重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白治疗类风湿关节炎双盲随机多中心对照临床研究

目的研究注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白[rhTNFR：Fc,益赛普,（etanercept）]对活动性类风湿关节炎（RA）患者的疗效及安全性.方法238例患者随机分为试验组和对照组.试验组每周1次口服空白模拟甲氨蝶呤（MTX）,同时接受rhTNFR：Fc皮下注射治疗,每周2次,每次25 mg;对照组每周1次口服定量MTX（每周7.5 mg起,8周内增至15 mg）,同时每周2次皮下注射空白模拟rhTNFR：Fc.疗程24周.疗效评价采用美国风湿病学会（ACR）疗效评定标准.结果治疗2周后,rhTNFR：Fc组ACR20有效率为35.59%,MTX组为22.50%,组间比较差异有统计学意义（P＜0.05）.治疗8周后,rhTNFR：Fc组和MTX组的ACR20、ACR50和ACR70组间比较差异均有统计学意义（（P＜0.05）.治疗12周后,rhTNFR：Fc组ACR20有效率为66.10%,MTX组是51.67%,两组间比较差异有统计学意义（（P＜0.05）.治疗24周后,rhTNFR：Fc组ACR20有效率为75.42%,且ACR70有效率优于MTX组（（P＜0.05）,显示rhTNFR：Fc疗效强于MTX.两组药物之间总的不良反应发生率差异无统计学意义.结论rhTNFR：Fc用于治疗中、重度RA具有良好的安全性和显著的疗效;在前12周治疗期间,rhTNFR：Fc较MTX起效快、效果更明显.     

甲氨蝶呤联合环磷酰胺治疗类风湿关节炎随机单盲对照临床研究

目的 评价甲氨蝶呤(MTX)联合环磷酰胺(CTX)及单独应用MTX、单独应用CTX治疗类风湿关节炎(RA)的疗效和安全性.方法 本研究为随机、单盲、对照的临床试验.符合纳入及排除标准的RA患者随机分为单用MTX(10～15 mg/周)、单用CTX(400 mg/2～3周)及MTX联合CTX治疗组(MTX10～15 mg/周+CTX 400 mg/2～3周).疗程24周,在基线、6、12、24周进行疗效及安全性评估.以美国风湿病学会(ACR)疗效评价指标ACR20为主要疗效指标,ACR50、ACR70、欧洲抗风湿联盟(EULAR)疗效指标、疼痛目视模拟测试表(VAS)评分、患者对自身健康状况的总体评估(PGA)、医生总体评价、压痛关节数(TJC)、压痛关节指数(TJI)、肿胀关节数(SJC)、肿胀关节指数(SJI)、健康评估问卷(HAQ)为次要疗效指标.结果 在第24周,MTX+CTX组达ACR20改善的患者比例(81%)高于MTX组(56%)及CTX组(35%),差异有统计学意义(P＜0.05).24周时MTX+CTX组达ACR50改善的患者比例高于CTX组(P＜0.05).与MTX组之间差异无统计学意义(P＞0.05).在第24周,MTX+CTX组达到EULAR有效的患者比例(77%)高于MTX组(48%)及CTX组(35%),差异有统计学意义(P＜0.05).24周时MTX+CTX组在TJC/TJI、SJC/SJI疼痛VAS评分、ESR的改善程度高于MTX组(P＜0.05).在压痛关节数脂数、肿胀关节数/指数、疼痛VAS评分、PGA、医生总体评价、HAQ、ESR的改善程度高于CTX组(P＜0.05).3组之间不良反应发生率差异无统计学意义.结论 MTX联合CTX治疗能显著改善RA的症状、体征和实验室炎性指标,疗效优于单用MTX及单用CTX.两者联合治疗安全耐受性好,与单用MTX及单用CTX相比,并不增加不良反应的发生率.     

