Evidence map›Paper›PMID 41629292›Full record

Trial reportNature communications2026

Daratumumab in systemic lupus erythematosus: a single-arm phase 2 trial.

Lennard Ostendorf, Jan Zernicke, Jens Klotsche, Robin Kempkens, Anne E Beenken, Robert Biesen, Qingyu Cheng, Laleh Khodadadi, Gabriela Maria Guerra, Frederik Heinrich and 6 more

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nature communications, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04810754 (A Monocenter, Open Label Study to Evaluate the Safety and Efficacy of Daratumumab in Combination With Standard Background Therapy in Participants With Moderate to Severe Systemic Lupus Erythematosus), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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.

NCT04810754 phase2unknown statusnot on this map

A Monocenter, Open Label Study to Evaluate the Safety and Efficacy of Daratumumab in Combination With Standard Background Therapy in Participants With Moderate to Severe Systemic Lupus Erythematosus

TypeinterventionalSponsorCharite University, Berlin, GermanyRan2021 to 2023Enrolled10ConditionsSystemic Lupus ErythematosusArmsDaratumumab Injection
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
  4. Potential new targets for rheumatic diseases.EULAR rheumatology open · 2026
    Review
  5. Review
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

16 authors.

Lennard OstendorfGerman Rheumatology Research Centre (DRFZ), an Institute of the Leibniz Association, Berlin, Germany.ORCID http://orcid.org/0000-0003-3553-6406
Jan ZernickeDepartment of Rheumatology and Medical Immunology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.
Jens KlotscheGerman Rheumatology Research Centre (DRFZ), an Institute of the Leibniz Association, Berlin, Germany.
Robin KempkensGerman Rheumatology Research Centre (DRFZ), an Institute of the Leibniz Association, Berlin, Germany.
Anne E BeenkenGerman Rheumatology Research Centre (DRFZ), an Institute of the Leibniz Association, Berlin, Germany.
Robert BiesenDepartment of Rheumatology and Medical Immunology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.ORCID http://orcid.org/0000-0002-0434-7832
Qingyu ChengGerman Rheumatology Research Centre (DRFZ), an Institute of the Leibniz Association, Berlin, Germany.
Laleh KhodadadiGerman Rheumatology Research Centre (DRFZ), an Institute of the Leibniz Association, Berlin, Germany.ORCID http://orcid.org/0009-0007-4821-1543
Gabriela Maria GuerraGerman Rheumatology Research Centre (DRFZ), an Institute of the Leibniz Association, Berlin, Germany.
Frederik HeinrichGerman Rheumatology Research Centre (DRFZ), an Institute of the Leibniz Association, Berlin, Germany.ORCID http://orcid.org/0000-0001-6097-5422
Pawel DurekGerman Rheumatology Research Centre (DRFZ), an Institute of the Leibniz Association, Berlin, Germany.ORCID http://orcid.org/0000-0002-6179-0670
Gerd-Rüdiger BurmesterDepartment of Rheumatology and Medical Immunology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.
Gerhard KrönkeGerman Rheumatology Research Centre (DRFZ), an Institute of the Leibniz Association, Berlin, Germany.ORCID http://orcid.org/0000-0002-7566-4325
Falk HiepeGerman Rheumatology Research Centre (DRFZ), an Institute of the Leibniz Association, Berlin, Germany.ORCID http://orcid.org/0000-0003-3584-5292
Mir-Farzin MashreghiGerman Rheumatology Research Centre (DRFZ), an Institute of the Leibniz Association, Berlin, Germany.ORCID http://orcid.org/0000-0002-8015-6907
Tobias AlexanderGerman Rheumatology Research Centre (DRFZ), an Institute of the Leibniz Association, Berlin, Germany. tobias.alexander@charite.de.ORCID http://orcid.org/0000-0003-1193-0097

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Antibody-secreting cells (ASCs) play a central role in the pathophysiology of systemic lupus erythematosus (SLE). This single-arm, open-label, phase 2 clinical trial aims to evaluate the safety and efficacy of the ASC-depleting anti-CD38 monoclonal antibody daratumumab in patients with SLE (NCT04810754). The primary endpoint is the reduction in serum anti-double-stranded DNA (anti-dsDNA) antibody levels at week 12. Key secondary end points include safety, clinical efficacy, and immunologic changes. Ten female patients with active disease and inadequate responses to at least two immunosuppressive drugs have received eight subcutaneous injections of 1800 mg daratumumab weekly, with dexamethasone as premedication (20 mg for first two injections, then 10 mg). By week 12, anti-dsDNA antibody levels have been reduced by a median of 109.6 IU/ml (95% CI 38.1 - 274.5). The treatment resulted in rapid and sustained clinical improvements across all patients and organ domains, reflected by a 100% SRI-4 (Systemic Lupus Erythematosus Responder Index-4) response rate at week 12. Hypogammaglobulinemia occurred in 5/10 patients, requiring immunoglobulin substitution. Daratumumab treatment has depleted circulating ASCs, reduced type I interferon activity, and profoundly modulated the T-cell responses. These findings highlight the pivotal role of ASCs in SLE pathogenesis and support daratumumab as therapeutic option for SLE.

Indexed as

Antibodies, MonoclonalLupus Erythematosus, SystemicAdultAgammaglobulinemiaAntibodies, AntinuclearFemaleHumansMiddle AgedTreatment OutcomeAntibodies, AntinuclearAntibodies, Monoclonalanti-dsDNA autoantibodydaratumumab

Identifiers

PMID41629292
PMCPMC12868738

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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.