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Outcomes of COVID-19 in 79 Patients with IBD in Italy

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Outcomes of COVID-19 in 79 Patients with IBD in Italy Inflammatory bowel disease ORIGINAL RESEARCH Outcomes of COVID-19 in 79 patients with IBD in Gut: first published as 10.1136/gutjnl-2020-321411 on 30 April 2020. Downloaded from Italy: an IG- IBD study Cristina Bezzio ,1 Simone Saibeni ,1 Angela Variola,2 Mariangela Allocca,3,4 Alessandro Massari,5 Viviana Gerardi,6 Valentina Casini,7 Chiara Ricci,8 Fabiana Zingone,9 Arnaldo Amato ,10 Flavio Caprioli ,11,12 Marco Vincenzo Lenti ,13 Chiara Viganò,14 Marta Ascolani,15 Fabrizio Bossa,16 Fabiana Castiglione,17 Claudio Cortelezzi,18 Laurino Grossi,19 Monica Milla,20 Daniela Morganti,21 Luca Pastorelli,22 Davide Giuseppe Ribaldone ,23 Alessandro Sartini ,24 Alessandra Soriano,25 Gianpiero Manes,26 Silvio Danese,3,4 Massimo Fantini,27 Alessandro Armuzzi,28,29 Marco Daperno,30 Gionata Fiorino ,3,4 on behalf of Italian Group for the Study of Inflammatory Bowel Disease (IG-­IBD) ► Additional material is ABSTRact published online only. To view, Objectives COVID-19 has rapidly become a major Significance of this study please visit the journal online health emergency worldwide. Patients with IBD are at (http:// dx. doi. org/ 10. 1136/ What is already known on this subject? gutjnl- 2020- 321411). increased risk of infection, especially when they have active disease and are taking immunosuppressive ► COVID-19 has rapidly become a major health For numbered affiliations see emergency worldwide, resulting in >1.7 million end of article. therapy. The characteristics and outcomes of COVID-19 in patients with IBD remain unclear. persons infected with 6% lethality. ► Patients with IBD are at increased risk of Correspondence to Design This Italian prospective observational cohort Dr Cristina Bezzio, study enrolled consecutive patients with an established infection, especially when they have active Gastroenterology Unit, Rho IBD diagnosis and confirmed COVID-19. Data regarding disease and are taking immunosuppressive Hospital, Rho (MI), ASST age, sex, IBD (type, treatments and clinical activity), therapy. Rhodense, Garbagnate ► The characteristics and outcomes of COVID-19 other comorbidities (Charlson Comorbidity Index (CCI)), http://gut.bmj.com/ Milanese, Italy; in patients with IBD remain unclear. cribezzio03@ yahoo. it signs and symptoms of COVID-19 and therapies were compared with COVID-19 outcomes (pneumonia, What are the new findings? Received 14 April 2020 hospitalisation, respiratory therapy and death). ► Active IBD, older age and presence of Revised 18 April 2020 Results Between 11 and 29 March 2020, 79 patients Accepted 20 April 2020 comorbidities have been found to be associated with IBD with COVID-19 were enrolled at 24 IBD referral with a higher risk of COVID-19 pneumonia and units. Thirty- six patients had COVID-19- related pneumonia death in patients with IBD. (46%), 22 (28%) were hospitalised, 7 (9%) required on September 28, 2021 by guest. Protected copyright. ► Concomitant therapy with biologics and non-mechanical ventilation, 9 (11%) required continuous immunosuppressants did not associate with positive airway pressure therapy, 2 (3%) had endotracheal worse COVID-19 prognosis in patients with IBD. intubation and 6 (8%) died. Four patients (6%) were diagnosed with COVID-19 while they were being How might it impact on clinical practice in the hospitalised for a severe flare of IBD. Age over 65 years foreseeable future? (p=0.03), UC diagnosis (p=0.03), IBD activity (p=0.003) ► This is the first report on the characteristics and and a CCI score >1 (p=0.04) were significantly associated outcomes of COVID-19 in patients with IBD. with COVID-19 pneumonia, whereas concomitant IBD ► Maintaining effective therapy to avoid disease treatments were not. Age over 65 years (p=0.002), active flares in patients with IBD may reduce the risk IBD (p=0.02) and higher CCI score were significantly of fatal COVID-19. associated with COVID-19- related death. Conclusions Active IBD, old age and comorbidities (SARS- CoV-2) that was first identified in Wuhan, were associated with a negative COVID-19 outcome, China, but has now spread worldwide. COVID-19 © Author(s) (or their whereas IBD treatments were not. Preventing acute IBD has rapidly become a major health emergency employer(s)) 2020. No flares may avoid fatalC OVID-19 in patients with IBD. that has evolved into a pandemic. On 30 January commercial re- use. See rights and permissions. Published Further research is needed. 