益赛普联合甲氨蝶呤片治疗老年类风湿关节炎患者的临床疗效

目的 分析重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白(益赛普)联合甲氨蝶呤片治疗老年类风湿关节炎(RA)患者的临床疗效.方法 选取80例老年RA患者,随机分为对照组、实验组,每组40例.对照组给予口服甲氨蝶呤片,实验组在对照组基础上应用益赛普治疗.比较两组治疗第12、24周后关节晨僵持续时间、双手握力、关节疼痛、关节肿胀...     

重组人Ⅱ型肿瘤坏死因子受体-体融合蛋白联合甲氨蝶呤对改善病情抗风湿药治疗无效活动性类风湿关节炎的疗效

目的观察重组人Ⅱ型肿瘤坏死因子受体．抗体融合蛋白（rhTNFR：Fc，益赛普）联合甲氨蝶呤（methotrexate，MTX）对改善病情抗风湿药（disease—modifying antirheumatic drug，DMARD）无效类风湿关节炎（rheumatoid arthritis，RA）患者的疗效。方法DMARD治疗效果不佳的活动性RA患者64例，根据患者性别、年龄、病程及疾病活动程度将患者随机分为具有可比性的两组。试验组32例，予每周2次皮下注射rhTNFR：Fc 25mg／次．同时口服MTX 15mg／周；对照组32例，13服泼尼松5～10mg／d，同时口服MTX1 5mg／周。疗程12周。疗效评价采用美国风湿病学会（ACR）疗效评定标准。结果治疗第4、8和12周，试验组ACR20有效率（45．2％、54．8％和64．5％）均显著高于对照组（16．1％、19．4％和22．6％）（P〈0．05）。治疗第8和12周试验组ACR50有效率亦显著高于对照组（P〈0．05）。结论相对于应用小剂量激素联合甲氨蝶呤，rhTNFR：Fc联合甲氨蝶呤治疗DMARD无效的RA效果更佳。     

益赛普联合甲氨蝶呤治疗对类风湿关节炎临床及炎性细胞因子的影响

目的 研究类风湿关节炎（RA）患者益赛普（ETA）联合甲氨蝶呤（MTX）治疗后,临床表现及血清肿瘤坏死因子α（TNF-α）、白细胞介素-6（IL-6）、干扰素-γ（IFN-γ）浓度的变化.方法 选取活动性RA患者25例和正常人18例作为研究对象,研究期间患者均给予甲氨蝶呤10 mg每周1次口服,以及益赛普25 mg每周2次,皮下注射.治疗前及治疗后第6周收集患者血清,检测其TNF-α,IFN-γ、IL-6浓度,并记录肿胀关节数、压痛关节数、疾病活动性评分（DAS）、健康评估问卷评分（HAQ）、血沉（ESR）、C反应蛋白（CRP）和类风湿因子（RF）等,同时收集正常人血清检测上述指标.结果 RA组患者血清IL-6、TNF-α和IFN-γ浓度明显高于正常对照组（P分别＜0.01、0.05、0.05）.治疗后患者DAS28评分降低（P＜0.01）,HAQ、ESR、CRP、肿胀及压痛关节数也明显好转（P＜0.01）,血清RF、IL-6和TNF-α浓度也明显下降（P分别＜0.05,0.01,0.05）,治疗后血清IFN-γ浓度较前下降,但无显著性差异.结论 血清IL-6、TNF-α和IFN-γ浓度增高以及ESR、CRP、RF增加可作为RA病情活动指标.益赛普和甲氨蝶呤联合治疗能快速缓解患者关节炎症,并改善关节功能.     

