tetano
Editor, Senior Moderator
J Rheumatol. 2012 Jun 15. [Epub ahead of print]
Effect of Belimumab on Vaccine Antigen Antibodies to Influenza, Pneumococcal, and Tetanus Vaccines in Patients with Systemic Lupus Erythematosus in the BLISS-76 Trial.
Chatham WW, Wallace DJ, Stohl W, Latinis KM, Manzi S, McCune WJ, Tegzov? D, McKay JD, Avila-Armengol HE, Utset TO, Zhong ZJ, Hough DR, Freimuth WW, Migone TS; on behalf of the BLISS-76 Study Group.
Source
From the Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama; Cedars-Sinai Medical Center, Los Angeles, California; Division of Rheumatology, Los Angeles County + University of Southern California Medical Center and University of Southern California Keck School of Medicine, Los Angeles, California; Internal Medicine, Division of Rheumatology, University of Kansas Medical Center, Kansas City, Kansas; Department of Medicine, West Penn Allegheny Health System, Temple University School of Medicine, Pittsburgh, Pennsylvania; Internal Medicine, Division of Rheumatology, University of Michigan Medical Center - Regents of the University of Michigan, Ann Arbor, Michigan, USA; Institute of Rheumatology, Prague, Czech Republic; Oklahoma Center for Arthritis Therapy and Research, Tulsa, Oklahoma, USA; Instituto Jalisciense de Investigaci?n Cl?nica, Guadalajara, Jalisco, Mexico; Internal Medicine, Division of Rheumatology, University of Chicago Pritzker School of Medicine, Chicago, Illinois; and Human Genome Sciences Inc., Rockville, Maryland, USA.
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 ].
PMID:
22707609
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/22707609
Effect of Belimumab on Vaccine Antigen Antibodies to Influenza, Pneumococcal, and Tetanus Vaccines in Patients with Systemic Lupus Erythematosus in the BLISS-76 Trial.
Chatham WW, Wallace DJ, Stohl W, Latinis KM, Manzi S, McCune WJ, Tegzov? D, McKay JD, Avila-Armengol HE, Utset TO, Zhong ZJ, Hough DR, Freimuth WW, Migone TS; on behalf of the BLISS-76 Study Group.
Source
From the Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama; Cedars-Sinai Medical Center, Los Angeles, California; Division of Rheumatology, Los Angeles County + University of Southern California Medical Center and University of Southern California Keck School of Medicine, Los Angeles, California; Internal Medicine, Division of Rheumatology, University of Kansas Medical Center, Kansas City, Kansas; Department of Medicine, West Penn Allegheny Health System, Temple University School of Medicine, Pittsburgh, Pennsylvania; Internal Medicine, Division of Rheumatology, University of Michigan Medical Center - Regents of the University of Michigan, Ann Arbor, Michigan, USA; Institute of Rheumatology, Prague, Czech Republic; Oklahoma Center for Arthritis Therapy and Research, Tulsa, Oklahoma, USA; Instituto Jalisciense de Investigaci?n Cl?nica, Guadalajara, Jalisco, Mexico; Internal Medicine, Division of Rheumatology, University of Chicago Pritzker School of Medicine, Chicago, Illinois; and Human Genome Sciences Inc., Rockville, Maryland, USA.
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 ].
PMID:
22707609
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/22707609