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.
Keywords: BAFF; adult SLE; pediatric SLE; phase-III trials; real-world experience.