1. Administration of subcutaneous interferon beta 1a in the evening: data from RELIEF study.
- Author
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Patti F, Zimatore GB, Brescia Morra V, Aguglia U, Bossio RB, Marziolo R, Valentino P, Chisari CG, Capacchione A, and Zappia M
- Subjects
- Adult, Female, Humans, Injections, Subcutaneous, Male, Treatment Outcome, Drug-Related Side Effects and Adverse Reactions prevention & control, Immunologic Factors administration & dosage, Immunologic Factors adverse effects, Interferon beta-1a administration & dosage, Interferon beta-1a adverse effects, Multiple Sclerosis, Relapsing-Remitting drug therapy
- 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.
- Published
- 2020
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