Can Belimumab Patients Be Immunized?

Nancy H. Hope, PharmD


June 14, 2011


Can patients on belimumab receive immunizations?

Response from Nancy H. Hope, PharmD
Assistant Professor of Pharmacy Practice, Presbyterian College School of Pharmacy, Clinton, South Carolina; Contracted Family Medicine Clinical Pharmacist, Self Regional Healthcare, Greenwood, South Carolina

Belimumab is a monoclonal antibody indicated for the treatment of patients with systemic lupus erythematosus (SLE), specifically those with active, autoantibody-positive SLE receiving standard therapy. Belimumab is a B-lymphocyte stimulator-specific inhibitor that inhibits B-cell survival and prevents B-cell differentiation into immunoglobulin-producing plasma cells. Due to this mechanism of action, patients receiving this agent may not be able to mount an appropriate immune response and are at increased risk for infection.[1]

Patients receiving belimumab should not be administered live vaccines 30 days prior to or concurrently with therapy.[1] Live vaccines that should not be given to this patient population include measles, mumps, rubella, varicella, zoster, smallpox, rotavirus, and intranasal influenza.[2]

The BLISS-76 study[3] looked at the percentage change in antibody levels from baseline to week 52 in patients who had received pneumococcal or tetanus vaccine within 5 years prior to belimumab or seasonal influenza vaccine within 1 year prior to belimumab therapy. The study did not show a statistically significant decrease in pre-existing antibodies to pneumococcal and tetanus vaccines, and responses to seasonal influenza were generally not affected by belimumab.

This is a positive finding as most patients who have received pneumococcal or tetanus vaccines within 5 years or influenza vaccine within 1 year of beginning belimumab therapy are able to maintain antibody titers for up to 52 weeks. However, as belimumab may inhibit appropriate response to vaccine or toxoid immunizations,[4] clinicians should consider checking postimmunization antibody titers to ensure adequate immunologic response.

Guidelines do not exist for when live vaccines may be administered to patients after discontinuation of belimumab. The Centers for Disease Control and Prevention recommends that patients who have received therapeutic monoclonal antibodies such as infliximab, adalimumab, or etanercept not receive live-attenuated vaccines for at least 1 month after therapy with such agents.[5]

Live vaccines are documented contraindications to many monoclonal antibodies and should be withheld in patients being treated with belimumab. However, it is appropriate to give vaccines and toxoids that are not live to patients receiving belimumab therapy, keeping in mind that patients may not be able to mount an appropriate immune response to the vaccine given.


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