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- Title
Real-World Efficacy and Safety of Tixagevimab Plus Cilgavimab in Patients with Cancer.
- Authors
Tong, Anhthy; Ashouri, Karam; Cai, Yijun; Mohrbacher, Ann; Hernandez, Eduardo Fernandez; Shi, Samantha; Yaghmour, George; Ali, Amir
- Abstract
BACKGROUND: At a time when coronavirus variants are persistently emerging, effective strategies to protect immunocompromised patients with cancer from COVID-19 and its complications are critically needed. Because tixagevimab plus cilgavimab is a novel drug combination, there is a lack of real-world data that reveal the safety and efficacy data for patients with cancer. Only 7% of patients had an active cancer or history of cancer in the phase 3 PROVENT study, with 3% of the total population receiving immunosuppressive therapy. OBJECTIVE: To evaluate the efficacy of tixagevimab plus cilgavimab in patients with cancer as pre-exposure prophylaxis to COVID-19 in the reduction of positive COVID-19 cases, hospitalizations, inpatient length of stay, and mortality. METHODS: This retrospective study evaluated the incidence of COVID-19 among adults with malignancies who did or did not receive tixagevimab plus cilgavimab between January 4, 2022, and December 31, 2022. The secondary study outcomes included hospitalization, hospital length of stay, and mortality resulting from COVID-19, as well as the incidence of tixagevimab plus cilgavimab–related adverse events. To validate the accurate reporting of positive COVID-19 cases, texted and emailed surveys were distributed by the Keck School of Medicine of the University of Southern California (USC) research department. RESULTS: In a single-center, retrospective review of 13,522 patients with cancer who had a visit within the USC system in 2022, 305 (2.3%) patients received tixagevimab plus cilgavimab. After propensity score matching, 304 patients of the 13,522 were in the tixagevimab plus cilgavimab group and 304 patients of the 13,217 patients with cancer who did not receive tixagevimab plus cilgavimab were in the control group. The overall median patient age was 66 years (range, 19-96 years). Treatment with tixagevimab plus cilgavimab significantly decreased the risk for COVID-19 between January 2022 and June 2022 (risk ratio, 0.23; 95% confidence interval, 0.03-0.74; P=.038). A total of 32 (10.5%) patients in the tixagevimab plus cilgavimab group tested positive for COVID-19 versus 45 (14.8%) patients in the control group. Between January 2022 and June 2022, 2 patients were COVID-19 positive in the tixagevimab plus cilgavimab group versus 18 patients in the control group, which increased in July 2022 to December 2022 to 30 cases and 27 cases, respectively. Among the COVID-19–positive patients, 4 (1.3%) who received tixagevimab plus cilgavimab were hospitalized versus 11 (3.6%) patients in the control group (P=.114). The median lengths of stay were 2 days (range, 2-7) and 4 days (range, 1-15 days), respectively (P=.906). Adverse events occurred in 3 (3.4%) patients in the tixagevimab plus cilgavimab group and included nausea, vomiting, blurry vision, and headache. The COVID-19–unrelated deaths included 10 (3.4%) in the tixagevimab plus cilgavimab group and 22 (8.5%) in the control group. There was 1 COVID-19–related death in the control group. CONCLUSION: Treatment with tixagevimab plus cilgavimab was effective in reducing COVID-19 infection during the first half of 2022 but was unsuccessful in reducing COVID-19 infection in the latter half of 2022, likely as a result of high mutation rates of the coronavirus and the medication’s inability to adapt to newer strains of the virus. However, there was a clinically meaningful reduction in hospitalization and in the severity of COVID-19 in a small number of patients who received tixagevimab plus cilgavimab in our study. Although tixagevimab plus cilgavimab is not currently approved for use in the United States, our findings provide a better understanding of how the use of tixagevimab plus cilgavimab, and potential future monoclonal antibodies, play a role in minimizing COVID-19–related complications in patients with cancer.
- Subjects
UNITED States Code; UNIVERSITY of Southern California; CANCER patients; CORONAVIRUS diseases; COVID-19; SARS-CoV-2; LENGTH of stay in hospitals; COVID-19 pandemic
- Publication
Journal of Hematology Oncology Pharmacy, 2023, Vol 13, Issue 6, p302
- ISSN
2164-1153
- Publication type
Article