Less Oral Glucocorticoid Use After Belimumab Initiation in US Patients with Lupus Nephritis

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Background: The therapeutic strategy for lupus nephritis (LN) aims for steroid reduction due to long-term risks of cumulative use. Belimumab (BEL), a B-cell modulator monoclonal antibody that selectively inhibits BLyS and reduces autoreactive B cells that drive systemic lupus erythematosus (SLE), shows steroid-sparing effects, but real-world data evaluating this in patients with LN are limited. We assessed how oral glucocorticoid (OGC) dosage changed in US patients with LN who initiated BEL. Methods: This retrospective cohort study (GSK Study 222165) identified patients with LN in the MarketScan Claims database (9/23/2015–9/30/2023); eligibility criteria included continuous enrollment ≥12 months + 100 days pre-index (baseline) and ≥12 months follow-up, OGC use at baseline and index date (first BEL claim for LN during: 1/1/2017–9/30/2022), no pre-index BEL use or drug-induced SLE at any time. Outcomes were reduction or complete discontinuation of OGC at follow-up, and change in median OGC average daily dosage (ADD; mg/day prednisone equivalent) at baseline and follow-up periods (0–24 months). Statistical analysis in Fig footnote. Results: Of 148 identified patients (mean [SD] age: 36.7 [11.7] years; 92% female), 84% used immunosuppressants; 82% and 97% had moderate SLE flare and renal flare pre-index. After starting BEL, 83% of patients reduced/discontinued OGC within 6 months; ≥86% did so 6–24 months post-BEL initiation (Fig A). Among patients with OGC ADD ≥5 and ≥10 mg/day (N=134 and 111) 6 months before index, 32% and 30% reduced ADD to <5 mg/day by 6 months post-BEL initiation. OGC ADD decreased ≥70% from baseline to 12–24 months post-BEL initiation (13.4–17.5 vs 3.8–4.0 mg/day; Fig B). Compared to 6–12 months before index, OGC ADD at 6–12 months post-BEL initiation was significantly lower (13.4 vs 5.3 mg/day; p<0.0001; Fig B). Conclusion: Most patients with LN initiating BEL in the US consistently reduced or discontinued OGC. Median OGC doses decreased throughout follow-up, maintaining a reduction to <5 mg/day between 12 and 24 months post-BEL initiation in line with EULAR and ACR recommendations for LN. Funding: Commercial Support - GSK

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