Regional Neuromuscular Service, University Hospitals Birmingham, Birmingham, UK.
School of Life and Health Sciences, Aston Brain Centre, Aston University, Aston Triangle, Birmingham, B4 7ET, UK.
J Neurol. 2019 Feb;266(2):461-467. doi: 10.1007/s00415-018-9157-4. Epub 2018 Dec 17.
The clinical and economic implications of an individualised intravenous immunoglobulin (IVIg) protocol for chronic inflammatory demyelinating polyneuropathy (CIDP) are unknown. Comparison with standard dosing regimens has not been performed.
We retrospectively studied 47 IVIg-treated subjects with CIDP over 4 years with an individualised, outcome-measured, dose-modifying protocol. We evaluated responder and remission rates, clinical improvement levels and dose requirements. We compared clinical benefits and costs with those reported with standard dosing at 1 g/kg every 3 weeks.
The IVIg-responder rate was 83% and the 4-year remission rate was 25.6%. Mean IVIg dose requirements were 22.06 g/week (SD:15.29) in patients on ongoing therapy. Dose range was wide (5.83-80 g/week). Mean infusion frequency was every 4.34 weeks (SD:1.70) and infusion duration of 2.79 days (SD:1.15). Mean Overall Neuropathy Limitation Scale improvement was 2.54 (SD:1.89) and mean MRC sum score improvement of 12.23 (SD:7.17) in IVIg-responders. Mean modified-INCAT (Inflammatory Neuropathy Cause and Treatment) score improvement was similar (p = 0.47) and mean MRC sum score improvement greater (p < 0.001) in our cohort, compared to the IVIg-treated arm of the ICE Study. Mean drug costs were GBP 37,660/patient/year (€ 43,309) and mean infusion-related costs of GBP 17,115/patient/year (€ 19,682), totalling GBP 54,775/patient/year (€ 62,991). Compared to standard dosing using recorded weight, mean savings were of GBP 13,506/patient/year (€ 15,532). Compared to standard dosing using dosing weight, savings were of GBP 6,506/patient/year (€ 7,482).
Our results indicate that an individualised IVIg treatment protocol is clinically non-inferior and 10-25% more cost-effective than standard dosing regimens in CIDP.
针对慢性炎症性脱髓鞘性多发性神经病(CIDP),采用个体化静脉注射免疫球蛋白(IVIg)方案的临床和经济意义尚不清楚。尚未与标准剂量方案进行比较。
我们回顾性研究了 47 名接受 IVIg 治疗的 CIDP 患者,这些患者在 4 年内接受了个体化、基于结果的、剂量调整方案。我们评估了应答者和缓解率、临床改善水平和剂量需求。我们将临床获益和成本与标准剂量(每 3 周 1g/kg)进行了比较。
IVIg 应答率为 83%,4 年缓解率为 25.6%。持续治疗的患者平均每周需要 22.06g 的 IVIg(SD:15.29)。剂量范围很广(5.83-80g/周)。平均输注频率为每 4.34 周(SD:1.70),输注时间为 2.79 天(SD:1.15)。IVIg 应答者的总体神经病变限制量表改善平均为 2.54(SD:1.89),MRC 总和评分改善平均为 12.23(SD:7.17)。改良 INCAT(炎症性神经病病因和治疗)评分的改善相似(p=0.47),而我们队列中的 MRC 总和评分改善更大(p<0.001),与 ICE 研究中的 IVIg 治疗组相比。药物成本平均为每位患者每年 37660 英镑(€43309),输注相关成本为每位患者每年 17115 英镑(€19682),合计每位患者每年 54775 英镑(€62991)。与使用记录体重的标准剂量相比,平均节省 13506 英镑/患者/年(€15532)。与使用剂量体重的标准剂量相比,节省了 6506 英镑/患者/年(€7482)。
我们的结果表明,与 CIDP 的标准剂量方案相比,个体化 IVIg 治疗方案在临床上非劣效,并且具有 10-25%的成本效益优势。