Department of Gastroenterology, Icahn School of Medicine at Mt Sinai, New York, New York, USA.
Division of Gastroenterology, Inflammatory Bowel Disease Center, University of California San Diego, La Jolla, California, USA.
Am J Gastroenterol. 2014 Nov;109(11):1771-80. doi: 10.1038/ajg.2014.242. Epub 2014 Aug 26.
The safety and efficacy of adalimumab for patients with moderately to severely active ulcerative colitis (UC) has been reported up to week 52 from the placebo-controlled trials ULTRA (Ulcerative Colitis Long-Term Remission and Maintenance with Adalimumab) 1 and 2. Up to 4 years of data for adalimumab-treated patients from ULTRA 1, 2, and the open-label extension ULTRA 3 are presented.
Remission per partial Mayo score, remission per Inflammatory Bowel Disease Questionnaire (IBDQ) score, and mucosal healing rates were assessed in adalimumab-randomized patients from ULTRA 1 and 2 up to week 208. Corticosteroid-free remission was assessed in adalimumab-randomized patients who used corticosteroids at lead-in study baseline. Maintenance of remission per partial Mayo score and mucosal healing was assessed in patients who entered ULTRA 3 in remission per full Mayo score and with mucosal healing, respectively. As observed, last observation carried forward (LOCF) and nonresponder imputation (NRI) were used to report efficacy. Adverse events were reported for any adalimumab-treated patient.
A total of 600/1,094 patients enrolled in ULTRA 1 or 2 were randomized to receive adalimumab and included in the intent-to-treat analyses of the studies. Of these, 199 patients remained on adalimumab after 4 years of follow-up. Rates of remission per partial Mayo score, remission per IBDQ score, mucosal healing, and corticosteroid discontinuation at week 208 were 24.7%, 26.3%, 27.7% (NRI), and 59.2% (observed), respectively. Of the patients who were followed up in ULTRA 3 (588/1,094), a total of 360 patients remained on adalimumab 3 years later. Remission per partial Mayo score and mucosal healing after ULTRA 1 or 2 to year 3 of ULTRA 3 were maintained by 63.6% and 59.9% of patients, respectively (NRI). Adverse event rates were stable over time.
Remission, mucosal healing, and improved quality of life were maintained in patients with moderately to severely active UC with long-term adalimumab therapy, for up to 4 years. No new safety signals were reported.
阿达木单抗治疗中重度活动性溃疡性结肠炎（UC）患者的安全性和疗效已在安慰剂对照试验 ULTRA（阿达木单抗治疗溃疡性结肠炎的长期缓解和维持）1 和 2 中得到证实，随访时间达 52 周。本文介绍了 ULTRA 1、2 和开放标签扩展 ULTRA 3 中阿达木单抗治疗患者长达 4 年的数据。
在 ULTRA 1 和 2 中，对阿达木单抗随机分组的患者，在第 208 周时评估部分 Mayo 评分缓解、炎症性肠病问卷（IBDQ）评分缓解和黏膜愈合率。在基线时使用皮质类固醇的阿达木单抗随机分组患者中，评估皮质类固醇无缓解的情况。在分别以完全 Mayo 评分缓解和黏膜愈合进入 ULTRA 3 的患者中，评估部分 Mayo 评分缓解和黏膜愈合的维持情况。如观察到的那样，使用最后观察值结转（LOCF）和非应答者插补（NRI）来报告疗效。报告了任何接受阿达木单抗治疗的患者的不良事件。
共有 600/1094 名纳入 ULTRA 1 或 2 的患者被随机分配接受阿达木单抗治疗，并纳入了研究的意向治疗分析。其中，199 名患者在 4 年随访后仍接受阿达木单抗治疗。在第 208 周时，部分 Mayo 评分缓解、IBDQ 评分缓解、黏膜愈合和皮质类固醇停药率分别为 24.7%、26.3%、27.7%（NRI）和 59.2%（观察）。在 ULTRA 3 中随访的 588/1094 名患者中，360 名患者在 3 年后仍接受阿达木单抗治疗。在 ULTRA 1 或 2 至 ULTRA 3 第 3 年，分别有 63.6%和 59.9%的患者维持部分 Mayo 评分缓解和黏膜愈合（NRI）。不良事件发生率随时间保持稳定。
在中重度活动性 UC 患者中，长期接受阿达木单抗治疗可维持缓解、黏膜愈合和改善生活质量，最长可达 4 年。未报告新的安全性信号。
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