tetano
Editor, Senior Moderator
J Clin Med
. 2024 Mar 31;13(7):2029.
doi: 10.3390/jcm13072029. Pre-Exposure Prophylaxis and Treatment with Tixagevimab/Cilgavimab for COVID-19 among Immunocompromised Pediatric Patients
Jowita Frączkiewicz[SUP] 1 [/SUP], Katarzyna Pawińska-Wąsikowska[SUP] 2 [/SUP], Katarzyna Szymbor[SUP] 2 [/SUP], Walentyna Balwierz[SUP] 2 [/SUP], Szymon Skoczeń[SUP] 2 [/SUP], Krzysztof Czyżewski[SUP] 3 [/SUP], Sylwia Kołtan[SUP] 3 [/SUP], Jan Styczyński[SUP] 3 [/SUP], Anna Małecka[SUP] 4 [/SUP], Ninela Irga-Jaworska[SUP] 4 [/SUP], Joanna Trelińska[SUP] 5 [/SUP], Wojciech Młynarski[SUP] 5 [/SUP], Olga Zając-Spychała[SUP] 6 [/SUP], Agnieszka Sobkowiak-Sobierajska[SUP] 6 [/SUP], Katarzyna Derwich[SUP] 6 [/SUP], Wioletta Bal[SUP] 7 [/SUP], Radosław Chaber[SUP] 7 [/SUP], Agnieszka Książek[SUP] 8 [/SUP], Tomasz Szczepański[SUP] 8 [/SUP], Joanna Zawitkowska[SUP] 9 [/SUP], Katarzyna Drabko[SUP] 9 [/SUP], Agnieszka Chodała-Grzywacz[SUP] 10 [/SUP], Grażyna Karolczyk[SUP] 10 [/SUP], Christopher Kobierzycki[SUP] 11 [/SUP], Krzysztof Kałwak[SUP] 1 [/SUP]
Affiliations
Background: Patients treated with hemato-oncological malignancies (HO) or undergoing cellular therapies such as hematopoietic stem cell transplantation (HSCT) or chimeric antigen receptor T cells (CAR-T) were significantly affected by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Despite the success of SARS-CoV-2 vaccination, immunocompromised patients remain at increased risk for severe coronavirus disease (COVID-19), rendering this group of population a high priority for additional prevention and treatment options. Tixagevimab and Cilgavimab (TIXA/CILGA, AZD7442, Evusheld[SUP]®[/SUP]) is a combination of two fully human, long-acting monoclonal antibodies. TIXA/CILGA have been approved as pre-exposure prophylaxis and treatment in patients at risk of severe disease with impaired vaccine response. Our objective was to describe the efficacy and safety among immunocompromised pediatric patients. Methods: This was an observational multicenter cohort study of immunocompromised pediatric patients receiving TIXA/CILGA conducted at nine Polish centers of Pediatric Oncology, Hematology and Bone Marrow Transplantation. We analyzed patients in two groups; those treated with HO and those undergoing cellular therapies: HSCT or CAR-T cells. In addition, two other cohorts were identified: patients given TIXA/CILGA as pre-exposure prophylactic and therapeutic intervention. Results: A total of 78 patients were evaluated during the study period: 69 (88.5%) received TIXA/CILGA as pre-exposure prophylaxis and 9 (11.5%) as a treatment strategy. A total of 52 (66.6%) patients were treated with standard chemotherapy at HO departments; 21 (27%) underwent HSCT, and 5 (6.4%) received CAR-T cell therapy. All children with COVID-19 receiving TIXA/CILGA presented a mild degree of severity. The most common clinical manifestations were fever, cough and coryza. At least one adverse event (AE) was reported in two (3.8%) patients excluding standard injection site reactions. Reported AEs were mild or moderate in intensity. One child reported mild myalgia and one reported moderate bone pain and weakness. Conclusions: In our observational multicenter cohort study, we explored the use of TIXA/CILGA as pre-exposure prophylaxis and treatment for COVID-19 among immunocompromised pediatric patients. While our findings suggest a potential benefit in preventing and managing COVID-19 in this vulnerable population, it is important to note the study's non-comparative design. Our results highlight the need for well-designed clinical trials to confirm these observations and further assess the efficacy and safety of TIXA/CILGA in immunocompromised children.
Keywords: COVID-19; cilgavimab; evusheld; immunocompromised patients; monoclonal antibodies; tixagevimab.
