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Application of SLE-DAS to assess subcutaneous belimumab efficacy in a cohort of systemic lupus erythematosus patients

1, 2, 3, 4, 5, 6, 7

 

  1. Lupus Clinic, Division of Rheumatology, Department of Internal Clinical Sciences, Anaesthesiologic and Cardiovascular Sciences, Sapienza University of Rome, Italy. fulviaceccarelli@gmail.com
  2. Lupus Clinic, Division of Rheumatology, Department of Internal Clinical Sciences, Anaesthesiologic and Cardiovascular Sciences, Sapienza University of Rome, Italy.
  3. Lupus Clinic, Division of Rheumatology, Department of Internal Clinical Sciences, Anaesthesiologic and Cardiovascular Sciences, Sapienza University of Rome, Italy.
  4. Lupus Clinic, Division of Rheumatology, Department of Internal Clinical Sciences, Anaesthesiologic and Cardiovascular Sciences, Sapienza University of Rome, Italy.
  5. Lupus Clinic, Division of Rheumatology, Department of Internal Clinical Sciences, Anaesthesiologic and Cardiovascular Sciences, Sapienza University of Rome, Italy.
  6. Lupus Clinic, Division of Rheumatology, Department of Internal Clinical Sciences, Anaesthesiologic and Cardiovascular Sciences, Sapienza University of Rome, Italy.
  7. Lupus Clinic, Division of Rheumatology, Department of Internal Clinical Sciences, Anaesthesiologic and Cardiovascular Sciences, Sapienza University of Rome, Italy.

CER17038
2024 Vol.42, N°7
PI 1491, PF 1494
Brief Papers

purchase article

PMID: 38819948 [PubMed]

Received: 01/08/2023
Accepted : 04/12/2023
In Press: 28/05/2024
Published: 18/07/2024

Abstract

OBJECTIVES:
To assess the efficacy of subcutaneous (sc) belimumab (BLM) by the application of SLE-DAS in a monocentric SLE cohort.
METHODS:
We evaluated SLE patients treated with sc BLM from March 2019. Disease activity has been assessed by SLEDAI-2k, SLE-DAS and PGA (Physician Global Assessment) in all the established time-points [baseline (T0), after 1 (T1), 3 (T3), 6 (T6) and 12 (T12) months]. Furthermore, we applied and compared the achievement of remission according to SLE-DAS values (SLEDAS ≤2.08 + PDN ≤5mg/daily) and DORIS definition (clinical SLEDAI- 2k=0 + PGA<0.5 + antimalarial treatment, PDN≤5mg/daily, stable immunosuppressive treatment).
RESULTS:
We enrolled 86 patients [M/F 5/81, median age 48 years (IQR 17.5), median disease duration 166 months (IQR 216)]. At baseline, median values of SLEDA-2k and SLE-DAS were 6 (IQR 4) and 5.77 (IQR 4.33), respectively, and they significantly correlated (r=0.719, CI 95% 0.586-0.815, p<0.0001). Median duration of treatment was 14 months (IQR 20). We found a significant reduction of SLEDAI-2k and SLE-DAS already at T1, maintained in the subsequent time-points (p<0.0001). At T12, a remission state was achieved by 60.4% of patients according to SLE-DAS definition and by 62.3% according to the DORIS definition. Both definitions of remission have demonstrated an agreement of 84%, with a Cohen’s kappa equal to 0.6.
CONCLUSIONS:
In this study we applied SLE-DAS to assess the efficacy of sc BLM, by analysing its over-time changes and by comparing its performance with SLEDAI-2k. Indeed, our results suggest the usefulness of this new activity index in a real-life setting.

DOI: https://doi.org/10.55563/clinexprheumatol/l5976o

Rheumatology Article