Adverse events and efficacy of TNF-α blockade with infliximab in patients with systemic lupus erythematosus: long-term follow-up of 13 patients
Adverse events and efficacy of TNF-α blockade with infliximab in patients with systemic lupus erythematosus: long-term follow-up of 13 patients
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DOI：
10.1093/rheumatology/kep270
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发表时间：
2009-11-01
期刊：
影响因子：
5.5
通讯作者：
Smole, Josef S.
中科院分区：
文献类型：
--
作者：
Aringer, Martin;Houssiau, Frederic;Smole, Josef S.
目标。对所有可用的英夫利昔单抗治疗的系统性红斑狼疮患者进行安全性和远期疗效的随访，以提取有助于计划英夫利昔单抗治疗系统性红斑狼疮的适当对照试验的信息。我们分析了在一项开放标签安全试验中接受治疗的6名患者和另外7名接受英夫利昔单抗治疗的未受控制的系统性红斑狼疮器官炎症患者的图表。在9名狼疮性肾炎患者中，6名患者在4次英夫利昔单抗联合AZA注射后出现长期反应，持续时间长达5年。所有五名狼疮性关节炎患者都有反应，但这种反应在最后一次注射后没有持续两个月。另有一名患者在系统性红斑狼疮间质性肺病方面有长期改善。所有患者均未出现英夫利昔单抗引起的系统性红斑狼疮发作症状。短期治疗似乎相对安全，但一名患者出现了深静脉血栓形成和几种感染。在长期治疗下，有两名患者出现危及生命或致命的事件，分别是中枢神经系统淋巴瘤和军团菌肺炎。复治和未伴免疫抑制的治疗导致药物反应。四种英夫利昔单抗联合AZA的短期治疗相对安全，对狼疮性肾炎和潜在的间质性肺部疾病有显著的长期疗效。然而，英夫利昔单抗的长期治疗与三分之二的系统性红斑狼疮患者的严重不良反应有关，这可能是由英夫利昔单抗和/或他们长期难治性的系统性红斑狼疮和以前的治疗引起的。
Objective. To follow-up on all available infliximab-treated SLE patients for safety and long-term efficacy in order to extract information that is useful for planning appropriate controlled trials with infliximab in SLE.Methods. We analysed charts of six patients treated in an open-label safety trial and seven additional patients treated with infliximab on a compassionate care basis for uncontrolled SLE organ inflammation.Results. Out of nine patients with lupus nephritis, six had a long-term response after four infusions of infliximab in combination with AZA, lasting for up to 5 years. All five patients with lupus arthritis responded, but this response did not last for >2 months after the last infusion. One additional patient had a long-lasting improvement in SLE interstitial lung disease. No symptoms suggestive of infliximab-induced SLE flares occurred in any patients. Short-term treatment appeared relatively safe, but one patient developed deep-vein thrombosis and several infections. Under long-term therapy, two patients had life-threatening or fatal events, namely CNS lymphoma and Legionella pneumonia. Retreatment and treatment without concomitant immunosuppression led to drug reactions.Conclusions. Short-term therapy with four infusions of infliximab in combination with AZA was relatively safe, and had remarkable long-term efficacy for lupus nephritis and, potentially, also interstitial lung disease. Long-term therapy with infliximab, however, was associated with severe adverse events in two out of three SLE patients, which may have been provoked by infliximab and/or by their long-standing refractory SLE and previous therapies.