不同英夫利昔单抗剂量方案对462例银屑病关节炎患者治疗反应和药物留存率的影响：来自全国性登记处DANBIO和ICEBIO的结果
Impact of different infliximab dose regimens on treatment response and drug survival in 462 patients with psoriatic arthritis: results from the nationwide registries DANBIO and ICEBIO.
作者信息
Glintborg Bente, Gudbjornsson Bjorn, Krogh Niels Steen, Omerovic Emina, Manilo Natalia, Holland-Fischer Mette, Lindegaard Hanne M, Loft Anne Gitte, Nordin Henrik, Johnsen Laura, Oeftiger Sussi Flejsborg, Hansen Annette, Rasmussen Claus, Grondal Gerdur, Geirsson Arni Jon, Hetland Merete Lund
机构信息
Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Danish Rheumatologic Database (DANBIO), Glostrup Hospital, Glostrup, Denmark, Center for Rheumatology Research (ICEBIO), Landspitali University Hospital of Iceland, Faculty of Medicine, University of Iceland, Reykjavik, Iceland, Zitelab Aps, Department of Rheumatology, Frederiksberg Hospital, Copenhagen, Department of Rheumatology, Aalborg University Hospital, Aalborg, Department of Rheumatology, Odense University Hospital, Odense, Department of Rheumatology, Vejle Sygehus, Sygehus Lillebælt, Department of Infectious Diseases and Rheumatology, Rigshospitalet, Copenhagen, Department of Rheumatology, Helsingør and Hillerød Hospital, Hillerød, Department of Rheumatology, Køge Hospital, Køge, Department of Rheumatology, Gentofte University Hospital, Copenhagen, Department of Rheumatology, Vendsyssel Teaching Hospital, Hjørring, Denmark, Department of Rheumatology, Landspitali University Hospital of Iceland, Reykjavik, Iceland and Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark. Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Danish Rheumatologic Database (DANBIO), Glostrup Hospital, Glostrup, Denmark, Center for Rheumatology Research (ICEBIO), Landspitali University Hospital of Iceland, Faculty of Medicine, University of Iceland, Reykjavik, Iceland, Zitelab Aps, Department of Rheumatology, Frederiksberg Hospital, Copenhagen, Department of Rheumatology, Aalborg University Hospital, Aalborg, Department of Rheumatology, Odense University Hospital, Odense, Department of Rheumatology, Vejle Sygehus, Sygehus Lillebælt, Department of Infectious Diseases and Rheumatology, Rigshospitalet, Copenhagen, Department of Rheumatology, Helsingør and Hillerød Hospital, Hillerød, Department of Rheumatology, Køge Hospital, Køge, Department of Rheumatology, Gentofte University Hospital,
Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Danish Rheumatologic Database (DANBIO), Glostrup Hospital, Glostrup, Denmark, Center for Rheumatology Research (ICEBIO), Landspitali University Hospital of Iceland, Faculty of Medicine, University of Iceland, Reykjavik, Iceland, Zitelab Aps, Department of Rheumatology, Frederiksberg Hospital, Copenhagen, Department of Rheumatology, Aalborg University Hospital, Aalborg, Department of Rheumatology, Odense University Hospital, Odense, Department of Rheumatology, Vejle Sygehus, Sygehus Lillebælt, Department of Infectious Diseases and Rheumatology, Rigshospitalet, Copenhagen, Department of Rheumatology, Helsingør and Hillerød Hospital, Hillerød, Department of Rheumatology, Køge Hospital, Køge, Department of Rheumatology, Gentofte University Hospital, Copenhagen, Department of Rheumatology, Vendsyssel Teaching Hospital, Hjørring, Denmark, Department of Rheumatology, Landspitali University Hospital of Iceland, Reykjavik, Iceland and Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
出版信息
Rheumatology (Oxford). 2014 Nov;53(11):2100-9. doi: 10.1093/rheumatology/keu252. Epub 2014 Jun 17.
OBJECTIVE
The aim of this study was to describe dose regimens, dose escalation and clinical outcomes in TNF-α inhibitor (TNFi)-naive patients with PsA treated with infliximab in routine rheumatology care.
METHODS
We conducted an observational cohort study based on the nationwide Danish Rheumatologic Database (DANBIO) and Center for Rheumatology Research (ICEBIO) registries. Stratified by country, characteristics of patients treated with ≤3 mg infliximab/kg body weight, 3-5 mg/kg or ≥5 mg/kg every 8 weeks were described. Outcomes were evaluated by ACR 20%, 50% and 70% (ACR20/50/70) responses and European League Against Rheumatism good response after 6 months, disease activity after 12 months, Kaplan-Meier plots and regression analyses.
RESULTS
Four hundred and sixty-two patients (376 Danish, 86 Icelandic) received treatment with infliximab. In Danish patients, the starting dose was ≤3 mg/kg in 110 patients (29%), 3-5 mg/kg in 157 (42%), ≥5 mg/kg in 38 (10%) and unregistered in 71 (19%). In Icelandic patients, corresponding numbers were 64 (74%), 17 (27%), 0 (0%) and 5 (6%). Patients with a higher body weight received lower doses per kilogram. Danish patients received higher doses than Icelandic patients at baseline [median 3.1 (interquartile range 3.0-3.8) vs 2.3 (2.1-2.9) mg/kg, P < 0.05] and after 12 months [3.3 (3.0-4.5) vs 2.9 (2.2-3.5) mg/kg, P < 0.0001]. After 12 months, 58% of Danish and 66% of Icelandic patients maintained treatment. Danish patients had shorter drug survival than Icelandic patients (1183 vs 483 days). In univariate analyses stratified by country, time until dose escalation, response rates, drug survival and 1-year's disease activity were independent of starting dose. Drug survival was shorter among patients not receiving concomitant MTX.
CONCLUSION
In clinical practice, > 70% of Icelandic and Danish PsA patients treated with infliximab received sustained doses below the 5 mg/kg every 8 weeks recommended in international guidelines. Lower starting doses did not affect drug survival or response.
目的
本研究旨在描述在常规风湿病护理中接受英夫利昔单抗治疗的初治银屑病关节炎（PsA）患者的给药方案、剂量递增情况及临床结局。
方法
我们基于丹麦全国风湿病数据库（DANBIO）和风湿病研究中心（ICEBIO）登记处进行了一项观察性队列研究。按国家分层，描述了每8周接受≤3mg英夫利昔单抗/千克体重、3 - 5mg/kg或≥5mg/kg治疗的患者特征。通过美国风湿病学会（ACR）20%、50%和70%（ACR20/50/70）反应、6个月后的欧洲抗风湿病联盟良好反应、12个月后的疾病活动度、Kaplan - Meier曲线和回归分析来评估结局。
结果
462例患者（376例丹麦患者，86例冰岛患者）接受了英夫利昔单抗治疗。在丹麦患者中，起始剂量≤3mg/kg的有110例（29%），3 - 5mg/kg的有157例（42%），≥5mg/kg的有38例（10%），未记录的有71例（19%）。在冰岛患者中，相应数字分别为64例（74%）、17例（27%）、0例（0%）和5例（6%）。体重较高的患者每千克体重接受的剂量较低。丹麦患者在基线时接受的剂量高于冰岛患者[中位数3.1（四分位间距3.0 - 3.8）mg/kg对2.
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