Shergy William J, Isern Reuben A, Cooley David A, Harshbarger John L, Huffstutter J Eugene, Hughes Gordon M, Spencer-Smith Elizabeth A, Goldman Allan L, Roth Sanford H, Toder J Scott, Warner Diana, Quinn Adrienne, Keenan Gregory F, Schaible Thomas F
Centocor Inc., Malvern, Pennsylvania, USA.
J Rheumatol. 2002 Apr;29(4):667-77.
To assess the timing of onset of clinical benefit following the initial infusion of infliximab and to obtain additional safety experience of infliximab when given in an office setting to patients with rheumatoid arthritis (RA). In addition, the safety of reducing the infusion time from 2 hours to 1 hour was evaluated.
Patients (n = 553) with active RA despite receiving methotrexate (MTX) were treated with infliximab 3 mg/kg given over 2 h at baseline (Week 0), and Weeks 2, 6, and 14 in this multicenter open-label trial. Patients continued to receive a stable dose of MTX (> or = 7.5 mg/wk). At selected sites, patients tolerating the first 4 infusions were eligible to receive 2 additional infusions at twice the usual infusion rate (given over 1 h). Patients returned for efficacy assessments at 48 h following the initial infusion and several times throughout study participation.
By 48 h following the first infusion, significant (p < 0.001) improvements were observed in duration of morning stiffness (34% mean improvement), physician's global disease assessment scores (30%), patient's global disease assessment scores (25%), and patient's pain assessment scores (30%). By Week 16, 52 to 63% mean improvements in these efficacy variables were observed (p < 0.001), the significant improvement was maintained through the end of study participation in the subset of patients who received the additional 1 h infliximab infusions. Through 16 weeks, 10% (54/553) of patients reported an adverse event associated with at least 1 of the 4 infusion procedures; the majority were mild and transient in nature. In the subset of 197 patients who received 2 additional infusions over 1 h, no increase in the frequency or severity of infusion-related adverse events was observed compared to the 2 h infusion.
Infliximab administered to patients with RA in an outpatient setting resulted in significant clinical improvement within 48 h that was sustained with additional infusions. Approximately 10% of patients experienced an infusion reaction, highlighting the need for direct supervision over patient treatment. Patients who tolerated infliximab infusions given over 2 h also tolerated a 1 h infusion.
评估首次输注英夫利昔单抗后临床获益的起效时间，并获取英夫利昔单抗在门诊环境中用于类风湿关节炎（RA）患者时的更多安全性经验。此外，还评估了将输注时间从2小时缩短至1小时的安全性。
在这项多中心开放标签试验中，尽管接受了甲氨蝶呤（MTX）治疗但仍患有活动性RA的患者（n = 553）在基线（第0周）、第2周、第6周和第14周接受2小时内静脉输注3 mg/kg英夫利昔单抗治疗。患者继续接受稳定剂量的MTX（≥7.5 mg/周）。在选定的研究点，耐受前4次输注的患者有资格以通常输注速率的两倍（在1小时内输注）再接受2次输注。患者在首次输注后48小时返回进行疗效评估，并在整个研究参与过程中多次进行评估。
首次输注后48小时内，晨僵持续时间（平均改善34%）、医生整体疾病评估评分（30%）、患者整体疾病评估评分（25%）和患者疼痛评估评分（30%）均有显著改善（p < 0.001）。到第16周时，这些疗效变量平均改善了52%至63%（p < 0.001），在接受额外1小时英夫利昔单抗输注的患者亚组中，这种显著改善一直持续到研究结束。在16周内，10%（54/553）的患者报告了与4次输注程序中至少1次相关的不良事件；大多数不良事件性质轻微且为一过性。在197例接受额外2次1小时输注的患者亚组中，与2小时输注相比，未观察到输注相关不良事件的频率或严重程度增加。
在门诊环境中给RA患者输注英夫利昔单抗可在48小时内带来显著的临床改善，且后续输注可维持这种改善。约10%的患者出现输注反应，这突出了对患者治疗进行直接监测的必要性。耐受2小时英夫利昔单抗输注的患者也耐受1小时输注。
