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. 2020 Oct;7(1):e000412.
doi: 10.1136/lupus-2020-000412.

Comparative analysis of long-term organ damage in patients with systemic lupus erythematosus using belimumab versus standard therapy: a post hoc longitudinal study

Murray B Urowitz  1 , Robert L Ohsfeldt  2 , Ronald C Wielage  3 , John J Dever  3 , Mehdi Zakerifar  3 , Yumi Asukai  4 , Sulabha Ramachandran  5 , Ashish V Joshi  5
Affiliations

Comparative analysis of long-term organ damage in patients with systemic lupus erythematosus using belimumab versus standard therapy: a post hoc longitudinal study

Murray B Urowitz et al. Lupus Sci Med. 2020 Oct.

Abstract

Objective: Long-term extension (LTE) studies of belimumab in SLE do not include a comparator arm, preventing comparisons between belimumab plus standard therapy and standard therapy alone for organ damage accrual. Propensity score matching can be used to match belimumab-treated patients from LTE studies with standard therapy-treated patients from observational cohort studies. This analysis was designed to compare organ damage progression between treatment groups (belimumab plus standard therapy vs standard therapy alone) in patients with SLE with ≥5 years of follow-up, reproducing our previous study with more generalisable data.

Methods: This exploratory post hoc analysis used a heterogeneous population of US and non-US patients receiving monthly intravenous belimumab from pooled BLISS LTE trials (BEL112234/NCT00712933) and standard therapy-treated patients from the Toronto Lupus Cohort. Sixteen clinical variables were selected to calculate the propensity score.

Results: The 592 LTE and 381 Toronto Lupus Cohort patients were highly dissimilar across the 16 variables; an adequately balanced sample of 181 LTE and 181 matched Toronto Lupus Cohort patients (mean bias=3.7%) was created using propensity score matching. Belimumab treatment was associated with a smaller increase in Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) over 5 years than standard therapy alone (mean treatment difference=-0.453 (95% CI -0.646 to -0.260); p<0.001). Patients treated with belimumab were 60% less likely to progress to a higher SDI score over any given year of follow-up, compared with standard therapy alone (HR (95% CI) 0.397 (0.275 to 0.572); p<0.001).

Conclusion: Using propensity score matching, this highly heterogeneous sample was sufficiently matched to the Toronto Lupus Cohort, suggesting that patients treated with intravenous belimumab may have reduced organ damage progression versus standard therapy alone. This analysis of a large and diverse pooled SLE population was consistent with our previously published US-focused study.

Keywords: autoimmune diseases; lupus erythematosus; systemic; therapeutics.

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Conflict of interest statement

Competing interests: MBU has received research grants from GSK. YA, SR and AVJ are employees of GSK and hold stocks and shares in GSK; RCW, JJD and MZ are employees at Medical Decision Modeling Inc., contracted by GSK for this analysis. RLO is a non-employee consultant for Medical Decision Modeling Inc.

References

    1. Navarra SV, Guzmán RM, Gallacher AE, et al. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial. Lancet 2011;377:721–31. 10.1016/S0140-6736(10)61354-2 - DOI - PubMed
    1. Furie R, Petri M, Zamani O, et al. A phase III, randomized, placebo-controlled study of belimumab, a monoclonal antibody that inhibits B lymphocyte stimulator, in patients with systemic lupus erythematosus. Arthritis Rheum 2011;63:3918–30. 10.1002/art.30613 - DOI - PMC - PubMed
    1. van Vollenhoven RF, Navarra SV, Levy RA, et al. Long-term safety and limited organ damage in patients with systemic lupus erythematosus treated with belimumab: a phase III study extension. Rheumatology 2019;166:281–91. 10.1093/rheumatology/kez279 - DOI - PMC - PubMed
    1. Furie RA, Wallace DJ, Aranow C, et al. Long‐term safety and efficacy of belimumab in patients with systemic lupus erythematosus: a continuation of a seventy-six–week phase III parent study in the United States. Arthritis Rheumatol 2018;70:868–77. 10.1002/art.40439 - DOI - PMC - PubMed
    1. Urowitz MB, Ohsfeldt RL, Wielage RC, et al. Organ damage in patients treated with belimumab versus standard of care: a propensity score-matched comparative analysis. Ann Rheum Dis 2019;78:372–9. 10.1136/annrheumdis-2018-214043 - DOI - PMC - PubMed

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