Abstract Details

Title Understanding IVIg Prescribing Habits through INSIGHTS (Immunological and Neurological Study of Immune Globulin Habits Treatments and Standards)

Topic Peripheral Nerve

Presentation(s) P01 - (-)

Poster/Presentation
Number 153

Objective

Background BACKGROUND: IVIg is considered standard of care for several neuromuscular disorders and is FDA-approved for two of these conditions. Many of these diseases are rare and have variant presentations requiring specific criteria for diagnosis. Off-label use is common, while treatment is often provided without the benefit of specific guidance from clinical trials. Prescribing regimens can be variable and strategies for tapering patients in remission are unknown. Despite this practice environment, there has been little effort to coordinate data collection to understand practice habits and outcomes. As a home infusion provider of IVIG, we have designed a quality improvement study to collect this data across the scope of practice.

Design/Methods DESIGN/METHODS: INSIGHTS is a physician led quality assessment/quality improvement study that is now part of NuFACTOR's healthcare operations. Data collected is limited to that supplied through routine clinical care and basic medical documentation for patients prescribed IVIG. Time to an objective or subjective response and quality of life score are the primary endpoints. They are compared with diagnosis, specific clinical and electrodiagnostic findings, and dose of IVIG. Records are assessed by a team of physicians with experience in neuromuscular disorders, who will parse out the key phenotypic data and outcomes.

Results RESULTS: To date, 113 patients are enrolled in the study. This data will be presented in April.

Conclusions CONCLUSIONS: Organizing data and determining practice habits for patients prescribed IVIg is critical. These novel methods enable the collection of data on a large number of patients receiving IVIg and serve as an initial step in understanding outcomes within NuFACTOR'S patient population.

Authors/Disclosures
Jonathan S. Katz, MD (CPMC) PRESENTER	Dr. Katz has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Katz has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mitsubishi Tanabe. Dr. Katz has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Calico. Dr. Katz has received personal compensation in the range of $500-$4,999 for serving as a Consultant for CSL Behring. Dr. Katz has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Argenyx. Dr. Katz has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amylyx. Dr. Katz has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Denali. Dr. Katz has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Griffols. Dr. Katz has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Katz has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Alexion.
Todd D. Levine, MD (Honor Health)	Dr. Levine has received personal compensation for serving as an employee of CND life sciences . Dr. Levine has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Nufactor. Dr. Levine has received personal compensation in the range of $50,000-$99,999 for serving as an Expert Witness for PNA. Dr. Levine has or had stock in CND Life Sciences.Dr. Levine has or had stock in Corinthian reference lab.
Richard J. Barohn, MD, FAAN (University of Missouri)	Dr. Barohn has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for NuFactor. The institution of Dr. Barohn has received research support from FDA OPD R01. Dr. Barohn has received intellectual property interests from a discovery or technology relating to health care.
Tahseen Mozaffar, MD, FAAN (University of California Irvine)	Dr. Mozaffar has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Alexion Pharmaceuticals. Dr. Mozaffar has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Argenx. Dr. Mozaffar has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi-Genzyme. Dr. Mozaffar has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amicus. Dr. Mozaffar has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Grifols. Dr. Mozaffar has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Astellas Gene Therapy. Dr. Mozaffar has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bayer. Dr. Mozaffar has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sarepta. Dr. Mozaffar has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Applied Therapeutics. The institution of Dr. Mozaffar has received research support from NIH. The institution of Dr. Mozaffar has received research support from Muscular Dystrophy Association. The institution of Dr. Mozaffar has received research support from Sanofi. The institution of Dr. Mozaffar has received research support from Argenx. The institution of Dr. Mozaffar has received research support from Amicus Therapeutics. The institution of Dr. Mozaffar has received research support from Astellas Gene Therpay. The institution of Dr. Mozaffar has received research support from Cartesian. The institution of Dr. Mozaffar has received research support from Cabaletta. Dr. Mozaffar has received personal compensation in the range of $500-$4,999 for serving as a Study Section Member with NIH.
Gil I. Wolfe, MD, FAAN (Univ. At Buffalo, SUNY)	Dr. Wolfe has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Grifols. Dr. Wolfe has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Alexion. Dr. Wolfe has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for ArgenX. Dr. Wolfe has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for UCB/Ra. Dr. Wolfe has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. Dr. Wolfe has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Cartesian. Dr. Wolfe has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Grifols. The institution of Dr. Wolfe has received research support from UCB/Ra. The institution of Dr. Wolfe has received research support from Immunovant. The institution of Dr. Wolfe has received research support from Roche. Dr. Wolfe has received personal compensation in the range of $0-$499 for serving as a Advisor with FDA Advisory Panel for Cellular, Tissue and Genetic Therapies.
Andrew D. Goodman, MD, FAAN (University of Rochester Dept. Neurology)	Dr. Goodman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Swan Bio. Dr. Goodman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Goodman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. Dr. Goodman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lilly. Dr. Goodman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Goodman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TG Therapeutics. Dr. Goodman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for IMCYSE. Dr. Goodman has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Pfizer. The institution of Dr. Goodman has received research support from Atara. The institution of Dr. Goodman has received research support from Genzyme. The institution of Dr. Goodman has received research support from EMD-Serono.
David S. Saperstein, MD (Center for Complex Neurology, EDS & POTS)	No disclosure on file
Lara W. Katzin, MD (Colorado Permanente Medical Group)	Dr. Katzin has nothing to disclose.
Elissa A. Ritt (Argenx)	No disclosure on file
Leslie J. Vaughan, RPh (NuFACTOR)	No disclosure on file
Michelle Greer	No disclosure on file

��ɫ��

��ɫ��