Statistics from Altmetric.com
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 …
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.
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.