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Abstract Number: 2867

Efficacy and Safety of Intravenous Belimumab in Children with Systemic Lupus Erythematosus

Hermine I. Brunner1, Carlos Abud-Mendoza2, Diego I. Viola3, Inmaculada Calvo4, Deborah M. Levy5, Julia Calderon Gallegos6, Manuel Ferrandiz7, Vyacheslav Chasnyk8, Vladmir Keltsev9, Jordi Anton10, Maria Paz11, Michael Shishov12, Alina Lucica Boteanu13, Michael Henrickson14, Damon Bass15, Kenneth Clark16, Anne Hammer15, Beulah Ji16, David Roth15, Herbert Struemper17, Mei-Lun Wang18, Alberto Martini19, Daniel J Lovell20 and Nicola Ruperto19, 1Pediatric Rheumatology Collaborative Study Group (PRCSG), Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, 2Hospital Central Dr. Ignacio Morones Prieto, San Luis Potosy, Mexico, 3CAICI Institute, Rosario City, Santa Fe State, Argentina, 4Hospital Universitario La Fe, Valencia, Spain, 5Rheumatology, Hospital for Sick Children, Toronto, ON, Canada, 6Instituto de Ginecologia y Reproduccion, Santiago De Surco, Peru, 7Instituto Nacional de Salud del Nino, Lima, Peru, 8St Petersburg State Pediatric Medical Academy, St Petersburg, Russian Federation, 9City Clinical Hospital No.5, Tolyatti, Russian Federation, 10SJD Barcelona Children’s Hospital, Barcelona, Spain, 11Clinica Anglo Americana, Lima, Peru, 12Phoenix Children's Hospital, Phoenix, AZ, 13University Hospital Ramón y Cajal, Madrid, Spain, 14Cincinnati Children’s Medical Center, Cincinnati, OH, 15GlaxoSmithKline, Philadelphia, PA, 16GlaxoSmithKline, Stevenage, United Kingdom, 17GlaxoSmithKline, Research Triangle Park, NC, 18GlaxoSmithKline, Collegeville, PA, 19Universita di Genova Pediatria II, Genova, Italy, 20Cincinnati Children's Medical Center, Cincinnati, OH

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: belimumab, juvenile SLE, Pediatric rheumatology and systemic lupus erythematosus (SLE)

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Session Information

Date: Tuesday, October 23, 2018

Session Title: 5T107 ACR Abstract: Pediatric Rheum–Clinical II: Treatment Update (2862–2867)

Session Type: ACR Concurrent Abstract Session

Session Time: 4:30PM-6:00PM

<>Background/Purpose: Belimumab (BEL) is approved in adults with active systemic lupus erythematosus (SLE). There are no approved biologic therapies for pediatric patients with childhood-onset SLE (cSLE). This Phase 2, multicenter, randomized, double-blind trial (NCT01649765) evaluated the efficacy, safety, and pharmacokinetics (PK) of intravenous (IV) BEL vs placebo (PBO), plus standard therapy (SoC), in cSLE.  <>Methods: Patients with cSLE aged 5–17 years were randomized to BEL 10 mg/kg IV or PBO every 4 weeks, plus SoC. The primary endpoint was SLE Responder Index 4 (SRI4) at Week (Wk) 52. Major secondary endpoints were: proportion of patients achieving the Pediatric Rheumatology International Trials Organization/ACR (PRINTO/ACR) cSLE Evaluation criteria for improvement using two definitions at Wk 52; cSLE core response variables at Wk 52 (Table); and sustained SRI4 and Parent Global Assessment (ParentGA) responses (Wks 44–52). Other secondary endpoints included time to first severe flare (modified SELENA-SLEDAI Flare Index). Safety and PK were assessed. The study was not powered for statistical testing.  

