PMID- 26098143
OWN - NLM
STAT- MEDLINE
DCOM- 20160129
LR  - 20220317
IS  - 1744-7593 (Electronic)
IS  - 1742-5247 (Linking)
VI  - 12
IP  - 8
DP  - 2015 Aug
TI  - Adherence to, and effectiveness of, subcutaneous interferon beta-1a administered by 
      RebiSmart(R) in patients with relapsing multiple sclerosis: results of the 1-year, 
      observational SMART study.
PG  - 1239-50
LID - 10.1517/17425247.2015.1057567 [doi]
AB  - BACKGROUND: Patients with multiple sclerosis who have poor adherence to treatment 
      have a higher risk of relapse than adherent patients. This study assessed 
      adherence to, and effectiveness and convenience of, treatment with subcutaneous 
      (sc) interferon (IFN) beta-1a (Rebif(R), Merck Serono SA) 44 or 22 mug three times 
      weekly in patients with relapsing multiple sclerosis (RMS) using the RebiSmart(R) 
      electronic, multidose, autoinjector for 1 year. STUDY DESIGN: European, 
      multicentre, observational study among neurologists: inclusion criteria included 
      RMS, Expanded Disability Status Scale score </= 6, sc IFN beta-1a administered by 
      RebiSmart for </= 6 weeks. The primary endpoint was cumulative adherence recorded 
      by RebiSmart. RESULTS: The safety population included 912 patients, 77.4% (n = 
      823) of whom completed the Month-12 visit. Mean (+/- standard deviation) cumulative 
      adherence was 97.1 +/- 7.3% (n = 791). The most common reason for missed injection 
      was 'forgot to inject' (37.0%). At Month 12/ED, 79.5% of patients were 
      relapse-free. Of 353 patients who rated the convenience of the device, 68.3% 
      found injecting 'very easy'. No unknown safety issues were detected. CONCLUSIONS: 
      Patients with RMS self-injecting sc IFN beta-1a with RebiSmart had excellent 
      adherence at Month 12/ED, which was associated with good clinical outcomes and no 
      unexpected safety issues. Patients rated RebiSmart as convenient and easy to use.
FAU - Bayas, Antonios
AU  - Bayas A
AD  - Department of Neurology, Klinikum Augsburg , Stenglinstr 2, D-86156, Augsburg , 
      Germany +49 821 400 3892 ; +49 821 400 2691 ; 
      antonios.bayas@klinikum-augsburg.de.
FAU - Ouallet, Jean Christophe
AU  - Ouallet JC
FAU - Kallmann, Boris
AU  - Kallmann B
FAU - Hupperts, Raymond
AU  - Hupperts R
FAU - Fulda, Ulrich
AU  - Fulda U
FAU - Marhardt, Kurt
AU  - Marhardt K
CN  - SMART study group
LA  - eng
SI  - ClinicalTrials.gov/NCT01108887
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
DEP - 20150622
PL  - England
TA  - Expert Opin Drug Deliv
JT  - Expert opinion on drug delivery
JID - 101228421
RN  - 0 (Adjuvants, Immunologic)
RN  - XRO4566Q4R (Interferon beta-1a)
SB  - IM
MH  - Adjuvants, Immunologic/*administration & dosage
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Female
MH  - Humans
MH  - Injections, Subcutaneous
MH  - Interferon beta-1a/*administration & dosage
MH  - Male
MH  - *Medication Adherence
MH  - Middle Aged
MH  - Multiple Sclerosis, Relapsing-Remitting/*drug therapy
MH  - Young Adult
OTO - NOTNLM
OT  - adherence
OT  - autoinjector
OT  - interferon beta
OT  - multiple sclerosis
EDAT- 2015/06/23 06:00
MHDA- 2016/01/30 06:00
CRDT- 2015/06/23 06:00
PHST- 2015/06/23 06:00 [entrez]
PHST- 2015/06/23 06:00 [pubmed]
PHST- 2016/01/30 06:00 [medline]
AID - 10.1517/17425247.2015.1057567 [doi]
PST - ppublish
SO  - Expert Opin Drug Deliv. 2015 Aug;12(8):1239-50. doi: 
      10.1517/17425247.2015.1057567. Epub 2015 Jun 22.