Timing and course of clinical response to intravenous immunoglobulin in chronic inflammatory demyelinating polyradiculoneuropathy.
OBJECTIVE
To investigate the timing, course, and clinical characteristics of the response to intravenous immunoglobulin in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).


METHODS
Data were extracted from the ICE trial, a randomized, double-blind, placebo-controlled trial of immune globulin intravenous, 10% caprylate/chromatography purified (IGIV-C).


METHODS
Multiple international centers.


METHODS
One hundred seventeen individuals with CIDP. Intervention Treatment with IGIV-C (Gamunex, n = 59) or placebo (n = 58), with IGIV-C administered as a 2-g/kg loading dose followed by a 1-g/kg maintenance dose every 3 weeks, for up to 24 weeks.


METHODS
The primary efficacy parameter was an improvement of 1 or more points in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score. Participants treated with IGIV-C were divided into subgroups based on meeting responder vs nonresponder definitions and by time to first improvement.


RESULTS
Among 30 responders to IGIV-C, 14 (47%) patients had improved adjusted INCAT scores by week 3, and 16 (53%) patients improved at week 6 after a second infusion. Participants who improved by week 3 were more severely disabled at baseline than those who improved at 6 weeks. In patients who improved, the number of individuals reaching maximal improvement continued to increase during maintenance therapy for up to 24 weeks. For patients with first improvement by week 3, the change in dominant-hand grip strength over time tended to parallel the INCAT score. In patients with first improvement by week 6, however, the improvement in dominant-hand grip strength preceded initial improvement in INCAT score.


CONCLUSIONS
Data suggest that treatment with 2 courses of IGIV-C administered 3 weeks apart may be required for initial improvement, and continued maintenance therapy may be necessary to achieve a maximal therapeutic response. Trial Registration clinicaltrials.gov Identifier: NCT00220740.
Latov
Norman
N
Peripheral Neuropathy Center, Cornell University, New York, New York 10021, USA. nol2002@med.cornell.edu
Deng
Chunqin
C
Dalakas
Marinos C
MC
Bril
Vera
V
Donofrio
Peter
P
Hanna
Kim
K
Hartung
Hans-Peter
HP
Hughes
Richard A C
RA
Merkies
Ingemar S J
IS
van Doorn
Peter A
PA
D000200:Action Potentials / Q000187:drug effects; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018592:Cross-Over Studies; D004185:Disability Evaluation; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D018737:Hand Strength / Q000502:physiology; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000627:therapeutic use*; D007155:Immunologic Factors / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D053580:Muscle Strength / Q000187:drug effects; D009431:Neural Conduction / Q000187:drug effects; D020277:Polyradiculoneuropathy, Chronic Inflammatory Demyelinating / Q000188:drug therapy* / Q000503:physiopathology; D013997:Time Factors; D016896:Treatment Outcome
D016756:Immunoglobulins, Intravenous; D007155:Immunologic Factors