Results: 93 patients comprised the intent-to-treat population (BEL, 53; PBO, 40). Mean (SD) baseline SELENA-SLEDAI was 10.4 (3.63) for PBO and 10.3 (3.34) for BEL; 17 (42.5%) PBO and 22 (41.5%) BEL patients were anti-dsDNA positive and had low complement. At Wk 52 there were numerically more SRI4 and PRINTO/ACR responders in BEL vs PBO (Figure). Numerically more BEL patients had sustained SRI4 and ParentGA responses at Wks 44–52 vs PBO (Figure). Changes in cSLE core response variables are shown in the Table. Severe flares were 62% less frequent with BEL vs PBO (hazard ratio 0.38 [95% CI 0.18, 0.82]); median (IQR) time to first severe flare was 159.5 (47.5, 314.5) vs 82.0 (57.0, 228.0) days for BEL vs PBO. Overall incidence of adverse events (AEs) was similar between groups. 9/53 (17%) BEL patients experienced ≥1 SAE vs 14/40 (35%) PBO patients. 1/53 [1.9%] BEL patients experienced depression/suicide/self-injury vs 4/40 [10%] PBO patients. One PBO patient died of acute pancreatitis. At Wk 52 the geometric mean (95% CI) BEL trough concentration was 44.96 (27.52, 73.43) µg/mL for patients aged 5–11 years, and 59.71 (46.41, 76.81) µg/mL for patients aged 12–17 years.  

Conclusion: The benefit/risk profile and PK of BEL IV plus SoC in cSLE are generally consistent with those in adult BEL study populations. The 10 mg/kg IV dose used in adults may be an appropriate dose in cSLE.

 


Disclosure: H. I. Brunner, GlaxoSmithKline (GSK), F. Hoffman-La Roche, Novartis, Pfizer, Sanofi Aventis, Merck Serono, 5,AbbVie, Amgen, Biogenidec, Alter, AstraZeneca, Baxalta Biosimilars, Biogenidec, Boehringer, BMS, Celgene, CrescendoBio, EMD Serono, F. Hoffman-La Roche, Janssen, MedImmune, Novartis, Pfizer, Sanofi Aventis, Takeda, and UCB Biosciences GmbH, 5; C. Abud-Mendoza, None; D. I. Viola, None; I. Calvo, None; D. M. Levy, None; J. Calderon Gallegos, None; M. Ferrandiz, None; V. Chasnyk, None; V. Keltsev, None; J. Anton, None; M. Paz, None; M. Shishov, None; A. L. Boteanu, None; M. Henrickson, None; D. Bass, GSK, 1, 3; K. Clark, GSK, 1, 3; A. Hammer, GSK, 1, 3; B. Ji, GSK, 1, 3; D. Roth, GSK, 1, 3; H. Struemper, GSK, 1, 3; M. L. Wang, GSK, 1, 3; A. Martini, Abbvie, Biogen, Boehringer, Bristol Myers and Squibb, EMD Serono, Janssen, Novartis, Pfizer, R-Pharm on behalf of the Gaslini Institute, 5; D. J. Lovell, AstraZeneca, Amgen, Abbott, Pfizer, 5,Wyeth Pharma, 8; N. Ruperto, Abbott, AbbVie, Amgen, Biogenidec, Astellas, Alter, AstraZeneca, Baxalta Biosimilars, Boehringer, BMS, CD-Pharma,Celgene, CrescendoBio, EMD Serono, Hoffman-La Roche, Italfarmaco, Janssen, MedImmune, Medac, Novartis, Novo Nordisk, Pfizer, Rewind Arms, 5, 6, 7, 8,R-Pharma, Sanofi Aventis, Servier, Sinergie, Takeda, Vertex, UCB Biosciences GmbH., 5, 6, 7, 8,BMS, "Francesco Angelini", GlaxoSmithKline (GSK), Hoffman-La Roche, Italfarmaco, Janssen, Novartis, Pfizer, Sanofi Aventis, Schwarz Biosciences, Sobi, Xoma, Wyeth., 2.

To cite this abstract in AMA style:

Brunner HI, Abud-Mendoza C, Viola DI, Calvo I, Levy DM, Calderon Gallegos J, Ferrandiz M, Chasnyk V, Keltsev V, Anton J, Paz M, Shishov M, Boteanu AL, Henrickson M, Bass D, Clark K, Hammer A, Ji B, Roth D, Struemper H, Wang ML, Martini A, Lovell DJ, Ruperto N. Efficacy and Safety of Intravenous Belimumab in Children with Systemic Lupus Erythematosus [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/efficacy-and-safety-of-intravenous-belimumab-in-children-with-systemic-lupus-erythematosus/. Accessed March 28, 2023.
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