【medical-news】英夫利昔单抗对巨细胞动脉炎或风湿性多肌痛无效
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.
http://www.medscape.com/viewarticle/555877