We read with great interest the article by Mazlumzadeh M et al addressing the effectiveness and safety of induction therapy with high-dose pulse intravenous methylprednisolone in giant cell arteritis (GCA) (1). The results of that trial provide a rationale for the use of this treatment approach, which allows for more rapid tapering of the glucocorticoid dosage while at the same time enabling patients to experience sustained remission.
This study is notable given the small number of interventional trials in GCA and given that patients with this condition are usually elderly and therefore prone to comorbid conditions which can be triggered by treatment itself. However, some concerns arise for us after reading this article.
First, disease relapses occurred more frequently among patients in the placebo arm and in most of them (54 of 58 events) occurred along with increments in levels of acutephase reactants. However, upon longitudinal monitoring of acute-phase reactant levels, no differences between treatment groups were found in the curves for either erythrocyte sedimentation rates or C-reactive protein levels. Second, patients in the placebo arm did not have as great a degree of improvement as those in the active treatment arm of the study. However, and as stated by the authors, the glucocorticoid dosages used in the placebo arm were lower and tapered more quickly than is recommended in the medical literature (2). Finally, it is well recognized that GCA can be a rapidly devastating disease which can cause severe and sometimes irreversible complications in a matter of hours if not treated adequately (2). In Mazlumzadeh et al's study, during the interval from diagnosis to inclusion in the trial, some of the patients were treated with low-dose prednisone (Յ10 mg/day), for which there is no rationale. The last two points are inconsistent with standard medical practice in which GCA is usually treated with high doses of glucocorticoids, as well as with practices regarding research in human subjects in which it must be assured that patients receive the best treatment known for the specific entity (3,4).