Objective To explore the 7-year tolerability profile of glucocorticoids (GC) for early rheumatoid arthritis (RA).
Methods We examined data for 602 patients with RA from the early arthritis Etude et Suivi des POlyarthrites Indifférenciées Récentes (ESPOIR) cohort (<6 months disease duration) stratified into two groups: with or without GC treatment at least once during follow-up (median 7 years (IQR 0.038–7.65)). The main outcome was a composite of death, cardiovascular disease (including myocardial ischaemia, cerebrovascular accident and heart failure), severe infection and fracture.
Results Among the 602 patients with RA (476 women (79%), mean age 48±12 years), 386 with GC (64.1%) received low-dose prednisone (mean 3.1±2.9 mg/day for the entire follow-up): 263 started GC during the first 6 months (68%), and the mean duration of total GC treatment was 1057±876 days. As compared with patients without GC (216 (35.9%)), those with GC showed greater use of non-steroidal anti-inflammatory drugs, synthetic and biological disease-modifying antirheumatic drugs and had more active disease disability, higher C reactive protein and anticitrullinated protein antibody levels. Among 65 events (7 deaths, 14 cardiovascular diseases, 19 severe infections and 25 fractures), 44 and 21 occurred in patients with and without GC (p=0.520). Infections were more frequent, although not significantly, in patients with than without GC (p=0.09). On weighted Cox proportional-hazards analysis, with use of propensity score and inverse-probability-of-treatment weighting, and including age, gender, history of hypertension and GC treatment, outcomes did not differ with and without GC (p=0.520; HR=0.889; 95% CI 0.620 to 1.273).
Conclusions This 7-year analysis of the ESPOIR cohort supports the good safety profile of very low-dose GC for early active RA.
- Rheumatoid Arthritis
- Early Rheumatoid Arthritis
- Outcomes research
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Handling editor Tore K Kvien
Contributors All authors participated in the conception and design of the study, contributed to the acquisition of data, participated in the analysis and interpretation of data and read, revised and approved the final manuscript. NR and JPD performed and are responsible for the statistical analyses.
Funding CR received a grant (2838) from the French Society of Rheumatology (SFR). The Etude et Suivi des POlyarthrites Indifférenciées Récentes (ESPOIR) cohort was supported by an unrestricted grant from Merck Sharp and Dohme for the first 5 years. Part of the biological database was supported by two additional grants from Institut National de la Santé et de la Recherche Médicale (INSERM), and the ESPOIR cohort study was also supported by the French Society of Rheumatology, AbbVie, Pfizer and Roche Chugai.
Competing interests None declared.
Ethics approval EC Montpellier University Hospital, France.
Provenance and peer review Not commissioned; externally peer reviewed.
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