coronavirus disease 2019 (COVID-19) are at an increased risk of incident cardiovascular disease (CVD) including cerebrovascular disease, dysrhythmias, ischemic heart disease, myocarditis, pericarditis, heart failure and thromboembolic disease. Little is known regarding the short and long-term risk of COVID-19 related complications in patients with inflammatory bowel disease (IBD) Methods: We compared the 1 year risk of cardiac complications (arrhythmias, heart failure, myocarditis and pericarditis), venous thromboembolism (VTE), peripheral artery disease (PAD), ischemic stroke and acute kidney injury (AKI) in patients between IBD and non-IBD cohort after COVID-19 using TriNetX, a multi-institutional database. Risk of CVD, thrombotic and renal complications after COVID-19 in IBD patients on TNFi, non-TNFi, chronic steroids and immunomodulators compared to 5-ASA Complication IBD medication (%) OR 95% CI TNFi 5-ASA Composite 10.79 10.83 0.99 0.64 – 1.52 Cardiac complication 8.36 7.52 1.12 0.70 – 1.77 VTE 4.60 3.72 1.24 0.70 – 2.22 Ischemic stroke 4.87 4.15 1.18 0.68 – 2.04 PAD 2.33 1.56 1.5 0.67 – 3.38 AKI 2.86 3.17 0.89 0.46 – 1.74 Immunomodulators 5-ASA Composite 14.14 14.06 1 0.68 – 1.47 Cardiac complication 8.50 11.30 0.72 0.48 – 1.08 VTE 6.90 6.50 1.06 0.71 – 1.60 Ischemic stroke 6.45 4.81 1.36 0.87 – 2.12 PAD 2.48 2.13 1.17 0.62 – 2.18 AKI 5.93 4.74 1.26 0.80 – 1.98 Non-TNFi 5-ASA Composite 12.50 12.50 1 0.55 – 1.79 Cardiac complication 8.15 11.62 0.67 0.36 – 1.24 VTE 4.74 3.86 1.24 0.54 – 2.81 Ischemic stroke 3.44 5.28 0.64 0.28 – 1.45 PAD 3.24 3.24 1 0.41 – 2.45 AKI 4.61 3.49 1.33 0.57 – 3.09 Steroid 5-ASA Composite 17.4 14.9 1.20 0.91 – 1.58 Cardiac complication 12.9 12.4 1.04 0.80 – 1.137 VTE 7.6 7.2 1.05 0.79 – 1.40 Ischemic stroke 7.9 6.07 1.33 0.99 – 1.78 PAD 2.3 2.1 1.09 0.69 – 1.74 AKI 7.01 5.97 1.18 0.87 – 1.61

9.
The American Journal of Gastroenterology ; 117(10S):e504-e505, 2022.
Article in English | ProQuest Central | ID: covidwho-2111050