甲氨蝶呤联合环磷酰胺对胶原诱导性关节炎大鼠滑膜细胞p53表达的研究

目的 通过对类风湿关节炎(RA)动物模型胶原诱导性关节炎(CIA)大鼠的实验研究,从滑膜细胞p53表达的角度,探讨甲氨蝶呤(MTX)联合环磷酰胺(CTX)治疗RA协同作用和机制.方法 建立Ⅱ型胶原诱导的雌性Wistar大鼠CIA模型,将造模成功的75只大鼠随机分成5组:CIA模型对照组、小剂量MTX治疗组(每周0.9 mg/kg)、大剂量MTX治疗组(每周2.7 mg/kg),小剂量CTX治疗组(每3周24 mg/kg)及小剂量MTX联合小剂量CTX组(MTX每周0.9 mg/kg+CTX每3周24 mg/kg).选8只大鼠为健康对照组,共6组.治疗24周后处死全部动物并取材,经固定、脱钙、包埋,通过免疫组织化学法检测滑膜细胞突变型p53的表达.结果 突变型p53在CIA组表达上调(P<0.05),联合治疗组下调突变型p53优于小剂量MTX、小剂量CTX组(P<0.05),与大剂量MTX组相当(P<0.05).结论 联合治疗组在下调突变型p53表达的作用均优于小剂量MTX、小剂量CTX单用药治疗组,提示MTX和CTX联合治疗为协同作用.     

依那西普治疗中国接受甲氨蝶呤治疗的活动性类风湿关节炎患者随机双盲多中心对照研究

目的 研究依那西普每周1次皮下注射50 mg对接受甲氨蝶呤(MTX)治疗的中国活动性类风湿关节炎(RA)患者的疗效及安全性.方法 本研究由2部分组成:12周双盲治疗阶段和12周安全性开放研究阶段.双盲期间的随机通过临床操作随机化(CORE)系统完成.在双盲阶段,RA患者被随机分配到依那西普50mg治疗组或安慰剂组,每周1次皮下注射给药,同时坚持一定剂量MTX给药.完成双盲治疗的RA患者在开放治疗中均接受每周1次依那西普50 mg和MTX给药.以美国风湿病学会(ACR)疗效评价指标ACR 20为主要终点疗效指标.次要终点疗效指标包括医生和患者总体评价、晨僵持续时间、疼痛目视模拟测试表(VAS)、健康评估问卷(HAQ)、C反应蛋白(CRP)值、疼痛和肿胀关节数.并且比较2组的安全性结果.采用Fisher精确概率法对主要终点疗效指标第12周ACR 20应答情况及其他次要终点疗效指标进行分析.使用协方差方法分析连续终点相对于基线的变化.结果 双盲治疗期间修正的意向性治疗人群(Mitt)共有156例患者,其中依那西普+MTX组77例.安慰剂+MTX组79例,149例患者完成双盲阶段的治疗.治疗4周时,依那西普+MTX组ACR 20有效率为39%(30/77),安慰剂+MTX组为16%(13/79),差异有统计学意义(P<0.01);12周时,依那西普+MTX组ACR 20有效率为62%(48/77),安慰剂+MTX组为23%(18/79),差异有统计学意义(P<0.01).其他疗效指标包括医生和患者总体评价、晨僵持续时间、疼痛VAS、HAQ、CRP、触痛关节数、肿胀关节数等均从第4周开始,在依那西普+MTX组明显优于安慰剂+MTX组(P<0.01).总的不良反应发生率在2组间差异无统计学意义.结论 与安慰剂治疗活动性RA相比.依那西普治疗活动性RA起效迅速、疗效显著.依那西普50 mg+MTX每周1次给药治疗中国成年活动性RA患者24周,耐受性良好.     

