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Sustained responses after anti-CD38 treatment with daratumumab in two patients with refractory systemic lupus erythematosus
  1. Tobias Alexander1,2,
  2. Lennard Ostendorf2,3,
  3. Robert Biesen1,
  4. Udo Schneider1,
  5. Gerd R Burmester1,
  6. Falk Hiepe1,2
  1. 1 Department of Rheumatology and Clinical Immunology, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health (BIH), Berlin, Germany
  2. 2 Deutsches Rheuma-Forschungszentrum (DRFZ), Berlin, an Institute of the Leibniz Association, Autoimmunology Group, Berlin, Germany
  3. 3 Department of Nephrology and Medical Intensive Care, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health (BIH), Berlin, Germany
  1. Correspondence to Dr Tobias Alexander, Department of Rheumatology and Clinical Immunology, Charite Universitatsmedizin Berlin, Berlin, 10117, Berlin, Germany; tobias.alexander{at}charite.de

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We recently reported the successful treatment of two systemic lupus erythematosus (SLE) patients with daratumumab, a CD38-targeting human monoclonal antibody, demonstrating a clinically relevant depletion of plasma cells (PCs) with marked reduction of anti-double-stranded DNA (dsDNA) antibodies over a follow-up period of 12 months.1 Here, we report 3-year follow-up data of both patients.

In patient 1, a 51-year-old woman suffering from lupus-nephritis WHO class-III/V, proteinuria further declined from 1197 mg/g creatinine at 12 months to 467 mg/g at the last follow-up, with creatinine levels remaining within normal limits despite tapering the mycophenolate mofetil dosage to 1 g after 21 months, and discontinuation of prednisolone after 33 months, respectively (figure 1A). According to the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Flare Index, no flares or new disease manifestations occurred, while anti-dsDNA antibodies decreased from 254 IE/ml at the 12 months follow-up to 38 IE/mL at 36 months while antinuclear antibodies nearly normalised. Overall, clinical remission was achieved according to Definition of Remission In SLE (DORIS) remission criteria,2 with a clinical SLEDAI-2K score of 0 that persisted until the last follow-up. Notably, the patient reported a marked improved quality of life (HR-QoL) with an 36-Item Short Form Survey (SF-36) score increasing in all …

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Footnotes

  • Handling editor Josef S Smolen

  • Twitter @lost_endorf

  • Contributors All authors contributed to the acquisition, analysis or interpretation of data and critical revision of the manuscript for important intellectual content. TA and FH had full access to all the data in the study and take full responsibility for the conduct of the study, the integrity of the data, the accuracy of the data analysis and serve as the guarantor. TA, LO, US, RB made substantial contributions to clinical data acquisition. TA, GRB and FH designed the study. TA, LO and FH wrote the manuscript.

  • Funding This work was supported by the Deutsche Forschungsgemeinschaft through DFG Transregio SFB TRR 130 (TP15).

  • Competing interests TA received study support from Janssen.

  • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

  • Provenance and peer review Not commissioned; externally peer reviewed.