Background The effects that therapies for inflammatory bowel disease (IBD) have on immune responses to SARS-CoV-2 vaccination are not yet fully known. Therefore, we sought to determine whether COVID-19 vaccineinduced antibody responses were altered in patients with IBD on commonly used immunosuppressive drugs. Methods In this multicentre, prospective, case-control study (VIP), we recruited adults with IBD treated with one of six different immunosuppressive treatment regimens (thiopurines, infliximab, a thiopurine plus infliximab, ustekinumab, vedolizumab, or tofacitinib) and healthy control participants from nine centres in the UK. Eligible participants were aged 18 years or older and had received two doses of COVID-19 vaccines (either ChAdOx1 nCoV-19 [Oxford-AstraZeneca], BNT162b2 [Pfizer-BioNTech], or mRNA1273 [Moderna]) 6-12 weeks apart (according to scheduling adopted in the UK). We measured antibody responses 53-92 days after a second vaccine dose using the Roche Elecsys Anti-SARS-CoV-2 spike electrochemiluminescence immunoassay. The primary outcome was anti-SARS-CoV-2 spike protein antibody concentrations in participants without previous SARS-CoV-2 infection, adjusted by age and vaccine type, and was analysed by use of multivariable linear regression models. This study is registered in the ISRCTN Registry, ISRCTN13495664, and is ongoing. Findings Between May 31 and Nov 24, 2021, we recruited 483 participants, including patients with IBD being treated with thiopurines (n=78), infliximab (n=63), a thiopurine plus infliximab (n=72), ustekinumab (n=57), vedolizumab (n=62), or tofacitinib (n=30), and 121 healthy controls. We included 370 participants without evidence of previous infection in our primary analysis. Geometric mean anti-SARS-CoV-2 spike protein antibody concentrations were significantly lower in patients treated with infliximab (156•8 U/mL [geometric SD 5•7]; p<0•0001), infliximab plus thiopurine (111•1 U/mL [5•7]; p<0•0001), or tofacitinib (429•5 U/mL [3•1]; p=0•0012) compared with controls (1578•3 U/mL [3•7]). There were no significant differences in antibody concentrations between patients treated with thiopurine monotherapy (1019•8 U/mL [4•3]; p=0•74), ustekinumab (582•4 U/mL [4•6]; p=0•11), or vedolizumab (954•0 U/mL [4•1]; p=0•50) and healthy controls. In multivariable modelling, lower anti-SARS-CoV-2 spike protein antibody concentrations were independently associated with infliximab (geometric mean ratio 0•12, 95% CI 0•08-0•17; p<0•0001) and tofacitinib (0•43, 0•23-0•81; p=0•0095), but not with ustekinumab (0•69, 0•41-1•19; p=0•18), thiopurines (0•89, 0•64-1•24; p=0•50), or vedolizumab (1•16, 0•74-1•83; p=0•51). mRNA vaccines (3•68, 2•80-4•84; p<0•0001; vs adenovirus vector vaccines) were independently associated with higher antibody concentrations and older age per decade (0•79, 0•72-0•87; p<0•0001) with lower antibody concentrations. Interpretation For patients with IBD, the immunogenicity of COVID-19 vaccines varies according to immunosuppressive drug exposure, and is attenuated in recipie...

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Background and aims The COVID-19 risk and disease course in inflammatory bowel disease (IBD) patients remains uncertain. Therefore, we aimed to assess the clinical presentation, disease course and outcomes of COVID-19 in IBD patients. Second, we determined COVID-19 incidences in IBD patients and compared this with the general population. Methods We conducted a multicenter, nationwide IBD cohort study in the Netherlands and identified patients with COVID-19. First, we assessed the COVID-19 disease course and outcomes. Second, we compared COVID-19 incidences between our IBD study cohort and the general Dutch population. Results We established an IBD cohort of 34,763 patients. COVID-19 was diagnosed in 100/34,763 patients (0.29%). 20/100 patients (20%) had severe COVID-19 defined as admission to the intensive care unit, mechanical ventilation, and/or death. Hospitalization occurred in 59/100 (59.0%) patients and 13/100 (13.0%) died. All patients who deceased had comorbidities and all but one were &gt; 65 years. In line, we identified &gt; 1 comorbidity as an independent risk factor for hospitalization (OR 4.20, 95% CI 1.58-11.17, p = 0.004). Incidences of COVID-19 between the IBD study cohort and the general population were comparable (287.6 (95% CI 236.6-349.7) versus 333.0 (95% CI 329.3-336.7) per 100,000 patients, respectively; p = 0.15). Conclusions Of 100 cases with IBD and COVID-19, 20% developed severe COVID-19, 59% was hospitalized and 13% died. A comparable COVID-19 risk was found between the IBD cohort (100/34,763 = 0.29%) and the general Dutch population. The presence of &gt; 1 comorbidities was an independent risk factor for hospitalization due to COVID-19.

We demonstrated that switching from Remicade® to CT-P13 in a real-life cohort of IBD patients did not have a significant impact on short-term clinical outcomes. These results suggest that switching from Remicade® to CT-P13 for the treatment of IBD is feasible.

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