Hormone levels of female patients with SLE after anti-CD19 CAR T-cell treatment do not indicate a signal of impaired ovarian reserve

Pecher AC, Henes J, Henes M, Lengerke C, Bethge W, Wirsching A, Rothe T, Müller F, Mackensen A, Schett G, Hagen M (2026)

Publication Type: Journal article

Publication year: 2026

Journal

Rheumatology Oxford University Press

Book Volume: 65

Article Number: keag413

Journal Issue: 8

DOI: 10.1093/rheumatology/keag413

Abstract

Objectives: Women with SLE are at increased risk of infertility due to disease activity and exposure to gonadotoxic therapies. Anti-CD19 chimeric antigen receptor (CAR) T-cell therapy has recently been shown to induce durable, drug-free remission in refractory SLE; however, its effects on ovarian function remain unknown. We assessed longitudinal changes in reproductive endocrine markers to evaluate the impact of CAR T-cell therapy on ovarian reserve and hypothalamic–pituitary–ovarian (HPO) axis function. Methods: Women with severe, treatment-refractory SLE receiving autologous anti-CD19 CAR T-cell therapy (Miltenyi Biomedicine) in conjunction with standard lymphodepletion at two tertiary care centres were studied. Anti-Müllerian hormone (AMH), oestradiol (E2), progesterone, follicle-stimulating hormone (FSH), luteinizing hormone (LH) and prolactin were measured at baseline and 12 months after therapy. Blood samples were obtained independent of menstrual cycle phase. Paired statistical analyses were performed. Results: Thirteen women were included; median age at CAR T-cell therapy was 27 years. AMH levels were stable (1.54 ng/ml [IQR 0.64–3.15] vs 2.14 ng/ml [0.63–3.26]; P = 0.886). E2 (243 pmol/l [186–346] vs 484 pmol/l [277–829]; P = 0.339) and progesterone (0.90 nmol/l [0.80–0.90] vs 1.80 nmol/l [0.90–3.40]; P = 0.054) showed substantial variability without significant longitudinal change. FSH increased modestly (6.60 IU/l [4.00–7.90] vs 7.20 IU/l [4.50–9.90]; P = 0.033) without a concomitant decline in AMH. LH (6.10 IU/l [5.10–12.90] vs 7.00 IU/l [5.00–12.90]; P = 0.946) and prolactin (10.0 µg/l [8.0–10.0] vs 8.0 µg/l [5.0–9.0]; P = 0.123) remained stable. Conclusion: Anti-CD19 CAR T-cell therapy, including standard lymphodepletion, showed no signal of impaired ovarian reserve, as assessed by AMH and hormone profiles. Observed hormonal changes, including FSH, should be interpreted with caution given study limitations.

Authors with CRIS profile

Andreas Wirsching Department of Medicine 3 – Rheumatology and Immunology Tobias Rothe Department of Medicine 3 – Rheumatology and Immunology Fabian Müller Interdisziplinäres Zentrum für Klinische Forschung IZKF-Förderlinien Andreas Mackensen Lehrstuhl für Innere Medizin V Georg Schett Lehrstuhl für Innere Medizin III Melanie Hagen Department of Medicine 3 – Rheumatology and Immunology

Involved external institutions

Universitätsklinikum Tübingen DE Germany (DE) Eberhard Karls Universität Tübingen DE Germany (DE)

How to cite

APA:

Pecher, A.C., Henes, J., Henes, M., Lengerke, C., Bethge, W., Wirsching, A.,... Hagen, M. (2026). Hormone levels of female patients with SLE after anti-CD19 CAR T-cell treatment do not indicate a signal of impaired ovarian reserve. Rheumatology, 65(8). https://doi.org/10.1093/rheumatology/keag413

MLA:

Pecher, Ann Christin, et al. "Hormone levels of female patients with SLE after anti-CD19 CAR T-cell treatment do not indicate a signal of impaired ovarian reserve." Rheumatology 65.8 (2026).

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