Abstract Details

Title Safety, Tolerability and Patient Evaluation of Peginterferon beta-1a Administered Via a Single-Use Autoinjector in Relapsing Multiple Sclerosis: Data from the Phase 3 ATTAIN Study

Topic MS and Related Diseases

Presentation(s) P01 - (-)

Poster/Presentation
Number 167

Objective

Background BACKGROUND: An autoinjector could simplify self-injection of peginterferon beta-1a from a prefilled syringe (PFS). Simplification of the injection process may reduce the burden of administering a long-term therapy, as required in the management of chronic and debilitating conditions such as multiple sclerosis (MS), thereby potentially improving patient quality of life and compliance.

Design/Methods DESIGN/METHODS: ATTAIN is a multicenter, dose-frequency blinded extension study of the Phase 3, placebo-controlled, double-blind, multicenter ADVANCE study investigating peginterferon beta-1a 125 [micro]g given every 2 or 4 weeks. In the 8-week ATTAIN sub-study, a subset of patients, self-administered peginterferon beta-1a (125 [micro]g) or placebo subcutaneously every 2 weeks; the first 2 injections used the manual PFS and the next 2 injections used the single-use peginterferon beta-1a or placebo autoinjector. Patients were trained in the proper use of the autoinjector prior to the first injection. Primary endpoints of the sub-study were incidence of adverse events associated with use of the autoinjector, patient assessment of injection pain score (via a Visual Analog Scale), and clinician assessment of injection site reactions. Additional endpoints included patient assessment of ease-of-use and satisfaction with the autoinjector and evaluation of autoinjector training materials (via questionnaire).

Results RESULTS: A total of 39 patients were involved in this sub-study. Data for endpoints listed above are being analyzed and will be presented.

Conclusions CONCLUSIONS: Results will help to establish the safety and tolerability profiles of peginterferon beta-1a administered via autoinjector in MS patients, and evaluate patient perceptions of the injection process using the autoinjector.

Authors/Disclosures
Peter A. Calabresi, MD, FAAN (Johns Hopkins University) PRESENTER	Dr. Calabresi has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Calabresi has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lilly. Dr. Calabresi has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Idorsia. An immediate family member of Dr. Calabresi has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for MyMD. Dr. Calabresi has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Myelin Repair Foundation. The institution of Dr. Calabresi has received research support from Genentech. Dr. Calabresi has received publishing royalties from a publication relating to health care. Dr. Calabresi has received personal compensation in the range of $500-$4,999 for serving as a Study Section Member with NIH. Dr. Calabresi has received personal compensation in the range of $500-$4,999 for serving as a Grant reveiwer with Myelin Repair Foundation. Dr. Calabresi has received personal compensation in the range of $500-$4,999 for serving as a Speaker for CME with NYAS. Dr. Calabresi has received personal compensation in the range of $500-$4,999 for serving as a Speaker with Academic CME.
Shifang Liu	No disclosure on file
Ali Seddighzadeh	No disclosure on file
Bjorn K. Sperling, MD	No disclosure on file
Serena W. Hung, MD	No disclosure on file
Aaron Deykin, MD (Biogen Idec)	No disclosure on file
	No disclosure on file

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