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2.
Nat Commun ; 13(1): 1379, 2022 03 16.
Article in English | MEDLINE | ID: covidwho-1747222

ABSTRACT

Anti tumour necrosis factor (anti-TNF) drugs increase the risk of serious respiratory infection and impair protective immunity following pneumococcal and influenza vaccination. Here we report SARS-CoV-2 vaccine-induced immune responses and breakthrough infections in patients with inflammatory bowel disease, who are treated either with the anti-TNF antibody, infliximab, or with vedolizumab targeting a gut-specific anti-integrin that does not impair systemic immunity. Geometric mean [SD] anti-S RBD antibody concentrations are lower and half-lives shorter in patients treated with infliximab than vedolizumab, following two doses of BNT162b2 (566.7 U/mL [6.2] vs 4555.3 U/mL [5.4], p <0.0001; 26.8 days [95% CI 26.2 - 27.5] vs 47.6 days [45.5 - 49.8], p <0.0001); similar results are also observed with ChAdOx1 nCoV-19 vaccination (184.7 U/mL [5.0] vs 784.0 U/mL [3.5], p <0.0001; 35.9 days [34.9 - 36.8] vs 58.0 days [55.0 - 61.3], p value < 0.0001). One fifth of patients fail to mount a T cell response in both treatment groups. Breakthrough SARS-CoV-2 infections are more frequent (5.8% (201/3441) vs 3.9% (66/1682), p = 0.0039) in patients treated with infliximab than vedolizumab, and the risk of breakthrough SARS-CoV-2 infection is predicted by peak anti-S RBD antibody concentration after two vaccine doses. Irrespective of the treatments, higher, more sustained antibody levels are observed in patients with a history of SARS-CoV-2 infection prior to vaccination. Our results thus suggest that adapted vaccination schedules may be required to induce immunity in at-risk, anti-TNF-treated patients.


Subject(s)
COVID-19 , Inflammatory Bowel Diseases , Viral Vaccines , Antibodies, Monoclonal, Humanized/therapeutic use , COVID-19 Vaccines , Humans , Inflammatory Bowel Diseases/drug therapy , Infliximab/therapeutic use , SARS-CoV-2 , T-Lymphocytes , Tumor Necrosis Factor Inhibitors
3.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-315494

ABSTRACT

To inform healthcare policy for immunosuppressed patients there is a need to define SARS-CoV-2 vaccine responses. Here we report SARS-CoV-2 vaccine-induced antibody and T cell responses in patients treated with anti-tumour necrosis factor (anti-TNF), a commonly used biologic in inflammatory diseases, compared to patients treated with vedolizumab, a gut-specific antibody targeting integrin a4b7 that does not impair systemic immunity. In anti-TNF recipients, the magnitude of anti-SARS-CoV2 antibodies was reduced five-fold, and rapidly decayed towards the seroconversion threshold by 14 weeks after second dose of vaccine. In contrast, anti-SARS-CoV-2 antibodies were sustained up to 16 weeks in vedolizumab-treated patients. Anti-SARS-CoV2 antibody decay was not observed in vaccinated patients previously infected with SARS-CoV-2. T cell responses were absent in one-fifth of anti-TNF and vedolizumab-treated patients after a second dose of either vaccine. Our data have important implications for anti-TNF recipients, including the need for vaccine prioritization, booster doses, and social distancing strategies.

4.
EuropePMC; 2020.
Preprint in English | EuropePMC | ID: ppcovidwho-313974

ABSTRACT

Background: The COVID-19 pandemic has necessitated identifying individuals at higher risk of severe outcomes who should be shielded and provided with government support. We describe the initial results and validation of a web-based tool targeted at patients in the UK with inflammatory bowel disease (IBD) to self-stratify their risk according to a risk grid developed by an expert consensus body within gastroenterology.Methods: We designed a secure web-based survey, compliant with information governance, which was targeted directly at patients in the UK with IBD and promoted via social media. Patient-entered data were directly compared to data held by their local IBD specialist teams.Findings: Between 1st April and 3rd August 2020, we received responses from 34,078 participants with IBD from 176 UK trusts or health boards. Overall, based on these data, 25·9% of participants met the consensus criteria defined for shielding and a further 46·5% were in a moderate risk category. We assessed intra-rater reliability in 1,442 participants using the tool twice or more;most items had almost perfect agreement (kappa >0·80).We validated the patient-entered data against hospital-entered data and medical records for 2,862 patient datasets from ten hospitals. Weighted kappa was 0·59 (95% confidence interval 0·56 - 0·62). After manual resolution of discrepancies, kappa was 0·89 (95% CI 0·87 - 0·91). Of 966 patients identified as requiring shielding in the final dataset for these ten centres, 51·0% had been missed by the hospital-entered data, largely because of incomplete or discrepant information on comorbidity and current disease activity.Interpretation: We have demonstrated that patient-generated data can facilitate rapid risk stratification with respect to COVID-19 and compensate for deficiencies in hospital data. We have validated these data across repeat entry and have demonstrated their reliability compared to pre-existing secondary care data. These findings have important implications for public health and chronic disease management.Funding Statement: Galapagos Biotech Ltd;Biogen GmbH;Tillotts Pharma UK Ltd;Amgen LtdDeclaration of Interests: Author Vida Cairnes has received honoraria for speaking from Falk, Pharmacosmos, Abbvie and Tillots. I have received support to attend conferences fromPharmacosmos, Ferring, Takeda, Falk and Abbvie. I am in receipt of education funding from Crohn’s & Colitis UK. All other authors have nothing to declare. Ethics Approval Statement: The IBD Registry was the Data Controller for the COVID-19 UK IBD Risk Tool. Information Governance (IG) included the DPIA, Privacy Notices, approved information/content development for patients plus Information Sharing Agreements for hospital teams in order to allow the data to be shared. The lawful basis for data collection was under the COPI Notice issued for COVID-19.10 Information was freely provided by participants.

5.
Gut ; 69(6): 984-990, 2020 06.
Article in English | MEDLINE | ID: covidwho-72238

ABSTRACT

The COVID-19 pandemic is putting unprecedented pressures on healthcare systems globally. Early insights have been made possible by rapid sharing of data from China and Italy. In the UK, we have rapidly mobilised inflammatory bowel disease (IBD) centres in order that preparations can be made to protect our patients and the clinical services they rely on. This is a novel coronavirus; much is unknown as to how it will affect people with IBD. We also lack information about the impact of different immunosuppressive medications. To address this uncertainty, the British Society of Gastroenterology (BSG) COVID-19 IBD Working Group has used the best available data and expert opinion to generate a risk grid that groups patients into highest, moderate and lowest risk categories. This grid allows patients to be instructed to follow the UK government's advice for shielding, stringent and standard advice regarding social distancing, respectively. Further considerations are given to service provision, medical and surgical therapy, endoscopy, imaging and clinical trials.


Subject(s)
Betacoronavirus , Coronavirus Infections , Inflammatory Bowel Diseases , Pandemics , Pneumonia, Viral , Antiviral Agents/adverse effects , Antiviral Agents/therapeutic use , COVID-19 , Coronavirus Infections/complications , Coronavirus Infections/drug therapy , Coronavirus Infections/therapy , Coronavirus Infections/transmission , Humans , Immunosuppressive Agents/adverse effects , Immunosuppressive Agents/therapeutic use , Inflammatory Bowel Diseases/therapy , Pneumonia, Viral/complications , Pneumonia, Viral/therapy , Pneumonia, Viral/transmission , Risk Assessment , SARS-CoV-2 , United Kingdom
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