Evidence map›Paper›PMID 35338035›Full record

Trial reportAnnals of the rheumatic diseases2022

Anifrolumab efficacy and safety by type I interferon gene signature and clinical subgroups in patients with SLE: post hoc analysis of pooled data from two phase III trials.

Edward M Vital, Joan T Merrill, Eric F Morand, Richard A Furie, Ian N Bruce, Yoshiya Tanaka, Susan Manzi, Kenneth C Kalunian, Rubana N Kalyani, Katie Streicher and 2 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2022. 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. Cited by 79 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
79citing papers in PubMed, 4 pooled it
20.6field-weighted citation impact, top 1% 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.

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
3 · Its place in the literature

Who cites it

79 citing papers in PubMed, 4 syntheses or guidelines pooled it, 130 citations in OpenAlex.

  1. Guideline
  2. Pooled it
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  5. Litifilimab efficacy on skin outcomes in cutaneous lupus erythematosus in the Phase 2 LILAC study.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026
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  14. CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2026
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19 more citing papers are in PubMed but not listed here.

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

12 authors at 11 institutions in 6 countries.

Edward M VitalLeeds Institute of Rheumatic and Musculoskeletal Medicine, School of Medicine, University of Leeds, Leeds, UK.ORCID http://orcid.org/0000-0003-1637-4755
Joan T MerrillOklahoma Medical Research Foundation, Oklahoma City, Oklahoma, USA.
Eric F MorandCentre for Inflammatory Disease Monash Health, Monash University, Melbourne, Victoria, Australia.ORCID http://orcid.org/0000-0002-9507-3338
Richard A FurieDivision of Rheumatology, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Great Neck, New York, USA.
Ian N BruceCentre for Epidemiology Versus Arthritis, The University of Manchester, NIHR Manchester Biomedical Research Centre, Manchester, UK.
Yoshiya TanakaThe First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health Japan, Kitakyushu, Japan.ORCID http://orcid.org/0000-0002-0807-7139
Susan ManziLupus Center of Excellence, Autoimmunity Institute, Allegheny Health Network, Pittsburgh, Pennsylvania, USA.
Kenneth C KalunianDivision of Rheumatology, Allergy and Immunology, University of California San Diego, La Jolla, California, USA.
Rubana N KalyaniBioPharmaceuticals R&D, AstraZeneca US, Gaithersburg, Maryland, USA.
Katie StreicherBioPharmaceuticals R&D, AstraZeneca US, Gaithersburg, Maryland, USA.
Gabriel AbreuBioPharmaceuticals R&D, AstraZeneca R&D, Gothenburg, Sweden.
Raj TummalaBioPharmaceuticals R&D, AstraZeneca US, Gaithersburg, Maryland, USA Raj.Tummala@astrazeneca.com.
AstraZeneca (United States) · USAllegheny Health Network · USAstraZeneca (Australia) · AUAstraZeneca (Sweden) · SEDonald & Barbara Zucker School of Medicine at Hofstra/Northwell · USManchester Academic Health Science Centre · GBMonash Health · AUOklahoma Medical Research Foundation · USUniversity of California San Diego · USUniversity of Leeds · GBUniversity of Occupational and Environmental Health Japan · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo characterise the efficacy and safety of anifrolumab in patients with systemic lupus erythematosus (SLE) according to interferon gene signature (IFNGS), demographic and clinical subgroups.

methodsWe performed post hoc analyses of pooled data from the 52-week phase III TULIP-1/TULIP-2 placebo-controlled trials of intravenous anifrolumab in moderate-to-severe SLE. Outcomes were assessed in predefined subgroups: IFNGS (high/low), age, sex, body mass index, race, geographic region, age of onset, glucocorticoid use, disease activity and serological markers.

resultsIn pooled data, patients received anifrolumab 300 mg (360/726) or placebo (366/726); 82.6% were IFNGS-high. IFNGS-high patients had greater baseline disease activity and were more likely to have abnormal serological markers versus IFNGS-low patients. In the total population, a greater proportion of patients treated with anifrolumab versus placebo achieved British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response at week 52 (difference 16.6%; nominal p<0.001). BICLA response treatment differences with anifrolumab versus placebo were comparable to the total population across most predefined subgroups, including subgroups for baseline glucocorticoid dosage (<10/≥10 mg/day prednisone/equivalent) and for clinical disease activity (SLE Disease Activity Index 2000 score <10/≥10). Subgroups with larger treatment differences included IFNGS-high patients (18.2%), patients with abnormal baseline serological markers (23.1%) and Asian patients (29.2%). The safety profile of anifrolumab was similar across subgroups.

conclusionsOverall, this study supports the consistent efficacy and safety of anifrolumab across a range of patients with moderate-to-severe SLE. In a few subgroups, small sample sizes limited conclusions from being drawn regarding the treatment benefit with anifrolumab. TRIAL REGISTRATION NUMBER: NCT02446912, NCT02446899.

Indexed as

Antibodies, Monoclonal, HumanizedInterferon Type ILupus Erythematosus, SystemicBiomarkersDouble-Blind MethodFemaleGlucocorticoidsHumansMaleTreatment OutcomeanifrolumabAntibodies, Monoclonal, HumanizedBiomarkersGlucocorticoidsInterferon Type Ibiological therapylupus erythematosussystemictherapeutics

Identifiers

PMID35338035
PMCPMC9213795
OpenAlexW4221106889

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.