NorthShore University Health System and University of Chicago, Pritzker School of Medicine, Northbrook, Illinois, USA.
J Am Acad Dermatol. 2012 Feb;66(2):241-51. doi: 10.1016/j.jaad.2010.12.005. Epub 2011 Jul 14.
REVEAL was a 52-week phase III trial of adalimumab therapy for moderate to severe chronic plaque psoriasis. Patients from REVEAL could enter an open-label extension trial to receive adalimumab for approximately 3 years of total therapy.
We sought to determine long-term efficacy and safety of continuous adalimumab therapy for patients from REVEAL.
Efficacy and safety over greater than 3 years of treatment were analyzed for 4 groups of patients from REVEAL. Patients who received adalimumab continuously from baseline were grouped by their responses in REVEAL: (1) greater than or equal to 75% improvement in Psoriasis Area and Severity Index (PASI) score (PASI 75) at weeks 16 and 33 (sustained responders); (2) less than PASI 75 at week 16; and (3) greater than or equal to PASI 75 at week 16 with 50% to less than 75% improvement in PASI score at week 33. Results were also analyzed for patients who began adalimumab after 16 weeks of placebo therapy.
For patients with sustained PASI 75 responses during REVEAL, efficacy was generally well maintained over 3 years, with 75%/90%/100% improvement in PASI score response rates (last observation carried forward) of 83%/59%/33% after 100 weeks and 76%/50%/31% after 160 weeks of continuous therapy. Some patients with less than PASI 75 responses in REVEAL also achieved long-term PASI 75 responses. Efficacy in the placebo/adalimumab group was consistent with the ensemble of results from the other 3 groups. Adverse event rates were consistent with those during REVEAL.
The REVEAL study design prevented analyzing all patients from the adalimumab arm as one long-term cohort.
Adalimumab efficacy was well maintained over more than 3 years of continuous therapy for patients with sustained initial PASI 75 responses. Maintenance was best at the PASI 100 level.
REVEAL 是一项为期 52 周的阿达木单抗治疗中度至重度慢性斑块型银屑病的 III 期临床试验。来自 REVEAL 的患者可以进入开放标签扩展试验，接受约 3 年的阿达木单抗治疗。
我们旨在确定 REVEAL 中连续阿达木单抗治疗的长期疗效和安全性。
分析了来自 REVEAL 的 4 组患者超过 3 年的治疗效果和安全性。根据他们在 REVEAL 中的反应，将基线时连续接受阿达木单抗治疗的患者分为以下 4 组：（1）第 16 周和第 33 周时银屑病面积和严重程度指数（PASI）评分≥75%改善（PASI75）（持续应答者）；（2）第 16 周时 PASI＜75%；（3）第 16 周时 PASI≥75%，但第 33 周时 PASI 评分改善 50%但＜75%。还分析了在接受 16 周安慰剂治疗后开始接受阿达木单抗治疗的患者的结果。
对于在 REVEAL 中持续达到 PASI75 应答的患者，在 3 年的时间里，疗效通常得到很好的维持，在第 100 周时，PASI 评分应答率（末次观察推进）为 75%/90%/100%，83%/59%/33%；在第 160 周时为 76%/50%/31%。在 REVEAL 中应答小于 PASI75 的一些患者也获得了长期的 PASI75 应答。安慰剂/阿达木单抗组的疗效与其他 3 组的结果一致。不良事件发生率与 REVEAL 期间一致。
REVEAL 研究设计阻止了将阿达木单抗组的所有患者作为一个长期队列进行分析。
对于初始 PASI75 应答持续的患者，连续治疗超过 3 年，阿达木单抗的疗效得到了很好的维持。在 PASI100 水平时效果最好。
