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SAT0564 Sublingual vaccine: new challenge in the prevention of recurrent infections in autoimmune diseases
  1. K Hernández Llano1,
  2. S Ramόn Sanchez1,
  3. J Ochoa Grullon1,
  4. P Macarron2,
  5. C Morado2,
  6. C Martínez-Prada2,
  7. A De La Peña Rodríguez1,
  8. E Frías Rodríguez1,
  9. M Nuñez Beltran1,
  10. B Fernández2,
  11. JΆ Jover2,
  12. G Candelas2
  1. 1Inmunology
  2. 2Rheumatology, Madrid Clinic Hospital, Madrid, Spain


Background Disease-modifying antirheumatic drugs (DMARDs) and new biologicals have improved the prognosis of systemic autoimmune diseases (SAD), but reciprocally increase the risk of recurrent respiratory tract (RRTI) and urinary tract (RUTI) infections. Given the rising of antibiotic resistance, the search for new strategies for the prevention of recurrent infections is a priority.

Objectives The purpose of this study was to evaluate the clinical benefit of the sublingual polybacterial vaccines on infections' rates in SAD patients.

Methods A retrospective observational study on a cohort of SAD patients on active inmunosuppression with RRTI and RUTI was conducted. Patients were treated with multibacterial sublingual vaccine formulations either for RRTI (Staphylococcus spp., S. pneumoniae, K. pneumoniae, M. catarrhalis, H. influenzae)3 or/and RUTI (K. pneumoniae, E. coli, E. faecalis, P. vulgaris)4 (Bactek/Uromune®, Inmunotek SL Madrid, Spain) for 3-months period and clinical follow-up at 6- and 12-months. We monitored the frequency of infections, the intensity and severity of infections during follow-up. Immunological evaluation was performed, including: Serum immunoglobulin levels, IgG subclasses, specific antibodies' production: anti-pneumococcal, anti-Typhi polysaccharide and anti-tetanus toxoid antibodies, and B and T cell phenotype.

Results A total of 50 patients were evaluated, and 34 were eligible at 12-months.The mean age of the patients was 58±13 years, 31 women (91.17%) and 3 men (8.82%), 44.11% (n=15) with rheumatoid arthritis (RA), 23.52% (n=8) with systemic lupus erythematosus (SLE), 8.82% (n=3) mixed connective tissue disease, 2.94% (n=1) ankylosing spondylitis, 2.94% ( n=1) sacroileitis, 2,94% (n=1) psoriatic arthritis, 2,94% (n=1) SLE/RA, 2.94% (n=1) discoid LE/Sjögren, 2.94% (n=1) adult onset Still disease, 2,94% (n=1) sarcoidosis, 2.94% (n=1) SLE-like. All patients showed a significant decrease in RRTI (3.15±2.66 vs 0.46±1.07, p<0.01) and RUTI (1.85±2.49 vs 0.35±1.06, p<0.01) frequency and use of antibiotics at 6-months of vaccine, except one with sarcoidosis. 23 of 34 patients (67.64%) disclosed defects on specific antibody production to polysaccharide and protein immunization. Three patients with antibody production deficit and pneumonia required prophylactic intravenous Ig. No adverse effects or SAD relapses were noted during the 1-year observational period.

Conclusions Mucosal vaccination in immunosuppressed patients due to SAD with recurrent infections resulted in lower rates of RRTIs and RUTIs with subsequent improvement in their quality of life. Our preliminary results need to be validated in controlled trials.


  1. G. Avila, A. Alonso, A. Pluma, C. Diaz, R. Juvernau, M. Lüpez Lasanta, S. Marsal. FRI0252 Risk Analysis for Recurrent Infectionsduring Biological Therapy in Chronic Inflammatory Arthritis. Ann Rheum Dis 2014;73:474–475 doi:10.1136/annrheumdis-2014-eular.5736.

  2. Sánchez-Ramόn S, de Diego RP, Dieli-Crimi R, Subiza JL. Extending the clinical horizons of mucosal bacterial vaccines: current evidence and future prospects. Curr Drug Targets. 2014;15(12):1132–43.


Disclosure of Interest None declared

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