Infliximab Ineffective for Giant Cell Arteritis or Polymyalgia Rheumatica
NEW YORK (Reuters Health) Apr 30 - Infliximab is not an effective treatment for giant cell arteritis or polymyalgia rheumatica and may actually be harmful, according to the results of two placebo-controlled trials appearing in the Annals of Internal Medicine for May 1.
In the first study, Dr. Gary S. Hoffman, from the Cleveland Clinic Foundation, and colleagues assessed the benefits of infliximab in 44 patients with newly diagnosed giant cell arteritis that was in steroid-induced remission.
Twenty-eight patients were randomized to infliximab 5 mg/kg of body weight plus glucocorticosteroids and 16 to placebo plus glucocorticosteroids.
At week 22, the proportion of patients in the infliximab group who relapsed was actually higher than that in the placebo group: 57% vs. 50% (p = 0.65). Moreover, infliximab use did not increase the proportion of patients who were able to taper their steroid dosages without relapse.
Infliximab use seemed to increase the risk of infection, the report indicates. Seventy-one percent of patients treated with the drug developed an infection compared with 56% of control subjects.
The second study, conducted by Dr. Carlo Salvarani, from Arcispedale S. Maria Nuova in Reggio Emilia, Italy, and colleagues, yielded similar results -- this time in patients with polymyalgia rheumatica. The study included 51 patients with newly diagnosed disease who were randomized to receive prednisone in combination with infliximab or placebo.
The disease relapse-free rate at 52 weeks was not significantly different between the groups -- 30% in the infliximab group vs. 37% in controls.
Eight adverse events were recorded in each group with no significant differences observed, the report indicates.
While the findings suggest that in the very least, infliximab is not effective for these diseases, the authors of both studies caution that because of the small sample sizes, the results should not be considered definitive.
In light of these null findings, editorialist Dr. Raashid Luqmani, from the University of Oxford in the UK, comments that for now "giant cell arteritis and polymyalgia rheumatica remain therapeutic challenges. For physicians who manage these diseases, the message is that steroids are still the cornerstone of treatment."
Ann Intern Med 2007;146:621-639,674-675.
> 4月30日 新闻报道，据5月1日《内科学》年报上的两项安慰剂-对照试验结果显示，用英夫利昔单抗治疗巨细胞动脉炎或风湿性多肌痛无效，而且可能会有害。
在第一项研究中，克立夫兰临床基金的Gary S. Hoffman博士及其同事评价了英夫利昔单抗对44名新近诊断患巨细胞动脉炎患者的治疗效果，这些患者通过类固醇药物可以减轻症状。其中28名患者被随机分入英夫利昔单抗5 mg/kg体重联合糖皮质类固醇治疗组，16名被分入安慰剂联合糖皮质类固醇治疗组。在第22周，英夫利昔单抗组患者的复发比率明显高于安慰剂组，57% ：50% (p = 0.65)。另外，使用英夫利昔单抗不会增加减少类固醇用量而不复发的患者比率。而且报告指出，使用英夫利昔单抗似乎会增加感染风险。使用该药治疗的患者有71％出现感染，而对照组为56%。
第二项研究，意大利Reggio Emilia Arcispedale S. Maria Nuova的Carlo Salvarani博士及其同事对风湿性多肌痛患者进行的研究也得出类似结果。此项研究纳入51名新近被诊断患有风湿性多肌痛的患者，然后被随机分组接受强的松联合英夫利昔单抗或强的松联合安慰剂治疗。两组间的52周疾病无复发率没有明显差别，英夫利昔单抗组为30%，对照组为37%。且报告显示各组记录的8种不良事件也没有明显差别。
虽然这些研究发现显示英夫利昔单抗对这些疾病至少是无效的，但两项研究的作者却谨慎的认为，由于样本量小这些结果并不能做为最后的结论。
籍由这些无效结果，评论家英国牛津大学的Raashid Luqmani博士认为目前“巨细胞动脉炎和风湿性多肌痛的治疗仍存在挑战。对处理这些疾病的医生所提供的信息是类固醇仍然是最基本的治疗。”（丁香）
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