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Belimumab corticosteroid-sparing treatment in systemic lupus erythematosus: a real-life observational study (BESST study)

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Abstract

Data about the impact of Belimumab on corticosteroid sparing in real life are scarce. To assess the corticosteroid-sparing effect among patients with systemic lupus erythematosus (SLE) treated with Belimumab in real-life settings. Multicentric observational retrospective study including patients with SLE and having received Belimumab for at least 6 months between 2011 and 2020, in eight French hospitals. “Low dose” referred to patients receiving up to 7.5 mg of prednisone a day and “Very low dose” to those receiving strictly ≤ 5 mg prednisone a day The primary endpoint was the reduction of daily prednisone dose after six months of Belimumab. The secondary endpoint was a change in the proportion of patients with low or very low dose of prednisone as well as those without prednisone during the Belimumab course. Censoring occurred for patients who stopped Belimumab. Bivariate analyses were performed using the Wilcoxon signed-rank test. The threshold for statistical significance was set at p < 0.05. Thirty patients were included. All were female with a median age of 38 years. A significant reduction in prednisone dose was observed at month 6 (10 [7–20] vs 6.75 [2–9] mg, p < 0.0001), continued until month 12 (10 [7–20] mg vs 5 [0–7.12] mg, p < 0.001) and was sustained until month 24. The proportion of patients with very low dose of prednisone and those without prednisone progressively increased during the Belimumab course. Introducing Belimumab in patients with SLE, in real-life conditions, is associated with early and sustained corticosteroid-sparing effect.

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Acknowledgements

Mr Jeffrey Arsham, for English editing (CHU de Poitiers)

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Author notes

  1. Mickaël Martin and Amandine Perier participated equally in the work.

Authors and Affiliations

  1. Department of Internal Medicine, Poitiers University Hospital, 2 Rue de La Milétrie, 86021, Poitiers Cedex, France

    Marie Jaïs, Pascal Roblot, Mathieu Puyade & Mickaël Martin

  2. University of Poitiers, Poitiers, France

    Pascal Roblot & Mickaël Martin

  3. Department of Internal Medicine and Clinical Immunology, Tours University Hospital, Tours, France

    François Maillot

  4. University of Tours, Tours, France

    François Maillot

  5. Department of Internal and Vascular Medicine, Nantes University Hospital, Nantes, France

    Mohamed Hamidou & Antoine Enfrein

  6. University of Nantes, Nantes, France

    Mohamed Hamidou

  7. Department of Internal Medicine, Rennes University Hospital, Rennes, France

    Alain Lescoat

  8. University of Rennes, Rennes, France

    Alain Lescoat

  9. CIC-1402, Poitiers University Hospital, Poitiers, France

    Mathieu Puyade

  10. INSERM U1313, University of Poitiers, B36, 86000, Poitiers, France

    Mickaël Martin

  11. Department of Internal Medicine, Niort Hospital, Niort, France

    Amandine Perier

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Contributions

All the authors fulfilled the following criteria for authorship according to ICMJE recommendations: Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND Drafting the work or reviewing it critically for important intellectual content; AND Final approval of the version to be published; AND Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. All authors take full responsibility for the integrity and accuracy of all aspects of the work.

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Correspondence to Mickaël Martin or Amandine Perier.

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Conflict of interest

Marie Jaïs, Pascal Roblot, François Maillot, Mohamed Hamidou, Antoine Enfrein, Alain Lescoat, Mathieu Puyade, Mickaël Martin, and Amandine Perier declare that they have no conflict of interest.

Ethics approval

This is an observational study. The Poitiers University Hospital Research Ethics Committee has confirmed that no ethical approval is required and that individual patient consent is not required according to current French law about MR004 regimen studies. All the patients received a non-opposition letter before their inclusion.

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Individual patient consent is not required according to current French law about MR004 regiment studies.

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Jaïs, M., Roblot, P., Maillot, F. et al. Belimumab corticosteroid-sparing treatment in systemic lupus erythematosus: a real-life observational study (BESST study). Rheumatol Int (2024). https://doi.org/10.1007/s00296-024-05589-2

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