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1997 Monitoring of Patients with Autoimmune Cytopenias during Sars-Cov-2 Vaccination Campaign: The Experience of a Reference CenterClinically Relevant Abstract

Program: Oral and Poster Abstracts
Session: 101. Red Cells and Erythropoiesis, Excluding Iron: Poster II
Hematology Disease Topics & Pathways:
autoimmune disorders, Epidemiology, Workforce, Health Outcomes Research, Diversity, Equity, Inclusion, and Accessibility (DEI/DEIA) , Diseases, Immune Disorders, SARS-CoV-2/COVID-19, Real World Evidence, Infectious Diseases
Sunday, December 12, 2021, 6:00 PM-8:00 PM

Bruno Fattizzo, MD1,2*, Juri Alessandro Giannotta, MD3*, Nicola Cecchi, MD4,5*, Paola Bianchi, PhD, BSc6 and Wilma Barcellini, MD2*

1Department of Oncology and Oncohematology, University of Milan, Italy, Milan, Italy
2Hematology Unit, Pathophysiology of Anemias Unit, Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy
3Hematology Unit, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy, Milano, Italy
4University of Milan, Milan, Italy
5Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico e Università degli Studi, Milan, Italy
6Foundation IRCCS Ca' Granda,, Milano, Italy

SARS-CoV-2 infection and vaccination have raised concern in immune mediated diseases, including autoimmune cytopenias (AIC, i.e. autoimmune hemolytic anemia, AIHA; autoimmune thrombocytopenia, ITP; autoimmune neutropenia, AIN; aplastic anemia, AA; and their combination, termed Evans syndrome, ES). The latter are highly heterogeneous conditions with variable severity and a clinical course marked by several relapses often triggered by immune-activating events (infections, traumas, surgery, etc.) including vaccines. Some reports of ITP and AIHA post-SARS-CoV-2 vaccines have been described but no population studies have been conducted in AIC patients. Here we systematically studied a large series of 100 patients with AIC (44 AIHA, 38 ITP, 7 AIN, 6 ES, and 5 AA) prospectively followed at a reference center in Milan, Italy, who underwent SARS-CoV-2 vaccination from 24th of March until the end of June 2021. Patients (median age 62 years, range 25-89, female/male ratio 1.7) were monitored with whole blood counts and LDH testing the week before and the week after each vaccination dose. Importantly, ongoing AIC therapy (38% of cases, including steroids, cyclosporine, eltrombopag, and complement inhibitor sutimlimab) were kept stable within the 2 weeks before vaccination. Patients mainly received Pfizer-BioNtech vaccine (N=88), followed by Moderna (N=10), and Astra-Zeneca (N=2). Table 1 summarizes hematologic trends and side effects observed after each dose in patients with ITP and AIHA. Regarding the former, a delta percentage reduction of 10% or higher was observed in up to 13% of cases after the first and the second dose, requiring therapy adjustment in 2 patients. They were two elderly male subjects on low dose eltrombopag treatment and experienced a severe/moderate relapse (platelets 28 and 21x10^9/L) with mucosal bleeding, after the 2nd dose of Pfizer vaccine. Both had a concomitant trigger (1 hip fracture and 1 bronchitis reactivation) and were rescued by increasing eltrombopag dose and with the addition of prednisone 1 mg/Kg day. Regarding AIHA, 3 elderly patients experienced a clinically significant relapse (>10% Hb decrease): 1 female patient experienced an Hb reduction from 10.4 to 9.1 g/dL after the first dose of Pfizer vaccine, that required a slight increase of steroid dose (to 5 mg day prednisone) and remained stable after the second dose; 1 male subject had an Hb reduction from 13.9 to 9.1 g/d>L after the first dose of Moderna vaccine, requiring prednisone 0.5 mg/kg day; the third male patient experienced a severe relapse (Hb reduction by 47%, from 14 to 7.4 g/dL) with LDH increase to 2.3 x ULN after the second dose of Pfizer vaccine. The patient required high dose intravenous steroids and hemolysis improved in about 1 week. All patients had warm type AIHA and had complained no other triggers or non-hematologic adverse events. Patients with AIN, AA and ES had no significant changes in their hematologic values (1 AIN had a neutrophil decrease by 30% but was consistent with previous oscillations; 2 ES had a platelet or neutrophil decrease within the normal range) and required no treatment changes. Finally, the following non-hematologic adverse events were observed: fever (7%), pain at the injection site (15%) and arthralgia (<5%), without significant differences between the first and the second dose.

These data show that SARS-CoV-2 vaccination may be associated with a mild decrease of hematologic values in about 10% of AIC cases. However, true ITP and AIHA relapses occurred in 5% of cases only, sometimes in the presence of a concomitant trigger, and were rapidly rescued with treatment adaptation. Overall, the hematologic monitoring of SARS-CoV-2 vaccine adopted in our survey appears appropriate to early detect and manage AIC reactivation, ensuring a safe vaccination campaign in this patient population.

Disclosures: Fattizzo: Alexion: Speakers Bureau; Amgen: Honoraria, Speakers Bureau; Annexon: Consultancy; Apellis: Speakers Bureau; Novartis: Speakers Bureau; Momenta: Honoraria, Speakers Bureau; Kira: Speakers Bureau. Bianchi: Agios pharmaceutics: Consultancy, Membership on an entity's Board of Directors or advisory committees. Barcellini: Novartis: Honoraria; Bioverativ: Membership on an entity's Board of Directors or advisory committees; Alexion Pharmaceuticals: Honoraria; Agios: Honoraria, Research Funding; Incyte: Membership on an entity's Board of Directors or advisory committees.

*signifies non-member of ASH