Faculty of Pharmaceutical Sciences, The University of Iceland, Reykjavik, Iceland.
Faculty of Pharmaceutical Sciences, The University of Iceland and Hospital Pharmacy, The University Hospital of Iceland, Reykjavik, Iceland.
Clin Exp Rheumatol. 2018 Nov-Dec;36(6):1068-1073. Epub 2018 Jun 14.
To identify the proportion of patients with psoriatic arthritis (PsA) who would meet inclusion criteria of the randomised clinical trials that were performed leading up to registration of the tumour necrosis factor inhibitors (TNFi).
Data from 329 patients with PsA were obtained from an Icelandic database, ICEBIO, medical records at the University Hospital of Iceland, and the private out-patient clinic Laeknasetrid Ltd. The patients were classified according to whether they met the inclusion criteria of the clinical trials that were performed ahead of the registration of each respective TNFi. The reasons for exclusion were also explored.
34% of the patients with complete data available met the inclusion criteria. Clinical data in respect to exclusion and inclusion criteria were incomplete for 13% of the cases. The proportion of patients who met the inclusion criteria was highest among those who received adalimumab and etanercept (53%). Patients who received in iximab had the lowest inclusion rate (23%). The main reason why patients did not meet the inclusion criteria was too few swollen and/or tender joints, or in 45% of excluded cases.
Our results demonstrate that two thirds of patients with PsA in Iceland who are treated with TNFi would not have qualified for the randomised clinical trials performed leading up to the registration of the medications. Further studies with regards to whether outcomes are different between those who met the inclusion criteria and those who did not remain to be performed.
确定符合 TNF 抑制剂（TNFi）注册前开展的随机临床试验纳入标准的银屑病关节炎（PsA）患者比例。
从冰岛 ICEBIO 数据库、冰岛大学医院病历和私人门诊 Laeknasetrid Ltd. 获取了 329 例 PsA 患者的数据。根据患者是否符合每种 TNFi 注册前开展的临床试验的纳入标准对其进行分类。还探讨了排除的原因。
34%的患者具有可用的完整数据，符合纳入标准。13%的病例在排除和纳入标准方面的临床数据不完整。接受阿达木单抗和依那西普的患者符合纳入标准的比例最高（53%）。接受英夫利昔单抗治疗的患者纳入率最低（23%）。患者不符合纳入标准的主要原因是关节肿胀和/或压痛的关节数太少，在 45%的排除病例中都是这种情况。
我们的结果表明，冰岛接受 TNFi 治疗的 PsA 患者中有三分之二不符合药物注册前开展的随机临床试验的纳入标准。需要进一步研究符合纳入标准和不符合纳入标准的患者之间的结局是否存在差异。
