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Published in: Journal of Neurology 6/2020

01-06-2020 | Multiple Sclerosis | Original Communication

Administration of subcutaneous interferon beta 1a in the evening: data from RELIEF study

Authors: Francesco Patti, Giovanni Bosco Zimatore, Vincenzo Brescia Morra, Umberto Aguglia, Roberto Bruno Bossio, Roberto Marziolo, Paola Valentino, Clara Grazia Chisari, Antonio Capacchione, Mario Zappia, RELIEF Study Group

Published in: Journal of Neurology | Issue 6/2020

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Abstract

Background

Subcutaneous recombinant interferon-beta 1a (IFN-β1a SC) is indicated for treatment of relapsing multiple sclerosis (RMS); however, it is associated with development of flu-like syndrome (FLS) in 75% of patients. No recommendations are available on whether evening or morning administration could induce better or worse FLS.

Objective

Primary objective was to investigate whether morning administration of IFN-β1a 44 µg (Rebif) would affect the severity of FLS versus evening administration, in patients with RMS. Secondary objectives were to investigate whether timing of administration could lead to a better quality of life.

Methods

Multicenter, open-label, 12-week, randomized, controlled, parallel-group, phase 4 study.

Results

Of 217 patients screened at 29 Italian sites, 200 were included in the study. Among these, 104 patients were randomized to IFN-β1a SC administration in the morning and 96 in the evening. Morning administration resulted in higher FLS scores, as measured by the Multiple Sclerosis Treatment Concern Questionnaire, at week 4 (p = 0.0083) and week 8 (p = 0.0079); however, the difference was no longer significant at the end of 12 weeks.

Conclusion

IFN-β1a evening injections in the first 8 weeks of treatment led to an improvement in FLS; when continuing therapy, time of administration could be decided according to patient’s lifestyle and preference.
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Metadata
Title
Administration of subcutaneous interferon beta 1a in the evening: data from RELIEF study
Authors
Francesco Patti
Giovanni Bosco Zimatore
Vincenzo Brescia Morra
Umberto Aguglia
Roberto Bruno Bossio
Roberto Marziolo
Paola Valentino
Clara Grazia Chisari
Antonio Capacchione
Mario Zappia
RELIEF Study Group
Publication date
01-06-2020
Publisher
Springer Berlin Heidelberg
Published in
Journal of Neurology / Issue 6/2020
Print ISSN: 0340-5354
Electronic ISSN: 1432-1459
DOI
https://doi.org/10.1007/s00415-020-09771-x

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