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Patient adherence to and tolerability of self-administered interferon β-1a using an electronic autoinjection device: a multicentre, open-label, phase IV study.

Lugaresi A, Florio C, Brescia-Morra V, Cottone S, Bellantonio P, Clerico M, Centonze D, Uccelli A, di Ioia M, De Luca G, Marcellusi A, Paolillo A, BRIDGE study gro - BMC Neurol (2012)

Bottom Line: No significant changes (baseline-Week 12) in mean HADS depression (P = 0.482) or anxiety (P = 0.156) scores were observed. 'Overall convenience' was the most important reported benefit of the autoinjection device.Mean MSTCQ scores for 'flu-like' symptoms (P = 0.022) and global side effects (P = 0.002) significantly improved from Week 4-12.No new safety signals were identified.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Neuroscience and Imaging, University "G, d'Annunzio", Via dei Vestini 31, 66100 Chieti, Italy. a.lugaresi@unich.it

ABSTRACT

Background: Achieving good adherence to self-injected treatments for multiple sclerosis can be difficult. Injection devices may help to overcome some of the injection-related barriers to adherence that can be experienced by patients. We sought to assess short-term adherence to, and tolerability of, interferon (IFN) β-1a administered via electronic autoinjection device in patients with relapsing-remitting multiple sclerosis (RRMS).

Methods: BRIDGE (RebiSmart to self-inject Rebif serum-free formulation in a multidose cartridge) was a 12-week, multicentre, open-label, single-arm, observational, Phase IV study in which patients self-administered IFN β-1a (titrated to 44 μg), subcutaneously (sc), three times weekly, via electronic autoinjection device. Patients were assessed at baseline and 4-weekly intervals to Week 12 or early termination (ET) for: physical examinations; diary card completion (baseline, Weeks 4, 8 only); neurological examinations (baseline, Week 12/ET only); MS Treatment Concern Questionnaire (MSTCQ; Weeks 4, 8, 12 only); Convenience Questionnaire (Week 12 only); Hospital Anxiety and Depression Scale (HADS); and Paced Auditory Serial Addition Task (PASAT; baseline only). Adherence was defined as administration of ≥ 80% of scheduled injections, recorded by the autoinjection device.

Results: Overall, 88.2% (105/119; intent-to-treat population) of patients were adherent; 67.2% (80/119) administered all scheduled injections. Medical reasons accounted for 35.6% (31/87) of missed injections, forgetfulness for 20.6% (18/87). Adherence did not correlate with baseline Expanded Disability Status Scale (P = 0.821) or PASAT (P = 0.952) scores, or pre-study therapy (P = 0.303). No significant changes (baseline-Week 12) in mean HADS depression (P = 0.482) or anxiety (P = 0.156) scores were observed. 'Overall convenience' was the most important reported benefit of the autoinjection device. Device features associated with handling and ease of use were highly rated. Mean MSTCQ scores for 'flu-like' symptoms (P = 0.022) and global side effects (P = 0.002) significantly improved from Week 4-12. Mean MSTCQ scores for pain at injection site and injection pain increased from Week 4-12 (P < 0.001). Adverse events were mild/moderate. No new safety signals were identified.

Conclusion: Convenience and ease of use of the autoinjection device may improve adherence and, therefore, outcomes, in patients with RRMS receiving sc IFN β-1a.

Trial registration: EU Clinical Trials Register (EU-CTR; http://www.clinicaltrialsregister.eu): 2009-013333-24.

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Patient adherence at Week 12 in the intent-to-treat population (n = 119). *Percentages may not add up to 100 due to rounding.
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Figure 2: Patient adherence at Week 12 in the intent-to-treat population (n = 119). *Percentages may not add up to 100 due to rounding.

Mentions: Overall, 88.2% (105/119) of patients administered ≥ 80% of scheduled injections over the 12-week study period (ITT population; Figure 2). Treatment adherence was similarly high in women (87.8% [79/90]) and men (89.7% [26/29]). No significant correlation between adherence and baseline EDSS score (P = 0.821) or pre-study DMD (P = 0.303) was observed. Overall, the proportions of patients adherent to treatment stratified by pre-study DMD were 84.0% (63/75; im IFN β-1a), 93.3% (14/15; GA), 96.2% (25/26; sc IFN β-1b) and 100% (3/3; sc IFN β-1a). The proportion of patients who were adherent to treatment (i.e. administered ≥ 80% of scheduled injections) decreased significantly over time (P < 0.001; repeated measures ANOVA) from 99.2% (118/119) at Week 4 to 95.6% (114/119) at Week 8 and 81.5% (97/119) at Week 12. Sixty-seven percent of patients (80/119) administered all (100%) scheduled injections over the 12-week study; however, this proportion decreased significantly over time (P < 0.01) from 99.2% (118/119) at Week 4 to 95.0% (113/119) at Week 8 and to 67.2% (80/119) at Week 12.


