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3.9.1 Internationale NIS: BETAEVAL

BetaEval Global: Prospective, multinational, observational cohort study of patients using BETACONNECT

Auszug aus der Publikation von Patti F et al., Poster EP1807, 2017

Introduction

  • Disease modifying treatment (DMT) for multiple sclerosis (MS) is most effective when patients maintain long-term treatment with minimal interruptions; poor adherence is associated with worse disease outcomes1,2
    • Many factors have been associated with poor adherence, including psychological issues, perceived lack of efficacy, adverse events, disease-related factors, depression, fatigue, motor impairments, and cognitive deficits3,4,5
    • Use of autoinjectors to administer DMTs has been associated with improved adherence6,7
       
  • BETACONNECT is an electronic autoinjector for interferon beta-1b with communication capabilities that may help patients to remain adherent with prescribed therapy; the main features of BETACONNECT include:
    • Electronic control of injection speed, depth, dwell time, and needle retraction
    • Visual and auditory indications at end of dose
    • Quiet injection procedures
    • Auditory and visual injection reminders
    • Data capture: injection time and date, status, depth, speed, and dose
       
  • Several patient surveys of BETACONNECT users found preference for the novel device over the previous injection methods8,9,10

Objective

  • The objective of the BetaEval Global study was to evaluate compliance and adherence to interferon beta-1b among patients using BETACONNECT

Methods

  • BetaEval was a prospective, non-interventional cohort study conducted in 77 centers in 11 European countries
    • Enrolled patients had relapsing-remitting MS (RRMS) or clinically isolated syndrome (CIS) and were starting or currently on treatment with interferon beta-1b per the direction of their treating physicians
       
  • Compliance was defined as the (number of treatment days during observation period / expected number of treatment days during observation period) x 100
    • Compliance was monitored through the read-outs of BETACONNECT or in some instances by patient self-report
    • Assessments were conducted at the initial visit, with follow-up visits planned for Weeks 4, 12, and 24
    • Patients with a compliance ≥80% were considered adherent
    • Multivariate logistic regression models were used to identify potential predictors for compliance and adherence at the final visit using the following covariates: age, sex, baseline Expanded Disability Status Scale (EDSS) score, baseline Center for Epidemiological Studies-Depression (CES-D) score, concomitant diseases and medications, education level, baseline Functional Assessment of Multiple Sclerosis (FAMS) total score, baseline Fatigue Scale – Motor and Cognitive score (FSMC), frequency of myBETAapp use, baseline Hospital Anxiety and Depression Scale (HADS) score, MS duration at the initial visit, participation in the BETAPLUS nurse support program, previous treatment, pain intensity with previous injection method, baseline Symbol-Digit Modalities Test (SDMT) score, satisfaction with myBETAapp, and previous injection method
       
  • Satisfaction with BETACONNECT and the patient`s previous method of injection was assessed using questionnaires at the initial visit and at each individual visit
    • Questionnaires asked patients to rank their satisfaction on a scale from 0 (lowest) to 10 (highest)
    • Use of and satisfaction with myBETAapp was assessed by standardized questions

Results

Patient disposition

  • 500 patients were enrolled, with 498 in the full analysis set
  • 81.4% completed the study
    • The main reasons for study discontinuation were: switching to another injection method (25.8%), withdrawal of consent (22.6%), becoming lost to follow-up (17.2%), and adverse events (9.7%)
    • 96.3% of patients completing the study (and 26.8% of dropouts) still used BETACONNECT at their final visit

Compliance

  • Median compliance remained stable between 93.9% and 95.4% at all visits (Figure 1A)
    • 76.4%, 76.6%, and 81.1% of patients with non-missing compliance data qualified as adherent (ie, had a compliance of ≥80%) at study visits 1, 2, and 3, respectively (Figure 1B)
       
  • Multivariate logistic regression models indicated that better compliance as well as adherence were associated with male gender, existing concomitant disease, shorter disease duration, higher SDMT score at the initial visit, and higher satisfaction with the myBETAapp
Abb. 31: Internationale NIS

Satisfaction with BETACONNECT

  • 450 of 483 patients already being treated with interferon beta-1b (90.4%) completed the satisfaction survey at baseline
    • 66 of these patients (14.7%) were BETACONNECT users
       
