{ "abstract": "The impact of venetoclax-based therapies on autoimmune cytopenias (AIC) in patients with chronic lymphocytic leukemia (CLL) is largely unknown. This study aimed to evaluate preexisting and treatment-emergent AIC in patients with CLL treated with venetoclax, focusing on the differential impact of venetoclax monotherapy versus venetoclax-based combinations. In this retrospective multicenter study, data from 1720 patients were collected; 23.1% received venetoclax single agent and 76.9% venetoclax combinations (mostly containing anti-CD20 monoclonal antibodies and/or BTK inhibitors). Combination regimens were used in 97.7% of treatment-naïve (TN) patients and 65.8% of patients with relapsed/refractory (R/R) CLL. Preexisting AIC were reported in 11.7% of patients (8.7% in TN and 13.4% in R/R, P = 0.005). CLL-related genetic risk factors and disease outcomes did not differ in patients with and without preexisting AIC. Irrespective of treatment type, venetoclax therapy resulted in AIC resolution or improvement in 63% of patients with active or controlled AIC. Treatment-emergent AIC occurred in 2.6% of patients (2% in TN and 2.9% in R/R, not statistically significant). AIC episodes were reported in 4.3% of patients treated with venetoclax monotherapy and in 2.1% of those treated with venetoclax-based combinations (P = 0.02). After standard management, AIC was considered resolved or controlled in 82% of the patients, with no substantial difference between treatment groups. Venetoclax-based therapies have a beneficial impact on the outcome of CLL-associated preexisting AIC. Treatment-emergent AIC is a rare and generally manageable event. Although more frequent with venetoclax monotherapy in unadjusted analysis, this association was attenuated after adjustment for baseline prognostic factors.", "abstract_shown": true, "affiliations": [ "Division of Hematology, A.O.U. Città della Salute e della Scienza di Torino and Department of Molecular Biotechnology and Health Sciences University of Torino Torino Italy.", "Institute of Applied Biosciences Centre for Research and Technology Hellas Thessaloniki Greece.", "Department of Hematology Santa Croce e Carle Hospital Cuneo Italy.", "Department of Medicine, Faculty of Medicine Kuwait University Kuwait City Kuwait.", "Hematology Unit, Department of Medicine University of Padova Padova Italy.", "Hematology Department, Hospital de la Santa Creu i Sant Pau, IIB-Sant Pau and José Carreras Leukemia Research Institutes, Departamento de Medicina Universidad Autónoma de Barcelona Barcelona Spain.", "Department of Internal Medicine - Hematology and Oncology University Hospital Brno and Faculty of Medicine, Masaryk University Brno Czech Republic.", "Division of Hematology, Department of Internal Medicine University Hospital Zagreb Zagreb Croatia.", "Haematology St. George's University Hospital London United Kingdom.", "Haematology Department Medical University Hospital Bialystok Poland.", "Department of Hematology and Oncology Wroclaw Medical University Wroclaw Poland.", "Oncology Support Centre for Clinical Trials Alfred Sokolowski Specialist Hospital in Walbrzych Walbrzych Poland.", "Department of Medical Oncology Dana-Farber Cancer Institute Boston Massachusetts United States.", "Hematology Unit, 1st Department of Internal Medicine AUTH, AHEPA Hospital Thessaloniki Greece.", "Servicio de Hematología Consorcio Hospital General Universitario de Valencia, Fundación de Investigación Hospital General Universitario de Valencia Valencia Spain.", "Department of Hematology Fundacion Jimenez Diaz University Hospital, Health Research Institute IIS-FJD Madrid Spain.", "Division of Internal Medicine, Hematology Unit ASL Vercelli Vercelli Italy.", "Department of Hematology, Niguarda Cancer Center ASST Grande Ospedale Metropolitano Niguarda Milano Italy.", "Department of Hematology and Bone Marrow transplantation Unit National and Kapodistrian University