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Peer-reviewedCC BYAnnals of the Rheumatic Diseases

Teclistamab for treatment-refractory autoimmune diseases: a multicentre case series

25 more authors
18 affiliations
  1. 1Department of Rheumatology and Clinical Immunology, Charité - Universitätsmedizin Berlin, Berlin, Germany; Fraunhofer Institute for Translational Medicine and Pharmacology, Allergology and Immunology, c/o Charité - Universitätsmedizin Berlin, Berlin, Germany
  2. 2Department of Rheumatology and Clinical Immunology, Charité - Universitätsmedizin Berlin, Berlin, Germany
  3. 3Institute of Clinical Pharmacology and Toxicology, Charité - Universitätsmedizin Berlin, Berlin, Germany
  4. 4Department of Rheumatology and Clinical Immunology, Charité - Universitätsmedizin Berlin, Berlin, Germany; German Rheumatism Research Centre (DRFZ) Berlin, a Leibniz Institute, Berlin, Germany
  5. 5Department of Rheumatology and Clinical Immunology, Charité - Universitätsmedizin Berlin, Berlin, Germany; Department of Rheumatology and Clinical Immunology, Immanuel Krankenhaus, Berlin, Germany
  6. 6Faculty of Medicine and Dentistry, University La Sapienza, Rome, Italy
  7. 7Department of Immunology, Labor Berlin - Charité Vivantes GmbH, Berlin, Germany
  8. 8Department of Hematology, Oncology and Cancer Immunology, Charité - Universitätsmedizin Berlin, Berlin, Germany
  9. 9Department of Hematology, Oncology and Cancer Immunology, Charité - Universitätsmedizin Berlin, Berlin, Germany; ImmunoPreCept Cluster, Berlin, Germany; Max-Delbrück-Center for Molecular Medicine, Berlin, Germany
  10. 10Department of Hematology, Oncology and Cancer Immunology, Charité - Universitätsmedizin Berlin, Berlin, Germany; Max-Delbrück-Center for Molecular Medicine, Berlin, Germany
  11. 11Department of Hematology, Oncology and Cancer Immunology, Charité - Universitätsmedizin Berlin, Berlin, Germany; Department of Hematology and Oncology, Universitätsmedizin Greifswald, Greifswald, Germany
  12. 12Division of Rheumatology and Systemic Inflammatory Diseases, III, Department of Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
  13. 13Division of Rheumatology, Department of Medicine V, University Hospital Heidelberg, Heidelberg, Germany
  14. 14Division of Rheumatology, Department of Internal Medicine II (Haematology, Oncology, Clinical Immunology and Rheumatology), University Hospital Tübingen, Tübingen, Germany
  15. 15Department of Rheumatology, Aarhus University Hospital, Aarhus, Denmark; Department of Clinical Medicine, Aarhus University, Aarhus, Denmark
  16. 16Department of Rheumatology, Aarhus University Hospital, Aarhus, Denmark; Department of Clinical Medicine, Aarhus University, Aarhus, Denmark; Department of Biomedicine, Aarhus University, Aarhus, Denmark
  17. 17Department of Rheumatology and Clinical Immunology, Charité - Universitätsmedizin Berlin, Berlin, Germany; Fraunhofer Institute for Translational Medicine and Pharmacology, Allergology and Immunology, c/o Charité - Universitätsmedizin Berlin, Berlin, Germany; German Rheumatism Research Centre (DRFZ) Berlin, a Leibniz Institute, Berlin, Germany; ImmunoPreCept Cluster, Berlin, Germany
  18. 18Department of Rheumatology and Clinical Immunology, Charité - Universitätsmedizin Berlin, Berlin, Germany; Fraunhofer Institute for Translational Medicine and Pharmacology, Allergology and Immunology, c/o Charité - Universitätsmedizin Berlin, Berlin, Germany; German Rheumatism Research Centre (DRFZ) Berlin, a Leibniz Institute, Berlin, Germany. Electronic address: [email protected]

Abstract

OBJECTIVES: This study aimed to evaluate the safety and efficacy of teclistamab, a T cell-redirecting bispecific antibody targeting B-cell maturation antigen, in a case series of severe autoimmune diseases. METHODS: Data were retrospectively collected from patients with treatment-refractory systemic sclerosis (SSc), idiopathic inflammatory myopathies (IIMs), systemic lupus erythematosus (SLE), undifferentiated connective tissue disease (UCTD), or IgG4-related disease (IgG4-RD) who received 1 cycle of teclistamab at 5 European centres. RESULTS: Eighteen patients (72% women, median age 48.5 years, 10 SSc, 4 IIM, 2 SLE, 1 UCTD, and 1 IgG4-RD) with a median of 5 prior therapies and a median cumulative dose of 6.36 mg/kg teclistamab were included. The median follow-up was 5.1 months (range, 0.8-21.2 months). A total of 22 cytokine release syndrome episodes (16 grade 1 and 6 grade 2) occurred in 12 patients (67%). All patients developed severe hypogammaglobulinaemia, and 5 (28%) experienced severe infections. Two patients developed an inflammatory bowel disease-like colitis. Two patients with severe SSc-associated cardiac involvement died, 1 due to sudden cardiac death and the other following diffuse alveolar haemorrhage and heart failure. B-cell depletion was observed in all patients, accompanied by significant reductions in autoantibody levels. Teclistamab was associated with major clinical responses in 11 (61%) and minimal-to-moderate responses in 4 (22%) patients, despite discontinuation of immunosuppressive therapy. CONCLUSIONS: Teclistamab demonstrated the potential to induce treatment-free responses in refractory autoimmune disease, but clinically relevant safety events, including infections and fatal outcomes in patients with advanced cardiac involvement, highlight the need for careful patient selection and monitoring.

