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
Department of Immunology, AbbVie, Maidenhead, UK.
Department of Gastroenterology, Guy's and St Thomas' NHS Foundation Trust, London, UK.
Curr Med Res Opin. 2025 May;41(5):829-839. doi: 10.1080/03007995.2025.2506808. Epub 2025 May 23.
To evaluate real-world patient-reported experience with subcutaneous (SC) risankizumab administered by on-body device (OBD) in patients with Crohn's disease (CD).
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.
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.
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.
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。
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。
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。
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。