Session Information
Session 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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ACR Meeting Abstracts - https://acrabstracts.org/abstract/overview-of-the-safety-of-epratuzumab-in-systemic-lupus-erythematosus/