Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose:
Epratuzumab is a monoclonal antibody targeting CD22. In EMBLEMTM (a dose-ranging phase IIb study), epratuzumab produced clinically relevant improvements in disease activity in patients with moderate-to-severe systemic lupus erythematosus (SLE).1 The open-label extension (OLE) of EMBLEMTM (NCT00660881) reports long-term data on the efficacy of epratuzumab. The improvement in British Isles Lupus Assessment Group (BILAG) 2004 index according to body systems is reported.
Methods:
Patients from any EMBLEMTM arm completing 12 weeks’ blinded treatment and patients who discontinued due to lack of efficacy but completed ≥8 weeks were eligible. In the OLE, all patients received 1200mg epratuzumab at weeks 0 and 2 of repeating 12-week cycles. Data are reported to week 108, the last time point when more than 50% of patients reported data for BILAG improvement. Independent central readers determined BILAG grades for all 9 systems. Data for the BILAG improvement component of the combined index in body systems for which a sufficient number of patients entering the OLE (≥20) had baseline disease activity to assess response are reported. Observed case analysis are presented.
Results:
Improvements from BILAG A/B scores to BILAG C or D were observed following 12 weeks of epratuzumab treatment (EMBLEMTM OLE screening) in all body systems (Table). In the musculoskeletal body system 44.8% of patients with BILAG A/B at EMBLEMTM baseline improved to BILAG C or D at EMBLEMTM OLE screening. This was 41.6%, 34.7%, 36.0%, 84.1% and 52.0% in the mucocutaneous, cardiorespiratory, neuropsychiatric, constitutional and renal body systems respectively. The percentage of patients with an improvement in baseline BILAG A/B scores to BILAG C or D was further increased up to week 108 in the EMBLEMTM OLE. At week 108 the proportion of patients with BILAG C or D exceeded 60% in the musculoskeletal, mucocutaneous, cardiorespiratory, constitutional and renal systems (observed data) (Table).
Conclusion:
Treatment with epratuzumab provided BILAG improvements in disease activity in all affected body systems. Improvements were sustained and enhanced with long-term treatment. Within specific body systems, most patients had symptom reduction or absence of active disease with treatment.
References:
1. Wallace DJ. et al. Ann Rheum Dis, Online First 12 January 2013. DOI: 10.1136/annrheumdis-2012-202760.
Disclosure:
K. Kalunian,
Exagen, BMS, Kowata Kirin California, Lilly, Genentech, Biogen IDEC Inc, Cephalon, MedImmune, Novo Nordisk, UCB Pharma,
2,
Bristol-Myers Squibb, Genentech, Biogen IDEC Inc, Anthera, MedImmune, Novo Nordisk, Exagen, BMS, Kowata Kirin California, Lilly, Serono, UCB Pharma,
5;
M. E. B. Clowse,
UCB Pharma,
5;
F. Houssiau,
UCB Pharma,
2,
UCB Pharma,
5;
M. A. Petri,
UCB Pharma,
2,
UCB Pharma,
5;
B. Kilgallen,
UCB Pharma,
1,
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;
S. Bongardt,
UCB Pharma,
3;
D. J. Wallace,
Bristol-Myers Squibb, Genentech, Biogen IDEC Inc, GlaxoSmithKline, Human Genome Sciences Inc, MedImmune, Novo Nordisk and UCB Pharma,
5.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/sustained-british-isles-lupus-assessment-group-measured-improvement-in-moderately-and-severely-affected-body-systems-in-patients-with-systemic-lupus-erythematosus-by-epratuzumab-results-from-an-open/