Multiple sclerosis patients treated with intramuscular IFN-β-1a autoinjector in a real-world setting: prospective evaluation of treatment persistence, adherence, quality of life and satisfaction

Abstract

Objectives: The 12-month observational PERSIST study (NCT01405872) evaluated adherence associated with the intramuscular IFNβ-1a (i.m. IFN-β-1a) autoinjector pen in multiple sclerosis (MS) patients.

Methods: MS patients initiating i.m. IFN-β-1a autoinjector treatment were prospectively assessed for physician-reported persistence (percentage of patients remaining on therapy) and patient-reported outcomes, including adherence (percentage of unmissed injections), compliance (percentage of patients missing no injections), tolerability (injection-site reactions [ISRs] and pain) and satisfaction.

Results: The intent-to-treat population included 232 patients; of the 188 physician-reported 12-month completers, 182 patients remained on treatment (96.8% persistence). Monthly compliance rates were 87.5 – 96.2%. Mean monthly pain scores were 1.5 – 1.8 (scale: 0 = ‘no pain’; 10 = ‘extremely painful’). At 12 months, 73.5% of respondents reported no ISRs, 94.9% were satisfied/very satisfied with the autoinjector and 88.2% found using the device easy/very easy. Injection fear, injection anxiety and need for injection assistance by caregivers decreased from the initial visit to 12 months. No new safety signals were observed.

Conclusions: The autoinjector pen is associated with high levels of persistence, compliance, adherence, and satisfaction, little-to-no pain and low need for caregiver assistance. Although these data are limited by reliance on patient questionnaires and the absence of a direct comparator group, this treatment may reduce barriers to injection therapy, while supporting long-term MS management.

Keywords:

• clinical trial
• IFN-β-1a
• medication adherence
• multiple sclerosis
• Phase IV
• self-administration

Acknowledgments

Parts of this material have been presented at the Sixth Pan-Asian Committee for Treatment and Research in Multiple Sclerosis, 6–8 November 2013, Kyoto, Japan; the 66th Annual Meeting of the American Academy of Neurology, 26 April–3 May 2014, Philadelphia, PA, USA; the 2014 Annual Meeting of the Consortium of Multiple Sclerosis Centers and the Sixth Cooperative Meeting with Americas Committee for Treatment and Research in Multiple Sclerosis, 28–31 May 2014, Dallas, TX, USA; the Joint Congress of European Neurology, 31 May–3 June 2014, Istanbul, Turkey; and the Seventh Pan-Asian Committee for Treatment and Research in Multiple Sclerosis, 6–8 November 2014, Taipei, Taiwan. The authors gratefully acknowledge the study investigators and Gergio Slawka, MD MPH, of Biogen Idec for their contributions.

Declaration of interest

Biogen Idec provided funding for editorial support in the development of this paper. M Hill, PhD, of Infusion Communications provided writing support based on input from the authors. J Safran of Infusion Communications copyedited and styled the manuscript per journal requirements. Biogen Idec reviewed and provided feedback on the paper to the authors. The authors had full editorial control of the paper and provided final approval of all content. R Hupperts has received honoraria and consulting fees from Biogen Idec, Merck Serono, Novartis, Sanofi/Genzyme and Teva. V Becker has received consulting fees from Biogen Idec, Genzyme, Merck Serono and Novartis and grant support from Novartis and Teva. J Friedrich has received funding from Biogen Idec for medical equipment, has participated in an advisory board for Biogen Idec and has been invited to participate in medical congresses or educational activities by Biogen Idec, Genzyme, Merck Serono and Teva. C Gobbi has received honoraria and consulting fees from Biogen Idec, Merck Serono, Novartis, Sanofi/Genzyme and Teva. AV Salgado has received consulting fees from Biogen Idec, Boehringer Ingelheim, Merck Serono, Merck Sharp & Dohme, Novartis, Roche, Sanofi and Servier. B Sperling and X You are employees of Biogen Idec.

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