ABSTRACT

Methods: We reviewed data collected from the prospective cohort, Partnership to Report Effectiveness of Vaccination in populations Excluded from iNitial Trials of COVID (PREVENT-COVID). Results: A total of 1,768 patients were included;69% with Crohn’s disease and 73% females. 49% were on anti-TNF monotherapy, 11% on combination therapy (anti-TNF and immunomodulator), 11% on vedolizumab, and 14% on ustekinumab. 11% of participants held therapy before or after vaccine administration. Antibody titers based on whether IBD therapy was held before, after, or any time before or after second BNT162b2 and mRNA-1273 COVID-19 vaccine administration Initial COVID-19 Antibody Titers by Whether Medication was Held Before Second Vaccine BNT162b2 P value mRNA-1273 P value Medication Held Mediation Not Held Medication Held Medication Not Held Total N Post Vaccination Titer Median IQR Total N Post Vaccination Titer Median IQR Total N Post Vaccination Titer Median IQR Total N Post Vaccination Titer Median IQR Anti-TNF 15 8.5 3.6, 19.0 426 9.9 4.5, 16.0 0.872 7 14 9.0, 24.0 228 17 9.7, 28.0 0.676 Combo therapy (TNF + thiopurine or MTX) 4 4.45 2.0, 10.2 110 5.1 2.3, 13.0 0.764 3 18 10.0, 23.0 73 15 6.7, 22.0 0.541 Novel Biologic (Uste or Vedo) 6 62 39.0, 161.0 264 22 13.0, 40.0 0.038 7 119 89.0, 203.0 167 51 28.0, 99.0 0.026 Thiopurine Only 4 12.65 8.3, 22.5 112 15 7.1, 23.5 0.976 4 55.5 38.5, 68.0 68 35.5 20.5, 66.0 0.434 Methotrexate Only 4 23 16.5, 105.0 22 18.5 13.0, 34.0 0.505 1 74 74.0, 74.0 15 69 21.0, 101.0 1.000 Tofacitinib 0 n/a n/a 20 15 8.9, 19.0 - 2 47.5 21.0, 74.0 6 74.5 66.0, 78.0 0.632 Initial COVID-19 Antibody Titers by Whether Medication was Held After Second Vaccine BNT162b2 P value mRNA-1273 P value Medication Held Medication Not Held Medication Held Medication Not Held Total N Post Vaccination Titer Median IQR Total N Post Vaccination Titer Median IQR Total N Post Vaccination Titer Median IQR Total N Post Vaccination Titer Median IQR Anti-TNF 38 11 4.4, 19.0 403 9.8 4.5, 16.0 0.759 25 14 9.0, 27.0 210 17 9.7, 28.0 0.405 Combo therapy (TNF + thiopurine or MTX) 11 4 1.9, 6.4 103 5.3 2.3, 13.0 0.343 5 18 10.0, 23.0 71 15 6.7, 22.0 0.587 Novel Biologic (Uste or Vedo) 16 22.5 16.0, 49.0 254 22 13.0, 40.0 0.786 14 88.5 36.0, 119.0 160 51 28.5, 99.0 0.238 Thiopurine Only 4 9.65 8.3, 19.5 112 15 7.1, 23.5 0.763 5 49 28.0, 62.0 67 37 20.0, 69.0 0.732 Methotrexate Only 7 26 16.0, 148.0 19 19 11.0, 33.0 0.205 1 74 74.0, 74.0 15 69 21.0, 101.0 1.000 Tofacitinib 0 n/a n/a 20 15 8.9, 19.0 - 2 47.5 21.0, 74.0 6 74.5 66.0, 78.0 0.632 Initial COVID-19 Antibody Titers by Whether Medication was Held Before or After Second Vaccine BNT162b2 P value mRNA-1273 P value Medication Held Medication Not Held Medication Held Medication Not Held Total N Post Vaccination Titer Median IQR Total N Post Vaccination Titer Median IQR Total N Post Vaccination Titer Median IQR Total N Post Vaccination Titer Median IQR Anti-TNF 42 10.15 4.4, 19.0 399 9.9 4.5, 16.0 0.833 27 14 9.0, 27.0 208 17.5 9.9, 28.5 0.255 Combo therapy (TNF + thiopurine or MTX) 13 4 1.9, 6.4 101 5.3 2.5, 13.0 0.369 5 18 10.0, 23.0 71 15 6.7, 22.0 0.587 Novel Biologic (Uste or Vedo) 22 29 18.0, 48.0 248 22 13.0, 40.0 0.285 14 88.5 36.0, 119.0 160 51 28.5, 99.0 0.238 Thiopurine Only 5 10 9.3, 16.0 111 15 7.0, 24.0 0.823 6 54.5 28.0, 62.0 66 35.5 20.0, 69.0 0.556 Methotrexate Only 8 23 17.0, 120.0 18 18.5 11.0, 33.0 0.213 1 74 74.0, 74.0 15 69 21.0, 101.0 1.000 Tofacitinib 0 n/a n/a 20 15 8.9, 19.0 - 2 47.5 21.0, 74.0 6 74.5 66.0, 78.0 0.632

10.
Inflamm Bowel Dis ; 2022 Sep 14.
Article in English | MEDLINE | ID: covidwho-2029029

ABSTRACT

BACKGROUND: Some patients with inflammatory bowel disease (IBD) on immunosuppressive therapies may have a blunted response to certain vaccines, including the messenger RNA (mRNA) coronavirus disease 2019 (COVID-19) vaccines. However, few studies have evaluated the cell-mediated immune response (CMIR), which is critical to host defense after COVID-19 infection. The aim of this study was to evaluate the humoral immune response and CMIR after mRNA COVID-19 vaccination in patients with IBD. METHODS: This prospective study (HERCULES [HumoRal and CellULar initial and Sustained immunogenicity in patients with IBD] study) evaluated humoral immune response and CMIR after completion of 2 doses of mRNA COVID-19 vaccines in 158 IBD patients and 20 healthy control (HC) subjects. The primary outcome was the CMIR to mRNA COVID-19 vaccines in patients with IBD. The secondary outcomes were a comparison of (1) the CMIR in patients with IBD and HC subjects, (2) CMIR and humoral immune response in all participants, and (3) correlation between CMIR and humoral immune response. RESULTS: The majority (89%) of patients with IBD developed a CMIR, which was not different vs HC subjects (94%) (P = .6667). There was no significant difference (P = .5488) in CMIR between immunocompetent (median 255 [interquartile range, 146-958] spike T cells per million peripheral blood mononuclear cells) and immunosuppressed patients (median 377 [interquartile range, 123-1440]). There was no correlation between humoral and cell-mediated immunity after vaccination (P = .5215). In univariable analysis, anti-tumor necrosis factor therapy was associated with a higher CMIRs (P = .02) and confirmed in a multivariable model (P = .02). No other variables were associated with CMIR. CONCLUSIONS: Most patients with IBD achieved CMIR to a COVID-19 vaccine. Future studies are needed evaluating sustained CMIR and clinical outcomes.


