Quach Lien T, Chang Bei-Hung, Brophy Mary T, Soe Thwin Soe, Hannagan Keri, O'Dell James R
Cooperative Studies Program, Massachusetts Veterans Epidemiology Research and Information Center VA, Boston Healthcare System.
Department of Gerontology, University of Massachusetts, Boston.
Rheumatology (Oxford). 2017 Mar 1;56(3):378-383. doi: 10.1093/rheumatology/kew412.
The main aim of this study was to examine the differences between triple therapy (T: SSZ and HCQ added to MTX) and etanercept (E) added to MTX with regard to the infectious and gastrointestinal (GI) adverse events (AEs) reported in The Rheumatoid Arthritis Comparison of Active Therapies Trial.
The patients were 353 RA MTX incomplete responders who were randomized to T (n = 178) or E (n = 175). Of these, 88 patients were switched to the alternative treatment from the initial treatment (E or T) at 24 weeks per protocol. Infectious and GI serious AEs (SAEs) and non-serious AEs (NAEs) were reported during 48 and 4 weeks after the intervention period. Generalized linear models were used to estimate the incidence rate ratios (IRRs) of AEs between the two therapies.
Patients on E therapy were more likely to have infectious NAEs (IRR = 1.56, 95% CI: 1.11, 2.19). There was a greater number of infectious SAEs that occurred when patients received E than T therapy [12 E (6.9%) vs 4 T (2.2%), P = 0.19]. Pneumonia was the most common infectious SAE for both treatments [6 E (3.4%) and 2 T (1.1%)]. Conversely, patients who were on E were less likely to have GI NAEs than those on T therapy (IRR = 0.62, 95% CI: 0.40, 0.94). The most common GI SAE reported was GI haemorrhage, which occurred among three patients on E (1.7%).
This study provides evidence of different likelihoods of infectious and GI AEs associated with two common, equally effective treatments for RA patients who have had incomplete responses to MTX.
ClinicalTrials.gov, http://clinicaltrials.gov , NCT00405275.
本研究的主要目的是探讨在类风湿关节炎活性治疗比较试验中报告的感染性和胃肠道（GI）不良事件（AE）方面，三联疗法（T：甲氨蝶呤（MTX）联合柳氮磺胺吡啶（SSZ）和羟氯喹（HCQ））与甲氨蝶呤联合依那西普（E）之间的差异。
患者为353例甲氨蝶呤治疗反应不完全的类风湿关节炎患者，随机分为T组（n = 178）或E组（n = 175）。其中，88例患者按照方案在24周时从初始治疗（E或T）转换为替代治疗。在干预期后的48周和4周内报告感染性和胃肠道严重不良事件（SAE）及非严重不良事件（NAE）。采用广义线性模型估计两种疗法之间不良事件的发生率比（IRR）。
接受E治疗的患者更易发生感染性NAE（IRR = 1.56，95%CI：1.11，2.19）。接受E治疗的患者发生的感染性SAE数量多于T治疗组[12例E组（6.9%）对4例T组（2.2%），P = 0.19]。肺炎是两种治疗中最常见的感染性SAE[6例E组（3.4%）和2例T组（1.1%）]。相反，接受E治疗的患者发生胃肠道NAE的可能性低于接受T治疗的患者（IRR = 0.62，95%CI：0.40，0.94）。报告的最常见胃肠道SAE是胃肠道出血，发生在3例接受E治疗的患者中（1.7%）。
本研究为甲氨蝶呤治疗反应不完全的类风湿关节炎患者的两种常见且同等有效的治疗方法在感染性和胃肠道AE发生可能性方面存在差异提供了证据。
ClinicalTrials.gov，http://clinicaltrials.gov ，NCT00405275。
