Audio
Rate
Adverse Events
Associated With
Corticosteroid Use in
Chronic Spontaneous
Urticaria Management
This study was funded by Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Poster presented at the American College of Allergy, Asthma & Immunology Annual Scientific Meeting,
November 6–10, 2025, Orlando, FL, USA.
• CSU-related corticosteroid use was associated with the
occurrence of AEs; the most common AEs were lipid disorders,
hypertension, anxiety, and obesity
• Prolonged corticosteroid use (>60 days) was observed in the
management of CSU, and was typically associated with more
frequent AEs and greater AE-related HCRU
• These data support restricting corticosteroids to short-term use
only as a rescue treatment for managing CSU in accordance
with current guidelines1
KEY FINDINGS & CONCLUSIONS
METHODS
• This retrospective cohort study used data from the US HealthVerity health insurance claims database between January 2016 and
October 2023 (Figure 1)
• HealthVerity data are HIPAA compliant; therefore, no IRB approval was necessary
• Patients ≥18 years of age with a confirmed diagnosis of CSU and at least 1 year of continuous enrollment prior to CSU diagnosis
(allowing gaps in continuous enrollment of less than 30 days) were included
• AEs (identified using ICD-10-CM diagnosis codes) and HCRU, occurring within 1 year after the first prescription of systemic
corticosteroids, were analyzed in corticosteroid users and non-users
– Only patients using systemic corticosteroids within 15 days of CSU diagnosis were included; those with systemic corticosteroid
use during the baseline period were excluded
– For non-users, AEs and HCRU were assessed for 1 year after a reference date derived from corticosteroid users
Table 1. Patient Characteristics
All CS users (n = 42,478)
Patient characteristics Non-users
n = 44,806
All CS users
n = 42,478
≤31D
(n = 39,510)
>31–≤60D
(n = 2104)
>60D
(n = 864)
Age at index date,a years, mean (SD) 44.3 (16.6) 43.3 (15.4) 43.1 (15.4) 45.5 (14.3) 48.6 (14.3)
Female sex, n (%) 32,592 (72.7) 31,656 (74.5) 29,584 (74.9) 1466 (69.7) 606 (70.1)
Payer type,b n (%)
Commercial 29,420 (65.7) 27,751 (65.3) 25,605 (64.8) 1514 (72.0) 632 (73.1)
Medicaid 12,307 (27.5) 12,126 (28.5) 11,504 (29.1) 465 (22.1) 157 (18.2)
Medicare Advantage 2717 (6.1) 2255 (5.3) 2081 (5.3) 106 (5.0) 68 (7.9)
Unknown 362 (0.8) 346 (0.8) 320 (0.8) 19 (0.9) 7 (0.8)
CCI, mean (SD) 0.5 (1.1) 0.4 (1.0) 0.4 (1.0) 0.4 (1.0) 0.5 (1.1)
Duration of follow-up period, years, mean (SD) 2.7 (1.3) 3.0 (1.5) 3.0 (1.5) 3.1 (1.5) 3.2 (1.5)
aThe index date was specified as the earliest of the two diagnosis dates used to confirm CSU. bWhen multiple payer types were reported, commercial insurance was prioritized, followed by Medicaid, and then Medicare Advantage.
Patients were categorized according to total days of systemic CS supply in the 1 year after the first systemic CS prescription (or reference date) during the follow-up period.
CCI, Charlson Comorbidity Index; CS, corticosteroid(s); CSU, chronic spontaneous urticaria; D, days; SD, standard deviation.
RESULTS
Patient Selection and Baseline Characteristics
• Of the 224,958 patients in this study, a total of 174,555 (77.6%) were prescribed systemic corticosteroids: 96,816 (43.0%) during the baseline period and 153,679 (68.3%) following CSU diagnosis
– The mean (SD) number of episodes of systemic corticosteroid use was 2.1 (1.6), and the duration of use was 82.6 (143.2) days
• Overall, 87,284 met the inclusion criteria for this analysis, of whom 42,478 were corticosteroid users and 44,806 were non-corticosteroid users (Figure 2)
• The mean age at the index date was 43.3 and 44.3 years for corticosteroid users and non-users, respectively, and most patients were female (Table 1)
Abbreviations
AE, adverse event; CCI, Charlson Comorbidity Index; CS, corticosteroid(s);
CSU, chronic spontaneous urticaria; D, days; ED, emergency department;
H1-AH, H1-antihistamine; HCRU, health care resource utilization; HIPAA, Health
Insurance Portability and Accountability Act; ICD-10-CM, International Classification
of Diseases, Tenth Revision, Clinical Modification; IRB, institutional review board;
PPPY, per patient per year; SD, standard deviation; US, United States.
Disclosures
GY has received honoraria as a consultant and/or advisory board member for AbbVie, Amgen, Arcutis Biotherapeutics, Celldex, CSL Vifor, Eli Lilly, Escient Pharmaceuticals, Galderma,
GSK, Kamari Pharma, Kiniksa Pharmaceuticals, LEO Pharma, Maruho, Novartis, Pfizer, Pierre Fabre, Regeneron Pharmaceuticals, Inc., Sanofi, and Trevi Therapeutics; has received
research funding from Celldex, Eli Lilly, Escient Health, Kiniksa Pharmaceuticals, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., and Sanofi. DP, JR, MK, and TR are full-time
employees of Novartis and may own stock or stock options. IP, JD, and JS are full-time employees of Analysis Group, Inc., a consulting company that has provided paid consulting
services to Novartis Pharma AG. MAR has received research and/or consulting support from Astria Therapeutics, BioCryst, BioMarin, Celldex, CSL Behring, Cycle Pharmaceuticals,
Grifols, Intellia Therapeutics, Ionis Pharmaceuticals, KalVista Pharmaceuticals, Novartis, Pfizer, Pharming, Pharvaris, Sanofi-Regeneron, and Takeda Pharmaceuticals.
