COVID-19 VACCINATION in A REAL-LIFE SETTING of A RHEUMATOLOGICAL OUTPATIENT CENTER

ABSTRACT

Background: Since approvement of the frst vaccines against COVID-19 in European in 12/2020, a large vaccination (VAC) campaign was started. Patients with infammatory diseases (ID) were graded as higher risk. Many of our patients used the possibility and got vaccinated. Until know, there is few knowledge about the efficacy and safety of VAC in patients with ID. There are some reports of less VAC response in patients with ID (1). Many antibody (AB) studies are ongoing but monitoring of AB status is not recommended by official recommendations (1,2). Nevertheless, AB testing is commonly used in daily care in outpatient centers (OC). Objectives: To evaluate in a real life setting of a single rheumatological OC how many patients have been vaccinated against COVID-19, how many of these did not develop AB and search for possible explanations. Methods: All consecutive patients of the routine follow up visits from 03/2021 to 12/2021 were retrospectively evaluated if VAC and an AB testing (e.g. ELI-SA-tests) was done ≥4 weeks after the 2nd VAC was documented. All AB tests were classifed for AB levels (Ratio <0,8 negative, >0,8 Ratio < 4,5 low to moderate, Ratio ≥ 4,5 high level). The group of patients without AB was specifed. Results: N=1206 persons were questioned. N=23/1206 (1.9%) patients refused a VAC. N=1183/1206 (98.1%) have got a VAC. N=984/1183 (83.2%) were had an ID, n=199/1183 (16.8%) were healthy persons (HP). In n=608/1138 (51%) an AB status after ≥4 weeks after VAC was available. N=14/608 (20%) HP developed all but one high AB levels. 1 HP had a low to moderate AB level. In n=595/1183 (50%) patients with ID an AB status was available. N=438/595 (74%) patients developed high AB levels, n=126/595 (21%) low to moderate, n=30/595 (5%) had no AB. Mean age in the group without any AB was 69years (range 38-95). N=27/30 (90%) patients received ≥1 DMARD (disease modifying antirheumatic drug), n=3/30 patients were not treated with DMARD, n=2/3 of these patients received Prednisolone (P) instead. N=4/30 received Rituximab (RTX), n=1/30 Abatacept (ABA), n=1/30 MMF (3g), n=1/30 Azathioprine in combination with high P (55mg), n=15(50%) MTX alone or in combination, n=24/30(80%) P (range mg 1-55, mean 5,7). One 52y old patient without any AB did receive nether a DMARD nor P. N=3/30 patients got both vaccinations with Vaxzevira (V), n=25/30 (83,3%) Comirnaty (C), n=1/30 Spikevax, n=1/30 first V, second C. 1 patient, treated with ABA has been vaccinated with 2 doses of C. A AB testing 4 months later did not reveal any antibodies. This patient came down with COVID-19 5 months after complete VAC and died. Conclusion: There is very high number of VAC (98,1%) in a real life setting of a rheumatological OC. Many patients (95%) developed low to high AB levels after 2 VAC, independently which agent was used. Otherwise, we must be aware of the small group of patients (5%) without developing any AB. Unfortunately, our group was too small to find significant risk factors (RF). But RF seems to be the age, therapy with RTX, ABA and P. This is in line with reported RF in clinical studies (1). Furthermore, we see lower levels in elderly patients who get vaccinated with C. This could be biased by the fact that, in the first months of the VAC campaign, C was used in patients with higher age and the 2nd C-VAC was given 3 weeks after 1st VAC. Retrospectively, this interval seems to be too short. Thus now, the 2nd VAC is given 4-6 weeks after 1st VAC. In conclusion it is still unclear, which levels of AB make VAC effective and which patients will develop AB levels. AB levels should be evaluated to pick out patients with VAC gap, since the high risk of fatal course of COVID-19-disease. The booster campaign and 3rd VAC will change the current state again, therefore revaluation will be necessary.