霉酚酸酯治疗系统性硬化症和系统性硬化症相关间质性肺病：来自日本医院索赔数据库的信息。

Use of mycophenolate mofetil for systemic sclerosis and systemic sclerosis-associated interstitial lung disease: Information from a Japanese hospital claims database.

机构信息

Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.

出版信息

Mod Rheumatol. 2022 Jul 1;32(4):755-760. doi: 10.1093/mr/roab111.

DOI:10.1093/mr/roab111

PMID:34850080

Abstract

OBJECTIVES

Limited information is available on patients with systemic sclerosis (SSc) or SSc-associated interstitial lung disease (SSc-ILD) receiving mycophenolate mofetil (MMF) in Japan. The dose, treatment duration, and patient characteristics of SSc and SSc-ILD patients receiving MMF were investigated.

METHODS

We used data from a Japanese hospital claims database (2008-2020).

RESULTS

Data on 486 SSc patients ≥18 years old receiving MMF were captured; 314 had SSc complicated with ILD. The most common initial daily doses were 1000 mg (SSc, 39.5%; SSc-ILD, 38.1%) and 500 mg (SSc, 36.6%; SSc-ILD, 34.6%). The most common maximum daily doses were 1000 mg (SSc, 33.3%; SSc-ILD, 34.9%), 1500 mg (SSc, 24.4%; SSc-ILD, 23.1%), and 2000 mg (SSc, 23.8%; SSc-ILD, 24.4%). Doses ranged from 250 to 3000 mg/day and were similar for SSc and SSc-ILD patients. Over 27% of patients received treatment for >1 year. There was a gradual decrease in steroid doses during MMF treatment.

CONCLUSIONS

Our study suggests that the off-label use of MMF for SSc and SSc-ILD has been increasing annually since 2015 in Japan. The doses used in patients with SSc and SSc-ILD were similar to the approved doses of MMF for lupus nephritis in Japan.

摘要

目的

关于在日本接受吗替麦考酚酯（MMF）治疗的系统性硬化症（SSc）或 SSc 相关间质性肺病（SSc-ILD）患者，相关信息有限。本研究调查了接受 MMF 治疗的 SSc 和 SSc-ILD 患者的剂量、治疗持续时间和患者特征。

方法

我们使用了来自日本医院索赔数据库（2008-2020 年）的数据。

结果

共纳入 486 例≥18 岁接受 MMF 治疗的 SSc 患者，其中 314 例 SSc 合并 ILD。最常见的初始日剂量为 1000mg（SSc，39.5%；SSc-ILD，38.1%）和 500mg（SSc，36.6%；SSc-ILD，34.6%）。最常见的最大日剂量为 1000mg（SSc，33.3%；SSc-ILD，34.9%）、1500mg（SSc，24.4%；SSc-ILD，23.1%）和 2000mg（SSc，23.8%；SSc-ILD，24.4%）。剂量范围为 250-3000mg/天，SSc 和 SSc-ILD 患者的剂量相似。超过 27%的患者接受治疗时间超过 1 年。在 MMF 治疗期间，皮质类固醇剂量逐渐下降。