沙利度胺治疗慢性多形性红斑患者的疗效评价：一项多中心回顾性队列研究。

Evaluation of Thalidomide Treatment of Patients With Chronic Erythema Multiforme: A Multicenter Retrospective Cohort Study.

机构信息

Department of Dermatology, Henri Mondor Hospital, AP-HP, Créteil, France.

Université Paris Est Créteil EpiDermE, Créteil, France.

出版信息

JAMA Dermatol. 2021 Dec 1;157(12):1472-1476. doi: 10.1001/jamadermatol.2021.4083.

DOI:10.1001/jamadermatol.2021.4083

PMID:34757396

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8581790/

Abstract

IMPORTANCE

Erythema multiforme (EM) may become long term, with a recurrent or persistent course. First-line treatment for chronic EM is valaciclovir. There is no consensus for selection of second-line treatment of chronic EM.

OBJECTIVE

The aim of this study was to assess the effectiveness of treatment with thalidomide for patients with chronic EM.

DESIGN, SETTING, AND PARTICIPANTS: In this retrospective national multicenter cohort study, among 68 French hospital dermatology departments contacted by e-mail, 10 reported having eligible cases. All adults aged 18 years or older under dermatology care for chronic EM (including recurrent and persistent forms) who had received thalidomide between 2010 and 2018 were included. Analyses were conducted from June 24, 2019, to December 31, 2019.

MAIN OUTCOMES AND MEASURES

The primary outcome was the proportion of patients who did not experience an EM flare within 6 months of initiating thalidomide treatment for recurrent EM or with complete clearance at 6 months for persistent EM (complete remission).

RESULTS

Overall, 35 patients with chronic EM (median [range] age, 33 [15-65] years; 20 [57%] female) experienced failure of at least 1 previous treatment prior to initiating treatment with thalidomide. After 6 months of continuous thalidomide treatment, 23 (66%) were in complete remission, 5 (14%) had stopped the treatment, and 7 (20%) experienced at least 1 flare. The median (IQR) initial dose followed by remission was 50 (50-100) mg/d. Main adverse effects were asthenia (16 [46%]) and neuropathy (14 [40%]). Twenty-five (71%) of patients stopped thalidomide treatment after a median (IQR) of 12 (8-20) months owing to lack of effect (7/25 [28%]), neuropathy or another adverse effect (14/25 [56%]), or long-term complete remission (4/25 [16%]). Low-dose thalidomide, less than 50 mg every other day was sufficient in 9 of 23 (39%) of responders and was associated with less neuropathy and longer treatment duration.

CONCLUSIONS AND RELEVANCE

In this cohort study, second-line therapy with thalidomide was associated with complete remission in two-thirds of the 35 patients with chronic EM. However, adverse events were a common cause of thalidomide withdrawal. In the long term, dose reduction when possible may allow for continuation by improving tolerance.

摘要

重要性

多形红斑（EM）可能长期存在，具有复发性或持续性病程。慢性 EM 的一线治疗是伐昔洛韦。对于慢性 EM 的二线治疗选择尚无共识。

目的

本研究旨在评估沙利度胺治疗慢性 EM 患者的疗效。

设计、地点和参与者：在这项回顾性全国多中心队列研究中，通过电子邮件联系了法国的 68 家皮肤科医院，其中 10 家报告了符合条件的病例。所有在皮肤科接受慢性 EM（包括复发性和持续性）治疗的年龄在 18 岁及以上的成年人，在 2010 年至 2018 年期间接受过沙利度胺治疗，均纳入研究。分析于 2019 年 6 月 24 日至 2019 年 12 月 31 日进行。

主要结局和测量指标

主要结局是在开始沙利度胺治疗复发性 EM 的 6 个月内，或在 6 个月时持续性 EM 完全缓解（完全缓解）的患者比例。

结果

总体而言，35 例慢性 EM 患者（中位[范围]年龄，33[15-65]岁；20[57%]为女性）在开始沙利度胺治疗前至少经历过 1 次先前治疗失败。在连续服用沙利度胺 6 个月后，23 例（66%）患者完全缓解，5 例（14%）停止治疗，7 例（20%）至少出现 1 次发作。初始剂量（中位数[IQR]）为 50（50-100）mg/d。主要不良反应为乏力（16[46%]）和神经病变（14[40%]）。由于疗效不佳（7/25[28%]）、神经病变或其他不良反应（14/25[56%]）或长期完全缓解（4/25[16%]），25 例（71%）患者在中位（IQR）12（8-20）个月后停止了沙利度胺治疗。低剂量沙利度胺（隔日低于 50mg）对 23 例（39%）应答者有效，且不良反应更少，治疗持续时间更长。