Defining conditions where long-term glucocorticoid treatment has an acceptably low level of harm to facilitate implementation of existing recommendations: viewpoints from an EULAR task force

Abstract

There is convincing evidence for the known and unambiguously accepted beneficial effects of glucocorticoids at low dosages. However, the implementation of existing recommendations and guidelines on the management of glucocorticoid therapy in rheumatic diseases is lagging behind. As a first step to improve implementation, we aimed at defining conditions under which long-term glucocorticoid therapy may have an acceptably low level of harm. A multidisciplinary European League Against Rheumatism task force group of experts including patients with rheumatic diseases was assembled. After a systematic literature search, breakout groups critically reviewed the evidence on the four most worrisome adverse effects of glucocorticoid therapy (osteoporosis, hyperglycaemia/diabetes mellitus, cardiovascular diseases and infections) and presented their results to the other group members following a structured questionnaire for final discussion and consensus finding. Robust evidence on the risk of harm of long-term glucocorticoid therapy was often lacking since relevant study results were often either missing, contradictory or carried a high risk of bias. The group agreed that the risk of harm is low for the majority of patients at long-term dosages of ≤5 mg prednisone equivalent per day, whereas at dosages of>10 mg/day the risk of harm is elevated. At dosages between >5 and ≤10 mg/day, patient-specific characteristics (protective and risk factors) determine the risk of harm. The level of harm of glucocorticoids depends on both dose and patient-specific parameters. General and glucocorticoid-associated risk factors and protective factors such as a healthy lifestyle should be taken into account when evaluating the actual and future risk.

Seven-year tolerability profile of glucocorticoids use in early rheumatoid arthritis: data from the ESPOIR cohort

“…However, the GC risk/benefit balance has little evidence base, with most recent data provided by observational studies. These studies provide the opportunity to explore the real-life tolerability profile of GC, with doses and duration commonly used in daily practice, but often present bias such as confounding by indication 20. As well, the evidence from randomised clinical trials is scarce 11 23…”

The 2016 Eular Guidelines for the Diagnosis and Treatment of Early Arthritis

“…Обращается особое внимание на риск НР (инфекционных осложнений и кардиоваску-лярной патологии, увеличения массы тела, артериальной гипертензии, диабета, катаракты, остеопороза), который нарастает при достижении высокой кумулятивной дозы ГК и их длительном приеме [83][84][85][86][87][88][89][90][91].…”

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“…This increased fracture risk occurs at low dosages ~5mg Prednisolone daily and even with cessation of steroids, bone quality does not return to baseline [12]. That being said current European League against Rheumatism (EULAR) guidelines suggest that the risk of harm is low ≤5 mg prednisone equivalent per day while doses between 5-10mg dependent on patient specific factors [13].…”