The natural history of COVID-19 in vaccinated inflammatory bowel disease patients.

AIM: Assess the characteristics of break through COVID-19 in Inflammatory Bowel Disease (IBD) patients, despite complete vaccination. METHODS: Patients who reported a COVID-19 at least 3 weeks after complete vaccination were asked to answer an on-line anonymous questionnaire which included patient and disease characteristics, vaccination history, and the evolution of COVID-19. RESULTS: Among 3240 IBD patients who reported complete vaccination between 1st May 2021 and 30thJune 2022, 402 (12.4%) were infected by SARS Cov-2 [223 male, 216 Crohn's disease (CD), 186 Ulcerative Colitis (UC), mean (SD) age 42.3 (14.9) years, mean (SD) IBD duration 10.1 (9.7) years]. Three hundred and sixty-nine patients (91.8%) were infected once and 33 (8.2%) twice. The mean (SD) time between last vaccination and infection was 4.1 (1.6) months. Overall, 351 (87.3%) patients reported mild constitutional and/or respiratory symptoms, 34 (8.4%) were asymptomatic and only 17 patients (4.2%) required hospitalization. Of hospitalized patients, 2 UC patients died of COVID-19 pneumonia. The remaining hospitalized patients did not need high flow oxygen supply or ICU admission. CONCLUSIONS: A minority of completely vaccinated IBD patients developed COVID-19 which evolved with mild symptoms and a favorable outcome. These results reinforce the importance of vaccination especially in vulnerable populations.

The Natural History of Covid-19 in Vaccinated Inflammatory Bowel Disease Patients

Introduction: Patients with Inflammatory Bowel Disease (IBD), especially those on immunosuppressives (IMS), should be vaccinated against SARSCoV- 2 to prevent hospitalization, mechanical ventilation, and death. However, IMS may adversely affect response to vaccination, raising concerns as to how vulnerable these patients are to break through COVID-19 infections. Thus, we aimed to assess the proportion of IBD patients who despite complete vaccination developed COVID-19, as well as the course of COVID-19 disease. Aims & Methods: This study was an initiative of the Hellenic IBD Study Group (EOMIFNE) and involved 12 IBD referral Centers. Patients attending these Centers who reported a COVID-19 infection at least 3 weeks after vaccination completion were asked to complete an on-line anonymous questionnaire which included patient demographics and IBD clinical and therapeutic data, a detailed vaccination history, and the course and outcome of COVID-19, especially the need for hospitalization, oxygen supply, and admission to ICU. In patients with a grave outcome information was sought by family members. Result(s): On estimate, 3240 patients reported full vaccination (vaccination scheme either with combined Vaxzevria- Comirnaty or onlyComirnaty vaccine) in the 12 centers. Between 1stMay 2021 and 20thApril 2022,351 (10.8%) fully vaccinated IBD patients reported COVID-19 infection [187 male, 212 CD, 139 UC, mean (SD) age 42.3 (14.9) years, mean (SD) IBD duration mean (SD), 10.1 (9.7) years]. Among them, 322 (91.7%) were infected once and 29 (8.3%) patients twice. Seventy-three patients were receiving 5-ASAs, 15 corticosteroids, 46 azathioprine/methotrexate, 117 anti-TNFs as monotherapy and 21 in combination with azathioprine/methotrexate, and 2 with corticosteroids, 43 vedolizumab, 25 ustekinumab, 5 tofacitinib and 1 rizakinzumab at the time of COVID-19 diagnosis. Three patients did not receive any treatment. IBD was in remission in 279/351 patients (79.5%). Comorbidities were reported by 112 patients (thyroid disease 66;diabetes mellitus 13;hypertension 12;coronary heart disease 11;prior cancer 4;psoriasis 2;spondyoartropathy 2;dyslipidemia 1;and PSC 1 patient). The mean (SD) time between last vaccination dose and infection was 4.1 (1.6) months. Overall, 308 (87.7%) patients reported mild constitutional and respiratory symptoms, 29 (8.6%) were asymptomatic and only 14 patients (3.9%) required hospitalization. Of those hospitalized, 2 patients, both with UC, died because of COVID pneumonia (one aged 67, on infliximab, with diabetes and the second one aged 80, on 5-ASA, with a history of laryngeal cancer);however, the remaining 12 patients did not need high flow oxygen supply or ICU admission, and none reported symptoms of long COVID. IBD medications were stopped in 145 patients (41.3%) during the COVID-19 infection. Conclusion(s): A minority of fully vaccinated IBD vaccinated patients developed COVID-19 which was relatively mild and uneventful. These results reinforce the importance of vaccination especially in vulnerable populations.