References
1. Zuberbier T, et al. Allergy. 2022;77(3):734–766.
2. Ledford D, et al. Allergy Asthma Proc. 2016;37(6):458–465.
3. Waljee AK, et al. BMJ. 2017;357:j1415.
Acknowledgments
Writing support was provided by Hayley Loy, PhD (BOLDSCIENCE
Ltd., UK), and was funded by Novartis Pharmaceuticals Corporation.
This poster was developed in accordance with Good Publication
Practice (GPP) guidelines. The authors had full control of the
content and made the final decision on all aspects of this publication.
INTRODUCTION
• CSU is characterized by the occurrence of itch, wheals, and/or angioedema lasting
>6 weeks without an identifiable trigger1
• The recommended 1st-line treatment for CSU is second-generation H1-AHs, whereas
systemic corticosteroids are reserved only for short-term (≤10 days) use during
acute flares1
• Frequent and/or prolonged use of systemic corticosteroids can result in serious AEs2,3
• Here, we describe systemic corticosteroid use and associated outcomes in patients
with CSU in the US
Limitations
• Dosage and potency of corticosteroids were not considered in this analysis
• Changes in AE-related HCRU were assessed as a whole; therefore, the weighted attribution of specific AEs could not be ascertained
• Corticosteroid users were categorized by total days of systemic corticosteroid supply as a proxy for duration of use: ≤31 days (≤31D), >31
and ≤60 days (>31–≤60D), and >60 days (>60D)
• P values were generated from univariable binomial logistic regression models and refer to statistical comparisons of the frequency of AEs
between different corticosteroid user groups vs non-users
Figure 3. Most Common AEs Within 1 Year After the First Prescription of Systemic CS Following CSU Diagnosis
Patients were categorized according to total days of systemic CS supply in the 1 year after the first systemic CS prescription (or reference date) during the follow-up period. Data for the “All CS users” group is not displayed on the bar chart. Numerical differences between the “Non-users” and “>60D” groups are shown on the chart
for each AE.
AE, adverse event; CS, corticosteroid(s); CSU, chronic spontaneous urticaria; D, days.
Proportion of patients (%)
40.0
35.0
30.0
25.0
20.0
15.0
10.0
5.0
0.0
Lipid disorders Hypertension Anxiety Obesity Fatigue Depression Diabetes Insomnia Cataracts Gastritis
31.2% 28.9% 25.0% 21.3% 18.0% 16.0% 12.3% 7.1% 5.8% 5.2%
31.4% 25.6% 21.1% 16.3% 14.8% 13.6% 12.7% 6.7% 7.3% 4.7%
Non-users
(n = 44,806)
31.8%
(P=0.701)
29.7%
(P<0.001)
25.0%
(P<0.001)
21.8%
(P<0.001)
20.5%
(P<0.001)
17.3%
(P<0.001)
12.1%
(P=0.467)
7.1%
(P=0.507)
6.4%
(P=0.121)
4.8%
(P=0.755)
>31D–≤60D
(n = 2104)
33.4%
(P=0.199)
35.4%
(P<0.001)
26.7%
(P<0.001)
24.0%
(P<0.001)
25.3%
(P<0.001)
18.1%
(P<0.001)
14.7%
(P=0.076
10.3%
(P<0.001)
8.8%
(P=0.087)
5.0%
(P=0.706)
>60D
(n = 864)
All CS users
(n = 42,478)
31.2%
(P=0.467)
28.7%
(P<0.001)
25.0%
(P<0.001)
21.2%
(P<0.001)
17.7%
(P<0.001)
15.9%
(P<0.001)
12.2%
(P=0.064)
7.1%
(P=0.050)
5.7%
(P<0.001)
5.2%
(P<0.001)
≤31D
(n = 39,150)
Non-users (n = 44,806)
>31D–≤60D (n = 2104)
>60D (n = 864)
≤31D (n = 39,510)
+ 2.0%
+ 9.8%
+ 5.6%
+ 7.7%
+ 10.5%
+ 4.5%
+ 2.0%
+ 3.6%
+ 1.5%
+ 0.3%
Adverse Event-Related Health Care Resource Utilization
• AE-related outpatient visits, inpatient admissions, and ED visits increased with longer corticosteroid use (Figure 4)
Figure 4. AE-Related HCRU During Follow-Up PPPY
Patients were categorized according to total days of systemic CS supply in the 1 year after the first systemic CS prescription (or reference date) during the follow-up period.
Patients with other visits are not displayed on the graph. Other visits included causes where a visit could not be identified as any of the prespecified categories of visit.
AE, adverse event; CS, corticosteroid(s); D, days; ED, emergency department; HCRU, health care resource utilization; PPPY, per patient per year