. 2024 Mar 31;13(7):2029.
doi: 10.3390/jcm13072029. Pre-Exposure Prophylaxis and Treatment with Tixagevimab/Cilgavimab for COVID-19 among Immunocompromised Pediatric Patients
Jowita Frączkiewicz[SUP] 1 [/SUP], Katarzyna Pawińska-Wąsikowska[SUP] 2 [/SUP], Katarzyna Szymbor[SUP] 2 [/SUP], Walentyna Balwierz[SUP] 2 [/SUP], Szymon Skoczeń[SUP] 2 [/SUP], Krzysztof Czyżewski[SUP] 3 [/SUP], Sylwia Kołtan[SUP] 3 [/SUP], Jan Styczyński[SUP] 3 [/SUP], Anna Małecka[SUP] 4 [/SUP], Ninela Irga-Jaworska[SUP] 4 [/SUP], Joanna Trelińska[SUP] 5 [/SUP], Wojciech Młynarski[SUP] 5 [/SUP], Olga Zając-Spychała[SUP] 6 [/SUP], Agnieszka Sobkowiak-Sobierajska[SUP] 6 [/SUP], Katarzyna Derwich[SUP] 6 [/SUP], Wioletta Bal[SUP] 7 [/SUP], Radosław Chaber[SUP] 7 [/SUP], Agnieszka Książek[SUP] 8 [/SUP], Tomasz Szczepański[SUP] 8 [/SUP], Joanna Zawitkowska[SUP] 9 [/SUP], Katarzyna Drabko[SUP] 9 [/SUP], Agnieszka Chodała-Grzywacz[SUP] 10 [/SUP], Grażyna Karolczyk[SUP] 10 [/SUP], Christopher Kobierzycki[SUP] 11 [/SUP], Krzysztof Kałwak[SUP] 1 [/SUP]
Affiliations
- PMID: 38610794
- PMCID: PMC11012437
- DOI: 10.3390/jcm13072029
Background: Patients treated with hemato-oncological malignancies (HO) or undergoing cellular therapies such as hematopoietic stem cell transplantation (HSCT) or chimeric antigen receptor T cells (CAR-T) were significantly affected by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Despite the success of SARS-CoV-2 vaccination, immunocompromised patients remain at increased risk for severe coronavirus disease (COVID-19), rendering this group of population a high priority for additional prevention and treatment options. Tixagevimab and Cilgavimab (TIXA/CILGA, AZD7442, Evusheld[SUP]®[/SUP]) is a combination of two fully human, long-acting monoclonal antibodies. TIXA/CILGA have been approved as pre-exposure prophylaxis and treatment in patients at risk of severe disease with impaired vaccine response. Our objective was to describe the efficacy and safety among immunocompromised pediatric patients. Methods: This was an observational multicenter cohort study of immunocompromised pediatric patients receiving TIXA/CILGA conducted at nine Polish centers of Pediatric Oncology, Hematology and Bone Marrow Transplantation. We analyzed patients in two groups; those treated with HO and those undergoing cellular therapies: HSCT or CAR-T cells. In addition, two other cohorts were identified: patients given TIXA/CILGA as pre-exposure prophylactic and therapeutic intervention. Results: A total of 78 patients were evaluated during the study period: 69 (88.5%) received TIXA/CILGA as pre-exposure prophylaxis and 9 (11.5%) as a treatment strategy. A total of 52 (66.6%) patients were treated with standard chemotherapy at HO departments; 21 (27%) underwent HSCT, and 5 (6.4%) received CAR-T cell therapy. All children with COVID-19 receiving TIXA/CILGA presented a mild degree of severity. The most common clinical manifestations were fever, cough and coryza. At least one adverse event (AE) was reported in two (3.8%) patients excluding standard injection site reactions. Reported AEs were mild or moderate in intensity. One child reported mild myalgia and one reported moderate bone pain and weakness. Conclusions: In our observational multicenter cohort study, we explored the use of TIXA/CILGA as pre-exposure prophylaxis and treatment for COVID-19 among immunocompromised pediatric patients. While our findings suggest a potential benefit in preventing and managing COVID-19 in this vulnerable population, it is important to note the study's non-comparative design. Our results highlight the need for well-designed clinical trials to confirm these observations and further assess the efficacy and safety of TIXA/CILGA in immunocompromised children.
Keywords: COVID-19; cilgavimab; evusheld; immunocompromised patients; monoclonal antibodies; tixagevimab.