P616 Safety of COVID-19 vaccines in patients with IBD
Dussias, N.(1);Carbone, A.(1);Melotti, L.(1);Privitera Hrustemovic, H.(1);Salice, M.(1);Scaioli, E.(1);Calabrese, C.(1);Rizzello, F.(1);Gionchetti, P.(1);
(1)University of Bologna, Dept. of surgical and medical sciences, Bologna, Italy;
Background
COVID-19 vaccines have demonstrated excellent efficacy and safety profiles among the general population. However, studies have shown that vaccine hesitancy remains a significant problem especially in patients with chronic diseases, in part because of a lack of data regarding vaccine safety in these special populations. With this in mind, we investigated rates of vaccine-related side effects and disease flares in patients with inflammatory bowel disease (IBD).
Methods
We conducted an online survey of patients with Crohn’s disease (CD) and ulcerative colitis (UC) who were vaccinated from January 23 to October 15, 2021 with COVID-19 vaccines approved in Europe. We collected data regarding patient demographics, disease type, treatment and activity at the time of vaccination, patient-reported systemic side effects, and rates of disease flares and outcomes within 15 days of both vaccine doses.
Results
A total of 329 (179 M, 150 F) patients participated in the survey, 162 with CD and 167 with UC. Mean age was 47.1 years (range 19-80). Patients were vaccinated with Pfizer-BioNTech (46.8%), Moderna (51.7%) or Oxford/AstraZeneca (1.5%). Three patients received only one dose because of recent prior infection, and one patient received a single dose dose due to infection before vaccine cycle completion. At the time of vaccination most patients (63.8%) reported disease remission, 22.8%= mild activity, 12.8%= moderate, 0.6%= severe. Mesalazine monotherapy was reported in 174 patients, 89 were on biologics, 8 were on azathioprine, and 58 were not undergoing treatment at the time of vaccination. Nineteen were on concomitant corticosteroid treatment.
After the first dose, the most common side effects were mild: fatigue (38.6%), arthromyalgia (16.7%), headache (14.3%), fever (6.7%) and nausea (1.8%). Side effects after the second dose were more frequent but similar in nature (fatigue= 54.8%, fever= 34.8%, arthromyalgia= 31.7%, headache= 22.8%, nausea= 2.5%).
Fourteen patients (4.3%) reported disease flare after the first dose and 26 patients (8%) after the second dose. Characteristiscs of these patients are summarized in Table 1. Most flares were self-limiting and did not require modification in treatment. In the five cases where treatment modification was required, two already had moderate/severe disease at the time of vaccination, one had suspended biologic treatment, and two patients had autonomously suspended maintenance therapy.
Conclusion
Disease flares are infrequent and generally self-limiting after COVID-19 vaccination in patients with IBD. Other side effects are mild and comparable to the general population. Vaccination is strongly recommended in patients with IBD, and patients should be reassured about their safety.