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The enzyme inhibitor apremilast blocks the degradation of cyclic adenosine monophosphate (cAMP), resulting in inhibition of leukocyte production of interleukin (IL)-12, IL-23, tumor necrosis factor α and interferon-γ. The drug is under investigation for the treatment of many inflammatory diseases, including psoriasis, eczema, rheumatoid arthritis, lichen planus, dermatomyositis, Behçet disease, and cutaneous lupus erythematosus (LE).
These authors conducted an open-label, pilot study of apremilast in eight patients with discoid LE. They assessed response via the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) scoring system. Treatment was intended to continue for 85 days, but only four patients were able to complete the study (1 stopped at 4 weeks and 3 others at 8 weeks). Response was measured by a modified intent-to-treat analysis, which carried forward the last response noted. The authors report significant decreases in the CLASI score, but response was delayed. Toxicity was considered to be drug related, but it was mild and mainly affected the gastrointestinal tract. One patient's lichenoid dermatitis resolved 3 weeks after drug discontinuation, and another patient's sensory neuropathy rapidly resolved after discontinuation.
De Souza A et al. Apremilast for discoid lupus erythematosus: Results of a phase 2, open-label, single-arm, pilot study. J Drugs Dermatol 2012 Oct; 11:1224.
Comment
Although a graph of CLASI activity scores indicates improvement in four of seven patients, I could not discern such improvement in the photograph of a patient presented for demonstration, perhaps because of variations in angle, distance, and lighting. In a small study such as this, carrying forward the last observation may be statistically valid, but I wonder if it is clinically meaningful. The bottom line is that there appears to be some response of discoid lupus erythematosus to this intervention, a finding that needs validation by a larger, blinded, placebo-controlled study.