Disease activity and glucocorticoid tapering patterns in Japanese patients with systemic lupus erythematosus treated with anifrolumab: Post hoc analysis of the Japanese subpopulation of the TULIP-2 study

被引:0
作者
Tanaka, Yoshiya [1 ]
Atsumi, Tatsuya [2 ,3 ]
Okada, Masato [4 ]
Miyamura, Tomoya [5 ]
Ishii, Tomonori [6 ]
Nishiyama, Susumu [7 ]
Matsumura, Ryutaro [8 ]
Morishima, Yosuke [9 ]
Yamaguchi, Yoshiyuki [9 ]
Abreu, Gabriel [10 ]
Lindholm, Catharina [11 ]
Morand, Eric F. [12 ]
Takeuchi, Tsutomu [13 ,14 ]
机构
[1] Univ Occupat & Environm Hlth, Dept Internal Med 1, 1-1 Iseigaoka, Kitakyushu 8078555, Japan
[2] Hokkaido Univ, Fac Med, Dept Rheumatol Endocrinol & Nephrol, Sapporo, Hokkaido, Japan
[3] Hokkaido Univ, Grad Sch Med, Sapporo, Hokkaido, Japan
[4] St Lukes Int Hosp, Immuno Rheumatol Ctr, Tokyo, Japan
[5] Natl Hosp Org, Kyushu Med Ctr, Dept Internal Med & Rheumatol, Fukuoka, Japan
[6] Tohoku Med & Pharmaceut Univ, Div Hematol & Rheumatol, Sendai, Miyagi, Japan
[7] Kurashiki Med Ctr, Rheumat Dis Ctr, Okayama, Japan
[8] Tsuchida Clin, Chiba, Japan
[9] AstraZeneca KK, Immunol Resp & Immunol Dept, Med, Osaka, Japan
[10] AstraZeneca, Biometr Late Resp & Immunol, BioPharmaceut R&D, Gothenburg, Sweden
[11] AstraZeneca, Late Resp & Immunol, BioPharmaceut R&D, Gothenburg, Sweden
[12] Monash Univ, Monash Med Ctr, Melbourne, Australia
[13] Keio Univ, Dept Internal Med, Div Rheumatol, Sch Med, Tokyo, Japan
[14] Saitama Med Univ, Fac Med, Saitama, Japan
关键词
Anifrolumab; glucocorticoid tapering; lupus low disease activity state; systemic lupus erythematosus; type I interferon; ACTIVITY STATE; I INTERFERON; TO-TARGET; PATHOGENESIS; DAMAGE; VALIDATION; INDEX;
D O I
10.1093/mr/roae105
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Objectives The aim of this study is to investigate the efficacy of anifrolumab in disease activity and glucocorticoid (GC) tapering patterns in Japanese patients with systemic lupus erythematosus (SLE).Methods We analysed disease activity and GC tapering in the Japanese subpopulation (anifrolumab, n = 24; placebo, n = 19) of the Treatment of Uncontrolled Lupus via the Interferon Pathway (TULIP-2) trial, which showed the efficacy and safety of anifrolumab in patients with moderate-to-severe active SLE.Results The percentage of patients who achieved a British Isles Lupus Assessment Group-based Composite Lupus Assessment response at Week 52 was greater in the anifrolumab group than in the placebo group [50.0% (12/24) vs 15.8% (3/19); P = .014]. Lupus low disease activity state (LLDAS) was achieved at Week 52 by 9/24 (37.5%) and 3/19 (15.8%) patients receiving anifrolumab and placebo, respectively. During the 52-week study period, in the anifrolumab vs placebo groups, 5/24 (20.8%) patients were in LLDAS >= 50% of the observed time vs 0/19 (0.0%), and 14/24 (58.3%) vs 6/19 (31.6%) patients were classified into favourable GC tapering patterns. Anifrolumab had an acceptable tolerability profile, consistent with the overall population.Conclusions In the Japanese subpopulation of the TULIP-2 trial, anifrolumab resulted in improvements in disease activity to those reported for the overall population, suggesting a beneficial effect for disease control.
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页码:470 / 477
页数:8
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