Pneumococcal Vaccine PPSV23 Does Not Protect RA patients

The 23-valent pneumococcal polysaccharide vaccine (PPSV23) does not prevent pneumonia in rheumatoid arthritis patients, a new study finds.

This study appears in the January 25 online issue of Arthritis Research & Therapy.

“While PPSV23 vaccination is recommended for adults who are at least 65 years of age, our results suggest uncertainty regarding its effectiveness for pneumonia in rheumatoid arthritis patients at high risk for infections. Clinicians should keep in mind the patient’s age and the presence of interstitial pneumonia because such patients are at an increased risk of developing pneumonia,” researchers wrote.

This was a prospective, double-blind, randomized, placebo-controlled trial conducted with 900 rheumatoid arthritis patients treated with biological or immunosuppressive agents. The goal of the study was to evaluate the effectiveness of PPSV23 in preventing overall pneumonia in high risk patients. Patients were recruited between December 2012 and March 2014 from 32 hospitals across Japan and randomized in a 1:1 ratio to the vaccine group receiving 0.5 ml of PPSV23 or the placebo group. The two primary endpoints were pneumonia and pneumococcal pneumonia. Additionally, demographic and clinical characteristics were evaluated for potential associations with risk for developing pneumonia. Patients were monitored for 12 months after enrollment.

In total, 17 of 464 patients in the vaccine group, or 3.7 percent, and 15 patients of 436 in the placebo group, or 3.4 percent, developed pneumonia. There was no significant difference between the two groups.  

Independent of group assignment, researchers found that the presence of interstitial pneumonia and older age were significantly associated with increased risk of developing pneumonia.

It should be noted that neither glucocorticoid dosage or biologic disease-modifying anti-rheumatic drugs usage predicted risk of developing pneumonia in this study.

Patients with rheumatoid arthritis are at higher risk for developing pneumonia compared to the general population. Pneumonia is a vaccine-preventable condition in most patients and PPSV23 has been demonstrated to be effective at preventing invasive pneumococcal disease in older adults. However, the efficacy of PPSV23 in patients undergoing immunotherapy is not well researched or understood.

To date, few of the clinical trials that have evaluated the effectiveness of PPSV23 have included patients with autoimmune diseases. Given that pneumonia is a leading cause of death among patients with rheumatoid arthritis, a better understanding of how and when to use PPSV23 with this population is needed. This is one of the first-known studies to evaluate a pneumonia vaccine in patients with autoimmune disease.

“Our study confirmed that polysaccharide vaccine alone is not effective for prevention of pneumonia. Therefore, sequential administration of PCV13 and PPSV23 could also be an appropriate approach for the prevention for pneumonia in RA patients receiving immunosuppressive treatments,” wrote Kiyoshi Migita, of the Japanese National Hospital Organization, and colleagues.

Disclosures:

This research was supported by a grant from the Japanese National Hospital Organization Evidence-based Medicine study group.

References:

Yasumori Izumi, Manabu Akazawa, Yukihiro Akeda, et al. “The 23-valent pneumococcal polysaccharide vaccine in patients with rheumatoid arthritis: a double-blinded, randomized, placebo-controlled trial,” Arthritis Research & Therapy. Published online January 25, 2017. DOI: 10.1186/s13075-016-1207-7.