Large real-world evidence studies reveal disproportionate burden of COVID-19 on the immunocompromised

Data covering almost 30 million individuals show continued burden of disease;
immunocompromised individuals comprise approximately one quarter of all COVID-19 hospitalizations, ICU admissions and deaths

INFORM and EPOCH studies underscore the continued need for preventative options for people inadequately protected by COVID-19 vaccination alone

New data from two extensive real-world evidence studies from AstraZeneca highlight that immunocompromised (IC) individuals continue to face significant and disproportionate burdens from COVID-19, with substantially higher rates of severe COVID-19 outcomes compared to the general population.

The INFORM and EPOCH studies were published in Lancet Regional Health Europe and Current Medical Research and Opinion respectively. 1,2 Data from INFORM are also being presented at the 12th Annual IDWeek Conference currently taking place in Boston.

As with other vaccines, COVID-19 vaccines are not as effective in immunocompromised individuals as they are in the general population due to an inability to produce a robust protective response to the vaccine.3 As a result, immunocompromised individuals can be insufficiently protected against COVID-19 and remain at high risk for SARS-CoV-2 infection and serious outcomes from COVID-19.4

Key data from the studies include:

  • In the INFORM study, despite accounting for up to 4% of the population, immunocompromised individuals account for around a quarter of all COVID-19 hospitalizations (22%), ICU admissions (28%) and deaths (25%) in England.1
  • Even after repeated doses of COVID-19 vaccines, IC individuals had up to a 14 times greater risk of COVID-19 hospitalization compared to the general population.1
  • The risk of hospitalization, ICU admissions and death was disproportionately higher than the general population across all immunocompromised individuals, regardless of the primary condition. Certain immunocompromised populations, such as solid organ and stem cell transplant recipients and those recently treated for blood cancers, demonstrated greater than 10-fold increases in risk compared to those without these conditions.1
  • Data from EPOCH demonstrate long hospital stays and high costs for IC patients, with mean total costs for hospitalizations associated with the first COVID-19 diagnosis for IC patients estimated at nearly $1 billion (2021 US dollars), with a mean cost of $64,029 per patient and mean length of hospitalization stay of 15 days.2

Paul Moss, Institute of Immunology and Immunotherapy, Deputy Head of College of Medical and Dental Sciences and Professor of Haematology, University of Birmingham, UK and INFORM investigator, said: “To date, our understanding of the burden of COVID-19 in the immunocompromised population has been limited due to a lack of dedicated research in this area. INFORM and EPOCH are the first large-scale studies that jointly provide detailed insight into the impact that COVID-19 continues to have on those patient groups across different geographies. As our data show, vaccination alone is often not enough to protect these individuals from potential devastating consequences of COVID-19 and effective prevention strategies are needed for this population. We must work together to find solutions so that this vulnerable population can move on from the pandemic.”

Hugh Montgomery, Professor of Intensive Care Medicine at University College London, UK, said: “With a higher likelihood of severe disease, longer hospital stays and high associated costs, the burden of COVID-19 falls disproportionately on immunocompromised patients and puts significant strain on healthcare systems. Now that COVID-19 cases and hospitalizations are on the rise once again, these burdens on the immunocompromised may worsen as we head into the 2023-2024 winter season. Accelerating development of new therapies that could help protect these vulnerable individuals from COVID-19 and ensure they can properly manage their underlying conditions remains an urgent health priority.”

INFORM is an observational, population-based, retrospective cohort study among nearly 12 million people aged 12 years and older in England to assess clinical outcomes and utilization of healthcare resources due to COVID-19. EPOCH provides robust real-world data on COVID-19 risks and outcomes in IC and non-IC populations in the US, conducted using an extensive insurance claims database of nearly 17 million individuals.

Additional data from INFORM and EPOCH will be shared with the medical community at upcoming medical congresses and other publications.

Notes

INFORM
INFORM (Investigation of COVID-19 risk among immunocompromised populations) is an observational, retrospective cohort study to describe clinical outcomes and utilization of healthcare resources among individuals with COVID-19 in England during Omicron (January-December 2022) as the pandemic began to transition to an endemic phase. These first published data from INFORM aim to clearly define and provide a comprehensive assessment of risk for serious outcomes from COVID-19 in IC populations. Data beyond 2022 are also being analyzed and will be shared at a later date.

COVID-19-related hospitalizations, ICU admissions and deaths were compared among different groups of immunocompromised individuals vs. the general population using de-identified, routinely collected electronic health data from a random 25% sample representative of the total English population 12 years of age and older using the National Health Service’s databases (NHS Digital). In INFORM, IC individuals were shown to represent about 4% of the population aged 12 years and older in England.1

Individuals were considered immunocompromised (broadly defined) if they had: primary or secondary immunodeficiency, chronic immune-mediated inflammatory diseases and taking high-dose or long-term moderate corticosteroids; end-stage renal disease or dialysis; solid organ transplant within the last five years; stem cell transplant within the last two years; solid tumor or haematological cancer within the last five years; advanced or untreated HIV.

