PDF(Pubmed)
Abstract：
In patients with moderate to severe Crohn\'s disease (CD), intravenous induction and subcutaneous maintenance dosing with risankizumab was efficacious and well tolerated. Long-term management of CD via self-administration of risankizumab using an on-body injector (OBI) may improve treatment adherence through convenience and ease of use.
Within the FORTIFY maintenance study, 46 patients from the United States (US) sites participated in an open-label extension Substudy and received 180 mg or 360 mg risankizumab delivered subcutaneously via OBI [360 mg (2.4 mL, 150 mg/mL) or 180 mg (1.2 mL, 150 mg/mL)]. At the Week 0 visit, patients were trained (pre-injection) by site staff, using Instructions for Use (IFU) and a training video, to self-administer risankizumab at Weeks 0 (on site), 8 (at home), and 16 (on site). Key objectives of the Substudy 4 were to assess OBI usability (observer rating of successful self-administration), hazard-free self-injection at Weeks 0 and 16, and patient rating of acceptability using the Self-Injection Assessment Questionnaire (SIAQ) at Weeks 0, 8, and 16. Additionally, the proportion of patients in clinical remission (CD Activity Index < 150) was collected at Weeks 0 and 16.
All patients successfully self-administered risankizumab via OBI, including two patients who successfully self-administered with a second OBI (i.e., required two injection attempts). Acceptability of self-injection was high. Two patients (n = 2) experienced a use-related hazard. Stable clinical remission was observed with both risankizumab doses. Two patients experienced injection site reactions; neither was related to the OBI per investigator\'s assessment. Two device-related adverse events related to topical adhesive reactions were reported, both mild and resolved. No new safety risks were observed.
The efficacy and safety of maintenance risankizumab delivered via OBI and OBI usability support the use of this device in patients with moderate to severe CD.
ClinicalTrials.gov identifiers NCT03105102 (FORTIFY).
Within the FORTIFY maintenance study, 46 patients from the United States (US) sites participated in an open-label extension Substudy and received 180 mg or 360 mg risankizumab delivered subcutaneously via OBI [360 mg (2.4 mL, 150 mg/mL) or 180 mg (1.2 mL, 150 mg/mL)]. At the Week 0 visit, patients were trained (pre-injection) by site staff, using Instructions for Use (IFU) and a training video, to self-administer risankizumab at Weeks 0 (on site), 8 (at home), and 16 (on site). Key objectives of the Substudy 4 were to assess OBI usability (observer rating of successful self-administration), hazard-free self-injection at Weeks 0 and 16, and patient rating of acceptability using the Self-Injection Assessment Questionnaire (SIAQ) at Weeks 0, 8, and 16. Additionally, the proportion of patients in clinical remission (CD Activity Index < 150) was collected at Weeks 0 and 16.
All patients successfully self-administered risankizumab via OBI, including two patients who successfully self-administered with a second OBI (i.e., required two injection attempts). Acceptability of self-injection was high. Two patients (n = 2) experienced a use-related hazard. Stable clinical remission was observed with both risankizumab doses. Two patients experienced injection site reactions; neither was related to the OBI per investigator\'s assessment. Two device-related adverse events related to topical adhesive reactions were reported, both mild and resolved. No new safety risks were observed.
The efficacy and safety of maintenance risankizumab delivered via OBI and OBI usability support the use of this device in patients with moderate to severe CD.
ClinicalTrials.gov identifiers NCT03105102 (FORTIFY).
摘要：
背景：在患有中度至重度克罗恩病（CD）的患者中，利沙珠单抗静脉内诱导和皮下维持给药是有效且耐受性良好的.通过使用体内注射器（OBI）自我施用risankizumab进行CD的长期管理可以通过便利性和易用性来提高治疗依从性。
方法：在FORTIFY维护研究中，来自美国（US）站点的46名患者参加了一项开放标签扩展子研究，并通过OBI[360mg（2.4mL，150mg/mL）或180mg（1.2mL，150mg/mL)]。在第0周访问中，患者接受了现场工作人员的培训（注射前），使用使用说明（IFU）和培训视频，在第0周(现场)自我施用利沙珠单抗，8（在家）和16（现场）。子研究4的主要目标是评估OBI可用性（成功自我管理的观察者评级），在第0周和第16周进行无风险自我注射，并在第0、8和16周使用自我注射评估问卷（SIAQ）对患者的可接受性进行评级。此外,在第0周和第16周收集临床缓解(CD活动指数<150)的患者比例.
结果：所有患者均通过OBI成功自用利沙单抗，包括两名成功自我给予第二次OBI的患者(即，需要两次注射尝试)。自我注射的可接受性高。两名患者（n=2）经历了使用相关的危险。使用两种利沙珠单抗剂量观察到稳定的临床缓解。两名患者出现注射部位反应；根据研究者的评估，两者均与OBI相关。报告了两个与局部粘合剂反应相关的器械相关不良事件，既温和又坚定。没有观察到新的安全风险。
结论：通过OBI和OBI可用性提供的维持利沙珠单抗的有效性和安全性支持该设备在中度至重度CD患者中的使用。
背景：ClinicalTrials.gov标识符NCT03105102（FORTIFY）。
方法：在FORTIFY维护研究中，来自美国（US）站点的46名患者参加了一项开放标签扩展子研究，并通过OBI[360mg（2.4mL，150mg/mL）或180mg（1.2mL，150mg/mL)]。在第0周访问中，患者接受了现场工作人员的培训（注射前），使用使用说明（IFU）和培训视频，在第0周(现场)自我施用利沙珠单抗，8（在家）和16（现场）。子研究4的主要目标是评估OBI可用性（成功自我管理的观察者评级），在第0周和第16周进行无风险自我注射，并在第0、8和16周使用自我注射评估问卷（SIAQ）对患者的可接受性进行评级。此外,在第0周和第16周收集临床缓解(CD活动指数<150)的患者比例.
结果：所有患者均通过OBI成功自用利沙单抗，包括两名成功自我给予第二次OBI的患者(即，需要两次注射尝试)。自我注射的可接受性高。两名患者（n=2）经历了使用相关的危险。使用两种利沙珠单抗剂量观察到稳定的临床缓解。两名患者出现注射部位反应；根据研究者的评估，两者均与OBI相关。报告了两个与局部粘合剂反应相关的器械相关不良事件，既温和又坚定。没有观察到新的安全风险。
结论：通过OBI和OBI可用性提供的维持利沙珠单抗的有效性和安全性支持该设备在中度至重度CD患者中的使用。
背景：ClinicalTrials.gov标识符NCT03105102（FORTIFY）。