  • Median satisfaction scores for BETACONNECT were either 8 or 9 at all time points for both patients with and without prior BETACONNECT experience
    • Median satisfaction with the previous injection method was 8 (on a scale from 0 [lowest] to 10 [highest]) for patients with and without BETACONNECT experience

myBETAapp use

  • The myBETAapp became available in 4 out of the 11 participating countries during the study period
  • 55 of the patients who already had access to the app at the time of the study answered questionnaires used myBETAapp
    • 34.6% of these patients used the app very often
    • 65.5% used the app to remind themselves when it was time to inject
    • 61.8% of the patients using the app agreed or strongly agreed that myBETAapp is user-friendly, and median satisfaction was 8 on a scale from 0-10 (entirely satisfied)
    • 37 patients reported not using the app because they “don`t use apps”, 29 patients stated they did not use it because they “don`t need help with injection tracking and site rotation”

Discussion

  • BetaEval Global showed high rates of compliance and adherence among patients with RRMS or CIS using BETACONNECT to administer interferon beta-1b
    • The BETACONNECT injection data confirmed the high rate of compliance over the entire observation period, with a median compliance >90%
    • This comes along with high satisfaction scores reported during the study, suggesting that patients may perform their injections more regularly when the injection experience is less onerous
       
  • Among patients using myBETAapp >70% (40/55) were adherent
    • This may have occurred because the reminder function on the app limited the impact of patient forgetfulness on adherence
       
  • Over 60% of the patients using myBETAapp agreed or strongly agreed that it was user-friendly (median satisfaction 8 out of 10)
  • Additional research will explore potential benefits of improved compliance through the use of the autoinjector on disease outcomes

Conclusions

  • In this cohort of patients with RRMS or CIS being treated with interferon beta-1b, use of the BETACONNECT autoinjector was associated with high rates of compliance, adherence, and patient satisfaction
  • Ongoing studies will attempt to gain a better understanding of medication intake behavior over the long term and its relationship to outcomes
Literatur

 

  1. Al-Sabbagh A, Bennett D, Kozma C, Dickson M, Meletiche D. Medication gaps in disease-modifying drug therapy for multiple sclerosis are associated with an increased risk of relapse: findings from a national managed care database. J Neurol. 2008;255(Suppl. 2):S79.
  2. Tremlett H, van dM, I, Pittas F, et al. Adherence to the immunomodulatory drugs for multiple sclerosis: contrasting factors affect stopping drug and missing doses. Pharmacoepidemiol Drug Saf. 2008;17(6):565-576.
  3. Treadaway K, Cutter G, Salter A, et al. Factors that influence adherence with disease-modifying therapy in MS. J Neurol. 2009;256(4):568-576.
  4. Lugaresi A. Addressing the need for increased adherence to multiple sclerosis therapy: can delivery technology enhance patient motivation? Expert Opin Drug Deliv. 2009;6(9):995-1002.
  5. Meyniel C, Spelman T, Jokubaitis VG, et al. Country, sex, EDSS change and therapy choice independently predict treatment discontinuation in multiple sclerosis and clinically isolated syndrome. PLoS One. 2012;7(6):e38661.
  6. Pozzilli C, Schweikert B, Ecari U, Oentrich W, Bugge JP. Quality of life and depression in multiple sclerosis patients: longitudinal results of the BetaPlus study. J Neurol. 2012;259(11):2319-2328.
  7. Lugaresi A, Florio C, Brescia-Morra V, et al. Patient adherence to and tolerability of self-administered interferon s-1a using an electronic autoinjection device: a multicentre, open-label, phase IV study. BMC Neurol. 2012;12:7.
  8. Barone DA, Singer BA, Merkov L, Rametta M, Suarez G. Survey of US Patients with multiple sclerosis: comparison of the new electronic interferon beta-1b autoinjector (BETACONNECT) with mechanical autoinjectors. Neurol Ther. 2016;5(2):155-167
  9. Ziemssen T, Sylvester L, Rametta M, Ross AP. Patient satisfaction with the new interferon beta-1b autoinjector (BETACONNECT). Neurol Ther. 2015;4(2):125-136.
  10. Weller I, Saake A, Schreiner T, Vogelreuter J, Petroff N. Patient satisfaction with the BETACONNECT autoinjector for interferon beta-1b. Patient Prefer Adherence. 2015;9:951-959.

Patti F et al., Poster EP1807, A/ECTRIMS 25.10.-28.10.2017, Paris (Frankreich)