PMID- 28453541
OWN - NLM
STAT- MEDLINE
DCOM- 20170907
LR  - 20231112
IS  - 1932-6203 (Electronic)
IS  - 1932-6203 (Linking)
VI  - 12
IP  - 4
DP  - 2017
TI  - The real-world effectiveness and safety of fingolimod in relapsing-remitting 
      multiple sclerosis patients: An observational study.
PG  - e0176174
LID - 10.1371/journal.pone.0176174 [doi]
LID - e0176174
AB  - Fingolimod approval was based mainly on two clinical trials, FREEDOMS and 
      TRANSFORMS, which demonstrated the efficacy and safety of fingolimod in patients 
      with multiple sclerosis (MS). We present an observational study that validates 
      these trials findings in a real-world setting, whereby the effectiveness and 
      safety of fingolimod was assessed in Seville's' (Spain) clinical practice. This 
      retrospective study in MS patients assessed effectiveness (relapses, EDSS, 
      gadolinium-enhancing T1 and new/enlarged T2-weighted lesions): total cohort (n = 
      249) and stratified according to prior treatment (glatiramer acetate/interferon 
      beta-1 [immunomodulator], natalizumab, naive), gender, basal EDSS score, basal 
      Gd+ lesions, ARR prior to treatment, age at treatment initiation and number of 
      prior treatments. A multivariante model was used to assess the ARR with baseline 
      characteristics. The safety profile (adverse events [AEs]) was also described. 
      Fingolimod reduced the annualized relapse rate (ARR) by 75%, 67% and 85% in the 
      total cohort, patients previously treated with immunomodulatory and naive 
      patients (p<0.0001 all cases). However, patients previously treated with 
      natalizumab kept a constant ARR. The ARR results and the consequent increase in 
      the proportion of relapse-free patients were independent of the age at treatment 
      initiation, number of prior treatments, gender and basal Gd+ lesions. Although 
      fingolimod was effective regardless the basal EDSS score and ARR prior to 
      fingolimod treatment, better outcomes were observed in patients with basal EDSS 
      score <3 (0.2 vs. 0.4; p = 0.0244) and ARR >/= 2 prior to fingolimod treatment (p = 
      0.0338). Only the basal EDSS score was association with ARR in the first 24 
      months of fingolimod treatment in the multivariante model (p = 0.0439). The 
      cumulative probability of disability progression was 20% (month-24) in the total 
      cohort, and was independent from prior treatment, age at treatment initiation, 
      number of prior treatments, gender, basal EDSS score, basal Gd+ lesions and ARR 
      prior to treatment. The real-world fingolimod benefits observed in this study 
      seem to be similar than those observed in previous clinical trials.
FAU - Izquierdo, Guillermo
AU  - Izquierdo G
AUID- ORCID: 0000-0002-6340-5609
AD  - Servicio de Neurologia, Hospital Universitario Virgen Macarena, Sevilla, 
      Andalucia, Spain.
FAU - Damas, Fatima
AU  - Damas F
AD  - Servicio de Neurologia, Hospital Universitario Virgen Macarena, Sevilla, 
      Andalucia, Spain.
FAU - Paramo, Maria Dolores
AU  - Paramo MD
AD  - Servicio de Neurologia, Hospital Universitario Virgen Macarena, Sevilla, 
      Andalucia, Spain.
FAU - Ruiz-Pena, Juan Luis
AU  - Ruiz-Pena JL
AD  - Servicio de Neurologia, Hospital Universitario Virgen Macarena, Sevilla, 
      Andalucia, Spain.
FAU - Navarro, Guillermo
AU  - Navarro G
AD  - Servicio de Neurologia, Hospital Universitario Virgen Macarena, Sevilla, 
      Andalucia, Spain.
LA  - eng
PT  - Journal Article
PT  - Observational Study
DEP - 20170428
PL  - United States
TA  - PLoS One
JT  - PloS one
JID - 101285081
RN  - G926EC510T (Fingolimod Hydrochloride)
SB  - IM
MH  - Adult
MH  - Disabled Persons
MH  - Female
MH  - Fingolimod Hydrochloride/*adverse effects/*therapeutic use
MH  - Humans
MH  - Magnetic Resonance Imaging
MH  - Male
MH  - Multiple Sclerosis, Relapsing-Remitting/diagnostic imaging/*drug therapy
MH  - Recurrence
MH  - Retrospective Studies
MH  - *Safety
PMC - PMC5409154
COIS- Competing Interests: The authors have declared that no competing interests exist.
EDAT- 2017/04/30 06:00
MHDA- 2017/09/08 06:00
PMCR- 2017/04/28
CRDT- 2017/04/29 06:00
PHST- 2016/07/01 00:00 [received]
PHST- 2017/04/06 00:00 [accepted]
PHST- 2017/04/29 06:00 [entrez]
PHST- 2017/04/30 06:00 [pubmed]
PHST- 2017/09/08 06:00 [medline]
PHST- 2017/04/28 00:00 [pmc-release]
AID - PONE-D-16-26366 [pii]
AID - 10.1371/journal.pone.0176174 [doi]
PST - epublish
SO  - PLoS One. 2017 Apr 28;12(4):e0176174. doi: 10.1371/journal.pone.0176174. 
      eCollection 2017.