Figueiredo I T, Morel J, Sany J, Combe B
Department of Immuno-Rheumatology, Teaching Hospital Lapeyronie, and University of Montpellier 1, France.
Clin Exp Rheumatol. 2008 Jan-Feb;26(1):18-23.
To determine the maintenance, tolerability and safety of infliximab in an unselected cohort of patients with rheumatoid arthritis (RA).
One hundred and fifty-two RA patients receiving at least one course of infliximab between 2000 and 2003 were included in this study. Response to treatment and safety were assessed through recording adverse events, physical examinations and standard laboratory tests. The dosage of infliximab was patient specifically modified, when therapeutic response was judged inadequate by the assessment of a physician.
The mean duration of follow-up was 401 days (85-1221). One hundred and twenty-two patients (78%) continued to receive infliximab after one year. 40 patients (26.3%) stopped infliximab therapy: 14 (9.2%) for inefficacy, 21 (13.8%) for adverse events. Fifty nine patients (38.8%) required an increase of the dosage (n=23, 15%) or a shortening of the interval between the infusions (n=20, 13.2%), or both (n=16, 10.5%) for symptomatic control. Infliximab discontinuation tended to be more frequent in smokers (p=0.055). Ninety-four patients (62%) reported at least one adverse event during the study: 64 infections (43%), 35 infusion reaction events (23%) which led to a discontinuation for 10 patients. Infusion reactions were more frequent in patients with a history of allergy. Three cases of tuberculosis and 1 breast carcinoma were reported during the study.
Adjustments in the treatment of RA patients treated with recommended doses of infliximab were common (38.8% of the treated patients). Furthermore, the observed rate of infections (43%), including three cases of tuberculosis, should alert physicians to be vigilant in the routine care of patients treated with infliximab.
确定英夫利昔单抗在未经挑选的类风湿关节炎（RA）患者队列中的维持效果、耐受性及安全性。
本研究纳入了152例在2000年至2003年间接受至少一个疗程英夫利昔单抗治疗的RA患者。通过记录不良事件、体格检查及标准实验室检查来评估治疗反应及安全性。当医生评估治疗反应不充分时，英夫利昔单抗的剂量会根据患者具体情况进行调整。
平均随访时间为401天（85 - 1221天）。122例患者（78%）在一年后继续接受英夫利昔单抗治疗。40例患者（26.3%）停止使用英夫利昔单抗治疗：14例（9.2%）因无效，21例（13.8%）因不良事件。59例患者（38.8%）为了症状控制需要增加剂量（n = 23，15%）或缩短输注间隔时间（n = 20，13.2%），或两者都需要（n = 16，10.5%）。吸烟者停用英夫利昔单抗的情况往往更频繁（p = 0.055）。94例患者（62%）在研究期间报告了至少一次不良事件：64例感染（43%），35例输注反应事件（23%），其中10例患者因输注反应而停药。有过敏史的患者输注反应更频繁。研究期间报告了3例结核病和1例乳腺癌。
在用推荐剂量英夫利昔单抗治疗的RA患者中，调整治疗方案很常见（占接受治疗患者的38.8%）。此外，观察到的感染率（43%），包括3例结核病，应提醒医生在对接受英夫利昔单抗治疗的患者进行常规护理时保持警惕。
