Objectives The study (206347) compared organ damage progression in patients with systemic lupus erythematosus (SLE) who received belimumab in the BLISS long-term extension (LTE) study with propensity score (PS)-matched patients treated with standard of care (SoC) from the Toronto Lupus Cohort (TLC).
Methods A systematic literature review identified 17 known predictors of organ damage to calculate a PS for each patient. Patients from the BLISS LTE and the TLC were PS matched posthoc 1:1 based on their PS (±calliper). The primary endpoint was difference in change in Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) score from baseline to 5 years.
Results For the 5- year analysis, of 567 (BLISS LTE n=195; TLC n=372) patients, 99 from each cohort were 1:1 PS matched. Change in SDI score at Year 5 was significantly lower for patients treated with belimumab compared with SoC (−0.434; 95% CI –0.667 to –0.201; p<0.001). For the time to organ damage progression analysis (≥1 year follow-up), the sample included 965 (BLISS LTE n=259; TLC n=706) patients, of whom 179 from each cohort were PS-matched. Patients receiving belimumab were 61% less likely to progress to a higher SDI score over any given year compared with patients treated with SoC (HR 0.391; 95% CI 0.253 to 0.605; p<0.001). Among the SDI score increases, the proportion of increases ≥2 was greater in the SoC group compared with the belimumab group.
Conclusions PS-matched patients receiving belimumab had significantly less organ damage progression compared with patients receiving SoC.
- disease activity
- systemic lupus erythematosus
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Handling editor Josef S Smolen
Presented at Data from this study have previously been presented at the American College of Rheumatology Annual Scientific meeting (ACR 2017).
Contributors MBU, RLO, RCW, KAK, YA and SR contributed to the study conception/design and data analysis/interpretation. SR contributed to the acquisition of data.
Funding This study (206347) was funded by GSK.
Competing interests MBU has received research grants from GSK. YA and SR are employees of GSK and hold shares in the company. RCW and KAK are employees of Medical Decision Modeling and RLO is a non-employee consultant for Medical Decision Modeling.
Patient consent Not required.
Ethics approval The original parent study (BEL110751) and the BLISS LTE study (BEL112233) were conducted in accordance with the ethical principles of the Declaration of Helsinki and the International Council for Harmonisation on Good Clinical Practice and with applicable country-specific regulatory requirements. Ethics approval was not required for this study.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement GSK makes available anonymised individual participant data and associated documents from interventional clinical studies which evaluate medicines, on approval of proposals submitted to www.clinicalstudydatarequest.com. To access data for other types of GSK sponsored research, for study documents without patient-level data and for clinical studies not listed, please submit an enquiry via the website.
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