稳定期多发性硬化症患者由注射用药物转换为自我注射肌肉内干扰素β-1a 的耐受性、治疗满意度和生活质量结局：SFERA 研究。

Tolerability, treatment satisfaction and quality of life outcomes in stable multiple sclerosis patients switched from injectable therapies to auto injected intramuscular interferon beta 1a: The SFERA study.

机构信息

Neurocenter of Southern Switzerland, Ospedale Regionale di Lugano, Via Tesserete 46, 6903 Lugano, Switzerland; Faculty of biomedical Sciences, Università della Svizzera Italiana, Via Buffi 13, 6900 Lugano, Switzerland.

Neurologicka klinika LF UK a FN, Sokolská 581, 500 05 Nový Hradec Králové, Czech Republic.

出版信息

Mult Scler Relat Disord. 2019 May;30:104-109. doi: 10.1016/j.msard.2019.02.010. Epub 2019 Feb 6.

DOI:10.1016/j.msard.2019.02.010

PMID:30763907

Abstract

BACKGROUND

Interferon beta (IFNB) and Glatiramer acetate, long-term first line disease modifying treatments (DMTs) for multiple sclerosis (MS), have different injection frequencies crucial for injection site related side effects. We aimed at investigating whether switching to intramuscular IFNB-1a injected once/week with the Avonex®Pen™ device improves treatment tolerability and quality of life in stable MS patients.

METHODS

Clinically stable MS patients, whom their treating neurologist switched from high frequency injectable DMTs to weekly intramuscular IFNB-1a because of bothersome injection site reactions, were included. Injection site and systemic tolerability were measured by a composite 100 mm visual analogue scale at screening, months 4 and 12. Treatment satisfaction, quality of life, relapses and EDSS progression were also recorded. The primary endpoint was change in injection site tolerability from screening to Month 4. Descriptive statistics and Wilcoxon paired signed-rank tests were applied.

RESULTS

The median injection site tolerability and systemic tolerability were significantly improved at months 4 (n = 36) and 12 (n = 33) [change -51.60 (IQR: -60.13, -39.60) mm (p < 0.0001); -26.00 (-54.00, 2.25) mm (p = 0.002)]. Median treatment satisfaction was significantly improved at month 12 [change of 18.00 (2.00, 47.50) mm (p = 0.0003)]. Physical and mental components of the SF-36 did not change significantly, and 30/33 (90.9%) and 33/33 (100%) patients were free from relapses and EDSS progression at month 12.

CONCLUSIONS

Weekly intramuscular IFNB-1a may represent an alternative treatment option for clinically stable MS patients suffering from intolerable injection-related side effects under treatment with high frequency injectable DMTs.

摘要

背景

干扰素β（IFNB）和醋酸格拉替雷是治疗多发性硬化症（MS）的长期一线疾病修正治疗药物（DMT），其注射频率不同，这对与注射部位相关的副作用至关重要。我们旨在研究在稳定的 MS 患者中，改用每周一次肌肉注射 IFNB-1a 是否可以改善治疗耐受性和生活质量。

方法

纳入了因注射部位反应而导致治疗的神经科医生将其从高频注射 DMT 转换为每周一次肌肉注射 IFNB-1a 的临床稳定的 MS 患者。在筛查、第 4 个月和第 12 个月通过 100mm 视觉模拟量表来测量注射部位和全身耐受性。还记录了治疗满意度、生活质量、复发和 EDSS 进展情况。主要终点是从筛查到第 4 个月时注射部位耐受性的变化。采用描述性统计和 Wilcoxon 配对符号秩检验。

结果

第 4 个月（n=36）和第 12 个月（n=33）时，注射部位耐受性和全身耐受性的中位数显著改善[变化-51.60（IQR：-60.13，-39.60）mm（p<0.0001）；-26.00（-54.00，2.25）mm（p=0.002）]。第 12 个月时，治疗满意度中位数显著改善[变化 18.00（2.00，47.50）mm（p=0.0003）]。SF-36 的生理和心理成分没有显著变化，30/33（90.9%）和 33/33（100%）患者在第 12 个月时无复发和 EDSS 进展。