Adherence, satisfaction and functional health status among patients with multiple sclerosis using the BETACONNECT® autoinjector: a prospective observational cohort study

BMC Neurol. 2017 Sep 6;17(1):174. doi: 10.1186/s12883-017-0953-8.

Abstract

Background: Maintaining patient adherence to disease modifying drugs in multiple sclerosis is a challenge, which can be improved by autoinjectors. The BETACONNECT® is a fully electronic autoinjector for the injection of interferon beta-1b (IFN beta-1b) automatically recording injections.

Methods: The BETAEVAL study was a prospective, observational, cohort study over 24 weeks among patients with relapsing remitting multiple sclerosis or clinically isolated syndrome treated with IFN beta-1b in Germany using the BETACONNECT®. The primary aim was to investigate treatment adherence, secondary aims included assessing satisfaction and functional health status. Adherence was evaluated from injection data recorded by the device. Patient-related data were obtained from clinical examinations and patient questionnaires.

Results: Of the 151 patients enrolled, 143 were available for analysis. Thirty-four patients discontinued the study prematurely. 107/143 (74.8%) patients still used the BETACONNECT® at the end of the study. Injection data from the device at any visit was available for 107 patients. Among those, the percentage of adherent patients injecting ≥80% of doses and still participating in the study was 57.9% at week 24. 29% of patients prematurely stopped the study, 13.1% injected <80%. Among patients with BETACONNECT® data at the respective visit, the proportion of adherent patients was high over the entire study period (week 4: 81.1% [N = 95], week 12: 86.7% [N = 83], week 24: 80.5% [N = 77]). Participants (N = 143) indicated high satisfaction with the BETACONNECT®. At week 24, 98.0% of patients who completed the corresponding questionnaire (strongly) agreed that it was user-friendly, 81.2% felt confident in using it compared to their previous way and 85.5% preferred it to their previous way of injection. Injection-related pain was rated as mild to moderate at all follow-up visits. Whereas 17.2% of patients with corresponding questionnaire indicated using analgesics prior to injection at week 4, only 9.1% did at week 24. Outcomes from questionnaires assessing functional health status, depression, fatigue and cognitive function were very similar throughout the study course.

Conclusions: The majority of patients continued using the BETACONNECT® for IFN beta-1b treatment during the 24-week study period. Adherence was high among participants still using the BETACONNECT® and patients were highly satisfied with the device. Ongoing studies will evaluate long-term adherence and treatment outcomes in patients using the BETACONNECT®.

Trial registration: clinicaltrails.gov NCT02121444 (registered April 22, 2014).

Keywords: Adherence; Autoinjector; BETACONNECT®; Compliance; Disease modifying drugs; Interferon beta-1b; Multiple sclerosis; Persistence; Satisfaction.

Publication types

  • Observational Study

MeSH terms

  • Adult
  • Aged
  • Cohort Studies
  • Female
  • Germany
  • Health Status
  • Humans
  • Injections, Subcutaneous
  • Interferon beta-1b / administration & dosage*
  • Interferon beta-1b / therapeutic use
  • Male
  • Medication Adherence*
  • Middle Aged
  • Multiple Sclerosis / drug therapy*
  • Multiple Sclerosis, Relapsing-Remitting / drug therapy*
  • Patient Satisfaction
  • Prospective Studies
  • Surveys and Questionnaires
  • Treatment Outcome
  • Young Adult

Substances

  • Interferon beta-1b

Associated data

  • ClinicalTrials.gov/NCT02121444