Efficacy of the BNT162b2 mRNA COVID-19 vaccine in patients with chronic lymphocytic leukemia

Yair Herishanu, Irit Avivi, Anat Aharon, Gabi Shefer, Shai Levi, Yotam Bronstein, Miguel Morales, Tomer Ziv, Yamit Shorer Arbel, Lydia Scarfò, Erel Joffe, Chava Perry, Paolo Ghia, Yair Herishanu, Irit Avivi, Anat Aharon, Gabi Shefer, Shai Levi, Yotam Bronstein, Miguel Morales, Tomer Ziv, Yamit Shorer Arbel, Lydia Scarfò, Erel Joffe, Chava Perry, Paolo Ghia

Abstract

Patients with chronic lymphocytic leukemia (CLL) have an increased risk for severe COVID-19 disease and mortality. The goal of this study was to determine the efficacy of COVID-19 vaccine in patients with CLL. We evaluated humoral immune responses to the BNT162b2 messenger RNA (mRNA) COVID-19 vaccine in patients with CLL and compared responses with those obtained in age-matched healthy control subjects. Patients received 2 vaccine doses, 21 days apart, and antibody titers were measured by using the Elecsys Anti-SARS-CoV-2 S assay after administration of the second dose. In a total of 167 patients with CLL, the antibody response rate was 39.5%. A comparison between 52 patients with CLL and 52 sex- and aged-matched healthy control subjects revealed a significantly reduced response rate among patients (52% vs 100%, respectively; adjusted odds ratio, 0.010; 95% confidence interval, 0.001-0.162; P < .001). The response rate was highest in patients who obtained clinical remission after treatment (79.2%), followed by 55.2% in treatment-naive patients and 16.0% in patients under treatment at the time of vaccination. In patients treated with either Bruton's tyrosine kinase inhibitors or venetoclax ± anti-CD20 antibody, response rates were considerably low (16.0% and 13.6%). None of the patients exposed to anti-CD20 antibodies <12 months before vaccination responded. In a multivariate analysis, the independent predictors of response were younger age, female sex, lack of currently active treatment, immunoglobulin G levels ≥550 mg/dL, and immunoglobulin M levels ≥40 mg/dL. In conclusion, antibody-mediated response to the BNT162b2 mRNA COVID-19 vaccine in patients with CLL is markedly impaired and affected by disease activity and treatment. This trial was registered at www.clinicaltrials.gov as #NCT04746092.

Keywords: BNT162b2; CLL; COVID-19 vaccine; NEOPLASIA/Lymphoid leukemias; antibody response.

© 2021 by The American Society of Hematology.

Figures

Graphical abstract
Graphical abstract
Figure 1.
Figure 1.
Anti–SARS-CoV-2 antibody response in patients with CLL and healthy control subjects. (A-B) Distribution of individual responses in patients with CLL (n = 52) and sex- and age-matched control subjects (n = 52). Each column represents the level of antibodies in individual patients (red bars indicate treatment naive, green bar indicates on-therapy, blue bars indicate off-therapy in remission, and purple bars indicate off-therapy in relapse) in panel A and in individual healthy control subjects (red bars) in panel B. (C) Response rate in patients with CLL (n = 52) and sex- and age-matched control subjects (n = 52). (D) Anti–SARS-CoV-2 antibody levels in patients with CLL (n = 52) and sex- and age-matched control subjects (n = 52).
Figure 2.
Figure 2.
Anti–SARS-CoV-2 antibody responses in patients with CLL according to disease status and treatment. (A-B) Response rate and anti–SARS-CoV-2 antibody levels in patients with CLL according to disease status: Treatment naive (n = 58), on-therapy (n = 75), off-therapy in remission (n = 24), and off-therapy in relapse (n = 10). (C) Response rate in patients with CLL treated with BTKi (n = 50) and venetoclax (Ven) ± anti-CD20 antibody (n = 22). NS, not significant.
Figure 3.
Figure 3.
Local and systemic reactions reported after injection of BNT162b2 in patients with CLL (N = 167). Reactions reported after the first vaccine dose (A) and after the second vaccine dose (B).

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Source: PubMed

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