Glucocorticoids for Early Rheumatoid Arthritis: Assessing Long-term Safety
The primary safety end point was composite death, cardiovascular disease, severe infection and fracture.
Patients with early rheumatoid arthritis (RA) treated with very low-dose glucocorticoids over 7 years experienced similar toxicity as patients who were not treated with glucocorticoids, according to a study published in the Annals of the Rheumatic Diseases.1
Although glucocorticoids are frequently prescribed in patients with early RA, their long-term use is controversial. Glucocorticoids provide relief of symptoms and delay or prevent structural damage, but their benefits may be outweighed by the risk of adverse events that increases with length of exposure and dose. However, data on the safety of glucocorticoid use are limited.
Researchers examined the long-term safety of glucocorticoid use in patients with early RA, defined as disease duration <6 months, from the multicenter observational Etude et Suivi des POlyarthrites Indifférenciées Récentes (ESPOIR) cohort. The primary safety end point was composite death, cardiovascular disease (myocardial ischemia, stroke, and heart failure), severe infection and fracture.
Of 602 patients, 386 were treated with low-dose prednisone (mean dose 3.1 mg/day) for the entire duration of the follow-up period (median 7 years), and 216 did not receive glucocorticoids during the course of follow-up.
Patients with glucocorticoid treatment had higher disease activity — as measured by Disease Activity Score in 28 joints (DAS-28), C-reactive protein (CRP) level, and Health Assessment Questionnaire (HAQ score) — than patients without glucocorticoid treatment.
The higher disease activity in the glucocorticoid group may have manifested in the more frequent use of nonsteroidal anti-inflammatory drugs (NSAIDs), disease-modifying antirheumatic drugs (DMARDs), and biological agents in this group.
A total of 65 adverse events occurred, with similar event rates in the glucocorticoid and no glucocorticoid groups (11.4% vs 9.7%; P =.52).
Rates of severe infection were higher in patients receiving glucocorticoids than in patients not receiving glucocorticoids, but this difference did not reach statistical significance (4.1% vs 1.4%; P =.09).
Summary and Clinical Applicability
Glucocorticoids are commonly prescribed to treat early RA, but their use remains controversial given concerns about long-term safety. In an observational study, researchers demonstrated that the safety profile of glucocorticoids over 7 years is comparable to that of treatment regimens that do not use glucocorticoids.
“Although our findings need further confirmation, they strongly support the current recommendations that [glucocorticoids] should be used for early RA, with DMARDs, for the shortest period and at the lowest possible dose,” the researchers wrote.
- The results of this study may be subject to recall bias since adverse events were self-reported.
- The study may have been underpowered, given the small number of adverse events.
The ESPOIR cohort was supported by Merck Sharp and Dohme for 5 years, and the ESPOIR cohort study was funded by the French Society of Rheumatology, AbbVie, Pfizer, and Roche Chugai.
Roubille C, Rincheval N, Dougados M, et al. Seven-year tolerability profile of glucocorticoids use in early rheumatoid arthritis: data from the ESPOIR cohort [published online February 17, 2017] Ann Rheum Dis. doi:10.1136/annrheumdis-2016-210135