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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

Alessandra Lugaresi1,11*, Ciro Florio2, Vincenzo Brescia-Morra3, Salvatore Cottone4, Paolo Bellantonio5, Marinella Clerico6, Diego Centonze7, Antonio Uccelli8, Maria di Ioia1, Giovanna De Luca1, Andrea Marcellusi9, Andrea Paolillo10 and for the BRIDGE study group

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Author affiliations

1 Department of Neuroscience and Imaging, University "G. d'Annunzio", Via dei Vestini 31, 66100 Chieti, Italy

2 Multiple Sclerosis Regional Center, Azienda Ospedaliera "Antonio Cardarelli", Via Antonio Cardarelli 9, 80131 Naples, Italy

3 Department of Neurological Science, University of Naples Federico II, Via Giovanni Paladino 39, 80138 Naples, Italy

4 Department of Neurology, Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello, Via Ninni Cassarà, 90146 Palermo, Italy

5 Department of Neurology, Istituto Mediterraneo di Neuroscienze, NEUROMED, Via Atinense 18, 86077 Pozzilli, IS, Italy

6 Division of Neurology, Department of Clinical and Biological Science, University of Turin, Via Giuseppe Verdi 8, 10124 Turin, Italy

7 Department of Neuroscience, University of Rome "Tor Vergata", Via Montpellier 1, 00133 Rome, Italy

8 Department of Neuroscience, Ophthalmology and Genetics, University of Genoa, Via De Toni 5, 16132 Genoa, Italy

9 CEIS Sanità (CHEM-Centre for Health Economics and Management), Faculty of Economics, University of Tor Vergata, Via Columbia 2, 00133 Rome, Italy

10 Merck Serono S.p.A., Via Casilina 125, 00176 Rome, Italy

11 Department of Neuroscience and Imaging, University G. d'Annunzio, c/o Centro Sclerosi Multipla, Ospedale Clinicizzato "SS Annunziata", Via dei Vestini 31, 66100 Chieti, Italy

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Citation and License

BMC Neurology 2012, 12:7 doi:10.1186/1471-2377-12-7

Published: 5 March 2012

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 webcite): 2009-013333-24

Keywords:
Relapsing-remitting multiple sclerosis; IFN beta; Medication adherence; Drug delivery systems; Self administration