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Established organ damage reduces belimumab efficacy in systemic lupus erythematosus
  1. Ioannis Parodis1,2,
  2. Alvaro Gomez1,2,
  3. Sharzad Emamikia1,2,
  4. Katerina Chatzidionysiou1,2
  1. 1 Division of Rheumatology, Department of Medicine, Karolinska Institutet, Stockholm, Sweden
  2. 2 Rheumatology, Karolinska University Hospital, Stockholm, Sweden
  1. Correspondence to Dr Ioannis Parodis, Division of Rheumatology, Department of Medicine, Karolinska Institutet, Stockholm 17176, Sweden; ioannis.parodis{at}

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Post hoc analyses of the phase III trials of belimumab BLISS-521 and BLISS-762 revealed superiority of belimumab over placebo in patients with systemic lupus erythematosus (SLE) with high baseline disease activity, positive anti–double-stranded (ds)DNA titres and low complement levels, as well as in patients receiving corticosteroids.3 Later, real-life observations demonstrated that established organ damage prior to treatment initiation predicted reduced belimumab efficacy.4 We aimed at validating this finding in the BLISS-52 and BLISS-76 SLE populations. Access to data was granted by GlaxoSmithKline (Uxbridge, UK).

In total, 1684 patients were included in the analysis. The BLISS-52 trial comprised 865 and the BLISS-76 trial 819 patients with SLE who were randomised to receive belimumab 1 mg/kg, belimumab 10 mg/kg or placebo, along with standard-of-care treatment.

Organ damage was assessed using the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI).5 Response to treatment was defined as fulfilment of the SLE responder index 4 (SRI-4) conditions at week 52 (primary endpoint of the BLISS trials).1 2 Patients who withdrew or required changes in the background therapy other than those permitted by protocol …

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  • Handling editor Josef S Smolen

  • Contributors Study conception, design and coordination: IP, KC. Acquisition of data: IP, AG, SE. Statistics: IP, AG, SE. Interpretation of the results: IP, AG, SE, KC. Manuscript draft: IP, AG. All authors read and critically revised the manuscript for intellectual content, approved its final version prior to submission and agree to be accountable for all aspects of the work.

  • Funding The study was supported by grants from the Swedish Research Council, Professor Nanna Svartz Foundation (reference no. 2017-00213), Swedish Rheumatism Association, King Gustaf V’s 80-year Foundation, Ingegerd Johansson’s Fund, Stockholm County Council and Karolinska Institutet Foundations, and was independent of pharmaceutical sponsors.

  • Competing interests None declared.

  • Patient consent for publication Not required.

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

  • Data sharing statement The datasets used and analysed during the current study are available from the corresponding author on reasonable request.

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