Evidence map›Paper›PMID 25424122›Full record

Trial reportBMC neurology2014

Impact of a switch to fingolimod versus staying on glatiramer acetate or beta interferons on patient- and physician-reported outcomes in relapsing multiple sclerosis: post hoc analyses of the EPOC trial.

Jonathan Calkwood, Bruce Cree, Heidi Crayton, Daniel Kantor, Brian Steingo, Luigi Barbato, Ron Hashmonay, Neetu Agashivala, Kevin McCague, Nadia Tenenbaum and 1 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC neurology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01216072 (A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient OutComes, Safety and Tolerability of Fingolimod), which is not on this map. Cited by 19 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 3 pooled it
2.5field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01216072 phase4completednot on this map

A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient OutComes, Safety and Tolerability of Fingolimod (FTY720) 0.5 mg/Day in Patients With Relapsing Forms of Multiple Sclerosis Who Are Candidates for MS Therapy Change From Previous Disease Modifying Therapy (EPOC)

TypeinterventionalSponsorNovartis PharmaceuticalsRan2010 to 2012Enrolled1,053ConditionsRelapsing Forms of Multiple SclerosisArmsFingolimod, Standard MS DMTs
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 3 syntheses or guidelines pooled it, 37 citations in OpenAlex.

  1. MS Fatigue Post High-Efficacy Treatment.European journal of neurology · 2025
    Pooled it
  2. Use of pragmatic randomized trials in multiple sclerosis: A systematic overview.Multiple sclerosis (Houndmills, Basingstoke, England) · 2024
    Pooled it
  3. Fingolimod for relapsing-remitting multiple sclerosis.The Cochrane database of systematic reviews · 2016
    Pooled it
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 7 institutions in 3 countries.

Jonathan CalkwoodMinneapolis Clinic of Neurology, Golden Valley, MN, USA. jcalkwood@gmail.com.
Bruce CreeUniversity of California San Francisco, San Francisco, CA, USA. Bruce.Cree@ucsf.edu.
Heidi CraytonMS Center of Greater Washington, Vienna, VA, USA. msdoc1@hotmail.com.
Daniel KantorNeurologique, Ponte Vedra, FL, USA. dkantor@neurologique.org.
Brian SteingoFort Lauderdale MS Center, Pompano Beach, FL, USA. ogniets@yahoo.com.
Luigi BarbatoNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA. lou.barbato@biogenidec.com.
Ron HashmonayNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA. ronny.hashmonay@novartis.com.
Neetu AgashivalaNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA. neetu.agashivala@novartis.com.
Kevin McCagueNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA. kevin.mccague@novartis.com.
Nadia TenenbaumNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA. nadia.tenenbaum@novartis.com.
Keith EdwardsMS Center of Northeastern New York, Latham, NY, USA. kedwards@tristateneuro.com.
Novartis (Switzerland) · CHChildren’s Minnesota - St. Paul Hospital · USMSD (Austria) · ATMultiple Sclerosis Center Of Northeastern New York · USMultiple Sclerosis Foundation · USNeurologique Foundation · USUniversity of California, San Francisco · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe Evaluate Patient OutComes (EPOC) study assessed physician- and patient-reported outcomes in individuals with relapsing multiple sclerosis who switched directly from injectable disease-modifying therapy (iDMT; glatiramer acetate, intramuscular or subcutaneous interferon beta-1a, or interferon beta-1b) to once-daily, oral fingolimod. Post hoc analyses evaluated the impact of a switch to fingolimod versus staying on each of the four individual iDMTs.

methodsOverall, 1053 patients were randomized 3:1 to switch to fingolimod or remain on iDMT. The primary endpoint was the change in Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction score. Secondary endpoints included changes in scores for TSQM Effectiveness, Side Effects and Convenience subscales, Beck Depression Inventory-II (BDI-II), Fatigue Severity Scale (FSS), Patient-Reported Outcome Indices for Multiple Sclerosis (PRIMUS) Activities, 36-item Short-Form Health Survey (SF-36) Mental Component Summary (MCS) and Physical Component Summary (PCS) and mean investigator-reported Clinical Global Impressions of Improvement (CGI-I). All outcomes were evaluated after 6 months of treatment.

resultsChanges in TSQM Global Satisfaction scores were superior after a switch to fingolimod when compared with scores in patients remaining on any of the iDMTs (all p <0.001). Likewise, all TSQM subscale scores improved following a switch to fingolimod (all p <0.001), except when compared with glatiramer acetate for the TSQM Side Effects subscale (p = 0.111). FSS scores were found to be superior for fingolimod versus remaining on subcutaneous interferon beta-1a and interferon beta-1b, BDI-II scores were significantly improved for fingolimod except for the comparison with intramuscular interferon beta-1a, and SF-36 scores were superior with fingolimod compared with remaining on interferon beta-1b (MCS and PCS; p = 0.030 and p = 0.022, respectively) and subcutaneous interferon beta-1a (PCS only; p = 0.024). Mean CGI-I scores were superior with fingolimod when compared with continuing treatment with any of the iDMTs (all p <0.001).

conclusionsAfter 6 months, a switch to fingolimod showed superiority compared with remaining on each iDMT for a range of patient- and physician-reported outcomes, including global satisfaction with treatment.

trial registrationClinicalTrials.gov NCT01216072 .

Indexed as

AdultAgedFemaleFingolimod HydrochlorideGlatiramer AcetateHumansImmunosuppressive AgentsInjections, IntramuscularInterferon beta-1aInterferon beta-1bMaleMiddle AgedMultiple Sclerosis, Relapsing-RemittingFingolimod HydrochlorideGlatiramer AcetateImmunosuppressive AgentsInterferon beta-1aInterferon beta-1b

Identifiers

PMID25424122
PMCPMC4253981
OpenAlexW2027367341

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.