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AB0542 Blocking the Human B Lymphocyte Stimulator Molecule (BLYS) Using A Monoclonal Antibody (Belimumab) in Systemic Lupus Erythematosus: First Results in Real-Life Spanish Patients with Refractory Disease (Biogeas-Semi Registry)
  1. P. Brito Zeron1,
  2. L. Caminal-Montero2,
  3. A. Chamorro3,
  4. J. de la Hera Fernández4,
  5. A. Gato5,
  6. A. Marín-Ballvé6,
  7. A. Robles7,
  8. M. Rodríguez-Carballeira8,
  9. G. Salvador9,
  10. L. Saez10,
  11. G. Ruiz-Irastorza11,
  12. H. Gheitasi1,
  13. S. Retamozo1,
  14. M. Ramos-Casals1
  1. 1Lab. Autoimmune Diseases Josep Font, Hospital Clinic, IDIBAPS, Barcelona
  2. 2Hospital Universitario Central de Asturias, Asturias
  3. 3Complejo Hospitalario Universitario de Ourense, Ourense
  4. 4Fundaciόn Jiménez Díaz, Madrid
  5. 5Complejo Hospitalario Universitario de Albacete, Albacete
  6. 6Hospital Universitario Lozano Blesa, Zaragoza
  7. 7Hospital La Paz, Madrid
  8. 8Hospital Universitario Mutua Terrassa, Terrassa
  9. 9Hospital de Manises, Valencia
  10. 10Hospital Universitario Miquel Servet, Zaragoza
  11. 11Hospital de Cruces, Bizkaia, Spain

Abstract

Objectives To analyze the efficacy and safety of treatment with belimumab, a monoclonal antibody that specifically binds the soluble form of the protein human B lymphocyte stimulator B (BLyS), in SLE patients refractory to standard treatment.

Methods In 2006, the Study Group on Autoimmune Diseases (GEAS) of the Spanish Society of Internal Medicine created the BIOGEAS registry, a multicenter study recruiting patients with refractory systemic autoimmune diseases treated with biological agents.

Results On December 31, 2013, a total of 10 patients treated with belimumab were included in the BIOGEAS Registry, 9 females and 1 male, with a mean age of 41.8 years (range 24-71 years). These patients were heavily treated, with a mean of 7 years of corticosteroid treatment, antimalarials and at least one immunosuppressive agent, mycophenolate in 9, azathioprine in 7, metothrexate in 4, cyclosphosphamide in 2, cyclosporine A in 2, tacrolimus in 2 and talidomide in 2. Belimumab (10mg/kg) was administered in combination with corticosteroids (in all patients), antimalarials (6 patients) and immunosuppressive agents (8 patients, 6 with mycophenolate). The baseline average activity score (SELENA-SLEDAI) was 12 (range 6-33); 8 patients had high titers of anti-dsDNA and/or hypocomplementemia. Therapeutic indication included refractory mucocutaneous involvement (4 patients), refractory vasculitis (3 patients), systemic disease (2 patients) and refractory lupus nephritis (1 patient). After a mean follow-up of 7 months (range 2-12), clinical response could be evaluated in 9 patients, 8 classified as responders (improvement greater than 80% in 5 patients), while the remaining patient was classified as stable. Two patients (20%) developed adverse events (raised transaminases and systemic cryptococcosis due to severe CD4 lymphopenia); there were no deaths or lupus flares.

Conclusions These postmarketing data in Spanish SLE patients in whom belimumab was used following the recommendations approved by the FDA/EMA (refractory disease to standard treatment, clinical and immunological active disease, SELENA-SLEDAI>6) have showed promising results, with a good therapeutic response and a safety profile similar to other biological therapies used off-label in patients with SLE.

Disclosure of Interest None declared

DOI 10.1136/annrheumdis-2014-eular.5447

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