Safety and efficacy of intravenous belimumab in children with systemic lupus erythematosus: results from a randomised, placebo-controlled trial

Annals of the Rheumatic Diseases
Hermine I BrunnerPaediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group

Abstract

This ongoing Phase-2, randomised, placebo-controlled, double-blind study evaluated the efficacy, safety and pharmacokinetics of intravenous belimumab in childhood-onset systemic lupus erythematosus (cSLE). Patients (5 to 17 years) were randomised to belimumab 10 mg/kg intravenous or placebo every 4 weeks, plus standard SLE therapy. Primary endpoint: SLE Responder Index (SRI4) response rate (Week 52). Key major secondary endpoints: proportion of patients achieving the Paediatric Rheumatology International Trials Organisation/American College of Rheumatology (PRINTO/ACR) response using 50 and '30 alternative' definitions (Week 52), and sustained response (Weeks 44 to 52) by SRI4 and Parent Global Assessment of well-being (Parent-global). Safety and pharmacokinetics were assessed. Study not powered for statistical testing. Ninety-three patients were randomised (belimumab, n=53; placebo, n=40). At Week 52, there were numerically more SRI4 responders with belimumab versus placebo (52.8% vs 43.6%; OR 1.49 (95% CI 0.64 to 3.46)). PRINTO/ACR 30 alternative (52.8% vs 27.5%; OR 2.92 (95% CI 1.19 to 7.17)) and PRINTO/ACR 50 (60.4% vs 35.0%; OR 2.74 (95% CI 1.15 to 6.54)) responses were more frequent with belimumab than placebo, as were su...Continue Reading

References

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Citations

Nov 28, 2020·Clinical Pharmacology in Drug Development·Richard DimelowHerbert Struemper
Feb 12, 2021·Current Rheumatology Reports·A CharrasC M Hedrich
Jan 26, 2021·Therapeutics and Clinical Risk Management·Ayse Bag-Ozbek, Joyce S Hui-Yuen
Oct 31, 2020·Frontiers in Immunology·Bingyi YangQianjin Lu
Feb 26, 2021·Expert Opinion on Biological Therapy·Roberto DepascaleLuca Iaccarino
Mar 9, 2021·Current Rheumatology Reports·Gabriella GiancaneNicolino Ruperto
Jul 10, 2021·Lupus·Roger A LevyDavid A Roth
Jul 11, 2021·Paediatric Drugs·Vitor Cavalcanti TrindadeClovis Artur Silva
Aug 12, 2021·Pediatric Nephrology : Journal of the International Pediatric Nephrology Association·Shiyuan QiuMo Wang
Aug 13, 2021·Pediatric Nephrology : Journal of the International Pediatric Nephrology Association·Marina VivarelliFrancesco Emma
Aug 17, 2021·Current Opinion in Rheumatology·Rachel L Randell, Mara L Becker
Nov 4, 2021·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Bin WangGuixiu Shi
Nov 9, 2021·Zeitschrift für Rheumatologie·Tobias Alexander, Christian M Hedrich

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NCT01649765
NCT01639339

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