Efficacy and safety of intravenous belimumab in Japanese patients with systemic lupus erythematosus: A subgroup analysis of a phase 3 randomized placebo-controlled trial

Abstract

In Japanese patients with SLE, belimumab improved disease activity, with efficacy and safety results similar and consistent to the pivotal Phase 3 trials, suggesting that belimumab is a potential treatment option in this population.

Systemic Lupus Erythematosus: Targeted Literature Review of the Epidemiology, Current Treatment, and Disease Burden in the Asia Pacific Region

“…A total of 70 unique publications (3,4,10,11, comprised of 27 clinical studies, 16 epidemiologic studies, and 27 studies reporting economic and humanistic burden and unmet need met the inclusion criteria (see Supplementary Appendix C, available at http:// onlinelibrary.wiley.com/doi/10.1002/acr.24431/abstract). Most of the studies were conducted in China (n = 14) (11,19,21,23,28,29,38,43,47,54,59,78,79,82), Japan (n = 13) (31,(33)(34)(35)(36)(37)40,58,65,67,74,75,77), and Taiwan (n = 12) (20,22,24,25,45,52,56,60-62, 64,69), followed by Korea (n = 9) (17,26,32,42,44,53,63,72,76), Australia (n = 7) (4,18,39,49,50,57,…”

“…Disease characteristics of patients in included studies. Disease characteristics were reported for SLE patients in studies from Australia (n = 6) (4,18,39,50,57,66), China (n = 15) (11,19,21,23,28,29,38,43,47,54,59,78,79,82), Hong Kong (n = 6) (10,30,46,71,80,81), Japan (n = 13) (31,(33)(34)(35)(36)(37)40,58,65,67,74,75,77), Korea (n = 7) (17,26,41,42,44,63,72), Singapore (n = 4) (27,48,55,70), and Taiwan (n = 10) (20,22,24,25,45,52,…”

“…However, cyclophosphamide is associated with significantly more adverse events (AEs) compared with MMF, including anemia and thrombocytopenia. The B cell modulator belimumab demonstrated a higher SLE response index rate compared with placebo in a metaanalysis conducted in China (38), an observational study in Japan (34), and a phase III clinical trial in China, Japan, and Korea (41), along with a manageable safety profile. In contrast, the B cell modulator rituximab, which has been studied as an off-label treatment in Australia, Japan, Korea, and Singapore when conventional immunosuppressive therapy fails (17,18,36,39), was associated with a unfavorable safety profile, including malignancy, anaphylaxis, and death.…”

Effect of combined use of prednisone and immunosuppressive therapy in patients with systemic lupus erythematosus, and its influence on incidence of adverse reactions

“…In addition, the drug inhibits the proliferation of connective tissue, controls the permeability of cell membranes, and reduces severe exudation, thereby suppressing the immune response and reducing the inflammatory response. However, it has been clinically found that the therapeutic effect of prednisone when used as a single drug, is poor, while the addition of immunosuppressive therapy effectively improves clinical efficacy [14,15]. Cyclophosphamide, a clinically potent immunosuppressant, acts as an antiinflammatory agent by effectively blocking the release of cytokines.…”

Organ system improvements in Japanese patients with systemic lupus erythematosus treated with belimumab: A subgroup analysis from a phase 3 randomized placebo-controlled trial

“…These studies consistently showed significant improvement in disease activity with belimumab versus placebo [14][15][16][17]. A subgroup analysis of the North-East Asia study, conducted to specifically assess the safety and efficacy of belimumab within the Japanese population, also demonstrated improved disease activity, as assessed by the SLE Responder Index (SRI) 4 at Week 52 [18].…”