Efficacy and safety of tabalumab plus standard of care in Japanese patients with active systemic lupus erythematosus: Subgroup analyses of the ILLUMINATE-1 study

Abstract

Objective: To assess the efficacy and safety of tabalumab, an anti-B cell activating factor (BAFF) antibody, in combination with standard of care (SoC) therapy in Japanese patients with active systemic lupus erythematosus (SLE).

Methods: A subgroup analysis was conducted in Japanese patients (n = 45) enrolled in ILLUMINATE-1, a phase III global trial in SLE patients (N = 1164). Patients received SoC plus tabalumab or placebo, starting with a loading dose (240 mg) at week 0, followed by 120 mg every 4 weeks (120 Q4W, n = 15), 120 mg every 2 weeks (120 Q2W, n = 15), or placebo Q2W (n = 15). The primary endpoint was proportion achieving SLE Responder Index-5 (SRI-5) improvement at week 52.

Results: A numerically greater SRI-5 response rate was achieved with 120 Q2W (46.7%; p = 0.059 vs. placebo) compared with 120 Q4W (20.0%) and placebo Q2W (13.3%). The proportion of patients with severe SLE flare was lower for 120 Q2W (0%) and 120 Q4W (6.7%) than for placebo (26.7%). The rates of serious adverse events (AEs) and treatment-emergent AEs were similar across treatments.

Conclusion: In Japanese SLE patients, tabalumab 120 Q2W improved SRI-5 response rate and reduced the frequency of severe flares compared with placebo. Safety profiles were similar with tabalumab and placebo.

Keywords:

• BAFF
• Japanese
• Safety
• SRI
• Systemic lupus erythematosus

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Erratum

Acknowledgments

The authors would like to thank patients and investigators for their participation in the study, Dr. Pierre-Yves Berclaz and Dr. Taeko Ishii of Eli Lilly Japan K.K. (Kobe, Japan) for assistance with trial design and execution, Rebecca Taha of Eli Lilly and Company (Indianapolis, IN) for assistance with statistical analyses, and Gina Moore of inVentiv Health Clinical (Princeton, NJ) for assistance with manuscript writing and editing, respectively.

Conflict of interests

This study was supported by Eli Lilly and Company. Y.Tanaka has received speaking fees, consulting fees and/or honoraria from AbbVie GK, Daiichi-Sankyo Co., Ltd., Chugai Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Mitsubishi-Tanabe Pharma Corporation, Bristol-Myers K.K., Astellas Pharma, Eisai Co., Ltd., Janssen Pharmaceutical K.K., Pfizer Japan Inc., Asahi-kasei Corporation, Eli Lilly Japan K.K., GlaxoSmithKline K.K., UCB Japan Co. Ltd., Teijin Pharma Ltd., MSD K.K., Santen Pharmaceutical Co., Ltd and has received research grants from Mitsubishi-Tanabe Pharma Corporation, Takeda Pharmaceutical Co., Chugai Pharmaceutical Co., Ltd., Astellas Pharma, Eisai Co. Ltd., Taisho-Toyama Pharmaceutical Co., Ltd., Kyowa-Kirin Co., Ltd., Abbvie GK, Bristol-Myers K.K.

T.Takeuchi has received speaking fees from AbbVie G.K., Bristol–Myers K.K., Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Janssen Pharmaceutical K.K., Mitsubishi Tanabe Pharma Co., Pfizer Japan Inc., Takeda Pharmaceutical Co., Ltd., Astellas Pharma, and Diaichi Sankyo Co.,Ltd., Celtrion Inc., Nipponkayaku Co.Ltd, has received consultant fees from Astra Zeneca K.K., Eli Lilly Japan K.K., Novartis Pharma K.K., Mitsubishi Tanabe Pharma Co., Asahi Kasei Medical K.K., Abbivie G.K., Daiichi Sankyo Co.,Ltd., Bristol–Myers K.K., Nipponkayaku Co.Ltd. has received grants from Astellas Pharma, Bristol–Myers K.K., Chugai Pharmaceutical Co, Ltd., Daiichi Sankyo Co., Ltd., Eisai Co., Ltd., Mitsubishi Tanabe Pharma Co., Pfizer Japan Inc., Santen Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Teijin Pharma Ltd., AbbVie GK, Asahikasei Pharma Corp., Taisho Toyama Pharmaceutical Co., Ltd. and SymBio Pharmaceuticals Ltd.

N.Akashi, Y.Takita and S.Kariyasu are employees of Eli Lilly Japan K.K.

B.Kovacs is an employee and stock owner of Eli Lilly and Company.

Supplementary material available online