COVID-19 BOOSTER VACCINATION, EITHER MRNA OR PROTEIN SUBUNIT VACCINES, APPEARS SAFE IN RITUXIMAB-TREATED PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS, RHEUMATOID ARTHRITIS AND VASCULITIS
Bibliographic record
Abstract
PV144 / #585 Poster Topic: AS17 - Miscellaneous Background/Purpose People living with systemic autoimmune rheumatic diseases (SARD) on B cell depletion agents have impaired immunogenicity and increased vulnerability to severe COVID-19. We assessed the 7-day solicited reactogenicity and safety of booster doses following COVID-19 vaccine primary series. Methods We recruited adults with SARDs on rituximab post-third or fourth dose of a messenger RNA (mRNA) COVID-19 vaccine in an open-label, non-randomized, comparative trial. Participants chose to receive either a fourth dose of mRNA Spikevax ® or Nuvaxovid TM , a protein subunit vaccine (PSV). Patients who had already received a fourth dose of mRNA vaccine were offered the PSV as their fifth dose. From study entry, up to 180 days post-booster, subjects self-reported solicited 7-days reactogenicity, and unsolicited adverse events, adverse events of special interest (AESI) (defined as medically confirmed flares of the underlying SARD), new COVID-19 infections, and serious adverse events (SAEs) (requiring hospitalization). We used descriptive statistics for demographics and Chi-square tests to report reactogenicity and adverse events. Results We recruited 86 participants with rheumatoid arthritis (39%), ANCA vasculitis (32%), idiopathic inflammatory myositis (9%), systemic lupus erythematosus (8%), systemic sclerosis (7%), and undifferentiated SARDs (4%). Mean (SD) age was 57.3 (15.3); 73% were female; 91% White; 23% were on prednisone, 21% on antimalarials, and 42% on other immunosuppressors. The most significant reactogenicity manifestations were fever, erythrema, swelling and pain. The proportion of side effects for all types of AEs were similar comparing the fourth-dose mRNA vs the fourth-dose PSV, and the fourth-dose PSV vs the fifth-dose PSV. Fever was only present in the fourth-dose mRNA group; erythema and swelling were reported more often in fifth-dose PSV vs fourth-dose mRNA; and pain significantly more in fourth-dose mRNA vs 5 th -dose PSV. Disease flares (N=3, occurring at 14, 92, and 131 days) are presented in Table 1, along with COVID-19 and other infections (N=6). Including infections, there were 9 SAEs experienced by 8 participants (Table 1). There were no deaths. Table 1. Adverse Events of Special Interest and Serious Adverse Events. Conclusions Three of 86 patients experienced a disease flare and 9 others required hospitalization, most for COVID-19/other infections. A fourth or fifth booster dose of either an mRNA or a PSV vaccine were not clearly associated with unexpected vaccine reactions in rituximab-treated SARD patients. Revaccination of patients on rituximab with either mRNA or PSV vaccines appears safe.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".