Department of Dermatology and Allergy, Charité University Medicine 10117, Berlin, Germany.
BMJ. 2010 Feb 2;340:c147. doi: 10.1136/bmj.c147.
To compare the efficacy over 12 weeks of two different etanercept regimens in treating the skin manifestations of psoriasis in patients who also have psoriatic arthritis and to evaluate efficacy and safety over an additional 12 weeks of open label etanercept treatment. Design Randomised double blind multicentre outpatient study.
98 outpatient facilities in Europe, Latin America, and the Asia Pacific region. Participants 752 patients with both psoriasis (evaluated by dermatologists) and psoriatic arthritis (evaluated by rheumatologists).
During the blinded portion of the study, participants were randomised to receive etanercept 50 mg twice weekly (n=379) or 50 mg once weekly (n=373) for 12 weeks by subcutaneous injection. All participants then received open label etanercept 50 mg once weekly for 12 additional weeks, while remaining blinded to the regimen.
The primary efficacy end point was the proportion of participants achieving "clear" or "almost clear" on the physician's global assessment of psoriasis at week 12. Secondary efficacy analyses included psoriasis area and severity index, American College of Rheumatology responses, psoriatic arthritis response criteria, and improvement in joint and tendon disease manifestations.
At week 12, 46% (176/379) of participants receiving etanercept 50 mg twice weekly achieved a physician's global assessment of psoriasis of "clear" or "almost clear" compared with 32% (119/373) in the group treated with 50 mg once weekly (P<0.001). In contrast, an equally high percentage of participants in both groups achieved psoriatic arthritis response criteria (77% (284/371) in the twice weekly/once weekly group versus 76% (282/371) in the once weekly/once weekly group). Participants treated with 50 mg twice weekly/once weekly had greater mean reductions from baseline in the psoriasis area and severity index at week 12 compared with those who received 50 mg once weekly/once weekly (71% v 62%, P<0.001), with less difference at week 24 (78% v 74%, P<0.110). Joint and tendon disease manifestations improved from baseline in both groups to a similar extent. No new safety signals were seen in either etanercept treatment group, and no significant difference in the safety profiles was observed.
In participants with active psoriasis and psoriatic arthritis, initial treatment of the psoriasis with etanercept 50 mg twice weekly may allow for more rapid clearance of skin lesions than with 50 mg once weekly. A regimen of 50 mg once weekly seems to be appropriate for treatment of joint and tendon rheumatic symptoms. The choice of regimen should be determined by the clinical needs of the individual patient.
Clinical trials NCT00245960.
比较两种不同依那西普方案治疗银屑病关节炎合并银屑病患者皮肤表现的 12 周疗效，并评估依那西普开放标签治疗 12 周以上的疗效和安全性。
随机、双盲、多中心门诊研究。
欧洲、拉丁美洲和亚太地区的 98 家门诊机构。
752 名同时患有银屑病（由皮肤科医生评估）和银屑病关节炎（由风湿病医生评估）的患者。
在研究的盲法部分，参与者被随机分配接受依那西普 50mg，每周 2 次（n=379）或每周 1 次（n=373）皮下注射，持续 12 周。所有参与者随后接受依那西普 50mg，每周 1 次，开放标签治疗 12 周，同时仍对方案保持盲态。
主要疗效终点是在第 12 周时，医生对银屑病的总体评估中达到“清除”或“几乎清除”的参与者比例。次要疗效分析包括银屑病面积和严重程度指数、美国风湿病学会反应、银屑病关节炎反应标准以及关节和肌腱疾病表现的改善。
第 12 周时，每周接受依那西普 50mg，2 次治疗的参与者中有 46%（176/379）达到医生对银屑病的总体评估“清除”或“几乎清除”，而每周接受依那西普 50mg，1 次治疗的参与者中这一比例为 32%（119/373）（P<0.001）。相比之下，两组中同样有很高比例的参与者达到了银屑病关节炎反应标准（每周接受 2 次/1 次治疗的组为 77%（284/371），每周接受 1 次/1 次治疗的组为 76%（282/371））。与每周接受依那西普 50mg，1 次/1 次治疗的患者相比，每周接受依那西普 50mg，2 次/1 次治疗的患者在第 12 周时从基线到银屑病面积和严重程度指数的平均下降幅度更大（71%比 62%，P<0.001），第 24 周时的差异较小（78%比 74%，P<0.110）。两组的关节和肌腱疾病表现均从基线开始得到改善，改善程度相似。在两个依那西普治疗组中均未发现新的安全性信号，且安全性特征无显著差异。
在患有活动性银屑病和银屑病关节炎的患者中，最初使用依那西普 50mg，每周 2 次治疗银屑病可能比每周 1 次治疗更快地清除皮损。每周 50mg 1 次的方案似乎适合治疗关节和肌腱风湿症状。方案的选择应根据患者的临床需求确定。
临床试验 NCT00245960。
