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Abstract Details

Intravenous Immunoglobulin for Treatment of Demyelinating Polyneuropathy in Patients with Diabetes Mellitus: A Randomized, Double-Blinded, Placebo-Controlled Crossover Trial
Neuromuscular and Clinical Neurophysiology (EMG)
S58 - Therapeutics in Neuromuscular Disorders (1:00 PM-1:11 PM)
001

The management of patients with diabetes and demyelinating polyneuropathy is quite challenging; as it may be difficult to determine if the neuropathy is due to diabetes alone, versus a concomitant immune polyneuropathy, such as CIDP (chronic inflammatory demyelinating polyneuropathy).  Often, there may be overlap in clinical features (particularly if proximal weakness is present), nerve conduction testing, and cerebrospinal fluid profile. As a result, patients with diabetes have typically been excluded from treatment trials in inflammatory polyneuropathies.

To report results from a single-center, double-blinded, randomized, placebo-controlled, cross-over trial testing the response to IVIg immunodulatory treatment, in a population of patients with demyelinating polyneuropathy and diabetes. 

Treatment phases consisted of intravenous immunoglobulin (IVIg) and normal saline placebo, separated by a 3-month washout phase.  The primary outcome measure was the mean change in ONLS (Overall Neuropathy Limitation Scale) during the IVIg phase, as compared with the placebo phase. Secondary outcomes include changes in the Rasch-built Overall Disability Scale, Medical Research Council sum scores, grip strength, electrophysiologic measurements, quality of life, and adverse effects. 

25 subjects underwent randomization between March 2015 and April 2017.  The mean change in ONLS score was -0.2 points during IVIg phase and 0.0 points during the placebo phase (p=0.23). Secondary outcomes also did not show significant differences between IVIg and placebo. Post-hoc exploratory analyses showed more significant improvement in mean ONLS scores in the subgroup exposed to IVIg first, possibly related to duration of neuropathy.
There was no significant improvement in disability scores, strength testing, or quality of life in patients with demyelinating neuropathy and diabetes. 
Authors/Disclosures
Vera Bril, MD (Toronto General Hospital)
PRESENTER
Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for CSL. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alnylam. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Grifols. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Takeda. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Octapharma. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pfizer. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Powell Mansfield. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Akcea. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ionis. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Immunovant. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Momenta (now J&J). Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for NovoNordisk. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Takeda. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Immunovant. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Bril has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Akcea. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alnylam. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for CSL. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Argenx. The institution of Dr. Bril has received research support from UCB. The institution of Dr. Bril has received research support from Argenx. The institution of Dr. Bril has received research support from Momenta (now J&J). The institution of Dr. Bril has received research support from Immunovant. The institution of Dr. Bril has received research support from Alexion. The institution of Dr. Bril has received research support from Takeda. The institution of Dr. Bril has received research support from Grifols. The institution of Dr. Bril has received research support from CSL. The institution of Dr. Bril has received research support from Octapharma. The institution of Dr. Bril has received research support from Akcea. The institution of Dr. Bril has received research support from Ionis. The institution of Dr. Bril has received research support from Viela Bio (now Horizon). Dr. Bril has received intellectual property interests from a discovery or technology relating to health care.
Ari Breiner, MD (Ottawa Hospital, Civic Campus) Dr. Breiner has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Breiner has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alynylam. Dr. Breiner has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Mitsubishi Tanabe. The institution of Dr. Breiner has received research support from Muscular Dystrophy Canada.
Carolina Barnett Tapia, MD Dr. Barnett Tapia has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Argenx. Dr. Barnett Tapia has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. Dr. Barnett Tapia has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for UCB. Dr. Barnett Tapia has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Barnett Tapia has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for argenx. Dr. Barnett Tapia has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen. Dr. Barnett Tapia has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for UCB. Dr. Barnett Tapia has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for argenx. The institution of Dr. Barnett Tapia has received research support from Department of defense. The institution of Dr. Barnett Tapia has received research support from Muscular dystrophy canada. The institution of Dr. Barnett Tapia has received research support from MgNet. The institution of Dr. Barnett Tapia has received research support from NIH. Dr. Barnett Tapia has received intellectual property interests from a discovery or technology relating to health care.
No disclosure on file
Bruce A. Perkins, MPH (Toronto General Hospital) No disclosure on file
Hans D. Katzberg, MD, FAAN An immediate family member of Dr. Katzberg has received personal compensation for serving as an employee of Alexion. Dr. Katzberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Argenx. Dr. Katzberg has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for UCB. Dr. Katzberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Katzberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Dyne. Dr. Katzberg has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merz. Dr. Katzberg has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for CSL Behring. Dr. Katzberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Johnson and Johnson. Dr. Katzberg has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for UCB. Dr. Katzberg has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Syneos Health. Dr. Katzberg has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Katzberg has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for ArgenX.