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Published on: November 1, 2015
Belimumab for the treatment of pediatric patients with lupus nephritis
1Division of Rheumatology, Department of Medicine, University of Southern California Keck School of Medicine, Los Angeles, CA, USA.
Insights
Belimumab is approved for lupus nephritis (LN) and systemic lupus erythematosus (SLE) in adults and children. However, robust evidence for its effectiveness in pediatric patients is limited, despite FDA approvals.
Area of Science:
- Immunology
- Nephrology
- Rheumatology
Background:
- Belimumab, an anti-BAFF monoclonal antibody, received FDA approval for adult systemic lupus erythematosus (SLE) in 2011.
- Subsequent approvals included pediatric SLE (2019), adult lupus nephritis (LN) (2020), and pediatric LN (2022).
Purpose of the Study:
- To review the efficacy and safety of belimumab in adult and pediatric SLE and LN.
- To assess the current evidence base for belimumab in pediatric lupus populations.
Main Methods:
- A comprehensive literature search of the PubMed database was conducted through November 2022.
- Search terms included 'belimumab and lupus nephritis,' and variations of 'belimumab and pediatric/childhood/juvenile SLE.'
- Pertinent references and personal literature collections were also utilized.
Main Results:
- Belimumab demonstrates established utility and safety in adult SLE and LN based on clinical trials and real-world data.
- Evidence supporting belimumab's effectiveness in pediatric SLE and pediatric LN is notably limited.
- The sole randomized controlled trial in pediatric SLE showed a trend favoring belimumab, but did not reach statistical significance; no RCTs exist for pediatric LN.
Conclusions:
- While belimumab is approved for pediatric indications, the evidence for its efficacy is currently sparse.
- Clinicians may cautiously consider belimumab for pediatric LN patients, extrapolating from adult data while awaiting further research.
- Further investigation is warranted to establish definitive efficacy in pediatric SLE and LN.
Introduction:
The FDA approved the anti-BAFF monoclonal antibody, belimumab, in 2011 for adult systemic lupus erythematosus (SLE), in 2019 for pediatric SLE, in 2020 for adult lupus nephritis (LN), and in 2022 for pediatric LN.
Areas Covered:
We performed a PUBMED database search through November 2022, using 'belimumab and lupus nephritis,' 'belimumab and childhood systemic lupus erythematosus,' 'belimumab and pediatric systemic lupus erythematosus,' and 'belimumab and juvenile systemic lupus erythematosus' as the search phrases. We also vetted pertinent references cited in the papers gleaned from the above search, and we drew from our personal literature collections.
Expert Opinion:
Based on clinical-trials and real-world experience, belimumab is useful and safe in adult SLE and LN. In contrast and despite FDA approval, evidence of effectiveness in pediatric SLE and pediatric LN is very limited. Whereas there was a trend favoring belimumab in the only randomized, controlled trial to date in pediatric SLE, the difference between the belimumab and placebo groups failed to achieve statistical significance. Moreover, there have been no randomized, controlled trials for belimumab in pediatric LN. Based largely on information gleaned from experience in adults, the clinician can cautiously prescribe belimumab to his/her pediatric LN patient and hope for benefit.
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