Juvenile Dermatomyositis Responds Best to Methotrexate and Prednisone Save

Lancet reports the results of a randomized controlled trial comparing prednisone alone to prednisone combined with either methotrexate (MTX) or cyclosporine (CyA) in new-onset juvenile dermatomyositis (JDM).

This multinational, multicenter trial enrolled 139 treatment-naive JDM patients randomized to receive open-label prednisone alone or in combination with either CyA or MTX. The primary outcomes included the JDM PRINTO 20 level of improvement (20% improvement in three of six core set variables at 6 months), time to clinical remission, and time to treatment failure. Patients were enrolled over a 4 year period (2006-2010) and had a median duration of follow-up was 35 months.

After 6 months the JDM PRINTO 20 response was achieved in 51% of prednisone, 70% of Pred + CyA, and 72% of Pred + MTX (p=0·0228). Pred + MTX showed a superior time to clinical remission was (41·9 mos) and combination therapy with either MTX or CyA had a shorter time to prednisone discontinuation (29 vs 36 mos) compared to prednisone alone. Treatment failures were seen earlier and more frequently with prednisone alone. Although Pred + CyA and Pred + MTX showed similar and superior efficacy, significantly more adverse events were seen in those children receiving Pred + CyA (including skin, GI and infectious adverse events). No patients died during the study.

Combining prednisone with either CyA or MTX yielded the best efficacy, but the safety profile and steroid-sparing effect favored the combination of Pred + MTX.