Efficacy and safety of tabalumab plus standard of care in Japanese patients with active systemic lupus erythematosus

Subgroup analyses of the ILLUMINATE-1 study

Yoshiya Tanaka, Tsutomu Takeuchi, Naotsugu Akashi, Yasushi Takita, Birgit Kovacs, Sawako Kariyasu

Research output: Contribution to journalArticle

3 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)1-8
Number of pages8
JournalModern Rheumatology
DOIs
Publication statusAccepted/In press - 2016 Jul 28

Fingerprint

Standard of Care
Systemic Lupus Erythematosus
Placebos
Safety
B-Cell Activating Factor
tabalumab
Therapeutics
Antibodies

Keywords

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

ASJC Scopus subject areas

  • Rheumatology

Cite this

Efficacy and safety of tabalumab plus standard of care in Japanese patients with active systemic lupus erythematosus : Subgroup analyses of the ILLUMINATE-1 study. / Tanaka, Yoshiya; Takeuchi, Tsutomu; Akashi, Naotsugu; Takita, Yasushi; Kovacs, Birgit; Kariyasu, Sawako.

In: Modern Rheumatology, 28.07.2016, p. 1-8.

Research output: Contribution to journalArticle

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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.",
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