The natural history of covid-19 in vaccinated inflammatory bowel disease patients

Background: Patients with Inflammatory Bowel Disease (IBD), especially those on immunosuppressive (IMS) treatment should be vaccinated against SARS-CoV-2 to prevent hospitalization, mechanical ventilation, and death. However, IMS may adversely affect vaccination, raising concerns as to how vulnerable these patients are to break through COVID-19 infections. Thus, we aimed to assess the proportion of IBD patients who despite complete vaccination developed COVID-19, as well as the course of the infection. Methods: This study was an initiative of the Hellenic Group for the study of IBD which involved seven IBD referral Centers. Patients attending these Centers who reported a COVID-19 infection at least 3 weeks after vaccination completion were asked to complete an on-line anonymous questionnaire which included patient demographics and IBD clinical and therapeutic data, a detailed vaccination history, and the course and outcome of COVID-19, especially the need for hospitalization, oxygen supply, and admission to ICU. In patients with grave outcome information was sought by family members Results: On estimate, 2940 patients reported full vaccination (Pfizer vaccine) in the 7 centers. Between 1st May 2021 and 30th October 2021, 46 (1.5%) fully vaccinated IBD patients reported COVID-19 infection [25 male, 32 CD, 14 UC, mean (SD) age 40.8 (13.7) years, mean (SD) IBD duration mean, 11.2 (10.8) years]. Five patients were receiving 5-ASAs, 2 corticosteroids, 5 azathioprine/methotrexate, 23 anti-TNFs as monotherapy and 3 in combination with azathioprine/methotrexate, and 1 with corticosteroids, 3 vedolizumab and 1 each ustekinumab, tofacitinib and rizakinzumab at the time of COVID-19 diagnosis;one patient was receiving no treatment. IBD was in remission in 37/46 patients (80.4%). Comorbidities were seen in 21 patients (thyroid disease 11;diabetes mellitus 2;hypertension 2;psoriasis 1;prior breast cancer 1;spondyoartropathy 2;dyslipidemia 1;and PSC 1 patient). The mean (SD) time between last vaccination dose and infection was 3.2 (1.4) months. Overall, 40 (86.9%) patients reported mild constitutional and respiratory symptoms, 4 (8.7%) were asymptomatic and only 2 patients (4.3%) required hospitalization which was uneventful in both. None needed high flow oxygen supply or ICU admission, and none reported symptoms of long COVID. No deaths were reported by patient relatives. IBD medications were stopped in 21 patients (45.6%) during the COVID-19 infection. Conclusion: A minority of fully vaccinated IBD vaccinated patients developed COVID-19 which was relatively mild and uneventful. These results reinforce the importance of vaccination especially in vulnerable populations.

Efficacy of switching from infliximab to golimumab in patients with ulcerative colitis in deep remission.

BACKGROUND-AIM: Intravenously administered biologicals are associated with a huge pressure to Infusion Units and increased cost. We aimed to assess the impact of switching infliximab to golimumab in ulcerative colitis (UC) patients in deep remission. Patients and method: In a prospective, single-centre pilot study UC patients on infliximab mono-therapy for = 2 years, whowere in deep remission, consented to switch to golimumab and were followed for 1 year with clinical assessment, serum and faecal biomarkers, work productivity, satisfaction with treatment and quality of life parameters. Endoscopic remission was assessed by colonoscopy at 1 year. Patients fulfilling the same inclusion criteria, who did not consent to switch to golimumab and continued to receive infliximab mono-therapy, for the same period, served as controls. PATIENTS AND METHODS: In a prospective, single-centre pilot study UC patients on infliximab mono-therapy for ≥ 2 years, who were in deep remission, consented to switch to golimumab and were followed for 1 year with clinical assessment, serum and faecal biomarkers, work productivity, satisfaction with treatment and quality of life parameters. Endoscopic remission was assessed by colonoscopy at 1 year. Patients fulfilling the same inclusion criteria, who did not consent to switch to golimumab and continued to receive infliximab mono-therapy, for the same period, served as controls. RESULTS: Between October 2015 and October 2017, 20 patients were recruited; however one patient stopped therapy because of pregnancy. All 19 patients who were switched to golimumab were still in clinical, biomarker and endoscopic remission at 1 year and maintained excellent quality of life without any complications. In the control group, 18 of 19 patients were also in deep remission, since only one patient had a flare which was managed with IFX dose intensification. During a median 3 years extension treatment with golimumab only 2 patients experienced a flare of colitis. CONCLUSIONS: This pilot study indicates that switching from in-fliximab to golimumab in UC patients in deep remission does not compromise treatment effectiveness or the course of disease; golimumab offers a valid alternative to intravenous infliximab infusions during the COVID-19 pandemic.