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P131 Belimumab in the treatment of 38 portuguese SLE patients: a real-life multicentric study
  1. Bruno Fernandes1,
  2. Miguel Bernardes1,
  3. Sofia Barreira2,3,
  4. João Eurico Fonseca2,3,
  5. Margarida Cunha4,
  6. Maria José Santos3,4,
  7. Nuno Gonçalves5,
  8. Ana Lúcia Fernandes6,
  9. Joana Rodrigues7,
  10. Tomás Fontes8 and
  11. Lúcia Costa1
  1. 1Rheumatology Dept., Centro Hospitalar Universitário São João, Porto
  2. 2Rheumatology Dept., Hospital de Santa Maria, Lisboa
  3. 3Rheumatology Research Unit, Instituto de Medicina Molecular, Faculdade de Medicina, Universidade de Lisboa, Lisboa
  4. 4Rheumatology Dept., Hospital Garcia de Orta, Almada
  5. 5Rheumatology Dept., Hospital Egas Moniz, Lisboa
  6. 6Rheumatology Dept., Centro Hospitalar Universitário do Algarve, Faro
  7. 7Rheumatology Dept., Unidade Local de Saúde do Alto Minho, Ponte de Lima
  8. 8Rheumatology Dept., Hospital do Divino Espírito Santo, Ponta Delgada, Portugal


Background Belimumab, an anti-BLyS monoclonal antibody, is the first biologic available for SLE treatment. We studied its effectiveness and safety in clinical practice.

Methods Multicentric cohort study of SLE patients, fulfilling the 2012 SLICC classification criteria, treated with belimumab in rheumatology departments and registered in the Portuguese registry

Results Thirty-eight patients were included: 37 (97.4%) female, aged 46.2±13.9 years, mean disease duration of 11.9±8.6 years. The reasons for prescribing belimumab were: multiorgan involvement in 20 (52.6%), haematologic disorders in 9 (23.7%), cutaneous manifestations in 5 (13.0%), arthritis in 3 (7.9%), necrotizing vasculitis in 1 (2.6%). Belimumab was administered intravenously for a mean of 22.3±20.3 months.

SRI response was achieved in 14/27 (51.9%), 12/20 (60%) and 11/12 (91.7%) at 6, 12 and 24 months of belimumab treatment, respectively. Mean SLEDAI significantly decreased from 8.2±3.9 at baseline to 3.8±2.2, 4.1±3.2 and 3.1±1.6 at 6, 12 and 24 months, respectively.

Anti-dsDNA antibodies significantly decreased at 6, 12 and 24 months and C3 increased at 12 months of belimumab (table 1). We found a significant reduction in mean daily prednisolone dosage (p<0.001) from baseline (10.8±5.1 mg) to the last evaluation under belimumab (5.5±3.0 mg).

Abstract P131 Table 1

Evolution of SLEDAI, anti-dsDNA antibodies and C3 levels at 6, 12 and 24 months of belimumab and its significance compared to baseline values.

Eleven (28.9%) patients discontinued belimumab: loss of effectiveness in 4, lost to follow-up in 4, adverse events in 3 (urinary tract infections, acute myocardial infarction, breast cancer). Three presented infections related to belimumab.

Conclusions We confirmed belimumab effectiveness and safety in real-life active SLE patients.

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