of Athens Laikon General Hospital Athens Greece.", "Clinical Haematology Belfast City Hospital Belfast United Kingdom.", "Department of Hematology Transplantation and Internal Medicine Medical University of Warsaw Warsaw Poland.", "Division of Hematology ASST Sette Laghi - Ospedale di Circolo di Varese Varese Italy.", "Hematology-Oncology and Stem Cell Transplantation Unit, Department of Onco-Hematology and Innovative Diagnostics Istituto Nazionale Tumori IRCCS Fondazione G. Pascale Napoli Italy.", "Dr. B.R.A. IRCH, All India Institute of Medical Sciences (AIIMS) New Delhi India.", "Hematology Department Infanta Leonor University Hospital Madrid Spain.", "First Department of Internal Diseases Medical University of Plovdiv, Clinical Hematology Clinic, St. George University Hospital for Active Treatment Plovdiv Bulgaria.", "Department of Hematology and Bone Marrow Transplantation Polish Red Cross Maritime Hospital Gdynia Poland.", "Department of Hematology The First Affiliated Hospital of Nanjing Medical University Nanjing China.", "Department of General Hematology and Internal Medicine Copernicus Memorial Hospital Lodz Poland.", "Department of Hematology Medical University of Lodz Lodz Poland.", "Department of Nursing, Faculty of Nursing and Midwifery Wroclaw Medical University Wroclaw Poland.", "Department of Hematology Dubrava University Hospital Zagreb Croatia.", "Clinical Department of Hematology, Cell Therapies and Internal Diseases Wroclaw Medical University Wroclaw Poland.", "Department of Hematology, Oncology, and Chemotherapy, S. P. Botkin's City Hospital Russian Medical Academy of Continuous Professional Education Moscow Russia.", "Department of Hematology, Shamir Medical Center, Zerifin and Sackler Faculty of Medicine Tel Aviv University Tel Aviv Israel.", "Department of Haematology, Faculty of Medicine School of Health Sciences University of Ioannina Ioannina Greece.", "Department of Hemato-Oncology, Faculty of Medicine and Dentistry Palacký University and University Hospital Olomouc Olomouc Czech Republic.", "Department of Hematology Hospital Universitario de Burgos, Instituto de Investigación Biosanitaria de Burgos (IBioBURGOS) Burgos Spain.", "Hematology Clinic, ASUFC Udine Italy.", "Department of Hematology, Tel Aviv Sourasky Medical Center and Faculty of Medicine Tel Aviv University Tel Aviv Israel." ], "article_type": "research article", "arxiv": null, "author_total": 107, "authors": [ { "affs": [ 0 ], "name": "Candida Vitale", "orcid": "0000-0002-2592-8724" }, { "affs": [ 1 ], "name": "Thomas Chatzikonstantinou", "orcid": "0000-0003-4105-1253" }, { "affs": [ 1 ], "name": "Christina Papangelou" }, { "affs": [ 0 ], "name": "Francesca Perutelli", "orcid": "0000-0002-7538-9626" }, { "affs": [ 0 ], "name": "Maria Chiara Montalbano" }, { "affs": [ 0 ], "name": "Giulia Bondielli" }, { "affs": [ 2 ], "name": "Elia Boccellato", "orcid": "0000-0001-5202-2621" }, { "affs": [ 3 ], "name": "Salem Alshemmari", "orcid": "0000-0002-5597-5839" }, { "affs": [ 4 ], "name": "Francesco Angotzi" }, { "affs": [ 5 ], "name": "Miguel Arguello-Tomas", "orcid": "0000-0002-3329-4151" }, { "affs": [ 6 ], "name": "Tomas Arpas" }, { "affs": [ 7 ], "name": "Sandra Bašić-Kinda" }, { "affs": [ 8 ], "name": "Sotiria Besikli-Dimou" }, { "affs": [ 9 ], "name": "Łukasz Bołkun", "orcid": "0000-0002-6629-8626" }, { "affs": [ 10, 11 ], "name": "Tomasz Buczek", "orcid": "0000-0002-8194-6265" }, { "affs": [ 10, 11 ], "name": "Aleksandra Butrym", "orcid": "0000-0002-8199-2018" }, { "affs": [ 12 ], "name": "Katherine Chapis" }, { "affs": [ 13 ], "name": "Sofia Chatzileontiadou" }, { "affs": [ 14 ], "name": "Rosa Collado", "orcid": "0000-0002-8205-6192" }, { "affs": [ 15 ], "name": "Raul Cordoba Mascuñano", "orcid": "0000-0002-7654-8836" }, { "affs": [ 16 ], "name": "Lorenzo De Paoli", "orcid": "0000-0002-7488-8247" }, { "affs": [ 17 ], "name": "Marina Deodato", "orcid": "0000-0003-0010-6107" }, { "affs": [ 