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




Patient adherence to and tolerability of self-administered interferon β-1a using an electronic autoinjection device: a multicentre, open-label, phase IV study - Download this document for free, or read online. Document in PDF available to download.

BMC Neurology

, 12:7

First Online: 05 March 2012Received: 04 October 2011Accepted: 05 March 2012

Abstract

BackgroundAchieving 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.

MethodsBRIDGE 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.

ResultsOverall, 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.

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

Trial registrationEU Clinical Trials Register EU-CTR; http:-www.clinicaltrialsregister.eu: 2009-013333-24

KeywordsRelapsing-remitting multiple sclerosis IFN beta Medication adherence Drug delivery systems Self administration AbbreviationsAEAdverse event

ANOVAAnalysis of variance

BRIDGERebiSmart to self-inject Rebif serum-free formulation in a multidose cartridge

CIConfidence interval

DMDDisease-modifying drug

EDSSExpanded Disability Status Scale

ETEarly termination

FLS-flu-like- symptom

GAGlatiramer acetate

GSEGlobal side effect

HADSHospital Anxiety and Depression Scale

IFNInterferon

imIntramuscular

ISRInjection-site reaction

ITTIntent-to-treat

MPRMedication possession ratio

MSMultiple sclerosis

MSTCQMS Treatment Concern Questionnaire

PASATPaced Auditory Serial Addition Task

RRMSRelapsing-remitting multiple sclerosis

SAESerious adverse event

scSubcutaneously

SDStandard deviation

TEAETreatment-emergent adverse event

tiwThree times weekly

VASVisual analogue scale.

Electronic supplementary materialThe online version of this article doi:10.1186-1471-2377-12-7 contains supplementary material, which is available to authorized users.

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Author: Alessandra Lugaresi - Ciro Florio - Vincenzo Brescia-Morra - Salvatore Cottone - Paolo Bellantonio - Marinella Clerico - Die

Source: https://link.springer.com/







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