PMID- 26848561
OWN - NLM
STAT- MEDLINE
DCOM- 20161213
LR  - 20181202
IS  - 1468-1331 (Electronic)
IS  - 1351-5101 (Linking)
VI  - 23
IP  - 5
DP  - 2016 May
TI  - Minocycline added to subcutaneous interferon beta-1a in multiple sclerosis: 
      randomized RECYCLINE study.
PG  - 861-70
LID - 10.1111/ene.12953 [doi]
AB  - BACKGROUND AND PURPOSE: Combining different therapies may improve disease control 
      in patients with relapsing-remitting multiple sclerosis (RRMS). This study 
      assessed the efficacy and safety of minocycline added to subcutaneous (sc) 
      interferon (IFN) beta-1a therapy. METHODS: This was a double-blind, randomized, 
      placebo-controlled multicentre study. Within 3 months (+/-1 month) of starting sc 
      IFN beta-1a 44 mug three times weekly, patients with RRMS were randomized to 
      minocycline 100 mg twice daily or placebo, added to sc IFN beta-1a, for 96 weeks. 
      The primary efficacy endpoint was the time to first qualifying relapse. Secondary 
      efficacy endpoints were the annualized relapse rate for qualifying relapses, the 
      number of new/enlarging T2-weighted lesions and change in brain volume [magnetic 
      resonance imaging (MRI) was performed only in a few selected centres]. In 
      addition, a number of tertiary efficacy endpoints were assessed. RESULTS: One 
      hundred and forty-nine patients received minocycline and 155 received placebo; 
      MRI data were available for 23 and 27 patients, respectively. The time to first 
      qualifying relapse did not differ significantly for minocycline versus placebo 
      (hazard ratio 0.85; 95% confidence interval 0.53, 1.35; log-rank = 0.50; P = 
      0.48). There were no statistically significant differences between the two groups 
      on other efficacy endpoints, although some numerical trends in favour of 
      minocycline were observed. No unexpected adverse events were reported, but more 
      patients discontinued because of adverse events with minocycline versus placebo. 
      CONCLUSION: Minocycline showed no statistically significant beneficial effect 
      when added to sc IFN beta-1a therapy.
CI  - (c) 2016 EAN.
FAU - Sorensen, P S
AU  - Sorensen PS
AD  - Danish Multiple Sclerosis Center, Department of Neurology, Rigshospitalet, 
      University of Copenhagen, Copenhagen, Denmark.
FAU - Sellebjerg, F
AU  - Sellebjerg F
AD  - Danish Multiple Sclerosis Center, Department of Neurology, Rigshospitalet, 
      University of Copenhagen, Copenhagen, Denmark.
FAU - Lycke, J
AU  - Lycke J
AD  - Department of Neurology, Sahlgrenska University Hospital, Gothenburg, Sweden.
FAU - Farkkila, M
AU  - Farkkila M
AD  - Department of Neurology, University Central Hospital, Helsinki, Finland.
FAU - Creange, A
AU  - Creange A
AD  - Service de Neurologie, Hopital Henri Mondor, Universite Paris Est Creteil, 
      Creteil, France.
FAU - Lund, C G
AU  - Lund CG
AD  - Department of Neurology, Oslo University Hospital, Oslo, Norway.
FAU - Schluep, M
AU  - Schluep M
AD  - Service de Neurologie, Departement des Neurosciences Cliniques, Centre 
      Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
FAU - Frederiksen, J L
AU  - Frederiksen JL
AD  - Department of Neurology, Glostrup Esbjerg, Sonderborg, and Vejle, and University 
      of Copenhagen, Copenhagen, Denmark.
FAU - Stenager, E
AU  - Stenager E
AD  - Department of Neurology, Esbjerg Hospital, Sonderborg Hospital, Vejle Hospital, 
      Odense, Denmark.
FAU - Pfleger, C
AU  - Pfleger C
AD  - Department of Neurology, Aalborg Hospital, Aalborg, Denmark.
FAU - Garde, E
AU  - Garde E
AD  - Danish Research Centre for Magnetic Resonance, Centre for Functional and 
      Diagnostic Imaging and Research, Hvidovre Hospital, University of Copenhagen, 
      Copenhagen, Denmark.
FAU - Kinnunen, E
AU  - Kinnunen E
AD  - Department of Neurology, HUS Hyvinkaan Hospital, Hyvinkaa, Finland.
FAU - Marhardt, K
AU  - Marhardt K
AD  - Merck Serono Global Medical Affairs, Merck GmbH, Vienna, Austria.
CN  - RECYCLINE Study Investigators
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20160205
PL  - England
TA  - Eur J Neurol
JT  - European journal of neurology
JID - 9506311
RN  - 0 (Anti-Bacterial Agents)
RN  - FYY3R43WGO (Minocycline)
RN  - XRO4566Q4R (Interferon beta-1a)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Anti-Bacterial Agents/*therapeutic use
MH  - Brain/diagnostic imaging/drug effects/pathology
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - Interferon beta-1a/*therapeutic use
MH  - Magnetic Resonance Imaging/methods
MH  - Male
MH  - Middle Aged
MH  - Minocycline/*therapeutic use
MH  - Multiple Sclerosis/diagnostic imaging/*drug therapy/pathology
MH  - Organ Size/drug effects
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - combination therapy
OT  - interferon beta
OT  - minocycline
OT  - multiple sclerosis
OT  - randomized controlled trial
EDAT- 2016/02/06 06:00
MHDA- 2016/12/15 06:00
CRDT- 2016/02/06 06:00
PHST- 2015/08/14 00:00 [received]
PHST- 2015/11/26 00:00 [accepted]
PHST- 2016/02/06 06:00 [entrez]
PHST- 2016/02/06 06:00 [pubmed]
PHST- 2016/12/15 06:00 [medline]
AID - 10.1111/ene.12953 [doi]
PST - ppublish
SO  - Eur J Neurol. 2016 May;23(5):861-70. doi: 10.1111/ene.12953. Epub 2016 Feb 5.