18 ], "name": "Maria Dimou", "orcid": "0000-0001-8197-9895" }, { "affs": [ 19 ], "name": "David Donaldson", "orcid": "0009-0008-5314-3028" }, { "affs": [ 20 ], "name": "Joanna Drozd-Sokołowska", "orcid": "0000-0002-4562-6264" }, { "affs": [ 12 ], "name": "Salem Elias" }, { "affs": [ 21 ], "name": "Andrea Ferrario" }, { "affs": [ 22 ], "name": "Alberto Fresa", "orcid": "0000-0002-8084-9009" }, { "affs": [ 17 ], "name": "Anna Maria Frustaci", "orcid": "0000-0003-2587-7901" }, { "affs": [ 14 ], "name": "Rocío García-Serra" }, { "affs": [ 23 ], "name": "Ajay Gogia", "orcid": "0000-0001-6500-1061" }, { "affs": [ 24 ], "name": "Isabel González-Gascón-Y-Marín", "orcid": "0000-0001-6329-1704" }, { "affs": [ 25 ], "name": "Vasko Graklanov", "orcid": "0000-0002-7059-1411" }, { "affs": [ 26 ], "name": "Maria Hryniewiecka" }, { "affs": [ 27 ], "name": "Zhu Huayuan", "orcid": "0000-0003-3073-6345" }, { "affs": [ 28, 29 ], "name": "Elzbieta Iskierka-Jażdżewska", "orcid": "0000-0003-2772-8870" }, { "affs": [ 30 ], "name": "Paula Jablonowska-Babij", "orcid": "0000-0001-6984-2116" }, { "affs": [ 31 ], "name": "Ozren Jaksic", "orcid": "0000-0003-4026-285X" }, { "affs": [ 32 ], "name": "Elzbieta Kalicińska", "orcid": "0000-0002-4797-8001" }, { "affs": [ 33 ], "name": "Maria Kislova", "orcid": "0000-0002-8794-0120" }, { "affs": [ 34 ], "name": "Maya Koren-Michowitz", "orcid": "0000-0002-7223-328X" }, { "affs": [ 35 ], "name": "Epameinondas Koumpis", "orcid": "0000-0003-0035-467X" }, { "affs": [ 36 ], "name": "Zuzana Kubová" }, { "affs": [ 37 ], "name": "Jorge Labrador", "orcid": "0000-0002-3696-0287" }, { "affs": [ 38 ], "name": "Pietro Lauzzana" }, { "affs": [ 39 ], "name": "Shai Levi", "orcid": "0000-0002-1453-9029" }, { "name": "Francesca Martini", "orcid": "0000-0002-1168-6568" }, { "affs": [ 12 ], "name": "Mariia Mikhaleva" }, { "affs": [ 1 ], "name": "Eva Minga" }, { "name": "Riccardo Moia", "orcid": "0000-0001-7393-1138" }, { "name": "Elżbieta Morawiec-Szymonik" }, { "name": "Marta Morawska" }, { "name": "Femke V M Mulder" }, { "name": "Roberta Murru", "orcid": "0000-0001-9792-9542" }, { "affs": [ 38 ], "name": "Jacopo Olivieri" }, { "name": "Ewa Paszkiewicz-Kozik", "orcid": "0000-0003-2629-3932" }, { "affs": [ 23 ], "name": "Lata Rani" }, { "name": "Josep Maria Roncero" }, { "affs": [ 29 ], "name": "Wojciech Salamon" }, { "name": "Alessandro Sanna", "orcid": "0000-0002-5015-381X" } ], "bibtex": "https://research.draconitic.com/paper/08pgmg9twexqc.bib", "cited_by": 0, "doi": "10.1002/hem3.70522", "fulltext_url": "https://europepmc.org/articles/PMC13743197", "id": "08pgmg9twexqc", "issns": [ "2572-9241" ], "landing_url": "https://europepmc.org/article/MED/42997681", "language": "eng", "licence": "CC-BY", "licence_label": "CC BY", "licence_source": "article", "licence_url": "https://creativecommons.org/licenses/by/4.0/", "metadata_licence": null, "native_subjects": [ [ "openalex", "2720|Chronic Lymphocytic Leukemia Research" ] ], "openalex": "W7225408441", "pdf_url": "https://europepmc.org/articles/PMC13743197?pdf=render", "pmcid": "PMC13743197", "pmid": "42997681", "published": "2026-11-06", "publisher": null, "ris": "https://research.draconitic.com/paper/08pgmg9twexqc.ris", "sources": [ { "first_seen": "2026-11-09T15:20:34Z", "native_id": "MED:42997681", "source": "europepmc", "url": "https://europepmc.org/article/MED/42997681" } ], "subjects": [ { "field": "medicine", "origin": "openalex:2720|Chronic Lymphocytic Leukemia Research", "subfield": "general" } ], "title": "Impact of venetoclax-based therapies on CLL-associated autoimmune cytopenias: A retrospective study conducted by ERIC.", "title_text": "Impact of venetoclax-based therapies on CLL-associated autoimmune cytopenias: A retrospective study conducted by ERIC.", "type": "peer-reviewed", "updated_at": "2026-11-09T15:20:34Z", "url": "https://research.draconitic.com/paper/08pgmg9twexqc", "venue": "HemaSphere", "versions": [] }