英夫利昔单抗在强直性脊柱炎治疗中的维持治疗：一项为期一年的随机对照试验结果，比较系统性治疗与按需治疗。

Maintenance of infliximab treatment in ankylosing spondylitis: results of a one-year randomized controlled trial comparing systematic versus on-demand treatment.

作者信息

Breban Maxime, Ravaud Philippe, Claudepierre Pascal, Baron Gabriel, Henry Yves-Dominique, Hudry Christophe, Euller-Ziegler Liana, Pham Thao, Solau-Gervais Elisabeth, Chary-Valckenaere Isabelle, Marcelli Christian, Perdriger Aleth, Le Loët Xavier, Wendling Daniel, Fautrel Bruno, Fournié Bernard, Combe Bernard, Gaudin Philippe, Jousse Sandrine, Mariette Xavier, Baleydier Alain, Trape Gérard, Dougados Maxime

机构信息

Hôpital Ambroise Paré, Assistance Publique Hôpitaux de Paris, Boulogne-Billancourt, France.

出版信息

Arthritis Rheum. 2008 Jan;58(1):88-97. doi: 10.1002/art.23167.

DOI:10.1002/art.23167

PMID:18163509

Abstract

OBJECTIVE

Continuous treatment with the anti-tumor necrosis factor alpha (anti-TNFalpha) antibody infliximab is efficacious in ankylosing spondylitis (AS), whereas treatment discontinuation results in disease relapse, with variable delay. This study was undertaken to compare the efficacy of continuous treatment with infliximab with that of a treatment regimen adapted to symptom recurrence. Methotrexate (MTX) in combination with infliximab was also tested.

METHODS

Patients with active AS were randomly assigned at week 0 to receive infliximab every 6 weeks (continuous treatment) or upon symptom recurrence (on-demand treatment), following infusions at weeks 4, 6, and 10. Patients in the on-demand group were randomly assigned to receive either MTX in combination with infliximab or infliximab alone. Patients were monitored for 1 year. The primary end point was the proportion of patients who met the ASsessment in AS International Working Group criteria for 20% improvement (ASAS20) at week 58.

RESULTS

Of 247 patients, 124 were assigned to receive infliximab every 6 weeks and 123 to receive on-demand treatment. Among the latter, 62 received MTX, and 61 received infliximab alone. A greater proportion of patients receiving infliximab every 6 weeks fulfilled ASAS20 response criteria at week 58 than did patients receiving on-demand treatment (75% versus 46%; P<0.0001). Patients in the continuous treatment group received more infliximab infusions after week 10 than did those in the on-demand group (mean+/-SD 5.8+/-2.2 versus 3.5+/-2; P<0.0001). Addition of MTX did not significantly affect the proportion of patients with an ASAS20 response at week 58, nor the number of infliximab infusions administered.

CONCLUSION

These findings indicate that continuous treatment of AS with infliximab is more efficacious than on-demand treatment, and that the addition of MTX to infliximab provides no significant benefit.

摘要

目的

使用抗肿瘤坏死因子α（抗TNFα）抗体英夫利昔单抗进行持续治疗对强直性脊柱炎（AS）有效，而停止治疗会导致疾病复发，复发延迟时间不一。本研究旨在比较英夫利昔单抗持续治疗与根据症状复发调整的治疗方案的疗效。还对甲氨蝶呤（MTX）联合英夫利昔单抗进行了测试。

方法

活动性AS患者在第0周被随机分配，在第4、6和10周输注后，每6周接受一次英夫利昔单抗（持续治疗）或症状复发时接受（按需治疗）。按需治疗组的患者被随机分配接受MTX联合英夫利昔单抗或单独接受英夫利昔单抗。对患者进行1年的监测。主要终点是在第58周达到强直性脊柱炎国际工作组20%改善标准（ASAS20）的患者比例。

结果

247例患者中，124例被分配每6周接受一次英夫利昔单抗，123例接受按需治疗。在按需治疗组中，62例接受MTX，61例单独接受英夫利昔单抗。与按需治疗的患者相比，每6周接受一次英夫利昔单抗的患者在第58周达到ASAS20反应标准的比例更高（75%对46%；P<0.0001）。持续治疗组的患者在第10周后接受英夫利昔单抗输注的次数比按需治疗组多（平均±标准差5.8±2.2对3.5±2；P<0.0001）。添加MTX对第58周达到ASAS20反应的患者比例或英夫利昔单抗输注次数没有显著影响。