Abstract：
Upadacitinib is an oral, selective Janus kinase inhibitor.
To assess the efficacy and safety of upadacitinib in patients with moderate-to-severe ulcerative colitis following 16-week extended induction therapy, and 52-week maintenance therapy in patients achieving clinical response after 16-week extended induction therapy METHODS: Patients without clinical response to 8 weeks\' upadacitinib 45 mg once daily induction therapy in two induction trials were eligible for an additional 8 weeks of therapy. Patients achieving clinical response at Week 16 were subsequently re-randomised (1:1) to upadacitinib 15 or 30 mg once daily for 52-week maintenance therapy. Efficacy was assessed at induction Week 16 (integrated) and maintenance Week 52; safety was assessed throughout.
Overall, 127/663 (19.2%) patients did not achieve clinical response to upadacitinib 45 mg at Week 8 and received an additional 8 weeks of therapy; 75/127 (59.1%) subsequently achieved clinical response at Week 16 and entered the maintenance trial. At Week 52, 26.5% of patients receiving upadacitinib 15 mg, and 43.6% receiving 30 mg, achieved clinical remission; efficacy was observed across all other endpoints with both doses. Herpes zoster rates increased with longer duration (16 weeks) of exposure to upadacitinib 45 mg during induction compared with the same population during the first 8 weeks. No other new safety signals were observed, and results are otherwise consistent with the known safety profile of upadacitinib.
Patients without clinical response after 8 weeks\' upadacitinib 45 mg induction therapy, may benefit from an additional 8 weeks of therapy.
NCT02819635; NCT03653026.
To assess the efficacy and safety of upadacitinib in patients with moderate-to-severe ulcerative colitis following 16-week extended induction therapy, and 52-week maintenance therapy in patients achieving clinical response after 16-week extended induction therapy METHODS: Patients without clinical response to 8 weeks\' upadacitinib 45 mg once daily induction therapy in two induction trials were eligible for an additional 8 weeks of therapy. Patients achieving clinical response at Week 16 were subsequently re-randomised (1:1) to upadacitinib 15 or 30 mg once daily for 52-week maintenance therapy. Efficacy was assessed at induction Week 16 (integrated) and maintenance Week 52; safety was assessed throughout.
Overall, 127/663 (19.2%) patients did not achieve clinical response to upadacitinib 45 mg at Week 8 and received an additional 8 weeks of therapy; 75/127 (59.1%) subsequently achieved clinical response at Week 16 and entered the maintenance trial. At Week 52, 26.5% of patients receiving upadacitinib 15 mg, and 43.6% receiving 30 mg, achieved clinical remission; efficacy was observed across all other endpoints with both doses. Herpes zoster rates increased with longer duration (16 weeks) of exposure to upadacitinib 45 mg during induction compared with the same population during the first 8 weeks. No other new safety signals were observed, and results are otherwise consistent with the known safety profile of upadacitinib.
Patients without clinical response after 8 weeks\' upadacitinib 45 mg induction therapy, may benefit from an additional 8 weeks of therapy.
NCT02819635; NCT03653026.
摘要：
背景：Upadacitinib是一种口服，选择性Janus激酶抑制剂。
目的：评估upadacitinib在16周延长诱导治疗后对中重度溃疡性结肠炎患者的疗效和安全性，16周延长诱导治疗后达到临床缓解的患者的52周维持治疗方法:在两项诱导试验中,对8周upadacitinib45mg每日1次诱导治疗无临床缓解的患者可再接受8周治疗.在第16周达到临床反应的患者随后被重新随机(1:1)给予upadacitinib15或30mg,每天一次,用于52周维持治疗。在诱导第16周(综合)和维持第52周评估功效;自始至终评估安全性。
结果：总体而言，127/663（19.2%）患者在第8周未达到对45mgupadacitinib的临床反应，并接受了另外8周的治疗；75/127（59.1%）随后在第16周达到临床反应，并进入维持试验。在第52周，26.5％的患者接受upadacitinib15mg，43.6%的人接受30毫克，达到临床缓解;两种剂量的所有其他终点均观察到疗效.与前8周相同人群相比，在诱导期间暴露于45mgupadacitinib的持续时间更长（16周），带状疱疹发病率增加。没有观察到其他新的安全信号，结果与奥帕替尼的已知安全性一致.
结论：upadacitinib45mg诱导治疗8周后无临床反应的患者，可能受益于额外的8周的治疗。
背景：NCT02819635;NCT03653026。
目的：评估upadacitinib在16周延长诱导治疗后对中重度溃疡性结肠炎患者的疗效和安全性，16周延长诱导治疗后达到临床缓解的患者的52周维持治疗方法:在两项诱导试验中,对8周upadacitinib45mg每日1次诱导治疗无临床缓解的患者可再接受8周治疗.在第16周达到临床反应的患者随后被重新随机(1:1)给予upadacitinib15或30mg,每天一次,用于52周维持治疗。在诱导第16周(综合)和维持第52周评估功效;自始至终评估安全性。
结果：总体而言，127/663（19.2%）患者在第8周未达到对45mgupadacitinib的临床反应，并接受了另外8周的治疗；75/127（59.1%）随后在第16周达到临床反应，并进入维持试验。在第52周，26.5％的患者接受upadacitinib15mg，43.6%的人接受30毫克，达到临床缓解;两种剂量的所有其他终点均观察到疗效.与前8周相同人群相比，在诱导期间暴露于45mgupadacitinib的持续时间更长（16周），带状疱疹发病率增加。没有观察到其他新的安全信号，结果与奥帕替尼的已知安全性一致.
结论：upadacitinib45mg诱导治疗8周后无临床反应的患者，可能受益于额外的8周的治疗。
背景：NCT02819635;NCT03653026。
