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Abstract Number: 888

Phase 3 Trial Results with Blisibimod, a Selective Inhibitor of B-Cell Activating Factor, in Subjects with Moderate-to-Severe Systemic Lupus Erythematosus

Joan T. Merrill1, Renee S. Martin2, William Shanahan2, Morton Scheinberg3, Kenneth C. Kalunian4 and David Wofsy5, 1Oklahoma Medical Research Foundation, Oklahoma City, OK, 2Anthera, Hayward, CA, 3Department of Immunology, Center for Clinical Immunology, Sao Paulo SP, Brazil, 4Division of Rheumatology, Allergy and Immunology, UCSD School of Medicine, La Jolla, CA, 5Rheumatology, UCSF, San Francisco, CA

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: BAFF, Lupus and SLE

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Session Information

Date: Sunday, November 5, 2017

Session Title: Systemic Lupus Erythematosus – Clinical Aspects and Treatment I: Novel and Current Therapies

Session Type: ACR Concurrent Abstract Session

Session Time: 2:30PM-4:00PM

Background/Purpose: The Phase 3 CHABLIS-SC1 trial (NCT01395745) evaluated blisibimod, an inhibitor of B-cell activating factor (BAFF), in SLE. Prior SLE trials suggested that treatments are better distinguished from placebo in patients with higher disease activity, greater corticosteroid use, anti-double-stranded DNA (dsDNA), low complement1. The population in this study was enriched for these factors.

Methods: 442 SLE patients on corticosteroids (≤ 0.5 mg/kg or 40 mg) with anti-nuclear antibodies and/or anti-dsDNA and SELENA-SLEDAI score ≥10 on standard of care medications were randomized to weekly subcutaneous blisibimod (200 mg) or placebo. Patients with renal activity were eligible unless proteinuria exceeded 6 g/24hour or disease severity required escalation of immunosuppressive therapy. Corticosteroid taper was encouraged from Week 8 with the goal to reach ≤7.5 mg prednisone/day. The primary endpoint was the Week 52 SLE Responder Index-6 (SRI-6) in the absence of new/increased immunosuppressives or antimalarials: ≥6-point improvement in SELENA-SLEDAI, no new BILAG 1A or 2B domain scores, and <0.3-point increase in Physician’s Global Assessment.

Results:  At enrollment, the mean SELENA-SLEDAI score and corticosteroid dose was 13.5±4.2 and 15.6±9.1mg, respectively. The SRI-6 primary endpoint at Week 52 was not met (Figure), and placebo response was greater than reported in previous studies. More blisibimod-treated subjects achieved corticosteroid taper to prednisone ≤ 7.5 mg/day during Weeks 40-52 and better blisibimod effect was observed under the secondary endpoint which, in addition to meeting SRI-6 criteria at Week 52, required corticosteroid dose in Weeks 40-52 to be lower than baseline (Figure). Reductions in anti-dsDNA, significant reductions in peripheral B cell lineages, anti-phospholipid antibodies, and immunoglobulins, and significant increases in complement C3 and C4 were observed with blisibimod.

In a subgroup of subjects with baseline urinary protein:creatinine ratio (UPCR) ≥0.5 mg/mg, greater decreases in UPCR from baseline were observed in the blisibimod arm (Figure). At week 52, significantly more subjects who received blisibimod achieved >50% reduction in UPCR from baseline (59.7 vs 30.8%, p=0.006), and/or UPCR <0.5 (53.2 vs 30.8%, p=0.02).

Adverse events were balanced between treatment arms except injection/application site reactions which were more common with blisibimod. None were serious or severe.

Conclusion: This study did not meet its primary endpoint. Blisibimod treatment was associated with successful steroid reduction, decreased UPCR, and biomarker responses.

References: (1) van Vollenhoven Ann Rheum Dis 2012;71:1343


Disclosure: J. T. Merrill, Anthera, Amgen, EMD Serono, GSK, 5; R. S. Martin, Anthera, 1,Anthera, 3; W. Shanahan, Anthera Pharmaceuticals Inc, 1,Anthera Pharmaceuticals Inc, 3; M. Scheinberg, Anthera, 5; K. C. Kalunian, Anthera Pharmaceuticals, 5; D. Wofsy, Anthera, Celgene, GSK, Coherus, 5.

To cite this abstract in AMA style:

Merrill JT, Martin RS, Shanahan W, Scheinberg M, Kalunian KC, Wofsy D. Phase 3 Trial Results with Blisibimod, a Selective Inhibitor of B-Cell Activating Factor, in Subjects with Moderate-to-Severe Systemic Lupus Erythematosus [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/phase-3-trial-results-with-blisibimod-a-selective-inhibitor-of-b-cell-activating-factor-in-subjects-with-moderate-to-severe-systemic-lupus-erythematosus/. Accessed February 28, 2021.
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