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患者报告的司库奇尤单抗体内装置(OBD)在英国治疗克罗恩病的真实世界经验(COMMODUS)。

Patient-reported real-world experience of risankizumab on-body device (OBD) for the treatment of Crohn's disease in the UK (COMMODUS).

作者信息

Jaulim Adil, Stanton Anna, Tripoli Sherill, Ibarra Ana, Young David, Doona Mary, Cummings Fraser, Speight Ally, Din Shahida, Lindsay James O, Horsfall Rachel, Sephton Mark, Samaan Mark A

机构信息

Department of Immunology, AbbVie, Maidenhead, UK.

Department of Gastroenterology, Guy's and St Thomas' NHS Foundation Trust, London, UK.

出版信息

Curr Med Res Opin. 2025 May;41(5):829-839. doi: 10.1080/03007995.2025.2506808. Epub 2025 May 23.

Abstract

OBJECTIVE

To evaluate real-world patient-reported experience with subcutaneous (SC) risankizumab administered by on-body device (OBD) in patients with Crohn's disease (CD).

METHODS

Uncontrolled observational cross-sectional study in five UK units between October 2023 and May 2024. Patients who had received maintenance risankizumab SC injection of four pre-filled syringes (PFS) self-administered in hospital were switched to OBD self-injection. Self-Injection Assessment Questionnaires (SIAQ) were completed pre- and post-first OBD use. The primary end-point was "Overall, how satisfied are you with your current way of taking your medication (self-injection)?" from post-injection SIAQ. Baseline patient data were collected retrospectively from medical records.

RESULTS

The study recruited 50 patients with moderate-to-severe CD, 48 completed the study. Most (81%) were satisfied/very satisfied with self-injection using OBD vs only 54% with PFS. Satisfaction with the OBD was highest with home use (90% vs 65%). Confidence was high with the OBD; numerically higher rates of patients were confident in giving themselves an injection in the right way (83% vs 64%), in a clean and sterile way (90% vs 74%) and safely (85% vs 72%) post-OBD than before using OBD. Self-injection using the OBD was reported as easy by 92% and convenient by 83% of participants. Most participants reported that they would continue to use the OBD (82%) and be confident to self-inject at home (81%). The OBD was well tolerated.

CONCLUSION

The OBD provides a safe, easy to use and convenient way to self-administer risankizumab at home using one injection with improved satisfaction and confidence vs self-administration of four PFS in hospital.

摘要

目的

评估克罗恩病(CD)患者通过体内装置(OBD)皮下注射司库奇尤单抗的真实世界患者报告体验。

方法

2023年10月至2024年5月在英国五个单位进行的非对照观察性横断面研究。在医院自行皮下注射四支预充式注射器(PFS)进行司库奇尤单抗维持注射的患者改用OBD自行注射。在首次使用OBD之前和之后完成自我注射评估问卷(SIAQ)。主要终点是注射后SIAQ中“总体而言,您对当前服药(自我注射)方式的满意度如何?”。从病历中回顾性收集患者基线数据。

结果

该研究招募了50例中重度CD患者,48例完成研究。大多数(81%)患者对使用OBD自我注射感到满意/非常满意,而使用PFS时这一比例仅为54%。在家中使用OBD时满意度最高(90%对65%)。对OBD的信心较高;与使用OBD之前相比,使用OBD后,在正确注射(83%对64%)、以清洁无菌方式注射(90%对74%)和安全注射(85%对72%)方面,患者的信心在数值上更高。92%的参与者报告使用OBD自我注射很容易,83%的参与者报告很方便。大多数参与者表示他们会继续使用OBD(82%)并对在家中自我注射有信心(81%)。OBD耐受性良好。

结论

与在医院自行注射四支PFS相比,OBD提供了一种在家中自行皮下注射司库奇尤单抗的安全、易用且方便的方式,提高了满意度和信心。

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