EPOCH
EPOCH (Emerging Populations and Outcomes associated with COVID-19-Health Conditions in the United States) is a retrospective, observational cohort study evaluating the burden of illness and healthcare resource utilization conducted among US commercially insured patients in the Healthcare Integrated Research Database (HIRD) of nearly 23 million people. Data was anonymized and HIPPA compliant. The aim of EPOCH was to estimate the prevalence of patients with an immunocompromising condition at risk for COVID-19, estimate COVID-19 prevalence rate and incidence rate by immunocompromising condition, and describe COVID-19 related healthcare resource utilization (HCRU) and costs. The study period was between April 1, 2018 and March 31, 2022, with infections analyzed from April 1, 2020 to March 31, 2022.

About 3% (2.7%) of the EPOCH study source population were identified as immunocompromised.2 Immunocompromising conditions included: haematologic or solid tumour under active treatment; solid organ or stem cell transplant; primary immunodeficiency or end-stage renal disease. The source population (n= 16,873,161) included patients with at least one claim for an immunocompromising at-risk condition during the study period or at least two pharmacy or medical claims for an immunocompromising treatment within the 6 months prior to the infection period. Outcomes measured included prevalence of immunocompromising conditions and use of immunosuppressive treatments; prevalence and incidence of COVID-19; length of stay and costs (health plan- plus patient-paid) associated with COVID-19 hospitalization.

COVID-19 and the Immunocompromised
Immunocompromised individuals often do not mount an adequate immune response to COVID-19 vaccination and continue to have an increased and disproportionate risk of severe COVID-19 outcomes including hospitalization, ICU admissions and death, compared to the general population.1,3,4  Without adequate protection, many IC people continue to shield from virus exposure, which can have a detrimental impact on management of their primary condition, overall mental health and employment.5-9 The high cost of care for COVID-19 hospitalizations can also burden these individuals as well as health systems.2,10

AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit  www.astrazeneca-us.com and follow us on social media @AstraZeneca.

Contacts

Brendan McEvoy        +1 302 885 2677
Jillian Gonzales          +1 302 885 2677       

US Media Mailbox: usmediateam@astrazeneca.com           

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References

  1. Evans R, et al. Impact of COVID-19 on Immunocompromised Populations During the Omicron Era: Insights from the Observational Population-Based INFORM Study. Lancet Regional Health Europe. Published online October 13, 2023. doi: 10.1016/j.lanepe.2023.100747   
  2. Ketkar A et al. Assessing the Risk and Costs of COVID-19 in Immunocompromised Populations in a Large United States Commercial Insurance Health Plan: The EPOCH-US Study. Curr Med Res Opin. 2023. 39 (8):1103-1118
  3. Centers for Disease Control and Prevention. People Who Are Immunocompromised. https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-who-are-immunocompromised.html [Last accessed: October 2023]
  4. Singson JRC et al. Factors Associated with Severe Outcomes Among Immunocompromised Adults Hospitalized for COVID-19 — COVID-NET, 10 States, March 2020–February 2022. MMWR Morb Mortal Wkly Rep. 2022;71(27):878-884
  5. All-Party Parliamentary Group on Vulnerable Groups to Pandemics. Covid-19 Inquiry Update and Position Statement, March 2023  
  6. Di Iorio M et al. DMARD Disruption, Rheumatic Disease Flare, and Prolonged COVID-19 Symptom Duration after Acute COVID-19 among Patients with Rheumatic Disease: A Prospective Study. Semin Arthritis Rheum. 2022;55:152025
  7. Conway SE et al. COVID-19 Severity Is Associated with Worsened Neurological Outcomes in Multiple Sclerosis and Related Disorders. Mult Scler Relat Disord. 2022 Jul;63:103946
  8. Kareff SA et al. Prevalence and Outcomes of COVID-19 among Hematology/Oncology Patients and Providers of a Community-Facing Health System during the B1.1.529 (“Omicron”) SARS-CoV-2 Variant Wave. Cancers. 2022;14(19):4629
  9. American Society of Transplant Surgeons. Re-Engaging Organ Transplantation in the COVID-19 Era. https://asts.org/advocacy/advocacy-library/covid-19-library [Last accessed: October 2023]
  10. Willems SH et al. Digital Solutions to Alleviate the Burden on Health Systems During a Public Health Care Crisis: COVID-19 as an Opportunity. JMIR Mhealth Uhealth. 2021;9(6):e25021