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Corticosteroid exposure associated with hospitalization for severe pain event among patients with sickle cell disease

People with sickle cell disease (SCD) who were recently prescribed a corticosteroid – a medicine frequently used to treat asthma or inflammation – were found to be significantly more likely to be hospitalized for a severe pain event, according to a paper published today in the journal Blood. The research also found that older adults, women, and people who were not taking the drug hydroxyurea to manage their underlying SCD symptoms were the most likely to be hospitalized.

SCD is the most common inherited red blood cell disorder in the United States, affecting an estimated 100,000 people. According to the Centers for Disease Control and Prevention (CDC), SCD affects one out of every 365 Black or African American births and one out of every 16,300 Hispanic American births. Pain events, also known as vaso-occlusive episodes (VOE), are the most common complications of SCD and can result in intense pain and potentially irreversible organ damage.

Apart from case reports, researchers say this is the first study to systematically evaluate the association between corticosteroid exposure and hospitalization for VOE.

Individuals living with SCD often suffer crippling episodes of pain, which can greatly impair their quality of life. Based on our data, corticosteroids are commonly prescribed for conditions unrelated to their underlying SCD. Vaso-occlusive events and related hospitalization appear to follow corticosteroid prescription fairly quickly. This evidence suggests corticosteroids may be contributing to the events and should be avoided as much as possible in these patients.”

Ondine Walter, MD, Study Author, Toulouse University Hospital in France

Notably, the median time between filling a prescription for a corticosteroid and hospitalization was just five days. Also striking was the fact that nearly half (46%) of patients with SCD had been prescribed at least one systemic corticosteroid during the study period. Dr. Walter said the results underscore the need for widespread education of clinicians and patients alike about the potential risks of using corticosteroids, especially when there isn’t a clear indication to use them.

“Corticosteroids are mostly easy to avoid, and in circumstances when they are necessary, it’s important to start them in collaboration with an SCD expert and to take all appropriate precautionary measures to administer them safely,” said Dr. Walter.

The study used data from a total of 5,151 patients with SCD drawn from the French National Health Insurance Database between 2010 and 2018. Patients had to have at least one hospitalization for VOE to be included, and corticosteroid exposure was identified using outpatient prescribing records.

The study found that those who had exposure to a corticosteroid – defined in the month leading up to the event – were significantly more likely to be hospitalized for VOE. People who were also taking hydroxyurea seem to have less risk of hospitalization compared with those not taking the drug, which may signal a potential protective effect of hydroxyurea on the occurrence of VOE, Dr. Walter explained. Hydroxyurea is often prescribed to reduce the number of pain events caused by SCD as well as the need for blood transfusions. The risk of admission was also lower in men compared to women and in children compared to adults.

“Some factors such as hydroxyurea use, male gender, and younger age were associated with a lower risk of hospitalization for VOE after corticosteroid exposure in our study. Still, based on these results, we still need to think twice about using corticosteroids when treating patients with SCD,” said Dr. Walter.

This study is limited in that it can only show an association between corticosteroids and VOE-related hospitalizations and not prove causation. Because corticosteroid exposure was based on dispensing data, it is also not possible to confirm that patients took the medicine, only that the prescription was filled.

With future research, investigators aim to understand how corticosteroids may prompt VOE. Studies have shown that the cessation of corticosteroids, in particular, has been associated with rebound pain. ASH’s Clinical Practice Guidelines on SCD recommend against using corticosteroids for acute pain management in patients with SCD. This study adds important data about the association of corticosteroid use with subsequent VOE to a growing body of evidence that suggests corticosteroids should be used only when needed, and under the guidance of an SCD expert.

Source:

American Society of Hematology

Journal reference:

Walter, O., et al. (2022) Risk of vaso-occlusive episode after exposure to corticosteroids in patients with sickle cell disease. Blood. doi.org/10.1182/blood.2021014473.

Clinical, Economic Burden of Corneal Adverse Events in MM Is Low Compared With Total All-Cause Costs

Researchers concluded that incident corneal adverse events in patients with multiple myeloma (MM) carry a low clinical and economic burden compared with total all-cause costs and MM-related per-patient-per-month costs.

Although corneal adverse events (AEs) were observed in about 12% of patients with multiple myeloma (MM) treated with anticancer therapies, the clinical and economic burden of treating corneal AEs was low compared with total all-cause or MM-related per-patient-per-month (PPPM) costs, investigators concluded.

“As the current treatment landscape includes newer treatments, better understanding of these targeted treatments and their level of resource utilization is important. Therefore, further research and real-world evidence are warranted to assess the relationship between corneal AEs and MM treatment and to explore costs associated with specific treatments,” the investigators wrote.

In addition, the real-world retrospective cohort study, published in the Journal of Medical Economics, found that the majority of incident corneal AEs reported were mostly treated in outpatient care centers by ophthalmologists rather than by a hematologist or oncologist.

With increased use of novel anticancer therapies, adverse effects on patients’ eyes have become more common. However, given the novelty of many of these agents, oncologists may not be very familiar with the potential ophthalmologic AEs associated with targeted anticancer therapies. Knowing that AEs can affect patient quality of life and increase economic burden on the health care system, there remains a need to assess the incidence and extent of the burden of managing corneal AEs and related symptoms among patients receiving MM therapies.

The investigators collected information from the IQVIA PharMetrics Plus database, which contains adjudicated health insurance claims data from US commercial insurance plans. The evaluation period lasted between January 1, 2011, and December 31, 2017. Adults with newly diagnosed MM and adults with lymphatic or hematopoietic malignant neoplasm were included in the analysis. The index period, defined as the date that a patient first received a novel MM therapy, was from January 1, 2012, to December 31, 2016.

Within the index period, 2120 patients with MM and 26,923 patients with hematologic malignant neoplasm were identified and enrolled into the MM cohort and the hematology cohort.

Among the MM cohort, 248 (11.7%) patients had at least 1 incident of corneal AEs after initial onset of MM therapy. Also, 7.4% of the hematology cohort experienced at least 1 corneal AE after therapy onset. The most commonly reported corneal AEs in the MM cohort were dry eye (6.1%), keratopathy or keratitis (2.5%), blurred vision or decreased acuity (3.4%), and photophobia (0.2%).

For the patients with MM who reported a corneal AE, the overall median PPPM cost for a corneal AE was $27, representing less than 1% of the median all-cause costs during the follow-up period. The median total all-cause PPPM cost was $17,286 and the median MM-related PPPM cost was $13,851. The investigators noted that the costs were primarily driven by outpatient care, as most of the patients visited an outpatient facility for their AEs.

Emergency department visits, which cost a median PPPM of $66, and hospitalizations, which cost a median PPPM of $16, were rate. Reports for blurred vision and decreased acuity were associated with the highest PPPM cost compared with other corneal AEs, costing a median PPPM of $41.

The use of a 12-month washout period to identify newly treated patients, lack of generalizability to the general MM population or to patients with MM older than 65 years who are enrolled in Medicare, and lack of information on comorbidities were listed as study limitations. Additionally, there may be a potential underreporting of corneal AEs because older patients have a higher risk of dry eye syndrome.

Reference

Wang F, Sansbury L, Ferrante S, et al. Incidence of corneal adverse events in patients with multiple myeloma and their clinical and economic impact: a real-world retrospective cohort study. J Med Econ. 2022:25(1):182-192. doi:10.1080/13696998.2022.2029088