Also, the study found, a small percentage of these patients are receiving biological therapies (those using compounds derived from living organisms), despite not being approved in the U.S. for the treatment of sarcoidosis.
The study, “Treatment of Sarcoidosis in U.S. Rheumatology Practices: Data from ACR’s Rheumatology Informatics System for Effectiveness (RISE) Registry,” was published in the journal Arthritis Care Research.
There are several treatment options available for sarcoidosis, including corticosteroids and non-steroid therapies. The latter comprise disease-modifying anti-rheumatic drugs (DMARDs), which can be conventional (cDMARDs), biological (such as tumor necrosis factor inhibitors or TNFi) and targeted synthetic (tsDMARDs).
However, treatment for sarcoidosis is not currently standardized due to the high variability of the disease and to the lack of non-steroid therapies approved by the U.S. Food and Drug Administration (FDA).
In fact, the number of biological therapies prescribed to people with sarcoidosis in the U.S. has never been explored. Since there is no clear notion of the medications used by this patient population, there are areas for which therapeutic needs are still unidentified.
To address these issues, a team led by researchers at the University of California San Francisco reported all treatments prescribed in a sarcoidosis patient cohort — the Rheumatology Informatics System for Effectiveness (RISE) registry — and evaluated the differences in prescriptions across several healthcare services.
The “RISE registry represents an estimated 32% of the U.S. clinical rheumatology workforce,” the researchers wrote.
A total of 3,276 sarcoidosis patients, age 18 or older (mean age 59.1 years) were included in the study. The team analyzed all therapies prescribed in 184 healthcare services, particularly systemic corticosteroids, cDMARDs, biologic DMARDs (including TNFi and non-TNF-i) and tsDMARDs.
Results showed that corticosteroids, including prednisone and other oral and intravenous steroids, were prescribed to 59.3% of patients. Of these, a quarter (24.7%) received prolonged therapy (daily 10 mg or greater for at least 90 days) and 18.2% received monotherapy (without any DMARDs).
Recent guidelines suggest that a daily dose of prednisone of 10 mg daily is quite far from the optimal dose and is associated with significant side effects.
Therefore, “the finding that a quarter of patients exceed this dose for a prolonged period highlights the need for additional and more effective therapies to be developed in this disease,” the team wrote.
Researchers also found that about 12.1% of the patients were prescribed one or more biologic or tsDMARD, with TNFi being prescribed most (10.9%).
This result is slightly higher than previously reported “perhaps because patients had more musculoskeletal complaints or because they were all seen by rheumatologists, who were comfortable prescribing these drugs,” researchers wrote.
Regarding the type of healthcare services, among high-volume healthcare practices (with 30 or more sarcoidosis patients) there was a wide variation in the use of biologics — ranging from 15.6% to 69.2% of patients. Infliximab was the most common prescribed biologic (zero to 40% of patients).
Likewise, non-TNF biologics were used by zero to 50% of patients, again showing a wide variation in their prescription.
According to the researchers, this variation might be explained by several factors such as race, insurance status, disease manifestations or severity, or even clinicians’ preferences.
Since sarcoidosis is a rare disease, patients may seek healthcare professionals from different fields, including neurology, dermatology, pulmonology and rheumatology. Thus, the treatments adopted by these specialists may be quite variable, even among those with the same specialty.
“We found wide variations in the patterns of biologic therapies used by U.S. rheumatologists to treat sarcoidosis, likely reflecting the lack of standardized treatment recommendations for this disease,” the team wrote.
Researchers emphasized the need for further clinical studies evaluating the effectiveness and safety of biological therapies in people with sarcoidosis.
“We found a significant number of patients were receiving chronic glucocorticoids [corticosteroids] and a clinically important fraction were receiving biologics. With no FDA-approved drugs available for extrapulmonary sarcoidosis, our findings highlight the need for a greater focus on developing standardized treatments for patients with this disease,” researchers concluded.
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