PMID- 30706431
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20210422
IS  - 2193-8253 (Print)
IS  - 2193-6536 (Electronic)
IS  - 2193-6536 (Linking)
VI  - 8
IP  - 1
DP  - 2019 Jun
TI  - Real-World Characterization of Dimethyl Fumarate-Related Gastrointestinal Events 
      in Multiple Sclerosis: Management Strategies to Improve Persistence on Treatment 
      and Patient Outcomes.
PG  - 109-119
LID - 10.1007/s40120-019-0127-2 [doi]
AB  - INTRODUCTION: Delayed-release dimethyl fumarate (DMF) is an effective treatment 
      for multiple sclerosis (MS). Some patients experience gastrointestinal (GI) 
      adverse events (AEs) that may lead to premature DMF discontinuation. This study 
      characterized the impact of site-specific GI management strategies on the 
      occurrence of GI events and discontinuation patterns. METHODS: Data on GI events 
      and DMF persistence were retrospectively abstracted from medical records of 
      patients treated with DMF in routine medical practice in the EFFECT study 
      (NCT02776072). GI management strategies were assessed via a study site 
      questionnaire. Discontinuation rates were analyzed according to counseling 
      patterns. RESULTS: Of 826 DMF-treated patients at 66 sites, 809 from 65 sites 
      were eligible for the GI analysis; of these, 27% experienced GI AEs. Within 
      1 year of treatment, 14% (118/826) of patients discontinued DMF, 5% (44/809) due 
      to GI events. Most sites (92%) reported that patients were very likely (> 75% of 
      the time) to be counseled about GI events at/before DMF treatment initiation 
      and/or to be recommended that DMF be taken with food (86%); 48% of sites reported 
      to be very likely to recommend using symptomatic therapies for GI AEs. Lower 
      discontinuation rates were reported at sites very likely versus not very likely 
      (</= 75% of the time) to (1) provide counseling; (2) provide specific details 
      regarding GI events; or (3) recommend taking DMF with food, and/or using 
      symptomatic GI therapies. CONCLUSION: Counseling and other GI management 
      strategies at initiation of DMF treatment appear to reduce the burden of GI 
      events, and a variety of GI management strategies may improve DMF persistence. 
      TRIAL REGISTRATION: NCT02776072. FUNDING: Biogen (Cambridge, MA, USA).
FAU - Min, Jinny
AU  - Min J
AD  - Biogen, Cambridge, MA, USA.
FAU - Cohan, Stanley
AU  - Cohan S
AD  - Providence Multiple Sclerosis Center, Providence Brain and Spine Institute, 
      Providence St Joseph Health, Portland, OR, USA.
FAU - Alvarez, Enrique
AU  - Alvarez E
AD  - Rocky Mountain Multiple Sclerosis Center, University of Colorado, Aurora, CO, 
      USA.
FAU - Sloane, Jacob
AU  - Sloane J
AD  - Beth Israel Deaconess Medical Center, Boston, MA, USA.
FAU - Phillips, J Theodore
AU  - Phillips JT
AD  - Department of Neurology, University of New Mexico Health Sciences Center, 
      Albuquerque, NM, USA.
FAU - van der Walt, Anneke
AU  - van der Walt A
AD  - Multiple Sclerosis Research Unit, Royal Melbourne Hospital, Parkville, VIC, 
      Australia.
FAU - Koulinska, Irene
AU  - Koulinska I
AD  - Biogen, Cambridge, MA, USA.
FAU - Fang, Fang
AU  - Fang F
AD  - Cytel Inc, Cambridge, MA, USA.
FAU - Miller, Catherine
AU  - Miller C
AD  - Biogen, Cambridge, MA, USA. Catherine.miller@biogen.com.
FAU - Chan, Andrew
AU  - Chan A
AD  - Department of Neurology, Inselspital-Bern University Hospital, University of 
      Bern, Bern, Switzerland.
LA  - eng
SI  - ClinicalTrials.gov/NCT02776072
PT  - Journal Article
DEP - 20190131
PL  - New Zealand
TA  - Neurol Ther
JT  - Neurology and therapy
JID - 101637818
PMC - PMC6534646
OTO - NOTNLM
OT  - Gastrointestinal events
OT  - Multiple sclerosis
OT  - Retrospective study
OT  - Tecfidera
EDAT- 2019/02/02 06:00
MHDA- 2019/02/02 06:01
PMCR- 2019/01/31
CRDT- 2019/02/02 06:00
PHST- 2018/11/27 00:00 [received]
PHST- 2019/02/02 06:00 [pubmed]
PHST- 2019/02/02 06:01 [medline]
PHST- 2019/02/02 06:00 [entrez]
PHST- 2019/01/31 00:00 [pmc-release]
AID - 10.1007/s40120-019-0127-2 [pii]
AID - 127 [pii]
AID - 10.1007/s40120-019-0127-2 [doi]
PST - ppublish
SO  - Neurol Ther. 2019 Jun;8(1):109-119. doi: 10.1007/s40120-019-0127-2. Epub 2019 Jan 
      31.