Wacharapornin Pathawut, Suwannalai Parawee
J Med Assoc Thai. 2014 Nov;97(11):1157-63.
Optimal outcome of treatment in rheumatoid arthritis (RA) is early clinical remission to delay joint damage. Therefore, severe RA patients with inadequate response to conventional disease modifying anti-rheumatic drugs (cDMARDs) need highpotency drug as biological DM4RDs (bDMARDs). In general, one-third of RA patient could not get into disease remission with cDMARDs, and half ofthem are still suffering from severe arthritis. However, high cost of this agent is the major barrier for patient engagement, and it is affordable to only 5-10% of patients. We need a good strategy to distribute bDMARDs to patients, especially in limited resource situation.
We explored the characteristics ofRA patients who were currently using biologic agents in Ramathibodi Hospital to determine the favorable treatment outcome.
The studied patients were RA patients classified according to ACR/EULAR 2010 criteria and using any biologic agents, between 2010 and2012. Demographic data and treatment outcome (low disease activity and remission) were retrievedfrom patient records. Univariate analysis and generalized estimating equation (GEE) were used to analyze predicting factors to control disease at one year. Kaplan-Meier and log rank test were used to analyze time to disease remission or low disease activity.
Patients treated with bDMARDs in Ramathibodi Hospital demonstrated long disease duration (mean 130.7 months) and severe disease activity (mean DAS28 5.37). At 1-year after treatment, 19.4% and 12.9% ofpatients achieved low disease activity (low DAS) and disease remission, respectively. At 3-years after treatment, 88.9% and 45.2% of patients attained low DAS and remission. Patients who started bDMARDs after 2010 had significantly shorter time to control disease when compared to patients who started bDMARDs before 2010 (10 months vs. 34 months). Moreover, we observed that patient who started bDMARDs after 2010 using more cDMARDs (2.5 vs. 1.7, p = 0.02) and higher dose of methotrexate (10.7 vs. 6.5, p = 0.03). There were no association between disease control status and treatment (methotrexate, prednisolone, biologic agent) or disease duration. However the exposedstatus ofbiologic agent was associated with low DAS or remission at the first year of observation (p = 0.004 and 0.04, respectively).
Chance to control rheumatoid arthritis in the level of remission or low disease activity is predicted by time of bDAMRDs exposure. This result is mainly influenced by dose ofmethotrexate and number of cDMARDs.
类风湿关节炎（RA）治疗的最佳结果是早期临床缓解以延缓关节损伤。因此，对传统改善病情抗风湿药物（cDMARDs）反应不足的重度RA患者需要强效药物，如生物DMARDs（bDMARDs）。一般来说，三分之一的RA患者使用cDMARDs无法实现疾病缓解，其中一半仍患有严重关节炎。然而，这种药物的高成本是患者接受治疗的主要障碍，只有5% - 10%的患者能够负担得起。我们需要一个好的策略来将bDMARDs分配给患者，尤其是在资源有限的情况下。
我们探讨了拉玛蒂博迪医院目前正在使用生物制剂的RA患者的特征，以确定有利的治疗结果。
研究对象为按照2010年美国风湿病学会/欧洲抗风湿病联盟（ACR/EULAR）标准分类且在2010年至2012年间使用任何生物制剂的RA患者。从患者记录中获取人口统计学数据和治疗结果（低疾病活动度和缓解）。采用单因素分析和广义估计方程（GEE）分析控制疾病一年的预测因素。使用Kaplan - Meier法和对数秩检验分析疾病缓解或低疾病活动度的时间。
在拉玛蒂博迪医院接受bDMARDs治疗的患者病程较长（平均130.7个月）且疾病活动度严重（平均DAS28为5.37）。治疗1年后，分别有19.4%和12.9%的患者达到低疾病活动度（低DAS）和疾病缓解。治疗3年后，88.9%和45.2%的患者达到低DAS和缓解。与2010年前开始使用bDMARDs的患者相比，2010年后开始使用bDMARDs的患者控制疾病的时间明显更短（10个月对34个月）。此外，我们观察到2010年后开始使用bDMARDs的患者使用更多的cDMARDs（2.5对1.7，p = 0.02）和更高剂量的甲氨蝶呤（10.7对6.5，p = 0.03）。疾病控制状态与治疗（甲氨蝶呤、泼尼松龙、生物制剂）或病程之间无关联。然而，在观察的第一年，生物制剂的暴露状态与低DAS或缓解相关（分别为p = 0.004和0.04）。
bDAMRDs暴露时间可预测类风湿关节炎达到缓解或低疾病活动度水平的控制机会。这一结果主要受甲氨蝶呤剂量和cDMARDs数量的影响。