Antibody and T cell responses to coronavirus disease 2019 vaccines in patients with inflammatory bowel disease do not correlate. Most patients with inflammatory bowel disease mount a T cell response despite being on biologic therapies, those on anti-tumor necrosis factor may have a higher T cell response. Anti-tumor necrosis factor therapy has been associated with a lower antibody response to coronavirus disease 2019 vaccines, but the T cell response is augmented.

13.
Int J Colorectal Dis ; 37(3): 685-691, 2022 Mar.
Article in English | MEDLINE | ID: covidwho-1850322

ABSTRACT

PURPOSE: We aimed to examine the role of cytomegalovirus (CMV) infection in patients with inflammatory bowel disease (IBD), which remains highly debated. METHODS: Retrospective, observational study using the Nationwide Inpatient Sample (NIS) 2015-2017. Patients with ICD9/10CM codes for Crohn's disease (CD), ulcerative colitis (UC), and CMV colitis were included in the study. The primary outcome was the odds of CMV colitis in patients with IBD compared to patients without IBD. Secondary outcomes were differences in inpatient morbidity, mortality, resource utilization, colectomy rates, hospital length of stay (LOS), and inflation-adjusted total hospitalization costs. RESULTS: A total of 992,445 patients with IBD were identified, out of which 520 (0.05%) had associated CMV colitis. Patients with IBD had significantly higher odds of CMV colitis compared to patients without IBD (aOR: 19.76, p < 0.01), having an even greater association with UC (aOR: 31.13, p < 0.01). CMV colitis in patients with CD was associated with a significant increase in odds of mortality, shock, and ICU stay, while patients with UC had higher odds of colectomy. The patients with IBD and CMV colitis had higher odds of acute kidney injury, multiorgan failure, markedly increased additional hospital costs, and LOS compared to patients with IBD and no CMV colitis. CONCLUSION: IBD has a significant association with CMV colitis, and the presence of CMV colitis in patients with IBD was associated with higher mortality, morbidity, and hospital costs. Prospectively designed studies may better elucidate the risk factors and impact of CMV colitis on patients with IBD.


Subject(s)
Colitis, Ulcerative , Colitis , Cytomegalovirus Infections , Inflammatory Bowel Diseases , Colitis/complications , Colitis, Ulcerative/complications , Colitis, Ulcerative/surgery , Cytomegalovirus , Cytomegalovirus Infections/complications , Humans , Inflammatory Bowel Diseases/complications , Retrospective Studies
14.
Inflamm Bowel Dis ; 28(11): 1781-1786, 2022 11 02.
Article in English | MEDLINE | ID: covidwho-1784354

ABSTRACT

Herein, we evaluated the humoral immunogenicity of a third coronavirus disease 2019 messenger RNA vaccine dose in patients with inflammatory bowel diseases. All patients displayed a humoral immune response, and median antibody concentrations were higher after the third dose than after completion of the 2-dose series.


Subject(s)
COVID-19 , Colitis, Ulcerative , Inflammatory Bowel Diseases , Humans , COVID-19 Vaccines , RNA, Messenger , Colitis, Ulcerative/genetics
15.
Inflamm Bowel Dis ; 27(10): 1703-1705, 2021 Oct 18.
Article in English | MEDLINE | ID: covidwho-1740876

ABSTRACT

The recent emergency use authorization of a third COVID-19 vaccine means that most patients with inflammatory bowel disease (IBD) will soon be eligible to be vaccinated. Gastroenterology clinicians should be prepared to address patients' concerns regarding safety and efficacy of vaccines. They should also strongly recommend that all their patients be vaccinated with a COVID-19 vaccine. Additionally, they should be prepared to educate patients about logistics that will result in successful vaccination completion. All these measures will be crucial to ensure high uptake among their patients with IBD.