Patient adherence to and tolerability of self-administered interferon β-1a using an electronic autoinjection device: a multicentre, open-label, phase IV study.

Lugaresi A, Florio C, Brescia-Morra V, Cottone S, Bellantonio P, Clerico M, Centonze D, Uccelli A, di Ioia M, De Luca G, Marcellusi A, Paolillo A, BRIDGE study gro - BMC Neurol (2012)

Patient adherence at Week 12 in the intent-to-treat population (n = 119). *Percentages may not add up to 100 due to rounding.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3368780&req=5

Figure 2: Patient adherence at Week 12 in the intent-to-treat population (n = 119). *Percentages may not add up to 100 due to rounding.
Mentions: Overall, 88.2% (105/119) of patients administered ≥ 80% of scheduled injections over the 12-week study period (ITT population; Figure 2). Treatment adherence was similarly high in women (87.8% [79/90]) and men (89.7% [26/29]). No significant correlation between adherence and baseline EDSS score (P = 0.821) or pre-study DMD (P = 0.303) was observed. Overall, the proportions of patients adherent to treatment stratified by pre-study DMD were 84.0% (63/75; im IFN β-1a), 93.3% (14/15; GA), 96.2% (25/26; sc IFN β-1b) and 100% (3/3; sc IFN β-1a). The proportion of patients who were adherent to treatment (i.e. administered ≥ 80% of scheduled injections) decreased significantly over time (P < 0.001; repeated measures ANOVA) from 99.2% (118/119) at Week 4 to 95.6% (114/119) at Week 8 and 81.5% (97/119) at Week 12. Sixty-seven percent of patients (80/119) administered all (100%) scheduled injections over the 12-week study; however, this proportion decreased significantly over time (P < 0.01) from 99.2% (118/119) at Week 4 to 95.0% (113/119) at Week 8 and to 67.2% (80/119) at Week 12.

Bottom Line: No significant changes (baseline-Week 12) in mean HADS depression (P = 0.482) or anxiety (P = 0.156) scores were observed. 'Overall convenience' was the most important reported benefit of the autoinjection device.Mean MSTCQ scores for 'flu-like' symptoms (P = 0.022) and global side effects (P = 0.002) significantly improved from Week 4-12.No new safety signals were identified.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Neuroscience and Imaging, University "G, d'Annunzio", Via dei Vestini 31, 66100 Chieti, Italy. a.lugaresi@unich.it

ABSTRACT

Background: Achieving good adherence to self-injected treatments for multiple sclerosis can be difficult. Injection devices may help to overcome some of the injection-related barriers to adherence that can be experienced by patients. We sought to assess short-term adherence to, and tolerability of, interferon (IFN) β-1a administered via electronic autoinjection device in patients with relapsing-remitting multiple sclerosis (RRMS).

Methods: BRIDGE (RebiSmart to self-inject Rebif serum-free formulation in a multidose cartridge) was a 12-week, multicentre, open-label, single-arm, observational, Phase IV study in which patients self-administered IFN β-1a (titrated to 44 μg), subcutaneously (sc), three times weekly, via electronic autoinjection device. Patients were assessed at baseline and 4-weekly intervals to Week 12 or early termination (ET) for: physical examinations; diary card completion (baseline, Weeks 4, 8 only); neurological examinations (baseline, Week 12/ET only); MS Treatment Concern Questionnaire (MSTCQ; Weeks 4, 8, 12 only); Convenience Questionnaire (Week 12 only); Hospital Anxiety and Depression Scale (HADS); and Paced Auditory Serial Addition Task (PASAT; baseline only). Adherence was defined as administration of ≥ 80% of scheduled injections, recorded by the autoinjection device.

Results: Overall, 88.2% (105/119; intent-to-treat population) of patients were adherent; 67.2% (80/119) administered all scheduled injections. Medical reasons accounted for 35.6% (31/87) of missed injections, forgetfulness for 20.6% (18/87). Adherence did not correlate with baseline Expanded Disability Status Scale (P = 0.821) or PASAT (P = 0.952) scores, or pre-study therapy (P = 0.303). No significant changes (baseline-Week 12) in mean HADS depression (P = 0.482) or anxiety (P = 0.156) scores were observed. 'Overall convenience' was the most important reported benefit of the autoinjection device. Device features associated with handling and ease of use were highly rated. Mean MSTCQ scores for 'flu-like' symptoms (P = 0.022) and global side effects (P = 0.002) significantly improved from Week 4-12. Mean MSTCQ scores for pain at injection site and injection pain increased from Week 4-12 (P < 0.001). Adverse events were mild/moderate. No new safety signals were identified.

Conclusion: Convenience and ease of use of the autoinjection device may improve adherence and, therefore, outcomes, in patients with RRMS receiving sc IFN β-1a.

Trial registration: EU Clinical Trials Register (EU-CTR; http://www.clinicaltrialsregister.eu): 2009-013333-24.

Show MeSH
Related in: MedlinePlus