P612 Lack of seroconversion following COVID-19 vaccination, but not treatment, is an independent risk factor for breakthrough SARS-CoV-2 infection in patients with inflammatory bowel disease: data from ESCAPE - an IG-IBD Study

Macaluso, F.S.(1)*;Principi, M.(2);Facciotti, F.(3);Contaldo, A.(4);Todeschini, A.(5);Bezzio, C.(6);Saibeni, S.(6);Castiglione, F.(7);Nardone, O.M.(7);Spagnuolo, R.(8);Fantini, M.C.(9);Riguccio, G.(10);Conforti, F.S.(11);Caprioli, F.A.(11);Viganò, C.(12);Felice, C.(13);Fiorino, G.(14);Correale, C.(15);Bodini, G.(16);Milla, M.(17);Scardino, G.(18);Vernero, M.(19);Desideri, F.(20);Bossa, F.(21);Guerra, M.(21);Ventimiglia, M.(22);Mannino, M.(1);Rizzo, G.(23);Orlando, A.(1);

(1)"Villa Sofia-Cervello" Hospital, IBD Unit, Palermo, Italy;(2)“Aldo Moro” University, Gastroenterology Department, Bari, Italy;(3)Istituto Europeo di Oncologia IRCCS, Dipartimento di Oncologia Sperimentale, Milan, Italy;(4)IRCCS “S. De Bellis”, Gastroenterology 2 Unit-, Castellana Grotte- Bari, Italy;(5)IRCCS Sacro Cuore Don Calabria, IBD Unit, Negrar- Verona, Italy;(6)Rho Hospital- ASST Rhodense, Gastroenterology Unit, Rho- Milan, Italy;(7)Università Federico II di Napoli, Dipartimento di Medicina Clinica e Chirurgia, Napoli, Italy;(8)Università “Magna Graecia”, Dipartimento di Medicina Sperimentale e Clinica-, Catanzaro, Italy;(9)Università di Cagliari, Dipartimento di Scienze Mediche e Sanità Pubblica-, Cagliari, Italy;(10)Ospedale Santa Maria del Prato, UOSD Malattie Infiammatorie Croniche intestinali, Feltre, Italy;(11)Fondazione IRCCS Cà Granda- Ospedale Maggiore Policlinico di Milano, Gastroenterology and Endoscopy Unit, Milan, Italy;(12)University of Milano-Bicocca, Division of Gastroenterology and Center for Autoimmune Liver Diseases- Department of Medicine and Surgery, Monza, Italy;(13)Ospedale Ca'Foncello, UO Gastroenterologia, Treviso, Italy;(14)IRCCS Ospedale San Raffaele e Università Vita-Salute San Raffaele, Dipartimento di Gastroenterologia ed Endoscopia Digestiva, Milan, Italy;(15)Humanitas Clinical and Research Center, Irccs, Rozzano, Italy;(16)Università di Genova, IRCCS Policlinico San Martino, Genova, Italy;(17)Azienda Ospedaliero-Universitaria Careggi, IBD Referral Center- Gastroenterology Unit, Florence, Italy;(18)Ospedale Valduce, Gastroenterology Depatment, Como, Italy;(19)Department of Medical Sciences- University of Pavia, Gastroenterology Unit, Pavia, Italy;(20)San Maurizio Hospital, Gastroenterology Department-, Bolzano, Italy;(21)“Casa Sollievo della Sofferenza” Hospital- IRCCS, Division of Gastroenterology, San Giovanni Rotondo, Italy;(22)Italian Ministry of Health, Directorate General of Medical Device and Pharmaceutical Service-, Rome, Italy;(23)University of Palermo, Gastroenterology Unit- PROMISE, Palermo, Italy; Italian Group for the study of Inflammatory Bowel Disease (IG-IBD)


As patients with immune conditions were excluded from COVID-19 vaccine clinical trials, it is important to accumulate real-world data in this setting, particularly to identify those who would benefit from repeated doses.



Effectiveness and Safety of COVID-19 Vaccine in Patients with Inflammatory Bowel Disease (IBD) Treated with Immunomodulatory or Biological Drugs (ESCAPE) is a prospective, multicentre, observational study assessing effectiveness and safety of COVID-19 vaccines in patients with IBD (ClinicalTrials.gov ID: NCT04769258). Here we present data on the rate of breakthrough SARS-CoV-2 infections in the timeframe between 14 days after the second dose and the third dose of COVID-19 vaccine (or a maximum of 9 months from the second dose). The risk factors for SARS-CoV-2 infection, including lack of seroconversion (cut-off for IgG anti-SARS-CoV-2: OD 0.28) and IgG anti-SARS-CoV-2 levels after 8 weeks from the second dose, and treatment for IBD, were assessed.


Out of the 1076 patients with IBD enrolled in the ESCAPE study, data on breakthrough SARS-CoV-2 infection were available in 953 cases. Most of the patients received homologous, double-dose mRNA-based vaccines (BNT162b2 or mRNA-1273: 99.2%). Seroconversion was reported in 92.7% of cases (median OD 1.60 [IQR 0.8-3.6]), while SARS-CoV-2 infection was documented in 95 patients (10.0%), of whom 9 died. At multivariable regression analyses, age (OR 0.97, 95% CI 0.96-0.99; p<0.001) being former smoker (OR 2.23, 95% CI 1.26-3.88; p=0.005), and lack of seroconversion (OR 0.42, 95% CI 0.20-0.99; p=0.034) were independent predictors of SARS-CoV-2 infection. Conversely, none of the treatments for IBD was associated with breakthrough SARS-CoV-2 infection. Notably, all 9 patients who died had reported seroconversion after the second dose.


IBD patients without seroconversion after COVID-19 vaccines are at increased risk for SARS-CoV-2 infection, while medications for IBD had no impac