
Background: Patients with systemic lupus erythematosus have an increased risk of detecting respiratory diseases.
Objectives: To study the efficacy of 23-valent polysaccharide pneumococcal vaccine (PPV-23) in patients with systemic lupus erythematosus (SLE).
Methods: The study enrolled 72 patients diagnosed with SLE, including 64 women and 8 men aged 19 to 68 years with the disease duration ranging from 9 months to 42 years. Nine patients had high activity of disease, 17 - moderate, 40 - low, 6 - remission. Therapy: 68 patients received glucocorticoids (GC) 5-40 mg/day, 55-hydroxychloroquine (HC), 38 -cytostatics (CS), 26 - bDMARD: 14-rituximab (RTM), 10-belimumab (BLM), 2-RTM + BLM. Only 4 of 72 patients received monotherapy (GC-1, HC-1, CS-1, bDMARD-1); the remaining 68 received combined immunosuppressive therapy. PPV-23 in an amount of 0.5 ml (1 dose) was administered subcutaneously. Patients were observed and examined for 1 year after vaccination. Standard clinical and laboratory examinations were performed during the visits, and the serum antibody (AB) level to S. pneumoniae was determined. The presence of respiratory infections, including lower respiratory tract infections, during the year before and after vaccination was detected by questioning, as well as by studying medical records (hospital discharge papers, specialist reports, radiological and CT examinations). 25 patients were followed up for 5-6 years after vaccination.
Results: A year after vaccination, a more than twofold increase in the concentration of antibodies to pneumococcus persisted in 56% of patients. The clinical efficacy of the vaccine was superior to the resulting immunogenicity of PPV-23.
Respiratory infections in SLE patients at one year before and after vaccination (n=72)
| Respiratory infections | 1 year beforevaccination | 1 year aftervaccination | р |
|---|---|---|---|
| Lower respiratory infections | 31(43%) | 9(12,5%) | 0,0001 |
| Pneumonia, (including recurrent, 2-5 episodes) | 12(16,7%)5(7%) | 4(5,6%)- | 0,06 |
| Acute bronchitis | 13(18%) | 4(5,6%) | 0,04 |
| Exacerbation of chronic bronchitis | 6(8,3%) | 1(1,4%) | 0,1 |
| Upper respiratory infections | 14(19,4%) | 6(8,3%) | 0,04 |
| Acute sinusitis, | 11(15,3%) | 5(7%) | 0,1 |
| (Including recurrent) | 1(1,4%) | - | |
| Exacerbation of chronic tonsillitis | 2(2,8%) | - | |
| Acute otitis media | 1(1,4%) | 1(1,4%) |
During the year after vaccination, a decrease in episodes of infections of the lower respiratory tract by more than 3 times was recorded compared with the year preceding immunization (43% and 12.5%, respectively), p=0.0001. Not a single case of recurrent pneumonia was noted (before vaccination - in 5 patients). The number of infections of the upper respiratory tract has more than halved (19.4% and 8.3%, respectively). In 4 (5.6%) patients, non-severe pneumonia developed within a year after vaccination, all of these patients had risk factors for the development of respiratory infections: anti-B-cell therapy with the absence of an adequate vaccine response (3), interstitial lung damage (1), work activities and home environments associated with an increased risk of viral or bacterial infection (3). After a year of observation, 25 patients were followed up for another 4-5 years, the development of pneumonia was not registered in any case (2 out of 25 had pneumonia in the year prior to vaccination). At the same time, 5 years after vaccination, only 18% of patients had more than a 2-fold excess of the initial anti-pneumococcal antibodies.
Conclusion: Sufficient immunogenicity and clear clinical efficacy of PPV-23 have been demonstrated in SLE patients receiving combined immunosuppressive therapy.
Disclosure of Interests: None declared