Evidence map›Paper›PMID 31299922›Full record

Observational studyBMC neurology2019

Use of glatiramer acetate between 2010-2015: effectiveness, safety and reasons to start GA as first or second line treatment in Swiss multiple sclerosis patients.

Chiara Zecca, Giulio Disanto, Rosaria Sacco, Gianna C Riccitelli, Claudio Gobbi

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in BMC neurology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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

2 citing papers in PubMed.

  1. Review
  2. Review
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

5 authors.

Chiara ZeccaNeurocenter of Southern Switzerland, Ospedale Regionale di Lugano, Via Tesserete 46, 6903, Lugano, Switzerland. chiara.zecca@eoc.ch.ORCID http://orcid.org/0000-0002-9990-3431
Giulio DisantoNeurocenter of Southern Switzerland, Ospedale Regionale di Lugano, Via Tesserete 46, 6903, Lugano, Switzerland.
Rosaria SaccoNeurocenter of Southern Switzerland, Ospedale Regionale di Lugano, Via Tesserete 46, 6903, Lugano, Switzerland.
Gianna C RiccitelliNeurocenter of Southern Switzerland, Ospedale Regionale di Lugano, Via Tesserete 46, 6903, Lugano, Switzerland.
Claudio GobbiNeurocenter of Southern Switzerland, Ospedale Regionale di Lugano, Via Tesserete 46, 6903, Lugano, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGlatiramer acetate (GA) is one of the first therapies approved for multiple sclerosis (MS). We prospectively included and monitored drug-naïve and pre-treated MS patients who had been prescribed GA for 1 year, to investigate reasons for GA prescription, its effectiveness and safety in real life clinical practice.

methodsOne year, prospective, multicentre, observational study performed between 2010 and 2015 in consecutive MS and clinically isolated syndrome patients starting GA as a first ("naïve") or second ("switcher") line therapy. Primary endpoint was the annualized relapse rate (ARR) over 1 year of GA treatment (from baseline, V1, to 12 months, V2) in naïve and switchers compared to previous 24 months. Secondary endpoints were: EDSS changes between V1 and V2, frequency of adverse events, and reasons for prescribing and discontinuing GA. Baseline demographics and clinical characteristics were retrieved from medical records, and outcome measures were documented at V1 and V2, and in case of clinical worsening.

resultsOne hundred ninety-four consecutive patients were monitored over 12 months (N = 64 naïve, N = 130 switchers). Side effect profile (naïve = 36%, switchers = 28%) and comorbidities (naïve = 31%, switchers = 15%) were the most frequent reasons to start GA. The ARR was reduced in both naïve and switchers during V1-2 as compared to the 24 months preceding V1 [naïve: 0.0 (0.0-0.0) vs 0.5 (0.5-1.0, p = 2.9e-10); switchers: 0.0 (0.0-0.0) vs 0.5 (0.0-0.5, p = 0.022)]. EDSS at V2 was significantly reduced only in naïve [(1.5 (1.0-2.5) vs 2.0 (1.5-2.5), p = 0.003)]. Naïve status and EDSS at V1 were negatively associated with EDSS change between V1-V2 in multivariable analysis (regression coefficient = - 0.436, p = 0.008, and regression coefficient = - 0.263, p = 6.18e-05, respectively). No new unexpected AE was reported.

conclusionIn our Swiss cohort, GA was prescribed mainly to naïve or switcher MS patients fearing interferon related side effects, with various comorbidities or considering pregnancy, and showed effectiveness and safety comparable with data of previous GA studies.

Indexed as

AdultCohort StudiesFemaleGlatiramer AcetateHumansImmunosuppressive AgentsMaleMiddle AgedMultiple SclerosisMultiple Sclerosis, Relapsing-RemittingOutcome Assessment, Health CarePregnancyProspective StudiesRecurrenceGlatiramer AcetateImmunosuppressive AgentsCISGAGlatiramer acetateMultiple sclerosisRelapsing remittingTherapy

Identifiers

PMID31299922
PMCPMC6626416

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Registered trials

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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.