Efficacy and safety of tofacitinib dose de-escalation and dose escalation for patients with ulcerative colitis: results from OCTAVE Open.
Efficacy and safety of tofacitinib dose de-escalation and dose escalation for patients with ulcerative colitis: results from OCTAVE Open.
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DOI：
10.1111/apt.15555
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发表时间：
2020-01
影响因子：
7.6
通讯作者：
Su, Chinyu
中科院分区：
文献类型：
--
作者：
Sands, Bruce E.;Armuzzi, Alessandro;Marshall, John K.;Lindsay, James O.;Sandborn, William J.;Danese, Silvio;Panes, Julian;Bressler, Brian;Colombel, Jean-Frederic;Lawendy, Nervin;Maller, Eric;Zhang, Haiying;Chan, Gary;Salese, Leonardo;Tsilkos, Konstantinos;Marren, Amy;Su, Chinyu
对于UC患者，灵活的维持给药治疗可能在安全性、疗效、成本和患者偏好方面具有优势。托法替尼是一种口服小分子JAK抑制剂，用于治疗UC。评估托法替布剂量递减和递增在UC患者中的疗效和安全性。我们评价了OCTAVE Open的数据（数据截止日期为2017年11月），这是一项正在进行的开放标签长期扩展研究。剂量递减组包括66例托法替布10 mg b.d.治疗52周后缓解的托法替布诱导应答者。维持治疗，随后减量至5 mg b.d.在OCTAVE开放。剂量递增组包括57例托法替布诱导应答者，他们在接受5 mg b.d.治疗时发生治疗失败。维持治疗，随后递增至10 mg b.d.在OCTAVE开放。托法替尼剂量递减后，第2个月和第12个月分别有92.4%（61/66）和84.1%（53/63）的患者维持临床应答，80.3%（53/66）和74.6%（47/63）的患者维持缓解。剂量递增后，第2个月和第12个月分别有57.9%（33/57）和64.9%（37/57）的患者重新获得临床应答，35.1%（20/57）和49.1%（28/57）的患者达到缓解。剂量递增的带状疱疹发生率（7.6例患者发生事件/100患者年）在数值上高于总体托法替尼UC项目。托法替尼减量治疗已达到缓解的患者（每日10 mg）后，大多数维持缓解，尽管25.4%在12个月时失去缓解。对于5 mg b.d.治疗失败后剂量递增的诱导应答者维持治疗，49.1%在第12个月达到缓解。（ClinicalTrials.gov编号：NCT 01470612）。 链接内容本文链接到Amiot等人的论文。要查看本文，请访问https://doi.org/10.1111/apt.15638。
For patients with UC, flexible maintenance dosing therapy may confer advantages for safety, efficacy, costs and patient preference. Tofacitinib is an oral, small molecule JAK inhibitor for the treatment of UC. To assess the efficacy and safety of tofacitinib dose de‐escalation and escalation in patients with UC. We evaluated data (November 2017 data cut‐off) from OCTAVE Open, an ongoing, open‐label, long‐term extension study. The dose de‐escalation group comprised 66 tofacitinib induction responders in remission following 52 weeks' tofacitinib 10 mg b.d. maintenance therapy, subsequently de‐escalated to 5 mg b.d. in OCTAVE Open. The dose escalation group comprised 57 tofacitinib induction responders who experienced treatment failure while receiving 5 mg b.d. maintenance therapy, subsequently escalated to 10 mg b.d. in OCTAVE Open. After tofacitinib de‐escalation, 92.4% (61/66) and 84.1% (53/63) of patients maintained clinical response and 80.3% (53/66) and 74.6% (47/63) maintained remission, at months 2 and 12, respectively. After dose escalation, 57.9% (33/57) and 64.9% (37/57) of patients recaptured clinical response and 35.1% (20/57) and 49.1% (28/57) were in remission, at months 2 and 12, respectively. The incidence rate of herpes zoster with dose escalation (7.6 patients with events/100 patient‐years) was numerically higher than in the overall tofacitinib UC programme. Following tofacitinib de‐escalation in patients already in remission on 10 mg b.d., most maintained remission, although 25.4% lost remission, at month 12. For induction responders who dose‐escalated following treatment failure on 5 mg b.d. maintenance therapy, 49.1% achieved remission by month 12. (ClinicalTrials.gov number: NCT01470612). LINKED CONTENT This article is linked to Amiot et al paper. To view this article, visit https://doi.org/10.1111/apt.15638.
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