The immunogenicity and potential for disease modification of pneumococcal polysaccharide vaccine in systemic lupus erythematosus were evaluated in a controlled, double-blind study. Forty patients were randomly chosen to receive an intramuscular injection of either vaccine or placebo. Changes in mean antibody concentrations (nanograms antibody nitrogen per milliliter serum) to 12 type-specific pneumococcal capsular antigens from prevaccination to one month after vaccination were 177 to 1045 in the vaccine (P < 0.001) and 164 to 153 in the placebo-treated patients. In the month after vaccination, neither vaccine nor placebo-treated patients had a significant change in lupus disease activity as assessed by a composite clinical, laboratory, and serologic index. We conclude that patients with systemic lupus erythematosus can be successfully immunized with pneumococcal vaccine without detectable alterations of the underlying disease. Infections are a major cause of morbidity and mortality in patients with systemic lupus erythematosus (1-6). The potential protection afforded by immunuations might be of benefit in this infection prone population provided that vaccines are immunogenic and do not result in disease exacerbation. Recent studies have demonstrated that patients with systemic lupus can be successfully immunized to influenza without any apparent effects on the underlying disease (7-11). Recognition that immunization of patients with systemic lupus can be both effective and safe leads to consideration of other immunizations.We report here an evaluation of the immunogenicity and clinical and serologic effects of a pneumococcal polysaccharide vaccine in systemic lupus erythematosus in a controlled, randomized study.
MATERIALS AND METHODSThe study population consisted of 40 patients with systemic lupus erythematosus who satisfied preliminary classification criteria (12). The average patient age was 32 years (range 14-61), and 39 were females. Patients with surgical splenectomies were excluded from the study. Most of the patients had a relatively stable disease course and were followed during the period of study in the outpatient clinic. Drugs being taken at the time of study participation included varying doses of corticosteroids in 31 patients, nonsteroidal antiinflammatory drugs in 20 patients, and antimalarials, either chloroquine or hydroxychloroquine, in 17 patients. Five of the patients studied were receiving no medications; none was receiving cytotoxic drugs.