Title |
The 23-valent pneumococcal polysaccharide vaccine in patients with rheumatoid arthritis: a double-blinded, randomized, placebo-controlled trial
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Published in |
Arthritis Research & Therapy, January 2017
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DOI | 10.1186/s13075-016-1207-7 |
Pubmed ID | |
Authors |
Yasumori Izumi, Manabu Akazawa, Yukihiro Akeda, Shigeto Tohma, Fuminori Hirano, Haruko Ideguchi, Ryutaro Matsumura, Tomoya Miyamura, Shunsuke Mori, Takahiro Fukui, Nozomi Iwanaga, Yuka Jiuchi, Hideko Kozuru, Hiroshi Tsutani, Kouichirou Saisyo, Takao Sugiyama, Yasuo Suenaga, Yasumasa Okada, Masao Katayama, Kenji Ichikawa, Hiroshi Furukawa, Kenji Kawakami, Kazunori Oishi, Kiyoshi Migita |
Abstract |
Pneumococcal pneumonia is the most frequent form of pneumonia. We herein assessed the effectiveness of the 23-valent pneumococcal polysaccharide vaccine (PPSV23) in the prevention of pneumonia overall in rheumatoid arthritis (RA) patients at risk for infections. We hypothesized that PPSV23 vaccination is superior in preventing pneumococcal pneumonia compared with placebo in RA patients. A prospective, multicenter, double-blinded, randomized, placebo-controlled (1:1) trial was conducted across departments of rheumatology in Japanese National Hospital Organization hospitals. RA patients (n = 900) who had been treated with biological or immunosuppressive agents were randomly assigned PPSV23 or placebo (sodium chloride). The primary endpoints were the incidences of all-cause pneumonia and pneumococcal pneumonia. The secondary endpoint was death from pneumococcal pneumonia, all-cause pneumonia, or other causes. Cox regression models were used to estimate the risk of pneumonia overall for the placebo group compared with the vaccine group. Seventeen (3.7%) of 464 patients in the vaccine group and 15 (3.4%) of 436 patients in the placebo group developed pneumonia. There was no difference in the rates of pneumonia between the two study groups. The overall rate of pneumonia was 21.8 per 1000 person-years for patients with RA. The presence of interstitial pneumonia (hazard ratio: 3.601, 95% confidence interval: 1.547-8.380) was associated with an increased risk of pneumonia in RA patients. PPSV23 does not prevent against pneumonia overall in RA patients at relative risk for infections. Our results also confirm that the presence of interstitial lung disease is associated with pneumonia in Japanese patients with RA. UMIN-CTR UMIN000009566 . Registered 17 December 2012. |
X Demographics
Geographical breakdown
Country | Count | As % |
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United States | 1 | 25% |
Unknown | 3 | 75% |
Demographic breakdown
Type | Count | As % |
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Members of the public | 3 | 75% |
Practitioners (doctors, other healthcare professionals) | 1 | 25% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Unknown | 86 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Researcher | 17 | 20% |
Student > Bachelor | 11 | 13% |
Student > Ph. D. Student | 11 | 13% |
Student > Master | 8 | 9% |
Student > Doctoral Student | 6 | 7% |
Other | 14 | 16% |
Unknown | 19 | 22% |
Readers by discipline | Count | As % |
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Medicine and Dentistry | 37 | 43% |
Pharmacology, Toxicology and Pharmaceutical Science | 5 | 6% |
Immunology and Microbiology | 5 | 6% |
Biochemistry, Genetics and Molecular Biology | 4 | 5% |
Nursing and Health Professions | 2 | 2% |
Other | 8 | 9% |
Unknown | 25 | 29% |