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LSO-066 Spanish national regsitry of belimumab in patients with systemic lupus erythematosus
  1. Vicente Aldasoro1,
  2. María Laiño1,
  3. Mónica Enguita1,
  4. Javier Loricera2,
  5. Clara Moriano3,
  6. Carmen Lasa2,
  7. Vanesa Calvo2,
  8. Francisco Javier Narváez4,
  9. Pablo Navarro5,
  10. Ivette Casafont6,
  11. Judit Font6,
  12. Adela Gállego7,
  13. Irene Carrión8,
  14. Patricia Quiroga9,
  15. Santos Castañeda9,
  16. Ángel García10,
  17. Joaquín Belzunegui11,
  18. Juán Ramón de Dios12,
  19. Samuel Hernández13,
  20. Sergi Heredia14,
  21. Aaron Fariña15,
  22. Francisco Navarro16,
  23. Rafaela Ortega17,
  24. Leticia del Olmo18,
  25. Valvanera Pinillos19,
  26. Eztizen Labrador19,
  27. María Carmen Ortega20,
  28. Patricia Castro20,
  29. Juan Blanco21,
  30. Marcos Paulino22,
  31. María Ángeles Matías23,
  32. Cilia Peralta24,
  33. Silvia García25,
  34. Jordi Camins26,
  35. Ana Urruticoechea27,
  36. Miguel Medina28,
  37. Piter Cossio29,
  38. Eva Pérez30,
  39. Blanca Varas31,
  40. Carlos Vázquez32,
  41. Nuria Vegas33,
  42. Olga Rusinovich34,
  43. Emilio Giner35 and
  44. José Ramón Lamúa36
  1. 1Rheumatology, Hospital Universitario de Navarra/Navarrabiomed-Unidad de Metodología, Spain
  2. 2Rheumatology, Hospital Universitario Marqués de Valdecilla, Spain
  3. 3Rheumatology, Complejo Asistencial Universitario de León, Spain
  4. 4Rheumatology, Hospital Universitario de Bellvitge, Spain
  5. 5Rheumatology, Hospital Universitario Puerta de Hierro de Majadahonda, Spain
  6. 6Rheumatology, Hospital Universitaria German Trias i Pujol, Spain
  7. 7Rheumatology, Complejo Hospitalario Universitario de Badajoz, Spain
  8. 8Rheumatology, Hospital del Mar, Spain
  9. 9Rheumatology, Hospital Universitario de la Princesa, Spain
  10. 10Rheumatology, Hospital Universitario de Toledo, Spain
  11. 11Rheumatology, Hospital Universitario Donostia, Spain
  12. 12Rheumatology, Hospital Universitario Arava, Spain
  13. 13Rheumatology, Hospital Universitario Son Llatzer, Spain
  14. 14Rheumatology, Complex Hospitalari Moisès Broggi, Spain
  15. 15Rheumatology, Complejo Asistencial Universitario de Palencia, Spain
  16. 16Rheumatology, Hospital General Universitario de Elche, Spain
  17. 17Rheumatology, Hospital Reina Sofía Sevilla, Spain
  18. 18Rheumatology, Hospital Nuestra Señora del Prado Talavera de la Reina, Spain
  19. 19Rheumatology, Hospital San Pedro, Spain
  20. 20Rheumatology, Hospital Universitario de Getafe, Spain
  21. 21Rheumatology, Hospital Universitario Basurto, Spain
  22. 22Rheumatology, Hospital General Universitario de Ciudad Real, Spain
  23. 23Rheumatology, Hospital Universitario Infanta Leonor, Spain
  24. 24Rheumatology, Hospital Clínico Universitario Lozano Blesa, Spain
  25. 25Rheumatology, Hospital Parc Taulí, Spain
  26. 26Rheumatology, Hospital General de Granollers, Spain
  27. 27Rheumatology, Hospital Can Misses, Spain
  28. 28Rheumatology, Hospital Calahorra, Spain
  29. 29Rheumatology, Hospital Reina Sofía Tudela, Spain
  30. 30Rheumatology, Hospital Clínico Universitario de Santiago, Spain
  31. 31Rheumatology, Hospital Universitario Santa Cristina, Spain
  32. 32Rheumatology, Hospital Universitario Miguel Servet de Zaragoza, Spain
  33. 33Rheumatology, Hospital de Galdakao-Usansolo, Spain
  34. 34Rheumatology, Hospital Rey Juan Carlos, Spain
  35. 35Rheumatology, Hospital Royo Villanova, Spain
  36. 36Rheumatology, Hospital del Henares, Spain


Background First multicenter study in clinical practice in SLE patients treated with BLM in Spain.

Methods Descriptive, retrospective, multicenter study in patients diagnosed with SLE according to EULAR/ACR 2019, SLICC and/or ACR 1997 diagnostic criteria. Data regarding SLE patients treated with BLM were collected from medical records (2011–2022). Demographic features, efficacy, analytical variables, SLEDAI, renal involvement, steroid dose, administration routes and safety were assessed.

Results Baseline characteristics of patients are summarized in table 1.

A total of 462 patients (36 hospitals) were included, 50.9% were on intravenous (IV), 34% on subcutaneous (SC) and 15.1% switched from IV to SC route. The median number of pre-BLM csDMARD use was 2.0 (2.0–3.0), being hydroxychloroquine (HCQ) the most frequently used (94.5%). Fifty-two patients were treated with IV cyclophosphamide with a median of 6 bolus received. At the time of BLM start, 443 patients were on prednisone with a median dose of 6.2 mg (5.0–10.0). A statistically significant decrease in prednisone dose, SLEDAI and DNA was observed from baseline until the last visit, whereas complement C3 and C4 values raised (p<0.001) (figure 1). A total of 118 patients (27.4%) had renal involvement with a median proteinuria of 1.0 g/day (0.5–2.4). Renal biopsy was done in 102 out of 118 patients, being class IV (33%), class III (21%) and class V (16%) the most reported. After BLM, 73.3% of these patients improved (median proteinuria of 0.2 g/day (0.1–0.7)). A total of 143 (30.5%) patients discontinued treatment mostly due to inefficacy (55.9%) and infections (11.9%). In fact, 116 patients developed infections, most of them mild; 2 patients died, 16 had COVID and 4 patients developed tumors requiring discontinuation of the drug.

Conclusions In our cohort BLM has been effective, safe and seems to be a good choice for patients with not severe renal involvement.

Abstract LSO-066 Figure 1

Prednisone time-dependent evolution

Abstract LSO-066 Table 1

Baseline characteristics of patients included in Belimumab Spanish registry

  • Belimumab
  • Registry
  • SLE

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