周期联合甲氨蝶呤和环磷酰胺对大鼠胶原诱导性关节炎滑膜细胞周期蛋白D1表达的研究

目的 通过研究大鼠胶原诱导件关节炎(CIA)滑膜组织细胞周期蛋白D1(cyclin D1)的表达以及甲氨蝶呤(MTX)和环磷酰胺(CTX)对其的影响,从周期调控的角度探讨两者联合治疗类风湿关节炎(RA)可能的协同效应机制.方法 建立Ⅱ型胶原诱导的雌性Wistar大鼠CIA模型,随机分为正常对照组、CIA模型对照组、小剂量MTX治疗组(每周0.9 mg/kg)、大剂量MTX治疗组(每周2.7mg/kg)、小剂量CTX间歇治疗组(每3周24 mg/kg)、联合治疗组(MTX每周0.9 mg/kg+CTX每3周24mg/kg).治疗24周后全部动物处死取材,再经同定、脱钙、包埋,原位杂交法检测滑膜细胞周期蛋白cyclin D1 mRNA.结果 CIA模型组大鼠关节滑膜组织的cvclin D1 mRNA的阳性染色强度明显高于正常对照组(P＜0.05),各治疗组滑膜cvclin D1 mRNA下调,联合治疗组cyclin D1 mRNA表达最低,各组间平均灰度值差异有统计学意义(P＜0.05).MTX与CTX存在药物交互作用(P＜0.05),联合治疗组优于单用药治疗组.结论 提示MTX和CTX联合治疗为协同效应,可能的重要机制是使滑膜cyclin D1 mRNA下调,从而抑制了滑膜细胞异常增殖.     

肾上腺糖皮质激素和益赛普治疗老年类风湿关节炎的效果比较

目的对比分析益赛普和肾上腺糖皮质激素治疗老年类风湿关节炎(RA)的效果。方法将92例老年RA患者作为研究对象,并按照1∶1比例随机分为观察组与对照组。对照组采用基础药物与肾上腺糖皮质激素治疗,观察组采用基础药物与益赛普治疗。于治疗前、治疗后12 w观察两组血细胞沉降率(ESR)、类风湿因子(RF)、C反应蛋白(CRP)、抗环瓜氨酸肽(CCP)抗体、28关节疾病活动(DAS28)评分、关节压痛数(TJC)、关节肿胀数(SJC),不良反应发生情况。结果治疗前,两组ESR、CRP、抗CCP抗体、RF水平、TJC、SJC及DAS28评分对比无统计学差异(P>0.05);治疗12 w后,两组上述指标均显著降低(P<0.01);观察组ESR、RF、抗CCP抗体水平、TJC、SJC及DAS28评分较对照组降低更明显(P<0.01);CRP两组无统计学差异(P>0.05);与对照组(13.0%)比较,观察组不良反应发生率(2.2%)明显减低(P<0.05)。结论老年RA患者采用益赛普治疗可改善实验室指标,安全性高。     

小剂量糖皮质激素联合艾拉莫德治疗早期活动性类风湿关节炎的临床研究

目的 探讨小剂量糖皮质激素联合艾拉莫德治疗早期活动性类风湿关节炎（RA）的临床疗效及安全性。方法 将60例早期活动性RA患者随机分为观察组和对照组，每组各30例。两组患者均给予艾拉莫德25mg、每天2次口服，观察组患者在此基础上给予泼尼松5mg、每天2次口服，12周作为1个疗程，共治疗2个疗程。比较两组患者治疗12周及24周时美国风湿病学会(ACR)20、ACR50、ACR70缓解率，比较两组患者治疗前及治疗24周时RA疾病活动度评分DAS28及实验室检查指标。结果 与同组治疗12周时比较，观察组和对照组治疗24周时ACR20、ACR50、ACR70缓解率均呈上升趋势，但差异无统计学意义(P＞0.05)。观察组治疗12周、24周时ACR20缓解率均高于对照组同一时间，差异有统计学意义(P<0.05)。两组患者治疗前DAS28、红细胞沉降率(ESR)、C反应蛋白(CRP)、类风湿因子（RF）、基质金属蛋白酶(MMP)-1、MMP-3水平比较，差异均无统计学意义(P<0.05)。两组患者治疗后DAS28、ESR、CRP、RF、MMP-1、MMP-3水平均低于治疗前(P<0.05)。治疗后观察组DAS28、ESR、RF、MMP-1、MMP-3水平均低于对照组(P<0.05)。观察组和对照组患者不良反应发生率比较差异无统计学意义(30.0%比23.3%，P>0.05)。结论 小剂量糖皮质激素联合艾拉莫德可快速缓解早期活动性RA患者的关节症状，降低疾病活动度，抑制MMP-1和MMP-3的表达水平以防止骨破坏，安全性较好。     

