Abstract Details

Title Prospective, Open-Label Study Evaluating the Safety and Tolerability of Higher Infusion Rates of Intravenous Immunoglobulin in Patients with Chronic Inflammatory Demyelinating Polyneuropathy. Interim analyses.

Topic Neuromuscular and Clinical Neurophysiology (EMG)

Presentation(s) P2 - Poster Session 2 (5:30 PM-6:30 PM)

Poster/Presentation
Number 12-028

Objective To determine the safety and tolerability of higher infusion rates of 10% intravenous immunoglobulin (IVIG)in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).

Background IVIG, the first-line treatment for CIDP, is typically infused over 4-5 hours. The long infusion time is inconvenient for patients, and increases healthcare costs. Recent studies suggest that rapid infusion can be safe and well tolerated, but there are no prospective data in CIDP.

Design/Methods This is an open-label, prospective study. Patients naïve to IVIG, or those with the last infusion over a month before the screening visit, were loaded with 2g/kg IVIG 10% (Panzyga^®, Octapharma), over 2 days. All patients received a maintenance dose of 1g/kg every 3 or 4 weeks. In the first 4 infusions, IVIG was infused using standard rates, beginning at 0.01 mL/kg/min up to 0.08mL/kg/min. In patients who tolerated the highest standard rate, infusion rates were increased according to tolerance to 0.10mL/kg/min (infusion 5), 0.12mL/kg/min (infusion 6), and 0.14mL/kg/min (infusions 7-13). We recorded all adverse events during the infusions and during the study period.

Results We enrolled 25 patients. Up to October 2017, 114 infusions were completed at standard rate, 21 at 0.1 mL/kg/min, 14 at 0.12 mL/kg/min, and 81 at 0.14 mL/kg/min. During the study period, 45 adverse events (non-fatal) occurred in 18 patients. Only 12 adverse events occurred during the infusion: 11 with standard rates and 1 with higher infusion rate. 3 patients withdrew from the study due to adverse events after the loading dose, a fourth due to pneumonia, and a fifth for personal reasons. Seven patients have completed the study and the remaining will complete in February 2019.

Conclusions Rapid infusion of IVIG up to 0.14mL/kg/min is safe and well tolerated in CIDP subjects. Most adverse events occurred during standard infusion rates, particularly after the loading dose.

Authors/Disclosures
Yue Jiang, MD PRESENTER	No disclosure on file
Vera Bril, MD (Toronto General Hospital)	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.
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Carolina Barnett Tapia, MD	Dr. Barnett Tapia has received personal compensation in the range of $5,000-$9,999 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 as a Consultant for Novartis. Dr. Barnett Tapia has received personal compensation in the range of $500-$4,999 for serving as a Consultant for NMD pharma. 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. The institution of Dr. Barnett Tapia has received research support from Cartesian. The institution of Dr. Barnett Tapia has received research support from Alexion. Dr. Barnett Tapia has received intellectual property interests from a discovery or technology relating to health care.

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