Swedish Medical Center and University of Washington , Seattle, Washington , USA.
Oregon Health & Science University , Portland, Oregon , USA.
RMD Open. 2015 Jun 25;1(1):e000119. doi: 10.1136/rmdopen-2015-000119. eCollection 2015.
Previous reports of RAPID-PsA (NCT01087788) demonstrated efficacy and safety of certolizumab pegol (CZP) over 24 weeks in patients with psoriatic arthritis (PsA), including patients with prior antitumour necrosis factor (TNF) therapy. We report efficacy and safety data from a 96-week data cut of RAPID-PsA.
RAPID-PsA was placebo-controlled to week 24, dose-blind to week 48 and open-label to week 216. We present efficacy data including American College of Rheumatology (ACR)/Psoriasis Area and Severity Index (PASI) responses, HAQ-DI, pain, minimal disease activity (MDA), modified total Sharp score (mTSS) and ACR responses in patients with/without prior anti-TNF exposure, in addition to safety data.
Of 409 patients randomised, 273 received CZP from week 0. 54 (19.8%) CZP patients had prior anti-TNF exposure. Of patients randomised to CZP, 91% completed week 24, 87% week 48 and 80% week 96. ACR responses were maintained to week 96: 60% of patients achieved ACR20 at week 24, and 64% at week 96. Improvements were observed with both CZP dose regimens. ACR20 responses were similar in patients with (week 24: 59%; week 96: 63%) and without (week 24: 60%; week 96: 64%) prior anti-TNF exposure. Placebo patients switching to CZP displayed rapid clinical improvements, maintained to week 96. In patients with ≥3% baseline skin involvement (60.8% week 0 CZP patients), PASI responses were maintained to week 96. No progression of structural damage was observed over the 96-week period. In the Safety Set (n=393), adverse events occurred in 345 patients (87.8%) and serious adverse events in 67 (17.0%), including 6 fatal events.
CZP efficacy was maintained to week 96 with both dose regimens and in patients with/without prior anti-TNF exposure. The safety profile was in line with that previously reported from RAPID-PsA, with no new safety signals observed with increased exposure.
NCT01087788.
先前 RAPID-PsA（NCT01087788）的报告显示，在接受过抗肿瘤坏死因子（TNF）治疗的患者中，培塞利珠单抗（CZP）治疗 24 周可取得疗效和安全性[1]。我们报告了 RAPID-PsA 96 周数据截止时的疗效和安全性数据。
RAPID-PsA 从第 0 周开始进行安慰剂对照，第 48 周时进行剂量盲法，第 216 周时进行开放性治疗。我们提供了包括美国风湿病学会（ACR）/银屑病面积和严重程度指数（PASI）应答、健康评估问卷残疾指数（HAQ-DI）、疼痛、最小疾病活动度（MDA）、改良总 Sharp 评分（mTSS）和有/无既往抗-TNF 暴露患者的 ACR 应答在内的疗效数据，以及安全性数据。
在 409 名随机分组的患者中，有 273 名患者从第 0 周开始接受 CZP 治疗[1]。54 名（19.8%）CZP 患者既往接受过抗-TNF 治疗。在接受 CZP 治疗的患者中，91%完成了第 24 周，87%完成了第 48 周，80%完成了第 96 周。在第 96 周时，ACR 应答仍得以维持：24 周时，60%的患者达到 ACR20，96 周时为 64%[1]。两种 CZP 剂量方案均观察到改善。有（24 周：59%；96 周：63%）和无（24 周：60%；96 周：64%）既往抗-TNF 暴露的患者，ACR20 应答相似[1]。起始时皮肤受累≥3%的患者（60.8%的 CZP 患者在第 0 周），PASI 应答可维持至第 96 周[1]。在 96 周期间，未观察到结构损伤进展。在安全性人群（n=393）中，345 名患者（87.8%）发生不良事件，67 名患者（17.0%）发生严重不良事件，包括 6 例死亡事件[1]。
在接受两种剂量方案治疗的患者中，无论既往是否接受过抗-TNF 治疗，CZP 的疗效均维持至第 96 周。安全性与 RAPID-PsA 先前报告的一致，在增加暴露的情况下未观察到新的安全性信号[1]。
NCT01087788。
Zotero 插件
