Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.
Department of Neurology, Aalborg University Hospital, Aalborg, Denmark.
J Neuromuscul Dis. 2023;10(5):787-796. doi: 10.3233/JND-221615.
Attempting discontinuation of treatment in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) is recommended. However, there is no evidence based regimen for tapering off subcutaneous immunoglobulin (SCIG). This trial investigated stepwise tapering off SCIG to detect remission and the lowest effective dosage. During tapering off, frequent vs less frequent clinical evaluation was compared.
Patients with CIDP receiving a stable SCIG dosage followed a standardized tapering off regimen: 90%, 75%, 50%, 25% and 0% of the initial dose every 12th week, pending no deterioration occurred. In case of relapse during tapering off, the lowest effective dose was identified. Treatment with SCIG was registered for two years after participation. Disability score and grip strength were primary parameters. Participants were randomized to clinical evaluation every 6th week (frequent) or 12th week (less frequent).
Fifty-five patients were included of which thirty-five relapsed. Twenty patients (36%) were able to discontinue treatment without relapse. In relapsing patients, median dosage could be reduced by 10% (range, 0-75). After two years, 18 of 20 patients were still in remission without treatment. Frequent clinical evaluation did not detect deterioration more frequently than less frequent evaluation; RR 0.5 (95% CI, 0.2-1.2) (p = 0.17).
In stable CIDP patients, SCIG could be completely tapered off in 36% of the patients and only in 10% of these patients relapse occurred during the following two years. More frequent evaluation was not superior to detect deterioration.
建议尝试停止慢性炎症性脱髓鞘性多发性神经病（CIDP）患者的治疗。然而，目前尚无基于证据的皮下免疫球蛋白（SCIG）减量方案。本试验研究了 SCIG 逐步减量以检测缓解和最低有效剂量。在减量过程中，比较了频繁与不频繁的临床评估。
接受稳定 SCIG 剂量的 CIDP 患者遵循标准化的减量方案：每 12 周减少初始剂量的 90%、75%、50%、25%和 0%，前提是没有恶化发生。如果在减量过程中出现复发，则确定最低有效剂量。在参与后两年内登记 SCIG 治疗。残疾评分和握力是主要参数。参与者被随机分为每 6 周（频繁）或 12 周（不频繁）进行临床评估。
共纳入 55 例患者，其中 35 例复发。20 例（36%）患者能够在无复发的情况下停止治疗。在复发患者中，中位数剂量可减少 10%（范围，0-75）。两年后，20 例患者中有 18 例仍无需治疗即可缓解。频繁的临床评估并未比不频繁的评估更频繁地发现恶化；RR 0.5（95%CI，0.2-1.2）（p=0.17）。
在稳定的 CIDP 患者中，36%的患者可以完全停用 SCIG，并且在接下来的两年中，只有 10%的患者在减量过程中复发。更频繁的评估并不能更好地发现恶化。
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