Safety and tolerability in relapsing-remitting multiple sclerosis patients treated with high-dose subcutaneous interferon-beta by Rebiject autoinjection over a 1-year period: the CoSa study.
OBJECTIVE
Approved multiple sclerosis (MS) treatments include subcutaneous and intramuscular interferon beta (IFN-beta) Patient satisfaction during long-term IFN-beta treatment is crucial. This study investigated the satisfaction of patients with relapsing-remitting MS treated with IFN-beta-1a (Rebif) by the autoinjection system, Rebiject.


METHODS
This prospective observational study recruited subjects with relapsing-remitting MS (n = 76) from 19 neurological centers in Italy who were eligible for subcutaneous IFN-beta-1a treatment either as a first immunomodulatory therapy or as a switch from other treatments. Patients received IFN-beta-1a 44 mug 3 times weekly via the Rebiject system. A questionnaire on the use of Rebiject and the most common adverse effects related to IFN-beta-1a administration was completed monthly under the supervision of trained nurses.


RESULTS
Satisfaction with treatment was reported by 80.2% of patients who received at least 1 dose. Advantages reported for the Rebiject system included its convenience (53% of all patients), ease of use (25%), reduced trauma and pain (11% and 6%, respectively), and reduced local skin reactions (5%). No significant changes from baseline were observed regarding the frequency or severity of local reactions.


CONCLUSIONS
During the 1-year observation of this small cohort, most patients considered the Rebiject system to be convenient, with a third of the patients feeling that the system was easier to use than conventional procedures. Rebiject was also associated with less pain and trauma in some patients. Use of Rebiject may facilitate IFN-beta-1a administration and may lead to an increase in compliance and adherence, thus increasing the effectiveness of treatment.
Lugaresi
Alessandra
A
Department of Oncology and Neuroscience, University G. d'Annunzio, Chieti, Italy. lugaresi@unich.it
Durastanti
Valentina
V
Gasperini
Claudio
C
Lai
Marina
M
Pozzilli
Carlo
C
Orefice
Giuseppe
G
Sotgiu
Stefano
S
Pucci
Emilio
E
Ardito
Bruno
B
Millefiorini
Enrico
E
D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D004185:Disability Evaluation; D004305:Dose-Response Relationship, Drug; D006801:Humans; D007279:Injections, Subcutaneous; D000068556:Interferon beta-1a; D016899:Interferon-beta / Q000627:therapeutic use*; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D017060:Patient Satisfaction; D011446:Prospective Studies; D012008:Recurrence; D012646:Self Administration / Q000295:instrumentation* / Q000379:methods; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D013594:Syringes; D016896:Treatment Outcome
D000276:Adjuvants, Immunologic; D016899:Interferon-beta; D000068556:Interferon beta-1a