Aringer Martin, Houssiau Frederic, Gordon Caroline, Graninger Winfried B, Voll Reinhard E, Rath Eva, Steiner Guenter, Smolen Josef S
Department of Medicine III, Division of Rheumatology, University Clinical Center Carl Gustav Carus at the Technical University of Dresden, Fetscherstrasse 74, 01307 Dresden, Germany.
Rheumatology (Oxford). 2009 Nov;48(11):1451-4. doi: 10.1093/rheumatology/kep270. Epub 2009 Sep 11.
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.
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.
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.
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.
对所有接受英夫利昔单抗治疗的系统性红斑狼疮（SLE）患者进行随访，以评估安全性和长期疗效，从而获取有助于规划英夫利昔单抗治疗SLE的适当对照试验的信息。
我们分析了在一项开放标签安全性试验中接受治疗的6例患者以及在同情治疗基础上接受英夫利昔单抗治疗以控制SLE器官炎症的另外7例患者的病历。
在9例狼疮性肾炎患者中，6例在接受4次英夫利昔单抗联合硫唑嘌呤（AZA）输注后出现长期缓解，持续长达5年。所有5例狼疮性关节炎患者均有反应，但这种反应在最后一次输注后持续不超过2个月。另有1例患者的SLE间质性肺病有持久改善。所有患者均未出现提示英夫利昔单抗诱发SLE病情加重的症状。短期治疗似乎相对安全，但1例患者发生了深静脉血栓形成和数起感染。在长期治疗中，2例患者发生了危及生命或致命的事件，即中枢神经系统淋巴瘤和军团菌肺炎。再次治疗以及在未同时使用免疫抑制剂的情况下进行治疗导致了药物反应。
4次英夫利昔单抗联合AZA的短期治疗相对安全，对狼疮性肾炎以及可能对间质性肺病具有显著的长期疗效。然而，英夫利昔单抗的长期治疗在三分之二的SLE患者中与严重不良事件相关，这可能是由英夫利昔单抗和/或其长期难治性SLE及既往治疗引发的。
