According to the results of a phase IIa trial conducted in the United States in 8 adult patients with dermatomyositis with well-treated resistant skin lesions and a Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) greater than 14 :
- the addition of 2 tablets per day of apremilast (Otezla®) 30 mg resulted in a reduction of the CDASI by at least 4 points (12.9 on average) in 7 out of 8 participants, i.e. a response rate of 87.5%;
- RNA sequencing from muscle biopsies of the 7 participants shows that apremilast suppresses 13 inflammatory signalling pathways (STAT1, STAT3, IL-4, IL-6, IL-12, IL-23, IFNγ, TNFα…);
- the treatment is well tolerated.
As a reminder, a Japanese team had published positive results of apremilast in early 2022 in 3 participants of a phase Ib trial, also in dermatomyositis with refractory skin lesions.