Safety and efficacy of etanercept treatment in elderly subjects with rheumatoid arthritis

OBJECTIVE: To evaluate safety and efficacy of etanercept treatment in elderly (age > or = 65 yrs) and younger adult subjects (age < 65 yrs) with rheumatoid arthritis (RA). METHODS: Subset analyses were used to describe the safety and efficacy of etanercept in elderly and younger subjects treated for early and disease modifying antirheumatic drug-resistant or late-stage RA (ERA and LRA) in one of 4 randomized controlled clinical studies (N = 1353) or 2 longterm extensions (N = 1049). RESULTS: Rates of serious adverse events tended to be higher in elderly than younger subjects; however, rates of safety events observed in elderly etanercept-treated subjects did not exceed rates in elderly placebo or methotrexate (MTX)-treated subjects. With regard to efficacy measures [American College of Rheumatology 20% response (ACR20), ACR50, and ACR70], elderly subjects tended to have somewhat less robust responses to treatment than younger subjects. However, for both age groups, treatment with etanercept resulted in improved efficacy and function compared with control treatment, and combination therapy with etanercept plus MTX resulted in greater efficacy than either etanercept or MTX used alone. Efficacy responses of elderly subjects were sustained for up to 6 years. Radiographic progression (measured using modified Sharp Score) after one year of treatment was lower in subjects treated with both etanercept and MTX compared with subjects treated with either agent used alone, and this pattern was similar in both age groups. CONCLUSION: Consistent with responses in younger subjects, elderly subjects with RA treated with etanercept experienced significant improvement in disease activity and function without incurring additional safety concerns.     

Etanercept versus methotrexate in patients with early rheumatoid arthritis: two-year radiographic and clinical outcomes

OBJECTIVE: To compare the clinical and radiographic outcomes in patients with rheumatoid arthritis (RA) who received monotherapy with either etanercept or methotrexate (MTX) for 2 years and to assess the safety of this therapy. METHODS: In the Enbrel ERA (early rheumatoid arthritis) trial, 632 patients with early, active RA were randomized to receive either twice-weekly subcutaneous etanercept (10 mg or 25 mg) or weekly oral MTX (mean dosage 19 mg per week) for at least 1 year in a double-blind manner. Following the blinded phase of the trial, 512 patients continued to receive the therapy to which they had been randomized for up to 1 additional year, in an open-label manner. Radiograph readers remained blinded to treatment group assignment and the chronologic order of images. RESULTS: At 24 months, more 25-mg etanercept patients than MTX patients met American College of Rheumatology 20% improvement criteria (72% and 59%, respectively; P = 0.005), and more had no increase in total score and erosion scores on the Sharp scale (P = 0.017 and P = 0.012, respectively). The mean changes in total Sharp score and erosion score in the 25-mg etanercept group (1.3 and 0.66 units, respectively) were significantly lower than those in the MTX group (3.2 and 1.86 units, respectively; P = 0.001). Significantly more patients in the 25-mg etanercept group (55%) than in the MTX group (37%) had at least 0.5 units of improvement in the Health Assessment Questionnaire disability index (P < 0.001). Fewer patients in the etanercept group than in the MTX group experienced adverse events or discontinued treatment because of adverse events. CONCLUSION: Etanercept as monotherapy was safe and was superior to MTX in reducing disease activity, arresting structural damage, and decreasing disability over 2 years in patients with early, aggressive RA.     

