Tixagevimab/cilgavimab for the prevention of COVID-19 in vaccine-refractory patients with autoimmune diseases: a prospective cohort study
Authors' conclusion
Passive immunization with tixagevimab/cilgavimab is safe and effective in inducing anti-SARS-CoV-2 immunity and potentially in preventing COVID-19 in high-risk vaccine-refractory IMID patients.
Study context
- Population
- Vaccine-refractory patients with immune-mediated inflammatory diseases (IMIDs) at high risk of severe COVID-19
- Participants
- 38 vs 114
- Exposure
- Single dose tixagevimab/cilgavimab (150 mg/150 mg) vs untreated high-risk vaccine-refractory IMID controls
- Tixagevimab/cilgavimabn = 38
- Controlsn = 114reference
- Outcome
- COVID-19 SIR vs general population
Methodological detailsuntreated control population, standardized incidence ratios vs general population
- Untreated control population
- Standardized incidence ratios vs general population
Main finding
As reported in the abstract
SIR of COVID-19 vs general population in treated patients (tixagevimab/cilgavimab), despite the increased risk profile
0.76
95% CI 0.24, 1.58
SIR of COVID-19 vs general population in the control group, a significantly increased incidence
1.51
95% CI 1.07, 2.02
Observational data: associations, not effects.
Further findings
Serum anti-spike IgG after tixagevimab/cilgavimab
- Serum anti-spike IgG at day 1, mean OD (SD)
- 6.6 OD (s.d. 0.8)
- Serum anti-spike IgG remained positive at month 6, mean OD (SD)
- 6.3 OD (s.d. 1.4)
Salivary anti-spike IgG after tixagevimab/cilgavimab
- Salivary anti-spike IgG peak at month 2, mean OD (SD)
- 1.6 OD (s.d. 1.1)
- Salivary anti-spike IgG decreased from month 3, mean OD (SD)
- 0.8 OD (s.d. 0.3)
Safety
- Severe or extended infection — Tixagevimab/cilgavimab
- 0 events
Severe or extended infection
- No severe or extended infection observed in the tixagevimab/cilgavimab group
Original publication
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