Subject(s)
COVID-19 Vaccines/pharmacology , COVID-19 , Gastroenterologists , Inflammatory Bowel Diseases , Vaccination , COVID-19/epidemiology , COVID-19/prevention & control , Humans , Inflammatory Bowel Diseases/epidemiology , Inflammatory Bowel Diseases/immunology , Inflammatory Bowel Diseases/psychology , Patient Participation/methods , Patient Participation/psychology , Physician's Role , Preventive Health Services , Risk Assessment , SARS-CoV-2 , Vaccination/methods , Vaccination/psychology , Vaccination Coverage/methods
16.
Am J Gastroenterol ; 117(3): 462-469, 2022 03 01.
Article in English | MEDLINE | ID: covidwho-1625333

ABSTRACT

INTRODUCTION: Although an additional coronavirus disease 2019 vaccine dose for immunocompromised persons has been recommended in some countries, further data to guide vaccination strategies for patients with inflammatory bowel disease (IBD) are urgently needed. We sought to identify factors affecting initial humoral immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines among patients with IBD. METHODS: In this prospective cohort of SARS-CoV-2 immunized patients with IBD, we evaluated associations between participant age, sex, vaccine type, medication use, and the presence of a detectable antireceptor binding domain antibody and quantitative antibody level. RESULTS: In total, 1,909 participants were included (1,123, 692, and 94 received BNT162b2, mRNA-1273, and Ad26.COV2.S, respectively) of whom 96% achieved a positive antibody response. On multivariable analysis, factors associated with lack of antibody response were older age (P = 0.043), BNT162b2 vs mRNA-1273 (odds ratio [OR] 2.1, 95% confidence interval [CI] 1.0-3.9), and combination therapy with anti-TNF and 6MP, azathioprine, or methotrexate (OR 4.2, 95% CI 2.4-7.3). The use of 5-aminosalicylate or sulfasalazine (OR 0.3, 95% CI 0.1-0.8) and ustekinumab (OR 0.2, 95% CI 0.05-0.8) was associated with decreased odds of lacking antibody response. DISCUSSION: Most patients with IBD mount an initial response to SARS-CoV-2 vaccination; however, older patients and those treated with anti-TNF and immunomodulator have blunted responses and may benefit the most from an additional vaccine dose. Patients treated with other classes of immunosuppressive medications have more robust initial immune responses to vaccination. These data should inform key decisions about patient selection for additional coronavirus disease 2019 vaccine doses in patients with IBD.


Subject(s)
2019-nCoV Vaccine mRNA-1273 , Ad26COVS1 , BNT162 Vaccine , COVID-19/prevention & control , Immunity, Humoral/physiology , Inflammatory Bowel Diseases/immunology , Adult , Age Factors , Cohort Studies , Female , Humans , Immunologic Factors/therapeutic use , Inflammatory Bowel Diseases/drug therapy , Male , Middle Aged , Odds Ratio , Risk Factors , Sex Factors , Tumor Necrosis Factor Inhibitors/therapeutic use
17.
Aliment Pharmacol Ther ; 55(2): 191-200, 2022 01.
Article in English | MEDLINE | ID: covidwho-1570475

ABSTRACT

BACKGROUND: Accurate estimates for the risk of COVID-19 in IBD, and an understanding of the impact of COVID-19 on IBD course and the risk of incident post-infectious IBD are needed. AIMS: To estimate the risk of COVID-19 in IBD and study its impact on IBD course and the risk of incident post-infectious IBD. METHODS: A retrospective propensity score matched cohort study utilising multi-institutional research network TriNetX. COVID-19 patients with and without IBD were identified to quantify the risk of COVID-19 in patients with IBD, COVID-19 outcomes in patients with IBD and the impact of COVID-19 on IBD disease course. The risk of incident post-infectious IBD in COVID-19 patients was compared to the population not infected with COVID-19 during a similar time period. RESULTS: Incidence rate ratio for COVID-19 was lower in IBD patients compared to the non-IBD population (0.79, 95% CI: 0.72-0.86). COVID-19-infected patients with IBD were at increased risk for requiring hospitalisation compared to non-IBD population (RR: 1.17, 95% CI: 1.02-1.34) with no differences in need for mechanical ventilation or mortality. Patients with IBD on steroids were at an increased risk for critical care need (RR: 2.22, 95% CI: 1.29-3.82). Up to 7% of patients with IBD infected with COVID-19 suffered an IBD flare 3-months post-infection. Risk for incident IBD post-COVID was lower than that seen in the non-COVID population (RR: 0.64, 95% CI: 0.54-0.65). CONCLUSION: We observed no increase in risk for COVID-19 amongst patients with IBD or risk for de novo IBD after COVID-19 infection. We confirmed prior observations regarding the impact of steroid use on COVID-19 severity in patients with IBD.


