Abstract: Peginterferon Beta-1a Via Autoinjector in Relapsing Multiple Sclerosis (The 27th Annual Meeting of the CMSC and the 5th Cooperative Meeting of the CMSC-ACTRIMS)

Thursday, May 30, 2013

Peter A Calabresi, MD, FAAN , Johns Hopkins University, Baltimore, MD, USA, Baltimore, MD

Serena Hung, MD , Biogen Idec Inc, Cambridge, MA

Ali Seddighzadeh, MD , Biogen Idec Inc, Cambridge, MA

Shifang Liu, PhD , Biogen Idec Inc, Cambridge, MA

Bjorn Sperling, MD , Biogen Idec Inc, Cambridge, MA

Aaron Deykin, MD , Biogen Idec Inc, Cambridge, MA

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Background: An autoinjector could simplify self-injection of polyethylene glycol-interferon beta-1a (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.

Objectives: To evaluate safety, tolerability, ease-of-use, and patient satisfaction with a single-use autoinjector administering peginterferon beta-1a in a subset of relapsing multiple sclerosis (RMS) patients participating in ATTAIN, a long-term extension study involving patients who completed 96 weeks of the pivotal Phase 3 ADVANCE trial.

Methods: ATTAIN is a multicenter, dose-frequency blinded extension study of the randomized, multicenter, double-blind, placebo-controlled ADVANCE study investigating peginterferon beta-1a 125 µg given every 2 or 4 weeks. In the 8-week ATTAIN sub-study, a subset of patients, self-administered peginterferon beta-1a (125 µg) 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; they were not blinded to device. 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: A total of 39 patients were involved in this sub-study. Data from this study are currently being analyzed and will be presented.

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.

Abstract Supported by: Biogen Idec Inc.

DX15 Peginterferon Beta-1a Via Autoinjector in Relapsing Multiple Sclerosis