Comparison of combination therapies in the treatment of rheumatoid arthritis: leflunomide-anti-TNF-alpha versus methotrexate-anti-TNF-alpha

To compare the efficacy and safety of leflunomide (LEF)-anti-TNF-alpha combination therapy to methotrexate (MTX)-anti-TNF-alpha combination therapy in a group of patients with active rheumatoid arthritis (RA). We have recruited 120 patients with RA with a high disease activity despite being treated with MTX (15 mg/week) or LEF (20 mg/die) for 3 months, without side effects. In each of these patients, therapy with either MTX or LEF was continued and randomly combined with an anti-TNF-alpha drug: etanercept, infliximab, or adalimumab. Patients were assessed at study entry and at 4, 12, and at 24 weeks. The efficacy endpoints included variations in the DAS28-ESR and the ACR20, ACR50, and ACR70 responses. At each visit, any side-effect was recorded. There were no statistically significant differences in the DAS28 variations and in the ACR responses between the two groups or among the six subgroups. The number of discontinuation due to the appearance of serious side effects was higher, but not statistically significant, in the LEF-anti-TNF-alpha group than in the MTX-anti-TNF-alpha group. Other adverse events that did not necessitate the discontinuation of therapy occurred much more frequently in patients treated with MTX than in those treated with LEF. Anti-TNF-alpha drugs can be used in combination not only with MTX, but also with LEF, with the same probability of achieving significant clinical improvement in RA patients and without a significantly greater risk of serious adverse events. In contrast, it seems that combination therapy with LEF-anti-TNF-alpha is more readily tolerated than combination therapy with MTX-anti-TNF-alpha.     

B cells in rheumatoid arthritis: from hypothesis to the clinic

Rituximab (MabThera/Rituxan) is a therapeutic monoclonal antibody against CD20, an antigen expressed by B cells but not B-cell progenitor or plasma cells. It is currently approved for the treatment of relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL) and is well tolerated and efficacious. A small open-label study (conducted by Edwards and Cambridge) indicated that selective depletion of B cells using rituximab led to sustained benefits for patients with active rheumatoid arthritis. A 24-week, double-blind, randomized controlled trial was carried out to confirm these initial observations. In total, 161 patients with active rheumatoid arthritis were randomized to one of four treatment groups: rituximab monotherapy; rituximab plus methotrexate (R+MTX); rituximab plus cyclophosphamide (R+CTX); or methotrexate alone (MTX). Rituximab was administered as two 1000 mg infusions on days 1 and 15. An analysis at 24 weeks showed that the proportion of patients achieving an ACR20 response was significantly greater (P < or = 0.025 for all three comparisons) in all the rituximab groups compared with the MTX control group (rituximab alone, 65%; R+CTX, 76%; R+MTX, 73%; MTX alone, 38%). Both ACR50 (43 vs 13%; P = 0.005) and ACR70 (23 vs 5%; P = 0.048) responses were also significantly higher for the R+MTX group compared with the MTX group. The rituximab groups showed no significant safety differences compared with the MTX arm. The majority of adverse events were of mild to moderate intensity. Rituximab is a novel targeted therapy for the treatment of rheumatoid arthritis and it appears to be highly effective, safe and well tolerated.     

Clinical outcomes of patients with rheumatoid arthritis after switching from infliximab to etanercept

OBJECTIVE: To assess the efficacy and monitor serious adverse events in patients with rheumatoid arthritis (RA) switching treatment from infliximab to etanercept. METHODS: Adult patients with active RA who were discontinuing treatment with infliximab were eligible to enroll in this prospective, 12-week, open label, single-arm, observational study. Four to 10 weeks after their last infusion of infliximab, patients began treatment with etanercept (twice weekly subcutaneous injections of 25 mg). Clinical assessments using the American College of Rheumatology (ACR) criteria for improvement were performed at baseline and at Weeks 6 and 12, and serious adverse events were monitored throughout the study. RESULTS: Twenty-five patients were enrolled, 18 of whom had discontinued infliximab because of lack of efficacy, and 22 completed 12 weeks of etanercept treatment. After 12 weeks, 14 of 22 patients (64%) achieved at least a 20% improvement in ACR criteria (ACR20), 13 (59%) experienced improvements in physical function that were considered clinically important (> or = 0.22 point decrease in overall Health Assessment Questionnaire score), and mean values of all individual components of the ACR criteria had improved. No serious adverse events were reported during the study and no patient discontinued because of lack of efficacy. CONCLUSION: Etanercept, a soluble tumor necrosis factor (TNF) receptor, provided a well tolerated and effective treatment option for some patients even when infliximab, a monoclonal antibody to TNF, had been ineffective.     

