Department Clinical Immunology and Rheumatology, Amsterdam Rheumatology & Clinical Immunology Center, Amsterdam, Netherlands; Department of Rheumatology, Zuyderland Medical Center, Heerlen, Netherlands.
Department of Gastroenterology, Infectious Diseases, and Rheumatology, Charité Universitätsmedizin Berlin, Berlin, Germany.
Lancet. 2018 Jul 14;392(10142):134-144. doi: 10.1016/S0140-6736(18)31362-X. Epub 2018 Jun 29.
Success of treatment withdrawal in patients with non-radiographic axial spondyloarthritis who are in remission remains unknown. The ABILITY-3 study explored the ability to withdraw adalimumab treatment in patients with non-radiographic axial spondyloarthritis who achieved sustained clinical remission after open-label treatment with adalimumab.
ABILITY-3 was a multicentre, two-period study done in 107 sites in 20 countries. We enrolled adult patients (≥18 years) diagnosed with non-radiographic axial spondyloarthritis, fulfilling Assessment of SpondyloArthritis international Society classification criteria but not the modified New York radiologic criterion, who had objective evidence of active inflammation, active disease, and inadequate response to at least two non-steroidal anti-inflammatory drugs. Patients who achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease (<1·3) with open-label adalimumab (40 mg subcutaneously every other week for 28 weeks) at weeks 16, 20, 24, and 28 were randomly assigned (1:1) using an interactive voice or web response system to 40-week, double-blind treatment with adalimumab (continuation) or placebo (withdrawal). The primary efficacy endpoint was the proportion of patients who did not experience a flare (defined as ASDAS ≥2·1 at two consecutive visits) during the double-blind period. Patients who flared were rescued with open-label adalimumab. This study is registered with ClinicalTrials.gov, number NCT01808118.
Between June 27, 2013, and October 22, 2015, 673 patients were enrolled to the study. The trial completed on April 14, 2017. Of 673 enrolled patients, 305 (45%) achieved sustained remission and were randomly assigned to double-blind treatment (152 patients to adalimumab and 153 to placebo). A greater proportion of patients continuing adalimumab than those receiving placebo did not experience a flare (107 [70%] of 152 patients vs 72 [47%] of 153 patients; p<0·0001) up to and including week 68. Among 673 patients receiving adalimumab at any time, 516 (77%) patients reported an adverse event and 28 (4%) experienced a serious adverse event. The most common adverse events in both the adalimumab and placebo groups were nasopharyngitis (25 [16%] vs 20 [13%]), upper respiratory tract infection (20 [13%] vs 12 [8%]), and worsening of axial spondyloarthritis (ten [7%] vs 21 [14%]).
In patients with active non-radiographic axial spondyloarthritis who achieved sustained remission with adalimumab, continued therapy was associated with significantly fewer patients flaring than was treatment withdrawal.
AbbVie.
在处于缓解期的非放射性轴性脊柱关节炎患者中，成功停止治疗的情况仍不清楚。ABILITY-3 研究探讨了在接受阿达木单抗开放性治疗后达到持续临床缓解的非放射性轴性脊柱关节炎患者中停止阿达木单抗治疗的能力。
ABILITY-3 是一项多中心、两期研究，在 20 个国家的 107 个地点进行。我们招募了成年患者（≥18 岁），诊断为非放射性轴性脊柱关节炎，符合评估脊柱关节炎国际协会分类标准，但不符合改良纽约放射学标准，这些患者有客观的炎症活动证据、疾病活动和至少两种非甾体抗炎药治疗反应不足。在第 16、20、24 和 28 周接受阿达木单抗（皮下每两周 40mg，共 28 周）开放性治疗后达到强直性脊柱炎疾病活动评分（ASDAS）缓解（<1.3）的患者，通过交互式语音或网络应答系统随机分配（1:1）至 40 周的双盲阿达木单抗（延续）或安慰剂（停药）治疗。主要疗效终点是在双盲期间未出现病情加重（定义为连续两次就诊时 ASDAS≥2.1）的患者比例。出现病情加重的患者接受开放标签阿达木单抗治疗。本研究在 ClinicalTrials.gov 注册，编号为 NCT01808118。
2013 年 6 月 27 日至 2015 年 10 月 22 日，共纳入 673 名患者入组。该试验于 2017 年 4 月 14 日完成。在 673 名入组患者中，有 305 名（45%）达到持续缓解，并被随机分配至双盲治疗（152 名患者接受阿达木单抗治疗，153 名患者接受安慰剂治疗）。继续接受阿达木单抗治疗的患者病情加重的比例低于接受安慰剂的患者（152 名患者中 107 名[70%]，153 名患者中 72 名[47%]；p<0.0001），直至第 68 周。在任何时候接受阿达木单抗治疗的 673 名患者中，有 516 名（77%）报告了不良事件，28 名（4%）发生了严重不良事件。阿达木单抗组和安慰剂组中最常见的不良事件均为鼻咽炎（25 名[16%]比 20 名[13%]）、上呼吸道感染（20 名[13%]比 12 名[8%]）和脊柱关节炎恶化（10 名[7%]比 21 名[14%]）。
在接受阿达木单抗治疗达到持续缓解的活动性非放射性轴性脊柱关节炎患者中，继续治疗与病情加重的患者比例明显低于停药。
艾伯维。
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