Early experience with tixagevimab/cilgavimab pre-exposure prophylaxis in patients with immune-mediated inflammatory disease undergoing B cell depleting therapy and those with inborn errors of humoral immunity

Calabrese, Cassandra; Kirchner, E; Villa‐Forte, Alexandra; Hajj‐Ali, Rula A.; Moss, Brandon P; Fernandez, James P; Calabrese, Leonard H.

doi:10.1136/rmdopen-2022-002557

Cited by 29 publications

(54 citation statements)

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“…It included studies from the United States, France, Israel, Belgium, Spain and the United Kingdom. This review included ten retrospective cohort studies 12,[16][17][18][19][20][22][23][24][25] (including two preprints 16,20 ), six prospective, observational cohort studies [26][27][28][29][30][31] (also including one preprint…”

Section: Resultsmentioning

confidence: 99%

“…In the ten cohort studies without controls, rates of COVID-19-specific deaths were very low, ranging between 0.00-0.48% over a 0.5-4-month period 12,[22][23][24][25][27][28][29][30][31] . Eight of these studies reported mortality rates of 0.00% [22][23][24][25][28][29][30][31] . Al-Obaidi et al reported an all-cause mortality rate of 0.86% after a median of 53 days and was the only non-comparative cohort study which included all-cause mortality 23…”

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confidence: 99%

“…8,12,[16][17][18][19][20][22][23][24][25][27][28][29][30][31] (RRR: relative risk ratio; HR: hazard ratio; IRR: incidence risk ratio; OR: odds ratio; IQR: interquartile range)Neutralising ability of patient seraThis systematic review included 17 large scale human studies, including a total of 24,773 immunocompromised participants, of whom 10,775 received Tixagevimab/Cilgavimab as a prophylactic antibody therapy. While our findings are generally positive, it should be acknowledged that the real-world studies differed in quality.…”

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confidence: 99%

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Systematic review of the clinical effectiveness of Tixagevimab/Cilgavimab for prophylaxis of COVID-19 in immunocompromised patients

Suribhatla

Starkey

Ionescu³

et al. 2022

Preprint

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Background and aims Immunocompromised patients have a reduced ability to generate antibodies after COVID-19 vaccination and are at higher risk of SARS-CoV-2 infection, complications and mortality. Tixagevimab/Cilgavimab (Evusheld) is a monoclonal antibody combination which bind to the SARS-CoV-2 spike protein, preventing the virus entering human cells. The phase III PROVENT trial reported that immunocompromised patients given Tixagevimab/Cilgavimab had a significantly reduced risk of COVID-19 infection. However, PROVENT was conducted before the SARS-CoV-2 Omicron became prevalent. This systematic review provides an updated summary of real-world clinical evidence of Tixagevimab/Cilgavimab effectiveness in immunocompromised patients. Methods Two independent reviewers conducted PubMed and medRxiv searches for the period of 01/01/2021 to 01/10/2022. Clinical studies which reported the primary outcome of breakthrough COVID-19 infections after Tixagevimab/Cilgavimab administration were included in the review. COVID-19-related hospitalisations, ITU admissions and mortality were assessed as secondary outcomes. Clinical effectiveness was determined using the case-control clinical effectiveness methodology. The GRADE tool was used to ascertain the level of certainty for the primary outcome in each study. Results 17 clinical studies were included, comprising 24,773 immunocompromised participants of whom 10,775 received Tixagevimab/Cilgavimab. Most studies reported clinical outcomes during the SARS-CoV-2 Omicron wave. Six studies compared a Tixagevimab/Cilgavimab intervention group to a control group. Overall, the clinical effectiveness of prophylactic Tixagevimab/Cilgavimab against COVID-19 breakthrough infection, hospitalisation and ITU admission were 40.47%, 69.23% and 87.89%, respectively. For prevention of all-cause and COVID-19-specifc mortality, overall clinical effectiveness was 81.29% and 86.36%, respectively. Conclusions There is a growing body of real-world evidence validating the original PROVENT phase III study regarding the clinical effectiveness of Tixagevimab/Cilgavimab as prophylaxis for immunocompromised patients, notably demonstrating effectiveness during the Omicron wave. This review demonstrates the clinical effectiveness of prophylactic Tixagevimab/Cilgavimab at reducing COVID-19 infection, hospitalisation, ITU admission and mortality for immunosuppressed individuals. It is important that ongoing larger-scale and better-controlled real world studies are initiated and evaluated to provide ongoing certainty of the clinical benefit of prophylactic antibody treatment for immunocompromised patients in the face of new variants.

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Section: Resultsmentioning

confidence: 99%

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confidence: 99%

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confidence: 99%

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Systematic review of the clinical effectiveness of Tixagevimab/Cilgavimab for prophylaxis of COVID-19 in immunocompromised patients

Suribhatla

Starkey

Ionescu³

et al. 2022

Preprint

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“…They were the first outpatient treatment option shown to be effective in preventing severe COVID-19 among high-risk patients(1). Pre-exposure prophylaxis with monoclonal antibodies may also reduce severe outcomes, and among SARD patients who received B cell depleting therapy, monoclonal antibodies may be effective, even after vaccination(31, 38). Thus, our study adds to the literature by investigating all SARD patients, not only those at highest risk due to B cell depletion with resultant impaired humoral immunity.…”

Section: Discussionmentioning

confidence: 99%

“…We used electronic query to identify previous COVID-19 prior to the current episode. We performed manual medical record review to determine tixagevimab/cilgavimab use (31).…”

