Efficacy of the BNT162b2 mRNA COVID-19 vaccine in patients with chronic lymphocytic leukemia
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 vaccin...
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| Published in | Blood Vol. 137; no. 23; pp. 3165 - 3173 |
|---|---|
| Main Authors | , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
Elsevier Inc
10.06.2021
American Society of Hematology |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0006-4971 1528-0020 1528-0020 |
| DOI | 10.1182/blood.2021011568 |
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| 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.
•Antibody response to BNT162b2 mRNA COVID-19 vaccine in patients with CLL is markedly impaired and affected by disease activity and treatment.•In patients treated with either Bruton's tyrosine kinase inhibitors or venetoclax ± anti-CD20 antibody, responses are relatively low.
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| AbstractList | Patients with chronic lymphocytic leukemia (CLL) have been previously shown to have poor responses to antibacterial and antiviral vaccines. In a Plenary Paper that is also this month’s CME article, Herishanu and colleagues discuss the outcome of vaccination against COVID-19 in 167 patients with CLL, again demonstrating a significantly impaired vaccine response. The lowest response rates were seen in patients undergoing active treatment, while the highest responses were seen in patients who were in complete remission after therapy; however, even treatment-naïve patients had lower responses than healthy controls. In this series, no responses were achieved in patients treated with anti-CD20 antibodies within 12 months of vaccination.
Antibody response to BNT162b2 mRNA COVID-19 vaccine in patients with CLL is markedly impaired and affected by disease activity and treatment.In patients treated with either Bruton’s tyrosine kinase inhibitors or venetoclax ± anti-CD20 antibody, responses are relatively low.
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. 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. 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.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. 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. •Antibody response to BNT162b2 mRNA COVID-19 vaccine in patients with CLL is markedly impaired and affected by disease activity and treatment.•In patients treated with either Bruton's tyrosine kinase inhibitors or venetoclax ± anti-CD20 antibody, responses are relatively low. [Display omitted] |
| Author | Perry, Chava Ziv, Tomer Herishanu, Yair Shefer, Gabi Scarfò, Lydia Aharon, Anat Morales, Miguel Bronstein, Yotam Joffe, Erel Levi, Shai Shorer Arbel, Yamit Ghia, Paolo Avivi, Irit |
| AuthorAffiliation | 1 Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel 3 Department of Endocrinology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel 2 Department of Hematology and 6 Department of Medicine, Lymphoma Service, Memorial Sloan Kettering Cancer Center–Weill Cornell College of Medicine, New York, NY 5 European Research Initiative on CLL (ERIC), Barcelona, Spain; and 4 Division of Experimental Oncology, Università Vita-Salute San Raffaele, IRCCS Ospedale San Raffaele, Milan, Italy |
| AuthorAffiliation_xml | – name: 6 Department of Medicine, Lymphoma Service, Memorial Sloan Kettering Cancer Center–Weill Cornell College of Medicine, New York, NY – name: 4 Division of Experimental Oncology, Università Vita-Salute San Raffaele, IRCCS Ospedale San Raffaele, Milan, Italy – name: 2 Department of Hematology and – name: 5 European Research Initiative on CLL (ERIC), Barcelona, Spain; and – name: 1 Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel – name: 3 Department of Endocrinology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel |
| Author_xml | – sequence: 1 givenname: Yair surname: Herishanu fullname: Herishanu, Yair email: yairh@tasmc.health.gov.il organization: Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel – sequence: 2 givenname: Irit surname: Avivi fullname: Avivi, Irit organization: Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel – sequence: 3 givenname: Anat surname: Aharon fullname: Aharon, Anat organization: Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel – sequence: 4 givenname: Gabi surname: Shefer fullname: Shefer, Gabi organization: Department of Endocrinology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel – sequence: 5 givenname: Shai orcidid: 0000-0002-1453-9029 surname: Levi fullname: Levi, Shai organization: Department of Hematology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel – sequence: 6 givenname: Yotam surname: Bronstein fullname: Bronstein, Yotam organization: Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel – sequence: 7 givenname: Miguel surname: Morales fullname: Morales, Miguel organization: Department of Endocrinology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel – sequence: 8 givenname: Tomer orcidid: 0000-0002-2589-8473 surname: Ziv fullname: Ziv, Tomer organization: Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel – sequence: 9 givenname: Yamit surname: Shorer Arbel fullname: Shorer Arbel, Yamit organization: Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel – sequence: 10 givenname: Lydia surname: Scarfò fullname: Scarfò, Lydia organization: Division of Experimental Oncology, Università Vita-Salute San Raffaele, IRCCS Ospedale San Raffaele, Milan, Italy – sequence: 11 givenname: Erel orcidid: 0000-0002-7883-289X surname: Joffe fullname: Joffe, Erel organization: Department of Medicine, Lymphoma Service, Memorial Sloan Kettering Cancer Center–Weill Cornell College of Medicine, New York, NY – sequence: 12 givenname: Chava surname: Perry fullname: Perry, Chava organization: Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel – sequence: 13 givenname: Paolo orcidid: 0000-0003-3750-7342 surname: Ghia fullname: Ghia, Paolo organization: Division of Experimental Oncology, Università Vita-Salute San Raffaele, IRCCS Ospedale San Raffaele, Milan, Italy |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/33861303$$D View this record in MEDLINE/PubMed |
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| PublicationDate_xml | – month: 06 year: 2021 text: 2021-06-10 day: 10 |
| PublicationDecade | 2020 |
| PublicationPlace | United States |
| PublicationPlace_xml | – name: United States – name: Washington, DC |
| PublicationTitle | Blood |
| PublicationTitleAlternate | Blood |
| PublicationYear | 2021 |
| Publisher | Elsevier Inc American Society of Hematology |
| Publisher_xml | – name: Elsevier Inc – name: American Society of Hematology |
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| Snippet | 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... Patients with chronic lymphocytic leukemia (CLL) have been previously shown to have poor responses to antibacterial and antiviral vaccines. In a Plenary Paper... |
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| SubjectTerms | Aged antibody response BNT162 Vaccine BNT162b2 Clinical Trials and Observations CLL CME COVID-19 COVID-19 vaccine COVID-19 Vaccines Female Free s Humans Leukemia, Lymphocytic, Chronic, B-Cell - genetics Leukemia, Lymphocytic, Chronic, B-Cell - therapy Lymphoid Neoplasia NEOPLASIA/Lymphoid leukemias Plenary Papers RNA, Messenger - genetics SARS-CoV-2 |
| Title | Efficacy of the BNT162b2 mRNA COVID-19 vaccine in patients with chronic lymphocytic leukemia |
| URI | https://dx.doi.org/10.1182/blood.2021011568 https://www.ncbi.nlm.nih.gov/pubmed/33861303 https://www.proquest.com/docview/2514592686 https://pubmed.ncbi.nlm.nih.gov/PMC8061088 |
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