Journal article
Effect of Belimumab on Vaccine Antigen Antibodies to Influenza, Pneumococcal, and Tetanus Vaccines in Patients with Systemic Lupus Erythematosus in the BLISS-76 Trial
Journal of rheumatology, v 39(8), pp 1632-1640
01 Aug 2012
PMID: 22707609
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
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] (First Release June 15 2012; J Rheumatol 2012;39:1632-40; doi:10.3899/jrheum.111587)
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Details
- Title
- Effect of Belimumab on Vaccine Antigen Antibodies to Influenza, Pneumococcal, and Tetanus Vaccines in Patients with Systemic Lupus Erythematosus in the BLISS-76 Trial
- Creators
- W. Winn Chatham - University of Alabama at BirminghamDaniel J. Wallace - Cedars-Sinai Medical CenterWilliam Stohl - University of Southern CaliforniaKevin M. Latinis - University of KansasSusan Manzi - Temple UniversityW. Joseph McCune - Center for RheumatologyDana Tegzova - Institute of RheumatologyJames D. McKay - Oklahoma Ctr Arthrit Therapy & Res, Tulsa, OK USAHilario E. Avila-Armengol - Instituto Jalisciense de CancerologíaTammy O. Utset - University of ChicagoZ. John Zhong - Human Genome Sci Inc, Rockville, MD USADouglas R. Hough - Human Genome Sci Inc, Rockville, MD USAWilliam W. Freimuth - Human Genome Sci Inc, Rockville, MD USAThi-Sau Migone - Human Genome Sci Inc, Rockville, MD USABLISS-76 Study Grp
- Publication Details
- Journal of rheumatology, v 39(8), pp 1632-1640
- Publisher
- J Rheumatol Publ Co
- Number of pages
- 9
- Grant note
- Human Genome Sciences Inc. (HGS), Rockville, Maryland GlaxoSmithKline (GSK), Uxbridge, Middlesex, United Kingdom HGS GlaxoSmithKline
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- General Internal Medicine
- Web of Science ID
- WOS:000307795800018
- Scopus ID
- 2-s2.0-84864539854
- Other Identifier
- 991021933897504721
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- Collaboration types
- Industry collaboration
- Domestic collaboration
- International collaboration
- Web of Science research areas
- Rheumatology