Section: Other Covariatesmentioning

confidence: 99%

Outcomes with and without outpatient SARS-CoV-2 treatment for patients with COVID-19 and systemic autoimmune rheumatic diseases: A retrospective cohort study

Qian

Wang

Patel

et al. 2022

Preprint

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Objective: To investigate temporal trends, severe outcomes, and rebound among systemic autoimmune rheumatic disease (SARD) patients according to outpatient SARS-CoV-2 treatment. Methods: We performed a retrospective cohort study investigating outpatient SARS-CoV-2 treatments among SARD patients at Mass General Brigham (23/Jan/2022-30/May/2022). We identified SARS-CoV-2 infection by positive PCR or antigen test (index date=first positive test) and SARDs using diagnosis codes and immunomodulator prescription. Outpatient treatments were confirmed by medical record review. The primary outcome was hospitalization or death within 30 days following the index date. COVID-19 rebound was defined as documentation of negative then newly-positive SARS-CoV-2 tests. The association of any vs. no outpatient treatment with hospitalization/death was assessed using multivariable logistic regression. Results: We analyzed 704 SARD patients with COVID-19 (mean age 58.4 years, 76% female, 49% with rheumatoid arthritis). Treatment as outpatient increased over calendar time (p<0.001). A total of 426(61%) received outpatient treatment: 307(44%) with nirmatrelvir/ritonavir, 105(15%) with monoclonal antibodies, 5(0.7%) with molnupiravir, 3(0.4%) with outpatient remdesivir, and 6(0.9%) with combinations. There were 9/426 (2.1%) hospitalizations/deaths among those treated as outpatient compared to 49/278 (17.6%) among those with no outpatient treatment (adjusted odds ratio [aOR] 0.12, 0.05 to 0.25). 25/318 (8%) of patients who received oral outpatient treatment had documented COVID-19 rebound. Conclusion: Outpatient treatment was strongly associated with lower odds of severe COVID-19 compared to no outpatient treatment. At least 8% of SARD patients experienced COVID-19 rebound. These findings highlight the importance of outpatient COVID-19 treatment for SARD patients and the need for further research on rebound.

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A model program for pharmacist‐managed healthcare delivery: A tixagevimab–cilgavimab (EVUSHELD) clinic at a Veterans Affairs healthcare system

Buehrle,

Shields,

Lopez

et al. 2023

J Am Coll Clin Pharm

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BackgroundPharmacists are under‐utilized as caregivers who can improve patients’ access to medical treatments. In this study, effectiveness of a multidisciplinary pharmacist‐managed clinic in delivering tixagevimab‐cilgavimab pre‐exposure coronavirus disease 2019 (Covid‐19) prophylaxis was determined.MethodsAn observational study at the Veterans Affairs (VA) Pittsburgh Healthcare System tixagevimab‐cilgavimab clinic from 1/1/2022‐1/26/2023 was conducted. Pharmacists identified immunocompromised Veterans system‐wide, performed active (telephone) or passive (mail) outreach to those in 3 highest‐risk categories and a more moderate‐risk category, respectively, and prescribed and dispensed tixagevimab‐cilgavimab.ResultsEligible Veterans were stratified into Categories 1 (highest‐risk; 18% [193/1089]), 2 (2% [18/1089]), 3 (17% [188/1089[) or 4 (most moderate‐risk; 63% (690/1089)). Most common underlying conditions were rheumatologic (33%, 356/1089), oncologic (20%, 214/1089) and organ transplantation (18%, 197/1089). Twenty‐five percent (268/1089) of patients received ≥1 tixagevimab‐cilgavimab dose. Acceptance in Categories 1, 2 and 3 was 63% (121/193), 78% (14/18) and 37% (70/188), respectively (51% overall). Acceptance in Category 4 was 9% (63/690; p<0.0001 vs. Categories 1‐3). To put data into context, <2% of immunosuppressed persons in the United States were reported to receive tixagevimab‐cilgavimab. Acceptance was greater among Veterans with rheumatologic or oncologic diseases than those with transplant‐related or neurologic diagnoses (p<0.0001), and among Covid‐19‐vaccinated vs. non‐vaccinated Veterans (27% (261/952) and 5% (7/137), p<0.0001). Six percent (15/268) and 5% (42/821) of treated and untreated patients, respectively, were subsequently diagnosed in‐system with Covid‐19.ConclusionsA pharmacist‐managed clinic effectively delivered tixagevimab‐cilgavimab to immunocompromised Veterans, in particular those at highest Covid‐19 risk. This program is a model for pharmacist‐led clinics for other therapeutics or diseases.This article is protected by copyright. All rights reserved.

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Early experience with tixagevimab/cilgavimab pre-exposure prophylaxis in patients with immune-mediated inflammatory disease undergoing B cell depleting therapy and those with inborn errors of humoral immunity

Cited by 29 publications

References 8 publications

Systematic review of the clinical effectiveness of Tixagevimab/Cilgavimab for prophylaxis of COVID-19 in immunocompromised patients

Systematic review of the clinical effectiveness of Tixagevimab/Cilgavimab for prophylaxis of COVID-19 in immunocompromised patients

Outcomes with and without outpatient SARS-CoV-2 treatment for patients with COVID-19 and systemic autoimmune rheumatic diseases: A retrospective cohort study

A model program for pharmacist‐managed healthcare delivery: A tixagevimab–cilgavimab (EVUSHELD) clinic at a Veterans Affairs healthcare system

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