Evidence map›Paper›PMID 36018235›Full record

Trial reportRheumatology (Oxford, England)2023

Sustained glucocorticoid tapering in the phase 3 trials of anifrolumab: a post hoc analysis of the TULIP-1 and TULIP-2 trials.

Ian N Bruce, Ronald F van Vollenhoven, Eric F Morand, Richard A Furie, Susan Manzi, William B White, Gabriel Abreu, Raj Tummala

2 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Rheumatology (Oxford, England), 2023. 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 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
5.6field-weighted citation impact, top 3% 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

21 citing papers in PubMed, 35 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Article
  6. Review
  7. Article
  8. Review
  9. Review
  10. Cardiac Involvement in Systemic Lupus Erythematosus.Reviews in cardiovascular medicine · 2025
    Review
  11. Article
  12. Review
  13. Review
  14. Article
  15. Lupus Nephritis from Pathogenesis to New Therapies: An Update.International journal of molecular sciences · 2024
    Review
  16. Review
  17. Article
  18. Interferon Inhibition in SLE: From Bench to Bedside.Mediterranean journal of rheumatology · 2024
    Review
  19. Article
  20. Article
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

8 authors at 8 institutions in 5 countries.

Ian N BruceCentre for Epidemiology Versus Arthritis, The University of Manchester and NIHR Manchester Biomedical Research Centre, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.ORCID 0000-0003-3047-500X
Ronald F van VollenhovenAmsterdam Rheumatology and Immunology Center, University of Amsterdam, Amsterdam, The Netherlands.
Eric F MorandSchool of Clinical Sciences at Monash Health, Monash University, Melbourne, VIC, Australia.ORCID 0000-0002-9507-3338
Richard A FurieDivision of Rheumatology, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, USA.
Susan ManziLupus Center of Excellence, Autoimmunity Institute, Allegheny Health Network, Pittsburgh, PA, USA.
William B WhiteCalhoun Cardiology Center, University of Connecticut School of Medicine, Farmington, CT, USA.
Gabriel AbreuBioPharmaceuticals R&D, AstraZeneca R&D, Gothenburg, Sweden.
Raj TummalaBioPharmaceuticals R&D, AstraZeneca US, Gaithersburg, MD, USA.
Allegheny Health Network · USAstraZeneca (Sweden) · SEAstraZeneca (United States) · USDonald & Barbara Zucker School of Medicine at Hofstra/Northwell · USManchester Academic Health Science Centre · GBMonash Health · AUUniversity of Amsterdam · NLUniversity of Connecticut · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesGlucocorticoid sparing is a key priority for SLE management. We evaluated the effects of sustained glucocorticoid tapering in patients with SLE. MATERIAL AND

methodsThis was a post hoc analysis of the randomized, placebo-controlled, 52-week phase 3 Treatment of Uncontrolled Lupus via the Interferon Pathway (TULIP)-1 and TULIP-2 trials of anifrolumab (300 mg i.v. once every 4 weeks for 48  weeks) plus standard therapy in patients with moderate to severe SLE. In a cohort of patients receiving glucocorticoids (prednisone or equivalent) 10 mg or more per day at baseline, we assessed changes in glucocorticoid dosage, patient-reported outcomes (PROs) and safety. Outcome measures were compared between sustained glucocorticoid taper responders (7.5 mg or less per day by week 40 sustained through week 52) and non-responders, regardless of treatment group, and between patients receiving anifrolumab or placebo.

resultsAmong the 726 patients in the TULIP trials, 375 patients received glucocorticoids 10 mg or more per day at baseline, and of these, 155 (41%) patients were sustained glucocorticoid taper responders. Compared with non-responders (n = 220), sustained glucocorticoid taper responders reduced their mean cumulative glucocorticoid dose by 32%, improved PRO scores, reduced blood pressure and experienced fewer serious adverse events. Sustained glucocorticoid tapering was achieved by 51% (96/190) of patients receiving anifrolumab vs 32% (59/185) receiving placebo. Compared with placebo, more anifrolumab-treated patients achieved both sustained glucocorticoid taper and reduced overall disease activity [38% (72/190) vs 23% (43/185)].

conclusionsSustained glucocorticoid tapering is associated with clinical benefits. Anifrolumab treatment has potential to reduce disease activity and glucocorticoid exposure, a key goal of SLE management. STUDY REGISTRATION: ClinicalTrials.gov identifier: NCT02446912 and NCT02446899.

Indexed as

Lupus Erythematosus, SystemicTulipaAntibodies, Monoclonal, HumanizedGlucocorticoidsHumansTreatment OutcomeanifrolumabAntibodies, Monoclonal, HumanizedGlucocorticoidsbiologicscardiovascularclinical trialsglucocorticoidsglucocorticoid sparingpatient-reported outcomesSLE

Identifiers

PMID36018235
PMCPMC10070065
OpenAlexW4293116155

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.