Session Type: Abstract Submissions (ACR)
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.
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.
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).
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.
1. Wallace DJ. et al. Ann Rheum Dis, Online First 12 January 2013. DOI: 10.1136/annrheumdis-2012-202760.
Exagen, BMS, Kowata Kirin California, Lilly, Genentech, Biogen IDEC Inc, Cephalon, MedImmune, Novo Nordisk, UCB Pharma,
Bristol-Myers Squibb, Genentech, Biogen IDEC Inc, Anthera, MedImmune, Novo Nordisk, Exagen, BMS, Kowata Kirin California, Lilly, Serono, UCB Pharma,
M. E. B. Clowse,
M. A. Petri,
GSK, MedImmune, Merck Serono, Parexel and UCB Pharma ,
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,
D. J. Wallace,
Bristol-Myers Squibb, Genentech, Biogen IDEC Inc, GlaxoSmithKline, Human Genome Sciences Inc, MedImmune, Novo Nordisk and UCB Pharma,
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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/