Concerns regarding the safety and efficacy of immunization in patients with SLE have persisted for over 60 years, despite the increased risk of infection in these patients. There are many anecdotal case reports of SLE induction or exacerbation following immunization, but overall, these events seem to be very rare. Evidence from prospective trials suggests that inactivated and component vaccines are probably safe in patients with SLE. Live vaccines are contraindicated in patients on immunosuppressive agents or high dose steroids (prednisone 20 mg/day or greater).
There is limited evidence regarding efficacy of vaccination in patients with SLE. Studies assessing serological response to vaccination have generally shown that the majority of patients have an appropriate response, but a significant minority do not. Response to hepatitis B vaccination may be impaired and serological responses should be assessed post vaccination. It is not clear if disease activity or immunosuppressive medications are risk factors for a poor response, rather than intrinsic abnormalities of immune function in patients with SLE. The majority of patients appear to have a reasonable serological response to vaccination.
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