Table 3.
Study name | Study objective | Study design | Indication | Sample size | Follow-up period | Key results |
---|---|---|---|---|---|---|
Kleiter et al (2017)32 | To investigate adherence to therapy, satisfaction, and functional health status among patients treated with interferon β-1b using the BETACONNECT™ autoinjector | Prospective, observational | RRMS | 151 | 24 weeks | • Patient age (mean ± SD) was 41.2±11.5 years • Adherence of ≥80% declined from 72.0% (week 4) to 67.3% (week 12) and 57.9% (week 24) for patients with a least one data readout and from 81.1% at week 4 to 86.7% at week 12 to 80.5% at week 24 for patients at the respective visit • Compliance was 86.3% at week 4, 91.9% at week 12, and 92.9% at week 24 • Age tended to be a predictor of persistence at 24 weeks with patients ≥40 years being more likely to still use the BETACONNECT™ at follow-up visits (OR =1.047, 95% CI 1.003, 1.093) • Treatment-naive patients showed overall higher persistence (OR =12.246; 95% CI 2.191, 68.457) |
Patti et al (2017)33 | To measure adherence in patients with RRMS or CIS who were treated with interferon β-1b using BETACONNECT™ | Multicenter, prospective, single-arm, observational | RRMS and CIS | 498 (474 RRMS and 26 CIS) | 24 weeks | • Patient age (median) was 44 years • Adherence (defined as completing ≥80% of prescribed injections) was assessed at baseline, week 4, week 12, and week 24. Median adherence remained stable between 93.9% and 95.4% at all visits • Higher adherence was associated with male gender, existing concomitant disease, shorter disease duration, higher SDMT score and higher satisfaction with the myBETApp |
Rametta et al (2017)34 | To assess adherence to interferon β-1b therapy in patients who are using the BETACONNECT™ autoinjector | Multicenter, prospective, single-arm, observational | RRMS | 89 | 6 weeks | • Patient age (mean) was 52 years; majority (77.5%) of patients aged ≥45 years • Mean adherence rate was 97.6% (SD 9.0%) • 95.5% of patients reached ≥80% adherence |
Abbreviations: CIS, clinically isolated syndrome; OR, odds ratio; RRMS, relapsing-remitting multiple sclerosis; SDMT, Symbol Digit Modalities Test.