Low versus high initial oral glucocorticoid dose for lupus nephritis: a pooled analysis of randomised controlled clinical trials
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 do...
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BMJ Publishing Group
2025-01-01
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| Series: | Lupus Science and Medicine |
| Online Access: | https://lupus.bmj.com/content/12/1/e001351.full |
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| author | Amit Saxena Peter Izmirly Jill P Buyon Cristina Sorrento Janine Sullivan Monica Gamez-Perez Jammie Law Howard Michael Belmont |
| author_facet | Amit Saxena Peter Izmirly Jill P Buyon Cristina Sorrento Janine Sullivan Monica Gamez-Perez Jammie Law Howard Michael Belmont |
| author_sort | Amit Saxena |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-312e9692b32c48d391e31562d98b959d |
| institution | Kabale University |
| issn | 2053-8790 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | BMJ Publishing Group |
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| series | Lupus Science and Medicine |
| spelling | doaj-art-312e9692b32c48d391e31562d98b959d2025-01-07T08:10:10ZengBMJ Publishing GroupLupus Science and Medicine2053-87902025-01-0112110.1136/lupus-2024-001351Low versus high initial oral glucocorticoid dose for lupus nephritis: a pooled analysis of randomised controlled clinical trialsAmit Saxena0Peter Izmirly1Jill P Buyon2Cristina Sorrento3Janine Sullivan4Monica Gamez-Perez5Jammie Law6Howard Michael Belmont7Department of Medicine, Dvision of Rheumatology, NYU Grossman School of Medicine, New York City, New York, USADepartment of Medicine, Dvision of Rheumatology, NYU Grossman School of Medicine, New York City, New York, USADepartment of Medicine, Dvision of Rheumatology, NYU Grossman School of Medicine, New York City, New York, USADepartment of Medicine, Dvision of Rheumatology, NYU Grossman School of Medicine, New York City, New York, USADepartment of Medicine, Dvision of Rheumatology, NYU Grossman School of Medicine, New York City, New York, USADepartment of Medicine, Dvision of Rheumatology, NYU Grossman School of Medicine, New York City, New York, USADepartment of Medicine, Dvision of Rheumatology, NYU Grossman School of Medicine, New York City, New York, USADepartment of Medicine, Dvision of Rheumatology, NYU Grossman School of Medicine, New York City, New York, USAObjective 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.https://lupus.bmj.com/content/12/1/e001351.full |
| spellingShingle | Amit Saxena Peter Izmirly Jill P Buyon Cristina Sorrento Janine Sullivan Monica Gamez-Perez Jammie Law Howard Michael Belmont Low versus high initial oral glucocorticoid dose for lupus nephritis: a pooled analysis of randomised controlled clinical trials Lupus Science and Medicine |
| title | Low versus high initial oral glucocorticoid dose for lupus nephritis: a pooled analysis of randomised controlled clinical trials |
| title_full | Low versus high initial oral glucocorticoid dose for lupus nephritis: a pooled analysis of randomised controlled clinical trials |
| title_fullStr | Low versus high initial oral glucocorticoid dose for lupus nephritis: a pooled analysis of randomised controlled clinical trials |
| title_full_unstemmed | Low versus high initial oral glucocorticoid dose for lupus nephritis: a pooled analysis of randomised controlled clinical trials |
| title_short | Low versus high initial oral glucocorticoid dose for lupus nephritis: a pooled analysis of randomised controlled clinical trials |
| title_sort | low versus high initial oral glucocorticoid dose for lupus nephritis a pooled analysis of randomised controlled clinical trials |
| url | https://lupus.bmj.com/content/12/1/e001351.full |
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