1796: Safety & ImmUnogenicity of COVID-19 VaCcines in SystEmic immunE Mediated Inflammatory Diseases (SUCCEED)

Olga Tsyruk¹, Vinod Chandran², Carol Hitchon³, J. Antonio Avina-Zubieta⁴, Ines Colmegna⁵, Paul R. Fortin⁶, Maggie Larche⁷, Gilles Boire⁸, Luck Lukusa¹, Dawn Bowish⁷, Gilaad G Kaplan⁹, Daniel Pereira¹⁰, Roaya Dayam¹¹, Jennifer LF Lee¹, Elizabeth Turnbull¹, Valeria Valerio¹², Laurie Proulx¹³, Janet Gunderson¹⁴, Anne-Claude Gingras¹¹ and Sasha Bernatsky¹², ¹RI-MUHC, Montreal, QC, Canada, ²Schroeder Arthritis Institute, Krembil Research Institute, University Health Network and Division of Rheumatology, Department of Medicine, University of Toronto, Toronto, ON, Canada, ³University of Manitoba, Winnipeg, MB, Canada, ⁴Arthritis Research Canada, Vancouver, BC, Canada, ⁵The Research Institute of the McGill University Health Centre, Montréal, QC, Canada, ⁶Centre ARThrite - CHU de Québec - Université Laval, Quebec City, QC, Canada, ⁷McMaster University, Hamilton, ON, Canada, ⁸Université de Sherbrooke, Sherbrooke, QC, Canada, ⁹University of Calgary, Calgary, AB, Canada, ¹⁰University Health Network, Toronto, ON, Canada, ¹¹Lunenfeld-Tanenbaum Research Institute at Mount Sinai Hospital Sinai Health, Toronto, ON, Canada, ¹²Research Institute of the McGill University Health Centre, Montreal, QC, Canada, ¹³Canadian Arthritis Patient Alliance, Ottawa, ON, Canada, ¹⁴Canadian Arthritis Patient Alliance, Saskatoon, SK, Canada

Background/Purpose: The Canadian government's COVID Immunity Task Force funded SUCCEED to study COVID vaccination responses in immune-mediated inflammatory disease(IMID). We describe how drugs, clinical factors, and vaccine history influence serological response to vaccination, summarize safety, and describe breakthrough infections.

Methods: From Vancouver, Calgary, Winnipeg, Montreal, Quebec City, Sherbrooke, Toronto, and Hamilton, data and dried blood spots/sera post-COVID vaccination were collected from adults with rheumatoid arthritis, inflammatory bowel disease, SLE, ankylosing spondylitis/spondyloarthritis and psoriasis/psoriatic arthritis, with the first sample at enrolment and then 3, 6, and 12 months after latest vaccine dose. We evaluated anti-spike(S) trimer and anti-receptor-binding domain(RBD) IgG (indicating successful serologic response to vaccine) and anti-nucleocapsid (N) IgG (indicating recent infection, cross-referenced with self-report). Multivariate generalized estimating equation regressions (accounting for repeated measures) were used to evaluate serologic response, based on log-transformed anti-RBD titres.

Results: Baseline characteristics of 1556 participants are shown in Table 1. Table 2 shows crude and adjusted odds ratios(OR). Positive associations for anti-RBD/anti-S serologic responses were seenwithfemale sex, number of vaccine doses and infections in 2021-2022. Negative associations were seen with prednisone, anti-TNF agents and rituximab. Diminution of response was clearly seen even for daily prednisone doses of 1-10 mg (adjusted OR 0.73 95%CI 0.58-0.91) and 11-20 mg (aOR 0.62 95%CI 0.43-0.90). Methotrexate and other immunosuppressants were associated with reduced response only in univariate analyses. Time since last vaccination was negatively associated with serologic response; rate of decrease was similar during the period 15-120 days since last vaccine (OR 0.75 95%CI 0.64,0.87) and 121-210 days post-last vaccine (OR 0.79 95%CI 0.67,0.92) but worse after >210 days (OR 0.53 95%CI 0.43,0.66).
Self-reported post-vaccine adverse events leading to emergency department(ED) visits or hospitalizations occurred in only 1.5% of participants. Bell's Palsy represented one ED visit, with no confirmed Guillain-Barre or transverse myelitis in our preliminary analyses. Over 2021-2022, anti-N positivity (indicating recent infection) was present in 9.8% of samples; most (85%) were associated with a self-reported infection. Anti-N positivity was lowest in the summer of 2021 and highest post-Omicron (fall 2022).

Conclusion: Past infections and number of COVID-19 vaccine doses were positively associated with serologic response. Time since vaccination, particularly >210 days, was negatively associated with response. Anti-TNF agents, rituximab, and prednisone were associated with less immunogenicity. Few vaccine-related adverse events led to ED or hospitalization. Ours is the first assessment of drugs, vaccine history, and other factors on serologic COVID vaccine response in a large, pan-Canadian IMID sample. These findings may help patients, clinicians, and other stakeholders make personalized decisions about vaccination in 2023-2024 and beyond.






O. Tsyruk: None; V. Chandran: AbbVie, 1, 5, 6, Amgen, 1, 5, 6, AstraZeneca, 3, Bristol-Myers Squibb (BMS), 1, 6, Eli Lilly, 1, 5, 6, Janssen, 1, 6, Novartis, 1, 1, 6, UCB, 1, 2; C. Hitchon: Astra Zeneca, 1, Pfizer, 5; J. Avina-Zubieta: None; I. Colmegna: None; P. Fortin: AbbVie, 1, AstraZeneca, 1, 6, GlaxoSmithKlein(GSK), 1, 6, Roche-Genentech, 1; M. Larche: None; G. Boire: Eli Lilly, 1, Janssen, 6, Organon, 1, Orimed Pharma, 1, 6, Otsuka, 1, Pfizer, 1, 5, Sandoz, 1, Teva, 1, Viatris, 1, 6; L. Lukusa: None; D. Bowish: AstraZeneca, 2; G. Kaplan: AbbVie, 6, Ferring, 5, Janssen, 6, Pfizer, 6; D. Pereira: None; R. Dayam: None; J. Lee: None; E. Turnbull: None; V. Valerio: None; L. Proulx: AbbVie/Abbott, 5, ESDC, 5, IMC, 5; J. Gunderson: None; A. Gingras: ChairCIHR Institute of Genetics Advisory Board, and SAB of the National Research Council of Canada Human Health Therapeutics Board, 4, Participates in the COVID-19 Immunity Task Force (CITF) Immune Science and Testing working party, 2, Research funds from a research contract with Providence Therapeutics Holdings, Inc for other projects, 5; S. Bernatsky: None.