Background/Purpose: Glucocorticoids (GC) are used to treat a wide range of inflammatory diseases including rheumatic and musculoskeletal diseases. EULAR recommendations on GC therapy are up to date but uncertainty about the benefit-risk ratio of GC persists. To address this issue, a multidisciplinary EULAR task force was assembled. Bearing in mind the known beneficial effects of GC, the primary aim was to achieve consensus when formulating conditions under which these drugs have an acceptable low level of harm, based on systematic evaluation of available evidence on adverse effects (AE).

Methods: Focussing on the four most worrisome AE of GC (cardiovascular disease (CVD), effects on bone, GC-induced hyperglycaemia & diabetes mellitus and infections), a systematic literature review was performed and discussed in the expert group. One breakout group per AE discussed the relevant evidence in detail and presented their results to the other group members following a structured questionnaire for final discussion. The questions addressed dose-harm relationships, relevant patient characteristics, co-morbidities, co-medications and both preventive and therapeutic measures with regard to the AE mentioned above.

Results:

The common basis for the group´s work was (i) an initial agreement with current guidelines stating there is convincing evidence for the beneficial effects of GC also at low dosages and (ii) the view that data on AE are limited (e.g. in terms of duration of GC use), sometimes both contradictory and biased. As a result of the critical appraisal of available evidence, the task force members agreed that for the majority of patients:

– at dosages of ≤5mg/dprednisone equivalent the benefits are greater than the risks with the exception of patients at high risk for CVD who may require preventive measures

– at dosages of >10mg/dthe risks are greater than the benefits, with the exception of patients with (partial) GC resistance

At dosages between >5 and ≤10mg/d, the level of harm depends on patient-specific characteristics such as disease activity, presence of additional risk factors, and preventive measures. In general, an early diagnosis, low disease activity, low cumulative GC dosage, healthy life style (including appropriate exercise) and both, monitoring and treatment of risk factors and co-morbidities, respectively, represent factors which reduce the risk of harm. For each AE of GC, specific factors can affect the risk and, therefore, the level of harm in both directions. Moreover, for some GC induced AE (i) specific patient groups are at higher risk, (ii) certain co-morbidities increase the risk and (iii) the genetic background and (iv) specific disease characteristics may have impact on the risk of harm. Thus, the level of harm varies between individuals, and consequently our consensus is valid for the majority of patients rather than every individual patient.

Conclusion: There is no absolute condition or conditions under which GC always have an acceptable low level of harm. However, based on currently available evidence, our consensus provides the rationale to accomplish a relatively safe use of GC in the majority of patients.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/defining-the-conditions-under-which-long-term-glucocorticoid-treatment-has-a-good-benefit-risk-ratio/