PMID- 35414631 OWN - NLM STAT- MEDLINE DCOM- 20220414 LR - 20220526 IS - 2056-5933 (Electronic) IS - 2056-5933 (Linking) VI - 8 IP - 1 DP - 2022 Apr TI - Immunogenicity and safety of COVID-19 vaccination in patients with primary Sjogren's syndrome. LID - 10.1136/rmdopen-2022-002265 [doi] LID - e002265 AB - OBJECTIVES: To evaluate humoral and cellular immune responses and adverse events (AEs) after COVID-19 vaccination in patients with primary Sjogren's syndrome (pSS) compared to healthy controls (HC), and disease activity following vaccination in patients with pSS. METHODS: 67 patients with pSS and 33 HC (ratio 2:1) received COVID-19 vaccinations following the Dutch vaccination programme. Patients with pSS did not use immunomodulatory drugs, except hydroxychloroquine. Anti-spike 1 receptor binding domain IgG serum antibody levels were measured 28 days after complete vaccination. AEs were collected 7 days after vaccination. In a subgroup, salivary anti-SARS-CoV-2 antibodies and T-cell response by interferon-gamma enzyme-linked immune absorbent spot was measured. RESULTS: 47 patients with pSS (70%) and 14 HC (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). All participants had positive anti-SARS-CoV-2 antibody levels (>2500 AU/mL) postvaccination. No differences in anti-SARS-CoV-2 antibody levels were observed between patients with pSS and HC, for each vaccine type. Salivary anti-SARS-CoV-2 IgG antibodies also increased, and a T-cell response was observed in patients with pSS and HC. Frequencies of systemic AEs were comparable between patients with pSS 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 patient-reported and systemic disease activity, including auto-antibodies. CONCLUSIONS: Patients with pSS had similar humoral and cellular immune responses as HC, suggesting COVID-19 vaccination is effective in patients with pSS. AEs were also comparable, and no increase in disease activity was seen in patients with pSS. CI - (c) Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. FAU - Verstappen, Gwenny M AU - Verstappen GM AD - Rheumatology and Clinical Immunology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands. FAU - de Wolff, Liseth AU - de Wolff L AUID- ORCID: 0000-0002-7917-5449 AD - Rheumatology and Clinical Immunology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands. FAU - Arends, Suzanne AU - Arends S AUID- ORCID: 0000-0002-4422-7640 AD - Rheumatology and Clinical Immunology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands. FAU - Heiermann, Hella-Marie AU - Heiermann HM AD - Rheumatology and Clinical Immunology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands. FAU - van Sleen, Yannick AU - van Sleen Y AUID- ORCID: 0000-0002-7382-8322 AD - Rheumatology and Clinical Immunology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands. FAU - Visser, Annie AU - Visser A AD - Rheumatology and Clinical Immunology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands. FAU - Terpstra, Janneke H AU - Terpstra JH AD - Rheumatology and Clinical Immunology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands. FAU - Diavatopoulos, Dimitri A AU - Diavatopoulos DA AD - Radboud Centre for Infectious Diseases, Radboud University Medical Centre Nijmegen, Nijmegen, The Netherlands. AD - Laboratory of Medical Immunology, Radboud Institute for Molecular Life Sciences, Radboud University Medical Centre Nijmegen, Nijmegen, The Netherlands. FAU - van der Heiden, Marieke AU - van der Heiden M AD - Medical Microbiology and Infection Prevention, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands. FAU - Vissink, Arjan AU - Vissink A AD - Oral and Maxillofacial Surgery, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands. FAU - van Baarle, Debbie AU - van Baarle D AD - Medical Microbiology and Infection Prevention, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands. AD - Centre for Infectious Disease Control, National Institute of Public Health and the Environment, Bilthoven, The Netherlands. FAU - Kroese, Frans G M AU - Kroese FGM AD - Rheumatology and Clinical Immunology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands. FAU - Bootsma, Hendrika AU - Bootsma H AD - Rheumatology and Clinical Immunology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands h.bootsma@umcg.nl. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't PL - England TA - RMD Open JT - RMD open JID - 101662038 RN - 0 (Antibodies, Viral) RN - 0 (COVID-19 Vaccines) RN - 0 (Immunoglobulin G) RN - B5S3K2V0G8 (ChAdOx1 nCoV-19) RN - N38TVC63NU (BNT162 Vaccine) SB - IM MH - Antibodies, Viral MH - BNT162 Vaccine MH - *COVID-19/prevention & control MH - COVID-19 Vaccines/adverse effects MH - ChAdOx1 nCoV-19 MH - Humans MH - Immunoglobulin G MH - SARS-CoV-2 MH - *Sjogren's Syndrome/complications MH - Vaccination/adverse effects PMC - PMC9006196 OTO - NOTNLM OT - COVID-19 OT - Sjogren's Syndrome OT - Vaccination COIS- Competing interests: HB: reports grants and personal fees from Bristol Myers Squibb and Roche, and personal fees from Novartis, Medimmune, personal fees and Union Chimique Belge, outside the submitted work. EDAT- 2022/04/14 06:00 MHDA- 2022/04/15 06:00 PMCR- 2022/04/11 CRDT- 2022/04/13 05:34 PHST- 2022/02/03 00:00 [received] PHST- 2022/03/21 00:00 [accepted] PHST- 2022/04/13 05:34 [entrez] PHST- 2022/04/14 06:00 [pubmed] PHST- 2022/04/15 06:00 [medline] PHST- 2022/04/11 00:00 [pmc-release] AID - rmdopen-2022-002265 [pii] AID - 10.1136/rmdopen-2022-002265 [doi] PST - ppublish SO - RMD Open. 2022 Apr;8(1):e002265. doi: 10.1136/rmdopen-2022-002265.