Evidence map›Paper›PMID 34079229›Full record

ArticlePatient preference and adherence2021

Subcutaneous Interferon Beta Therapy in Multiple Sclerosis Patients - Characterization of Injection Site Reactions and Flu-Like Symptoms in a Daily Practice Setting - Results from the Non-Interventional Study PERFECT.

Borries Kukowski, Karin Rehberg-Weber, Kirsi Taipale, Andreas Kowalik, Patrick Oschmann

Abstract read
In one paragraph

Article in Patient preference and adherence, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

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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

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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

1 citing paper in PubMed.

  1. Trial
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.

Borries KukowskiNeurologische Gemeinschaftspraxis, Göttingen, Germany.
Karin Rehberg-WeberBiogen GmbH, Munich, Germany.
Kirsi TaipaleBiogen GmbH, Munich, Germany.
Andreas KowalikPraxis Dr. Kowalik, Stuttgart, Germany.
Patrick OschmannKlinik für Neurologie, Klinikum Bayreuth GmbH, Bayreuth, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe purpose of this study was to assess the prevalence of injection site reactions (ISR) and flu-like symptoms (FLS) during treatment with subcutaneous (SC) interferon (IFN) beta therapies and to document measures to mitigate and prevent ISR and FLS. PATIENTS AND

methodsThe cross-sectional post-authorization safety study PERFECT was conducted from 11/2017 to 7/2019 in neurology practices in Germany. Adult patients with relapsing-remitting multiple sclerosis (MS) receiving SC IFN beta for ≥3 months were eligible. The primary endpoints were patient-reported prevalence of ISR and FLS. Additional endpoints reported by patients, MS nurses, and neurologists included type, frequency, duration, time of occurrence, and management of ISR and FLS.

resultsIn total, 603 patients (median age 45 years [range 36-53], 74% female) were included in the analysis. Time since MS diagnosis was >5 years in most patients. The majority had received none (64%) or 1 (22%) prior therapy. Current MS therapy in 36%, 32%, and 30% of patients was IFN beta-1b, IFN beta-1a, and peginterferon beta-1a, respectively. ISR and FLS under current therapy were reported by 84% and 68% of patients, respectively. ISR developed within 5 days after injection (84%) and lasted for 2-14 days (53%) in most patients. The most frequent patient-reported symptom was erythema (39%). ISR resolved or abated with systemic treatments or topical ointments. Most frequent preventive measures included alternating injection sites (58%). Occurrence of ISR rarely resulted in treatment interruption (5%). FLS occurred predominantly up to 6 h after injection (40%) and lasted <12 h (26%). The most frequent patient-reported symptoms were fatigue (15%) and aching limbs (15%). Assessments by physicians and MS nurses differed from patient-reported results.

conclusionAlthough ISR were experienced by the majority of patients, they rarely resulted in treatment interruption. In this real-world setting, ISR and FLS management was in line with published expert recommendations.

Indexed as

disease-modifying therapyerythemapeginterferon beta-1apost-authorization safety studyreal-world

Identifiers

PMID34079229
PMCPMC8163742

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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.