Treatment with the tumor necrosis factor (TNF) inhibitor etanercept (Enbrel) was safe and provided steroid-sparing effects in patients with dermatomyositis, a small pilot study found.
Among 11 patients randomized to receive etanercept, five were able to gradually stop taking prednisone, whereas none of the five patients receiving placebo were able to taper their steroid and thus were classified as treatment failures, according to Anthony Amato, MD, from Brigham and Women's Hospital in Boston, and colleagues.
The median time to treatment failure in the placebo group was 148 days, while the time to failure in the etanercept group was 358 days (P=0.0002), Amato and colleagues reported online in the Annals of Neurology.
Treatment for the inflammatory myopathy dermatomyositis has been inadequate, with many patients experiencing severe weakness even when given prednisone, the first-line treatment, and second-line agents such as methotrexate.
In addition, long-term use of prednisone is associated with significant adverse effects.
Because the cytokine TNF is thought to contribute to the pathogenesis of this disease, as it does in other autoimmune diseases, some investigators have tried using the TNF inhibitors in refractory patients, but results have been contradictory.
To more formally explore the possibility of this potential treatment, Amato's group enrolled 16 patients with new or refractory dermatomyositis. Patients' mean age was 44, and at baseline most were on prednisone, 40 mg to 45 mg per day.