Evidence map›Paper›PMID 33956056›Full record

Trial reportRheumatology (Oxford, England)2021

Phase 2, randomized, placebo-controlled trial of dapirolizumab pegol in patients with moderate-to-severe active systemic lupus erythematosus.

Richard A Furie, Ian N Bruce, Thomas Dörner, Manuel Gustavo Leon, Piotr Leszczyński, Murray Urowitz, Birgit Haier, Teri Jimenez, Claire Brittain, Jiajun Liu and 2 more

Erratum issuedOpen access · greenAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Rheumatology (Oxford, England), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 72 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
72citing papers in PubMed, 5 pooled it
11.9field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

72 citing papers in PubMed, 5 syntheses or guidelines pooled it, 111 citations in OpenAlex.

  1. Pooled it
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  6. Trial
  7. Review
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  10. Observational
  11. Review
  12. Potential new targets for rheumatic diseases.EULAR rheumatology open · 2026
    Review
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  15. Article
  16. Article
  17. Review
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  20. Evolving role of CD8Frontiers in immunology · 2026
    Review

12 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 10 institutions in 6 countries.

Richard A FurieNorthwell Health, Great Neck, NY, USA.ORCID 0000-0001-6712-1585
Ian N BruceNIHR Manchester Biomedical Research Centre, Manchester University Hospitals NHS Trust.ORCID 0000-0003-3047-500X
Thomas DörnerCharité Berlin, Berlin, Germany.
Manuel Gustavo LeonInvestigaciones Clínicas, Lima, Peru.
Piotr LeszczyńskiPoznań University of Medical Sciences, Poznań, Poland.
Murray UrowitzToronto Western Hospital, Toronto, Ontario, Canada.
Birgit HaierUCB Pharma, Monheim am Rhein, Germany.
Teri JimenezUCB Pharma, Raleigh, NC, USA.
Claire BrittainUCB Pharma, Slough, UK.
Jiajun LiuBiogen, Cambridge, MA, USA.
Catherine BarbeyBiogen, Baar, Switzerland.
Christian StachUCB Pharma, Monheim am Rhein, Germany.
UCB Pharma (Germany) · DEBiogen (Switzerland) · CHBiogen (United States) · USCharité - Universitätsmedizin Berlin · DEManchester Academic Health Science Centre · GBNorthwell Health · USPoznan University of Medical Sciences · PLToronto Western Hospital · CAUCB Pharma (United Kingdom) · GBUCB Pharma (United States) · US

Funding

Costello Medical ConsultingUCB Pharma and Biogen Inc. Support
6 · The paper itself

Abstract

objectiveTo evaluate the dose-response, efficacy and safety of dapirolizumab pegol (DZP) in patients with SLE.

methodsAdults with moderately to severely active SLE (SLEDAI-2K score ≥6 and ≥1 BILAG A or ≥2 BILAG B domain scores), receiving stable CS (≤40 mg/day prednisone-equivalent), antimalarial or immunosuppressant drugs were included. Patients with stable LN (proteinuria ≤2 g/day) not receiving high-dose CS or CYC were permitted entry. Randomized patients received placebo or i.v. DZP (6/24/45 mg/kg) and standard-of-care (SOC) treatment every 4 weeks to week 24, after which patients received only SOC to week 48. The primary objective was to establish a dose-response relationship based on week 24 BILAG-Based Composite Lupus Assessment (BICLA) responder rates.

resultsAll DZP groups exhibited improvements in clinical and immunological outcomes vs placebo at week 24; however, BICLA responder rates did not fit pre-specified dose-response models [best-fitting model (Emax): P = 0.07]. Incidences of serious treatment-emergent adverse events across DZP groups were low and similar to placebo. Following DZP withdrawal, SLEDAI-2K, physician's global assessment (PGA), BILAG, and Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) scores stabilized; BICLA and SLE Responder Index (SRI-4) responder rates declined (likely due to interventions with disallowed escape medications), BILAG flares increased, and immunologic parameters returned towards baseline.

conclusionsAlthough the primary objective was not met, DZP appeared to be well tolerated, and patients exhibited improvements across multiple clinical and immunological measures of disease activity after 24 weeks relative to placebo. The potential clinical benefit of DZP warrants further investigation.

Indexed as

AdultDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansImmunoglobulin Fab FragmentsLupus Erythematosus, SystemicMaleMiddle AgedPolyethylene GlycolsTreatment Outcomedapirolizumab pegolImmunoglobulin Fab FragmentsPolyethylene GlycolsCD40 liganddapirolizumab pegollupusSLEsystemic lupus erythematosus

Identifiers

PMID33956056
PMCPMC9194804
OpenAlexW3158669775

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.