The immunogenicity, safety, and efficacy of etanercept liquid administered once weekly in patients with rheumatoid arthritis

OBJECTIVE: To evaluate the immunogenicity, safety, and efficacy of 50 mg/mL liquid etanercept. METHODS: In a multicenter, open-label study, adults with active rheumatoid arthritis (RA) received 50 mg/mL liquid etanercept subcutaneously once weekly for 24 weeks. Immunogenicity was assessed at baseline and weeks 24 and 28, safety at all study visits, and efficacy at baseline and weeks 12 and 24. RESULTS: Of 222 treated patients, 88% completed the study; 81% were women; 84% were white; mean age was 53 years; mean RA duration was 10 years. Antibodies to etanercept, all non-neutralizing, were detected in 12 of 214 patients; 7 of the 12 were borderline positive (antibody titers <1:50). The presence of non-neutralizing anti-etanercept antibodies did not appear to affect clinical safety or efficacy. Few patients reported serious adverse events (6.3%), serious infections (2.3%), or withdrew because of adverse events (4.5%). Most adverse events were mild or moderate. The most common event, injection site reaction, occurred in 29.3% patients. At week 24, 63% of patients achieved an ACR20 response, 36% an ACR50 response, and 14% an ACR70 response. Similar responses were apparent by week 12. Week 24 mean improvement in the Health Assessment Questionnaire disability index scores was 0.6 points; improvement in the Short Form-36 Physical Component Score was 10.0 points. CONCLUSION: The 50 mg/mL liquid etanercept formulation administered once weekly was well tolerated. The incidence of anti-etanercept antibodies, the nature and frequency of adverse events, and improvements in signs and symptoms of RA and patient physical function were similar to those in previous etanercept studies.     

A comparison study of a recombinant tumor necrosis factor receptor:Fc fusion protein (rhTNFR:Fc) and methotrexate in treatment of patients with active rheumatoid arthritis in China

The objective of this study is to evaluate the efficacy and safety of rhTNFR:Fc: a recombinant tumor necrosis factor receptor:Fc fusion protein compared with methotrexate (MTX) in patients with rheumatoid arthritis in China. We treated 238 patients with active rheumatoid arthritis with either twice weekly subcutaneous injection rhTNFR:Fc (25 mg) or weekly oral MTX (mean 15 mg per week) for 24 weeks (registration number: 2003L01264). Clinical responses were defined as the percent improvement in disease activity according to the criteria of the American College of Rheumatology (ACR-N). As compared with MTX-treated patients, more patients who received rhTNFR:Fc had ACR20 improvement in disease activity during the first 2 weeks (P < 0.05). Similarly, more patients treated with rhTNFR:Fc having ACR20, ACR50, ACR70 improvement in disease activity during 8 weeks (P < 0.05). At the end of 12-week treatment, patients received rhTNFR:Fc also had significant improvement at ACR20 (P < 0.05). Compared with oral MTX, patients received rhTNFR:Fc also had significant improvement at ACR70 at the end of 24 weeks treatment (P < 0.05). In conclusion, compared with oral MTX subcutaneous injection, rhTNFR:Fc acted more rapidly to release symptoms and signs of active RA in Chinese patients, and well tolerated in patients with rheumatoid arthritis in China.