Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Comparative Study
. 2025 Jan 6;12(1):e001351.
doi: 10.1136/lupus-2024-001351.

Low versus high initial oral glucocorticoid dose for lupus nephritis: a pooled analysis of randomised controlled clinical trials

Amit Saxena  1 , Cristina Sorrento  2 , Peter Izmirly  2 , Janine Sullivan  2 , Monica Gamez-Perez  2 , Jammie Law  2 , Howard Michael Belmont  2 , Jill P Buyon  2
Affiliations
Comparative Study

Low versus high initial oral glucocorticoid dose for lupus nephritis: a pooled analysis of randomised controlled clinical trials

Amit Saxena et al. Lupus Sci Med. .

Abstract

Objective: Traditional initial treatment regimens for lupus nephritis (LN) used oral glucocorticoids (GC) in starting doses up to 1.0 mg/kg/day prednisone equivalent with or without a preceding intravenous methylprednisolone pulse. More recent management guidelines recommend lower starting oral GC doses following intravenous pulse therapy. As there have been no large studies directly comparing patients receiving low versus high initial oral GC doses, this pooled analysis of high-quality randomised controlled trials (RCTs) aims to evaluate differences in efficacy and safety.

Methods: Published data were analysed from RCTs that assessed variable GC doses in the standard of care (SOC) treatment arms. Patients receiving starting prednisone doses up to 0.5 mg/kg/day (low dose) were compared with 1.0 mg/kg/day (high dose). Complete renal response requiring urine protein-creatinine ratio <0.5 mg/mg (CRR 0.5), CRR or partial renal response (PRR), serious adverse events (SAE) and SAE due to infections at 12 months of treatment were compared between groups.

Results: 417 patients from SOC arms of five studies were exposed to low-dose initial GC after intravenous pulse, while 521 patients from four studies were treated with high-dose oral GC. In patients with low-dose oral GC, 25.2% achieved CRR 0.5 at 12 months compared with 27.2% in high-dose groups, p=0.54. CRR or PRR was attained in 48.7% low-dose vs 43.6% high-dose patients, p=0.14. SAEs and infection SAEs were less common in the low-dose GC group (19.4% vs 31.6%, p<0.001 and 9.8% vs 16.5%, p=0.012, respectively).

Conclusions: Based on pooled RCT data, there was no significant difference in 12-month renal responses between patients receiving low-dose prednisone following intravenous GC compared with those receiving initial high doses. SAEs were less frequent in patients receiving low-dose initial GC. These findings support the use of lower oral GC doses in LN treatment.

Keywords: clinical trial; lupus erythematosus, systemic; lupus nephritis.

PubMed Disclaimer

Conflict of interest statement

Competing interests: AS, consultant: AbbVie, Amgen, AstraZeneca, Aurinia, BMS, Eli Lilly, GlaxoSmithKline, Synthekine; PI, consultant: GlaxoSmithKline, Momenta/Janssen; HMB, consultant: Aurinia, Alexion, Vertex Pharmaceuticals; JPB, consultant: Bristol-Myers Squibb; GlaxoSmithKline, Related Sciences, Ventus Therapeutics.

Figures

Figure 1
Figure 1. Identification of studies. CRR, complete renal response; CYC, cyclophosphamide; LN, lupus nephritis; SOC, standard of care.
See this image and copyright information in PMC

References

    1. Dall’Era M, Cisternas MG, Smilek DE, et al. Predictors of long-term renal outcome in lupus nephritis trials: lessons learned from the Euro-Lupus Nephritis cohort. Arthritis Rheumatol. 2015;67:1305–13. doi: 10.1002/art.39026. - DOI - PubMed
    1. Hahn BH, McMahon MA, Wilkinson A, et al. American College of Rheumatology guidelines for screening, treatment, and management of lupus nephritis. Arthritis Care Res (Hoboken) 2012;64:797–808. doi: 10.1002/acr.21664. - DOI - PMC - PubMed
    1. Apostolopoulos D, Kandane-Rathnayake R, Louthrenoo W, et al. Factors associated with damage accrual in patients with systemic lupus erythematosus with no clinical or serological disease activity: a multicentre cohort study. Lancet Rheumatol. 2020;2:e24–30. doi: 10.1016/S2665-9913(19)30105-5. - DOI - PubMed
    1. Zeher M, Doria A, Lan J, et al. Efficacy and safety of enteric-coated mycophenolate sodium in combination with two glucocorticoid regimens for the treatment of active lupus nephritis. Lupus (Los Angel) 2011;20:1484–93. doi: 10.1177/0961203311418269. - DOI - PubMed
    1. Bandhan IH, Islam MN, Ahmad HI, et al. Outcome of low-dose prednisolone use for the induction of remission in lupus nephritis patients. Int J Rheum Dis. 2022;25:121–30. doi: 10.1111/1756-185X.14265. - DOI - PubMed

Publication types

MeSH terms