A multidisciplinary EULAR task force has developed for the first time recommendations for the management of medium- to high-dose systemic glucocorticoid therapy in rheumatic diseases at the annual European Congress of Rheumatology.
"High doses are very important because systemic glucocorticoids work rapidly and are most effective, but there is very little known about adverse events and incidence," said Dr. Nurten Duru said in an interview. "There are many studies; however, the adverse events are not systematically assessed. The studies have not focused on the adverse events; they have involved investigation of efficacy."
"We expect to see adverse events at high doses but the question is how to handle these, and how to take the co-morbidities into consideration. This is difficult without data. The best we have is expert opinion and they advise vigilance for these adverse events."
The recommendations focus on patient education and informing general practitioners, preventive measures for osteoporosis, optimal glucocorticoid (GC) starting dosages, risk-benefit ratio of GC treatment, GC sparing therapy, screening for co morbidity, and monitoring for adverse events, according to Dr. Duru, a rheumatologist at University Medical Center Utrecht, the Netherlands.
To develop the recommendations the task force conducted a systematic literature search of PubMed, EMBASE, and the Cochrane Library, and the strength of recommendations was given according to available evidence, clinical expertise and patient preference. However, "robust evidence was often lacking and items in need for further research were defined," the task force noted.
The task force comprised eight rheumatologists, one endocrinologist, one rheumatologist/epidemiologist, four patients, and two research fellows from seven European countries. "Each participant contributed 10 propositions describing key clinical points concerning the safe use of medium to high dose GCs. The final recommendations were developed using a Delphi consensus approach and the wording was improved by a native speaker," according to the task force.
"In this EULAR task force patients participated. The most important issue from the patient point of view was their concern with side effects such as alopecia," she said.
Dr. Duru said the next steps maybe developing a patient-friendly version of the recommendations in different languages, or a website where physicians could search for information about glucocorticoids.
The recommendations – in three different categories – are as follows:
Education and prevention
• Explain to patients (and their family and/or caregivers, including general practitioners) the aim of medium-/high-dose GC treatment and the potential risks associated with such therapy.
• Discuss measures to mitigate such risks, including diet, regular exercise, and awareness of wounds.
• Dispense appropriate preventive/therapeutic interventions to patients with or at risk of GC-induced osteoporosis.
• Present appropriate, practical advice to patients and the patients’ treatment teams on how to manage with GC-induced hypothalamic-pituitary-adrenal axis suppression.
• Provide an accessible resource to promote best practice in the use of medium/high dose GCs to general practitioners.
Dosing/risk-benefit
• Consider comorbidities that might predispose patients to adverse effects before starting them on medium-/high dose GC treatment; these include diabetes, glucose intolerance, cardiovascular disease, peptic ulcer disease, chronic infections, severe immunosuppression, (risk factors of) glaucoma, and osteoporosis. Patients with these comorbidities require especially tight control of dosages to manage the risk/benefit ratio.
• Select the appropriate starting dose as the (expected) minimum required to achieve therapeutic response.
• Keep the requirement for continuing on GC treatment under constant review and titrate the dose against therapeutic response and any developing adverse effects.
Monitoring
• Regularly monitor all patients for frequent, clinically significant adverse effects. The minimum set of items to monitor includes diabetes, hypertension, dyslipidemia, weight gain, edema, osteoporosis, (hidden) infections, osteonecrosis, myopathy, eye problems, skin problems, and neuropsychological adverse effects.
The recommendation rejected by the task force is as follows:
• Actively consider GC sparing therapy if long-term medium-/high-dose GC therapy is anticipated to be necessary.
Dr. Duru reported that she has no relevant conflicts of interest.