从参考阿达木单抗或另一种阿达木单抗生物类似物过渡到 CT-P17 后的患者满意度和使用体验:真实世界YU-MATTER研究的结果。

IF 5.4 2区 医学 Q1 IMMUNOLOGY BioDrugs Pub Date : 2024-11-01 Epub Date: 2024-09-25 DOI:10.1007/s40259-024-00681-2
Guillaume Bouguen, Laure Gossec, Vered Abitbol, Eric Senbel, Guillaume Bonnaud, Xavier Roblin, Yoram Bouhnik, Stéphane Nancey, Nicolas Mathieu, Jérôme Filippi, Lucine Vuitton, Stéphane Nahon, Azeddine Dellal, Alice Denis, Lucile Foulley, Caroline Habauzit, Salim Benkhalifa, Hubert Marotte
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引用次数: 0

摘要

背景和目的:对于炎症性肠病(IBD)和慢性炎症性风湿病(CIRD)患者而言,生物仿制药是具有成本效益的参比产品替代品,但患者的观念可能会影响对过渡治疗的依从性。本研究旨在探讨患者转用CT-P17(一种高浓度(100毫克/毫升)、不含枸橼酸的阿达木单抗生物类似药)后的体验和满意度:这项观察性、多中心、前瞻性法国研究纳入了从参考阿达木单抗(R-ADA;100毫克/毫升)或低浓度阿达木单抗生物类似物(ADA-BioS;50毫克/毫升)转用CT-P17的IBD或CIRD成年患者。患者完成了在线问卷调查,以评估纳入研究时(之前接受过治疗)和接受 CT-P17 治疗 3 个月后的治疗感知、满意度和耐受性。主要标准是患者的总体满意度,采用 7 点李克特量表评估 "您对 CT-P17 注射的总体满意度如何?为确定改用 CT-P17 后治疗满意度提高的相关因素,进行了多变量逻辑回归分析:总分析人群包括 232 名患者(IBD 72.0%,CIRD 28.0%)。患者年龄中位数为 57.0 岁(四分位数间距 [IQR] 46.0-63.0),50.4% 为男性,病程中位数为 9 年(IQR 5-16)。约半数患者(51.2%)从ADA-BioS(包括19.4%从含枸橼酸盐的ADA-BioS)改用CT-P17,半数患者(48.7%)从R-ADA改用CT-P17。对治疗感到满意的患者比例在基线(之前的治疗)和 3 个月(CT-P17 治疗)之间保持稳定。从 ADA-BioS 转用 CT-P17 后(22.7% 对从 R-ADA 转用 CT-P17 时的 8.0%;p = 0.002),或从含有枸橼酸盐的 ADA-BioS 转用 CT-P17 后(28.9% 对从不含枸橼酸盐的 ADA-BioS 转用 CT-P17 时的 12.3%;p = 0.008),更多患者表示满意度提高。满意度提高的独立预后因素是既往接受过 ADA-BioS 治疗(几率比 [OR] 2.88 [95% 置信区间 1.17-7.08];p = 0.021)和既往治疗时注射部位疼痛(OR 1.26 [1.08-1.47];p = 0.004)。与基线相比,CT-P17 治疗 3 个月后报告疼痛、发红、瘙痒和血肿的患者明显减少(p 结论:CT-P17 治疗 3 个月后疼痛、发红、瘙痒和血肿的患者明显减少:从 R-ADA 或 ADA-BioS 改用 CT-P17 后,大多数患者的治疗满意度保持稳定或有所提高。特别是,从低浓度 ADA-BioS 或含有枸橼酸盐的 ADA-BioS 改用 CT-P17 与患者满意度提高有关。与之前的阿达木单抗治疗相比,CT-P17的总体耐受性也有所改善:试验注册:ClinicalTrials.gov标识符NCT05427942,2022年6月22日注册。
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Patient Satisfaction and Experience with CT-P17 Following Transition from Reference Adalimumab or Another Adalimumab Biosimilar: Results from the Real-World YU-MATTER Study.

Background and objectives: Biosimilars are cost-effective alternatives to reference products for patients with inflammatory bowel diseases (IBD) and chronic inflammatory rheumatic diseases (CIRD), but patient beliefs can affect adherence to the transition. This study aimed to explore patient experience and satisfaction after switching to CT-P17, a high-concentration (100 mg/mL), citrate-free adalimumab biosimilar.

Patients and methods: This observational, multicenter, prospective French study included adult patients with IBD or CIRD who switched to CT-P17 from reference adalimumab (R-ADA; 100 mg/mL) or a low-concentration adalimumab biosimilar (ADA-BioS; 50 mg/mL). Patients completed online questionnaires to assess treatment perceptions, satisfaction, and tolerance at study inclusion (under previous treatment) and over 3 months of CT-P17 treatment. The primary criterion was overall patient satisfaction, which was assessed with the question, "What is your global satisfaction with the CT-P17 injection?", using a 7-point Likert scale. Multivariate logistic regression analysis was performed to identify factors associated with increased treatment satisfaction after switching to CT-P17.

Results: The total analysis population included 232 patients (IBD 72.0%, CIRD 28.0%). Median patient age was 57.0 years (interquartile range [IQR] 46.0-63.0), 50.4% were men, and median disease duration was 9 years (IQR 5-16). Approximately half of the cohort (51.2%) switched to CT-P17 from an ADA-BioS (including 19.4% from an ADA-BioS with citrate) and half (48.7%) from R-ADA. The proportion of patients who were satisfied with treatment was stable between baseline (under previous treatment) and 3 months (under CT-P17). More patients reported increased satisfaction after switching to CT-P17 from an ADA-BioS (22.7% vs 8.0% when switching from R-ADA; p = 0.002), or from an ADA-BioS containing citrate (28.9% vs 12.3% when switching from a citrate-free ADA-BioS; p = 0.008). Independent prognostic factors for increased satisfaction were previous treatment with an ADA-BioS (odds ratio [OR] 2.88 [95% confidence interval 1.17-7.08]; p = 0.021) and pain at the injection site under previous treatment (OR 1.26 [1.08-1.47]; p = 0.004). Significantly fewer patients reported pain, redness, itching, and hematoma after 3 months of CT-P17 treatment versus baseline (p < 0.001).

Conclusions: The majority of patients had stable or increased treatment satisfaction after switching from R-ADA or an ADA-BioS to CT-P17. In particular, switching to CT-P17 from a low-concentration ADA-BioS or an ADA-BioS containing citrate was associated with increased patient satisfaction. An improvement in overall tolerance with CT-P17 versus previous adalimumab treatment was also reported.

Trial registration: ClinicalTrials.gov identifier NCT05427942, registered June 22, 2022.

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来源期刊
BioDrugs
BioDrugs 医学-免疫学
CiteScore
12.60
自引率
2.90%
发文量
50
审稿时长
>12 weeks
期刊介绍: An essential resource for R&D professionals and clinicians with an interest in biologic therapies. BioDrugs covers the development and therapeutic application of biotechnology-based pharmaceuticals and diagnostic products for the treatment of human disease. BioDrugs offers a range of additional enhanced features designed to increase the visibility, readership and educational value of the journal’s content. Each article is accompanied by a Key Points summary, giving a time-efficient overview of the content to a wide readership. Articles may be accompanied by plain language summaries to assist patients, caregivers and others in understanding important medical advances. The journal also provides the option to include various other types of enhanced features including slide sets, videos and animations. All enhanced features are peer reviewed to the same high standard as the article itself. Peer review is conducted using Editorial Manager®, supported by a database of international experts. This database is shared with other Adis journals.
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