Evaluation of apremilast, an oral phosphodiesterase 4 inhibitor, for refractory cutaneous dermatomyositis: A phase 1b clinical trial
The Journal of Dermatology Oct 07, 2021
Konishi R, Tanaka R, Inoue S, et al. - Because apremilast was effective in patients with refractory and recurrent dermatomyositis-associated cutaneous manifestations in this first phase Ib study with expected and recoverable digestive adverse events (diarrhea), it can be suggested as a possible treatment when aggressive immunosuppressive therapies with high-dose systemic corticosteroid and/or immunosuppressive agents for other manifestations, myositis, and interstitial lung disease have failed.
In total, five Japanese patients (one male and four females, median [range] age, 64 [37–71] years) with refractory dermatomyositis-associated cutaneous manifestations were selected and treated with a 12-week course of oral apremilast.
Three of the five enrolled patients experienced diarrhea while taking full-dose apremilast (30 mg twice daily), two of whom withdrew from the study and recovered quickly.
Apremilast was given to three evaluable female patients (median [range] age, 65 [64–71] years) for 12 weeks.
At week 12, all three patients had a 39.4% reduction from their baseline Cutaneous Dermatomyositis Disease Area and Severity Index total activity score, but not the damage score.
In one and two apremilast-treated patients, the visual analog scale of itching and quality of life as measured by the Dermatology Life Quality Index improved slightly.
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