Francesco Patti1, Giovanni Bosco Zimatore2, Vincenzo Brescia Morra3, Umberto Aguglia4, Roberto Bruno Bossio5, Roberto Marziolo6, Paola Valentino7, Clara Grazia Chisari8, Antonio Capacchione9, Mario Zappia8. 1. Department G. F. Ingrassia, Neuroscience Section, University of Catania, Via Santa Sofia, 78, 95123, Catania, Italy. patti@unict.it. 2. U.O.C. Neurology, Ospedale Generale Regionale "F. Miulli", Acquaviva delle Fonti, BA, Italy. 3. Department of Neuroscience (NSRO), University of Naples Federico II, Napoli, Italy. 4. Neurology Department, Hospital "Bianchi Melacrino Morelli", Reggio Calabria, Italy. 5. Multiple Sclerosis Center, Provincial Health Company of Cosenza, Cosenza, Italy. 6. Neurology Department, Emergency Hospital "Cannizzaro", Catania, Italy. 7. Neurology Department, University Hospital "Località Germaneto", Catanzaro, Italy. 8. Department G. F. Ingrassia, Neuroscience Section, University of Catania, Via Santa Sofia, 78, 95123, Catania, Italy. 9. Medical Affairs Department, Merck Serono S.p.A., Rome, Italy.
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.
RCT Entities:
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.
Entities:
Keywords:
Flu-like syndrome; Interferon beta; Multiple Sclerosis; Quality of life; Self-injection; Time of administration
Authors: James C Walton; William H Walker; Jacob R Bumgarner; O Hecmarie Meléndez-Fernández; Jennifer A Liu; Heather L Hughes; Alexis L Kaper; Randy J Nelson Journal: Clin Pharmacol Ther Date: 2020-11-29 Impact factor: 6.903