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Findings showed high-dose, intensive steroid treatment was linked with both short- and long-term adverse events in patients with immune thrombocytopenia.

High-dose, intensive steroid use was linked with increased rates of acute and chronic AEs in patients with primary immune thrombocytopenia, according to findings recently published in the British Journal of Haematology.

“The purpose of this research was to investigate the association between steroid use patterns and the risk for AEs in patients with primary immune thrombocytopenia,” study author Yi-Ming Chen, MD, PhD, told Physician’s Weekly. “This was important to research because steroids are a common first-line treatment for immune thrombocytopenia, but there are concerns about potential overuse and adverse effects. Understanding the relationship between steroid dose/intensity and AEs can help optimize treatment.”

Steroids in Thrombocytopenia

The researchers performed a population-based study using the National Health Insurance Research Database in Taiwan. The investigators identified 2,691 adults newly diagnosed with primary immune thrombocytopenia between 2011 and 2018.

The index date was the date of first-time steroid use. Dr. Chen and colleagues calculated post-index steroid use for 90 days after the start of treatment. The researchers categorized patients as receiving either high or low daily doses (less than 10 mg vs 10 mg or more) and categorized steroid treatment as either high- or low-intensity (medication possession ratio of less than 80% vs 80% or more).

The investigators followed patients for up to one year to observe acute AEs, then identified chronic AEs by the end of 2019 or time of death.

Patients were eligible for the study if they were 18 years of age or older and required to have at least two platelet tests indicating immune thrombocytopenia within three months of the initial diagnosis and three months after diagnosis. The patients were mostly women (65%) and an average age of 56.5 years. Overall, patients were treated with a prednisolone-equivalent mean dose of 39 mg per day, whereas the average intensity of treatment was a medication possession ratio of 51%.

Steroid Use and AEs

“The main questions we wanted to address were: How do different patterns of steroid use (considering both dose and intensity) affect the risk for acute and chronic AEs in ITP? Is there a joint effect of steroid dose and intensity on AE risk? How does cumulative steroid exposure impact chronic AEs?” Dr. Chen says.

The researchers reported a total of 2,370 acute AEs and 1,208 chronic AEs. Infectious disease was the most common acute AE (incidence rate: 869.18 per 1,000 person-years), whereas the most common chronic AEs were cardiovascular disorders (incidence rate: 80.05 per 1,000 person-years).

Patients who received treatment with both a high dose and high intensity faced an increased risk for acute AEs (adjusted incidence rate ratio [aIRR], 1.57, 95% CI, 1.38-1.78; P<0.01). The same was true of chronic AEs (aIRR, 1.26; 95% CI, 1.08-1.47; P<0.01).

The AEs most strongly correlated with high-dose, high-intensity steroid use were metabolic/endocrine disorders such as diabetes, gout and hyperuricemia, and ophthalmologic disorders such as glaucoma and cataracts.

“High-dose, high-intensity steroid use was associated with higher risk for both acute AEs (57% increased risk) and chronic AEs (26% increased risk) compared to low-dose, low-intensity use,” Dr. Chen says. “We also observed a cumulative dose effect, with higher cumulative steroid exposure associated with increased risk for chronic AEs.”

Clinical Implications

The researchers concluded that clinicians should keep a close eye on steroid use and its associated effects and consider other types of drugs to treat immune thrombocytopenia.

“Steroids should be used cautiously in ITP treatment, especially at high doses and intensities,” Dr. Chen says. “Clinicians should closely monitor for acute (metabolic/endocrine, GI/hepatobiliary, infection) and chronic (musculoskeletal, ophthalmologic, cardiovascular, neuropsychiatric, metabolic/endocrine) AEs in patients on steroids.”