Systemic Corticosteroids for COVID-19 in U.S. Outpatient Settings

Sunday, August 28, 2022

8:45 AM – 9:00 AM CEST

Location: Congress Hall D4

Publication Number: 219

Background: Background
The National Institutes of Health (NIH) COVID-19 treatment guidelines advise, in absence of another indication, against systemic corticosteroid use in patients with mild-to-moderate COVID-19 due to lack of efficacy and safety data. The UK RECOVERY trial released findings in June 2020, which first highlighted the potential for harm from dexamethasone in patients not requiring supplemental oxygen.

Objectives: Using four U.S. databases (Medicare, FDA's Sentinel System, Veterans Health Administration and HealthVerity), we examined new systemic corticosteroid use among non-hospitalized patients with COVID-19, from April 2020 -September 2021.

Methods: Patients with incident outpatient COVID-19 (ICD-10-CM diagnosis code (U07.1) or a SARS-CoV-2 positive test result), without COVID-19 in the 183 days prior, were identified and followed from diagnosis until the earliest of corticosteroid initiation, hospitalization, death, disenrollment, or 14 days. Demographics, clinical characteristics, and among corticosteroid initiators, corticosteroid type, timing, setting of initiation, provider specialty, concomitant therapies, and hospitalizations within 30 days of treatment were examined.

Results: Over 7.8 million COVID-19 patients were identified. The mean age was 74.6 (±7.2), 48.5 (±19.9), 39.3 (±21.1), and 56.3 (±16.4) years in Medicare, Sentinel, HealthVerity, and the VHA, respectively. Of these, 16.4%, 9.4%, 8.9%, and 4.8%, respectively, initiated corticosteroids in an outpatient setting within 14 days of COVID-19 diagnosis. The proportion of COVID-19 patients initiating corticosteroids in the South of the U.S. was higher than in any other region. Outpatient corticosteroid initiation dramatically increased over time and did not appear to be restricted to older people. Over 50% initiated corticosteroids on the day of diagnosis; mostly through pharmacy dispensings (70.8-92.0%). Azithromycin, the most common outpatient concomitant therapy (33.6-48.8%), was often initiated on the same date as the corticosteroid. Few patients (≤1.5%) had recorded oxygen use between COVID-19 and corticosteroid initiation. The proportion of any-cause and COVID-19-related hospitalizations in the 30 days post-initiation ranged from 7.9-17.5% and 6.3-16.1%, respectively.

Conclusions: Despite NIH recommendations, increasing numbers of non-hospitalized COVID-19 patients initiated systemic corticosteroids. Given the potential safety signal, lack of data in mild-to-moderate COVID-19 and potential delayed SARS-CoV-2 clearance, it is critical that providers consider the NIH guidelines for non-hospitalized COVID-19 patients.
The views expressed are the authors' and not necessarily those of the U.S. Food and Drug Administration,

Presenting Author(s)

Marie C. Bradley, PhD, MPharm, MPH

Senior Pharmacoepidemiologist
Office of Surveillance and Epidemiology, CDER, FDA
Silver Spring, Maryland, United States

Slides

Co-Author(s)

DG

David Graham, MPH, MD

Associate director
US Food and Drug Administration
Silver Spring, Maryland, United States
Efe Eworuke, PhD

US Food and Drug Administration
Silver Spring, Maryland, United States
HL

Hana Lee

U.S. Food and Drug Administration, United States
SA

Sandia Akhtar

Acumen, LLC
Burlingame, California, United States
HL

Hai Lyu

Policy Associate
Acumen LLC
Burlingame, CA, United States
KN

Kushal Naik

Acumen LLC, United States
YC

Yoganand Chillarige, MPA

Research Manager
Acumen LLC
Burlingame, California, United States
FC

Francesca Cunningham, Pharm.D.

Director, Center for Medication Safety
Department of Veterans Affairs
Hines, GA, United States
DD

Diane Dong

Department of Veterans Affairs, United States
RZ

Rongping Zhang

Department of Veterans Affairs, United States
Noelle M. Cocoros, DSc

Epidemiologist
Harvard Pilgrim Health Care Institute
Boston, Massachusetts, United States
AC

Austin Cosgrove

Harvard Pilgrim Healthcare Institute, United States
Ashley I. Martinez, PharmD, PhD

Research Scientist
Harvard Pilgrim Health Care Institute
Boston, Massachusetts, United States
JM

Judith C. Maro, PhD

Harvard Pilgrim Health Care Institute
Boston, Massachusetts, United States
AW

Andrew Weckstein

Aetion, Inc
New York, New York, United States
AB

Aidan Baglivo, BS

Aetion, Inc, United States
Sarah Vititoe, MPH

Aetion, Inc
Brooklyn, New York, United States
Elizabeth M. Garry, MPH, PhD

Head of Scientific Research
Aetion, Inc
Boston, Massachusetts, United States
Nicolle Gatto, PhD, FISPE

Chief Science Officer
Aetion, Inc., United States
JK

Jeffrey Kelman

CMS, United States
Silvia Perez-Vilar, PhD

Senior Epidemiologist
US Food and Drug Administration
Silver Spring, Maryland, United States