Evidence map›Paper›PMID 41986078›Full record

Observational studyLupus science & medicine2026

Real-world experience of anifrolumab treatment in patients with moderate-to-severe SLE: a retrospective study of patients in early access programmes.

Edward M Vital, François Chasset, Raquel Faria, Lucy M Carter, Danuta Kielar, Stephanie Y Chen, Samuel Chen, Jonatan Nåtman, Miina Waratani

2 registry-linked trialsAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Lupus science & medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.

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

NCT04750057 no longer availablenot on this map

An Early Access Program for Anifrolumab Treatment in Adult Patients With Active Systemic Lupus Erythematosus - AMANA

Typeexpanded_accessSponsorAstraZenecaConditionsSystemic Lupus ErythematosusArmsAnifrolumab
NCT06046534 completednot on this map

ERYTHRO Retrospective Medical Chart Review Study to Describe the Experience of SLE Patients Treated With Anifrolumab in the Early Access Programs.

TypeobservationalSponsorAstraZenecaRan2023 to 2024Enrolled46ConditionsSystemic Lupus ErythematosusArmsNone (Observational study)
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

9 authors.

Edward M VitalLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
François ChassetService de Dermatologie et Allergologie, Faculté de médecine, Sorbonne University, Tenon Hospital, Paris, France.ORCID 0000-0003-2580-8607
Raquel FariaUnidade de Imunologia Clínica, Unidade Local de Saúde de Santo António, Porto, Portugal.
Lucy M CarterLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
Danuta KielarBioPharmaceuticals Medical, AstraZeneca, Cambridge, UK.
Stephanie Y ChenBioPharmaceuticals Medical, AstraZeneca, Gaithersburg, Maryland, USA.
Samuel ChenBioPharmaceuticals Medical, AstraZeneca, Gothenburg, Sweden.
Jonatan NåtmanBioPharmaceuticals Medical, AstraZeneca, Gothenburg, Sweden jonatan.natman@astrazeneca.com.
Miina WarataniBioPharmaceuticals Medical, AstraZeneca, Cambridge, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe multinational ERYTHRO (NCT06046534) study investigated the experience of patients with moderate-to-severe SLE initiating anifrolumab treatment through routine clinical practice as part of two early access programmes.

methodsRetrospective data were extracted from medical charts of adults with SLE who received intravenous anifrolumab 300 mg every 4 weeks alongside standard therapy during AMANA (NCT04750057) or the France Temporary Authorisation for Use (ATUc). The baseline period included ≥6 months of data collection before anifrolumab initiation; follow-up data were collected for as long as data were available in the chart. Outcomes, including SLE Disease Activity Index-2000 (SLEDAI-2K), Physician Global Assessment (PGA) scores and rates of Definition of Remission in SLE (DORIS) and Lupus Low Disease Activity State (LLDAS) attainment, were assessed at baseline and at 6 months from the first anifrolumab dose. Outcome estimation at the 6-month follow-up time point was performed using data from two different windows (primary analysis: 6±1 month; sensitivity analysis: 6±2.5 months).

resultsOf 47 enrolled patients who initiated anifrolumab, treatment was ongoing in 41 patients (87.2%) at the end of the ERYTHRO study; 6 patients (12.8%) withdrew from anifrolumab (4 (8.5%) due to worsening symptoms, 1 (2.1%) due to improving symptoms and 1 (2.1%) for other reasons). SLEDAI-2K and PGA scores (median (IQR)) decreased over 6 months of treatment (SLEDAI-2K, baseline: 6.0 (8.0), n=47; and 6±1 month: 2.0 (4.0), n=40; PGA, baseline: 1.8 (1.0), n=39; and 6±1 month: 0.3 (1.0), n=29). DORIS remission and LLDAS attainment rates increased from baseline over time (DORIS, baseline: 0/39; 6±1 month: 9/29, 31.0%; and LLDAS, baseline: 3/39, 7.7%; 6±1 month: 17/29, 58.6%).

conclusionsBased on the changes in disease activity and attainment of DORIS remission and LLDAS seen within 6 months of anifrolumab initiation, this study supports anifrolumab use in a real-world population of patients with moderate to severe SLE.

Indexed as

Antibodies, Monoclonal, HumanizedLupus Erythematosus, SystemicAdultFemaleFranceHumansMaleMiddle AgedRemission InductionRetrospective StudiesSeverity of Illness IndexTreatment OutcomeanifrolumabAntibodies, Monoclonal, HumanizedAutoimmune DiseasesBiological ProductsLupus Erythematosus, Systemic

Identifiers

PMID41986078
PMCPMC13266247

What OpenQuestion holds

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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.