Aaltonen Kalle J, Ylikylä Suvi, Tuulikki Joensuu Jaana, Isomäki Pia, Pirilä Laura, Kauppi Markku, Rannio Tuomas, Eklund Kari, Blom Marja, Nordström Dan
Faculty of Pharmacy, University of Helsinki, Helsinki.
Department of Internal Medicine, Centre for Rheumatic Diseases, Tampere University Hospital.
Rheumatology (Oxford). 2017 May 1;56(5):725-735. doi: 10.1093/rheumatology/kew467.
Efficacy of TNF inhibitors in the treatment of RA assessed in randomized controlled trials (RCTs) may not be fully comparable to routine care owing to the stringent inclusion criteria. The objective of this study was to observe the effectiveness of TNF inhibitors in real-world patients and assess the patients' potential eligibility for the RCTs.
RA patients starting a TNF-inhibitor treatment between 2004 and 2014 were identified from the National Register for Biologic Treatment in Finland, which is a longitudinal observational cohort study. Effectiveness was measured using the ACR and EULAR response criteria and by studying the proportion of patients reaching DAS28 remission. The patients' baseline characteristics were compared against the inclusion criteria of 27 RCTs.
EULAR moderate and good treatment responses at 6 months were achieved by 69 and 40% of the users of the first TNF inhibitor, respectively. ACR20, ACR50 and ACR70 responses were reached by 48, 27 and 13%, respectively. DAS28 remission was reached by 47%. Only 7.6-44% of the patients would have been potentially eligible for the RCTs. The eligible patients had better treatment responses compared with the non-eligible patients. Different TNF inhibitors were mostly equipotent, but the usage of MTX co-therapy had a major influence on treatment response.
Only a small proportion of patients would have been eligible for RCTs, and the efficacy of TNF inhibitors assessed in them cannot be generalized directly into Finnish routine health care.
由于严格的纳入标准，随机对照试验（RCT）中评估的肿瘤坏死因子（TNF）抑制剂治疗类风湿关节炎（RA）的疗效可能无法完全与常规治疗相媲美。本研究的目的是观察TNF抑制剂在真实世界患者中的有效性，并评估患者参加RCT的潜在资格。
从芬兰国家生物治疗登记处识别出2004年至2014年间开始使用TNF抑制剂治疗的RA患者，该登记处是一项纵向观察队列研究。使用美国风湿病学会（ACR）和欧洲抗风湿病联盟（EULAR）反应标准并通过研究达到疾病活动度评分28（DAS28）缓解的患者比例来衡量有效性。将患者的基线特征与27项RCT的纳入标准进行比较。
首次使用TNF抑制剂的患者中，分别有69%和40%在6个月时达到EULAR中度和良好治疗反应。分别有48%、27%和13%的患者达到ACR20、ACR50和ACR70反应。47%的患者达到DAS28缓解。只有7.6% - 44%的患者可能符合RCT的条件。符合条件的患者与不符合条件的患者相比，治疗反应更好。不同的TNF抑制剂大多具有同等效力，但甲氨蝶呤（MTX）联合治疗的使用对治疗反应有重大影响。
只有一小部分患者符合RCT的条件，其中评估的TNF抑制剂的疗效不能直接推广到芬兰的常规医疗保健中。
