van der Bijl A E, Goekoop-Ruiterman Y P M, de Vries-Bouwstra J K, Ten Wolde S, Han K H, van Krugten M V, Allaart C F, Breedveld F C, Dijkmans B A C
Leiden University Medical Center, Leiden, The Netherlands.
Arthritis Rheum. 2007 Jul;56(7):2129-34. doi: 10.1002/art.22718.
To evaluate the efficacy of infliximab plus methotrexate (MTX) as induction therapy in patients with early rheumatoid arthritis (RA).
Disease-modifying antirheumatic drug (DMARD)-naive patients with active, early RA who were included as group 4 of the BeSt study were initially treated with infliximab (3 mg/kg) in combination with MTX (25 mg/week). The Disease Activity Score (DAS) was measured every 3 months. In patients with persistent low disease activity (DAS <or=2.4) for at least 6 months, the infliximab dosage was tapered and finally discontinued; the MTX dosage then was tapered to 10 mg/week. In patients with a DAS of >2.4, the infliximab dosage was increased (maximum 10 mg/kg), and they were subsequently switched to another DMARD. Except for intraarticular administration, corticosteroids were not permitted. Functional ability and the modified Sharp/van der Heijde score were determined after 2 years of therapy.
Of the 120 patients, 67 responders (56%) had persistent low disease activity and discontinued infliximab after a median of 9.9 months, with a median MTX dosage of 10 mg/week after 2 years. Ten other patients experienced a disease flare after discontinuation and resumed infliximab after a median of 3.7 months. Thirteen patients did not achieve persistent low disease activity and received infliximab at various dosages. Treatment was unsuccessful in 30 patients. In the 67 responders, the progression of joint damage was lower than in the 30 patients in whom treatment failed.
Fifty-six percent of patients with active early RA, initially treated with infliximab plus MTX, could discontinue infliximab after achieving a DAS of <or=2.4. Low disease activity was maintained in these patients while the MTX dosage was tapered to 10 mg/week.
评估英夫利昔单抗联合甲氨蝶呤（MTX）作为早期类风湿关节炎（RA）患者诱导治疗的疗效。
作为BeSt研究第4组纳入的初治、活动性早期RA且未使用改善病情抗风湿药（DMARD）的患者，最初接受英夫利昔单抗（3mg/kg）联合MTX（25mg/周）治疗。每3个月测量疾病活动评分（DAS）。对于疾病活动持续低水平（DAS≤2.4）至少6个月的患者，逐渐减少英夫利昔单抗剂量并最终停用；然后将MTX剂量逐渐减至10mg/周。对于DAS>2.4的患者，增加英夫利昔单抗剂量（最大10mg/kg），随后换用另一种DMARD。除关节内给药外，不允许使用糖皮质激素。治疗2年后测定功能能力和改良Sharp/van der Heijde评分。
120例患者中，67例缓解者（56%）疾病活动持续低水平，英夫利昔单抗在中位9.9个月后停用，2年后MTX中位剂量为10mg/周。另外10例患者停药后病情复发，中位3.7个月后恢复使用英夫利昔单抗。13例患者未达到疾病活动持续低水平，接受了不同剂量的英夫利昔单抗治疗。30例患者治疗未成功。在67例缓解者中，关节损伤进展低于30例治疗失败的患者。
56%的活动性早期RA患者最初接受英夫利昔单抗联合MTX治疗，在DAS≤2.4后可停用英夫利昔单抗。这些患者在MTX剂量逐渐减至10mg/周时维持了低疾病活动水平。
