PMID- 31729968
OWN - NLM
STAT- MEDLINE
DCOM- 20200127
LR  - 20200127
IS  - 1471-2377 (Electronic)
IS  - 1471-2377 (Linking)
VI  - 19
IP  - 1
DP  - 2019 Nov 15
TI  - Analysis of cardiac monitoring and safety data in patients initiating fingolimod 
      treatment in the home or in clinic.
PG  - 287
LID - 10.1186/s12883-019-1506-0 [doi]
LID - 287
AB  - BACKGROUND: Fingolimod (Gilenya(R)) is approved for relapsing forms of multiple 
      sclerosis in the USA. Owing to transient heart-rate effects when initiating 
      fingolimod, eligible patients undergo precautionary baseline assessment and 
      first-dose observation (FDO) for >/=6 h. Prior to 2014, FDO was undertaken only in 
      clinics. As the FDO period is short, and fingolimod has accumulated evidence of a 
      positive benefit:risk ratio, an in-home treatment-initiation program, 
      Gilenya@Home, was developed to offer a convenient alternative. METHODS: Cardiac 
      parameters and adverse events (AEs) were recorded by healthcare professionals 
      performing fingolimod FDOs in the US Gilenya@Home program or in US Gilenya 
      Assessment Network clinics. Anonymized data were collated retrospectively from 
      the first 34 months in the home setting and from 78 months in clinics; data are 
      reported descriptively. Satisfaction with Gilenya@Home was rated by patients 
      using a 7-item questionnaire that considered aspects such as ease of scheduling, 
      courtesy, and competency. RESULTS: Data were captured as part of standard care 
      from 5573 patients initiating fingolimod in-home (October 2014 to July 2017) and 
      from 15,025 patients initiating in-clinic (July 2010 to December 2016). In the 
      Gilenya@Home questionnaire, 91.7% of 1848 respondents rated their overall 
      satisfaction as "very good," and 7.6% rated their satisfaction as "good." AEs 
      were reported for 30.7 and 32.6% of in-home and in-clinic patients, respectively. 
      In total, 557 in-home (10.0%) and 398 in-clinic (2.6%) patients were monitored 
      for > 6 h; 15 (0.3%) in-home and 129 (0.9%) in-clinic patients were transferred 
      to an emergency room for overnight monitoring. The mean (standard deviation) 
      heart rate (HR; bpm) pre-FDO was 74.8 (12.2) in-home and 74.2 (11.3) in-clinic; 
      reduction in HR at 6 h postdose was 10.6 (12.0) and 6.3 (9.6), respectively. 
      New-onset first-degree atrioventricular block was experienced by 132 (2.4%) 
      in-home and 74 (0.5%) in-clinic patients, and Wenckebach (Mobitz type I) 
      second-degree atrioventricular block by four (0.07%) and nine (0.1%) patients, 
      with no cases of third-degree atrioventricular block. CONCLUSIONS: A substantial 
      number of patients have initiated fingolimod at home, reporting very high levels 
      of satisfaction. Gilenya@Home was as rigorous as the clinic setting in detecting 
      cardiovascular events. Overall, FDO safety outcomes were similar with 
      Gilenya@Home and in-clinic.
FAU - Brown, Brandon
AU  - Brown B
AD  - Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ, 07936, 
      USA.
FAU - Weiss, Jamie L
AU  - Weiss JL
AD  - Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ, 07936, 
      USA.
FAU - Kolodny, Scott
AU  - Kolodny S
AD  - Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ, 07936, 
      USA.
FAU - Meng, Xiangyi
AU  - Meng X
AD  - Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ, 07936, 
      USA.
FAU - Williams, Ian M
AU  - Williams IM
AD  - Oxford PharmaGenesis, Tubney Warren Barn, Tubney, Oxford, OX13 5QJ, UK.
FAU - Osborne, John A
AU  - Osborne JA
AD  - State of the Heart Cardiology, Plaza 1, Medical Pkwy. N Suite 103, Dallas, TX, 
      75234, USA. josborne@sothcardiology.com.
LA  - eng
GR  - -/Novartis Pharmaceuticals Corporation/
PT  - Journal Article
DEP - 20191115
PL  - England
TA  - BMC Neurol
JT  - BMC neurology
JID - 100968555
RN  - 0 (Immunosuppressive Agents)
RN  - G926EC510T (Fingolimod Hydrochloride)
SB  - IM
EIN - BMC Neurol. 2019 Dec 21;19(1):336. PMID: 31864306
MH  - Adult
MH  - Atrioventricular Block/*chemically induced/diagnosis
MH  - Electroencephalography
MH  - Female
MH  - Fingolimod Hydrochloride/*adverse effects
MH  - Heart Rate/drug effects
MH  - *Home Care Services, Hospital-Based
MH  - Humans
MH  - Immunosuppressive Agents/*adverse effects
MH  - Male
MH  - Middle Aged
MH  - Multiple Sclerosis, Relapsing-Remitting/*drug therapy
MH  - Patient Satisfaction
MH  - Retrospective Studies
PMC - PMC6857316
OTO - NOTNLM
OT  - Bradycardia
OT  - FDO
OT  - Fingolimod
OT  - First-dose observation
OT  - Gilenya@home
OT  - Relapsing-remitting multiple sclerosis
OT  - Safety
OT  - Sphingosine 1-phosphate receptor
COIS- BB, JLW, SK, and XM are employees of Novartis Pharmaceuticals Corporation. IMW is 
      an employee of Oxford PharmaGenesis. JAO has received honoraria for educational 
      programs that he has provided on behalf of Novartis, as well as consultation fees 
      for Gilenya@Home. In addition, he is Medical Director of the Gilenya@Home 
      program.
EDAT- 2019/11/16 06:00
MHDA- 2020/01/28 06:00
PMCR- 2019/11/15
CRDT- 2019/11/16 06:00
PHST- 2019/01/31 00:00 [received]
PHST- 2019/10/21 00:00 [accepted]
PHST- 2019/11/16 06:00 [entrez]
PHST- 2019/11/16 06:00 [pubmed]
PHST- 2020/01/28 06:00 [medline]
PHST- 2019/11/15 00:00 [pmc-release]
AID - 10.1186/s12883-019-1506-0 [pii]
AID - 1506 [pii]
AID - 10.1186/s12883-019-1506-0 [doi]
PST - epublish
SO  - BMC Neurol. 2019 Nov 15;19(1):287. doi: 10.1186/s12883-019-1506-0.