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95 Efficacy, damage accrual and predictors of response to belimumab in active sle patients: a large italian multicenter prospective study
  1. M Larosa1,
  2. L Iaccarino1,
  3. M Zen1,
  4. M Gatto1,
  5. L Emmi2,
  6. F Conti3,
  7. M Mosca4,
  8. P.L Meroni5,
  9. M Govoni6,
  10. S De Vita7,
  11. R De Angelis8,
  12. C Salvarani9,
  13. R Gerli10,
  14. A Tincani11 and
  15. A Doria1
  1. 1Università degli Studi di Padova – Azienda Ospedaliera, Department of Medicine-DIMED- Division of Rheumatology, Padova, Italy
  2. 2University of Florence, Interdisciplinary Internal Medicine- Centre for Autoimmune Systemic Diseases- Behçet Centre and Lupus Clinic, Florence, Italy
  3. 3Sapienza University, Rheumatology Unit- Department of Internal Medicine and Medical Specialities, Rome, Italy
  4. 4University of Pisa, Department of Clinical and Experimental Medicine- Rheumatology Unit, Pisa, Italy
  5. 5IRCCS Istituto- Auxologico Italiano, Experimental Laboratory of Immunological and Rheumatologic Researches, Milan, Italy
  6. 6University of Ferrara, Rheumatology Unit- Department of Medical Sciences, Ferrara, Italy
  7. 7University Hospital “Santa Maria della Misericordia”, Clinic of Rheumatology- DSMB, Udine, Italy
  8. 8University of Jesi, Rheumatology Department, Jesi, Italy
  9. 9Azienda Ospedaliera-IRCCS di Reggio Emilia, Rheumatology Unit- Department of Internal Medicine, Reggio Emilia, Italy
  10. 10University of Perugia, Rheumatology Unit- Department of Medicine, Perugia, Italy
  11. 11ASST Spedali Civili- University of Brescia, Rheumatology and Clinical Immunology Unit, Brescia, Italy


Background and aims To investigate effectiveness, damage accrual and predictors of response to belimumab in active SLE patients in clinical practice setting.

Methods 188 active SLE patients with anti-dsDNA antibodies and low C3 and/or C4, from 11 Italian centres, were treated with belimumab as add-on-therapy. Gender, age, disease duration, polyarthritis, skin rashes, glomerulonephritis, haematological involvement, SLEDAI-2K≥10, prednisone ≥7,5 mg/day and concomitant immunosuppressants were used to determine baseline predictors of 12- and 24 month response according to SRI-4. Data were analysed by SPSS (version 22.0).

Results Prominent clinical manifestations are summarised in Table 1. Clinical and serological variables at baseline, 12 and 24 months are reported in Table 2. SRI-4 was achieved by 71.3% and 68.7% of patients at 12 and 24 months, respectively. 92% of 12 month responders maintained SRI-4 response at 24 months; conversely, 87.5% of non-responders at 12 months were non-responders even at 24 months. Drug discontinuation for any cause was observed in 36.2% of patients; median treatment duration was 12 months. Damage accrual variation was significant between 5 years before drug initiation and baseline (p<0.001), but not between baseline and the end of follow-up (p=0.083). Baseline predictors of 12 month response were SLEDAI-2K≥10 (OR 25.8, 4.19–159.2) and polyarthritis (OR 8.33, 1.88–36.78); 24 month response predictors were SLEDAI-2K≥10 (OR 12.11, 1.63–89.80), polyarthritis (OR 32.56, 2.94–360.56), and prednisone dose ≥7.5 mg/day (OR 7.88, 1.02–61.48).

Table 1

Refractory prominent clinical manifestation at baseline.

Table 2

Disease features at baseline, 12 and 24 months (mean±SD).

Conclusions Belimumab seems to be effective and to reduce damage accrual in SLE patients in clinical practice setting. Patients with arthritis and high disease activity were the best responders to belimumab.

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