An open-label, multicenter study to evaluate the safe and effective use of the single-use autoinjector with an Avonex® prefilled syringe in multiple sclerosis subjects

Abstract

BackgroundThe ability to self-inject in patients with multiple sclerosis (MS) has been associated with a reduced risk of missed injections and drug discontinuation, and a beneficial effect on patients' independence. However, injection anxiety, needle phobia and disease-related disability are major barriers to a patient's ability to self-administer treatment. Use of an autoinjector may improve patients' ability to self-inject. This study evaluated the safe and effective use of Avonex Pen™ (prefilled pen), a single use autoinjector, for intramuscular delivery of interferon beta-1a (IM IFNβ-1a, Avonex) in MS patients.MethodsThis was a Phase IIIb, open-label, single-country, multicenter trial in MS patients currently using IM IFNβ-1a prefilled syringes. Patients received weekly 30 mcg IM IFNβ-1a treatment over 4 weeks. On Day 1, patients self-administered IM IFNβ-1a using a prefilled syringe at the clinic. On Day 8, patients received training on the prefilled pen and self-administered IM IFNβ-1a using the device. On Day 15, patients self-administered IM IFNβ-1a at home using the prefilled pen. A final injection occurred at the clinic on Day 22 when patients self-administered IM IFNβ-1a using the prefilled pen while clinic staff observed and completed a detailed questionnaire documenting patients' ability to self-inject with the device. Serum neopterin levels were evaluated pre and post-injection on Days 1 and 8. Adverse events were monitored throughout.ResultsSeventy-one (96%) patients completed the study. The overall success rate in safely and effectively using the prefilled pen was 89%. No device malfunctions occurred. One unsuccessful administration occurred at Day 22 due to patient error; no patient injury resulted. Patients gave the prefilled pen high ratings (8.7-9.3) on a 10-point scale for ease of use (0 = extremely difficult, 10 = extremely easy). Ninety-four percent of patients preferred the prefilled pen over the prefilled syringe. Induction of serum neopterin levels, serving as a biomarker for type 1 interferon action, was similar to that of the prefilled syringe. The prefilled pen demonstrated a safety profile comparable to the prefilled syringe.ConclusionsThe prefilled pen is a safe and effective device for administration of IM IFNβ-1a and represents an alternative method for self-injection for MS patients using this therapy.Trial registrationThis study is registered at clinicaltrials.gov, identifier: NCT00828204

Single-use autoinjector for peginterferon-β1atreatment of relapsing-remitting multiple sclerosis: safety, tolerability and patient evaluation data from the Phase IIIb ATTAIN study

“…Nevertheless, the consistency of these outcomes with those reported in Year 1 of the ADVANCE study lends support to the direction of the findings reported here. Data from this sub-study also compare well with tolerability and satisfaction data reported using other IFN self-injection devices [10][11][12][13][14][15][16][17][18]. In a 12-month open-label observational Phase IV study, 213 intent-to-treat patients self-administered 30 µg intramuscular IFN-b 1a once weekly via an autoinjector pen.…”

“…In a 6-month interim analysis, > 95% of patients reported being satisfied or very satisfied with the autoinjector, and reported injection fear and anxiety decreased between day 1 and month 6 [11]. Although these studies cannot be directly compared with the current study given the differences in form of IFN, formulation, dose and frequency, in addition to differences in study designs and patient populations, a common theme across the studies is that autoinjectors improve patient satisfaction/ease-of-use [10][11][12][13][14][15][16][17][18], with further evidence of > 95% of patient-reported adherence after 6 months of IFN-b 1a administration via an autoinjector [11]. In the ADVANCE study, patient compliance was > 99% in all study arms [7].…”

Safe and Effective Use of the Once Weekly Dulaglutide Single-Dose Pen in Injection-Naïve Patients With Type 2 Diabetes

“…24 Studies in other disease areas (eg, multiple sclerosis) have demonstrated the clinical benefits and favorable patient perceptions associated with easy-to-use and easy-to-train therapies that are self-injectable. 25,26 A positive self-injection experience, including successful injection, minimal to no pain, ease of use, confidence in ability to use the device, and a once weekly injection schedule, is an important consideration for patients and providers when initiating injectable therapy for T2D.…”

Autoinjector Preference Among Patients with Multiple Sclerosis: Results From A National Survey

“…2,12 A variety of surveys has evaluated patient satisfaction with electronic and mechanical autoinjectors as well as manual injection to date. [8][9][10][14][15][16][17][18][19] In our survey, we queried patient needs and preferences with respect to current electronic (Betaconnect, RebiSmart) and mechanical (ExtaviPro) autoinjectors. These are autoinjectors typically available in Europe for s.c. interferon beta formulations.…”