Low dose, add-on prednisolone in patients with rheumatoid arthritis aged 65+: the pragmatic randomised, double-blind placebo-controlled GLORIA trial
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  • Published on:
    Are chronic glucocorticoids truly safe in older patients with rheumatoid arthritis?
    • Giovanni Adami, Rheumatologist Rheumatology Unit, Department of Medicine, University of Verona, Verona, Italy
    • Other Contributors:
      • Angelo Fassio, Rheumatologist
      • Maurizio Rossini, Rheumatologist
      • Davide Bertelle, Rheumatologist
      • Davide Gatti, Rheumatologist

    Dear Editor,
    We read with great interest the article by Boers and colleagues [1]. The GLORIA trial is one-of-a-kind study and certainly represents a milestone for rheumatoid arthritis (RA) treatment in seniors. The overall message conveyed by the investigators is that glucocorticoids (GCs) at a dose of 5 mg/day is somehow safe and effective (at least for 2-years) in older patients with RA. However, we have some concerns regarding the latter claim and several questions for the authors.
    First, mean time on study drug was 19 months and only 60% completed the study. The authors stated that “the high rates of events in both groups over the observation period make it unlikely that the risk estimate would be substantially different in a more complete data set”. We somehow disagree. Fracture risk in glucocorticoid induced osteoporosis (GIOP) strictly depends on the treatment duration [2]. In addition, fracture risk remains elevated even after 1 year from GCs withdrawal [3], with possible long-term effects that were not captured by the GLORIA trial.
    Second, “over 2 years, spine bone density decreased by about 1% in prednisolone, but increased by 3% in placebo patients”. We frankly think that this difference might be relevant to many patients. BMD increases (in similar magnitude of the placebo group of the GLORIA trial) have been associated with significantly lower incidence of fracture in both clinical trials and observational studies [4,5]. Remarkably, a 2% perce...

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    Conflict of Interest:
    Giovanni Adami reports personal fees from Theramex, UCB, Lilly, Galapagos, Fresenius Kabi, Amgen. Davide Gatti has received advisory board honoraria, consultancy fees and/or speaker fees from Abiogen, Celgene, Eli-Lilly, Neopharmed-Gentili, Pfizer, UCB. Maurizio Rossini reports advisory board honoraria, consultancy fees and/or speaker fees from AbbVie, Abiogen, Amgen, BMS, Eli-Lilly, Galapagos, Theramex, UCB, outside the submitted work. Angelo Fassio reports personal fees from Abiogen, Novartis, Neopharmed.
  • Published on:
    The unbearable lightness of low-dose glucocorticoid therapy for rheumatoid arthritis
    • Alessandro Giollo, Consultant in Rheumatology Rheumatology Unit, Department of Medicine, University of Padua, Italy
    • Other Contributors:
      • Margherita Zen, Researcher
      • Andrea Doria, Full Professor of Rheumatology

    Glucocorticoid (GC) therapy is still the mainstay in managing rheumatoid arthritis (RA). The benefits of low-dose GC therapy are well established after decades of clinical experience in RA. Yet, it is essential to appoint the danger of exposure to chronic GC therapy.
    For many patients with RA and other inflammatory rheumatic musculoskeletal diseases (RMD), starting prednisolone means taking glucocorticoids for several years or decades, often indefinitely.1 The long-term complications of GC therapy are rarely emphasised by most clinical trials that usually run for only 1 or 2 years. In this regard, the GLORIA trial2 has illuminated both the harms and benefits of 2-year low-dose (5 mg daily) prednisolone in 451 elderly patients (≥65 years) with moderately active established RA. Indeed, there was an 11% increase in patients with at least one adverse event (AE) of special interest (mainly mild to moderate infections) in the prednisolone arm, accounting for a 1.24 (95% CL 0.4) fold higher risk compared to placebo, just within two years of treatment.2
    The likelihood of major osteoporotic fractures in GC users increases with the dosage, but more importantly, with the cumulative dose and duration of GC therapy.3 Moreover, low-dose GC therapy (≤5 mg/day) did not seem to be associated with a reduction of bone mineral density (BMD) in patients with inflammatory RMD and current or prior exposure to GC.4 However, while GC therapy effectively alleviates inflammation, it has...

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    Conflict of Interest:
    None declared.