Effect of belimumab on vaccine antigen antibodies to influenza, pneumococcal, and tetanus vaccines in patients with systemic lupus erythematosus in the BLISS-76 trial.
OBJECTIVE
In patients with systemic lupus erythematosus (SLE), evidence suggests that most vaccines (except live-virus vaccines) are safe, although antibody response may be reduced. This substudy from the phase III, randomized, double-blind, placebo-controlled BLISS-76 trial evaluated the effects of belimumab on preexisting antibody levels against pneumococcal, tetanus, and influenza antigens in patients with SLE.


METHODS
In BLISS-76, patients with autoantibody-positive, active SLE were treated with placebo or belimumab 1 or 10 mg/kg every 2 weeks for 28 days and every 28 days thereafter, plus standard SLE therapy, for 76 weeks. This analysis included a subset of patients who had received pneumococcal or tetanus vaccine within 5 years or influenza vaccine within 1 year of study participation. Antibodies to vaccine antigens were tested at baseline and Week 52, and percentage changes in antibody levels from baseline and proportions of patients maintaining levels at Week 52 were assessed. Antibody titers were also assessed in a small number of patients vaccinated during the study.


RESULTS
Consistent with preservation of the memory B cell compartment with belimumab treatment, the proportions of patients maintaining antibody responses to pneumococcal, tetanus, and influenza antigens were not reduced. In a small group receiving influenza vaccine on study, antibody responses were frequently lower with belimumab, although titer levels were > 1:10 in all patients treated with 10 mg/kg and in the majority treated with 1 mg/kg.


CONCLUSIONS
Treatment with belimumab did not affect the ability of patients with SLE to maintain antibody titers to previous pneumococcal, tetanus, and influenza immunizations. [ClinicalTrials.gov registration number NCT 00410384].
Rheumatology FOT 802, University of Alabama, Birmingham, AL 35294, USA. wchatham@uab.edu
W Winn
WW
Chatham
Daniel J
DJ
Wallace
William
W
Stohl
Kevin M
KM
Latinis
Susan
S
Manzi
W Joseph
WJ
McCune
Dana
D
Tegzová
James D
JD
McKay
Hilario E
HE
Avila-Armengol
Tammy O
TO
Utset
Z John
ZJ
Zhong
Douglas R
DR
Hough
William W
WW
Freimuth
Thi-Sau
TS
Migone
D000328:Adult; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000914:Antibodies, Viral / Q000276:immunology*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007252:Influenza Vaccines / Q000276:immunology* / Q000627:therapeutic use; D008180:Lupus Erythematosus, Systemic / Q000188:drug therapy* / Q000276:immunology; D008297:Male; D008875:Middle Aged; D022242:Pneumococcal Vaccines / Q000276:immunology* / Q000627:therapeutic use; D013745:Tetanus Toxoid / Q000276:immunology* / Q000627:therapeutic use
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000914:Antibodies, Viral; D007252:Influenza Vaccines; D022242:Pneumococcal Vaccines; D013745:Tetanus Toxoid; C511911:belimumab