Evidence map›Paper›PMID 42295083›Full record

ArticleACR open rheumatology2026

Long-Term Anifrolumab Treatment Normalizes Hematologic Parameters and Several Serologic Markers in Patients With Systemic Lupus Erythematosus.

Edward M Vital, Zahir Amoura, Kenneth C Kalunian, Ian N Bruce, Yoshiya Tanaka, Susan Manzi, Ihor Hupka, Jacob Knagenhjelm, Hussein Al-Mossawi, Catharina Lindholm

3 registry-linked trialsAbstract read
In one paragraph

Article in ACR open rheumatology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 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.

NCT02446899 phase3completednot on this map

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus

TypeinterventionalSponsorAstraZenecaRan2015 to 2018Enrolled373ConditionsActive Systemic Lupus ErythematosusArmsAnifrolumab, Placebo
NCT02446912 phase3completednot on this map

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus

TypeinterventionalSponsorAstraZenecaRan2015 to 2018Enrolled460ConditionsActive Systemic Lupus ErythematosusArmsAnifrolumab, Placebo
NCT02794285 phase3completednot on this map

A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus.

TypeinterventionalSponsorAstraZenecaRan2016 to 2021Enrolled559ConditionsActive Systemic Lupus ErythematosusArmsAnifrolumab, Placebo
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

10 authors.

Edward M VitalLeeds Institute of Rheumatic and Musculoskeletal Medicine, Faculty of Medicine and Health, University of Leeds, Leeds, United Kingdom.ORCID https://orcid.org/0000-0003-1637-4755
Zahir AmouraFrench National Reference Center for Systemic Lupus Erythematosus, Hôpital La Pitié-Salpêtrière, Sorbonne University, Paris, France.
Kenneth C KalunianSchool of Medicine, University of California, San Diego, La Jolla.
Ian N BruceCentre for Musculoskeletal Research, The University of Manchester, Manchester, United Kingdom.
Yoshiya TanakaThe First Department of Internal Medicine, University of Occupational and Environmental Health Japan, Kitakyushu, Japan.ORCID https://orcid.org/0000-0002-0807-7139
Susan ManziLupus Center of Excellence, Autoimmunity Institute, Allegheny Health Network, Pittsburgh, Pennsylvania.
Ihor HupkaBioPharmaceuticals Research and Development, AstraZeneca, Warsaw, Poland.
Jacob KnagenhjelmBioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden.
Hussein Al-MossawiSt Edmund Hall, University of Oxford, Oxford, United Kingdom.
Catharina LindholmBioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden.

Funding

AstraZeneca
6 · The paper itself

Abstract

objectiveTo evaluate the long-term effects of anifrolumab on hematologic and serologic parameters over four years.

methodsThis analysis included 536 patients with moderate-to-severe systemic lupus erythematosus (SLE) who received intravenous anifrolumab 300 mg (n = 358) or placebo (n = 178) in the 52-week, phase 3 TULIP-1/2 trials (NCT02446912 and NCT02446899) and continued the same treatment in the 3-year, long-term extension (LTE, NCT02794285), or would have done if not discontinued early; 369 patients entered the LTE. Changes from baseline to week 208 in lymphocytes, hemoglobin, platelets, neutrophils, complement C3, C4, anti-double-stranded DNA (dsDNA), and Igs were analyzed descriptively. British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response at week 52 was analyzed by treatment and lymphocyte, hemoglobin, and platelet normalization in responders versus nonresponders, regardless of treatment.

resultsNumerically greater improvements from baseline in lymphocyte, hemoglobin, platelet, and neutrophil levels were observed with anifrolumab over placebo. Comparing anifrolumab versus placebo, lymphocyte and hemoglobin normalization rates were higher and platelet normalization was comparable. BICLA response was associated with lymphocyte, hemoglobin, and platelet normalization over four years, regardless of treatment. Conversely, BICLA responses were higher with anifrolumab versus placebo, irrespective of baseline lymphocyte, hemoglobin, and platelet levels. Improvements in anti-dsDNA, C3, C4, and Igs from baseline were greater with anifrolumab versus placebo.

conclusionThe normalization of hematologic parameters and sustained improvements in serologic markers support the long-term efficacy of anifrolumab in patients with moderate-to-severe SLE. Clinical response to anifrolumab was associated with improvements in biomarkers, suggesting restoration of overall immune health.

Identifiers

PMID42295083
PMCPMC13267668

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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.