Pre-Exposure COVID-19 Prophylaxis in Rheumatology Patients

Pre-Exposure COVID-19 Prophylaxis in Rheumatology Patients Posted By:
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On December 8, 2021, the US Food and Drug Administration issued an emergency use authorization (EUA) for tixagevimab/cilgavimab as pre-exposure prophylaxis of COVID-19 in certain high-risk patients. This combination of 2 long-acting monoclonal antibodies is co-packaged and given as 2 separate injections at the same visit. Both tixagevimab and cilgavimab target the SARS-CoV-2 surface spike protein—binding to 2 separate, non-overlapping sites and blocking its attachment and entry to human cells. The EUA is currently authorized in adult and pediatric individuals (≥12 years of age and ≥40 kg) who are immunocompromised or who are contraindicated to receive one of the available COVID-19 vaccinations. Originally, the EUA dosing was 150 mg of each agent given every 6 months (while SARS-CoV-2 remains in circulation); in February, the FDA issued a revision increasing the initial dosing to 300 mg of each agent due to concerns regarding efficacy against Omicron. Thus far, tixagevimab/cilgavimab has demonstrated a statistically significant reduction in the risk of developing symptomatic COVID-19 in high-risk patients.

The designation for tixagevimab/cilgavimab in immunocompromised individuals includes those who are currently receiving treatment with biologic immunosuppressive medications and therefore may not adequately respond to COVID-19 vaccination. One biologic treatment that has been shown to significantly reduce antibody response from the COVID-19 vaccination is rituximab. In a small study out of France (N = 85), Bitoun et al showed that rituximab-treated patients (having received an infusion within the past year) with autoimmune diseases produced significantly lower average levels of immunoglobulin (Ig) G antibodies against SARS-CoV-2 spike protein 1 month after their second vaccine dose (BNT162b2 [Pfizer-BioNTech]). Only 29.2% of participants in the rituximab group had neutralizing antibodies, compared with 80% of those with autoimmune diseases but using other immunosuppressants, and with 92.3% of healthy controls. Notably, no patients who had received rituximab in the past 6 months had a response—indicating that time since last infusion is a factor in immune response. Another study out of Sweden showed similar findings. Jyssum et al found that at median 16 days following the second dose of an mRNA COVID-19 vaccine, only 21.8% of rituximab-treated patients with rheumatoid arthritis developed neutralizing antibodies towards the SARS-CoV-2 spike protein vs 98.4% of healthy controls. Again, it was found that time since last rituximab infusion played a role in response.

Therefore, it has been suggested that patients receiving rituximab receive tixagevimab/cilgavimab, especially if they received an infusion within the past year. Other rheumatology patients may also be candidates for tixagevimab/cilgavimab. The decision for such patients should take into account their current treatment, diagnosis, disease activity, and comorbidities.

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Filed under: Infectious Diseases , Preventive Medicine , Rheumatology

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