Evidence map›Paper›PMID 35653061›Full record

ArticleNeurology and therapy2022

Predictors of Cladribine Effectiveness and Safety in Multiple Sclerosis: A Real-World, Multicenter, 2-Year Follow-Up Study.

Maria Petracca, Serena Ruggieri, Elena Barbuti, Antonio Ianniello, Roberta Fantozzi, Giorgia Teresa Maniscalco, Vincenzo Andreone, Doriana Landi, Girolama Alessandra Marfia, Maria Di Gregorio and 11 more

Open access · goldAbstract read
In one paragraph

Article in Neurology and therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed
5.7field-weighted citation impact, top 3% 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

26 citing papers in PubMed, 40 citations in OpenAlex.

  1. Article
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  7. Identifying Cladribine prescription pattern in MS: an Italian multicentre study.Therapeutic advances in neurological disorders · 2025
    Article
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  11. Cladribine tablets in the new multiple sclerosis era.Therapeutic advances in neurological disorders · 2025
    Review
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  13. Cladribine use trend in Latin America: the changes in patient profile impact in the drug effectiveness.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024
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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

21 authors at 9 institutions in 1 country.

Maria PetraccaDepartment of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, 00185, Rome, Italy.
Serena RuggieriDepartment of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, 00185, Rome, Italy. serena.ruggieri@uniroma1.it.ORCID http://orcid.org/0000-0001-5287-3290
Elena BarbutiMS Center, S. Andrea Hospital, Sapienza University, Rome, Italy.
Antonio IannielloDepartment of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, 00185, Rome, Italy.
Roberta FantozziNeurology Unit, IRCCS Neuromed, Pozzilli, IS, Italy.
Giorgia Teresa ManiscalcoMultiple Sclerosis Center, "A. Cardarelli" Hospital, Naples, Italy.
Vincenzo AndreoneMultiple Sclerosis Center, "A. Cardarelli" Hospital, Naples, Italy.
Doriana LandiDepartment of Systems Medicine, Multiple Sclerosis Clinical and Research Unit, Tor Vergata University, Rome, Italy.
Girolama Alessandra MarfiaDepartment of Systems Medicine, Multiple Sclerosis Clinical and Research Unit, Tor Vergata University, Rome, Italy.
Maria Di GregorioNeurology Unit, MS Center, Department of Medicine, Surgery and Dentistry, University Hospital "San Giovanni di Dio e Ruggi d'Aragona", Salerno, Italy.
Rosa IodiceDepartment of Neurosciences, Reproductive Sciences, and Odontostomatology, University of Naples "Federico II", Naples, Italy.
Leonardo SinisiDivision of Neurology and MS Center, San Paolo Hospital, Naples, Italy.
Elisabetta MaidaSecond Division of Neurology, Department of Advanced Medical and Surgical Sciences, Multiple Sclerosis Center, University of Campania 'Luigi Vanvitelli', Naples, Italy.
Rosanna MissioneSecond Division of Neurology, Department of Advanced Medical and Surgical Sciences, Multiple Sclerosis Center, University of Campania 'Luigi Vanvitelli', Naples, Italy.
Cinzia CoppolaSecond Division of Neurology, Department of Advanced Medical and Surgical Sciences, Multiple Sclerosis Center, University of Campania 'Luigi Vanvitelli', Naples, Italy.
Simona BonavitaSecond Division of Neurology, Department of Advanced Medical and Surgical Sciences, Multiple Sclerosis Center, University of Campania 'Luigi Vanvitelli', Naples, Italy.
Giovanna BorrielloMS Center, Neurology Unit, San Pietro Fatebenefratelli Hospital, Rome, Italy.
Diego CentonzeNeurology Unit, IRCCS Neuromed, Pozzilli, IS, Italy.
Giacomo LusSecond Division of Neurology, Department of Advanced Medical and Surgical Sciences, Multiple Sclerosis Center, University of Campania 'Luigi Vanvitelli', Naples, Italy.
Carlo PozzilliDepartment of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, 00185, Rome, Italy.
Elisabetta SignorielloSecond Division of Neurology, Department of Advanced Medical and Surgical Sciences, Multiple Sclerosis Center, University of Campania 'Luigi Vanvitelli', Naples, Italy.
University of Campania "Luigi Vanvitelli" · ITSapienza University of Rome · ITUniversity of Rome Tor Vergata · ITFatebenefratelli Hospital · ITFondazione Santa Lucia · ITIstituto Neurologico Mediterraneo · ITOspedale San Paolo · ITOspedali Riuniti San Giovanni di Dio e Ruggi d'Aragona · ITUniversity of Naples Federico II · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionCladribine administration has been approved for the treatment of relapsing-remitting multiple sclerosis (MS) in 2017; thus, data on cladribine in a real-world setting are still emerging.

methodsWe report on cladribine effectiveness, safety profile, and treatment response predictors in 243 patients with MS followed at eight tertiary MS centers. Study outcomes were: (1) No Evidence of Disease Activity-3 (NEDA-3) status and its components (absence of clinical relapses, MRI activity, and sustained disability worsening); (2) development of grade III/IV lymphopenia. The relationship between baseline features and the selected outcomes was tested via multivariate logistic models.

resultsOf the 243 subjects included in the study (66.5% female, age 34.2 ± 10 years, disease duration 6.6 ± 9.6 years), 64% showed NEDA-3 at median follow-up (22 months). Patients with higher number of previous treatments had lower probability to retain NEDA-3 [odds ratio (OR) 0.64, 95% confidence interval (CI) 0.41-0.98, p = 0.04] and were more prone to experience clinical relapses (OR 1.6, 95% CI 1-2.6, p = 0.04). The presence of active lesions at baseline was associated with follow-up magnetic resonance imaging (MRI) activity (OR 1.92, 95% CI 1.04-3.55, p = 0.04). Patients with higher rate of relapses in the year prior to cladribine start were at higher risk of developing sustained disability worsening (OR 2.95% CI 1-4.2, p = 0.04). Lymphopenia grade III/IV over the follow-up was associated with baseline lymphocyte count (OR 0.998, 95% CI 0.997-0.999, p = 0.01).

conclusionIn this large cohort, we confirm previous data about cladribine effectiveness on disease activity and disability worsening and provide information on response predictors that might inform therapeutic choices.

Indexed as

CladribineMultiple sclerosisNEDA-3PredictorsSafety

Identifiers

PMID35653061
PMCPMC9338179
OpenAlexW4281636199

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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.