Evidence map›Paper›PMID 39578022›Full record

ArticleBMJ open2024

Anifrolumab Study for Treatment Effectiveness in the Real World (ASTER) among patients with systemic lupus erythematosus: protocol for an international observational effectiveness study.

Marta Mosca, Cathy Emmas, Cassandra Nekeman-Nan, Heide Stirnadel-Farrant, Samuel Chen, Lucy Carty, Miina Waratani, Caroline Seo, Stephanie Chen, Alessandro Sorrentino

Registry-linked trialAbstract read
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05637112 (ASTER), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT05637112 active not recruitingnot on this map

ASTER: Anifrolumab Study for Treatment Effectiveness in the Real World Multi-National, Observational, Post-Launch Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice

TypeobservationalSponsorAstraZenecaRan2023 to 2030Enrolled551ConditionsSystemic Lupus ErythematosusArmsNone (Observational study)
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Observational
  2. Review
  3. Review
  4. 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

10 authors.

Marta MoscaDepartment of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy marta.mosca@unipi.it.ORCID http://orcid.org/0000-0001-5937-4574
Cathy EmmasRespiratory & Immunology Evidence, BioPharmaceuticals Medical, AstraZeneca, Cambridge, UK.
Cassandra Nekeman-NanCVRM Evidence, BioPharmaceuticals Medical, AstraZeneca, Mölndal, Sweden.
Heide Stirnadel-FarrantOncology Outcomes Research, Global Medical Affairs, AstraZeneca, Cambridge, UK.
Samuel ChenEvidence Delivery, BioPharmaceuticals Medical, AstraZeneca, Mölndal, Sweden.
Lucy CartyBiostatistics, AstraZeneca, Cambridge, UK.
Miina WarataniImmunology, AstraZeneca, Cambridge, UK.
Caroline SeoPatient Centered Science, BioPharmaceuticals Medical Evidence, AstraZeneca, Gaithersburg, Maryland, USA.
Stephanie ChenBioPharmaceuticals Medical, AstraZeneca, Gaithersburg, Maryland, USA.
Alessandro SorrentinoGlobal Medical Affairs, Respiratory & Immunology, BioPharmaceuticals Medical, AstraZeneca, Cambridge, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionSystemic lupus erythematosus (SLE) is a chronic autoimmune disease with a diverse clinical presentation that involves multiple organ systems and may lead to organ damage and increased risk of mortality. SLE is associated with a high burden of disease that can include loss of productivity and employment and reduced health-related quality of life. The current standard of care for SLE is primarily based on immunosuppression and glucocorticoids and is associated with risk of toxicities and poor tolerability. Anifrolumab, a human monoclonal antibody to type I interferon receptor subunit 1, was recently approved as a new treatment for patients with moderate-to-severe SLE. METHODS AND ANALYSIS: Here, we report the study design of the ongoing, multinational Anifrolumab Study for Treatment Effectiveness in the Real World (ASTER) that includes 3-years of follow-up beginning with the first infusion of anifrolumab and 1 year of retrospective baseline data. ASTER aims to enrol 500 adult patients receiving anifrolumab for SLE in Europe and Canada. The key study objective is to describe the real-world effectiveness of anifrolumab in routine clinical practice, including clinician-reported disease activity and patient-reported outcomes collected via mobile application. This mobile application also includes a medication diary, where patients report their prescription and non-prescription medication use for SLE on a weekly basis; these data will lend insights on treatment patterns for the study population. ETHICS AND DISSEMINATION: The design of the ASTER study was informed through consultations with patients with SLE who provided important insights to help maximise patient engagement, retention and the collection of key, patient-relevant endpoints. ASTER enrolment began in February 2023 and the study is expected to finish in 2029. TRIAL REGISTRATION NUMBER: NCT05637112.

Indexed as

Antibodies, Monoclonal, HumanizedLupus Erythematosus, SystemicObservational Studies as TopicAdultCanadaEuropeFemaleHumansMalePatient Reported Outcome MeasuresQuality of LifeRetrospective StudiesTreatment OutcomeanifrolumabAntibodies, Monoclonal, HumanizedChronic DiseaseImmunologyObservational StudyPatient Reported Outcome MeasuresPatients

Identifiers

PMID39578022
PMCPMC11660324

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Registered trials

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.