Rheumatology Division, Faculdade de Medicina, Hospital das Clinicas HCFMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.
Division of Central Laboratory, Faculdade de Medicina, Hospital das Clinicas HCFMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.
Lupus. 2021 May;30(6):956-964. doi: 10.1177/0961203321998433. Epub 2021 Mar 3.
Few prospective studies in cutaneous and systemic lupus erythematosus (CLE/SLE) assessed thalidomide-induced peripheral neuropathy (TiPN) incidence/reversibility, and most have not excluded confounding causes neither monitored thalidomide plasma levels.
To evaluate TiPN incidence/reversibility, coasting effect and its association with thalidomide plasma levels in CLE/SLE.
One-year prospective study of thalidomide in 20 CLE/SLE patients without pregnancy potential, with normal nerve conduction study (NCS), and excluded other PN causes. Thalidomide levels were determined by high-performance liquid chromatography/tandem mass spectrometry.
Twelve patients (60%) developed TiPN: 33.3% were symptomatic and 66.6% asymptomatic. Half of this latter group developed coasting effect (TiPN symptoms 1-3 months after drug withdrawal). The main predictive factors for TiPN were treatment duration ≥6 months (p = 0.025) and cumulative dose (p = 0.023). No difference in plasma thalidomide levels between patients with/without TiPN was observed (p = 0.464). After drug withdrawal, 75% symptomatic TiPN patients improved their symptoms. Seven TiPN patients underwent an additional NCS after drug withdrawal: 42.8% worsened NCS, 14.2% was stable, and 42.8% had improved NCS.
Our data provides novel evidence of coasting effect in half of asymptomatic patients with TiPN. The irreversible nature of this lesion in 25% of TiPN patients reinforces the relevance of early NCS monitoring, and suggests thalidomide use solely as a bridge for other effective therapy for refractory cutaneous lupus patients.
很少有前瞻性研究评估过沙利度胺诱导的周围神经病（TiPN）在皮肤和系统性红斑狼疮（CLE/SLE）中的发病率/可逆转性，且大多数研究既未排除混杂因素，也未监测沙利度胺的血浆水平。
评估 TiPN 的发病率/可逆转性、滑行效应及其与 CLE/SLE 中沙利度胺血浆水平的关系。
对 20 名无妊娠潜能、神经传导研究（NCS）正常且排除其他周围神经病变（PN）原因的 CLE/SLE 患者进行为期 1 年的前瞻性沙利度胺研究。采用高效液相色谱/串联质谱法测定沙利度胺水平。
12 名患者（60%）发生 TiPN：33.3%有症状，66.6%无症状。其中一半的无症状患者出现滑行效应（停药后 1-3 个月出现 TiPN 症状）。TiPN 的主要预测因素为治疗持续时间≥6 个月（p=0.025）和累积剂量（p=0.023）。未观察到 TiPN 患者与无 TiPN 患者之间的血浆沙利度胺水平存在差异（p=0.464）。停药后，75%有症状的 TiPN 患者的症状有所改善。7 名 TiPN 患者在停药后接受了进一步的 NCS：42.8%的 NCS恶化，14.2%的 NCS稳定，42.8%的 NCS改善。
我们的数据为 TiPN 中一半无症状患者存在滑行效应提供了新的证据。25%的 TiPN 患者出现不可逆性病变，这进一步强调了早期 NCS 监测的重要性，并提示沙利度胺仅作为难治性皮肤狼疮患者其他有效治疗的桥梁使用。
