Abstract Details

Title Pharmacokinetics, Safety, and Tolerability of Peginterferon beta-1a Delivered by Single-Use Autoinjector and Pre-Filled Syringe

Topic MS and Related Diseases

Presentation(s) P01 - (-)

Poster/Presentation
Number 163

Objective

Background BACKGROUND: Peginterferon beta-1a is being developed to reduce the frequency of interferon beta-1a administration, and is being tested in a large Phase 3 study (ADVANCE). Autoinjectors are used by patients with multiple sclerosis (MS) to simplify the administration process and reduce the long-term injection burden.

Design/Methods DESIGN/METHODS: This was a Phase 1, single-center, randomized (1:1), open-label, two-sequence, crossover study. Thirty subjects were to be enrolled to have 24 evaluable subjects. Subjects (men and women 18-45 years, BMI 19-29 kg/m2 and ?50.0 kg) received a single dose of peginterferon beta-1a (125 [micro]g subcutaneously) on Day 1 delivered by autoinjector or PFS, followed by another single dose delivered by the other device on Day 22. PK measures of peginterferon beta-1a levels were obtained via serum sampling 2 hours pre-dose and at intervals over 240 hours after each single dose. Safety and tolerability were monitored throughout the study, with a final follow-up on study Day 50. The primary endpoint was area under the curve from time zero to infinity post-dose (AUC0-[infin]). The secondary endpoint was maximum serum concentration (Cmax). Additional PK endpoints included observed time to reach Cmax (Tmax), AUC0-240h, and terminal half-life. Safety and tolerability endpoints included adverse events (AEs), serious AEs, change from baseline in clinical laboratory assessments, vital signs, physical examination, electrocardiogram, and clinician assessment of the injection site.

Results RESULTS: The study has completed enrollment. Final data for the endpoints listed above are being analyzed and will be presented.

Conclusions CONCLUSIONS: The results from this study will help to establish whether administration of peginterferon beta-1a via autoinjector could be a viable option to reduce the burden associated with long-term MS treatment.

Authors/Disclosures
Xiao Hu, PhD (Biogen Idec) PRESENTER	No disclosure on file
Shifang Liu	No disclosure on file
Nicole LaVallee	No disclosure on file
Ali Seddighzadeh	No disclosure on file
Bjorn K. Sperling, MD	No disclosure on file
Edward Fox, MD, PhD, FAAN	Dr. Fox has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion Pharmaceuticals. Dr. Fox has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Fox has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. Dr. Fox has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for EMD Serono. Dr. Fox has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for GW Pharmaceuticals. Dr. Fox has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TG Therapeutics. Dr. Fox has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bristol Myers Squibb. Dr. Fox has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Fox has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Fox has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Alexion. Dr. Fox has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. Dr. Fox has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Genentech. Dr. Fox has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Bristol Myers Squibb. The institution of Dr. Fox has received research support from Biogen. The institution of Dr. Fox has received research support from Genentech. The institution of Dr. Fox has received research support from Celgene - BMS. The institution of Dr. Fox has received research support from Chugai. The institution of Dr. Fox has received research support from Novartis. The institution of Dr. Fox has received research support from EMD-Serono. The institution of Dr. Fox has received research support from TG Therapeutics. The institution of Dr. Fox has received research support from AbbVie. The institution of Dr. Fox has received research support from Sanofi Genzyme. The institution of Dr. Fox has received research support from AbbVie.
Serena W. Hung, MD	No disclosure on file
	No disclosure on file

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