IntroductionTo assess the incidence and risk factors for breakthrough COVID-19 infection in a vaccinated cohort of patients with autoimmune rheumatic diseases (AIRDs) and determine whether antibodies to receptor binding domain of spike protein (anti-RBD) serve as a reliable predictor of susceptibility to such infections.MethodsPatients with AIRDs who had completed two doses of SARS-CoV2 vaccines were included and anti-RBD antibodies were determined 4–6 weeks post the second vaccine dose and stratified into good responders (GR) (>212 IU), inadequate responders (IR) (0.8–212 IU) and non-responders (NR) (<0.8 IU). Patients who had completed a minimum of 8 weeks interval after the second dose of vaccine were followed up every 2 months to identify breakthrough infections. All sero converted patients who had contact with COVID-19 were also analysed for neutralising antibodies.ResultsWe studied 630 patients of AIRDs (mean age 55.2 (±11.6) years, male to female ratio of 1:5.2). The majority of patients had received AZD1222 (495, 78.6%) while the remaining received the BBV152 vaccine. The mean antibody titre was 854.1 (±951.9), and 380 (60.3%) were GR, 143 (22.7%) IR and 107 (16.9%) NR.Breakthrough infections occurred in 47 patients (7.4%) at a mean follow-up of 147.3 (±53.7) days and were proportionately highest in the NR group (19; 17.75%), followed by the IR group (13; 9.09%) and least in the GR group (15; 3.95%). On log-rank analysis, antibody response (p<0.00001), vaccine(p=0.003) and mycophenolate mofetil (p=0.007) were significant predictors of breakthrough infections. On multivariate Cox regression, only NR were significantly associated with breakthrough infections (HR: 3.6, 95% CI 1.58 to 8.0, p=0.002). In sero converted patients with contact with COVID-19, neutralisation levels were different between those who developed and did not develop an infection.ConclusionBreakthrough infections occurred in 7.4% of patients and were associated with seronegativity following vaccination. This provides a basis for exploring postvaccination antibody titres as a biomarker in patients with AIRD.

Patients with rheumatic and musculoskeletal (RMD) diseases may be at higher risks for COVID-19 infection. Data on the safety of the adenoviral vector-borne ChAdOx1 nCoV-19 and the heat-inactivated BBV152 Vaccines in this group are limited. 724 patients with RMD who had received at least one dose of either the ChAdOx1 or the BBV152 were audited to find out post-vaccination adverse effect (AE) or disease flares. The AE rates in patients with autoimmune rheumatic disease (AIRD) were compared with those with non-AIRD RMDs. The mean age of the cohort was 59.9 (± 10.43) years with a female ( n = 581; 80.24%) majority. 523 (70.8%) had AIRD. The ChAdOx1 and the BBV152 vaccines were received by 624 (86.18%) and 77 (10.63%), respectively. 23 (3.17%) were unaware of which vaccine they had received. 238 (32.87%) of patients had at least one comorbidity. 436 (60.22%) participants [306 (59.64%) of those with AIRD and 130 (61.61%) with other RMDs] had at least one adverse effect (AE). Four patients reported flare of arthritis that resolved within 5 days. No patient had any severe AE or required hospitalization. All AEs were self-limiting. Both the ChAdOx1 and the BBV152 vaccines appear safe in RMDs. AEs do not differ between patients with AIRD or non-AIRD. This information can help negate vaccine hesitancy amongst all stakeholders. Supplementary Information The online version contains supplementary material available at 10.1007/s00296-021-04917-0.

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There is paucity of data on extended dosing interval between two doses of AZD1222 (AstraZeneca) in patients with Autoimmune Rheumatic Diseases (AIRD). We aimed to study the humoral response and rate of breakthrough infections between the two groups who had received the second dose of vaccine at 4 weeks (Group 1) and 10–14 weeks (Group 2). From established cohort [COVID-19 vaccination cohort from CARE(CVCC)] of vaccinated patients with AIRD, those who had received AZD1222 were included and divided into two groups. Anti-Receptor Binding Domain (RBD) antibodies (IU/ml) were measured 1 month after the second dose. Its predictors and rate of breakthrough infections were studied. Four hundred ninety-five patients with AIRD were included in this study. Group 2 had higher anti-RBD antibody titres [1310.6 (±977.8) and [736 (±864.7), p = 0.0001. On univariate analysis, presence of Diabetes Mellitus; use of Methotrexate, Sulfasalazine, and Mycophenolate Mofetil; and vaccine interval were significantly associated with anti-RBD antibodies. Diabetes Mellitus and vaccine interval were independent predictors on multivariate analysis. Breakthrough infections were higher in Group 1 numerically on survival analysis but the difference was not significant (7.5% and 4.5%; log rank test: p = 0.25). In conclusion, increasing the gap between doses of the AZD1222 vaccine from 4 week to 10–14 weeks was found to be more beneficial in terms of antibody response in patients with AIRD. There was a trend towards higher breakthrough infections in the short interval group, supporting the antibody data. Key Points • There is paucity of data on effectiveness of increased dosing interval from 4-6 to 10-14 weeks for AZD1222 in patients with AIRDs • We observed a better humoral response with increased dosing interval with the interval and Diabetes Mellitus being independent predictors of the anti-RBD antibody levels • Breakthrough infections were numerically higher in the short interval group but the difference wasn't significant

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