Subject(s)
COVID-19 , Inflammatory Bowel Diseases , Cohort Studies , Humans , Incidence , Inflammatory Bowel Diseases/complications , Inflammatory Bowel Diseases/epidemiology , Retrospective Studies , SARS-CoV-2
18.
Inflamm Bowel Dis ; 28(10): 1497-1505, 2022 10 03.
Article in English | MEDLINE | ID: covidwho-1556255

ABSTRACT

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 vaccination is recommended for all individuals with inflammatory bowel disease (IBD), including those on immunosuppressive therapies; however, little is known about vaccine safety and efficacy in these patients or the impact of vaccination on IBD disease course. METHODS: We evaluated coronavirus disease 2019 (COVID-19) vaccine-related adverse events (AEs) and the effect of vaccination on IBD disease course among participants in the PREVENT-COVID (Partnership to Report Effectiveness of Vaccination in populations Excluded from iNitial Trials of COVID) study, a prospective, observational cohort study. Localized and systemic reactions were assessed via questionnaire. Disease flare was defined by worsening IBD symptoms and change in IBD medications. Outcomes were stratified by vaccine type and IBD medication classes. RESULTS: A total of 3316 individuals with IBD received at least 1 COVID-19 vaccine. Injection site tenderness (68%) and fatigue (46% dose 1, 68% dose 2) were the most commonly reported localized and systemic AEs after vaccination. Severe localized and systemic vaccine-related AEs were rare. The mRNA-1273 vaccine was associated with significantly greater severe AEs at dose 2 (localized 4% vs 2%, systemic 15% vs 10%; P < .001 for both). Prior COVID-19 infection, female sex, and vaccine type were associated with severe systemic reactions to dose 1, while age <50 years, female sex, vaccine type, and antitumor necrosis factor and vedolizumab use were associated with severe systemic reactions to dose 2. Overall rates (2%) of IBD flare were low following vaccination. CONCLUSIONS: Our findings provide reassurance that the severe acute respiratory syndrome coronavirus 2 vaccine is safe and well tolerated among individuals with IBD, which may help to combat vaccine hesitancy and increase vaccine confidence.


The severe acute respiratory syndrome coronavirus 2 vaccine is safe and well tolerated among individuals with inflammatory bowel disease (IBD). Severe localized and systemic vaccine-related adverse events were rare, and rates of IBD flare were low (2%) following severe acute respiratory syndrome coronavirus 2 vaccination in a cohort of 3316 participants with IBD.


Subject(s)
COVID-19 Vaccines , COVID-19 , Inflammatory Bowel Diseases , 2019-nCoV Vaccine mRNA-1273 , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Female , Humans , Middle Aged , Prospective Studies , SARS-CoV-2 , Vaccination/adverse effects
19.
Am J Gastroenterol ; 117(1): 176-179, 2022 01 01.
Article in English | MEDLINE | ID: covidwho-1527035

ABSTRACT

INTRODUCTION: Patients with inflammatory bowel disease (IBD) on immune-modifying therapies may have a lower vaccine response to certain vaccines. The aim of our study was to evaluate humoral immunogenicity of mRNA coronavirus disease 2019 (COVID-19) vaccines among patients with IBD and healthy controls (HCs). METHODS: We performed a prospective study to evaluate humoral immunogenicity among patients with IBD and HCs after completion of mRNA COVID-19 vaccines. RESULTS: One hundred twenty-two patients with IBD and 60 HCs were enrolled. All HCs and 97% of patients with IBD developed antibodies. Antibody concentrations were lower in patients with IBD compared with those in HCs (median 31 vs 118 µg/mL; P < 0.001). Those who received the mRNA-1273 (Moderna) COVID-19 (median 38; interquartile range [IQR] 24-75 vs µg/mL) had higher antibody concentrations compared with those who received the Pfizer-BNT vaccine series (median 22; IQR 11-42 µg/mL; P < 0.001). Patients on immune-modifying therapy (median 26; IQR 13-50 µg/mL) had lower antibody concentrations compared with those who were on no treatment, aminosalicylates, or vedolizumab (median 59; IQR 31-75 µg/mL; P = 0.003). DISCUSSION: Almost all patients with IBD in our study mounted an antibody response. Future studies are needed in evaluating sustained humoral immunity and the impact of booster dosing in patients with IBD.


Subject(s)
COVID-19/prevention & control , Inflammatory Bowel Diseases , SARS-CoV-2/immunology , 2019-nCoV Vaccine mRNA-1273/administration & dosage , Adult , Antibodies, Viral/blood , Female , Humans , Immunogenicity, Vaccine , Male , Middle Aged , Prospective Studies
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