2020, the WHO Director-General declared that by BMJ. the outbreak of this viral infection constitutes a Public Health Emergency of International Concern. To cite: Bezzio C, Saibeni S, BACKGROUND SARS- CoV-2, and a few other highly pathogenic Variola A, et al. Gut Epub ahead of print: [please COVID-19 is an infectious respiratory syndrome coronaviruses, pose a global threat to public 2 3 include Day Month Year]. with a wide spectrum of presentations and health, but the risk of severe disease and death is doi:10.1136/ outcomes.1 2 It is caused by a new virus called greater in elderly subjects and in those with comor- gutjnl-2020-321411 severe acute respiratory syndrome coronavirus 2 bidities.4 5 Bezzio C, et al. Gut 2020;0:1–5. doi:10.1136/gutjnl-2020-321411 1 Inflammatory bowel disease Patients with IBD are generally at increased infectious risk, Table 1 Baseline characteristics of patients with IBD with COVID-19 especially when being treated with steroids, immunosuppres- sants or biologics.6 The nature and magnitude of this risk vary Overall (n=79) CD (n=32) UC (n=47) Gut: first published as 10.1136/gutjnl-2020-321411 on 30 April 2020. Downloaded from with the type of immunosuppressive drug and with the patient’s Age, years, median (range) 45 (18–80) 39 (18–73) 51 (23–80) sex and age. Immunosuppressant therapy increases the risk of Female, n (%) 35 (44.3%) 15 (46%) 20 (43%) opportunistic viral infections,7 although one study found that Active disease, n (%) 22 (28%) 4 (12%) 18 (35%) the use of antitumour necrosis factor (TNF)-alpha appears to Concomitant therapy for IBD, n (%) 8 reduce the risk of opportunistic viral infections. Preliminary None 5 (6%) 5 (16%) 0 (0%) 9 10 data from China and Italy suggest that the incidence of severe Aminosalicylates 24 (30%) 3 (9%) 21 (45%) forms of COVID-19 in patients with IBD could be lower than Thiopurines 6 (8%) 1 (3%) 5 (11%) in the general population. The first reports of COVID-19 in Systemic corticosteroids 9 (11%) 1 (3%) 8 (17%) 11 patients with IBD with fatal outcomes are starting to emerge. Calcineurin inhibitors 1 (1%) 1 (3%) 0 (0%) So far, the risk, presentation and severity of coronavirus infec- Anti- TNF 29 (37%) 15 (47%) 14 (30%) tion in patients with IBD have not been studied. This study aimed Vedolizumab 15 (20%) 5 (16%) 10 (21%) to describe how COVID-19 presents and evolves in patients with Ustekinumab 3 (4%) 3 (9%) 0 (0%) IBD, and to identify risk factors that predict the severity and Investigational drugs (within a 2 (2%) 2 (6%) 1 (2%) outcomes of COVID-19 in patients with IBD. clinical trial) Pregnancy,n (%) 1 (1%) 0 (0%) 1 (2%) Comorbidities,n (%) 30 (38%) 10 (31%) 20 (43%) METHODS Charlson Comorbidity Index, n (%) This was a prospective, observational cohort study initiated and 0 43 (54%) 21 (66%) 22 (47%) supported by the Italian Group for the Study of Inflammatory 1 14 (18%) 7 (22%) 7 (15%) Bowel Disease (IG- IBD). All centres affiliated with IG- IBD were 2 12 (15%) 3 (9%) 9 (20%) invited to participate in the study with an open call for partici- 3 6 (8%) 1 (3%) 5 (11%) pation sent in the first week of March 2020. Patient enrolment 4 3 (4%) 0 (0%) 3 (6%) started on 11 March 2020. 5 1 (1%) 0 (0%) 1 (2%) Patients were eligible if they were adults who had an estab- Type of comorbidity, n (%) lished diagnosis of Crohn’s disease (CD) or UC for at least 6 None 49 (62%) 22 (68%) 27 (57%) months and who also had an either confirmed or likely diagnosis Essential hypertension 9 (11%) 2 (6%) 7 (14%) of COVID-19. A confirmed diagnosis of COVID-19 was defined Coronary heart disease 5 (6%) 0 (0%) 5 (10%) as the PCR- confirmed presence of SARS-CoV -2 genome in a COPD 5 (6%) 0 (0%) 4 (8%) nasopharyngeal swab. A likely diagnosis was made in patients CMV colitis 2 (3%) 0 (0%) 2 (4%) who did not undergo viral testing if they had a history of contact Psoriasis 2 (3%) 2 (6%) 0 (0%) with an infected person, together with at least three of the http://gut.bmj.com/ Ankylosing spondylitis 2 (3%) 2 (6%) 0 (0%) following signs and symptoms: fever, cough, dyspnoea, dysosmia Rheumatoid arthritis 1 (1%) 1 (3%) 0 (0%) and dysgeusia, or CT findings of COVID-19 lung infection.12 13 Multiple sclerosis 1 (1%) 0 (0%) 1 (2%) For all eligible patients, we collected the following data from Undifferentiated connective tissue 1 (1%) 1 (3%) 0 (0%) medical charts: age, sex, IBD type, IBD treatments, IBD clin- disease ical activity (defined as a partial Mayo score ≥3 with a rectal Hypothyroidism 1 (1%) 0 (0%) 1 (2%) 14 15 bleeding subscore ≥1 for UC, and a Harvey- Bradshaw Index Kaposi’s sarcoma 1 (1%) 0 (0%) 1 (2%) 16 for CD ≥5 ), other comorbidities (expressed with Charlson COVID-19- related symptoms, n (%) on September 28, 2021 by guest. Protected copyright. 17 Comorbidity Index (CCI) ), signs and symptoms of COVID-19 None 2 (3%) 1 (3%) 1 (3%) (fever, cough, dyspnoea, dysosmia/dysgeusia, pharyngitis, diar- Fever 71 (90%) 28 (88%) 43 (91%) rhoea, arthralgia- myalgia/asthenia, rhinitis, dysphonia), thera- Cough 52 (66%) 19 (59%) 33 (70%) pies for COVID-19 and COVID-19 outcomes.
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