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BibTeX
@article{albach2026teclistamab,
  title = {{Teclistamab for treatment-refractory autoimmune diseases: a multicentre case series}},
  author = {Fredrik N. Albach and Elpida Phithak and Robert Biesen and Arnd Kleyer and Elise Siegert and Ioanna Minopoulou and Engi Abd Elhady Algharably and Vincent Casteleyn and Anne Elisabeth Beenken and Udo Schneider and Sofia Trezzini and Marie Chiara Rehm and Arne Sattler and Benedikt Sinzinger and Edgar Wiebe and Nadine Unterwalder and Veronika Scholz and Anja Staeck and Marie Luise Hütter‐Krönke and Frank Buttgereit and Ulrich Bernd Keller and Antonia Busse and Jan Krönke and Ina Kötter and Phillip Kremer and Tarik Exner and Ann‐Christin Pecher and Dorothee Kaudewitz and Klaus Henrik Søndergaard and Anne Troldborg and Jörg C. Henes and Hanns‐Martin Lorenz and Isabell Haase and Martin Krusche and Gerhard Krönke and David Simón and Tobias Alexander},
  journal = {Annals of the Rheumatic Diseases},
  year = {2026},
  month = jun,
  doi = {10.1016/j.ard.2026.05.021},
  url = {https://doi.org/10.1016/j.ard.2026.05.021},
  note = {CC BY},
}
RIS
TY  - JOUR
TI  - Teclistamab for treatment-refractory autoimmune diseases: a multicentre case series
AU  - Fredrik N. Albach
AU  - Elpida Phithak
AU  - Robert Biesen
AU  - Arnd Kleyer
AU  - Elise Siegert
AU  - Ioanna Minopoulou
AU  - Engi Abd Elhady Algharably
AU  - Vincent Casteleyn
AU  - Anne Elisabeth Beenken
AU  - Udo Schneider
AU  - Sofia Trezzini
AU  - Marie Chiara Rehm
AU  - Arne Sattler
AU  - Benedikt Sinzinger
AU  - Edgar Wiebe
AU  - Nadine Unterwalder
AU  - Veronika Scholz
AU  - Anja Staeck
AU  - Marie Luise Hütter‐Krönke
AU  - Frank Buttgereit
AU  - Ulrich Bernd Keller
AU  - Antonia Busse
AU  - Jan Krönke
AU  - Ina Kötter
AU  - Phillip Kremer
AU  - Tarik Exner
AU  - Ann‐Christin Pecher
AU  - Dorothee Kaudewitz
AU  - Klaus Henrik Søndergaard
AU  - Anne Troldborg
AU  - Jörg C. Henes
AU  - Hanns‐Martin Lorenz
AU  - Isabell Haase
AU  - Martin Krusche
AU  - Gerhard Krönke
AU  - David Simón
AU  - Tobias Alexander
PY  - 2026
DA  - 2026/06/01
JO  - Annals of the Rheumatic Diseases
DO  - 10.1016/j.ard.2026.05.021
UR  - https://doi.org/10.1016/j.ard.2026.05.021
AB  - OBJECTIVES: This study aimed to evaluate the safety and efficacy of teclistamab, a T cell-redirecting bispecific antibody targeting B-cell maturation antigen, in a case series of severe autoimmune diseases. METHODS: Data were retrospectively collected from patients with treatment-refractory systemic sclerosis (SSc), idiopathic inflammatory myopathies (IIMs), systemic lupus erythematosus (SLE), undifferentiated connective tissue disease (UCTD), or IgG4-related disease (IgG4-RD) who received 1 cycle of teclistamab at 5 European centres. RESULTS: Eighteen patients (72% women, median age 48.5 years, 10 SSc, 4 IIM, 2 SLE, 1 UCTD, and 1 IgG4-RD) with a median of 5 prior therapies and a median cumulative dose of 6.36 mg/kg teclistamab were included. The median follow-up was 5.1 months (range, 0.8-21.2 months). A total of 22 cytokine release syndrome episodes (16 grade 1 and 6 grade 2) occurred in 12 patients (67%). All patients developed severe hypogammaglobulinaemia, and 5 (28%) experienced severe infections. Two patients developed an inflammatory bowel disease-like colitis. Two patients with severe SSc-associated cardiac involvement died, 1 due to sudden cardiac death and the other following diffuse alveolar haemorrhage and heart failure. B-cell depletion was observed in all patients, accompanied by significant reductions in autoantibody levels. Teclistamab was associated with major clinical responses in 11 (61%) and minimal-to-moderate responses in 4 (22%) patients, despite discontinuation of immunosuppressive therapy. CONCLUSIONS: Teclistamab demonstrated the potential to induce treatment-free responses in refractory autoimmune disease, but clinically relevant safety events, including infections and fatal outcomes in patients with advanced cardiac involvement, highlight the need for careful patient selection and monitoring.
SN  - 0003-4967
SN  - 1468-2060
ER  -