D'Ercole Manuela, Burattini Benedetta, D'Alessandris Quintino Giorgio, Fuggetta Maria Filomena, Pambianco Francesco, Annunziata Francesca, Izzo Alessandro, Montano Nicola
Department of Neurosurgery, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo A. Gemelli 8, Rome, 00168, Italy.
Department of Neuroscience, Università Cattolica del Sacro Cuore, Largo F. Vito, 1, Rome, 00168, Italy.
Neurol Sci. 2025 May;46(5):2229-2234. doi: 10.1007/s10072-024-07965-z. Epub 2025 Jan 13.
Intrathecal baclofen therapy (ITB) is a well-established treatment modality for severe spasticity, but it is burdened by the need for periodic pump refills. The introduction of a new formulation of baclofen with an extended stability of 180 days (Neteka, Nordic Group BV) could decrease the frequency of refills. We aimed at analyzing the clinical and economic impact of Neteka introduction in our outpatient facility.
Forty-eight patients with an implanted device for intrathecal baclofen infusion, who shifted from standard baclofen to Neteka, were included in the present study. We collected clinical and refilling data both from pre-Neteka and Neteka timeframes.
In patients treated with baclofen 2 mg/ml (45/48, 93.8%), the introduction of Neteka led to a significant decrease of median number of refills per year (2.7 vs. 4 in pre-Neteka timeframe, p < 0.0001). This resulted in an improved quality of life, as shown by the reduction of Oberst Caregiving Burden Scale score both for time and difficulty of caregiving (p < 0.0001 and p = 0.0003, respectively). Furthermore, a median saving of 302.40 euro per year per patient, as compared to pre-Neteka timeframe, was registered. Similar results were obtained in the smaller cohort treated with baclofen 0.5 mg/ml (3/48, 6.3%). Neteka appreciation rate was high. As expected, no changes in clinical effectiveness of ITB therapy were observed by comparing pre-Neteka and Neteka timeframes.
The extended half-life provided by Neteka, by reducing the number of refills, could improve patient quality of life, enhance caregiver satisfaction, and decrease the financial burden on healthcare system.
鞘内注射巴氯芬疗法（ITB）是一种成熟的治疗严重痉挛的方法，但需要定期补充泵内药物，这带来了负担。一种新的巴氯芬制剂（Neteka，北欧集团BV），其稳定性延长至180天，可能会减少补充药物的频率。我们旨在分析在我们的门诊机构引入Neteka的临床和经济影响。
本研究纳入了48例植入鞘内巴氯芬输注装置且从标准巴氯芬转换为Neteka的患者。我们收集了Neteka使用前和使用期间的临床及补充药物数据。
在接受2mg/ml巴氯芬治疗的患者中（45/48，93.8%），引入Neteka后每年补充药物的中位数显著减少（Neteka使用前为4次，使用后为2.7次，p<0.0001）。这导致生活质量得到改善，奥伯斯特护理负担量表中护理时间和护理难度得分均降低（分别为p<0.0001和p = 0.0003）。此外，与Neteka使用前相比，每位患者每年节省的费用中位数为302.40欧元。在接受0.5mg/ml巴氯芬治疗的较小队列中（3/48，6.3%）也得到了类似结果。Neteka的满意度很高。正如预期的那样，比较Neteka使用前和使用期间，未观察到ITB治疗的临床效果有变化。
Neteka提供的延长半衰期，通过减少补充药物次数，可以改善患者生活质量，提高护理人员满意度，并减轻医疗系统的经济负担。
