Journal
ARCHIVES OF DERMATOLOGY
Volume 148, Issue 8, Pages 890-897Publisher
AMER MEDICAL ASSOC
DOI: 10.1001/archdermatol.2012.812
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Funding
- Celgene Corp
- Abbott Laboratories
- Brickell Biotech Inc
- Centocor
- Galderma
- Medicis
- Novartis
- Stiefel
- Oregon Clinical and Translational Research Institute from the National Center for Research Resources, a component of the National Institutes of Health (NIH) [5 KL2 RR024141-04]
- NIH Roadmap for Medical Research
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Objective: To investigate the preliminary safety and efficacy of apremilast, an oral phosphodiesterase 4 inhibitor, for atopic dermatitis. Design: This investigator-initiated, open-label pilot study evaluated 2 doses of apremilast in patients with atopic dermatitis. Differential gene analysis was performed from peripheral whole blood using data before and after treatment. Setting: University-based dermatology clinical research unit. Patients: Sixteen adult patients with atopic dermatitis. Intervention: A specific phosphodiesterase 4 inhibitor, apremilast. Main Outcome Measures: The primary outcome was incidence of adverse events. Secondary outcomes included the differences in pruritus, Dermatology Life Quality Index (DLQI), and Eczema Area and Severity Index (EASI) scores between the baseline visit and end-of-study visit for each cohort. Results: The group receiving apremilast, 20 mg twice daily, displayed a significant reduction from baseline of pruritus (P=.02) and the DLQI (P=.003) at 3 months. The group receiving apremilast, 30 mg twice daily, displayed a significant reduction of the EASI (P=.008) and the DLQI (P=.01) at 3 months. At 6 months, there was a significant reduction of the EASI (P=.002), the visual analog scale (P=.03), and the DLQI (P=.03). Gene ontologic analyses comparing baseline with samples during treatment revealed alterations in immune response pathways, especially those related to cyclic adenosine monophosphate-mediated signaling. Conclusions: These results support further development of apremilast for treatment of atopic dermatitis. Larger randomized controlled studies are needed to more adequately evaluate both safety and efficacy. Limitations include the small sample size and absence of a control. Trial Registration: clinicaltrials.govIdentifier: NCT01393158
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