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.