POS0738 IMMUNOGENICITY AND SAFETY OF COVID-19 VACCINATION IN PATIENTS WITH PRIMARY SJÖGREN’S SYNDROME

Abstract

BackgroundPatients with primary Sjögren’s syndrome (pSS) worry about the effectiveness and safety of COVID-19 vaccination. pSS is characterized by B-cell hyperactivity, and previous influenza vaccination studies showed that pSS patients generate higher influenza-specific antibodies than healthy controls (HC).1,2 Furthermore, influenza vaccination resulted in elevated auto-antibody levels.1,2 Therefore, it is hypothesized that COVID-19 vaccination may also lead to a higher spike-specific antibody response.ObjectivesTo evaluate humoral and cellular immune response and adverse events (AEs) after COVID-19 vaccination in pSS patients compared to HC, and disease activity following vaccination in pSS patients. Furthermore, to evaluate change in spike-specific antibody levels in saliva and anti-SSA levels in serum following vaccination.MethodsIn this prospective, longitudinal cohort study, pSS patients and HC were included in a 2:1 ratio. Participants received COVID-19 vaccinations following the Dutch vaccination programme. pSS patients did not use immunomodulatory drugs, except hydroxychloroquine (HCQ). Anti-spike 1 (S1) receptor binding domain (RBD) IgG serum antibody levels were measured 28 days after complete vaccination. AEs were collected 7 days after vaccination. Change in disease activity following vaccination was measured with EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) and EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI). In a subgroup of participants, spike-specific T-cell response was measured 7 days after complete vaccination with IFN-γ ELIspot. Definition of a T-cell responder was ≥2-fold increase in spot-forming cell (SFC) counts from pre- to post-vaccination and SFC counts of ≥50/106 cells in the post-vaccination sample. Salivary anti-S1 and anti-RBD antibodies and serological anti-SSA antibodies were also measured in this subgroup in pre- and post-vaccination samples (28 days after complete vaccination).ResultsIn total, 67 pSS patients and 33 HC were included. Of these, 47 (70%) and 14 (42%) received BNT162b2 (Pfizer-BioNtech), 13 (19%) and 5 (15%) received ChAdOx1 nCoV-19 (AstraZeneca), 6 (9%) and 8 (24%) received mRNA-1273 (Moderna), and 1 (1%) and 6 (18%) received Ad.26.COV2.S (Janssen), respectively. Overall, pSS patients were significantly older than HC, which was mainly due to the younger age in the Moderna and Janssen groups.All participants had positive anti-SARS-CoV-2 antibody levels (>2500 AU/ml) post-vaccination. No differences in anti-SARS-CoV-2 antibody levels were observed between pSS patients and HC, for any of the vaccine types (Figure 1). Percentage of spike-specific T-cell responders was comparable between pSS patients (20/24, 83%) and HC (4/5, 80%). Salivary anti-SARS-CoV-2 IgG antibodies, but not IgA, increased post-vaccination in pSS patients (n=26) and HC (n=9). Salivary anti-RBD IgG antibodies were significantly correlated with serum anti-RBD antibodies (r= 0.597, p<0.001).Figure 1.Anti-S1 RBD IgG antibody levels of participants who received A) Pfizer-BioNtech B) AstraZeneca C) Moderna or D) Janssen. Dashed line indicates positive level.No serious AEs occurred. Frequencies of systemic AEs were comparable between pSS patients and HC (first vaccination: 34/67 (51%) vs. 16/33 (48%), p=0.83; second: 41/66 (62%) vs. 14/25 (56%), p=0.59). No significant worsening was observed in median ESSPRI (baseline: 6 (IQR 5-7), post-vaccination: 6 (4-7), p=0.16, n=64) and ESSDAI (baseline: 3 (IQR 1-4), post-vaccination: 2 (0-5), p=0.88, n=36). Furthermore, no increase in anti-Ro52 and anti-Ro60 antibody levels was seen (p=0.65 and p=0.58, respectively).ConclusionpSS patients had similar humoral and cellular immune responses as HC, providing evidence that COVID-19 vaccination is effective in pSS patients. AEs were also comparable, and no increase in disease activity was seen in pSS patients, indicating COVID-19 vaccination is safe in pSS patients.