Evidence map›Paper›PMID 41951251›Full record

Trial reportLupus science & medicine2026

Efficacy and safety of anifrolumab in patients with systemic lupus erythematosus without prior immunosuppressant use: post hoc analysis of phase 3 TULIP-1 and TULIP-2 trials.

Andrea Doria, Ronald F van Vollenhoven, Eric F Morand, Marta Mosca, Jonatan Nåtman, Miina Waratani, Jacob Knagenhjelm, Catharina Lindholm, Danuta Kielar

2 registry-linked trialsAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report 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.

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

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.

Andrea DoriaRheumatology Unit, Department of Medicine, Padova University School of Medicine, Padova, Italy.ORCID 0000-0003-0548-4983
Ronald F van VollenhovenDepartment of Rheumatology and Clinical Immunology, Amsterdam University Medical Centres, Amsterdam, The Netherlands.ORCID 0000-0001-6438-8663
Eric F MorandCentre for Inflammatory Diseases, Monash University, Melbourne, Victoria, Australia.ORCID 0000-0002-9507-3338
Marta MoscaRheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
Jonatan NåtmanBioPharmaceuticals Medical, AstraZeneca, Gothenburg, Sweden.
Miina WarataniBioPharmaceuticals Medical, AstraZeneca, Cambridge, UK.
Jacob KnagenhjelmBioPharmaceuticals Medical, AstraZeneca, Gothenburg, Sweden.
Catharina LindholmBioPharmaceuticals Medical, AstraZeneca, Gothenburg, Sweden Catharina.Lindholm@astrazeneca.com.
Danuta KielarBioPharmaceuticals Medical, AstraZeneca, Cambridge, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveAlthough current treatment recommendations for systemic lupus erythematosus (SLE) provide the option for biologic agents without prior failure of immunosuppressants (IS), data on this treatment approach are limited. This study evaluates the efficacy and safety of anifrolumab by IS exposure.

methodsPooled data from the Phase 3 TULIP-1 (NCT02446912) and TULIP-2 (NCT02446899) trials were analysed post hoc to compare patients with moderate-to-severe SLE treated with intravenous anifrolumab 300 mg or placebo alongside standard therapy by reported IS use. Efficacy outcomes by IS use included Definition of Remission in SLE (DORIS) remission and Lupus Low Disease Activity State (LLDAS) attainment, analysed using a stratified Cochran-Mantel-Haenszel approach; all p values are nominal. Safety was summarised descriptively.

resultsIn this analysis, 257 patients had no reported IS use (IS-inexperienced; anifrolumab 300 mg, n=127; placebo, n=130), and 469 were IS-experienced (anifrolumab 300 mg, n=233; placebo, n=236). At Week 52, DORIS remission and LLDAS attainment rates were higher with anifrolumab versus placebo in both IS subgroups (DORIS, IS-inexperienced, 16.2% vs 6.0%, p=0.0242; IS-experienced, 14.6% vs 7.3%, p=0.0304; LLDAS, IS-inexperienced, 34.0% vs 26.2%, p=0.1718; IS-experienced, 27.7% vs 16.2%, p=0.0038). Anifrolumab was well tolerated, regardless of reported IS history; safety was more favourable among IS-inexperienced versus IS-experienced patients.

conclusionsThis post hoc analysis of pooled TULIP-1/TULIP-2 data supports the efficacy and tolerability of anifrolumab in patients with moderate-to-severe SLE regardless of IS treatment history.

Indexed as

Antibodies, Monoclonal, HumanizedLupus Erythematosus, SystemicAdultFemaleHumansImmunosuppressive AgentsMaleMiddle AgedRemission InductionSeverity of Illness IndexTreatment OutcomeanifrolumabAntibodies, Monoclonal, HumanizedImmunosuppressive AgentsAutoimmune DiseasesBiological ProductsInterferon Type ILupus Erythematosus, Systemic

Identifiers

PMID41951251
PMCPMC13064137

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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.