ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1606

Overview Of The Safety Of Epratuzumab In Systemic Lupus Erythematosus

Daniel J. Wallace1, Josep Ordi-Ros2, C. Michael Neuwelt3, Kenneth Kalunian4, Michelle A. Petri5, Slawomir Jeka6, Ronald F. van Vollenhoven7, Brian Kilgallen8, Sabine Bongardt9, Caroline Gordon10 and Vibeke Strand11, 1Cedars-Sinai Medical Center, Los Angeles, CA, 2Internal Medicine, Vall De Hebron General Hospt, Barcelona, Spain, 3East Bay Rheumatology Research Institute, San Leandro, CA, 4UCSD School of Medicine, La Jolla, CA, 5Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD, 62nd University Hospital in Bydgoszcz Medical College of Nicolaus Copernicus University, Bydgoszcz, Poland, 7Clinical Trials Unit Department of Rheumatology, The Karolinska Institute, Stockholm, Sweden, 8UCB Pharma, Raleigh, NC, 9UCB Pharma, Brussels, Belgium, 10Rheumatology Research Group (East Wing), School of Immunity and Infection, University of Birmingham, Birmingham, United Kingdom, 11Adjunct, Division of Immunology / Rheumatology, Stanford University, Palo Alto, CA

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords: , ,

Session Information

Title: Systemic Lupus Erythematosus - Clinical Aspects II: Central Nervous System Manifestations, Therapeutics

Session Type: Abstract Submissions (ACR)

Background/Purpose:

The efficacy and safety of epratuzumab, a monoclonal antibody targeting CD22, has been evaluated in patients with moderate-to-severe systemic lupus erythematosus (SLE). A pooled analysis of epratuzumab adverse event (AE) data from open-label extension (OLE) studies in SLE is provided.

 Methods:

AE data were pooled from 2 completed OLE pilot studies (015 and SL0002 [NCT00113971]), and 4 completed and on-going long-term OLE studies (SL0006 [NCT00383513], EMBLEMTM OLE [NCT00660881], SL0012 [NCT01408576] and SL0027 [NCT01534403]. Data are presented for epratuzumab at a total monthly dose of 2400 mg (dose used in Phase III studies). These analyses are presented as event rates (AEs/100 patient-years [pt-yrs]) and as the proportion of pts experiencing each AE. Malignancies classified as serious AEs are reported.

 Results:

As of 15 April 2013 in OLE studies, 488 pts with moderate-to-severe SLE had received a total of 726 pt-yrs of exposure to epratuzumab. The overall rate of AEs, serious AEs (SAEs) and infusion reactions per 100 pt-years was 457.6, 21.1 and 23.1 respectively (Table). 40 patients (8.2%) withdrew due to AEs. The most common AEs (≥10% incidence for all epratuzumab dose group) were upper respiratory tract infection (17.0%), urinary tract infection (13.9%) and headache (12.3%). The most common SAEs (≥3 pts) were worsening of SLE (1.8%), cholelithiasis (0.6%), pneumonia (0.6%), sepsis (0.6%), depression (0.6%) and dyspnea (0.6%). The most common serious infections were pneumonia and sepsis (0.6 and 0.4 per 100 pt-yrs respectively). Malignancies were reported in 3 pts; 1 CNS lymphoma, 1 squamous cell CA and 1 patient experienced basal cell CA, breast CA and lip neoplasm. There were 6 deaths; 5 with known causes: bilateral lobal pneumonia, pneumonia/septic shock/acute respiratory failure, chronic heart failure, polydrug overdose, stroke. In 1 case cause was unknown.

Conclusion:

Epratuzumab at a total monthly dose of 2400 mg was well tolerated. These data, based on >700 pt-years of exposure, support the ongoing development of epratuzumab for treatment of SLE.

Disclosure:

D. J. Wallace,

Bristol-Myers Squibb, Genentech, Biogen IDEC Inc, GlaxoSmithKline, Human Genome Sciences Inc, MedImmune, Novo Nordisk and UCB Pharma,

5;

J. Ordi-Ros,

National Health Institud of Spain (FIS Grant),

2;

C. M. Neuwelt,

GSK and HGS ,

8;

K. Kalunian,

Genentech, Biogen IDEC Inc, Cephalon, Cypress, MedImmune, Novo Nordisk, UCB Pharma,

2,

Bristol-Myers Squibb, Genentech, Biogen IDEC Inc, Anthera, MedImmune, Novo Nordisk, Zymogenetics, Serono, UCB Pharma,

5;

M. A. Petri,

UCB Pharma,

2,

UCB Pharma,

5;

S. Jeka,
None;

R. F. van Vollenhoven,

AbbVie, BMS, GSK, MSD, Pfizer, Roche, UCB Pharma,

2,

Abbott, BMS, GSK, MSD, Pfizer, Roche, UCB Pharma, Lilly.,

5;

B. Kilgallen,

UCB Pharma,

1,

UCB Pharma,

3;

S. Bongardt,

UCB Pharma,

3;

C. Gordon,

GSK, MedImmune, Merck Serono, Parexel and UCB Pharma ,

5;

V. Strand,

Abbott Immunology Pharmaceuticals, Amgen Inc, AstraZeneca, Biogen Idec, Canfite Pharma, Centocor Inc, Cypress Biosciences Inc, Euro-Diagnostica Inc, Fibrogen, Forest Laboratories, Genentech, Human Genome Sciences Inc, Incyte, Novartis Pharmaceuticals Corp,

5.

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