Persistence and Treatment Satisfaction in Patients Using The Avonex Pen

Background: The AVONEX PEN (once-weekly intramuscular [IM] interferon [IFN] beta-1a autoinjector) is an approved, safe, and effective drug-delivery system. In a phase 3b study of 74 patients with multiple sclerosis (MS) treated initially with manual injection and subsequently switched to autoinjection for 4 weeks, patients preferred the AVONEX PEN over manual injection.

Objectives: Report first interim results of the PERSIST study, which assesses whether this preference translates into persistence, convenience, adherence, and quality of life (QOL) over 12 months in patients with MS using the AVONEX PEN.

Methods: PERSIST is a global, prospective, observational, 12-month phase 4 study of MS patients administering IM IFN beta-1a therapy by autoinjector. Outcomes evaluated at 6 and 12 months include physician-reported persistence and patient-reported adherence. Patient-reported tolerability, ease of use, satisfaction, fear of injection, and QOL are being assessed at 3, 6, and 12 months using questionnaires. Three-month patient satisfaction data have been analyzed.

Results: Two hundred sixty-nine MS patients (mean age 43.0 years; 75.5% female) have been enrolled in PERSIST. Enrollment is complete, and 3-month data are now available for nearly 100 patients. At 3 months, 76.6% of patients reported injection-related pain levels ≤2 (0=no pain; 10=extremely painful). The majority of patients (82.8%) reported no injection site reaction at 3 months; 95.8% of patients were satisfied or very satisfied with the autoinjector at 3 months, while 4.2% were dissatisfied or very dissatisfied. Autoinjection was reported to be easy or very easy by 90.1% of patients at 3 months and somewhat easy or not easy at all by 9.9%. The proportion of patients reporting fear of injection decreased from 33.3% at baseline to 4.2% at 3 months, and the proportion of patients reporting anxiety decreased from 25.0% to 4.2%. Of the patients who read the directions for use, the majority reported that the directions were helpful (88.9%) and easy to understand (88.9%); 77.8% were satisfied or very satisfied with the level of detail provided.

Conclusions: The IM IFN beta-1a autoinjector was well tolerated and perceived by patients as easy to use over the first 3 months of the PERSIST study. Patients reported being highly satisfied; fear and anxiety about injection decreased substantially over time. Analyses presented will include 6-month interim data for approximately 250 patients.