Immune Checkpoint Inhibitor-Related Cytopenias: About 68 Cases from the French Pharmacovigilance Database

SIMPLE SUMMARY: Data on immune checkpoint inhibitor (ICI)-related cytopenias are scarce. The aim of the study was to further characterize grade ≥ 2 ICI-related cytopenias using the French pharmacovigilance database. Immune thrombocytopenia and autoimmune hemolytic anemia were the most frequently reported ICI-related cytopenias (50.7% and 25.3%, respectively). Nearly half were grade ≥ 4, and 4.4% of patients died from cytopenia-related complications. Using the French pharmacovigilance database, this study provides a comprehensive analysis of ICI-related cytopenias that are rare but potentially life-threatening adverse drug reactions. Early recognition and timely initiation of appropriate treatment are key in their management in clinical practice. ABSTRACT: Immune checkpoint inhibitor (ICI)-related cytopenias have been poorly described. This study aimed to further characterize ICI-related cytopenias, using the French pharmacovigilance database. All grade ≥ 2 hematological adverse drug reactions involving at least one ICI coded as suspected or interacting drug according to the World Health Organization criteria and reported up to 31 March 2022, were extracted from the French pharmacovigilance database. Patients were included if they experienced ICI-related grade ≥ 2 cytopenia. We included 68 patients (75 ICI-related cytopenias). Sixty-three percent were male, and the median age was 63.0 years. Seven patients (10.3%) had a previous history of autoimmune disease. Immune thrombocytopenia (ITP) and autoimmune hemolytic anemia (AIHA) were the most frequently reported (50.7% and 25.3%, respectively). The median time to onset of ICI-related cytopenias was 2 months. Nearly half were grade ≥ 4, and three patients died from bleeding complications of refractory ITP and from thromboembolic disease with active AIHA. Out of 61 evaluable responses, complete or partial remission was observed after conventional treatment in 72.1% of ICI-related cytopenias. Among the 10 patients with ICI resumption after grade ≥ 2 ICI-related cytopenia, three relapsed. ICI-related cytopenias are rare but potentially life-threatening. Further studies are needed to identify risk factors of ICI-related cytopenias.