Trial reportLupus science & medicine2021
Within-trial economic analysis of flare data from the BLISS-SC trial of subcutaneous belimumab in systemic lupus erythematosus.
Trial report in Lupus science & medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01484496 (A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab), which is not on this map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects With Systemic Lupus Erythematosus (SLE)
Who cites it
2 citing papers in PubMed, 5 citations in OpenAlex.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThe management of systemic lupus erythematosus (SLE) flares can incur substantial healthcare costs. In the phase III BLISS-SC trial, subcutaneous (SC) belimumab 200 mg plus standard therapy was associated with significant reductions in time to severe flare, and risk of flares, versus placebo plus standard therapy, in adults with active SLE. We evaluated whether the reduction in SLE flares with belimumab SC plus standard therapy translated to lower healthcare costs.
methodsA retrospective, post hoc economic analysis of BLISS-SC data was conducted. Unit costs per flare from claims data were estimated and applied to flares observed in BLISS-SC to quantify costs associated with treating severe flares (primary objective) or flares of any severity (secondary objective).
resultsOf 836 patients (n=556 belimumab, n=280 placebo) analysed (94.4% female, mean (standard deviation, SD) age 38.6 (12.3) years), 13.2% and 62.8% had experienced a severe or mild/moderate flare, respectively. Mean (SD) unit costs per severe, moderate, mild or mild/moderate flare were US$9273 (38 800), US$3048 (9321), US$1671 (6202) and US$2303 (7821), respectively. Adjusted mean costs of treating flares were significantly lower with belimumab SC plus standard therapy than placebo plus standard therapy (severe flare, US$927 lower, p<0.001; flare of any severity, US$1379 lower, p<0.001).
conclusionsThis economic analysis of data from the BLISS-SC trial revealed significant cost reductions were associated with treating SLE flares with belimumab SC plus standard therapy versus placebo plus standard therapy. These findings may help to inform decision making about introducing belimumab to healthcare systems. TRIAL REGISTRATION NUMBER: NCT01484496.
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