From the Guidelines
Benlysta (belimumab) has been found to have no significant impact on the immunogenicity of anti-pneumococcal vaccines in SLE patients, suggesting that it does not significantly increase the risk of pneumococcal infections. As a human monoclonal antibody directed against the B-cell activating factor, belimumab exerts its effects on B cells, but unlike rituximab, it does not appear to impair the immune response to pneumococcal vaccination 1. This is supported by studies that have shown no significant effect of belimumab on antibody levels against influenza, pneumococcal, and tetanus vaccines in patients with SLE 1.
Key Points
- Belimumab has no significant impact on the immunogenicity of anti-pneumococcal vaccines in SLE patients 1
- SLE patients are at high risk for developing pneumococcal pneumonia, making anti-pneumococcal vaccination crucial in all age groups 1
- Anti-pneumococcal vaccination is associated with decreased in-hospital mortality in SLE and lupus nephritis patients 1
- Vaccine coverage among SLE patients remains low, highlighting the need for innovative approaches to improve vaccine uptake 1
Clinical Implications
- Patients with SLE should receive anti-pneumococcal vaccination regardless of treatment and disease activity due to the high mortality rate reported in these patients 1
- Belimumab can be used in conjunction with anti-pneumococcal vaccination without significantly impairing the immune response 1
- Healthcare providers should consider the importance of pneumococcal vaccination in SLE patients and take steps to improve vaccine uptake in this population 1
From the FDA Drug Label
In the controlled clinical trials of BENLYSTA administered intravenously in adults with SLE, the overall incidence of infections was 71% in patients receiving BENLYSTA compared with 67% in patients receiving placebo The most frequent infections (>5% of patients receiving BENLYSTA) were upper respiratory tract infection, urinary tract infection, nasopharyngitis, sinusitis, bronchitis, and influenza. Serious Infections: In controlled trials of BENLYSTA administered intravenously in adults with SLE, the incidence of serious infections was 6.0% in patients receiving BENLYSTA and 5.2% in patients receiving placebo. The most frequent serious infections included pneumonia, urinary tract infections, cellulitis, and bronchitis.
The infectious associations with Benlysta (belimumab) include:
- Upper respiratory tract infection
- Urinary tract infection
- Nasopharyngitis
- Sinusitis
- Bronchitis
- Influenza
- Pneumonia
- Cellulitis 2
From the Research
Infectious Associations with Benlysta (Belimumab)
- The risk of infections, particularly opportunistic infections, with belimumab is poorly documented 3.
- In a phase 2 trial, belimumab did not significantly increase the risk of serious infections in kidney transplant recipients 4.
- A meta-analysis of randomised controlled trials found no significant difference in the incidence of adverse events, including infections, between belimumab and control groups in patients with systemic lupus erythematosus (SLE) 5.
- However, the same meta-analysis found a significant correlation between belimumab and a reduced risk of infections and infestations (RR = 0.82,95% CI: 0.70-0.97, P = 0.02) 5.
- The clinical data on belimumab suggest that it can be used to treat SLE, but its effects on infections are not fully understood 6.