Evidence map›Paper›PMID 32318950›Full record

ArticleNeurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology2020

Effectiveness of fingolimod in real-world relapsing-remitting multiple sclerosis Italian patients: the GENIUS study.

Giancarlo Comi, Carlo Pozzilli, Vincenzo Brescia Morra, Antonio Bertolotto, Francesca Sangalli, Luca Prosperini, Antonio Carotenuto, Pietro Iaffaldano, Marco Capobianco, Delia Colombo and 3 more

Open access · hybridAbstract readMulticenter Study
In one paragraph

Article in Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.0field-weighted citation impact, top 25% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 12 citations in OpenAlex.

  1. Observational
  2. Article
  3. Observational
  4. Article
  5. Article
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

13 authors at 6 institutions in 1 country.

Giancarlo ComiSan Raffaele Hospital, Milan, Italy.
Carlo PozzilliDepartment of Human Neuroscience, Sapienza University, Rome, Italy.
Vincenzo Brescia MorraDepartment of Neurosciences, Reproductive and Odontostomatological Sciences, Federico II University, Naples, Italy.
Antonio BertolottoA.O.U. San Luigi Gonzaga, Orbassano, Turin, Italy.
Francesca SangalliSan Raffaele Hospital, Milan, Italy.
Luca ProsperiniMultiple Sclerosis Center, S. Andrea Hospital, Rome, Italy.
Antonio CarotenutoDepartment of Neurosciences, Reproductive and Odontostomatological Sciences, Federico II University, Naples, Italy.
Pietro IaffaldanoDepartment of Basic Medical Sciences, Neurosciences and Sense Organs, University of Bari Aldo Moro, Bari, Italy.
Marco CapobiancoA.O.U. San Luigi Gonzaga, Orbassano, Turin, Italy.
Delia ColomboNovartis Farma S.p.A, Origgio, VA, Italy. paperGENIUS@medineos.com.
Mihaela NicaNovartis Farma S.p.A, Origgio, VA, Italy.
Sara RizzoliMediNeos Observational Research, Modena, Italy.
Maria TrojanoDepartment of Basic Medical Sciences, Neurosciences and Sense Organs, University of Bari Aldo Moro, Bari, Italy.
Federico II University Hospital · ITNovartis (Italy) · ITOspedale San Luigi Gonzaga · ITUniversity of Bari Aldo Moro · ITCarlo Forlanini Hospital · ITSapienza University of Rome · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFingolimod is the first oral agent approved for treatment of relapsing-remitting multiple sclerosis (RRMS). We aimed to evaluate fingolimod effectiveness in a real-world sample of RRMS patients.

methodsA retrospective, multicentre study in patients treated with fingolimod, whom clinical and radiological data were collected in the 2 years preceding and following the initiation of fingolimod.

resultsOut of 414 patients, 56.8% received prior first-line injectable disease-modifying therapies, 25.4% were previously treated with natalizumab, 1.2% with immunosuppressant agents, and 16.7% were treatment naive. The annualized relapse rate decreased by 65% in the first year and by 70% after two years of treatment. Age ≤ 40 years, ≥ 1 relapse in the 24 months before fingolimod initiation and previous treatment with natalizumab were risk factors for relapses. Overall, 67.9% patients had no evidence of disease activity (NEDA-3) after 1 year and 54.6% after 2 years of treatment. A higher proportion of naïve (81.2% in 1 year and 66.7% after 2 years) or first-line injected patients (70.2% and 56.6%) achieved NEDA-3 than those previously treated with natalizumab (54.3% and 42.9%).

conclusionsFingolimod appeared to be effective in naive patients and after first-line treatment failure in reducing risk of relapse and disease activity throughout the 2-year follow-up.

Indexed as

Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingAdultFingolimod HydrochlorideHumansImmunosuppressive AgentsItalyNatalizumabRetrospective StudiesFingolimod HydrochlorideImmunosuppressive AgentsNatalizumabAnnualized relapse rateFingolimodNEDA-3Relapsing-remitting multiple sclerosis

Identifiers

PMID32318950
PMCPMC7479005
OpenAlexW3016996807

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.