Objectives To evaluate long-term kinetics of the BNT162b2 mRNA vaccine-induced immune response in adult patients with autoimmune inflammatory rheumatic diseases (AIIRD) and immunocompetent controls.
Methods A prospective multicentre study investigated serum anti-SARS-CoV-2 S1/S2 IgG titre at 2–6 weeks (AIIRD n=720, controls n=122) and 6 months (AIIRD n=628, controls n=116) after the second vaccine, and 2–6 weeks after the third vaccine dose (AIIRD n=169, controls n=45). T-cell immune response to the third vaccine was evaluated in a small sample.
Results The two-dose vaccine regimen induced a higher humoral response in controls compared with patients, postvaccination seropositivity rates of 100% versus 84.72%, p<0.0001, and 96.55% versus 74.26%, p<0.0001 at 2–6 weeks and at 6 months, respectively. The third vaccine dose restored the seropositive response in all controls and 80.47% of patients with AIIRD, p=0.0028. All patients treated with methotrexate monotherapy, anticytokine biologics, abatacept and janus kinase (JAK) inhibitors regained the humoral response after the third vaccine, compared with only a third of patients treated with rituximab, entailing a 16.1-fold risk for a negative humoral response, p≤0.0001. Cellular immune response in rituximab-treated patients was preserved before and after the third vaccine and was similar to controls. Breakthrough COVID-19 rate during the Delta surge was similar in patients and controls, 1.83% versus 1.43%, p=1.
Conclusions The two-dose BNTb262 regimen was associated with similar clinical efficacy and similar waning of the humoral response over 6 months among patients with AIIRD and controls. The third vaccine dose restored the humoral response in all of the controls and the majority of patients.
- Autoimmune Diseases
Data availability statement
Data are available upon reasonable request. The data used to support the findings of this study are included within the article
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Handling editor Josef S Smolen
VF, TE and TF contributed equally.
Contributors The study was designed, directed and coordinated by Prof Ori Elkayam, the principle investigator and the guarantor of the study, and Dr Devy Zisman. Drs Victoria Furer, Tali Eviatar, Devy Zisman, Hagit Peleg, the sub-investigators, were in charge of the study conduct at all stages. Dr David Hagin and Tal Freund, were responsible for the assessment of cellular immunity. All the MD co-authors recruited participants into the study. Mrs Pel and Mrs Nevo served as main study coordinators. Prof Ori Elkayam, Dr Victoria Furer, and Dr Tali Eviatar had a full access to the study’s data and wrote the article, which was critically reviewed by Prof Daphna Paran, Dr Devy Zisman, Dr Hagit Peleg, and Dr David Hagin.
Funding The study was funded by the department’s fund of each medical centre participating in the study. There was no external sponsor or grant support for this study. Vaccination was provided as part of a routine medical care and was not sponsored by this study.
Competing interests None declared.
Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.
Provenance and peer review Not commissioned; externally peer reviewed.
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