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Abstract Number: 672

Favorable Response to Belimumab in Pediatric-Onset Systemic Lupus Erythematosus

Joyce Hui-Yuen1, Jennifer Taylor2, Xiao Qing Li3, Liza Mariel Bermudez1, Josephine Isgro1, Andrew H. Eichenfield4, Amy J. Starr4, Lisa F. Imundo5, Jill P. Buyon6, Richard Furie7, Diane L. Kamen8, Susan Manzi9, Michelle Petri10, Rosalind Ramsey-Goldman11, Ronald van Vollenhoven12, Daniel J. Wallace13 and Anca Askanase4, 1Pediatric Rheumatology, Columbia University Medical Center, New York, NY, 2Pediatrics, Columbia University Medical Center, New York, NY, 3Adult Rheumatology, Columbia University Medical Center, New York, NY, 4Columbia University Medical Center, New York, NY, 5Assoociate Professor of Pediatrics in Medicine - Rheumatoology, Columbia University Medical Center, New York, NY, 6Department of Medicine, Division of Rheumatology, New York University School of Medicine, New York, NY, 7Division of Rheumatology, North Shore-LIJ Health System, Great Neck, NY, 8Department of Medicine, Division of Rheumatology, Medical University of South Carolina, Charleston, SC, 9Division of Rheumatology, University of Pittsburgh School of Medicine, Pittsburgh, PA, 10Johns Hopkins University School of Medicine, Baltimore, MD, 11Rheumatology, Northwestern University and Feinberg School of Medicine, Chicago, IL, 12Karolinska Institute, Stockholm, Sweden, 13Cedars-Sinai Medical Center, Los Angeles, CA

Meeting: 2014 ACR/ARHP Annual Meeting

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

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Session Information

Title: Systemic Lupus Erythematosus - Clinical Aspects and Treatment: Treatment and Management Studies

Session Type: Abstract Submissions (ACR)

Background/Purpose: Belimumab (Benlysta) is a human monoclonal antibody that inhibits soluble B-lymphocyte stimulator. It was approved by the FDA in 2011 for treatment of active, autoantibody-positive, systemic lupus erythematosus (SLE) in adults. Patients with pediatric-onset SLE (pSLE) have more severe disease requiring more aggressive immunosuppression than adult SLE. To date, there have been no published data on the use of belimumab in pSLE.

Methods: Observational study of patients with SLE diagnosed before their 19thbirthday, and treated with belimumab, from 10 large academic centers. Data were collected on demographic and disease characteristics, clinical manifestations requiring treatment, concomitant medications, disease course, and treatment outcomes. The outcome was defined as the physician’s impression of improvement in the initial manifestation(s) being treated without worsening in other organ systems. Chi-square and Student t-tests were used when appropriate.

Results: Of a cohort of 195 patients treated with belimumab, 38 patients had pSLE. The median age at diagnosis was 13.5 years old (range 4-18 years old); the median disease duration at initiation of belimumab was 12.5 years (range 2-43 years). Eighty-nine percent of the patients were female, 39% Black, 39% Caucasian, 11% Hispanic, 5% Asian. All patients were taking other background medications prior to initiation of belimumab (hydroxychloroquine 92%, prednisone 89% compared to 73% in the adult SLE patients, p=0.005, mycophenolate mofetil 47%, azathioprine 21%). The most common indications for initiation of therapy were inability to taper steroids (89%, mean prednisone equivalent dose 17.2mg/day compared to 27% in the adult SLE patients, p<0.0001), arthritis (61%), and rash (39%), accompanied by worsening serologic activity (increasing anti-dsDNA and hypocomplementemia). At 6 months, 71% of pSLE patients had responded clinically to belimumab compared to 48% of the entire patient population (p=0.01), and exhibited improvement in their laboratory abnormalities. Steroids were tapered in 63% of pSLE patients, and discontinued in 22%. Six months after initiation of belimumab, pSLE patients who responded clinically demonstrated an 86% decrease in anti-dsDNA (p<0.0001), 15% increase in C3 (p=NS), and 27% increase in C4 (p=NS).  Of note, 100% of blacks with pSLE responded clinically (p=0.0003) with improvement in all serologic markers. Thirty-two of 38 pSLE patients tolerated infusions well, with only 6 patients discontinuing treatment.

Conclusion: This is the first study investigating the use of belimumab in pSLE. Our data demonstrate favorable clinical and laboratory outcomes across all ethnic groups: 71% of patients responded clinically within 6 months and steroids were tapered in 63% of our patients, suggesting a more important role for belimumab in pediatric-onset SLE.


Disclosure:

J. Hui-Yuen,
None;

J. Taylor,
None;

X. Q. Li,
None;

L. M. Bermudez,
None;

J. Isgro,
None;

A. H. Eichenfield,
None;

A. J. Starr,
None;

L. F. Imundo,
None;

J. P. Buyon,
None;

R. Furie,
None;

D. L. Kamen,
None;

S. Manzi,
None;

M. Petri,
None;

R. Ramsey-Goldman,
None;

R. van Vollenhoven,
None;

D. J. Wallace,
None;

A. Askanase,

Glaxo Smith Kline,

2.

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