Surveys of more than 1,000 Italian patients and clinicians uncover why oral steroid use remains widespread in asthma care, revealing gaps in guideline adherence, patient education, and access to advanced biologic therapies.
Study: Use of oral corticosteroids in patients with asthma: how far is clinical practice from the guidelines? Results from surveys of patients and doctors. Image credit: zlikovec/Shutterstock.com
A recent Frontiers in Allergy study examined usage patterns and barriers to adherence to oral corticosteroid (OCS) treatment guidelines for asthma in Italy. To do so, surveys were conducted with healthcare professionals (HCPs) and patients.
The management of asthma using oral corticosteroids
Asthma affects an estimated 262 million people worldwide, with the highest incidence seen in children under nine. Globally, its prevalence has increased by about 15% between 1990 and 2019. In Italy alone, around 4 million people live with asthma, including approximately 200,000 with severe asthma (SA), a group that represents a substantial burden on healthcare resources and costs.
The management of SA often requires the use of long-acting β2-agonists (LABAs), inhaled corticosteroids (ICS), and long-acting muscarinic antagonists (LAMAs). Existing guidelines recommend the use of OCS only as a last option due to severe adverse effects, such as growth impairment in children and iatrogenic adrenal insufficiency. Despite this, OCS medications are commonly prescribed in asthma treatment. However, patients have their concerns, and research shows that about 44% of adults report worries about OCS use, sometimes leading them to reduce or discontinue treatment without medical supervision by HCPs. Therefore, a gap exists between clinical practice and guidelines, which needs to be examined.
About the study
To address the knowledge gap between guidelines and clinical practice concerning asthma treatment, the Respiriamo Insieme Association in Italy, in collaboration with Sanofi, conducted two surveys among HCPs (survey 1) and patients (survey 2). The current study documents the results of these surveys, which aim to reduce OCS dependence and enhance the quality of life of SA patients.
Survey 1 comprised seven closed-ended questions (six multiple-choice and one rating scale) and gathered insights into the OCS prescribing practices, barriers to proper use, potential overuse patterns, and adherence to current guidelines. Survey 2 explored patients’ perspectives on awareness and involvement in treatment decisions, usage patterns, treatment adjustment and monitoring, education provided by HCPs, management of adverse events (AEs), and safety practices concerning OCS use.
Study findings
A total of 366 HCPs completed the survey, and 82% preferred a 10-day OCS treatment duration. A duration of more than 21 days was preferred by 14% of HCPs, and the remaining opted for longer treatment durations. Ninety-nine percent of HCPs said that either more than 6 months of OCS use per year or 2 or 3 cycles per year was necessary to classify a patient as OCS-dependent. The remaining 1% thought a single cycle was enough. Concerning the annual cumulative corticosteroid use, 28% reported never keeping track of the total OCS dose for their patients, 40% reported doing this, 24% did this occasionally, and the remaining 8% based their calculations on prescribed OCS doses.
Twenty-seven percent of HCPs thought the maximum safe daily dose was 7.5 mg/day, while 43% put this at 5 mg/day. Twelve and 18% thought the safe limits were 2 mg/day and 10 mg/day, respectively. Regarding strategies to minimize the OCS dose in managing SA, 43% responded that changing the ICS/LABA combination was the most effective. This was closely followed by using biologic therapies (37%). More than half of the HCPs thought that a multidisciplinary approach is crucial to prevent adverse effects of OCS, and about 44% recommended monitoring visits for bone densitometry every two years.
Overall, patients and their families/caregivers completed 829 questionnaires, of which 468 belonged to patients with SA. Only two-thirds of patients with non-SA were prescribed OCS, compared with 95% of patients with SA. Around 47% of SA patients used OCS more than once, for at least two cycles per year, compared with 27% of non-SA patients. Overall, 13% of SA and 14% of non-SA patients reported having ceased OCS use. Forty-seven percent of SA patients and 24% of non-SA patients used OCS once a year or more without a valid prescription. Forty percent of SA and 31% of non-SA patients did not taper the dose when stopping, while 52% and 33% of SA and non-SA patients did, respectively.
In about 71% of SA patients, the physician involved them in the decision to take OCS, compared to 43% for non-SA patients. Physicians did not inform 45% of non-SA and 49% of SA patients about the possible alternatives to OCS, respectively. Concerning the long-term strategy, inhaler medications were common in the non-SA group, while biologics were most common in the SA group.
Twenty-two percent of non-SA patients reported being informed about adverse reactions, whereas 35% reported never being informed. Among the SA patients, 41% were informed about potential side effects, while 57% reported not being referred to a specialist. Most patients did not receive a bone health assessment. The study also found that about 40% of patients self-administered OCS at least once per year without a prescription, often due to fear of exacerbations or difficulty accessing healthcare. This reflects the ease of access to OCS without a prescription in Italy. A much higher proportion of SA patients acquired OCS without a valid prescription, relative to non-SA patients.
Conclusions
The findings show a significant discrepancy between guideline recommendations and clinical practice, and OCS use remains very high in Italy. Reducing unnecessary OCS use through biologic therapies could also help lower healthcare costs.
Several unmet needs and proposed systemic reforms: establishing a clearer and pragmatic definition of “OCS dependency,” improving patient education and shared decision-making, increasing access to multidisciplinary care (including psychological support), and using digital or diary-based monitoring tools to track OCS adherence and side effects.
A key limitation of the study was the inability to distinguish between respondents from pediatric and adult care settings. This may have led to misinterpretation of notable differences in OCS use between adults and children. Secondly, the study's cross-sectional nature exposes it to response bias, inaccurate self-reporting, and recall bias. Finally, the results may not be generalizable to other populations as the study was conducted on a selected set of Italian HCPs and patients.
The study underscores the persistence of high OCS use despite guideline recommendations, highlighting the need for coordinated education, standardized monitoring, and integrated psychological and specialist care to reduce unnecessary OCS exposure in severe asthma management.
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