RT Journal Article
SR Electronic
T1 Effect of Belimumab on Vaccine Antigen Antibodies to Influenza, Pneumococcal, and Tetanus Vaccines in Patients with Systemic Lupus Erythematosus in the BLISS-76 Trial
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP 1632
OP 1640
DO 10.3899/jrheum.111587
VO 39
IS 8
A1 W. WINN CHATHAM
A1 DANIEL J. WALLACE
A1 WILLIAM STOHL
A1 KEVIN M. LATINIS
A1 SUSAN MANZI
A1 W. JOSEPH McCUNE
A1 DANA TEGZOVÁ
A1 JAMES D. McKAY
A1 HILARIO E. AVILA-ARMENGOL
A1 TAMMY O. UTSET
A1 Z. JOHN ZHONG
A1 DOUGLAS R. HOUGH
A1 WILLIAM W. FREIMUTH
A1 THI-SAU MIGONE
YR 2012
UL http://www.jrheum.org/content/39/8/1632.abstract
AB 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. Conclusion. 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]