Russell L Chin1, Chunqin Deng2, Vera Bril3, Hans-Peter Hartung4, Ingemar S J Merkies5, Peter D Donofrio6, Pieter A Van Doorn7, Marinos C Dalakas8, Norman Latov1. 1. Weill Cornell Medical College, 1305 York Avenue, Room 217, New York, New York, 10021, USA. 2. Grifols, Durham, North Carolina, USA. 3. Toronto General Hospital, Toronto, Ontario, Canada. 4. Heinrich Heine University Düsseldorf, Düsseldorf, Germany. 5. Maastricht University Medical Center, Maastricht and Spaarne Hospital, Hoofdorp, The Netherlands. 6. Vanderbilt University, Nashville, Tennessee, USA. 7. Erasmus University Medical Center, Rotterdam, The Netherlands. 8. Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
Abstract
INTRODUCTION: Electrodiagnostic studies (EDX) are not performed routinely before treatment suspension in CIDP, and no data exist regarding their value in predicting clinical relapse. METHODS:Serial EDX (baseline and after IGIV-C therapy) were analyzed from subjects in the ICE clinical trial who responded to IGIV-C treatment and were subsequently re-randomized toplacebo in an extension phase. Comparisons were made between subjects who relapsed and those who did not. RESULTS: A total of 55% (6/11) of the Relapse group had an increase in total number of demyelinating findings (DF) versus 8% (1/13) in the No Relapse group (P = 0.023). In the Relapse group, 100% had ≥ 1 new DF and 73% (8/11) had ≥ 4 new DF versus 60% (8/13) and 8% (1/13), respectively, in the No Relapse group. CONCLUSIONS: An increased total number of DF or the occurrence of ≥ 4 new DF may indicate a higher risk of clinical relapse after treatment cessation in IGIV-C-responsive patients.
RCT Entities:
INTRODUCTION: Electrodiagnostic studies (EDX) are not performed routinely before treatment suspension in CIDP, and no data exist regarding their value in predicting clinical relapse. METHODS: Serial EDX (baseline and after IGIV-C therapy) were analyzed from subjects in the ICE clinical trial who responded to IGIV-C treatment and were subsequently re-randomized to placebo in an extension phase. Comparisons were made between subjects who relapsed and those who did not. RESULTS: A total of 55% (6/11) of the Relapse group had an increase in total number of demyelinating findings (DF) versus 8% (1/13) in the No Relapse group (P = 0.023). In the Relapse group, 100% had ≥ 1 new DF and 73% (8/11) had ≥ 4 new DF versus 60% (8/13) and 8% (1/13), respectively, in the No Relapse group. CONCLUSIONS: An increased total number of DF or the occurrence of ≥ 4 new DF may indicate a higher risk of clinical relapse after treatment cessation in IGIV-C-responsive patients.
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