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Abstract Number: L6

Blisibimod, an Inhibitor of B Cell Activating Factor, in Patients with Moderate-to-Severe Systemic Lupus Erythematosus

Richard A. Furie1, Morton A. Scheinberg2, Gustavo Leon3, Edgar B. Ramiterre4, Matthew Thomas5, Renee S. Martin6 and Michelle Petri7, 1The Feinstein Institute for Medical Research and North Shore-Long Island Jewish Health System, Lake Success, NY, 2Rheumatology Hospital Abreu Sodre Pesquisa Clínica, São Paulo, Brazil, 3Instituto De Ginecologia Y Reproduccion, Lima, Peru, 4Brokenshire Memorial Hospital, Davao City, Philippines, 5Health and Research Centre, Trivandrum, Kerala, India, 6Anthera Pharmaceuticals Inc, Hayward, CA, 7Johns Hopkins University School of Medicine, Baltimore, MD

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: BAFF, BLyS and Lupus

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Session Information

Title: ACR Late-breaking Abstracts Poster Session

Session Type: Late-Breaking Abstracts

Background/Purpose:

To evaluate the efficacy, safety, and tolerability of subcutaneously-administered blisibimod (A-623, AMG 623), an inhibitor of soluble- and membrane-bound B-cell activating factor (BAFF), in patients with systemic lupus erythematosus (SLE) in the Phase 2b clinical trial, PEARL-SC.

Methods:

547 SLE patients with anti-double-stranded DNA or anti-nuclear antibodies and SELENA-SLEDAI score ≥6 at baseline were randomized 1:1 to receive placebo or blisibimod administered at 1 of 3 dose levels, 100 mg weekly (QW), 200 mg QW, or 200 mg every 4 weeks.  Randomization was stratified by baseline SELENA-SLEDAI score (6-9 vs ≥10) and race.  The primary endpoint was the percentage of subjects who achieved an SLE Responder Index-5 (SRI-5) response at Week 24 in the pooled blisibimod arms compared to the pooled placebo arms.  An SRI-5 responder has: ≥5 point improvement in SELENA-SLEDAI, AND no new BILAG A or ≥2B organ domain scores, AND no worsening (<0.3 increase) in Physician's Global Assessment. 

Results:

The primary endpoint of this study was not met primarily due to the lack of efficacy in the two lowest dose groups.  However, SRI-5 responder rates were higher in subjects receiving blisibimod 200mg QW compared with pooled placebo, from Week 16 (DSRI‑5 for blisibimod-placebo=8%, p= 0.14), through Week 24 (DSRI‑5=8.2%, p=0.15), reaching statistical significance at Week 20 (DSRI‑5=13.4%, p = 0.02).

Treatment benefit was greater still when compared with the regimen-matched (QW) placebo.  In pre-specified secondary analyses, benefit was observed at Week 24 with the 200mg QW group compared with matched placebo (n=92 and 92, respectively) using modified SRI analyses in which responders attained SELENA-SLEDAI improvements of ≥7 or ≥8 (DSRI‑5 = 8.7% p=0.23; DSRI-7 =16.3% p=0.003;  DSRI-8 =17.4% p=0.001).

Blisibimod was also effective in a subgroup of SLE subjects with baseline SELENA-SLEDAI ≥10 and receiving corticosteroids  at any dose (n=278) utilizing more stringent response thresholds (DSRI-5=13.8%, p=0.18; DSRI-7=28.9%, p=0.002; DSRI-8=31.1%, p<0.001, Figure 1).  More than 82% of the subjects in this subgroup had mucocutaneous or musculoskeletal disease.

As expected with its mechanism of BAFF inhibition, blisibimod treatment resulted in significant reductions in total B cells and anti-dsDNA antibodies, and significant increases in C3 and C4.

Blisibimod was safe and well-tolerated at all dose levels with no meaningful imbalances in serious adverse events or infections compared with placebo.  Amongst the commonly-reported AEs, only injection site reactions occurred more frequently with blisibimod compared with placebo (15% and7%, respectively), but were never serious or severe.

Conclusion:

These data support further evaluation of 200mg QW blisibimod using more stringent thresholds of the SRI in patients with SLE, including mucocutaneous or musculoskeletal disease.

 


Disclosure:

R. A. Furie,

Anthera Pharmaceuticals Inc,

5;

M. A. Scheinberg,
None;

G. Leon,
None;

E. B. Ramiterre,
None;

M. Thomas,
None;

R. S. Martin,

Anthera Pharmaceuticals Inc,

1,

Anthera Pharmaceuticals Inc,

3;

M. Petri,

Anthera Pharmaceuticals Inc,

2,

Anthera Pharmaceuticals Inc,

5.

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