Background Treatment with anti-TNF agents and thiopurines has been associated with an impaired immune response to some vaccines. SARS-CoV-2 vaccination is very effective in healthy individuals, but studies in inflammatory bowel disease (IBD) populations are scarce, especially regarding T cell response. We aimed to evaluate the T cell and antibody response in a cohort of IBD patients on anti-TNF and thiopurine treatment who received two doses of the SARS-CoV2 mRNA vaccine. Methods An observational, prospective study was carried out at our IBD clinic. We included Crohn’s disease (CD) and Ulcerative colitis (UC) patients receiving anti-TNF as monotherapy or anti-TNF + thiopurine (combo) or thiopurines only for at least six months at inclusion. Blood samples were drawn for interferon-gamma release assay (IGRA) and antibody determination six (+/- 2) weeks after the second vaccine dose. The specific T cell response to SARS-CoV-2 was determined by IGRA using Qiagen® QuantiFERON® SARS-CoV-2 RUO tubes with a patented Spike protein combination. Interferon-gamma was measured by CLIA using the LIAISON® QuantiFERON-®TB Gold Plus assay. As there is no validated cut-off point, we used those obtained in a cohort of 20 healthy health professionals published by our group (doi.org/10.1016/j.medcli.2021.09.013). Antibodies to the Spike (S) SARS-CoV-2 protein were analyzed by CLIA. Adverse events (AEs) and clinical activity were recorded. Results We recruited 148 IBD patients, 57 treated with anti-TNF monotherapy, 53 with combo, and 38 with thiopurine only. Seventy percent had CD, and 60% were male. Using the cut-off value of the cohort mentioned above, the T-cell response was positive in 92% of anti-TNF monotherapy, 83% in combo, and 87% of the thiopurine group (p=ns). The anti-S antibodies were positive in 100% of our cohort. There were no changes in disease activity rates after the second vaccination, nor were severe AEs detected. Conclusion SARS-CoV-2 mRNA vaccination was very effective in IBD patients receiving anti-TNF (combo or monotherapy) or thiopurine treatment as measured by both T cell and antibody response. IGRA-specific tests may constitute a valuable tool in assessing cellular immunity in immunocompromised patients.
Health-related quality of life decline in clinically stable inflammatory bowel disease patients during the COVID-19 outbreak. Rev Esp Enferm Dig 2022.
Background Complex perianal disease in patients with Crohn’s disease (CD) represents a therapeutic challenge since, despite biological treatment, half of the patients do not achieve an adequate response. Treatment with allogenic expanded adipose-derived mesenchymal stem cells (Darvadstrocel) has proven to be an innovative treatment in patients refractory to treatment with immunomodulators and anti-TNF antibodies. Methods To assess the efficacy of Darvadstrocel treatment in clinical practice in patients with CD and complex perianal fistula. Method: We performed a prospective descriptive study in patients with CD and complex perianal fistula (high intersphincteric, transsphincteric, extrasphincteric or suprasphincteric; presence or ≥ 2 external opening or abscesses), refractory to antiTNF treatment, treated consecutively with Darvadstrocel at our Crohn’s and Colitis Attention Unit. Each patient was treated with 120 million stem cells (half of the dose was injected along the tract walls and the other half around the internal opening/s). Response to treatment was assessed as combined remission according to the criteria of the ADMIRE study (clinical assessment of closure of all treated external openings that drained before treatment and absence of collections> 2 cm confirmed by MRI). Results From July 2020 to October 2021 12 patients (10M / 2H) have been treated with Darvadstrocel. All patients were in clinical remission (luminal disease) and had perianal disease refractory to anti-TNF treatment. In addition, 7/12 patients were also refractory to ustekinumab. The patients had previously been treated with a mean of 5.7 perianal surgeries (1–16), most of them curettage and seton placement or replacement. One patient had previously been treated with mesenchymal stem cells in 2014 (ADMIRE participant). All fistulas were complex, 5 with a single tract, 2 with a branched tract and 5 with a double tract; 7 were transsphincteric, 1 intersphincteric (double), 1 supraelevator, 1 suprasphincteric, and 2 extrasphincteric. 6/10 patients underwent a previous conditioning surgery (cleaning, curettage and seton placement) two weeks before cell administration. Six of the 10 patients with a follow-up of at least 6 months had combined remission (60%). Two of the three patients with a 1-year follow-up presented combined remission. Regarding safety, no relevant adverse effects have been observed: 2 patients presented abscesses in the immediate postoperative period (self-drained without subsequent recurrence). Conclusion In real-life clinical practice, treatment with Darvadstrocel can be an effective and safe therapy in patients with CD and complex perianal disease refractory to biological treatment.
The latest consensus standards for patients with inflammatory bowel disease published by the European Crohn's and Colitis Organisation conclude that optimizing quality of care in inflammatory bowel disease involves information and education after diagnosis. A scoping review was performed to identify educational interventions in newly diagnosed inflammatory bowel disease patients. A systematic literature search was conducted using five databases and gray literature. Inclusion criteria were studies with at least one group of patients whom were less than 2 years from their initial inflammatory bowel disease diagnosis. The review process initially identified 447 articles, resulting in four relevant studies: three randomized controlled trials and one pre-/post-test. Only one study exclusively included newly diagnosed inflammatory bowel disease patients. All studies included a multidisciplinary assessment and three were based on a group intervention, but none of them was described in enough detail to be replicated. The content was the same for all patients regardless of the time elapsed since diagnosis. Education of newly diagnosed patients does not seem to be a priority given the lack of publications meeting our criteria despite the evidence of their need. Interventions and outcomes are heterogeneous. Interventions did not consider patient needs and suggest that they centered more on the professional than on the patient. More evidence is clearly needed about this topic.
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