Evidence map›Paper›PMID 32140867›Full record

Trial reportJournal of neurology2020

Administration of subcutaneous interferon beta 1a in the evening: data from RELIEF study.

Francesco Patti, Giovanni Bosco Zimatore, Vincenzo Brescia Morra, Umberto Aguglia, Roberto Bruno Bossio, Roberto Marziolo, Paola Valentino, Clara Grazia Chisari, Antonio Capacchione, Mario Zappia and 1 more

Abstract readClinical Trial, Phase IVMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of neurology, 2020. 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
0.4field-weighted citation impact, top 39% 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

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Circadian Variation in Efficacy of Medications.Clinical pharmacology and therapeutics · 2021
    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

11 authors at 5 institutions in 1 country.

Francesco PattiDepartment G. F. Ingrassia, Neuroscience Section, University of Catania, Via Santa Sofia, 78, 95123, Catania, Italy. patti@unict.it.ORCID http://orcid.org/0000-0002-6923-0846
Giovanni Bosco ZimatoreU.O.C. Neurology, Ospedale Generale Regionale "F. Miulli", Acquaviva delle Fonti, BA, Italy.
Vincenzo Brescia MorraDepartment of Neuroscience (NSRO), University of Naples Federico II, Napoli, Italy.
Umberto AgugliaNeurology Department, Hospital "Bianchi Melacrino Morelli", Reggio Calabria, Italy.
Roberto Bruno BossioMultiple Sclerosis Center, Provincial Health Company of Cosenza, Cosenza, Italy.
Roberto MarzioloNeurology Department, Emergency Hospital "Cannizzaro", Catania, Italy.
Paola ValentinoNeurology Department, University Hospital "Località Germaneto", Catanzaro, Italy.
Clara Grazia ChisariDepartment G. F. Ingrassia, Neuroscience Section, University of Catania, Via Santa Sofia, 78, 95123, Catania, Italy.
Antonio CapacchioneMedical Affairs Department, Merck Serono S.p.A., Rome, Italy.
Mario ZappiaDepartment G. F. Ingrassia, Neuroscience Section, University of Catania, Via Santa Sofia, 78, 95123, Catania, Italy.
RELIEF Study Group
University of Catania · ITAzienda ospedaliera "Bianchi-Melacrino-Morelli" · ITMagna Graecia University · ITAzienda Ospedaliera di Cosenza · ITOspedale Generale Regionale Francesco Miulli · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSubcutaneous recombinant interferon-beta 1a (IFN-β1a SC) is indicated for treatment of relapsing multiple sclerosis (RMS); however, it is associated with development of flu-like syndrome (FLS) in 75% of patients. No recommendations are available on whether evening or morning administration could induce better or worse FLS.

objectivePrimary objective was to investigate whether morning administration of IFN-β1a 44 µg (Rebif) would affect the severity of FLS versus evening administration, in patients with RMS. Secondary objectives were to investigate whether timing of administration could lead to a better quality of life.

methodsMulticenter, open-label, 12-week, randomized, controlled, parallel-group, phase 4 study.

resultsOf 217 patients screened at 29 Italian sites, 200 were included in the study. Among these, 104 patients were randomized to IFN-β1a SC administration in the morning and 96 in the evening. Morning administration resulted in higher FLS scores, as measured by the Multiple Sclerosis Treatment Concern Questionnaire, at week 4 (p = 0.0083) and week 8 (p = 0.0079); however, the difference was no longer significant at the end of 12 weeks.

conclusionIFN-β1a evening injections in the first 8 weeks of treatment led to an improvement in FLS; when continuing therapy, time of administration could be decided according to patient's lifestyle and preference.

Indexed as

AdultDrug-Related Side Effects and Adverse ReactionsFemaleHumansImmunologic FactorsInjections, SubcutaneousInterferon beta-1aMaleMultiple Sclerosis, Relapsing-RemittingTreatment OutcomeImmunologic FactorsInterferon beta-1aFlu-like syndromeInterferon betaMultiple SclerosisQuality of lifeSelf-injectionTime of administration

Identifiers

PMID32140867
OpenAlexW3010068287

What OpenQuestion holds

Textmetadata
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.