Manual push technique, an alternative route of subcutaneous immunoglobulin administration in chronic inflammatory demyelinating polyradiculoneuropathy: A proof-of-concept study.

OBJECTIVE: Subcutaneous immunoglobulin (SCIg) administered through infusion pump has been reported as effective in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) patients. In this study we evaluate an alternative technique of SCIg administration, based on the delivery of lower volumes administered daily using manual push technique (MPT) in 10 CIDP patients. METHODS: In this randomized, controlled, two-arm, crossover clinical trial, CIDP patients were randomly assigned 1:1 to receive SCIg either by MPT or pumps for 4 consecutive months with crossover to the other. The primary objective was to assess whether MPT had the same effectiveness as pumps. The secondary objectives were to assess whether MPT resulted in greater plasma IgG levels and improved quality of life (QoL). RESULTS: Ten patients (mean age = 48.3) were enrolled. No significant changes were observed in the efficacy parameters (INCAT, MRC, R-ODS, and GS scales). A positive mean variation of 5.4 % in plasma IgG levels in the group treated with MPT was observed at the end of MPT periods. Treatment interference, which is one of the dimensions of the Life Quality Index, showed a significant improvement in the MPT periods. CONCLUSION: In CIDP patients, the MPT technique was as effective as pump infusion, allowed comparable, slightly increases plasma IgG levels, and also improved the QoL.

Subcutaneous "bolus" immunoglobulin dose in CIDP: A proof-of concept study.

BACKGROUND: Subcutaneous (SC) immunoglobulin (Ig) is an effective therapy for Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP). However, optimal dosage and frequency of administration remain to be clarified. OBJECTIVES: We sought to assess the feasibility and tolerability of a novel regimen of SCIg administration, based on concentrated "bolus" doses delivered every other week, as compared to the "conventional" SCIg regimen, based on 1-3 administrations/week. MATERIALS AND METHODS: Consecutively consenting CIDP patients (6 men and 1 woman) were crossed-over from SCIg "conventional" to SCIg "bolus" and followed-up for 6months. The main endpoints were: tolerability, defined as the percentage of patients successfully completing the study, patient's perceived disability, as measured by the Rasch-built Overall Disability Scale (R-ODS), life quality index (LQI), and inflammatory neuropathy cause and treatment (INCAT) scale. RESULTS: SCIg "bolus" was well tolerated by all patients. The R-ODS score significantly improved (p=0.042), as well as the LQI sub-domains related to the interference of treatment in daily living activities (p=0.026), and therapy-related problems (p=0.039). No significant change was observed in the INCAT (p=0.317) score. There were no cases of drop-out and/or dose adjustment during follow-up. CONCLUSIONS: SCIg "bolus" seems to represent an effective and well-tolerated option for CIDP maintenance therapy.