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患者在由参考阿达木单抗或其他阿达木单抗生物类似药转换为 CT-P17 后的满意度和体验:来自真实世界 YU-MATTER 研究的结果。

Patient Satisfaction and Experience with CT-P17 Following Transition from Reference Adalimumab or Another Adalimumab Biosimilar: Results from the Real-World YU-MATTER Study.

机构信息

Rennes University Hospital, Rennes University, INSERM, CIC1414, NUMECAN (Nutrition Metabolism and Cancer) Institute, Rennes, France.

Sorbonne University, INSERM, Pierre Louis Institute of Epidemiology and Public Health, Paris, France.

出版信息

BioDrugs. 2024 Nov;38(6):867-878. doi: 10.1007/s40259-024-00681-2. Epub 2024 Sep 25.

Abstract

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.

摘要

背景和目的

生物类似药是炎症性肠病(IBD)和慢性炎症性风湿病(CIRD)患者替代参考产品的具有成本效益的选择,但患者的信念可能会影响其对转换的依从性。本研究旨在探索患者在转换为高浓度(100mg/mL)、无柠檬酸盐的阿达木单抗生物类似药 CT-P17 后的体验和满意度。

患者和方法

这是一项观察性、多中心、前瞻性法国研究,纳入了 IBD 或 CIRD 成年患者,他们从参考阿达木单抗(R-ADA;100mg/mL)或低浓度阿达木单抗生物类似药(ADA-BioS;50mg/mL)转换为 CT-P17。患者在研究纳入时(在先前治疗下)和 CT-P17 治疗的 3 个月内,通过在线问卷评估治疗认知、满意度和耐受性。主要标准是总体患者满意度,使用 7 分李克特量表评估“您对 CT-P17 注射的整体满意度如何?”问题。采用多变量逻辑回归分析来确定与转换为 CT-P17 后治疗满意度增加相关的因素。

结果

总分析人群包括 232 名患者(IBD 占 72.0%,CIRD 占 28.0%)。患者的中位年龄为 57.0 岁(四分位距 [IQR] 46.0-63.0),50.4%为男性,中位疾病持续时间为 9 年(IQR 5-16)。大约一半的队列(51.2%)从 ADA-BioS(包括 19.4%从含柠檬酸盐的 ADA-BioS)转换为 CT-P17,一半(48.7%)从 R-ADA 转换。从 ADA-BioS(22.7% vs 8.0%,从 R-ADA 转换;p=0.002)或含柠檬酸盐的 ADA-BioS(28.9% vs 12.3%,从无柠檬酸盐的 ADA-BioS 转换)转换为 CT-P17 的患者中,治疗满意度稳定增加。增加满意度的独立预测因素是先前使用 ADA-BioS(比值比 [OR] 2.88 [95%置信区间 1.17-7.08];p=0.021)和先前治疗时注射部位疼痛(OR 1.26 [1.08-1.47];p=0.004)。与基线相比,在 CT-P17 治疗 3 个月后,患者报告疼痛、发红、瘙痒和血肿的频率显著降低(p<0.001)。

结论

大多数患者在从 R-ADA 或 ADA-BioS 转换为 CT-P17 后,治疗满意度保持稳定或增加。特别是,从低浓度 ADA-BioS 或含柠檬酸盐的 ADA-BioS 转换为 CT-P17 与患者满意度的增加相关。与先前的阿达木单抗治疗相比,总体耐受性也有所改善。

临床试验注册

ClinicalTrials.gov 标识符 NCT05427942,于 2022 年 6 月 22 日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3ae2/11530508/d3335a802f40/40259_2024_681_Fig1_HTML.jpg

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