A new study reveals that adding belimumab to standard immunotherapy significantly improves outcomes for children with lupus nephritis, offering a promising treatment strategy for this challenging autoimmune condition.
The retrospective analysis, conducted at the Children's Hospital of Fudan University from January 2016 through December 2022, compared 38 patients receiving belimumab plus standard therapy against 63 patients on standard immunotherapy alone. The findings, published in Lupus Science & Medicine, demonstrate substantial benefits in both renal response rates and steroid reduction.
Superior Renal Response Rates
The study showed that 97.1% of patients treated with belimumab achieved primary efficacy renal response, significantly outperforming the 80% response rate in the standard therapy group (P = .046). Notably, the belimumab group demonstrated faster improvement, showing superior outcomes as early as three months into treatment and maintaining better results through 24 months (HR = 0.631; 95% CI, 0.415-0.959).
Improved Steroid Reduction Outcomes
A key advantage of the belimumab regimen was its steroid-sparing effect. At the 12-month mark:
- 82.9% of belimumab-treated patients reduced glucocorticoid doses to below 7.5 mg daily
- Only 30.4% of standard therapy patients achieved this reduction
- 42.9% of the belimumab group reached doses of 5 mg or less per day
- Just 19.6% of the standard therapy group achieved the 5 mg threshold
Treatment Protocol and Safety Profile
Patients in the belimumab group received 10 mg/kg doses on a structured schedule: every other week for the first month, followed by monthly administrations. The standard therapy protocol included combinations of glucocorticoids, hydroxychloroquine, cyclophosphamide, mycophenolate mofetil, and tacrolimus.
Safety monitoring revealed comparable infection rates between groups (60.5% in belimumab vs. 61.9% in standard therapy), with no serious infections reported in either group.
Clinical Implications
Dr. Yinv Gong and colleagues from the Children's Hospital of Fudan University emphasized the significance of early intervention: "The strategy of initial combination with belimumab helps to improve early response rates within the 'window of opportunity,' minimizing glomerular loss and glucocorticoid dose as much as possible."
This research builds upon previous successful trials of belimumab, including the BLISS-52 and BLISS-76 studies in adult SLE patients, and the more recent BLISS-LN and PLUTO trials focusing on active lupus nephritis and childhood-onset SLE respectively.
The findings suggest that an upfront combination approach with belimumab may be particularly beneficial for children with high disease activity, potentially establishing a new standard of care in pediatric lupus nephritis treatment.
