PMID- 24811754
OWN - NLM
STAT- MEDLINE
DCOM- 20160330
LR  - 20181202
IS  - 1879-114X (Electronic)
IS  - 0149-2918 (Linking)
VI  - 36
IP  - 12
DP  - 2014 Dec 1
TI  - The STAR Study: a real-world, international, observational study of the safety 
      and tolerability of, and adherence to, serum-free subcutaneous interferon beta-1a in 
      patients with relapsing multiple sclerosis.
PG  - 1946-1957
LID - S0149-2918(14)00199-4 [pii]
LID - 10.1016/j.clinthera.2014.04.002 [doi]
AB  - BACKGROUND: Adverse reactions, particularly injection site reactions (ISRs), are 
      common reasons for nonadherence to injectable multiple sclerosis (MS) treatments. 
      Adherence to MS treatment is important to ensure good treatment outcomes. 
      OBJECTIVE: The aim of this study was to assess the local tolerability of 
      subcutaneous (SC) serum-free interferon (IFN) beta-1a in patients with relapsing MS 
      over 1 year in a real-life, international setting. The study also assessed 
      safety, disease activity, and adherence. METHODS: This was a prospective, 
      international, multicenter, observational study of 251 patients with 
      relapsing-remitting MS treated with SC serum-free IFN beta-1a 44 mug or 22 mug 3 times 
      weekly for 12 months or until early discontinuation. The primary end point was 
      the proportion of patients with ISRs. Secondary end points included proportion of 
      patients with adverse events (AEs); annualized relapse rate (ARR); proportion of 
      patients remaining relapse-free; and adherence to treatment. RESULTS: During the 
      observation period, 27.5% (69 of 251) of patients experienced nonserious ISRs, 
      which was consistent with the incidence reported in clinical studies. Five 
      patients discontinued treatment and 2 patients suspended treatment because of 
      ISRs. Mean age was 35.8 years; patients were predominantly white (94.8%), and two 
      thirds (66.1%) were female. The overall incidence of AEs was 63.7% (160 of 251), 
      and overall safety and tolerability were assessed as excellent, very good, or 
      good in >85% of patients. More than 70% of patients remained relapse-free, and 
      the mean ARR was 0.4. More than 90% of patients had very good or good adherence 
      to treatment; a significantly greater proportion of these were relapse-free at 12 
      months compared with those with fair or poor adherence (77.6% vs 50.0%; P = 
      0.0107), and their ARR was significantly lower (0.3 vs 0.9; P = 0.0055). Patients 
      with fair or poor adherence had 4.6 times higher odds of experiencing a relapse 
      than those with very good or good adherence. CONCLUSIONS: The incidence of ISRs 
      and the overall safety profile in this observational study, in an international 
      population in a real-life setting, confirm the good local tolerability of SC 
      serum-free IFN beta-1a reported in clinical studies. The association between good 
      adherence and a lower ARR underlines the importance of good adherence. The good 
      local and general tolerability of SC IFN beta-1a may help ensure a high level of 
      adherence, which is associated with better clinical outcomes. ClinicalTrials.gov 
      identifier: NCT01080027.
CI  - Copyright (c) 2014 The Authors. Published by Elsevier Inc. All rights reserved.
FAU - Hupperts, Raymond
AU  - Hupperts R
AD  - Orbis Medical Centre, Sittard-Geleen, Maastricht University Medical Centre, the 
      Netherlands. Electronic address: r.hupperts@orbisconcern.nl.
FAU - Ghazi-Visser, Lizette
AU  - Ghazi-Visser L
AD  - Merck BV Schiphol-Rijk, the Netherlands.
FAU - Martins Silva, Ana
AU  - Martins Silva A
AD  - Department of Neurology, Centro-Hospitalar do Porto-Hospital de Santo Antonio, 
      Largo Abel Salazar, Oporto-Portugal.
FAU - Arvanitis, Michalis
AU  - Arvanitis M
AD  - Merck AE Hellas, Marousi, Greece.
FAU - Kuusisto, Hanna
AU  - Kuusisto H
AD  - Kanta-Hame Central Hospital, Hameenlinna and Tampere University Hospital, 
      Tampere, Finland.
FAU - Marhardt, Kurt
AU  - Marhardt K
AD  - Merck Gesellschaft mbH, Vienna, Austria.
FAU - Vlaikidis, Nikolaos
AU  - Vlaikidis N
AD  - 3rd Neurological Clinic, Aristotle University of Thessaloniki, Thessaloniki, 
      Greece.
CN  - STAR Study Group
LA  - eng
SI  - ClinicalTrials.gov/NCT01080027
PT  - Journal Article
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20140505
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - XRO4566Q4R (Interferon beta-1a)
SB  - IM
MH  - Adult
MH  - Female
MH  - Humans
MH  - Injections, Subcutaneous
MH  - Interferon beta-1a/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Multiple Sclerosis, Relapsing-Remitting/*drug therapy
MH  - Patient Compliance
MH  - Prospective Studies
MH  - Treatment Outcome
OTO - NOTNLM
OT  - adherence
OT  - injection site reactions
OT  - injection subcutaneous
OT  - interferon beta-1a
EDAT- 2014/05/09 06:00
MHDA- 2016/03/31 06:00
CRDT- 2014/05/10 06:00
PHST- 2013/10/22 00:00 [received]
PHST- 2014/04/01 00:00 [revised]
PHST- 2014/04/04 00:00 [accepted]
PHST- 2014/05/10 06:00 [entrez]
PHST- 2014/05/09 06:00 [pubmed]
PHST- 2016/03/31 06:00 [medline]
AID - S0149-2918(14)00199-4 [pii]
AID - 10.1016/j.clinthera.2014.04.002 [doi]
PST - ppublish
SO  - Clin Ther. 2014 Dec 1;36(12):1946-1957. doi: 10.1016/j.clinthera.2014.04.002. 
      Epub 2014 May 5.