Evidence map›Paper›PMID 30400884›Full record

ArticleBMC neurology2018

Seasonal adherence to, and effectiveness of, subcutaneous interferon β-1a administered by RebiSmart® in patients with relapsing multiple sclerosis: results of the 1-year, observational GEPAT-SMART study.

Spyros N Deftereos, Evangelos Koutlas, Efrosini Koutsouraki, Athanassios Kyritsis, Panagiotis Papathanassopoulos, Nikolaos Fakas, Vaia Tsimourtou, Nikolaos Vlaikidis, Antonios Tavernarakis, Konstantinos Voumvourakis and 3 more

Abstract readMulticenter Study
In one paragraph

Article in BMC neurology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–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

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. 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.

Spyros N DeftereosMerck Hellas, 41-45 Kifisias av, 15123, Athens, Greece. spyros.deftereos@external.merckgroup.gr.ORCID http://orcid.org/0000-0001-6757-543X
Evangelos KoutlasNeurology Department, Papageorgiou Hospital, Thessaloniki, Greece.
Efrosini KoutsourakiNeurology Department, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Athanassios KyritsisUniversity of Ioannina Neurology Department, Ioannina, Greece.
Panagiotis PapathanassopoulosNeurology Department, University of Patras, Patras, Greece.
Nikolaos FakasNeurology Department, 401 Army Hospital of Athens, Athens, Greece.
Vaia TsimourtouNeurology Department, University of Thessaly, Larissa, Greece.
Nikolaos VlaikidisNeurology Department, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Antonios TavernarakisNeurology Department, Evangelismos Hospital, Athens, Greece.
Konstantinos VoumvourakisB Neurology Department, University of Athens, Athens, Greece.
Michalis ArvanitisPrivate Practice, Athens, Greece.
Dimitrios SakellariouMerck Hellas, 41-45 Kifisias av, 15123, Athens, Greece.
Filippo DeLorenzoMerck Hellas, 41-45 Kifisias av, 15123, Athens, Greece.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLittle is known about whether tolerability and adherence to treatment can be influenced by weather and temperature conditions. The objective of this study was to assess monthly and seasonal adherence to and safety of sc IFN-β1a (Rebif®, Merck) in relapsing-remitting multiple sclerosis (RRMS) patients using the RebiSmart® electronic autoinjector.

methodsA multicentre, prospective observational study in Greece in adult RRMS patients with EDSS < 6, under Rebif®/RebiSmart® treatment for ≤6 weeks before enrollment. The primary endpoint was monthly, seasonal and annual adherence over 12 months (defined in text). Secondary endpoints included number of relapses, disability, adverse events.

resultsSixty four patients enrolled and 47 completed all study visits (Per Protocol Set - PPS). Mean annual adherence was 97.93% ± 5.704 with no significant monthly or seasonal variations. Mean relapses in the pre- and post- treatment 12-months were 1.1 ± 0.47 and 0.2 ± 0.54 (p < 0.0001, PPS). 10 patients (22%) showed 3-month disability progression, 19 (40%) stabilization and 18 (38%) improvement. EDSS was not correlated to pre- (r = 0.024, p = 0.87) or post-treatment relapses (r = 0.022, p = 0.88).

conclusionHigh adherence with no significant seasonal or weather variation was observed over 12 months. While the efficacy on relapses was consistent with published studies, we could not identify a relationship between relapses and disability.

trial registrationGreek registry of non-interventional clinical trials ID: 200136 , date of registration: February 18th, 2013.

Indexed as

SeasonsAdolescentAdultAgedDisease ProgressionFemaleGreeceHumansInterferon beta-1aMaleMiddle AgedMultiple Sclerosis, Relapsing-RemittingPersons with DisabilitiesProspective StudiesYoung AdultInterferon beta-1aClinical efficacyInterferonsMultiple sclerosisRebifRebismartTreatment adherence and compliance

Identifiers

PMID30400884
PMCPMC6218994

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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.