医学
耐受性
不利影响
内科学
安慰剂
析因分析
子群分析
人口
入射(几何)
随机对照试验
置信区间
物理
替代医学
环境卫生
病理
光学
作者
Yoshiya Tanaka,Tatsuya Atsumi,Masato Okada,Tomoya Miyamura,Tomonori Ishii,Susumu Nishiyama,Ryutaro Matsumura,Atsushi Kawakami,Nobuya Hayashi,Gabriel Abreu,Şule Yavuz,Catharina Lindholm,Hussein Al-Mossawi,Tsutomu Takeuchi
摘要
Evaluate the long-term safety and tolerability of anifrolumab 300 mg, alongside standard therapy, in patients from Japan with systemic lupus erythematosus (SLE) in the TULIP-LTE trial (NCT02794285).TULIP-LTE was a 3-year, randomized, double-blind, placebo-controlled long-term extension (LTE) of the TULIP trials. The primary safety outcome included serious adverse events (SAEs) and AEs of special interest (AESIs) during the LTE period. Exploratory efficacy outcomes included SLE Disease Activity Index 2000 (SLEDAI-2K) scores and glucocorticoid use. We performed a post hoc subgroup analysis of patients who enrolled in Japan.Exposure-adjusted incidence rates of SAEs during the LTE and follow-up for patients receiving anifrolumab 300 mg (n=21) were 8.7 per 100 patient-years; AESIs included influenza (6.9) and herpes zoster (3.5). One of three patients receiving placebo had an SAE (13.9). One patient per group discontinued due to an AE. There were no deaths. During the TULIP+LTE period, patients receiving anifrolumab 300 mg (n=24) had sustained reduction from baseline in mean SLEDAI-2K scores and cumulative glucocorticoid dosage.Anifrolumab 300 mg showed a favourable benefit-risk profile for the long-term treatment of adult patients with moderate to severe SLE from Japan, with safety, tolerability, and efficacy profiles consistent with the overall population.
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