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Effect of belimumab treatment on antiphospholipid antibody levels: post-hoc analysis based on two randomised placebo-controlled trials in systemic lupus erythematosus
  1. Katerina Chatzidionysiou1,
  2. Evangelia Samoli2,
  3. Petros P Sfikakis1,
  4. Maria G Tektonidou1
  1. 1 1st Department of Propaedeutic and Internal Medicine, Joint Rheumatology Program, Laiko Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece
  2. 2 Department of Hygiene, Epidemiology, and Medical Statistics, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece
  1. Correspondence to Professor Maria G Tektonidou, Associate Professor in Rheumatology, Head of Rheumatology Unit, First Department of Propaedeutic Internal Medicine, Medical School, National and Kapodistrian University of Athens, ‘Laiko’ Hospital, 17 Agiou Thoma str, 11527 Athens, Greece; mtektonidou{at}gmail.com

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The presence of antiphospholipid antibodies (aPL) in patients with systemic lupus erythematosus (SLE) has been associated with increased risk of thrombotic and/or obstetric manifestations.1 The mechanism of action of belimumab is inhibition of the binding of soluble circulating B lymphocyte stimulator to its target receptors on B cells. Belimumab use was associated with autoantibody reduction, such as antidouble-stranded DNA, anti-Sm and anticardiolipin (aCL) antibodies in some previous reports.2 The objective of this study was to assess the effect of belimumab 10 mg/kg versus placebo on aPL titres using pooled data from two large randomised SLE-controlled trials (BLISS-76 (NCT00410384) and BLISS-52 trial (NCT00424476)).

Levels of three isotypes of aCL antibodies (IgG, IgM and IgA) were assessed at baseline and at each visit. There we no available data on antiβ2GPI antibodies and lupus anticoagulant. The median (IQR) aCL titre, and the titre change from baseline (Δ titre) at 3, 6 and 12 months was compared between treatment arms by Mann-Whitney U test. At a second step, we undertook a random intercept mixed-effects model with the change of aCL titres from baseline as the dependent variable and treatment arm as a fixed effect. Time was added in the model, while the interaction of treatment and time was also assessed. The models were further adjusted for potential confounders (age, sex, concomitant immunosuppressive therapy, concomitant antimalarials, baseline prednisolone dose). Due to a potential effect of antimalarials on aCL titres, stratified analyses were also performed. We also assessed the …

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Footnotes

  • Handling editor Josef S Smolen

  • Contributors All authors contributed significantly to the idea, collection and analysis of data, preparation of the manuscript and all authors accepted the final version of the manuscript.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests KC: has received consultant fees from AbbVie, Pfizer, Lilly. ES: none. PPS: has received fees from grants deposited to the Special Account for Research Funding (ELKE) of the National and Kapodistrian University of Athens Medical School from AbbVie, Pfizer, MSD, Roche, UCB, GSK, Novartis. MGT: has received fees from grants deposited to the Special Account for Research Funding (ELKE) of the National and Kapodistrian University of Athens Medical School from AbbVie, MSD and Pfizer.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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